2018 Speaker Bios

Upstream Processing

Downstream Processing

Analytical & Quality

Formulation & Stability

Cell Therapy

Gene Therapy


Upstream Processing

Optimizing Cell Culture Technology

Sean Case, Scientist, Upstream Process Development, Novavax

Sean Case joined Novavax in 2015. As a Scientist, Sean manages the Upstream Process Development scale-up group responsible for cell culture processes from the 10 to 200 L scale. Sean received his Bachelor’s Degree in Chemical Engineering from University of Maryland and a MBA from Loyola University in Maryland.

Maria Choi, Engineer I, Cell Culture Development, Biogen

Maria is an Engineer I in the Cell Culture Development department at Biogen with over 2 years of experience in upstream development. Maria received a Bachelor’s degree in Chemical Engineering from Tufts University.

Carolanne Doherty, PhD, Manager, Marketing and Sales, Valitacell

Dr. Carolanne Doherty leads Marketing and Sales at Valitacell. She holds a PhD in Molecular & Computational Biology from University College Dublin. Previous experience as project manager in UCD School of Medicine, developing tech-health applications to improve global healthcare with the Bill & Melinda Gates Foundation.

Natalia Gomez, PhD, Principal Scientist, Amgen, Inc.

Senior and Principal Scientist – Group Leader, Bioprocess Development, Pre-Pivotal Drug Substance Technologies

2013 – Present
Amgen, Thousand Oaks, CA
Senior Scientist – Cell Culture Process Development Group Leader, Process Sciences
April 2012 – December 2013
Agensys Inc, an affiliate of Astellas Pharma Inc, Santa Monica, CA
Senior Engineer - Group Leader, Early Stage Cell Culture
2006 –2012
Genentech Inc, South San Francisco, CA
Ph.D., Chemical Engineering, 2006
The University of Texas at Austin
Master of Science, Chemical Engineering, 2004
The University of Texas at Austin
Bachelor of Science, Chemical Engineering, 2002
Universidad de Los Andes, Colombia

Joan Foster, Senior Field Applications Scientist, MaxCyte

Joan has over 25 years of experience in the biopharmaceutical industry with a core expertise in cell line development. At Stryker Biotech she created cell lines and companion activity bioassays. At J&J, she created the release bioassay for GDF-5, neutralization assays, and developed a serum-free process to isolate and maintain human umbilical cord stem cells. At Batavia, she developed high productivity cell lines which enabled clients to fast-track into proof of con­cept and safety studies.

Jean-François Hamel, PhD, Research Engineer & Lab Director, Chemical Engineering, Massachusetts Institute of Technology (MIT)

Dr. Hamel is a biological and bioprocessing engineer with extensive experience in both upstream and downstream processing.

Jean-François Hamel loves to share his passion for biological and bioprocessing engineering with academic students and professionals. He is a hands-on teacher in MIT’s Chemical Engineering Department and has been an industry consultant for more than 25 years.

Jean-François has studied original upstream and downstream problems in varied microbial and cell culture processes, at the bench (down to µL) and pilot scale (up to 1,500 L), and integrated advanced analytical technologies for process improvement. In his teaching and research Jean-François has had the opportunity to beta-test or evaluate novel technologies, such as the first rock-bed single-use bioreactor and portable microbial flow cytometer, in-situ glucose and O2/CO2 optical sensors, auto-samplers, modular analyzers, expanded-bed chromatography, and computer simulation tools. His current projects focus on biofuels from microalgae and yeast, vaccine antigen and monoclonal antibodies from mammalian cells, stem cells, and proteins from microbes, which have been studied in traditional or single-use bioreactors.

Jean-François received a master’s degree in biochemical engineering from MIT, and a PhD from the Pierre and Marie Curie University in Paris (part of Sorbonne Universités). He is enthusiastic about joining the BETC instructional staff, contributing to the center’s original course offerings, and working with the course participants.

Christoph Herwig, PhD, Professor, Bioprocessing Engineering, Vienna University of Technology (TU Wien), and Founder and Scientific Advisor, Exputec GmbH

Dr. Herwig possesses extensive research experience in quantification, error detection, and identification of bio-process performance, including application of novel techniques for on-line monitoring & control. In addition, he has comprehensive research understanding in microbial physiology and strain characterization tasks using dynamic process conditions. His background includes thorough experience in managing complex engineering projects with up to 40 team members inside functionality, time and cost in biopharmaceutical industry. Dr. Herwig’s PhD comes from École polytechnique fédérale de Lausanne (EPFL) in Bioprocess Engineering.

David T. Ho, Senior Scientist II, Research and Development, Irvine Scientific

David T. Ho received his B.S. in Molecular and Cell Biology from U.C. Berkeley and his Ph.D. in Biological Sciences from the U.C. Irvine. Prior to joining Irvine Scientific in 2014, David had worked over 10 years in the biopharma industry working on antibody engineering and protein expression. As a Senior Scientist at Irvine Scientific, David is currently establishing new technologies in R&D for developing new products and services.

Devika Kalsi, PhD Student, Chemical and Biological Engineering, The University of Sheffield

Devika is a final year PhD student at the University of Sheffield under the supervision of Prof. David James. The author is investigating high throughput media development for improving upstream processes in the biopharmaceutical field. The author’s PhD project is in partnership with Valitacell, a biotechnology company providing technologies to deliver faster and cheaper bioprocessing of therapeutic drugs.

Michael Laird, PhD, Senior Director & Principal Scientist, Process Development, Genentech, Inc.

Mike’s group is responsible for clinical and commercial CHO and E. coli cell line development, reagent production, early (Tox/Ph1) and late-stage (Ph3/commercial) process development, process validation, tech transfer, and GMP production of therapeutic candidates. Mike received his PhD in Microbiology from the Arizona State University in 1996, and did his post-doc at Genentech from 1996 to 1999. Mike spent 6 years at Human Genome Sciences, Inc., in positions of increasing responsibility in process development before returning to Genentech in 2005. Mike has authored 36 peer-reviewed publications, six patents and two book chapters.

Ricardo Lewis, MSc, MS&T Associate Scientist, Manufacturing Sciences & Technology, Bristol-Myers Squibb Co.

Ricardo is an Engineer/Scientist in the bio pharmaceutical industry who specializes in process analytical technology to improve ensure robustness in cell culture manufacturing as metabolomics process monitoring. His current work involves Raw Material characterization of media for current generation CHO cell line upstream processing. His Masters Degree in Pharmaceutical Engineering comes from the New Jersey Institute of Technology.

Weimin Lin, PhD, Principal Scientist, Cell Culture Development, Ambrx, Inc.

Dr. Lin possesses 18 years in mammalian cell culture process development/optimization, tech transfer and clinical manufacturing operation experience. She received her PhD from Georgia State University in Cellular Physiology.

Kyle McHugh, PhD, Research Scientist, Upstream Biologics Process Development, Bristol-Myers Squibb Co.

Dr. McHugh received his PhD in Chemical and Biological Engineering from the University of Delaware for his contributions to the development of cell culture models of neurodegenerative disease. More recently, he has been working in Upstream Biologics Process Development at Bristol-Myers Squibb in Devens, MA where he has supported the development of multiple therapeutic protein projects.

Paula Meleady, PhD, Associate Director, National Institute for Cellular Biotechnology, Dublin City University

Graduated in 1997 with a PhD in Cell Biology from Dublin City University (DCU), Dublin, Ireland. In 2007 was appointed Programme Leader of the Proteomics and Mass Spectrometry Core Facility at the National Institute for Cellular Biotechnology (NICB), DCU. Appointed Associate Director of the NICB in October 2015. Research interests are focused on the application of advanced proteomic and mass spectrometry methods to understand biological systems, in particular characterisation of recombinant mammalian cell lines (Chinese hamster ovary) in order to gain insights to improving efficiency of production of biopharmaceuticals. Also have research interests in clinical proteomics, specifically uveal melanoma and pancreatic cancer. Co-author of over 80 peer-reviewed publications and 12 book chapters to date in research areas related to proteomics, bioprocessing and cancer.

Bhanu Chandra Mulukutla, PhD, Principal Scientist, Process Development, Pfizer, Inc.

Biography unavailable

Ronan O’Kennedy, PhD, Consulting Bioprocess Specialist, ROK Bioconsulting

Dr O’Kennedy is the director and principal consultant at ROK Bioconsulting. ROK Bioconsulting provides technical and strategic support for biopharmaceutical development throughout the product development lifecycle. He has over twenty years of experience in the biopharmaceutical industry and academia working within process development and CMO organizations. Research focus include linking upstream process performance to downstream product quality and data driven process modelling in support of PAT and QbD objectives maximizing the value of process data and data re-use throughout the product lifecycle.

James M. Piret, PhD, Professor, Michael Smith Laboratories, Chemical & Biological Engineering, The University of British Columbia

The primary focus of our group is to investigate how to more efficiently understand and optimize mammalian cell bioprocesses for biotechnology and biomedical applications. The research topics range from molecular and stem cell biology to bioreactor engineering, usually within networked collaborations of biologists and engineers. I received my Doctor of Science degree from MIT in Chemical Engineering.

Silvino (Serry) Sousa, MSc, Senior Scientist, Global Protein Sciences, AbbVie

Silvino Sousa is a Senior Scientist that heads the expression scale-up laboratory in Abbvie’s Global Protein Sciences Department in Worcester MA and is responsible for production of antigen and therapeutic proteins to support discovery research. He has a Bachelor of Science degree in Biological Sciences (Gordon College) and a Master of Science degree in Molecular Biology (State University of NY at Albany). Serry has nearly 25 years of industry experience working very closely with discovery project teams in areas of molecular biology, protein engineering, gene expression and protein production as well as stable cell line generation.

Ralf Takors, PhD, Professor, Institute of Biochemical Engineering, University of Stuttgart

I am heading the institute of Biochemical Engineering (Institut für Bioverfahrenstechnik, IBVT, University Stuttgart) since July 2009. The main research topic is bioprocess development for microbial and mammalian production processes making intensive use of systems metabolic engineering and synthetic biology. Examples are the development and thorough application of metabolomics (including (13C) metabolic flux analyis, flux balance analysis etc.), analysis of transcriptional regulation patterns, development and use of structured metabolic models, experimental and in silico scale-up/scale-down studies, computational fluid dynamics and the creation of novel production platforms applying synthetic biology tools. In our labs E. coli, Corynebacterium glutamicum, Pseudomonas putida, Saccharomyces cerevisiae and Chinese hamster ovary (CHO) are currently applied. Being trained as a mechanical/process engineering at RWTH Aachen, I have gained doctoral degree in 1997. The PhD thesis, which was performed at the Forschungszentrum Juelich, covered biochemical engineering. In 2004, I finished the ‘Habilitation‘ in metabolic engineering, after I had led the fermentation group at the former Institute of Biotechnology (Forschungszentrum Juelich GmbH). Then I joined Evonik Industries AG, being responsible for bioprocess development from lab to production scale as well as for systems metabolic engineering topics.

Since 2014 I am also co-heading the group ‘Bioprozesstechnik‘ at DECHEMA e.V.

Kevin Tan, PhD, Senior Scientist, FUJIFILM Irvine Scientific Inc.

Kevin Tan is a senior scientist at FUJIFILM Irvine Scientific and works on developing and optimizing cell culture media for various industrial cell culture applications. He received his Ph.D. from the University of Washington and his B.S. from the University of California, Los Angeles.

Neil Templeton, PhD, Senor Scientist, Upstream Process Development Engineering, Merck Research Laboratories

Passionate about bringing medicine to the impoverished, Neil has utilized his talents to reduce manufacturing costs at Merck for the past 4 years. For this reason, he has focused his efforts upon increasing specific productivity and its metabolic underpinnings. In addition to his employment at Merck, he volunteers his time, travels when the opportunity presents itself, and is currently in awe by the number of goats that can climb a tree.

Jonathan Zmuda, PhD, Director, Cell Biology, Thermo Fisher Scientific

Jonathan Zmuda, Ph.D. is a Director of Cell Biology in the Life Sciences Solutions Group at Thermo Fisher Scientific in Frederick, MD (USA). Dr. Zmuda leads a team of scientists dedicated to discovering and developing new technologies for cell biology applications including protein expression, advanced cell culture and rare cell analysis to make the world a healthier, cleaner and safer place. Dr. Zmuda received his Ph.D. in Cell Biology from the University of Maryland, College Park and his undergraduate degree from Dickinson College in Carlisle, PA. 

Bioproduction: Scale, Bioreactors & Disposables

Srinivas Chollangi, PhD, Senior Scientist, Process Development, Bristol-Myers Squibb Co.

Srinivas is Manager of the Manufacturing Sciences & Process Development department at BMS. His experience encompasses the development of Antibodies (mAbs), Antibody-Drug Conjugates (ADCs), and Fusion Proteins, along with Cytokines, and Analytical & Preparative Protein Chromatography. Srinivas’ PhD in Bioengineering comes from the University of Oklahoma.

Trevor Deeks, PhD, QA/QC and GMP Consultant, Deeks Pharmaceutical Consulting Services, LLC

Trevor has 39 years of experience in pharmaceutical development, manufacturing, quality control and quality assurance. He is registered as an eligible QP under EC Directive and has also practiced as a registered Pharmacist in the UK. He now resides in Maryland and has his own consulting business. He has a Ph.D. in Peptide Chemistry and has extensive expertise in aseptic processing and in a wide range of unique and unusual biotechnology processes, including live vaccines, tissue culture products, and cell-based products.

He has practiced as a QP since 1983 and his QP experience includes commercial batch release, investigational medicinal products and “Specials”. He has established and operated Quality Systems in compliance with the European Clinical Trials Directive and with global regulatory expectations (FDA, WHO, ANVISA, etc.). He has led scale-up and technology transfer projects for large and small molecules, has managed many projects with contract manufacturing organizations, has undertaken a number of evaluations of new technologies, and has performed due diligence evaluations of such products for acquisition.

Michelet Dorceus, Bioprocess Field Application Manager, Eppendorf

Michelet Dorceus is the Bioprocess Field Application Manager at Eppendorf North America. Michelet earned his bachelor degree in biology and chemistry from Salem State University. Michelet has worked in process development and manufacturing in the biotechnology/biopharmaceutical industry for over 12 years.

Jill Fuss, PhD, Research Scientist, Molecular Biophysics and Integrated Bioimaging, Lawrence Berkeley National Laboratory

Jill O. Fuss, Ph.D., is a Research Scientist at Lawrence Berkeley National Laboratory and Founder and Chief Technology Officer of Cinder Biological, Inc. Dr. Fuss earned a B.A. in environmental science from Wesleyan University, and a Ph.D. in molecular and cell biology from the University of California, Berkeley. Her postdoctoral fellowship was performed at LBNL where she received a National Institutes of Health National Research Service Award and was named a U.S. Department of Energy Outstanding Mentor. She has received two LBNL Director’s Award for Exceptional Achievement in 2013 and 2016 and was recognized as a Berkeley Visionary in 2015.

Wei-Chien Hung, PhD, MHS, Process Development Scientist I, Late Stage Upstream Development, Alexion Pharmaceuticals, Inc.

Wei-Chien Hung holds a PhD degree majoring Chemical and Biomolecular Engineering and a MHS degree majoring Bioinformatics from Johns Hopkins University and did postdoctoral study focusing on rare-disease genetic discovery at Yale School of Medicine. His researching achievement to biological science especially in cancer biology and rare-disease has been acknowledged by Taiwanese government and he was awarded as Top Ten Young Taiwanese Oversea in 2017. Wei-Chien joined the biotechnology industry in 2017 and started as a scientist in upstream process development for therapeutic protein at Alexion Pharmaceuticals. His responsibility covers upstream development research, developing mathematical/statistical model to facilitate decision making, tech transfer/manufacturing support and preparing FDA-relevant documents such as Biologics License Application and Post-Market-Commitment.

Michelle LaFond, Senior Director, Bioreactor Scale-Up and Development, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals, Inc.

Michelle joined Regeneron in 1999 as a member of the Bioreactor Scale-Up & Development group within Preclinical Manufacturing and Process Development. She has focused her career on scale-up of CHO-expressed products (recombinant proteins, monoclonal antibodies) to pilot scale for preclinical studies, robustness testing for second generation processes, and is skilled in troubleshooting issues that arise during process scale-up. Michelle has been involved in the development and transfer of processes to Regeneron Manufacturing to produce material for early and late phase human clinical trials and has produced preclinical material for toxicology studies for over 30 programs. Michelle was a lead team member responsible for the specifications and design of Regeneron’s state of the art pilot bioreactor suite constructed in 2009 as well as lead on 2015 lab expansion design and coordination. In June 2010, Michelle was named one of Westchester County’s 40 Under 40 Rising Stars by the Business Council of Westchester and in May 2015, she was awarded the Healthcare Businesswomen’s Association (HBA) Rising Star award. Michelle graduated from University of Connecticut in December 1998 with a Bachelors of Science in Chemical Engineering.

Alfred Luitjens, Director, Cell Technology, Batavia Biosciences

Alfred Luitjens is Director Cell Technology at Batavia Biosciences. He has a profound background in vaccine development and manufacturing, with more than 30 years experience. He worked in R&D at Solvay, DSM, Crucell, had a management position at the Animal Science Group and was senior manager process architecture at GSK.

Dominique T. Monteil, PhD, Scientist II, Cell Culture, Process Science, Boehringer Ingelheim Fremont, Inc.

Dominique Monteil completed his Bachelor in Science in Biochemical engineering from the University of Maryland, Baltimore County (UMBC). After completing research projects with the NIH and FDA he moved to Switzerland to complete his PhD in Bioengineering at the École Polytechnique Fédérale de Lausanne (EPFL) under the supervision of Professor Florian Wurm. His thesis focused on the engineering of large-scale single-use bioreactors. After completing his PhD, Dominique moved to San Francisco where he currently works as a Scientist in the Cell Culture, Process Science department at Boehringer Ingelheim.

Stefan Schmidt, PhD, MBA, Head, Operations, Production, Lonza/Sanofi JV

Dr. Stefan R. Schmidt MBA, currently serves as Head of Operations at the Lonza/Sanofi JV in Switzerland. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma with overall responsibilities for development and production for more than 5 years. Before that he was CSO at ERA Biotech in Barcelona, directing the company’s R&D efforts. Prior to that he worked for 7 years at AstraZeneca in Sweden where he led the unit of Protein Sciences as Associate Director. He started his leadership career at Biotech companies in Munich where he built up protein biochemistry teams for Connex and GPC-Biotech.

Anne Tolstrup, PhD, Senior Manager, Manufacturing Sciences, Cell Culture, Biogen Manufacturing ApS

Dr Anne B. Tolstrup took her PhD in Molecular and Cell Biology at the University of Aarhus, Denmark doing cell-based interferon research, and has stayed in the field of mammalian cell culture ever since working with research, development and manufacture of Biologics. She holds the position as Sr Manager Manufacturing Sciences at Biogen Denmark, where here team responsibilities include Large Scale Process transfer, PPQs, Process improvements and troubleshooting. Prior to joining Biogen, she held positions as Director for the Cell Culture Process Development at Boehringer Ingelheim, Germany and Director for Antibody Expression at Symphogen, Denmark. In 2010, she was appointed adjunct professor at the Dept. for Systems Biology at the Danish Technical University.

Jose Vallejos, PhD, Manufacturing Scientist, MS&T, AstraZeneca

Dr. Vallejos earned his Doctorate Degree in Chemical Engineering from the University of Maryland at Baltimore County (UMBC) under the supervision of Professor Dr. Antonio Moreira and Professor Dr. Govind Rao at the Center of Advanced Sensor Technology (CAST). Dr. Vallejos is a Fulbright awarded scientist that has contributed significantly to the area of Process Monitoring and Engineering Characterization of Process Scouting Devices utilizing Non-invasive Optical Sensors. Dr. Vallejos research work in Mixing and Mass Transfer characterization of multi/single-use Process Scouting Devices (PSDs) using non-invasive optical sensors has been published in prestigious peer-reviewed scientific journals and in the Reference Book Comprehensive Biotechnology, 2nd Edition (Published by Elsevier). Additionally, he has presented his research work in Scientific National and International Meetings and Conferences. With more than 10 years of experience in the Fermentation and Cell culture Industry, Dr. Vallejos has played key roles such as Manufacturing Scientist where he led tech transfer work streams, led the Equipment Characterization studies for a new Biologics facility, authored process characterization studies to support BLA application of a new drug. Among other roles, in the past, Dr. Vallejos also managed the Manufacturing Group (including QA/QC/transportation/SCO) for a CO2 recovery plant from an ethanol fermentation process implementing state-of-the art technologies to reduce production costs by 30%.

