Speaker Biographies

Sr VP Pharmaceutical Dev & Technology

Susan Abu-Absi, Ph.D. is Senior Vice President of Pharmaceutical Development & Technology at bluebird bio, a gene therapy company located in Cambridge, MA. The integrated product platforms at bluebird bio encompass gene therapy, cancer immunotherapy and gene editing – providing the potential to treat a broad range of serious diseases. She leads the teams that develop the CMC strategy and deliver and support the manufacturing processes and analytical methods required to advance therapies through clinical stages to commercial products and throughout the lifecycle. Bluebird bio’s first product, ZYNTEGLO™, received conditional MAA approval in June of 2019. Susan has over 20 years of experience in biologics process development and manufacturing. Prior to joining bluebird bio, she spent more than ten years in the Manufacturing Sciences & Technology organization at Bristol-Myers Squibb. During her tenure at BMS, she supported clinical and commercial biologics drug substance manufacturing at internal sites and at contract manufacturers. She led teams of scientists, engineers and statisticians tasked with improving process robustness and yields and introducing new technologies into manufacturing. As a leader at BMS, Susan contributed to the successful development and commercial supply of several products, including the launches of Opdivo®, Empliciti®, Yervoy®, and Nulojix®. Before her tenure at BMS, Susan was a member of the Process Sciences team at Bayer Healthcare in Berkeley, CA. Susan earned a Ph.D. in Chemical Engineering from the University of Minnesota in the laboratory of Professor Wei-Shou Hu and a B.S. in Chemical Engineering from the University of Toledo (Toledo, OH).

VP, Head

VP Yongho Ahn has been the leader of bio therapeutics development and manufacturing at Korea’s top biopharma companies and has diverse experience in bio therapeutics CMC field. He is developing robust manufacturing process for clinical and commercial biologics production through Faster & Better service at Samsung Biologics.

Assoc Dir Global Quality

Currently Dr. Udayanath Aich is an Associate Director at Bristol Myers Squibb with extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late and commercial biologics products. 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. Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Then Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics, CMC analytical strategies as ATL and structure-function study. Finally, before joining at Bristol Myers Squibb, Uday was working at Sanofi related to high throughput technologies, process analytical technologies (PAT), Analytical method harmonization, multi-attribute method Dev, analytical method dev, robustness, qualification and transfer for early and late stage product including 2nd generation commercial product as part of life-cycle analytics.

Chief Manufacturing Development Center Officer

Julie Allickson, PhD , Chief Manufacturing Development Center Officer, Wake Forest Institute for Regenerative MedicineDr. Allickson has 30 years of experience in clinical translation of regenerative medicine products. Translational experience includes regulatory affairs, laboratory/cleanroom management, business management and board directorship. Experience as an executive officer with a publicly traded company building services for cellular banking including licensure of technology. Dr. Allickson heads the clinical translation team streamlining development to create a robust pipeline of products in development and early phase clinical trials including cell therapy, gene therapy, tissue engineered organs and tissues, biomaterials and devices. Prior to the Institute she was the Vice President of Research and Development and Laboratory Operations for Cryo-Cell International Inc. and held leadership roles at the University of Miami Diabetes Research Institute and the American Red Cross. Dr. Allickson is on the Board of Directors for AABB and the Regenerative Medicine Outcomes Foundation as a scientific advisor, Editorial board of CELLR4 and Journal of Translational Medicine, Vice Chair for Cord Blood Association Quality Committee, Technical Advisory Board for Tissue Engineered Products under ICCBBA, grant reviewer for state funded initiatives such as CIRM and serves on the ISCT Commercialization Committee.

Assoc Prof

Samiul Amin is currently Associate Professor of Chemical Engineering at Manhattan College. At Manhattan College Chemical Engineering Department, Prof. Amin currently leads the Cosmetic Engineering focus area. Prof. Amin also holds an appointment as an Adjunct Associate Professor at the Long Island University, School of Pharmacy. Prior to joining academia in January 2018, Prof. Amin has worked in industry across multiple industrial sectors for the past 20 years working across Engineering, R&D and Innovation/Open Innovation Management in global multinationals such as ExxonMobil, Unilever, Yet2, L’Oreal and Malvern Instruments in Asia, Europe and the US. Prof. Amin’s expertise is in colloids & complex fluids, rheology, tribology, advanced characterization and formulation design of consumer, personal care, homecare and biopharmaceutical products. Prof. Amin’s research at Manhattan College is focused on formulation design and performance optimization of consumer, cosmetic, biopharmaceutical and homecare products based on establishing structure-property-processing-performance linkages and generating high performance formulations through utilization of novel sustainable materials such as biosurfactants and biopolymers and novel polymer and surfactant chemistries including stimuli responsive or smart materials, all of which are sourced through collaborations with polymer and materials companies. Prof. Amin's research group is involved in multiple industrial research projects with global cosmetic/personal care, biopharmaceutical and advanced characterization/instrumentation companies. Prof. Amin has served on many committees of national and international societies/organizations such as the Royal Society of Chemistry (RSC)/Society of Chemical Industry (SCI) etc. and has chaired numerous international conferences in the cosmetics, biopharmaceuticals and complex fluids/soft matter area in Europe and the US. He is currently the section editor for Current Opinion in Colloid and Interface Science-Formulations and Cosmetics section. Prof. Amin received his PhD in Chemical Engineering from North Carolina State University, his MS in Chemical Engineering from The Johns Hopkins University and his BS in Chemical Engineering from Rutgers University. Prof. Amin also carried out a postdoctoral fellowship in the Soft Condensed Matter Physics Group at the University of Fribourg in Switzerland.