Sharat Varma, MSc, Engineer II, Cell Culture Process Development, Genentech, Inc.

Sharat is a bioprocess engineer with considerable experience in mammalian cell culture process development for antibody and non-antibody molecules. He also has experience with Small/Large scale bioreactors; Scale up; Pilot plant; Multivariate experimental design; Statistical data analysis; Product quality comparability; Cell culture media formulations; Chemically defined media; QbD; High throughput systems; and Flow cytometry. His Master’s Degree comes from the University of Pennsylvania in Biotechnology.

Thomas Villiger, PhD, Process Expert, Biopharmaceutical Operations, Novartis Pharma SAS

Thomas is a Process Expert in large-scale GMP production, located in Huningue, France. Both his Master’s Degree and PhD come from ETH Zurich in Chemical and Bioengineering.

Yong Wang, PhD, Senior Director and Head, Process Industrialization, Process Development & Technical Services, Shire, Inc.

Yong Wang holds a PhD degree from Aarhus University, Denmark and did a postdoctoral study at Harvard University. Yong joined biotechnology industry in 2004 and started in downstream process development for antibody and immuno-conjugates. He later joined Shire in 2008 and has taken different roles with increasing responsibilities, including downstream purification, CMC management, and pilot plant management. He now leads the process industrialization group covering manufacturing support, pilot plant, PD lab operation and systems, and tech transfer.

Ping Xu, PhD, Senior Scientist I, Biologics Development, Global Product Development & Supply, Bristol-Myers Squibb Co.

I am a Senior Scientist in Early Stage Upstream Process Development, BMS in New Jersey. I have worked in BMS for over 6 years and served as upstream leads for several projects from clone selection, process development to FIH. I established scale-down models for Ambr250 and 24-Deep well plates, and played a significant role in the upstream process optimization and media optimization. Before I joined in BMS, I received Ph.D. in Chemical & Biomolecular Engineering from University of Delaware, followed by a postdoctoral position at Weill Cornell Medical College.

Optimizing Cell Line Development

Niall Barron, PhD, Professor, Biochemical Engineering, National Institute for Bioprocessing Research and Training (NIBRT), University College Dublin

Niall Barron obtained a BA(Mod) in Microbiology from Trinity College Dublin and PhD in Applied Microbiology/Biochemistry from the University of Ulster in 1997. He spent three years at Baylor College of Medicine as a postdoctoral scientist working on genome engineering strategies to study nuclear steroid receptor function. He then returned to Ireland to work on stem cell engineering at Dublin City University. Subsequently, as a senior scientist in DCU, he was instrumental in growing the mammalian cell engineering group with a specific focus on the production of recombinant therapeutic proteins. He was appointed NIBRT Principal Investigator and Professor of Biochemical Engineering in the School of Chemical and Bioprocess Engineering in UCD in 2017.

Zhuo Cheng, PhD, Research Scientist, Molecular and Cell Biology, Bioprocess R&D, Eli Lilly and Company

Dr. Cheng possesses over nine years of experience in molecular biology and genetic engineering techniques. She is specialized in protein biochemistry: protein overexpression and purification, stability optimization, structure analysis, ligand binding, protein-protein/DNA interactions, modifications, signal transduction, and has authored 5 peer-reviewed publications. Dr. Cheng was awarded a patent on the development of a reporting system for tumor necrosis factor alpha. She received her PhD in Biochemistry from Indiana University Bloomington.

Valentina C. Ciccarone, PhD, Principal Scientist, Cell Line Development, Macrogenics, Inc.

Dr. Ciccarone has been a Principal Scientist at MacroGenics, Inc. since 2002. She is responsible for the development of stable cell lines for production of engineered, humanized antibodies and multi-specific proteins targeting tumor, auto-immune, and infectious disease markers. She is also responsible for transient protein expression in mammalian cells. Dr. Ciccarone was a Section Leader and Principal Scientist at Life Technologies from 1990 to 2002, responsible for the development of gene delivery and gene expression technologies in eukaryotic cells including Lipofectamine 2000, Bac-to-Bac Baculovirus Expression System and other transfection and expression technologies. She received her Ph.D. in Cell Biology from Fordham University and Sloan Kettering Cancer Center in New York.

Zhimei Du, PhD, Director, Cell Line Development, Biologics Process Development & Clinical Manufacturing, Merck Research Labs

Zhimei Du is currently the director of Merck Bioprocess. She earned a Ph.D. from Cornell University Medical College, in the Immunology Program, studying the signaling crosstalk during inflammation. After graduation, she joined Robert G. Roeder’s laboratory at Rockefeller University, studying transcriptional regulation mechanism and epigenetic effects during B cell development. After three years, she was recruited by Regeneron’s antibody engineering group, focusing on bi-specific Ab development. Later, she joined Amgen’s Cell Sciences & Technology department, focusing on cell line development and process development, and then became the Upstream process lead at Teva Pharmaceuticals.

Ted Eveleth, CEO, HocusLocus Inc.

Ted Eveleth as CEO of HocusLocus Inc has been working on developing a novel cell line selection approach originally conceived in conjunction with the Austrian Center for Industrial Biotechnology and with the support of the National Science Foundation and the National Institutes of Health.

Thomas Kelly, Scientist, Cell & Developability Sciences, Janssen R&D

Tom Kelly is a Scientist in the Cell & Developability Sciences group at Janssen R&D located in Spring House, Pennsylvania. Since joining the group in 2003, his focus has been on generating manufacturing cell lines that secrete protein with desirable product quality attributes. He received his BS in Chemical & Biomolecular Engineering from the University of Pennsylvania in 2003. While an undergrad, he worked at the Wistar Institute helping to identify oncogenes in the subtelomeric region of the genome.

Daniel Kordella, MSc, Associate Scientist, Cell Line Development, NIH/NIAID

I have been part of the Cell Development Group at the Vaccine Research Center for two years. While in this position, I have obtained a MSc in Biomedical Science from Hood College, Maryland. I have also been a post-bac intern at the National Cancer Institute, and was an instructor of high school biology and chemistry for eight years.

Claus Kristensen, PhD, CEO, GlycoDisplay Aps

Claus translates the science of Glycomics into optimizing and producing complex biologics. He is founder and runs Glycodisplay Aps, where targeted cell engineering is used to modify glycans on proteins and thus develop novel glyco-optimized biologics. Claus has extensive management experience and network within mammalian production cell line development and his track record include a number of biologics candidates moving into clinical trials and the marketed product NovoEight (Novo Nordisk).

Philip Probert, PhD, Senior Upsteam Scientist, Biologics, The Centre for Process Innovation (CPI)

Philip is a Senior Scientist and Manager of the Upstream team. He is an experienced scientist with diverse research experience including process development, cellular and liver toxicology and applied NGS. Philip received his PhD from Newcastle University in Toxicology.

Volker Sandig, PhD, CSO, Probiogen AG

Volker Sandig, Chief Scientific Officer at ProBioGen takes responsibility for the company’s Cell Line Development program. With his group, he co-developed the CHO-Freedom Kit with LTC (now Thermo-Fisher) and was instrumental in the creation of GlymaxX and other Glycoengineering technologies. In addition, his work aims at modernizing vaccine manufacturing with new cell lines derived from primary cells and packaging systems for a wide range of viruses and viral vectors.

Neal Schilling, PhD, Senior Scientist, Process Sciences, CHO Cell Line Development, AbbVie Bioresearch Center

Dr. Schilling is currently a Senior Scientist in the CHO Cell Line Development group at AbbVie where he has focused on new technology evaluation. Prior to joining AbbVie, he served as Director of Process Development and Characterization for Heat Biologics, a small clinical stage biotech focused on developing cell-based allogeneic cancer vaccines. Dr. Schilling received his Ph.D. from Dartmouth Medical School from the lab of Dr. David Robbins, where he studied the role of Hedgehog ligand processing in development and disease. 

Stefan Seeber PhD, Principal Scientist, Molecule & Cell Line Development, Roche Innovation Center Penzberg

Stefan is principal scientist and project leader in pRED (Roche Pharma Research and Early Development). He has been active in antibody and cell line development since 1997. In this function he discovered several therapeutic antibodies through all phases from the beginning until entry into human. This included standard antibodies and novel complex format antibodies. In previous positions at Boehringer Mannheim GmbH he worked in oncology projects, developed non-viral and viral vectors for gene therapy programs and tools for molecular biology. Dr. Seeber received his Ph.D. in Biology from the Eberhard Karls University in Tuebingen, Germany.

Joseph Shiloach, PhD, Director, Biotechnology Core Laboratory, Intramural Research, NIDDK/NIH

Dr. Shiloach heads the Biotechnology Core Lab at the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The Laboratory’s main interest is production and purification of biological products from both prokaryotes and eukaryotes of native and recombinant strains. The Lab’s work involves all aspects of this process including research, development, and production based on growth optimization, production scale-up and product recovery processes. They concentrate on protein production and purification with an emphasis on scaling up. One of the current research topics is aimed to achieve better understanding of the growth behavior and metabolism of both E. coli and several mammalian cell lines. The objective is to be able to overcome specific difficulties in the growth and the production process by modifying the properties of the producers. This work involved gene transcription and expression analysis as well as cells transfection and mutation. A recent achievement is identifying genes involve in mammalian cell adhesion, which allow us to modify the way the cells grow. Dr. Shiloach received his Ph.D. from Hebrew University in Jerusalem.

Leyu Wang, PhD, Senior Scientist II and Project Leader, Global Protein Sciences – Biologics, AbbVie Bioresearch Center

Dr. Wang is a Project Leader and Senior Scientist at AbbVie Biologics. Before joining AbbVie in 2010, he worked at Pfizer for 6 years focusing on protein expression and engineering enabling small molecule discovery. He got his Ph.D. from NYU and postdoctoral training at Harvard University.

Ron Weiss, PhD, Professor, Biological Engineering, Massachusetts Institute of Technology (MIT)

Ron Weiss is Professor in the Department of Biological Engineering and in the Department of Electrical Engineering and Computer Science at the Massachusetts Institute of Technology, and is the Director of the Synthetic Biology Center at MIT. Professor Weiss is one of the pioneers of synthetic biology. He has been engaged in synthetic biology research since 1996 when he was a graduate student at MIT and where he helped set up a wet-lab in the Electrical Engineering and Computer Science Department. After completion of his PhD, Weiss joined the faculty at Princeton University, and then returned to MIT in 2009 to take on a faculty position in the Department of Biological Engineering and the Department of Electrical Engineering and Computer Science. The research pursued by Weiss since those early days has placed him in a position of leadership in the field, as evidenced both by publications from his lab as well as a variety of awards and other forms of recognition. He pursued several aspects of synthetic biology, including synthesis of gene networks engineered to perform in vivo analog and digital logic computation. The lab focuses both on foundational research, e.g. creating general methods to improve our ability to engineering biological systems, as well as pursuing specific health related applications where synthetic biology provides unique capabilities.

Yizhou Zhou, PhD, Scientist II, Cell Culture Development, Biogen

Yizhou Zhou is currently a Scientist in the Cell Culture Development Team of Biogen. She is responsible for vector construction, molecular assay support, and cell line optimizations. She obtained Ph.D. in Molecular Biology at the University of Michigan.

Downstream Processing

Continuous Processing in Biopharm Manufacturing

Meredith Curran, Msc., Culture Process Development, Pfizer

Meredith Curran is a Scientist in the Culture Process Development Group at Pfizer with over 10 years of industry experience. She earned her BS in Chemical Engineering and her MS in Biotechnology Engineering from Tufts University.

Patrick Gilbert, PhD, Research & Development Manager, Agarose, Purolite Life Sciences

Dr Gilbert joined Purolite in 2011, and initially worked on synthetic resins for industrial and life science applications. From summer 2013, Dr Gilbert has been working on the development of the Praesto resin platform and now leads a dedicated R&D group in Purolite focused on improving agarose resin performance.

Vicky Goralczyk, PhD, Scientist USP, Cell Line and Bioprocess Development, Glycotope GmbH

2010: Doctoral Thesis, topic: development of a bioreactor for perfused sponge-like ceramic matrices

2011-2015: Product manager for fertility products

Since 2016: scientist in USP at Glycotope, managing continuous cultivation

Since 2018: director cell line and bioprocess development at Glycotope

Andrew Grube, Sr. Research Associate, Upstream Process Development, Codiak Biosciences

Andrew Grube is a process development specialist in upstream biologics production. He graduated from Northeastern University with a B.S. in Chemical Engineering and a minor in Biochemical Engineering in 2013. He has worked for Genzyme (now Sanofi) and Acceleron Pharma as a co-op in upstream process development, and for Biogen as an upstream process development engineer prior to his current position at Codiak Biosciences. He is experienced in working with mammalian cell culture in batch, fed-batch, and perfusion processes in both development and GMP environments.

Xuezhen (Connie) Kang, PhD, Principal Scientist, Continuous Manufacturing Skill Center, Sanofi

Xuezhen (Connie) Kang obtained her Ph.D. degree in Biochemical Engineering from University of Maryland. After that, Connie joined Genzyme Corporation to develop purification process for therapeutic proteins. She developed purification processes for many therapeutic proteins including antibodies, enzymes and hormones. Currently Connie works for the Continuous Manufacturing Skill Center at Sanofi, and is responsible for developing continuous and integrated downstream bioprocesses.

Stefano Menegatti, PhD, Professor, Chemical and Biomolecular Engineering, North Carolina State University

Dr. Menegatti has earned his Ph.D. in Chemical Engineering with a thesis on synthetic ligands for protein purification under the supervision of Dr. Ruben Carbonell. After a 2-years postdoctoral position in drug delivery with Dr. Samir Mitragotri, Dr. Menegatti has joint the Chemical Engineering faculty at NC State University, where he works on downstream bioprocessing, drug delivery, and stimuli-responsive colloids.

Thomas Mueller-Spaeth, PhD, Prof, Institute of Chemical and Bioengineering, ETH Zurich

Biography unavailable

William Nicholas Napoli, Scientist, Bioprocess Technology and Expression, Bioprocess Development, Merck & Co., Inc.

William Napoli earned his bachelor’s degree in chemical engineering from Bucknell University in 2012. Since 2012, he has worked for Merck & Co, in bioprocess technology development specializing in upstream technologies including intensified perfusion to support continuous processing, high throughput screening and aseptic sampling.

Michael Phillips, PhD, Director, Next Generation Processing R&D, MilliporeSigma

Dr. Michael Phillips is currently the Director of Next Generation Processing R&D at MilliporeSigma where he is responsible for identifying and developing innovative upstream, downstream, and process analytical technologies that enable process intensification for mAb processing, including integrated, connected, and continuous processing. Dr. Phillips has more than 26 years of experience at MilliporeSigma developing new bioprocess technologies and applications. Dr. Phillips holds a PhD in chemical engineering from Rensselaer Polytechnic Institute.

Martin Poggel, PhD, Manager, Biotech Projects, Bayer AG

Has a PhD in Bio Engineering from the Technical University of Aachen (RWTH Aachen). He was first employed with Sanofi-Aventis as Head of Pilot Plant Downstream Processing (DSP) working on insulin and monoclonal antibody processes. He joined Bayer in 2005 and has worked in different areas, mainly in the field of biotechnology development (USP/DSP) and also as a Life Science Key Account Manager.

In his current position at Bayer, he is accountable for global programs to increase understanding in biotech processes (e.g. rFVIII and mAb production) and to implement new production concepts. In this capacity he is responsible for the implementation of a new concept (MoBiDiK technology) for continuous antibody production.

Mark Schofield, Senior Research & Development Manager, Pall Biotech

Mark Schofield has a Bachelor's degree from the University of Edinburgh and received a molecular biology Ph.D from the University of Dundee. Mark and his team work on a variety of projects including chromatographic modelling, process economics analysis, process development for the continuous chromatography platform and virus clearance.

Rustin Shenkman, PhD, Senior Development Engineer, BDS Process Development, Shire

(from LinkedIn) I serve as a project development lead for early- and late-phase mammalian cell culture processes. As a subject matter expert I’m responsible for cell culture process development and characterization. As a manager I am responsible for defining timeline and resource requirements and executing on project goals.

Ricardo Silva, PhD, Scientist, Animal Cell Technology Unit, iBET

Ricardo Silva received his Ph.D. degree in Chemical and Biochemical Engineering from the New University of Lisbon in 2013. His studies focused on the development and optimization of countercurrent adsorption processes for purification of biopharmaceutical products. Since 2014 he is a researcher at Animal Cell Technology Unit in iBET, pursuing the development of continuous purification processes and identification of new purification strategies for vaccines, gene therapy vectors and cell-based products.

Andrew Sinclair, PhD, President and Founder, Biopharm Services Ltd.

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and is a Fellow of the Royal Academy of Engineering

Nicholas Trunfio, PhD, ORISE Fellow, FDA

Biography unavailable

Samir Varma, General Manager, Head of Manufacturing, Enzene Biosciences

Samir has more than 17 years of experience in the Biotech Industry. Having worked at various mid-size biotech and large pharma such as Medarex, Bristol Myers Squibb, Celgene and Lupin Ltd, he has extensive experience in all aspects of development and cGMP production of therapeutic biologics. Samir holds a MS in Biochemical Engineering from Drexel University, Philadelphia and a MBA from New York University, New York. He currently heads the Manufacturing Department at Enzene Biosciences. Enzene Biosciences is a full owned subsidiary of Alkem Laboratories and is based in Pune, India

Ji Zheng, PhD, Associate Director, Biologics Drug Substance Development, Biologics Development & Manufacturing, Celgene

Ji Zheng is the Associate Director, Biologics Drug Substance Development, Biologics Development & Manufacturing at Celgene. He has 17 years of experience in biologics process development and has held several roles for process development science at Bristol-Myers Squibb, Allergan and Tanox. He has delivered over 40 scientific papers and posters and received his Ph. D. in Biotehcnology and Bioengineering from Kyoto University, Japan.

Advances in Purification & Recovery

Ulrich Ernst, PhD, COO, Amunix

Dr. Ulrich Ernst is the Chief Operating Officer at Amunix. Dr. Ernst has previously held senior level positions with several global biopharmaceutical companies and brings over 25 years of experience in successfully moving products from clinical stage development to market approval. As VP/Site Head of Alexion’s commercial Rhode Island manufacturing facility, Dr. Ernst led the startup efforts to gain FDA, EMA and rest-of-world site approvals for SOLIRIS®. As Vice-President of Commercial Manufacturing at ZymoGenetics, Dr. Ernst helped create the infrastructure for the commercial manufacturing/medical device enterprise which launched the RECOTHROM® hemostasis franchise. Additionally, Dr. Ernst has held senior operations positions with JNJ and Baxter, where he contributed to the product development and global launches of NATRECOR® and ADVATE®, respectively. Dr. Ernst began his career at Regeneron and Somatogen where he contributed to development efforts on novel protein therapeutics. Dr. Ernst received a B.S. in Chemical Engineering from the University of Minnesota and a Ph.D. in Chemical Engineering from Lehigh University in Pennsylvania. Dr. Ernst is broadly published and is an inventor on several patents.

Xindu Geng, PhD, Director, Institute of Modern Separation Science, Northwest University

Prof. Xindu Geng has completed his BS at the age of 19 years from Northwest University (Xi’an) and Faculty Member of Department of Chemistry, University of Minnesota in 1982~1983; Visiting Professor of Purdue University separately at Department Biochemistry in 1982~1984 and Department Chemistry in 1985~1996, and Visiting Professor of Chemistry Department of Creighton University. He is the director of Institute of Modern Separation Science of Northwest University. He has published more than 260 papers in reputed journals and four books and and thus won 2 awards in National Scientific and Technology Rank of China; 5 awards in first rank of Provincial and States in Chind. He is serving as an editorial board member of repute Journals, Biomedical Chromatography, Separation Science, and Journal of Chinese Chromatography.

Mahsa Hadidi, PhD, Process Engineer III, MSAT, Sanofi

Mahsa Hadidi is a Process Engineer III in Sanofi Manufacturing Science and technology (MSAT) focusing on UF/DF of highly concentrated mAbs. She graduated from Penn State University with a PhD in chemical Engineering.

Partha Hazra, PhD, General Manager, Process Development Group, Biocon Research

Completed PhD in Biochemistry from Jadavpur University Kolkata, India and postdoctoral studies from University of California, San Diego, USA. I have more than 17 years of experiences of downstream process development, scale up and technology transfer of recombinant therapeutics. Presently, I am working as General Manager and CMC lead of multiple projects in research division of Biocon, India and leading a process development and technology transfer group. I have published more than 15 papers and 10 process related patents granted in US and EU

Ionela Iliescu, Msc, Scientist I, Technical Development, Biogen

Process Development Scientist at Biogen for 19 years. Coordinate purification development activities for monoclonal antibodies, fusion proteins, and other types of biological therapeutics. Lead for purification strategy, process development for internal and external programs, process characterization and process validation activities.

Alois Jungbauer, PhD, University of Natural Resources and Life Sciences, Vienna

Alois Jungbauer is professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Dep. Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules.

He has more than 300 publications on recombinant protein production and bioseparation, 15 patents and 12 book contributions and a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering.

Jonas Lee, PhD, Scientist, Protein Technologies, Amgen

Jonas is a scientist at Amgen Department of Therapeutics Discovery purifying membrane proteins. Jonas got PhD in University of California in Berkeley under a protein X-ray crystallographer Prof. Sung-Hou Kim studying properties of bacterial chemotaxis receptors, and he completed a postdoc in California Institute of Technology under a membrane protein X-ray crystallographer Prof. Doug Rees, delineating the structure and function of a heavy metal ABC transporter.

Zhi Li, PhD, Scientist, MS&T, Bristol-Myers Squibb

Zhi Li is a downstream scientist in Manufacturing Sciences and Technology at Bristol-Myers Squibb. He has 3 years of experience supporting commercial manufacturing of monoclonal antibodies and fusion proteins in a cGMP facility. Prior to joining BMS, he performed post-doctoral research at Cornell University. He received his PhD in 2012 from University of Illinois at Urbana-Champaign and his Bachelor’s degree in 2006 from Tsinghua University.

Duarte L. Martins, PhD Student, Laboratory of Protein Technology & Downstream Processing, Dept of Biotechnology, University of Natural Resources & Life Sciences, Vienna

Duarte L. Martins completed his master project at the Animal Cell Technology Unit, iBET/ITQB (Portugal) in 2013. He joined the CMO Novasep (Belgium) in 2014 as Process Development Engineer, where he worked on purification processes for vaccines and gene therapy vectors. Since 2016 he is a PhD student in Prof. Jungbauer’s research group at the University of Natural Resources and Life Sciences, Vienna (Austria). His current research interests include continuous processing and virus clearance.

Cristina Peixoto, PhD, Head, Downstream Process, Animal Cell Technology Unit, iBET

Cristina Peixoto graduated in Applied Chemistry (Branch Biotechnology), New University of Lisbon and holds a PhD in Engineering Sciences from Instituto de Tecnologia Quimica Biológica (ITQB) from New University of Lisbon. She is invited lecturer since 2010 in several PhD programs. The main research activities are related with the development and optimization of downstream process of different products with applications as therapeutics or vaccines associated with several biological systems. She published over 50 manuscripts in refereed international journals. Since 2009, Cristina Peixoto is responsible of the downstream process development laboratory at Animal Cell Technology Unit at IBET (Instituto de Biologia Experimental e Tecnológica) and also Project Manager in research contract projects with Industrial partners

Fabien Rousset, PhD, Head, Bioseparations, Business Unit, DAICEL/Chiral Technologies Europe

Dr ROUSSET began his career at PALL Corporation, where he spent eight years as R&D manager for the development of chromatography, filtration membranes and filters for bioprocesses. He then joined Novasep as Technical Director, to oversee consumables technology development and continuous chromatography. In 2016, he joined DAICEL Corporation and its wholly owned subsidiary, Chiral Technologies Europe, the worldwide leader in chiral chromatography. He currently holds the position of Head of Bioseparations Business Unit.

Keith Selvitelli, PhD, Biogen

Keith Selvitelli is a senior associate scientist in the Drug Product, Engineering and Technology organization in Biogen with 15 years of experience in downstream protein purification and chromatography development for products at all phases of a biotherapeutics lifespan. At Biogen he acutely balances the need for innovation with process manufacturability

Vitali Stanevich, PhD, Janssen Pharmaceuticals

Vitali Stanevich, PhD is Process Development Scientist in Janssen Pharmaceuticals (Malvern, PA). He received B.S. and M.S. degrees in Biochemistry from International Sakharov Environmental University (Minsk, Belarus) in 2006 and 2007 respectively. He continued his education at University of Wisconsin – Madison, where in 2013 he was awarded PhD degree in Biophysics. After 3 years of PostDoc at Baylor College of Medicine, in 2016 Dr. Stanevich joined “Process Development and Manufacturing Science” Department of Janssen Pharmaceuticals. His current work is focused on development of robust downstream purification processes for production of biopharmaceuticals.

Lizy Kaiyan Tang, MSc., Merck

Lizy graduated in Shanghai Medical University in China before came to the States for her master’s degree. Upon graduation she joined Amgen thousand oaks analytical group under process development department, where she matured as an analytical chemist specialized in liquid chromatography and capillary electrophoresis supporting various functions wthin monoclonal antibody process development, regulartory filing and manufacturing. She then brought her extensive experience to Merck focusing on process analytical technology marching towards quality by design and real time release of large molecule manaufuring stage.

David W. Wood, PhD, Professor, Chemical and Biomolecular Engineering, Ohio State University

David Wood is a Professor of Chemical and Biomolecular Engineering at The Ohio State University. He received his undergraduate degree from Caltech in 1990 with a double major in Chemical Engineering and Molecular Biology, and has worked on Neupogen® manufacturing at Amgen and downstream process development at Bristol Myers Squibb. He completed his PhD in 2001 at Rensselaer Polytechnic Institute, and held a previous faculty position at Princeton, where he received the NSF Career Award. He has significant expertise in protein purification using self-cleaving tag methods, and their potential applications in the biopharmaceutical industry.

Adam Zwolak, PhD, Janssen R&D

Adam Zwolak, Ph.D. is a senior scientist in the Multispecifics Engineering group at Janssen R&D. His research focuses on improving the stability and modulating function of antibodies through engineering. He earned a Ph.D. in Structural Biology from the New York University of Medicine in partnership with the National Heart, Lung and Blood Institute. He performed postdoctoral research at the University of Pennsylvania School of Medicine.

Detection, Characterization and Control of Impurities in Biologics

Cassandra Braxton, PhD, Senior Manager, Global QC Virology, Biogen

Cassandra is the lead for Global Quality Control Virology at Biogen, located in Research Triangle Park, North Carolina. Cassandra is spearheading efforts to implement several rapid methods for adventitious virus detection in addition to leading global viral safety initiatives at Biogen. She joined Biogen in 2014 and received her Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill, completed a Postdoctoral fellowship at Wake Forest University and is currently pursuing her MBA at the Kenan-Flagler Business School in Chapel Hill, NC

Kevin Carrick, PhD, Director, Science & Standards, Global Biologics, United States Pharmacopeia (USP)

Dr. Carrick is a Director of Science & Standards in USP’s Global Biologics Department. Kevin and his team work with the four USP Expert Committees and multiple Expert Panels for biologics to develop documentary standards (chapters and monographs) and Reference Standards that support biopharmaceutical quality assessment. Prior to joining the USP he worked at ProMetic BioTherapeutics as the Associate Director of Product Characterization where he directed the characterization of several drug substances in preclinical development. Dr. Carrick has also held positions, as group leader for protein characterization at the American Red Cross and as an Associate Director at the University of North Carolina at Chapel Hill Proteomics facility.

Richard Cavicchi, PhD, Research Physicist, Biomolecular Measurement Division, Material Measurement Laboratory, National Institute of Standards and Technology

Dr. Richard Cavicchi earned his Ph.D. in physics at Cornell University, was a post-doc at AT&T Bell Labs, and then joined the research staff at the National Institute of Standards & Technology in 1989. His work has covered a variety of electrical and optical measurements related to microfabricated sensors. Present research focuses on characterization of protein aggregates.

David Cetlin, Founder & CEO, MockV Solutions LLC

David Cetlin is the founder and C.E.O. of MockV Solutions, Inc. A company dedicated towards establishing and commercializing a novel series of BSL-1 compatible viral clearance prediction kits. These kits will be designed to benefit downstream purification process scientists as they develop, characterize, and validate their downstream purification processes. Prior to MockV, David helped develop, characterize, and validate several monoclonal antibody purification processes at Human Genome Sciences/Glaxo Smith Kline and has worked with various separation techniques including all modes of column chromatography, tangential flow filtration, nano-filtration. During his time at HGS/GSK, David routinely designed and executed process related studies including resin lifetime studies, viral clearance studies, design of experiment (DOE) studies, etc. He also participated in the technology transfer of several processes to manufacturing scale cGMP facilities, provided on-site support during cGMP campaigns and conducted investigational studies to support deviations that occurred during such campaigns. He also explored and introduced new technologies and ideas to his purification team including a single pass mode of operating tangential flow filtration, a salt tolerant ion exchange membrane, and a pre-protein A depth filter for improving protein A lifetime.

Audrey Jia, PhD, Principal Consultant, Regulatory Affairs, DataRevive LLC, Ex-FDA, Office of Biotechnology

Audrey Jia was a exFDA office of biotechnology full time reviewer from 2009 to 2015. During her time in FDA, she was responsible for IND/BLA review of biological products including antibody fragments, fusion proteins, antibody drug conjugate, combination products, and radiolabeled antibodies. She is specialized in both novel proteins/antibodies and biosimilar products reviews. She is currently an independent consultant. Dr. Jia holds a Master degree in Bioscience Regulatory Affairs from Johns Hopkins University, and a Ph.D. degree in Microbiology and Molecular Genetics from Emory University. Prior to that, Dr. Jia obtained her Bachelor degree of Medicine from Peking University.

Caitlin Kramer, MSc., Associate Scientist, Process Development Analytics, Bristol-Myers Squibb

Caitlin Kramer is an Associate Scientist in the Process Development Analytics Impurities Group at BMS in Devens. She has been with the company since early 2017. She holds a MSc in Chemistry from Northeastern University in Boston.

Kate Linterman, Business Development, Oritain

Kate holds a BSc (Hons) degree from the University of Otago, New Zealand. After graduating she spent four years researching viral gene therapy and T-cell therapy. In 2012 she joined the world of scientific sales, most recently with Thermo Fisher Scientific. In 2018 she joined Oritain's London-based team.

Edward Mee, DPhil, Senior Scientist, Live Viral Vaccines, Virology, National Institute for Biological Standards and Control

Edward Mee obtained a D.Phil in Clinical Medicine from the University of Oxford in 2005 and began investigating the influence of host genetics on infection with Simian Immunodeficiency Virus. Since 2013 he has worked in the Live Viral Vaccines section of NIBSC, performing control testing of rotavirus and MMR vaccines, adverse event investigations and related research. He is also developing reference materials to support method development for improved adventitious virus screening of vaccine and biotherapeutic products, intermediates and raw materials.

Diane Paskiet, MS, Director of Scientific Affairs, Scientific Affairs and Technical Services, West Pharmaceutical Services

Diane Paskiet has over twenty years of experience with qualifying packaging and delivery systems for use with pharmaceutical products. She is Currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of packaging systems. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is a co-recipient of the United States Pharmacopeia (USP) award for Innovative Response to a Public Health Challenge and Expert Committee member. She serves as Vice Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and Chair of Parenteral and Ophthalmic Drug Product Leachables and Extractables Working Group.

Jeremy Pike, MS, Development Scientist, Early Stage Process Development, Alexion Pharmaceuticals

Jeremy Pike is currently a senior scientist in the Early Stage Development Group at Alexion Pharmaceuticals, leading efforts to generate high-yielding, scalable, and robust upstream and downstream processes for biotherapeutics. He has worked at Alexion for 15 years, holding technical roles in Early and Late Stage Process Development groups. Prior to joining Alexion, Jeremy worked as a Molecular Biology Associate for Vion Pharmaceuticals, working on various cancer therapies. He received his M.S. in Cell and Molecular Biology from the University of Vermont in 1998.

Derek Ryan, PhD, Senior Scientist, Analytical Development, KBI Biopharma, Inc.

Derek Ryan Ph.D is currently a Senior Scientist in the Analytical Development Department at KBI Biopharma, Inc. He has worked at KBI Biopharma for 5 years after completing his post-doctoral studies at the University of North Carolina at Chapel Hill.

Anne Stokes, PhD, GSK Fellow and Director, TSE and Virus Control, GMP Operations, Biopharmaceutical Development and Supply, GlaxoSmithKline

Dr. Anne Stokes is a GlaxoSmithKline (GSK) Fellow, a member of the Council of Fellows and currently the Director of TSE and Virus Control within GMP Operations, Biopharmaceutical Product Development and Supply in Pennsylvania USA. For the past 20 years, she has worked for GSK, in the development and manufacture of Biopharmaceuticals and cell and gene therapy products. She has experience in Cell Banking and TSE and virus safety of Biopharmaceuticals and is responsible for the oversight of TSE and virus safety of a GMP manufacturing facility. She received a Doctorate in Viral Immunology whilst at the Pirbright Institute Surrey, UK. As a Fogarty Fellow at the NIH she worked on a vaccine for human parainfluenza virus 3. She is currently a member of the PDA and ISPE.

Srivalli Telikepalli, PhD, Research Chemist, Biomolecular Measurement Division, National Institute of Standards and Technology

Srivalli Telikepalli received her B.A. in chemistry at Cornell University in 2008 and Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 2014. Her thesis work was focused on understanding the formation of protein aggregates/particles as a function of different stresses and understanding the relationship between protein particle properties and their in-vitro immune responses. Upon completion of graduate school, she started working as a Research Chemist at the National Institute of Standards and Technology in the Biomolecular Measurements Division. Currently, her work focuses on developing protein-like particle standards, primarily subvisible and visible particle standards, as well supporting the development of a monoclonal antibody reference material.

Rosemary J. Versteegen, PhD, CEO, International Serum Industry Association

Dr. Versteegen received her B.Sc. and Ph.D. degrees in Biochemistry from Glasgow University, Scotland. She held Postdoctoral scholarships at Cambridge University, England and the National Institutes of Health, working in areas of disease research. Following several years in NIH sponsored cancer research programs, she joined Life Technologies and held various key roles, both technical and business oriented, including Vice President of the GIBCO Manufacturing Facility, Vice President of Regulatory Affairs, Vice President of New Business Development and Vice President of Strategic Planning. In 2000, Dr. Versteegen became a founding partner of the Lifia Group, a consulting organization focused on helping life science and biotechnology companies grow through clearly enunciated, actionable strategic plans. Since its inception in 2006, Dr. Versteegen has been the CEO of the International Serum Industry Association, a global life science not-for-profit association. The mission of the Association is to establish, promote and assure compliance with uncompromised standards of excellence and ethics in the business practices of the global animal serum and animal derived products supply industry. The primary focus is on safety and safe use of serum and animal derived products through proper origin traceability, truth in labeling, and appropriate standardization and oversight.

Jay West, PhD, Scientist II, Process Development Analytics, Bristol-Myers Squibb

Jay West has worked 4 years at Bristol Myers Squibb in Process Development Analytics at Devens MA. Previously he was a postdoctoral scientist doing drug discovery at Northeastern University, obtained his Ph.D. in Biochemistry from Boston College, worked in pilot scale manufacturing at Regeneron Pharmaceuticals, and obtained an M.S. in Physical Chemistry from University at Albany and B.S. in Chemistry from RPI.

Analytical and Quality

Host Cell Proteins: Detection, Analysis & Control

Eric Bishop, Vice President of R&D Research and Development, Cygnus Technologies

Eric has worked within the Biotechnology industry for 21 years. Eric was hired at Cygnus Technologies in, 2010 as the Vice President of Research and Development. His current responsibilities at the company include: business development, technical support, new product development,  custom services, along with being the Head of Research and Development Laboratory. 

Michelle Busch, PhD, Scientist, Bioanalytics Characterization, Sanofi

Ms. Busch received her bachelor's degree in Chemistry with an emphasis on Biochemistry from Montana State University in Bozeman, Montana. She spent four years at Alkermes analyzing long-acting formulations of proteins and small molecules before joining Sanofi (originally Genzyme) 12 years ago. Her current role is scientist in the Bioanalytics Characterization Group in BioPharmaceutics Development focusing on host cell protein identification and quantitation by mass spectrometry.

Erika Friedl, PhD, Quality Expert, Hematology and Transfusion Medicine, Paul-Ehrlich-Institute

Erika Friedl is currently working as quality expert (pharmaceutical quality/CMC) at the Paul-Ehrlich-Institute (PEI) in Langen, Germany. She is responsible for the evaluation of blood products, and is involved in GMP inspections. Erika is a member of the Host Cell Protein Working Party at the EDQM (European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France). Erika received her Ph.D. in biochemistry from the Albert-Ludwig University of Freiburg, Germany. She worked in the fields of virology and transcription factors and was research associate in the Department of Biochemistry at the Howard Hughes Medical Institute (UMDNJ, USA).

Feny Gunawan, PhD, Scientist, Analytical Operations, Genentech

Feny Gunawan is currently a technical development scientist in the Analytical Operations group in Genentech. She is the current process impurities global task force co-leader and process impurities analytical expert team leader. As the process impurities GTF co-leader, her goal is to enable the task force in providing harmonize guidance and strategies on the topics of process impurities across Roche and Genentech. As the analytical expert team leader, the goal is to support the technical development team by providing needed technical support in the area of Process Impurities.

Ken Hoffman, President, Cygnus Technologies

Ken founded Cygnus Technologies in 1996 to provide analytical solutions to the rapidly growing biopharmaceutical industry. During that time Cygnus has become a recognized technology and thought leader in the field of bioprocess impurity analysis developing a large menu of generic and custom Host Cell Protein assays and offering state-of-the-art orthogonal testing services. Prior to starting Cygnus, Ken worked in the clinical diagnostics field for three different companies developing automated systems and extensive menus of assays for infectious disease, metabolic disease, drugs and hormones. The most recent system was the worldwide leading VIDAS automated immunoasssay platform today owned by bioMerieux located in Marcy L’Etoile, France. Ken has his Masters of Science in Radiation Biology/Immunology, from University of Iowa, Iowa City, IA, 1976. In addition to his MS degree, Ken also holds a Certificate in Biomedical Research Management from The Harvard School of Public Health.

Caitlin Kramer, PhD, Associate Scientist, Process Development Analytics, Bristol-Myers Squibb

Caitlin Kramer is joined Bristol-Myers Squibb in February 2017. She is an Associate Scientist in the Process Development Analytics Impurities Group, where she routinely runs both commercial and in-house impurities ELISAs using automated and manual methods.

Denise Krawitz, PhD, Principal Consultant, CMC Paradigms LLC

Prior to becoming a consultant, Denise served multiple technical and team leadership roles at Genentech, BioMarin, and Ambrx. At Genentech, she was the subject matter expert for host cell protein (HCP) strategy and testing. Denise led all R&D related to HCP strategy, including development of HCP ELISAs, characterization of HCP ELISA reagents, CHO and E. coli proteomics, and implementation of orthogonal techniques to monitor HCPs. Additionally, Denise was responsible for setting the strategic direction for HCP management across the Genentech pipeline, including setting acceptance criteria, risk assessments, and authoring all regulatory documents. Denise has authored several peer-reviewed publications in the HCP field, and been invited to give presentations at multiple international conferences.

Maura Kibbey, PhD, Director, Global Biologics, U.S. Pharmacopeia

Dr. Maura Kibbey is a Director of Science & Standards in USP’s Global Biologics Department. Maura and her team work with the five USP Expert Committees and multiple Expert Panels for biologics and antibiotics to develop documentary standards (chapters and monographs) and Reference Standards that support biopharmaceutical quality assessment. Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area as well as at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences

Regina Kufer, PhD, Senior Associate Development Analytics, Roche Diagnostics GmbH

Regina Kufer is a Senior Associate at Roche Diagnostics with a major interest in proteomic mass spectrometry methods. Regina graduated with a M.Sc. in biochemistry in 2017 at University of Regensburg and CU Boulder. After graduation, Regina started working at Roche to support technical development for MCE methods and MS-based HCP characterization.