VP Global Biologics

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 including advanced therapies.. Prior to joining USP in 2006, his research at the U.S. National Institutes of Health focused on developing methods for the development of cell-based therapies for the treatment of diabetes. Dr. Atouf earned his Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.

Sr Lecturer

After completion of a first degree in Chemical Engineering/Biotechnology (FHO Emden, Germany) he carried out a PhD in Applied Molecular Biology at UMIST (Manchester, UK). Following a short postdoctoral period in the Department of Biochemical Engineering at UCL he became a Lecturer in 1999 and currently holds a position as Associate Professor. He has an established track record in modelling, engineering and scale-up/down of fermentation and cell culture processes. In recognition for his contributions to the development of miniature bioreactor technologies he received the 2010 Pharmaceuticals Division Plenary Award of the AIChE. He has published over 80 papers and co-authored 4 book chapters.

Sr Engineer III & Principal Engineer

Meisam is Head of the gene therapy downstream process development at Biogen. In this role, Meisam oversees development of purification processes to support Biogen’s AAV gene therapy pipeline. Meisam has 9 years of experience in developing downstream processes for protein biologics and viral vectors at different stages of development. Meisam received a PhD in Chemical Engineering from the Pennsylvania State University.

Senior Director Marketing

No bio available.

Senior Director Marketing

No bio available.

Senior Scientist

Bassem Ben Yahia is part of Upstream Process Sciences Group at UCB Pharma in Belgium since 2011 and is focusing on innovative cell culture technologies, media development, process optimization, process intensification and process modeling. Passionate about biology and modelling biological systems, Bassem holds a PhD degree in Biochemistry & Biochemical Engineering from University of Saarlandes in Germany focused on predictive macroscopic modeling of Chinese hamster ovary cells in fed-batch processes. During his PhD, he successfully developed a simple and robust modeling methodology to predict cell culture performances which is currently used at UCB to accelerate early stage process development.


Rebecca received her Bachelor's degree in Biology from Wellesley College and her Master's degree in Biotechnology from Worcester Polytechnic Institute. She has worked in bioassay development for 8 years, specializing in the design of residual DNA assays and cell-based relative potency assays.

Vice President

Eric Bishop has been leading Research and Development and Custom Development Services projects at Cygnus Technologies since 2010. Prior to joining Cygnus, Eric worked at MedImmune (now  AstraZeneca) where his responsibilities included Analytical Lead representation on CMC teams guiding projects from IND to BLA submissions; Head of New Technology Development group; in-house host cell protein expert; and development, validation and technology transfer of HCP and other analytical assays. 


Bioprocess Support Specialist

No bio available.

Global Head of R&D, Biologics

Dr. Bleck has more than 20 years of experience in biopharmaceutical research and development. He has a bachelor’s degree and doctorate from the University of Wisconsin-Madison and performed postdoctoral work at the University of Illinois-Urbana-Champaign working in the areas of gene regulation and expression. At Catalent, Dr. Bleck has transferred his knowledge of gene expression and transgenic systems to the development and continued optimization of retrovector expression systems and development of the proprietary GPEx process.

Consulting Regulatory Scientist

Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd, A Novartis Pharma AG Co. and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

Sr Associate Scientist

Shelby Breen is in Upstream Process Development at Pfizer, working with late stage programs and technology development. Before joining Pfizer, she worked in second generation process development for commercial monoclonal antibody programs at Sanofi. Shelby completed her undergraduate degree at Northeastern in Chemical Engineering and her MSc at Tufts in Engineering Management.


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 140 companies in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and CMC regulatory aspects of a wide range of cell therapy and gene therapy products, including CAR T-cell, NK, and DC immunotherapies, gene-edited cell therapy products, as well as stem cell- and somatic cell-based regenerative medicine products. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. His regulatory background includes numerous IND and IDE submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies (OTAT, formerly the Office of Cellular, Tissue and Gene Therapies, OCTGT). Dr. Burger is a member of several scientific advisory boards, and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis, and is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.