Nicholas Levy, PhD, Investigator, GSK

Biography unavailable

Emily Menesale, Senior Associate Scientist, Analytical Development, Biogen

Emily Menesale is a senior associate scientist in the analytical development group at Biogen where she has worked for the past 10 years. Emily’s work focuses on bioassay development, specifically HCP assay development and characterization methods. She received a Master of Science in Pharmaceutical Sciences from Northeastern University and a Bachelor of Science in Psychology and Neuroscience from UMass Amherst.

Veronika Reisinger, PhD, Lab Head, Biologics Technical Development and Manufacturing, Novartis

Veronika Reisinger works currently as laboratory head in the physico-chemical characterization group at Novartis Novartis-Global Drug Development in Austria. She obtained a Ph.D. in biology from the Ludwig-Maximilians-University Munich, Germany. Before joining Sandoz in 2011 as scientist in the characterization group, Veronika worked as a postdoctoral fellow in a protein biochemistry laboratory at the University of Stavanger, Norway. Her current work focuses on the mass spectrometric characterization of biopharmaceuticals and associated impurities.

Michael Schirm, PhD, Associate Director, Research & Development Proteomics, CAPRION BIOSCIENCES INC.

Michael Schirm Ph.D., is the Associate Director of the R&D Proteomics group at Caprion Biosciences. His research focused on the detection and characterization of protein glycosylation in bacterial systems. In 2005, Michael joined the MS group at Caprion where Michaels’ research interests include the development of robust and reproducible workflows for the quantification of peptides and proteins in various matrices, and the development of novel proteomics methods to solve challenging analytical problems for clients.

Jeffrey Schneiderheinze, PhD, Associate Director, Biochemistry Method Development, Regeneron Pharmaceuticals, Inc.

Biography unavailable

Suli Liu, PhD, Scientist II, Biogen

Biography unavailable

Abraham M. Lenhoff, Allan P. Colburn Professor, Department of Chemical and Biomolecular Engineering, University of Delaware

Abraham Lenhoff is the Allan P. Colburn Professor of the Department of Chemical and Biomolecular Engineering at the University of Delaware, where he has been on the faculty since 1984 and was Chair from 2012-7. He earned a Bachelor's degree from the University of Cape Town and Master's and Ph.D. degrees from the University of Wisconsin, all in chemical engineering. His research is primarily on application of principles of thermodynamics, transport phenomena, biophysics and colloid science to protein separations and phase behavior, especially chromatography and crystallization.

Michael Schirm, PhD, Associate Director, Research & Development Proteomics, CAPRION BIOSCIENCES INC.

Michael Schirm Ph.D., is the Associate Director of the R&D Proteomics group at Caprion Biosciences. His research focused on the detection and characterization of protein glycosylation in bacterial systems. In 2005, Michael joined the MS group at Caprion where Michaels’ research interests include the development of robust and reproducible workflows for the quantification of peptides and proteins in various matrices, and the development of novel proteomics methods to solve challenging analytical problems for clients.

Mindy Wan, PhD, Technical Director, Business Development, KBI Biopharma, Inc.

Dr. Mindy Wan is a Director for Technology Development at KBI Biopharma. She has obtained her Ph.D in Biochemistry from University Zurich, Switzerland. Over the past 26 years she has focused on biologics process and characterization. She currently leads an effort for an improved HCP detection strategy at KBI. Prior to join KBI, she held various leadership positions for process development and manufacturing sciences at AstraZeneca, AbbVie, and Covance Biotech.

Yi Wang, PhD, Senior Scientist, Protein Mass Spectrometry Department, Merck & Co., Inc.

More than five years of biopharmaceutical industry experience with LC-MS method development for biologics and HCPs characterization.

Ying Zhang, PhD, Senior Scientist, Analytical Research & Development, Pfizer

Ying Zhang is a Senior Scientist in the mass spectrometry and biophysical characterization group (MSBC) within Analytical Research and Development (ARD) at Pfizer. At present, Ying is responsible for the mass spectrometry based method development and characterization of protein therapeutics within Pfizer's biotherapeutics portfolio.

Christopher Yu, PhD, Principal Scientist, Genentech, A Member of the Roche Group

Biography unavailable

Accelerating Analytical Development

Tileli Amimeur, Data Scientist, Molecular Design, Just Biotherapeutics

Tileli is a Data Scientist at Just Biotherapeutics, with an MS in Electrical and Computer Engineering. She worked for 3 years at Intel in chip design, and spent several years in a Synthetic Biology lab designing and implementing a semi-automated wetlab system. Tileli is currently applying machine learning and AI methods to model elements of protein design.

Jeff Beckman, PhD, Senior Scientist, Bristol-Myers Squibb

I obtained a B.S. in chemistry from the University of Utah and a PhD in Biochemistry from the University of Colorado at Boulder where I studied the mechanisms of DNA replication fidelity. For the past seven years I have been leading the development, qualification and transfer of release methods for a variety of protein biologics, ranging from activity and kinetics methods to CE- and LC-based purity methods.

Alejandro Carpy, PhD, Laboratory Head Biochemistry, Roche Innovation Center Munich, Germany

Dr. Alejandro Carpy leads a Large Molecule Research group in pharma Research and Early Development (pRED) at the Roche Innovation Center Munich. Among his responsibilities are the protein purification, molecular assessment and in-depth biophysical characterization of therapeutic antibodies and next generation biologics. This includes the development of analytical methods and the handover to the Pharma technical development organization. He is involved in defining the analytical characterization strategy for several next generation biologics projects. He holds a PhD in Biochemistry from the University of Tübingen (Germany). Before joining Roche, he started his career at Novartis and worked at diverse sites gaining cross-functional experience in Quality, Production and Development.

Jessy Fan, PhD, Scientist, Amgen

Jessy Fan finished her graduate study in ETH Zurich, Switzerland, focusing on the mechanism of protein glycosylation. Her industry exposure started in 2012 as postdoc in Pfizer and stayed in the PKDM department as a senior scientist. She then moved to Amgen in 2016.

William Grimm, Scientist, Process Development Analytics, Bristol-Myers Squibb

William Grimm works in the process development analytics group at Bristol-Myers Squibb, and his team focuses on supporting late phase biotherapeutics. He has over five years of experience working with liquid handling automation and immunoassay development.

Joshua Laber, PhD, Postdoctoral Fellow, AbbVie

Joshua Laber recently graduated from the University of Texas at Austin where he worked on an array of projects involved in the development of proteins as therapeutics. Currently, he is in the AbbVie Postdoctoral Program and located at the AbbVie Bioresearch Center in Worcester, MA where he is investigating the effect of protein aggregates on immunogenicity.

Xinfang Li, Vice President, Process Development, MabPlex

Dr Xinfang Li, holds a Phd in Molecular Biology and Biochemistry from Peking University. Before MabPlex she was at Immunogen as a the Associate Director of Process Development. Xinfang has more than 18 years of experience in mAb and ADC research and development and lead many project groups in antibody downstream purification and antibody-drug conjugation process development.

Daniel McDonald, PhD, Researcher, Genentech

Daniel is a Senior Research Associate in Protein Analytical Chemistry at Genentech, Inc. He has over 12 years’ experience within the Pharma Technical Development division, developing analytical methods for characterization and quality control release testing. Currently he is the Characterization Scientist for an early phase therapeutic protein, while continuing various leadership roles in the development strategy of analytical methods, with a particular focus on multi-product Ion Exchange methods.

Shabnam Molloy, Senior Associate Scientist, Amgen

Currently, I am a Drug Product Technical Leader for a Phase 3 oncology program at Amgen. As lead, I am responsible for developing and delivering the final drug product presentation. Outside of the Drug Product Lead role, I serve as part of a team that leads transformative information systems initiatives to implement advanced data analytics capability across process development operations. As part of that effort, I am responsible for driving innovative solutions to improve capabilities for scientific insights, federation of data for filings, and faster information, and decision making.

Jennifer F. Nemeth, PhD, SCPM, Director, Biophysics, Structural Characterization, Biologics Discovery Sciences, Janssen Research & Development

Dr. Nemeth obtained a B.S. in Chemistry from the University of Scranton in 1995 followed by a Ph.D. in Analytical Chemistry from Emory University in 1999. After graduation, she worked under Dr. Richard Caprioli at Vanderbilt University as a post-doctoral research follow focusing on applied bioanalytical mass spectrometry. Leaving academia in 2000, Dr. Nemeth entered the biopharmaceutical industry where she was employed as a bioanalytical mass spectrometrist at Genetics Institute (now Wyeth BioPharma). In 2004, Dr. Nemeth joined Centocor’s Discovery Research department to head a new mass spectrometry group focused on the characterization of molecules from inception through pre-clinical. The principal role of the group was structural characterization of biopharmaceuticals, and the antigens and receptors used during drug development. From 2012-20-17, Dr. Nemeth switched roles and spent five years running both discovery and then clinical early development programs. In Late 2017, Dr. Nemeth returned to Biophysics to create a new structural characterization lab focused on structural analyses to drive discovery programs. Her publications include detailed protein characterizations, as well as new methods for protein analysis using mass spectrometry.

Richa Sarin, Scientist, Technical Development, Biogen

Richa has a Bachelors in Mathematics and Computer Science from Fairleigh Dickinson University and a Masters in Chemistry from Northeastern University, currently pursuing her PhD in Chemistry from Northeastern University as well. She has been at Biogen for over 9 years and has significant experience working with the analytical and process scientists and engineers to develop software automation and business process solutions. She is a representative for Biogen on the board of the Allotrope Foundation.

Karan Shah, Principal Development Associate, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

Karan received his Masters Degree in Pharmaceutical Sciences from Northeastern University. He is an experienced analytical chemist with several years experience in the Biopharmaceutical industry. His R&D experience includes formulation development as well as analysis and characterization of antibodies and antibody drug conjugates (ADCs). He has expertise in method development for characterization of antibodies and ADCs using multiple analytical techniques and in the application of these techniques to support CMC development.

Vaneet K. Sharma, Ph.D., Manager, Analytical Development, Vaccine Development & Manufacturing, International AIDS Vaccine Initiative (IAVI)

Vaneet Sharma is Manager, Analytical Development in the Vaccine Development & Manufacturing division of International AIDS Vaccine Initiative (IAVI). He is responsible for the analytical methods development and physiochemical characterization of the recombinant protein based HIV vaccine candidates for Phase I/II clinical trials. Prior to this position, Dr. Sharma was a scientist, technical development at Novartis Vaccines. Dr. Sharma is also member of the USP Viral Vaccines Expert Panel (2015-2020). Vaneet received his PhD from Northeastern University, MS from University of Connecticut, and BS from G.N.D. University, India

Christina Vessely, PhD, Senior Consultant, Analytical and Formulation Development, Biologics Consulting

Dr. Christina Vessely is a Senior Consultant, CMC Analytics and Formulation Development at Biologics Consulting, where she is in responsible for supporting analytical organizations and global regulatory agency interactions for biopharmaceutical clients. Her current role includes development, qualification and validation of analytical methods, developing strategies for formulation, characterization, comparability and biosimilarity, and managing CMC strategy and execution for investigational drugs, regulatory agency briefings and marketing applications. She has over 10 years of experience in the biotechnology industry, with various leadership roles managing analytical development, characterization and formulation development programs for large proteins and biologics at Insmed, Inc., KBI Biopharma and Merck, Inc., respectively. She received a Bachelor’s Degree in Chemical Engineering from the Colorado School of Mines and a doctorate degree in Pharmaceutical Sciences from the University of Colorado, Health Sciences Center.

Xiaoyu Yang, PhD, Principal Scientist, Merck

Xiaoyu Yang, Ph.D. is a principal scientist in Bioprocess Development, Merck Research Laboratories. Xiaoyu received a Ph.D in Biochemistry and Physics from Washington State University and later was trained in Harvard Medical School for postdoctoral studies. At Merck, Xiaoyu has had extensive experience in protein purification and analytics for various biologic drugs. He currently is a project leader in analytical development for mAbs, and has developed various analytical methods involved in extended characterization of antibodies and other proteins. Xiaoyu also leads multiple analytical teams in generating critical data for BLA submissions. He has provided key technical expertise and support in solving drug substance and drug product related issues and challenges

Xiaoyang Zheng, PhD, Principal Scientist, Biopharmaceutics Development, Sanofi US

Xiaoyang Zheng is currently a Principal Scientist and a group leader in the Department of Analytical Development at Sanofi US. Her group supports method development/qualification, product structural characterization, control strategy establishment and corresponding CMC regulatory filings for all the biological programs in development pipeline at Sanofi US, including antibodies, enzyme replacement therapy, conjugated proteins, and gene therapy. She is also an Analytical Team Leader for several programs and a Control Strategy Leader for Sanofi’s global biopharmaceutical development harmonization. She received her Ph.D. at Northeastern University in 2007. Her doctoral research focused on proteomic methods development and application in biomarker discovery and protein therapeutics development.

Process Characterization & Control

Udayanath Aich, PhD, Principal Scientist, Sanofi Genzyme

Dr. Udayanath Aich is a Principal Scientist at Sanofi-Genzyme with extensive experience and management skills in analytical chemistry, high throughput technologies and process analytical technologies (PAT). Dr. Aich completed his Ph.D. from Indian Institute of Technology Madras in the area of Chemical Biology. After completion Ph.D., he has joined in Biomedical Engineering Dept of Johns Hopkins for his postdoctoral study in the field of cell engineering, glycoengineering and structure-activity relationship. Subsequently, he has decided to move to Massachusetts Institute of Technology to gain extensive skills in the area of Biopharmaceutical characterization and drug development. In 2011, Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Before Sanofi-Genzyme, Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics and structure-function study.

Phillip Angart, PhD, ORISE Fellow, Office of Biotechnology Products, US Food and Drug Administration

Phillip Angart is an ORISE Fellow in the Office of Biotechnology Products at the FDA. His work is focused on the development and evaluation of analytical methods to support the upstream manufacturing research group, with a focus on high-throughput analytics and Process Analytical Technology Development. He received his BS in Chemical Engineering from the University of Wisconsin.

Darrin Cowley, PhD, Head, Development Quality, Biologics, AstraZeneca

Dr, Darrin Cowley is currently Head of Development Quality, Biologics at AstraZeneca/MedImmune. He was previously Executive Director Product Quality at Amgen Inc. Prior to working at Amgen, he was Senior Process Scientist Abbott Laboratories Diagnostic Division. He trained in Genetics and Cell Biology and has a PhD in Biochemistry. Darrin has extensive experience in the development, filing and commercialization of a wide range of synthetic and biological molecules including biosimilars. In addition, he has experience with the development and approval of several types of combination products such as auto-injectors and on body injectors.

Tim Dafforn, Ph.D., Professor, Biotechnology, University of Birmingham, United Kingdom

Prof Tim Dafforn is Professor of Biotechnology at the University of Birmingham. In 2009 he developed the Styrene Maleic Acid Lipid Particle (SMALP) method for encapsulation of membrane proteins. This method has revolutionized the process of membrane protein purification, greatly increasing the ease with which these proteins can be produced and studied. TD has demonstrated that the SMALP particle is an excellent mimic of the native membrane environment, making it ideal for functional and biophysical studies. Tim has founded two spinout companies and currently serves as the Chief Entrepreneurial Advisor to the Department of Business, Energy and Industrial Strategy, He has published more than 150 articles on a range of subjects from enzyme engineering to innate immunity in drosophila.

Taro Fujimori, PhD, MBA, Associate Director, Protein Analytics, Science and Technology Biologics, Abbvie Bioresearch Center

Taro Fujimori is currently leading the Protein Analytics Department at AbbVie Bioresearch Center. Taro has worked at AbbVie (formerly Abbott and BASF) for 23 years with increasing leadership roles in Discovery, DMPK, Project Management, Biologics CMC and Protein Analytics. Taro earned a PhD in Biophysics from Brandeis University. Taro has worked on 24 biologics in development and post-approval in diverse modalities: Antibodies, Antibody Drug Conjugates, Imaging Antibodies, Fusion Proteins, Therapeutic Proteins, and Enzyme Replacement Therapies.

Parag Kolhe, PhD, Group Leader and Associate Research Fellow, Pfizer

Parag Kolhe is Group Leader-Associate Research Fellow in Pfizer Biotherapeutics pharmaceutical sciences in St Louis. His expertise is in the area of biologics formulation, process development, tech transfer, PPQ and control strategy approaches. He has broad product development knowledge ranging from early stage to commercial life cycle management products. He has developed various biologics modalities ranging from monoclonal antibodies, antibody drug conjugates, vaccines and more recently Chimeric Antigen T Cell therapy and gene therapy. He has served on many AAPS committees and is former chair of sterile product focus group. He is an authored of more than 25 peer review articles and editor of a book on sterile product development.

He holds PhD in Chemical Engineering and material science from Wayne State University. Prior to joining Pfizer, he has worked at Amgen and Schering Plough.

Taehong Kwon, Graduate Research Assistant, Department of Electrical Engineering and Computer Science, MIT

Taehong Kwon is a PhD candidate in Electrical Engineering and Computer Science at MIT. He joined Professor Jongyoon Han’s Micro/Nanofluidic BioMEMS group in 2014. His research interests include applying micro/nanofluidic technologies to bioprocessing field. He has been collaborating with Dr. Jean-François P. Hamel in MIT Chemical Engineering Department to develop a membraneless microfluidic cell retention device and monitor antibody quality using a nanofluidic protein separation device.

Juhong Liu, PhD, Independent CMC Consultant

Prior to leaving FDA, Dr. Juhong Liu served as the Review Chief for Division of Biotechnology Review and Research II in the Office of Biotechnology Products at US FDA where he manages CMC reviews of a variety of biological products, including monoclonal antibodies, enzymes, cytokines as well as a wide array of biosimilar product classes. He received his Ph.D. in Biochemistry and Molecular Biology at Peking Union Medical College in 1995. He received his research training in the Section of Gene Regulation, Laboratory of Pathology at the National Cancer Institute in Bethesda, Maryland as a postdoctoral fellow and latterly as a staff scientist. His research focused on cloning and characterizing transcriptional factors involved in the regulation of the human c-myc oncogene. Dr. Liu joined the Office of Biotechnology Products as a product quality reviewer for therapeutic proteins 2008.

Seth Madren, PhD, Scientist, Biogen

Seth Madren is a Scientist I in the Analytical Development department at Biogen. He received a PhD in Analytical Chemistry from Indiana University where he focused on the fabrication and use of microfluidic devices. After graduate school he began working at Biogen, where he has worked for the past 4 years. At Biogen Seth supports both commercial and early phase programs. His activities include method development, troubleshooting, detailed characterization of protein therapeutics, and the evaluation of novel analytical methods.

Naveen Pathak, Director, Process Development, Shire

Naveen Pathak is Director of Process Development at Shire. He currently leads a team that owns deployment of QbD and Process Validation. Prior to joining Shire, Naveen has worked at leading biotech and pharmaceutical companies, including Genzyme, Amgen, DSM, and Novartis in Process Development and Manufacturing Science functions. Naveen is a seasoned biopharmaceutical industry professional with 20+ years of experience in process development and technical services spanning non-clinical, clinical, and commercial manufacturing. He has a Masters in Chemical Engineering from University of Oklahoma and Graduate certificate in Quality and Regulatory Affairs from Temple University. Naveen is also actively engaged in teaching QbD related courses at Graduate Schools in US and is an Adjunct Faculty at Keck Graduate Institute in Claremont, CA

Eugen Probst, Senior Scientist, Late Stage Upstream Development, Boehringer Ingelheim, Germany

Eugen joined the upstream department at BI in 2005 as trained expert and gained broad expertise in different fields. In 2012 to 2013 Eugen worked as Process Engineer, taking over the responsibility for global coordination of technical projects. From 2014 to 2017 Eugen worked as a Project Engineer in cell culture development, developing early and late stage cell culture processes. Since 2017 Eugen has been working as Senior Scientist in cell culture development in Biberach, focusing on late stage development of new biological entities (NBEs). His expertise is in designing and evaluation of Design of Experiment studies and risk assessment for cell culture processes.

Daniel Tong, PhD, Research Scientist, Gilead Sciences

Daniel joined Gilead Biologics in 2015 with seven years of industrial experience in upstream process development, following a post-doc at The Ohio State University with Jeff Chalmers. Daniel has been responsible for multiple projects at Gilead, including in-house chemically defined cell culture media development, continuous manufacturing, and late-stage process characterization. Outside of work, Daniel enjoys running, hiking and playing soccer.

Lintao Wang, Ph.D., Associate Director, Analytical and Pharmaceutical Development, ImmunoGen, Inc.

Dr. Lintao Wang is currently the Associate Director in Analytical and Pharmaceutical Science (APS) at ImmunoGen. His areas of expertise include analytical and bioanalytical development and mass spectrometric analysis of proteins and small-molecule compounds. Dr. Wang received his B.S. & M.S. degrees in Beijing University. In 2002 he graduated with Ph.D. in Chemistry from University of Nebraska-Lincoln (UNL) and Midwest Center for Mass Spectrometry (MCMS). He joined ImmunoGen in 2002 and started his career in developing anticancer immunotherapies such as antibody-drug conjugates (ADC). In 2007, he joined Shire as a senior scientist for tandem MS method development in Bioanalytical and Biomarker Development. In 2011, he rejoined ImmunoGen as the group leader for Mass Spec as well as the high throughput analytics. He supported ADC programs at all stages from early antibody cell line screening to late-stage in-depth structural characterization. Overall, with ~20 years of experience in protein analytics and a number of publications and conference presentations, Dr. Wang is a well-established analytical chemist in the antibody and ADC development of the biopharma/biotech industry.

Gang Xue, PhD, Scientific Director, Amgen

Dr. Gang Xue is a Scientific Director at Amgen Inc. located in Cambridge, MA. With B.S. degree in Chemistry and B.E. in Computer Science from Tsinghua University and Ph.D in Analytical Chemistry from the Iowa State University, Gang is currently leading the Process Analytics group within Amgen Process Development organization. One of his group’s focuses is the cross modality PAT strategy for the biologics and synthetic continous manufacturing with the goal of process control and real time release testing (RtRT). The other responsibilty is the design and implementation of lab informatics echosystem for Process Development labs and plants focusing on holistic scientific data capture and aggregation in Cloud based Enterprise Data Lake. He also is one of the founding member of Allotrope Foundation. Prior to his current role, Gang worked Pfizer as Associate Research Fellow with 11 years of experience in Analytical Development.

Min Zhang, PhD, Director, Manufacturing Sciences and Technology, AstraZeneca

Dr. Min Zhang, Director of Upstream Department, Manufacturing Sciences & Technology (MS&T) at AstraZeneca/Medimmune, where he leads an upstream team to support AZ biologics process transfer, scale-up, and large scale manufacturing. Prior to joining AZ, he was a Senior Principal Scientist and Group Leader at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) where he led a cell culture team to support upstream process development and cGMP manufacturing for cell culture programs at various development and clinical phases. Along with the tenures in Cell Culture Process Development at Eli Lilly and SAFC (Sigma-Aldrich), Min has achieved significant experience in mammalian cell culture, including Tech Transfer, process characterization, process scaling, process development, cGMP manufacturing, cell line engineering, Quality-by-Design (QbD), and therapeutic protein commercialization. Min was a Staff Scientist and did his postdoc research at University of California at Berkeley after he received his doctorate in Molecular Cell Biology from Institute of Genetics at Fudan University.

Formulation & Stability

Rapid Methods to Assess Quality & Stability of Biologics

Mark Brader, PhD, Research Fellow, Drug Product Analytical Development, Moderna Therapeutics, Inc.

Dr. Brader graduated with a Ph.D. in Chemistry from Massey University in New Zealand. His Ph.D. focused on using x-ray crystallography and spectroscopy to characterize small molecule mimics of metalloprotein centers. After completing postdoctoral positions at the University of California at Riverside and Rutgers University he joined Eli Lilly and Company’s bioproduct development division where he worked on Lilly’s early pipeline and insulin products for 12 years. He subsequently held scientific positions at Novo Nordisk (Denmark) and Biogen. With Biogen he led teams responsible for the formulation development of PLEGRIDY [pegylated interferon beta-1a] and ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein] from early stage through BLA filing readiness. He is currently a Research Fellow at Moderna Therapeutics focused on developing therapeutic messenger RNA technology. Throughout his career he has maintained a special interest in the characterization of biomolecular higher order structure and finding new ways to apply biophysical methodologies to aid biopharmaceutical product development.

Scott H. Chamberlain, Senior Research Associate, Protein Analytical Chemistry, Genentech

Scott has over 34 years of experience in the field of Protein Structure Analysis and Microchemistry using classical methods technology and mass spectrometry. He has worked for Chiron Corp., Scios, Inc. and is currently employed by Genentech, Inc. in Protein Analytical Chemistry. He received his Bachelors degree in Microbiology from the University of New Hampshire in 1981.

Danny Chou, PhD, President and Founder, Compassion BioSolution; Former Senior Research Scientist, Biologics Development, Gilead Sciences

Dr. Danny K. Chou is a biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, formulation development, and emerging technologies for protein aggregate/subvisible particle analysis. Currently, Dr. Chou is the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and analytical testing service provider that serves clients throughout the world. Prior to starting Compassion BioSolution, Dr. Chou was a lead formulation scientist at Gilead Sciences, where he successfully converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. In the past 15 years, Danny has developed stable pharmaceutical dosage form for proteins, monoclonal antibodies, peptides, and oligonucleotides for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology under the tutelage of Professor John Carpenter and his PharmD from the University of Florida.

Chia Chu, Senior Principal Scientist, Bioprocess Research & Development, Pfizer

Chia is an upstream process development scientist in the Bioprocessing R&D organization at Pfizer. Chia received his Ph.D. from the Johns Hopkins University. After joining Pfizer, Chia worked on several monoclonal antibody programs at both early and late stages, from developing drug substance processes for first-in-human trials to process validation and contributing to regulatory submissions. Chia is based in Chesterfield, MO and is currently leading upstream development efforts in gene therapy at Pfizer.

Robin Curtis, PhD, Senior Lecturer, Chemical Engineering and Analytical Science, University of Manchester

Robin Curtis joined the Chemical Engineering and Analytical Science School at University of Manchester in 2003. Previously he did his PhD at the University of California at Berkeley and post doctoral training at University of California Los Angeles and Rice University. His current research is focused on understanding the fundamentals of protein solution behaviour with an emphasis on elucidating non-specific protein-protein interactions and how they depend upon protein structural properties and the solution components including excipients. The approach relies on using a combination of light scattering methods (dynamic and static light scattering, electrophertic light scattering) as well as computational approaches based on structural informatics and molecular modelling. Current projects are focused on formulation issues such as protein phase behaviour, aggregation, and solution rheology.

Peter Fung, PhD, Senior Manager, Product Marketing, NanoTemper Technologies

Peter has over 23 years of industry experience developing, commercializing and marketing products in the life science sector. Peter is currently the Sr Product Marketing Manager at NanoTemper and oversees marketing activities for the flagship product lines as well as the launch activities of new platforms. Peter previously worked for Biocompare, ProteinSimple and Molecular Devices. He has his Ph.D. in molecular and cellular biology from Syracuse University and a B.S. in molecular biology from Iowa State University.

Caitlin Kramer, MSc., Associate Scientist, Process Development Analytics, Bristol-Myers Squibb

Caitlin Kramer is an Associate Scientist in the Process Development Analytics Impurities Group at BMS in Devens. She has been with the company since early 2017. She holds a MSc in Chemistry from Northeastern University in Boston.

Marina Gühlke, PhD, Analytical Scientist, Coriolis Pharma

Marina Guehlke is a scientist at Coriolis Pharma, a contract research organization in formulation development and analytics for biopharmaceuticals. Marina Guehlke is currently working on method development for subvisible particle quantitation. Before joining Coriolis Pharma in 2017, she obtained a Ph.D. in analytical chemistry, in the field of Raman spectroscopy.

Jay(Zhi) Guo, PhD, Senior Scientist, Biologics, AbbVie

I am a senior scientist at Global Protein Science group in the division of Biologics at Abbvie Bioresearch Center. I use various biochemistry and genetic tools to study drug targets to initiate biologic generation and I am specializing at protein engineering for fusion protein design like bi-specific antibodies and immunocytokines. I received my PhD from University of Texas at Austin where I studied cellular response to DNA damage and Oxidative stress. Before I joined Abbvie, I was a postdoc fellow at Harvard Medical School, where I performed genetic and proteomic screens for new treatment against breast cancer

John E. Harlan, PhD, Principle Research Scientist, Global Protein Sciences, AbbVie

Dr. John E. Harlan is a Principal Research Scientist in Pharmaceutical Discovery at AbbVie, Inc., located in North Chicago, Illinois. As part of Protein Sciences in Global Biologics Research, his work involves the production and characterization of protein therapeutic candidates across multiple therapeutic areas. In addition, his lab is actively exploring next-generation antibody-drug conjugation technologies. Prior to joining the Pharmaceutical Products Division of Abbott Laboratories as a staff scientist, Dr. Harlan did his post-doctoral training with Steve W. Fesik in the Structural NMR department at Abbott Laboratories. He received his Ph.D. degree in Biochemistry from the Department of Biochemistry and Molecular Biology at the University of Chicago. For his doctoral work, he studied hydrodynamics and ligand interactions of prostaglandin H2 synthase 1 with Dr. R. Michael Garavito. Dr. Harlan received a BA in Biology and Chemistry from Alma College, Alma, Michigan.

Krishna M.G. Mallela, PhD, Associate Professor of Biophysical Chemistry, Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus

Biography unavailable

Mehak Mehta, PhD, Scientist I, Technical Development, Biogen

Mehak Mehta is a Scientist in the Protein Pharmaceutical Development group at Biogen. She is responsible for formulation, process development, tech transfer and container development of parenterals with an expertise in lyophilized drug products and solid-form characterization. Mehak received her Ph.D. in Pharmaceutics from University of Minnesota.

Nathan P. Oien, PhD, Senior Scientist, Analytical Development Department, KBI Biopharma, Inc.

Nathan Oien is a Senior Scientist / Project Leader in the Analytical Development Department at KBI Biopharma. He is also leads the cell-based assay group in support of process development and GMP testing. Throughout his time at KBI Biopharma, he has provided analytical support for more than 30 biological entities through process development into manufacturing. Nathan received his Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill in 2014. Prior to attending UNC he worked at Eurofins-AvTech for 2 years as an analytical chemist performing small molecule release and stability testing.

Belinda Pastrana, PhD, CEO, Protein Dynamic Solutions

Following her training at Rutgers and Mayo, Dr. Pastrana has dedicated thirty years to developing and patenting cutting-edge solutions for protein and biologic characterization. She is a tenured faculty member at the University of Puerto Rico, and has trained a generation of students for subsequent employment in the biopharmaceutical industry.

Prasad Sarangapani, PhD, Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals

Biography unavailable

Zahra Shahrokh, PhD, CMC Consultant and Chief Development Officer, STC Biologics

Biography unavailable

Jeremy Springall PhD, Scientist I, Analytical Sciences, MedImmune, A member of the AstraZeneca Group

Jeremy Springall has worked in the Analytical Sciences group, part of the Bioprocess development department, at MedImmune for the past four years. His responsibilities include assess new technologies and work processes to support early and late stage development assets as well as being a CMC team member on several non-mAb projects currently in the MedImmune development pipeline. Previous roles include In-process analytical development scientist at UCB and analytical development scientist at Patheon, both in the UK. He holds a Ph.D. in bioorganic and medicinal chemistry and a BSc in chemistry from the University of Bath, UK.

Tingwan Sun, PhD, Senior Scientist, Protein Analytics, Adimab LLC

Dr. Tingwan Sun got his Ph.D. from UT Southwestern Medical Center in 2008. He joined the Protein Analytics group at Adimab in 2012 as a Scientist. Currently he is working on antibody characterization and developability related assays.

Nicholas Warne, PhD, Senior Director, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

Dr. Nicholas Warne is currently Senior Director of Formulations and Drug Product Process Development at Pfizer. Nick has 28 years of industrial experience focusing on biologics formulation development, dosage form design and manufacturing process development. He and his team have been fortunate to have contributed to the licensure of 10 biologics including clotting factors, growth proteins, mabs, vaccines and ADCs. Dr. Warne holds numerous protein formulation patents and, with his group, has made over 100 presentations at national meetings and in journals. Prior to his position at Pfizer, Nick had positions of increasing responsibility at Wyeth and Genetics Institute, and has been based in Andover, Massachusetts. Nick received his PhD in Chemistry from Purdue University under the guidance of Professor Michael Laskowski Jr. He received his BS in Biochemistry, with Distinction in Research, from the University of Rochester.

Overcoming Formulation Challenges for Biopharmaceutical Development

Sonia Bedi, PhD, Investigator, Biopharm Product Sciences, Biopharm R&D, GSK

Biography unavailable

Amit Gangar, PhD, Scientist II, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

Amit Gangar is a drug product and formulation development scientist at ImmunoGen. He is responsible for providing support for both early and late stage development activities for ImmunoGen’s antibody drug conjugate (ADC) candidates. Prior to joining ImmunoGen, Amit was a vaccine formulation scientist at Novavax in Maryland. Amit obtained his PhD degree in Medicinal Chemistry from University of Minnesota.

John E. Harlan, PhD, Principle Research Scientist, Global Protein Sciences, AbbVie

Dr. John E. Harlan is a Principal Research Scientist in Pharmaceutical Discovery at AbbVie, Inc., located in North Chicago, Illinois. As part of Protein Sciences in Global Biologics Research, his work involves the production and characterization of protein therapeutic candidates across multiple therapeutic areas. In addition, his lab is actively exploring next-generation antibody-drug conjugation technologies. Prior to joining the Pharmaceutical Products Division of Abbott Laboratories as a staff scientist, Dr. Harlan did his post-doctoral training with Steve W. Fesik in the Structural NMR department at Abbott Laboratories. He received his Ph.D. degree in Biochemistry from the Department of Biochemistry and Molecular Biology at the University of Chicago. For his doctoral work, he studied hydrodynamics and ligand interactions of prostaglandin H2 synthase 1 with Dr. R. Michael Garavito. Dr. Harlan received a BA in Biology and Chemistry from Alma College, Alma, Michigan.

Andrea Hawe, PhD, CSO, Coriolis Pharma Research GmbH

Andrea Hawe, is co-founder and Chief Scientific Officer of Coriolis Pharma, a science-driven contract research organization supporting drug product development of biopharmaceuticals, with focus on formulation development, lyophilization technologies and analytics (GMP and non-GMP) of biopharmaceuticals. Andrea Hawe received her PhD degree in Pharmaceutical Technology from the Ludwig Maximilian University of Munich, Germany in the field of protein lyophilization and formulation. Before founding Coriolis Pharma she has worked as post-doctoral scientist at Leiden University, The Netherlands, on different projects related to protein characterization, innovative fluorescence based methods, development of heat-stable formulations for third world countries and immunogenicity. She is an expert for protein formulation and protein characterization and has published more than 30 articles in peer-reviewed journals.

Jan Jezek, PhD, CSO, Research & Development, Arecor, Ltd.

Dr. Jezek is the Chief Scientific Officer at Arecor Ltd. He has been trained as a biophysical chemist. He was the principal scientist at Insense Ltd, leading the development of a range of novel medical devices from the proof-of-concept all the way to market. During his time at Insense, he and his team developed a novel formulation platform to achieve superior stability of proteins and other biological molecules. His inventions related to protein stabilisation led to inception of Arecor Ltd as a separate company focusing on commercialisation and further development of the stabilisation platform. He is the author of several papers and a number of patents which underpin Arecor’s technology.

Brian Keppler, PhD, Associate Director, Project Management, Metabolon

Dr. Keppler received his Ph.D. in Pharmaceutical Sciences from UNC Chapel Hill where he identified novel ways to inhibit telomerase as an anticancer approach. He completed postdoctoral training at the NIEHS Laboratory of Molecular Carcinogenesis. Dr. Keppler joined Metabolon in 2011 and works with global Pharmaceutical and Biotechnology clients.

James Kranz, PhD, Principal Scientist, Process Development Formulation, Shire

James (Jim) Kranz earned a B.S. in Biochemistry (University of Iowa), and a Ph.D. in Biophysics (Washington University), and was a postdoctoral fellow in Biophysics (University of Pennsylvania), investigating protein:protein interactions by NMR and thermodynamics.

Jim’s industry experience includes Biophysical and Enzymatic assay development for small molecule high-throughput screening (HTS), lab automation and novel assay formats at Johnson & Johnson (now Janssen). He has supported development of a plate-based Differential Scanning Fluorimetry (DSF) platform used in protein/enzyme characterization and high-throughput screening. Since 2010, he has worked in biopharmaceutical formulation development, DP manufacturing process development for both liquid and lyophilized presentations, supporting early and late-phase development programs. His biopharmaceutical development experience includes antibody-drug conjugates (ADCs), mAbs, fusion proteins, and enzyme-replacement therapies.

Mehak Mehta, PhD, Scientist I, Technical Development, Biogen

Mehak Mehta is a Scientist in the Protein Pharmaceutical Development group at Biogen. She is responsible for formulation, process development, tech transfer and container development of parenterals with an expertise in lyophilized drug products and solid-form characterization. Mehak received her Ph.D. in Pharmaceutics from University of Minnesota.

Haresh T. More, PhD, Research Investigator II, Parenteral Science and Technology, Bristol-Myers Squibb

Haresh More is currently working as a Research Investigator II at Bristol-Myers Squibb and works in Parenteral Science and Technology department. His work at BMS is focused on late-stage biologics formulation development and process development.

Atul Saluja, PhD, Associate Director, Global Pharmaceutical Development Biologics, Sanofi

Atul Saluja has been with Sanofi since January 2017 where he is engaged with drug product development of early and late stage biologic assets. Prior to joining Sanofi, he worked at BMS, Amgen and KBI Biopharma in product development groups. Over the past decade, Atul has successfully delivered on various clinical development programs including vial, PFS and device based products, transferred products from lab to site enabling manufacture of validation batches, instituted LCM process improvements as well as business workflow improvements through strategic initiatives spanning a broad development space and mentored scientists. He is presently leading a group of 10 people involved with developing biologic assets spanning a broad pre-clinical to commercial space. He has been actively engaged with the scientific community at large through presentations, symposia, focus groups, and publications in peer-reviewed journals. Atul received his Ph.D. in Pharmaceutics from University of Connecticut in 2006 (high concentration protein formulations) and has been with the industry since.

Christian Schoneich, PhD, Distinguished Professor and Chair, Pharmaceutical Chemistry, University of Kansas

Dr. Schöneich is the Takeru Higuchi Distinguished Professor and Chair in the Department of Pharmaceutical Chemistry at The University of Kansas. He received his Ph.D. in Chemistry in 1990 from the Technical University Berlin, Germany. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institute in Berlin, Germany. His research focuses on oxidation reactions of peptides and proteins in vivo and in vitro, and their potential consequences for the development of stable protein pharmaceuticals, biological aging and age-related pathologies. He has published > 250 papers in the field of peptide and protein oxidation reactions.

Helen Sjögren, PhD, Principal Scientist, Global Pharmaceutical R&D, Ferring Pharmaceuticals

Dr. Helen Sjögren works as principal scientist at Ferring Pharmaceuticals in Denmark. She holds a MSc in chemical engineering and a PhD in physical chemistry, both from Lund University, Sweden. She has over 20 years of experience from the pharmaceutical industry whereof the last 10 years with pharmaceutical development of biologicals. She has previously worked at Sandoz in Germany and at AstraZeneca at various positions and locations in Sweden. She has experience both as manager within quality control and as researcher on different levels.

Jason Stewart, BS, Senior Associate Scientist, Pharmaceutical Research and Development, Pfizer, Inc.

Jason Stewart received a Bachelor of Science degree in Chemical and Biological Engineering from University of Colorado in 2014. He started at Pfizer in 2014 and is currently a Senior Associate Scientist within the Pharmaceutical R&D group in Andover, MA. His current work is focused on evaluation of process analytical technologies for lyophilization as well as biotherapeutic drug product process development.