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) 14 years ago. Her current role is scientist in the Bioanalytics Characterization Group focusing on host cell protein identification and quantitation by mass spectrometry.

Assoc Dir Global Chem & Mfg & Ctrls Regultry Affrs

Allen Callaway is Associate Director, Global CMC Regulatory Affairs at Janssen, where he supports the cell and gene therapy portfolio. Allen’s 18 years of industry experience includes advanced therapy and biologics experience, including PRIME and breakthrough therapy designated products. Prior to J&J, Allen worked at BMS, supporting the biologics portfolio. Allen holds a M.S. from Thomas Jefferson University and a MBA from Syracuse University.

Assoc Prof

No bio available.

Northeast Regional Manager and Senior Applications Scientist

John Champagne is a Senior Applications Scientist for Wyatt Technology, responsible for customer support in the Northeast Applications Lab outside of Boston.  Since joining Wyatt, John has provided a range of analytical support with expertise in the use of multi-angle static and dynamic light scattering, field-flow fractionation and analytical ultracentrifugation.

Northeast Regional Manager and Senior Applications Scientist

John Champagne is a Senior Applications Scientist for Wyatt Technology, responsible for customer support in the Northeast Applications Lab outside of Boston.  Since joining Wyatt, John has provided a range of analytical support with expertise in the use of multi-angle static and dynamic light scattering, field-flow fractionation and analytical ultracentrifugation.

Nottingham Research Fellow in Bioinspired Therapeutics

Dr. Veeren Chauhan is a Nottingham Research Fellow in Bioinspired Therapeutics in the Advanced Materials & Healthcare Technologies (AMHT) division at the School of Pharmacy, University of Nottingham. He conducts multidisciplinary research at the interface of analytical, biological and medical sciences that endeavours to produce solutions for global challenges that will diagnose, cure, prevent and alleviate the symptoms of disease.

Principal Scientist

No bio available.

PhD Student

After MSc graduation in 2013, Valentine Chevallier has joined the upstream sciences group in UCB SA as associate scientist in media development. In 2017, she has started a PhD in UCB Nordic in collaboration with the Technical University of Denmark (DTU). The goal of this PhD project is to understand oxidative stress during bioprocesses using CHO cells.

Senior Scientist

Alex Chin earned a B.A. in Chemistry from Rutgers University in 2003. In 2004, he joined Merck’s Preformulation department, helping to establish the group’s first high-throughput automation lab. Over the years, automated workflows for small molecule solubility, excipient compatibility, forced degradation, solid dispersion, and others were created using a wide variety of automation platforms consisting of Unchained Labs, Tecan, and LEAP Technologies. More recently, Preformulation responsibilities have expanded into large molecules where Alex as spent the last year designing another, brand new automation lab by leveraging his years of knowledge from small molecule automation.

Founder & CEO & President

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 Contract Development Service provider that serves clients throughout the world. Dr. Chou has over 20 years of experience in the pharmaceutical industry, both as a pharmacist and pharmaceutical scientist. Over the past 15 years he has led the development of formulations for numerous therapeutic modalities ranging from peptides, growth factors, mAbs, ADCs, and bispecific antibodies. Prior to starting Compassion BioSolution, Dr. Chou was a Senior Scientist and Group Leader at Gilead Sciences, where he successfully built up state-of-the-art analytical capabilities for the company and converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. Prior to this, Danny was employed by Genzyme and Amgen, where he played critical roles in drug product process development, manufacturing technical support, and pharmaceutical development. Since founding Compassion BioSolution, Danny has developed stable pharmaceutical dosage form 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 a NIH Fellowship and his PharmD from the University of Florida.

Natl Institute for Bioprocessing Research & Training NIBRT

SFI Principal Investigator

Colin Clarke holds a MSc and PhD in Bioinformatics from Cranfield University, UK. He leads the Bioinformatics and Data Analytics Laboratory at the National Institute of Bioprocessing Research and Training, Dublin, Ireland and is an Associate Professor in the School of Chemical and Bioprocess Engineering at University College Dublin. The goal of Colin’s systems biology research is to enhance our understanding of CHO cell factories to enable more efficient production. Colin’s team also have an active research programme focussed on harnessing big data technologies for biopharmaceutical manufacturing. He was awarded the Martin Sinacore Outstanding Young Investigator Award at Cell Culture Engineering in 2014 and selected as the Young Leader of the Year at the 2017 Irish Laboratory Awards.

Global Head

Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. His previous roles include Global Product Manager for Charter Medical's cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions. Dominic currently serves as the Co-chair for the International Society for Cell and Gene Therapies' Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.