Pamela Thompson, PhD, Senior Scientist II, ADC Preformulation, NBE Development, AbbVie

Pamela earned her Ph.D. in 2011 in organic chemistry under the guidance of Prof. Geert-Jan Boons at the University of Georgia, where her research focused on fully synthetic carbohydrate-based cancer vaccines. She then moved on to the University of California – Berkeley to work on a glycoproteomics platform for biomarker discovery under Carolyn Bertozzi. Shortly thereafter, Pamela joined the Department of Antibody Discovery & Protein Engineering at MedImmune as a conjugation chemist to work on technology development of ADCs. In 2016, she joined Drug Product Development at AbbVie as an ADC Preformulation scientist, where she focuses on early candidate screening and the analytical characterization of ADCs.

Nicholas Warne, PhD, Senior Director, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

Dr. Nicholas Warne is currently Senior Director of Formulations and Drug Product Process Development at Pfizer. Nick has 28 years of industrial experience focusing on biologics formulation development, dosage form design and manufacturing process development. He and his team have been fortunate to have contributed to the licensure of 10 biologics including clotting factors, growth proteins, mabs, vaccines and ADCs. Dr. Warne holds numerous protein formulation patents and, with his group, has made over 100 presentations at national meetings and in journals. Prior to his position at Pfizer, Nick had positions of increasing responsibility at Wyeth and Genetics Institute, and has been based in Andover, Massachusetts. Nick received his PhD in Chemistry from Purdue University under the guidance of Professor Michael Laskowski Jr. He received his BS in Biochemistry, with Distinction in Research, from the University of Rochester.

Philip Wuthrich, Senior Scientist, Research, Research & Development, ReForm Biologics

Philip Wuthrich is a Senior Scientist at ReForm Biologics in Cambridge, holding a Bachelor of Science degree in Chemical Engineering (2010) from the University of Massachusetts-Lowell. He has eight years of experience in technology development, including the last four years at ReForm Biologics.

Melissa Yarbrough, MS, Scientist, Pharmaceutical Research and Development, Pfizer, Inc.

I received my Masters in Chemistry from Missouri State University in 2012. I have been with Pfizer for 4 years working in Biotherapeutics Pharmaceutical Sciences Pharmaceutical Research and Development, Formulation and Process Development group.

High-Concentration Protein Formulations

Sarah Altinoglu, PhD, Post-Doctoral Scientist, Bioproduct Research and Development, Eli Lilly and Company

Biography unavailable

Jean-René Authelin, PhD, Global Head of Pharmaceutical Engineering, Pharmaceutical Sciences, Sanofi France

Jean René Authelin has an Engineering degree in Chemical Engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90’s, he founded the Physical Quality function, dedicated to the API crystallization, drying, polymorphism for which he was for 10 years Global Head in Rhone Poulenc Rorer, Aventis and finally Sanofi. In 1988, JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest of JRA include: thermodynamics of hydrates, drug polymorphism, amorphous solids physics, drug stability, crystallization, nanoparticles engineering and processing, drying, milling; spray drying, fluid bed granulation, roller compaction, freeze drying. Jean René Authelin is the author or co-author of 20 publications or book chapters and the co-inventor of 9 patents.

Deborah Bitterfield, PhD, CEO and Founder, Lindy Biosciences, LLC

Dr. Bitterfield's experience reflects a broad range of disciplines, including R&D and corporate collaborations. Prior to launching Lindy Biosciences, she joined innovation lab Southeast TechInventures, where she led scientific operations and project management. She holds a PhD in Materials Science from Duke University. Her research has focused on the physical chemistry of two-phase microsystems, including protein dehydration and polymer microsphere formulation.

Robin Bogner, PhD, Professor, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut

Dr. Bogner is Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science.  She received her B.S. in Pharmacy from Rutgers University, M.S. from the University of Iowa, and Ph.D. from Rutgers University after which she joined the faculty of the University of Connecticut.  Dr. Bogner’s research interests are focused on the characterization and dissolution of pharmaceutical solids, both freeze-dried parenterals and oral dosage forms.  The amorphous form of drugs and the implications of partially crystalline systems are a more recent interest.  Dr. Bogner has a patent and many publications.  She has served on several editorial boards, a USP committee, an FDA advisory committee and in various leadership roles in the American Association of Pharmaceutical Scientists (AAPS).  Dr. Bogner is a Teaching Fellow at the University of Connecticut, and Fellow of the AAPS.

Christoph Brandenbusch, PhD, Group Leader, Department of Biochemical and Chemical Engineering, Laboratory of Thermodynamics, Technical, University of Dortmund

Dr. Christoph Brandenbusch studied Chemical Engineering at the Department of Biochemical and Chemical Engineering at TU Dortmund, (Germany) 2003-2007. He finished his Ph.D. thesis in the field of downstream processing in biocatalysis in 2011. Since 2012 he works as a group leader at the Laboratory of Thermodynamics, Department of Biochemical and Chemical Engineering, TU Dortmund (Germany). His main research fields include: Novel strategies for protein purifications in pharmaceutical bio-processes (e.g. precipitation, aqueous two-phase extraction) including hybrid-modeling approaches therefor. The development of physical-sound models for the identification of excipients and excipient mixtures in high-concentration biopharmaceutical formulations.

William Callahan, MSc, Senior Scientist, Process Development, Amgen

Bill Callahan is a Senior Scientist at Amgen. He has been with the company for 28 years. Bill was responsible for the formulation development of Romiplostim, currently on the market. He has also worked on and supported other formulation development projects. At present, he is involved in the lifecycle management of some existing products, in addition to managing the formulation development of new products. His research interests include novel formulation development, solubility theory and the stability of proteins.

Cesar Calero-Rubio, PhD, Scientist, Formulation Development, Global Pharmaceutical Development Biologics, Sanofi

I received my B.Eng. in Chemical Engineering at the Industrial University of Santander in Bucaramanga, Colombia in 2012 working on the solubility of polyphenols in supercritical CO2 with added cosolutes. I received my Ph.D. in Chemical Engineering at the University of Delaware in 2017 working with Prof. Christopher J. Roberts investigating the potential of coupling experimental and computational characterizations of protein self-interactions, unfolding and aggregation in solution from low to high protein concentrations. From 2012-2013, I was part of CENIVAM in Bucaramanga, Colombia working on the design and manufacturing of essential oils-based products and supercritical CO2 extractions. I am currently part of the Global Pharmaceutical Development Biologics department at Sanofi working as a Scientist in Formulation Development leveraging the use of experimental and computational techniques for risk assessment and formulation development of drug candidates.

Smeet Deshmukh, PhD, Senior Research Investigator II, Drug Product Science and Technology, Bristol-Myers Squibb Co.

Smeet Deshmukh is currently a Senior Research Investigator II in the Drug Product Science & Technology department at Bristol Myers Squibb with experience in early and late stages of biologics product development. Smeet received her M.S.C.E.P and Ph.D. from Massachusetts Institute of Technology in Chemical Engineering. She has formulation and process development experience in both small and large molecules at Janssen. Her focus at BMS is on robust biologics process development using different mini-piloting tools, scale down models as well as analytical techniques. She has worked extensively on evaluating alternative technologies for high concentration formulation encompassing different approaches - solid state proteins, combinatorial buffer systems, DOE approach as well as novel excipients for high volume delivery.

Jan Jezek, PhD, CSO, Research & Development, Arecor, Ltd.

Dr. Jezek is the Chief Scientific Officer at Arecor Ltd. He has been trained as a biophysical chemist. He was the principal scientist at Insense Ltd, leading the development of a range of novel medical devices from the proof-of-concept all the way to market. During his time at Insense, he and his team developed a novel formulation platform to achieve superior stability of proteins and other biological molecules. His inventions related to protein stabilisation led to inception of Arecor Ltd as a separate company focusing on commercialisation and further development of the stabilisation platform. He is the author of several papers and a number of patents which underpin Arecor’s technology.

Robert Kelley, PhD, Principal Scientist, Drug Delivery, Genentech, Inc.

Dr. Robert F. Kelley earned a Ph.D. in Biochemistry from University of Iowa, with thesis work on protein folding, followed by postdoctoral training at Yale University. Bob joined Genentech in 1986 where he has worked on a wide range of protein engineering projects with an emphasis on biophysical characterization. While in gRED, he led engineering efforts on 7 therapeutic antibody projects to successful early development decisions. He is an inventor on 20 issued US patents and an author on >90 peer-reviewed publications. Bob is currently a Principal Scientist in the Drug Delivery Dept. at Genentech focusing on delivery of antibodies to the eye for treatment of ocular disease

Charlotte Pellet, PhD, Pharmaceutical Sciences Operations, Sanofi, France

Dr Charlotte Pellet graduated from ESPCI Paris as an Engineer in Physico-chemistry. She has specialized in Physics of Fluids and completed her PhD from Pierre and Marie Curie University. She is currently working in Sanofi as a manager in charge of DP process development in Pharmaceutical Sciences Operations. Her mission includes developing commercial DP process for parenteral products, bringing support and expertise to industrial in fill & finish operations, especially on the rheology of protein solutions.

Shreya Kulkarni, PhD Candidate, Pharmaceutical Sciences, University of Connecticut

Shreya Kulkarni is a Doctoral Candidate in the Pharmaceutical Sciences department at the University of Connecticut where she works under the guidance of Dr. Robin Bogner. Ms. Kulkarni received a Bachelor’s degree in Pharmacy from Mumbai University, India (2011). Following graduation she joined Rubicon Research in Mumbai as a Research Associate in the Formulation Development department. Her interest in protein therapeutics brought her to the U.S. in 2012. Ms. Kulkarni earned her Masters from University of Colorado Denver (2014) where she worked on improving ocular protein delivery, before joining UConn for her Ph.D. She also spent a summer at GlaxoSmithKline as part of her Ph.D. program, assessing the stability of freeze-dried and spray-dried protein drug substance. Ms. Kulkarni’s current research focuses on the underlying causes of long reconstitution times in high concentration freeze-dried protein formulations. Ms. Kulkarni recently received graduate student awards for her dissertation research from the AAPS Manufacturing Science and Engineering section, the International Pharmaceutical Excipients Council (IPEC) and the American Association of Indian Pharmaceutical Scientists. Ms. Kulkarni is also actively involved in mentoring high school students to pursue a career in STEM under the New York Academy of Sciences 1000 Girls, 1000 Futures and STEM Scholars programs.

Thomas Laue, PhD, Professor Emeritus, Molecular, Cellular and Biomedical Sciences, University of New Hampshire

Tom Laue is the emeritus Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and professor of Material Sciences at the University of New Hampshire. He was the Director of both the Center to Advance Molecular Interaction Science and the Biomolecular Interaction Technologies Center. He received his bachelor’s degree in Natural Sciences from the Johns Hopkins University in 1971 and his Ph.D. in Biophysics and Biochemistry from the University of Connecticut in 1981. His post-doctoral studies were conducted at the University of Oklahoma. Between 1969 and 1975, he worked as a technician in the deep space program of NASA. He joined the University of New Hampshire in 1984 as an Assistant Professor, where he taught both undergraduate and graduate courses in biochemistry and biophysics. His research focused on the development of instrumentation and methods for examining macromolecular interactions. These instruments provide unique insights into these interactions, and resulted in extensive collaborations with both academic and industrial labs. Tom has over 120 publications, serves on several editorial boards, and gives over one hundred lectures, seminars and workshops a year.

Chaitanya Sudrik, Postdoctoral Associate, Chemical Engineering, Massachusetts Institute of Technology

Chaitanya Sudrik is a postdoctoral researcher in Prof. Bernhardt Trout’s lab at the Massachusetts Institute of Technology. His postdoctoral research focuses on the characterization of protein-excipient interactions in liquid formulations of monoclonal antibodies. Before joining MIT, Dr. Sudrik received his Ph.D. from Rensselaer Polytechnic Institute, under the guidance of Prof. Ravi Kane.

Danlin Yang, PhD, Senior Scientist, Biotherapeutics Discovery, Boehringer Ingelheim

I joined the Biotherapeutics Discovery CMC/Biophysics group at Boehringer Ingelheim in late 2010, and pursued a Ph.D. in Biochemistry while maintaining my full-time position at the company. Under the guidance of my Ph.D. advisor Dr. Tom Laue, my thesis work focused on investigating the influence of IgG subclasses and macromolecular cooperativity in structure, stability, and assembly using a variety of biophysical methods. Simultaneously, while working at BI, my core responsibilities have revolved around antibody candidate identification, selection, and characterization from early discovery to development stage on a variety of therapeutic indications, leading to the advancement of candidates into clinical development.

Cell Therapy

Cell Therapy CMC & Analytics

Fouad Atouf, PhD, Vice President, Global Biologics, USP

Fouad Atouf is Vice President, Science—Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics and antibiotics, and oversees the biologics laboratories in USP–U.S. and USP–India. His department supports the work of the associated USP Expert Committees. Dr. Atouf has been at USP for over 10 years and served in a variety of scientific leadership roles including being the regional champion for the Middle East and North Africa Region, where he helped facilitate programs designed to enhance the understanding of the role of regulations and standards in the registration of medicinal products. Dr. Atouf has strong background and experience in the development and regulation of cellular and tissue-based products. Prior to joining USP in 2006, his research at the U.S. National Institutes of Health focused on developing methods for the in vitro generation of cell-based therapies for diabetes. Dr. Atouf is the author of numerous publications in peer-reviewed journals and a frequent speaker at national and international scientific conferences. Dr. Atouf earned his Master’s degree in Biochemistry and his Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.

Bernadette Keane, PhD, Principal, Keane Consultancy

Independent Consultant with over 25 years experience in the biopharmaceutical industry, providing CMC Regulatory, GxP Quality, Drug development and Analytical strategic and Operational support for small to mid-sized innovative gene and cell therapy, biologics and small molecule based companies. Experience in lentiviral based gene modified HSC therapies for rare diseases, CART and TCR oncology immunotherapies, oncolytic and AAV virus gene therapy, CRISPR- gene editing and siRNA therapies, neoantigen based cancer vaccines, oligonucleotide TLR adjuvants and monoclonal antibody therapies.

Most recently, Bernadette held the position of VP Quality at bluebird bio, an innovative therapies company specializing in ex vivo gene modified cellular therapies for rare diseases (ALD and Beta thalassemia, sickle cell disease) and CART immune-oncology indications. For four plus years, Bernadette was responsible for development and implementation of corporate strategy for CMC Regulatory Compliance, GxP Quality Assurance, Quality Control and analytical activities for all bluebird bio programs through the drug development pipeline from early phase clinical research studies through pivotal trials and preparation for US/EU commercialization.

Matthias Renner, PhD, Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute

Biography unavailable

William Lee, PhD, Vice President, Regulatory Affairs, Cato Research

Dr. Lee has more than 25 years’ research and industrial experience in gene therapy, cellular immunology, and therapeutic vaccines, including 15 years in regulatory affairs. Before joining Cato Research, he was Principal Scientist at Chiron.

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Experienced Regulatory Scientist (>10 years) with a primary interest in advanced therapies (ATMP, cell, gene and tissue products) and other regenerative medicine products including protein therapeutics. Providing ICH-level quality/CMC and preclinical ‘regulatory science’ support and EU regulatory procedure/law support based on a deep knowledge gained from working in both biotech and regulatory agency. Deep understanding of EU clinical trials (IMPD), EMA licensing (MAA) and post-licensing (variations) requirements gained from time as an assessor (MHRA/EMA) and supporting a wide variety of clients over many years.

Laura Pierce, PhD, Biomedical Engineer, Biosystems and Biomaterials Division, Biomaterials Group, NIST

Laura Pierce is a Biomedical Engineer in the Biomaterials Group at the National Institute of Standards and Technology. Laura has over 12 years of experience in the biotechnology industry in the areas of drug discovery for oncology and infectious disease, as well as experience in high-throughput automation and robotics and bioassay development. She received her B.S.E. degree in chemical engineering from Princeton University and she holds a M.S. degree from Northeastern University. Currently, Laura supports development of ISO standards for cell counting and cell characterization and develops measurement assurance strategies for critical measurements in the biosciences.

Ruud Hulspas, PhD, Independent Consultant, Cellular Technologies Bioconsulting, LLC

Dedicated to increasing reproducibility and quality of (pre-)clinical research, in particular, in the development of manufacturing processes for cellular therapy. With over 25 years of experience in cytometry, I understand what it takes to build and incorporate a reliable cytometry-based quality control system into manufacturing platforms for cell-based products in cellular therapy. I help (flow) cytometry-related tech companies define product requirements, and optimize their business models. I educate about and engage stakeholders from government, academic, clinical, private and public entities in efforts to make cell characterization suitable for economically sustainable cellular therapies.

Ilya Shestopalov, PhD, Senior Scientist, Cellular Process Characterization and Analytics, bluebird bio

Ilya Shestopalov, PhD currently leads the cell analytics group within cellular process development at bluebird bio. His research focuses on development of cell-based assays for hematopoietic stem/progenitor and CAR-T products. Prior to bluebird bio, Dr. Shestopalov was a postdoctoral fellow in stem cell biology at Boston Children’s Hospital and Harvard University working with zebrafish hematopoietic stem cells. Dr. Shestopalov received his PhD in 2010 from the Chemical Biology program at Stanford University and a BS in Biological Chemistry from University of Chicago.

Sadik Kassim, PhD, Chief Scientific Officer, Mustang Bio, Inc.

Dr. Kassim has served as Chief Scientific Officer since March 2018. Dr. Kassim joined Mustang in March 2017 as Vice President of Process and Analytical Development, where he led process development, analytical development and manufacturing strategy for Mustang’s CAR T therapies and oversaw preclinical research and pipeline expansion activities. Prior to Mustang, Dr. Kassim was Head of Analytical Development for Novartis’ Cell and Gene Therapies Unit, where he played a key role in the Biologics License Application filing for Kymriah™ (CD19 CAR T) in pediatric acute lymphoblastic leukemia and diffuse large B-cell lymphoma. Earlier in his career, Dr. Kassim was a research biologist in the Surgery Branch at the National Cancer Institute, where he was involved in early research that led to the development of Kite’s Yescarta™ (CD19 CAR T) for lymphoma, held a senior research position in the Discovery Immunology Group at The Janssen Pharmaceutical Companies of Johnson & Johnson and was a research fellow in the University of Pennsylvania’s (Penn) Gene Therapy Program. Dr. Kassim holds a Ph.D. in microbiology and immunology from Louisiana State University School of Medicine, and a B.S. in ecology and evolutionary biology, as well as in cell and molecular biology, from Tulane University.

Stephen J. Duguay, PhD, Director, Cellular Process Characterization and Analytics, bluebird bio

Stephen J. Duguay, Ph.D., is Director of Cellular Analytics and Process Characterization at bluebird bio. He has 20 years experience in the biotechnology industry, with a focus on autologous cell and gene therapies. He is currently responsible for analytics and characterization for bluebird’s hematopoietic stem cell gene therapy platform. In his previous role at Genzyme, his group provided manufacturing technical support for commercial production of three autologous cell therapy products globally: Carticel, Epicel and MACI. Steve has led improvement of manufacturing processes, and development of novel identity, potency and viability assays for various cell therapy programs. His responsibilities have also included designing and executing technology transfers and comparability studies between manufacturing sites, and authoring CMC sections of MAA and BLA submissions. Steve earned his Ph.D. at the University of Washington and did post-doctoral research with the Howard Hughes Medical Institute at the University of Chicago.

Carlotta Peticone, PhD, Senior Scientist I, Process Development, Autolus

Biography unavailable

Marc-Olivier Baradez, PhD, Lead Analytical Development Scientist, Cell and Gene Therapy Catapult

Dr Marc-Olivier Baradez is Lead Scientist in Analytical Development at the Cell and Gene Therapy Catapult. He has over 12 years’ industrial experience in the implementation of analytical strategies for the characterization of cell therapies. He is currently the Catapult’s Strategic Lead for Data and Control, working on automating high-throughput data generation, streamlining data handling and analysis, developing decision algorithms for in-process controls in the characterization and translational context of Intelligent Manufacturing. Marc-Olivier’s multidisciplinary expertise lies in experimental designs and high-throughput multivariate quantitative approaches, in which established and new technologies are integrated to derive robust fingerprints between cell products, their potency, and the processes used in their manufacture. He was previously Science Leader in Cell Metrology at LGC, the UK designated National Measurement Institute for chemical and bio-measurements. He was also Senior Scientist at ReNeuron, a leading, clinical-stage stem cell company, where he characterized the Company’s first clinical conditional neural stem cell line for stroke therapy.

Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC

Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 25 years of experience developing cell and gene therapy products and has consulted for over 100 industry and academic clients in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and regulatory aspects of a wide range of cell therapy and gene therapy products, including CAR T-cells, gene-edited cells, dendritic cell vaccines, natural killer (NK) cells, and other immunotherapies, hematopoietic stem cells (HSCs) from bone marrow, blood, umbilical cord blood, and regenerative medicine products such as mesenchymal stem cells (MSCs), chondrocytes, pancreatic islet cells, and other somatic cell therapies.

Sean Mackay, CEO, IsoPlexis

Sean Mackay is the Co-Founder and Chief Executive Officer of IsoPlexis, a life sciences company dedicated to accelerating the fight against cancer and autoimmune disease through its single-cell platform. Sean is an experienced entrepreneur, specializing in the convergence of life sciences and health care. In partnership with co-founders at Yale and Caltech, Sean led IsoPlexis through foundational licensing and capital raising, while building a scientific and engineering team to develop applications and product.

Cell Therapy Manufacturing

Ohad Karnieli, PhD, MBA, CEO and Co-Founder, Atvio Biotech Ltd.; Chair, Process and Product Development Subcommittee, International Society of Cellular Therapies

Dr. Karnieli earned his PhD in Biotechnology focusing on Cell & Gene Therapy from the Sacler school of Medicine at Tel Aviv University and an MBA from the Haifa University school of management. Dr. Karnieli served in several executive rolls in the field of cell therapy and medical devices with his last position being the VP of Technology & Manufacturing at Pluristem Therapeutics. A well-known expert in the field of cell therapy process development and serves on several industry committees including chairing of the process & product development committee of the International Society for Cell Therapy and an expert member in the ISO TC276 Bioprocessing committee. Dr. Karnieli is the founder of Karnieli Ltd and ADVA Biotechnology.

Knut Niss, PhD, CTO, Mustang Bio

Dr. Niss has served as Chief Technology Officer since March 2018. Dr. Niss joined Mustang in March 2017 as Vice President of Operations, where he initiated and oversees the establishment of Mustang’s cell therapy manufacturing facility. Prior to Mustang, Dr. Niss was Cell Therapy Asset Leader at Biogen, where he oversaw CMC-related activities for gene-edited hematopoietic stem cell and lentiviral gene therapy programs for sickle cell disease and hemophilia, respectively. Earlier in his career, Dr. Niss was Senior Technical Project Leader at Novartis’ cell therapy manufacturing facility in Morris Plains, New Jersey, where he directed the transfer and implementation of the CTL019 process from Penn to Novartis. He also served as Senior R&D Program Manager at EMD Millipore, where he established processes for the large-scale expansion of adult and pluripotent stem cells. Dr. Niss began his career in senior research positions in Pfizer’s Regenerative Medicine and Immunology groups. He holds a Ph.D. in molecular biology from Humboldt University of Berlin, and an M.S. in microbiology from the University of Göttingen in Germany. Dr. Niss completed his postdoctoral research at Boston Children’s Hospital and the Dana-Farber Cancer Institute.

Keith R. Olson, PhD, Global Director, Business Operations, Life Sciences, Corning Incorporated

Dr. Keith R. Olson is the Global Director of Business Operations for Corning Life Sciences. In this role, he holds responsibility for the division P&L and manages the CLS team. Prior to joining Corning, Olson held positions in R&D, commercial operations, sales, business development and senior management. Olson holds a Bachelors of Science from Carnegie Mellon University, a Master’s in Molecular Biology from University of Rochester and a Ph.D. in Molecular Biology from University of Rochester.

Devyn Smith, PhD, Chief Strategy Officer, Strategy & Ops, Sigilon

Dr. Devyn Smith is Sigilon’s Chief Operating Officer. In this role, Dr. Smith is tasked with building the strategy and operational elements for a portfolio of potential new medicines Before joining Sigilon, Dr. Smith was part of Pfizer's Medicinal Sciences Division of R&D, where he was Head of Business Operations & Strategy. His responsibilities in this position included oversight of both the day-to-day business operations of the division and the development of implementable strategies. Dr. Smith also held several other high-level positions at Pfizer including Head of Strategy for the Pharmatherapeutics Division of Pfizer R&D and Chief Operating Officer of Pfizer's Neusentis Research Unit in the UK.

Brian Murphy, PhD, Director, Bioprocess Development, Celgene

Process development of placental cell therapies, including design of product attributes, scale-up, pre-validation, manufacturing support, change control, and regulatory interactions. Management of FTEs ranging from PhD scientists, senior bioengineers, associate engineers and interns. Represent CMC on project teams for multiple cell therapy products, and lead CMC initiatives in development, supply, and quality concerns.

Alan Smith, PhD, Executive Vice President, Technical Operations, Bellicum

Alan Smith, is currently the Executive Vice President Technical Operations at Bellicum Pharmaceuticals. He has broad experience in the cell therapy area with over 30 years working in various senior management roles in research and development, manufacturing and quality in cell and gene therapy companies. Prior to joining Bellicum, Dr. Smith held senior management positions at LifeNet Health, Cognate BioServices, Aastrom Biosciences, Geneic Sciences, Baxter Healthcare, BioSpecific Technologies and HyClone also as President of his own consulting company in the industry. Dr. Smith earned his BS degree in Chemistry at Southern Utah University and his doctorate in Biochemistry at Utah State University.

Przemyslaw Kruczek, PhD, Senior Scientist, Autolus

Biography unavailable

David Sourdive, PhD, Executive Vice President, Technical Operations, Cellectis

David Sourdive, Ph.D., is a co-founder of Cellectis and joined the Board of Directors in 2000. Dr. Sourdive holds the position of Executive Vice President, Technical Operations, with the mission to develop the Company’s industrial and technological basis as well as to deploy its operations in the pharmaceutical arena. Dr. Sourdive combines a strong scientific expertise with experience in managing industrial programs bringing innovative technologies to industrial fruition. He served as Executive Vice President, Corporate Development, from 2008 to 2016. In addition to his role at Cellectis, Dr. Sourdive has also served on the board of directors of the Mediterranean Institute for Life Sciences. David Sourdive graduated from École Polytechnique, received his Ph.D. in molecular virology at Institut Pasteur and completed a research fellowship in the Emory University Department of Microbiology and Immunology. His management training is from the HEC (Challenge +) and his decade-long experience in industrial program management was acquired at the French Department of Defense (DGA) prior to Cellectis’ inception.

Shashi Murthy, PhD, Professor, Chemical Engineering, Northeastern University

The primary focus of our research is the design of microfluidic devices for applications in clinical diagnostics and regenerative medicine. These devices are fabricated using technology originally designed for the semiconductor industry and are capable of handling and manipulating small volumes of fluids (down to tens of microliters) and small numbers of cells. Our expertise is in functionalizing microfluidic channels with a broad range of biomolecules and achieving high-resolution cell separation with these simple and easy-to-use devices.

Damian Marshall, PhD, Head, Analytical Development, Non-Clinical Operations, Cell & Gene Therapy Catapult UK

Damian Marshall is the head of analytical development for the Cell and Gene Therapy Catapult and has almost 20 years of industrial gained working for SME’s and large companies. He leads a team of ~30 scientists working with a wide range of therapy developers helping to de-risk their route to commercialisation. This is achieved through advanced product characterisation, helping companies to manage sources of variability and gain a high level of products and process knowledge. His team is also supporting the development of new adaptive manufacturing approaches by integrating technologies to allow real-time product monitoring and enable feedback control during product manufacture.

Tehila Sonnenfeld, PhD, Director, Manufacturing & Technology Transfer, Immunovative Therapies

Dr. Tehila Sonnenfeld joined the company at 2009 in order to develop the company’s personalized vaccine product. At 2012 she was promoted to the position of director of manufacturing and been serving in that position since. She has a Ph.D. in Biochemistry from the Hebrew University and has published several publications in the field of proteins interactions.

Patrick J. Hanley, PhD, Laboratory Facility Director, Cellular Therapy and Stem Cell Processing, Program for Cell Enhancement and Technologies for Immunotherapy, Division of Blood and Marrow Transplantation, Children’s National Health System

Dr. Hanley is the director of the Class 10,000 Good Manufacturing Practices (GMP) facility at Children’s National Health System, which is charged with manufacturing novel cellular therapies in the Program for Cell Enhancement and Technology for Immunotherapy (CETI) under investigational new drug (IND) applications, as well as processing for standard of care stem cell transplant products. He is also responsible for all follow up and immune reconstitution testing performed on patients treated on CETI’s protocols. Trained as an Immunologist, Dr. Hanley has an extensive background and interest in cellular therapy. For the past 10 years he has investigated and helped to translate the following into more than 15 clinical trials.

Linda L. Kelley, PhD, Senior Member, Director, Cell Therapy Facility, Moffitt Cancer Center

Dr. Kelley, Cell Therapy Facility Director, is a Senior Member at Moffitt Cancer Center and Professor at the University of South Florida. Dr. Kelley has provided leadership for cellular therapy facilities for over twenty years at three institutions, University of Utah, Dana Farber Cancer Institute and Moffitt Cancer Center. She received graduate and post-doctoral training in immunology and hematology from Vanderbilt University, Nashville, TN. Her scientific career evolved from a fundamental interest in immunological mechanisms of T lymphocyte function, growth mechanisms of hematopoietic stem and progenitor cells and molecular changes associated with malignant transformation. Knowledge of the hematopoietic system led to an interest in stem cell biology and therapies. As director of the Cell Therapy Facility at the University of Utah from 1994-2011, she was responsible for developing and expanding a Cell Therapy and Regenerative Medicine Laboratory. During her tenure she was responsible for pre-clinical and clinical cell therapy product development to support IND applications for the production of allogeneic mesenchymal stromal cells (MSC), autologous bone marrow-derived mononuclear cells and allogeneic fetal-derived oligodendrocytes. As director of the Cell Manipulation Core Facility at the Dana Farber Cancer Institute at Harvard from 2011-2012, she oversaw management of 20 FDA-approved INDs for the manufacture of gene-modified CD34+ cells, tumor cell vaccines, dendritic cells, MSCs and others. As director of the Cell Therapy Facility at Moffitt Cancer Center, she oversees 22 active INDs for a variety of cell therapy products largely to support immunotherapy for adult and pediatric patients. She currently serves as the Principal Investigator for Production Assistance for Cellular Therapies (PACT) – Cell Processing Facilities to perform pre-clinical cell therapy product development in collaboration with NHLBI and other PACT Centers and as Core Laboratory Technical Director for the Moffitt Cancer Center Support Grant. Dr. Kelley excels at bridging the gap between laboratory-based discoveries and new therapies for patients.

Lawrence Lamb, PhD, Clinical Laboratory Immunologist, Professor of Medicine, The University of Alabama at Birmingham; Co-Founder, Incysus

Dr. Lawrence Lamb is a Clinical Laboratory Immunologist and Professor of Medicine at the University of Alabama at Birmingham. specializing in transplantation immunology. He also holds appointments in Pathology and Pediatrics and is board-certified by the Oncology Nursing Certification Corporation for Advanced Practice in Oncology Nursing (AOCNS). Dr. Lamb directs the UAB Cell Therapy Laboratory in the Section of Bone Marrow Transplant and Cellular Therapy. While a Transplantation Medicine postdoctoral fellow at the University of South Carolina, Dr. Lamb was the first to describe homeostatic reconstitution of T cells in patients who receive T cell depleted bone marrow grafts as well as an association between T cell recovery and disease-free survival in allogeneic bone marrow. He currently directs research programs for evaluation and translation of T cell-based therapies for Glioblastoma Multiforme and Leukemia has been funded by the NINDS, NCI, Elsa Pardee Foundation, Leukemia and Lymphoma Society, the Brendan Franco Foundation, and the Southeastern Brain Tumor Foundation. He also held the National Brain Tumor Society's Samuel Gerson Leadership Chair for Glioblastoma Research for 2008-2010. Dr. Lamb serves on several national and international committees related to cell and gene therapy and currently chairs the Scientific Advisory Board for Incysus, Ltd.

Leo Chan, Manager, Technology Research & Development, Nexcelom Bioscience, LLC

Leo Chan serves as the Technology R&D Manager at Nexcelom Bioscience LLC.. His research involves in the development of instrument and applications for the Celigo and Cellometer image cytometer. He received his B.S., M.S., and Ph.D. in Electrical and Computer Engineering from the University of Illinois at Urbana-Champaign (2000-2008).

Gene Therapy

Gene Therapy CMC & Analytics

Karen Doucette, MBA, Director, Operations, ACF Bioservices

As Director of Operations, Karen's support spans consultative study design, internal and external project management, study execution and reporting. Playing a key role in coordinating research innovation with customer need, particularly in the areas of in vitro DDI and BE testing, and potency assays for cell and gene therapy products.

Michael Kelly, PhD, Director, Asset Leadership, Gene Therapy, Biogen

Biography unavailable

Yuan Zhao, PhD, Head of Gene Therapy Section, Division of Advanced Therapies, NIBSC/Medicines and Healthcare Products Regulatory Agency

Dr Zhao obtained her PhD at Manchester University and gained her postdoctoral experiences at the University of Oxford, CR-UK Cancer Institute and UCL. Dr. Yuan Zhao is currently a principal scientist and the head of gene therapy section at NIBSC/Medicines and Healthcare Products Regulatory Agency (MHRA). She is responsible for developing WHO international standards and EDQM/OMCL control assays to ensure product quality and safety and to support the development and manufacture process of gene therapy products and is actively contributing to the development of European and International Guidance on Advance Therapies.

Matthias Renner, PhD, Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute

Biography unavailable

Lawrence Thompson, PhD, Principal Scientist, Analytical Research & Development, BioTherapeutics Pharm Sciences, Pfizer

Lawrence (Larry) C. Thompson, PhD is a Principal Scientist in Analytical Research and Development within BioTherapeutic Pharmaceutical Sciences at Pfizer. He has been with Pfizer for more than 4 years and is currently analytical lead on viral and plasmid based immunotherapeutics/gene therapies. Previously, he spent 3 years in small biotech at two different companies as the analytical lead in the development of serum based cancer diagnostics. He is a graduate of the University of Tennessee (Chattanooga); BS Chemistry in 2001 and Vanderbilt University; PhD Biochemistry 2006. He did his post-doctoral work at the University of Tennessee (Knoxville) from 2006-2010. His education and research path covers a wide breadth including small molecule synthesis; protein cloning, expression and purification; enzyme structure/function determination; protein-protein interaction investigation; serum antigen identification and mAb production/selection; virus/plasmid analytical testing including method development and characterization generating a number of peer reviewed publications and presentations at scientific conferences as well as internally within Pfizer.

Danielle McAnally, PhD, Associate Scientist, Quality Control, AGTC

Biography unavailable

Josefina Nilsson, Head, EM services, Electron microscopy services, Vironova

Josefina Nilsson has a PhD in Virology from the Karolinska Institute and is since 2007 head of the Vironova CRO offering electron microscopy services specialized for biopharmaceuticals. She has since then served to shape the company services and solutions related to viral particle characterization. Vironova offers beside services also innovative hardware and software solutions for advanced electron microscopy image analysis.

Roman Raim, PhD, Analytical Product Owner, Process Development and Technical Services, Shire

Working for Shire since 2015 in the funtions Quality Product Owner and Analytical Product Owner

Lyndi Rice, PhD, Director, Analytics, Gene Therapy Program, University of Pennsylvania

Lyndi Rice is currently the Director of Analytics for the Gene Therapy Program (GTP) at the University of Pennsylvania, Philadelphia, PA, where she directs three teams focused on Quality Control of all vectors produced at GTP and Contract Manufacturing Organizations (CMOs). Her team develops and qualifies robust program-specific potency assays, utilizing technologies such as ELISAs, in-cell westerns, and high content imaging. Her team also develops novel characterization assays to support all programs. She oversees drug product release and all stability studies and device compatibility studies for toxicology and clinical lots supporting multiple programs entering Phase I clinical trials.

Jarrod Dean, Scientist, Analytical Development, Biopharmaceutics Development, Sanofi

Jarrod Dean received his B.Sc. at Fairfield University. Post undergraduate school, Jarrod worked for the Cardiovascular Research group of St. Elizabeth’s Medical Center (Brighton, MA), focusing on rAAV vector production and analytics in support of animal studies. Jarrod moved to the Sanford Burnham Prebys Medical Discovery Institute (La Jolla, CA), with a focus on characterizing the role of a novel Ileal Bile Acid Binding protein variant in the onset and progression of colorectal cancer. He then worked for Sequenom, Inc. (San Diego, CA), where his contributions resulted in the commercialization of a non-invasive next generation sequencing test for the diagnosis of Trisomy 21, 13 and 18 by targeting cell-free circulating fetal DNA. Currently, Jarrod is part of the Analytical Development group of Sanofi Biopharmaceutics Development (Framingham, MA), leading initiatives to implement next generation technologies and methods to advance internal Gene Therapy analytical paradigms.

Russell Goetze, PhD, Scientist, Vector Analytics, bluebird bio

Passionate scientist researching infectious disease and rare genetic diseases. Effective communicator with a proven track record of publishing research and contributing to collaborative research projects across multiple scientific disciplines. Articulate, creative, and strategic critical thinker.

Dong Xu, PhD, Senior Scientist, Analytical Development, Biogen, Inc.

Wei-Chiang Chen, PhD, Scientist I, Bioassay and Gene Therapy, Analytical Development, Biogen

Dr. Wei-Chiang Chen is a scientist in Bioassay and Gene Therapy group focusing on developing assays for gene therapy platforms in Biogen. Before joining his current group, he worked on development of high throughput analytical platforms supporting cell line development and process development for biologics. His expertise is in cell biology, cancer biology, gene therapy, high throughput assay development, and automation. He received his MS in Chemical Engineering from University of Florida and PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.

Christine Le Bec, Head of CMC Analytical, Technology Development, Genethon

Christine Le Bec joined Genethon in 1997 as a scientist and currently heads the CMC Analytical Department. She is responsible for the analytical activities in the characterization and release testing of gene therapy products at early stage development, stability studies, and interface with CMO for method transfer and validation, analytical/QC testing. She has a strong expertise in the development and qualification of analytical methods based on biochemical, biophysical and cell based assays to assess identity, potency, impurity profile, and safety. Before joining Genethon, she obtained her PhD in Bio-Organic Chemistry from Université Pierre et Marie Curie (Paris VI) in 1993. She worked as a postdoctoral researcher at Thomas Jefferson University (Philadelphia, US) and then at Institut Pasteur (Paris, France) in the field of synthesis, structural analysis and in vitro evaluation of antisense DNA as therapeutic agents for cancer and AIDS.

Pete Clarner, Senior Associate Scientist, Analytical Development, Biogen

Pete graduated from Boston College with a Bachelor’s degree in Biology. Following undergrad he joined the Bioassay group of the Analytical Development department at Biogen. For the last 6 years he has supported the characterization and development of protein biologic and AAV vector-based gene therapy programs, with specific expertise in PCR-based methods including qPCR and ddPCR. He is currently pursuing a Professional Science Master’s degree in Biotechnology at Northeastern University.

Simon Godwin, PhD, Senior Manager, Sanofi Gene Therapy Skill Center

Khandan Baradaran, PhD, Vice President and Global Head, Quality, Ultragenyx

Dr. Khandan Baradaran, Ph.D. serves as Head of Quality and served as Vice President of Regulatory and Quality Assurance at Dimension Therapeutics, Inc. Dr. Baradaran has extensive expertise in the areas of viral safety, gene therapy vector development, vaccine development and assay technologies. She has held positions of increasing responsibility in Regulatory Affairs, Quality Control and Quality Assurance at Shire Pharmaceuticals where she was responsible for early and late stage rare disease development programs utilizing novel medical device and gene therapy approaches. Before joining Shire Dr. Baradaran was at Biogen where she was the Global Regulatory lead for AVONEX®, an MS drug that is marketed in over 100 countries. While at Biogen, she was involved with the development of the Adenovirus Interferon gene therapy vector and served on the Adenovirus Reference Material Working Group. Prior to Biogen Dr. Baradaran played significant roles in the submission and approval of KALBITOR® and FLUCELVAX®, as well as several clinical dossiers at Dyax Corp. and Novartis Vaccines and Diagnostics. Dr. Baradaran received her B.A degree in Molecular Biology from Wellesley College and her Ph.D. in Virology from Harvard University.

Gene Therapy Manufacturing

Ratish Krishnan, Scientist, Bioprocesssing Research & Development, Pfizer

•Bachelors in Bioprocess Engineering and Biotechnology from Anna University, Chennai, India

•Masters in Biotechnology from Pennsylvania State University, University Park, PA

•3 years with Novartis Animal Health Vaccines

•5+ years with Pfizer Global Biologics R&D working on various modality of vaccines from Reg Tox to Phase 3 and Process Validation

Sadettin Ozturk, PhD, Senior Vice President, Process and Analytical Development, MassBiologics

Dr. Sadettin Ozturk, the Deputy Director Process Development, has had a long career in cell culture process development, technology transfer, product licensing, and commercial manufacturing. His early contributions to the field focused on applying chemical engineering principles and process control strategies to the optimization and scale-up of cell culture processes. He was responsible for the development of numerous cell culture based processes and novel technologies that helped not only the companies that he worked for (Verax, Bayer, GlaxoSmithKline, and Johnson & Johnson), but contributed to the rest of the field through his numerous presentations and publications. Sadettin led process development activities and played a key role in the licensing and commercialization of two monoclonal antibodies, Stelera®, and Simponi®. In addition, he transferred and supported the commercial manufacturing of Kogenate® and BeneFix®. Sadettin has published numerous research articles, given presentations, delivered keynote lectures, and edited books. He is a member of several societies including ESACT, American Association for the Advancement of Science, New York Academy of Sciences, American Chemical Society, and American Institute of Chemical Engineering. Sadettin is involved in these scientific organizations and other community activities by serving on their Scientific Advisory Boards and organizing meetings and sessions. He has served Biochemical Technology (BIOT) division of American Chemical Society as the Division Chair, and then as a Councilor. He co-authored a well-respected book in the field entitled Cell Culture Technology for Pharmaceutical and Cellular Therapies. Sadettin also serves on Editorial and Review Boards for several journals and other publications.

Kelly Kral, PhD, Associate Director, Vector Process Development and Manufacturing, bluebird bio

At bluebird bio, Kelly leads the upstream process development group focused on delivering high quality lentiviral vector for gene therapy applications for both clinical and commercial purposes. Prior to bluebird, she was at Percivia and Genzyme, working on mammalian cell culture process development for the production of viruses and therapeutic proteins. She holds a master’s degree from MIT and a bachelor’s degree from Clarkson, both in Chemical Engineering.

Jeffrey Bartlett, PhD, CSO, Calimmune, Inc.

Jeffrey Bartlett, Ph.D., leads the global research and development program for Calimmune. As chief scientific officer, he oversees external and internal research programs, product manufacturing, vector design and production, clinical laboratory activities and regulatory issues. He also provides scientific guidance for ongoing clinical programs and overall corporate strategy and operations. Dr. Bartlett, who joined Calimmune in 2012, brings more than 20 years of experience in the development of viral vectors, novel gene and cell-based therapies, and the transition of scientific innovation and early phase clinical studies into accepted treatments. Prior to Calimmune, Dr. Bartlett was an investigator within the Centers for Gene Therapy and Childhood Cancer at The Research Institute at Nationwide Children’s Hospital, and served as a tenured academic faculty member at the Ohio State University and the University of North Carolina at Chapel Hill. His academic research program focused on the development and application of cell and gene therapies; gene transfer technologies; cell therapy; viral vectors; AAV biology; and host responses to gene transfer agents. He has served on numerous NIH special emphasis and regular grant review panels, FDA and NIH advisory committees, and as a member of the NIH Recombinant DNA Advisory Committee (RAC). He is an inventor on numerous patents, patent applications, and licensed technologies relating to viral vectors, and cell and gene therapy. Dr. Bartlett holds a bachelor’s degree in biology and art from Middlebury College in Vermont and a doctorate in molecular biology from the University of Pittsburgh School of Medicine.

Aziza Manceur, Research Officer, Human Health Therapeutics Research Centre, National Research Council Canada

Aziza is a research officer at the National Research Council Canada, a Research and Technology organization funded by the government of Canada. She is part of the Cell Culture Scale Up team, a team that specializes in the large production of viral vectors and proteins using mammalian cells. She earned her PhD in biomedical engineering from the University of Toronto and went to the University of Pennsylvania for a post-doctorate training. Along with her colleagues Sven Ansorge, Rénald Gilbert and Parminder Chahal, she is currently working on the development and intensification of a lentiviral vector manufacturing process using suspension cells.

Michael Paglia, MSc, Vice President, CMC Operations, Oncorus

Michael has spent the last fifteen years in biotechnology building, leading and motivating process development and manufacturing teams to support clinical programs from early development to late stage clinical trials. Currently, Michael is the Vice President of CMC Operations at Oncorus and the program lead for the development of a next-generation oncolytic immunotherapy platform to treat cancer. The CMC Operations group at Oncorus consists of process development, manufacturing, analytical sciences, quality control and regulatory sciences responsible for the development and characterization of micro-RNA attenuated oncolytic herpes viruses.

Nitin Garg, PhD, Assistant Director, Upstream Development, AGTC

Biography unavailable

David Knop, PhD, Executive Director, Process Development, AGTC

Biography unavailable

Nathalie Clément, PhD, Associate Director and Associate Professor, Powell Gene Therapy Center, Pediatrics, University of Florida

Dr. Clément gained an extensive knowledge in both the Gene Therapy and Parvovirus fields during her Ph.D work and post-doctoral fellowship, with a special emphasis in the development of AAV-based vectors for Gene Therapy applications. She ran a core facility in the Mount Sinai Hospital where she was in charge of supervising the development of many new AAV-based vectors including their production, purification and quality control assays. She was recently recruited to the PGTC where she continues to dedicate her research to the development of AAV vectors for research and clinical projects.

Johannes C.M. van der Loo, PhD, Director, Clinical Vector Core, The Raymond G. Perelman Center for Molecular and Cellular Therapies, Children’s Hospital of Philadelphia

Dr. van der Loo obtained his Ph.D. from the Erasmus University in Groningen, the Netherlands and, after completing his post-doctoral training at Indiana University, obtained a faculty position at the University of Minnesota Stem Cell Institute. He was recruited to Cincinnati Children’s Hospital in 2002 where he built and directed a GMP Manufacturing Facility. In 2015 he joined the Children’s Hospital of Philadelphia as Director of the Clinical Vector Core. His expertise includes process development, scale up, and pre-clinical and clinical cGMP manufacturing of viral vectors, including gamma-retroviral vectors, AAV, foamy virus, and lentivirus.

Alois Jungbauer, PhD, Professor, Institute of Biotechnology, University of Natural Resources and Life Sciences (BOKU)

Meisam Bakhshayeshi, PhD, Sr Engineer, Gene Therapy Downstream Process Development, Biogen

Meisam is head of gene therapy downstream process development at Biogen. Meisam has number of years of experience in developing downstream processes for protein biologics and viral vectors at different stages of development. Meisam holds a PhD in Chemical engineering from Penn State university.

Tanvir Tabish, PhD, Head, Drug Product Development for Gene Therapy, Device and Combination Products, Shire

Tanvir joined Shire about two and a half years ago and is presently the Head of Formulation Development for Gene Therapy and Protein modalities; Tanvir is currently based in Vienna. His responsibilities include developing formulations for Gene Therapy and protein based Biopharmaceuticals. Prior to joining Shire, Tanvir worked as an Associate Director, for Ipsen, where he managed an early and pre-formulation development group. Tanvir has extensive experience of working in the Biopharmaceutical industry having also worked, for 15 years, in the Biopharmaceutical Product Development Division of GlaxoSmithKline

Scott Burger, MD, Consultant, Advanced Cell and Gene Therapy Ltd.

Biography unavailable

Chad Green, PhD, Principal & Senior Consultant, Dark Horse

Dr Chad Green is a Principal and Senior Consultant at Dark Horse Consulting responsible for partnering with clients across a broad range of technologies, including autologous and allogeneic cell therapy, biologic/device combination products, gene therapy and medical device. Prior to Dark Horse, Chad served as the Senior Director of Technical Operations at Fate Therapeutics and as the Director of Product Engineering at ViaCyte, Inc., where he was responsible for design, development, verification/validation and transfer to manufacturing activities for all macroencapsulation devices, delivery systems, disposables and ancillary surgical tools for the first-in-human cell therapy combination product. Chad specializes in process development, technology transfer and cGMP manufacturing of autologous and allogeneic cell therapies with an emphasis on iPSC and hESC-derived therapies, development of biologic/device combination products, Quality by Design, regulation of cell and gene therapies, Quality Systems for cGMP manufacturing, risk analysis and risk modeling, design control and development of Class II and III medical devices. He is an inventor on over 25 issued patents, and is a Lean Six Sigma Black Belt.

Mike Sheehan, MSc, MBA, PMP, Senior Project Manager, DPS Group

Solving complex facility design challenges motivates Mike in the work he completes for clients. Working with a globally diverse range of companies, he is adept at enabling collaborative work environments helping project teams turn innovations into life-saving, life-enhancing products. Mike has spent the last 16 years delivering project engineering services to biotechnology, pharmaceutical and microelectronics clients in Europe with a focus on design management of process manufacturing facility projects.


Manufacturing 4.0

Nicolas Cruz Bournazou, PhD, Technical Univeristat Berlin

Dr.-Ing. Mariano Nicolas Cruz Bournazou is leader of the Modeling, Simulation and Optimization group at the Bioprocess Engineering Laboratory of the Technical University of Berlin. He holds a BSc of Honors in Chemical Engineering from the National Autonomous University of Mexico (UNAM) and a PhD degree from Technical University of Berlin as part of the excellence cluster UNICAT, where he obtained the international Dimitris N. Chorafas award. His work focuses on building, adapting, and fitting first principle models for large scale bio-processes. His main tasks include Model Reduction, Optimal Experimental Design in high throughput screening systems, consistent bioprocess development and model-based process monitoring of wastewater treatment and biogas production.

Daniel G. Bracewell, PhD, Bioprocess Analysis, Dept of Biochemical Engineering, UCL

Daniel G. Bracewell is Professor of Bioprocess Analysis at the UCL Department of Biochemical Engineering. He has made major contributions to the fundamental understanding of biopharmaceutical purification operations, generating over $7.5 million in research funds including new international research collaborations with India and the USA. He has authored more than 90 peer reviewed journal articles in the area to date and currently supervises 15 doctoral and postdoctoral projects, many of these studies are in collaboration with industry. One such project became the technology basis from which the spinout Puridify (recently acquired by GE Healthcare) developed.

Eben Crawford, Process Engineer, Celldex Therapeutics

My name is Eben Crawford, I am a graduate of the University of Massachusetts Dartmouth’s Bioengineering program. I started working in Manufacturing at Celldex Therapeutics in 2013, and then transferred to the Process Development in 2015. Currently I am the Process Development Engineer for Celldex working on Downstream processes for monoclonal, fusion, and bispecific antibodies.

Robert Dream, PE, CPIP, Managing Director, HDR Company, LLC.

Robert Dream is an industry leader with 30+ years of experience, including 20 years of executive leadership in the pharmaceutical and biotechnology industries. He has led projects, improved processes, helped move drug substance and drug products from R&D, clinical, regulatory licensing approvals through operational excellence strategies and leading edge technologies. He is business minded person and has an innovative knowledge and knowhow of manufacturing, logistics, supply chain, risk mitigation and management. He is experienced in therapeutic biotechnology and biological drug substance and drug products manufacturing, with extensive hands-on, senior leadership and executive experience at world-leading organizations. He wrote numerous articles for many journals and publications and lead and presented at many institutions, organizations, and conferences. He is a registered professional engineer and an active member of the ISPE and PDA. He is a member of the editorial advisory Board; Pharmaceutical Processing, Pharmaceutical Manufacturing, Pharmaceutical Technology, Pharmaceutical Engineering, and the INTERPHEX Advisory Council. He is a member and Process Chair of the PDA “Aging Facilities Modernization” Team. He is the Chair of the ISPE GUIDE: “Biopharmaceutical Process Development and Manufacturing”; published 2013, ISPE “Sustainability Handbook”; Published 2015 and numerous other relevant publication to list few.

Christopher Earnhart, PhD, Department of Defense

Dr. Earnhart is the Deputy Joint Product Lead for the PRISM (Platforms for Rapid Integrated Solutions for Medical Countermeasures) office within the Joint Program Executive Office for Chemical and Biological Defense. Dr. Earnhart also leads the ADAMANT (Advanced Development and Manufacturing of Antibody Technologies) advanced technology demonstration which leverages the monoclonal antibody platform to provide unique, rapid onset prophylactics and therapeutics for Warfighter exposure to chemical and biological weapons. Prior to this assignment, he served as the Senior Scientist for the DoD Advanced Development and Manufacturing facility. Dr. Earnhart earned his doctorate from the College of William and Mary/Virginia Institute of Marine Science as a National Science Foundation research fellow studying comparative immunology, and completed postdoctoral training in pathogenic bacteriology and vaccine research at Virginia Commonwealth University School of Medicine.

Amanda Fitzgerald, PhD, Senior Scientific Consultant, Biologics, Genedata

Amanda Fitzgerald leads a team of scientific consultants at Genedata, who provide solutions for organizations with large molecule and data management needs. She received her doctorate in Biochemistry and Molecular Pharmacology from the University of Massachusetts Medical School and has several years of pharmaceutical industry experience in biotherapeutic discovery and production groups, including scientific support for strategic alliances and development of a high-throughput protein production platform at Pfizer.

Paul C. Goodwin, MSc, Science Director, GE Healthcare

Paul Goodwin is the Science Director for GE Healthcare, Life Sciences and resides in Seattle, WA. He has a B.A. in Biology from the University of California, San Diego and a M.S. in Physiology and Biophysics from the University of Washington. He spent 14 years in academia during which time he created and ran the Image Analysis Laboratory at the Fred Hutchinson Cancer Research Center in Seattle. For the past 19 years, he has held various positions at Applied Precision (now GE Healthcare, Issaquah) where he is the Science Director for GE Healthcare, Life Sciences. He is the inventor of eleven patents and numerous peer-reviewed scientific papers and book chapters. He has spent his career developing instruments, software, and components for scientific imaging and microscopy. He is a regular teacher at various microscopy courses at the Marine Biological Laboratory, Woods Hole, MA and serves on several Advisory Boards.

Nathanael Hughes, MPH, MPP, Director, Strategic Partnerships, Bioproduction Group

A biotech and pharma expert for 15 years, Nate Hughes is Director, Strategic Partnerships with Bio-G in Berkeley, CA. He has helped build such companies as Medicis, PruGen, ZELTIQ, and now Bio-G. His background is in corporate business development and epidemiology.

Constantin Loghinov, Managing Director, MILS Group LLC

Mr. Loghinov is the founder and managing director of MILS - Group LLC (stands for Machine Intelligence for Life Sciences), a research-driven company that supports innovation in BioPharma industry through application of Artificial Intelligence. Previously, Constantin worked at a leading biopharmaceutical contract manufacturing organization, as well as a business growth consultant for biopharma and medical device companies. Mr.Loghinov earned an MBA degree from Duke University with concentration in Health Sector Management.

Namit Mehta, PhD, Director, Health Industries - Operations Strategy, Strategy& (Part of the PwC Network)

Namit is a Director with over 12 years within PwC Strategy& Strategy Consulting practice. With 16+ years of experience he has demonstrated ability to lead teams of professionals to formulate and execute market-back growth strategies, customer experience enhancement and fit-for-growth and digital transformational strategies. His functional depth in Operations allows him to manage large cross-functional transformational projects for clients in Pharma, Medical Device and Retail/ CPG industries. Over the last few years, Namit has been helping leading Pharma clients on their digital disruption and digital transformation journey.

Govind Rao, PhD, Professor and Director, Center for Advanced Sensor Technology, UMBC

Govind Rao is Professor of Chemical & Biochemical Engineering at the University of Maryland, Baltimore County. He obtained his Bachelor of Technology degree in Chemical Engineering from the Indian Institute of Technology, Madras in 1984. His Ph.D. degree was obtained from Drexel University in Chemical Engineering in 1987. He has been a faculty member at UMBC since 1987 and has served as Department Chair from 2000-2006. In 2006, he founded the Center for Advanced Sensor Technology (CAST) and has been serving as its Director since its inception.

Dr. Rao’s research is targeted towards disruptive innovation, where the goal is to create paradigm shifts in the state-of-the-art. He has focused on applications of fluorescence spectroscopy to create novel low-cost sensors for bioprocess, biomedical and environmental applications. His lab has developed next-generation sensors for low-cost non-invasive monitoring of oxygen, pH and pCO2 in bioreactors. In addition, novel sensors for glucose and glutamine have been developed. These sensors have led to a paradigm shift in bioprocess technology, as they collectively enable high throughput bioprocessing and are ideal for single use. Recently, the Rao lab has developed non-invasive sensor technology for neonatal monitoring. A major effort at CAST is the application of sensor technology to reduce healthcare costs and close disparity gaps by making innovative low-cost devices for use in low-resource settings. As part of this strategy, technology transfer and partnerships have been set up with entities in low-resource settings. An example of this is the development of a low-cost cardboard incubator that is currently in clinical trials in India. The current focus in the CAST is a major effort to develop next generation bio-manufacturing technology and is aimed at producing protein-based therapeutics at the point-of-care. He has published over 175 papers in professional journals. His funding has come from several diverse sources including NSF, NIH, JDRF, DARPA, FDA, ONR and from several companies. Dr. Rao has given several invited Keynote and Plenary Lectures at various International Conferences and Corporations.

He has received several awards. These include the Presidential Young Investigator Award from the National Science Foundation, Outstanding Teaching and Research Awards from UMBC, the Van Lanen Award from the American Chemical Society, the Gaden Award from Biotechnology & Bioengineering, the University System of Maryland Regents Award for Excellence in Research and he has been named a 2003 Innovator of the Year by the Maryland Daily Record. Dr. Rao has several patents, many of which have been licensed. Dr. Rao has served as the Chair of the Biotechnology Division of the American Chemical Society and on the Editorial Board of several prominent journals. In 2007, he was elected as a Fellow of the American Association for the Advancement of Science. In 2009, he was named as Editor of the PDA Journal of Pharmaceutical Science and Technology. In 2015 he received a “50 bright ideas” award from UMBC for the number of inventions filed and named an Eminent Engineer by Tau Beta Pi. He received the 2017 Pioneer Award from Connected World Magazine.

Sunil Gangadharan, PhD, Strategic Partnerships, Life Science Technologies and Smart Electronics Applications Partnerships, imec Belgium

Sunil Gangadharan has a PhD in biochemistry from the Indian Institute of Science and post-doctoral stints in genetics and genomics at Johns Hopkins Medical School and the National Institutes of Health in Bethesda, USA. With a focus on life science technologies, he promotes industry R&D collaborations with imec, Belgium so that the can access and leverage imec's unique capabilities and solutions in advanced semi-conductor technology. He is based in Boston and prior to joining imec, he managed academic-industry collaborations and the licensing of technologies at Partners Healthcare Innovation in Boston. 

Michael Sokolov, PhD, Postdoctoral Fellow, ETH Zurich

Dr. Michael Sokolov is a chemical engineer by training and a Postdoctoral Fellow at ETH Zurich, where he also holds a Lecturer position for statistics for chemical engineers. His work focuses on the digitalization and modeling of industrial biotechnological and chemical processes. He is also co-founder and COO of DataHow AG, a spin-off company from ETH specialized in technological consulting and software solutions for the manufacturing industry.

Samet Yildirim, MSc, MBS, Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc.

Samet Yildirim received a BSc in Biology and an MSc in Biophysics from Ankara University and an MBS degree in bioprocessing and business of bioscience from Keck Graduate Institute of California. From 2008 to 2013 he held various positions within responsibilities for research, product innovation and business development in various life science companies. In 2013 he joined Boehringer Ingelheim in Fremont, CA and involved with the development of continuous process platform. Currently he is leading a global innovation portfolio for the Next Generation Manufacturing of biopharmaceuticals in Boehringer Ingelheim Biopharma Business Unit.

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