Assoc Dir Vector Mfg & Assoc Prof

Dr. Clement has more than 20 years of experience in the field of Gene Therapy, with a strong expertise in viral vectors, specifically adeno-associated vectors. During her thesis work at the University Libre of Brussels, Belgium, she developed new recombinant viruses derived from the parvovirus Minute Virus of Mice (MVM) for cancer-selective gene therapy treatments. She then joined Dr. Michael Linden’s laboratory at Mount Sinai School of Medicine, New York, where she developed novel recombinant AAV vectors and directed the AAV Vector Core. She joined the Powell Gene Therapy Center in 2008 as the Associate Director to supervise AAV production and testing at research, preclinical and clinical scales. She currently leads the Process and Development Group and the Quality Control group responsible for the production and release of all AAV preclinical and clinical lots. Her research is largely focused on optimizing processes supporting large-scale production of high-quality rAAV stocks and their implementation into the GMP settings.

Boehringer Ingelheim Pharmaceuticals Inc

Principal Scientist

Dr. Comeau completed his Ph.D. in Bioinformatics at Boston University, with a focus on in silico protein-protein docking. From there, he joined Dyax in 2007 and took a leading role within research, focusing on antibody engineering, antibody library design, sequence analysis, and database management. In 2016, he joined the Research group at Vaccinex, assisting with a platform technology for the display of membrane proteins on the surface of vaccinia virus. In 2019, he transitioned into a role at Boehringer Ingelheim in the Lead Engineering Group, incorporating in silico developability assessments at the research stage.


Philip is a pharmacist with academic and industrial research experience in drug development. He graduated from the University of Sunderland with an MPharm degree in 2012, and after undertaking pre-registration training between hospital and industrial pharmacy, completed a PhD at Durham University focusing on co-crystallisation as a technique to improve the properties of drugs. Following a post-doc position in the Northern Institute for Cancer Research (NICR) at Newcastle University developing a peptide based pro-drug, Philip is now based within the biologics downstream processing team at CPI. He is currently contributing to projects involving the development of an automated, integrated, continuous downstream process, and development and scale-up of a continuous non-chromatographic purification stage for monoclonal antibodies.


Maria Croyle is Professor of Molecular Pharmaceutics and Drug Delivery at the University of Texas at Austin. Her graduate studies involved formulating recombinant viruses for clinical testing and delivering recombinant adenovirus to the gastrointestinal tract for gene therapy applications. As a postdoctoral fellow at the University of Pennsylvania’s Institute for Gene Therapy, she developed and patented a novel method for modifying viruses to evade the immune system and published landmark papers on stabilization of viruses that are referenced today. In 2008, she led a 30 member international research team to develop a needle-free adenovirus based Ebola vaccine. During this project, her group discovered and patented a very novel method for stabilizing the vaccine and were the first to report long-lasting protection from Ebola after administration of a single dose of the vaccine in non-human primates. This technology was recently licensed and is the basis of a new startup company located in the Research Triangle Park area. Dr. Croyle’s research program trains young scientists to design and effectively conduct studies for pre-clinical evaluation of a variety of virus-based vaccines and vectors for gene therapy. Upon completion of their studies, many have obtained positions in the biotech industry, academia and in regulatory agencies such as the United States Food and Drug Administration.

Chair Bioprocess Engineeering

Dr. M. Nicolas Cruz-Bournazou is Bioprocess Modelling and Automation Expert at DataHow AG, as well as the Head of the KIWI-biolab. He works intensively in the fields of bioprocess digitalization, model-based tools for biotechnology and biopharma, high-throughput bioprocess development, and autonomous biolabs. In recent years, his research has pushed the integration of model-based methods and high-throughput experiments to accelerate bioprocess development. The most relevant results include the first adaptive algorithms for online optimal redesign of parallel experiments and novel hybrid (Machine Learning and dynamical modelling) tools for bioprocess engineering. The driving force of his research is the conviction that robotic systems need proper digital tools, models, and algorithms to fully exploit their capabilities.

Assoc Dir Antibody Discovery

Dr. Culyba has been working in the biotech industry for the past 9 years. She received her Ph.D. from the Scripps Research Institute, studying protein folding. Throughout her career, she has focused on understanding protein structure and function relationships and the biophysical properties of therapeutic proteins. She is currently an Associate Director at Verseau Therapeutics, focusing on antibody discovery and protein analytics.

Cell & Gene Therapy Catapult

Lead Tech Scientist

Mike is a Lead Technical Scientist that joined Cell and Gene Therapy Catapult in 2013 and has over 10 years’ experience within the cell and gene therapy sector. He is currently the Strategic Lead for the Viral Gene Delivery programme, responsible for managing developmental output of the group on core-funded, collaborative and commercial operations. Having completed an EngD in Biochemical Engineering and BioProcess Leadership at UCL in association with Onyvax Ltd and ReNeuron Group plc, Mike previously fulfilled a research engineer role at TAP Biosystems (now part of the Sartorius Stedim Biotech Group). Here he supported the development of automated micro-scale bioreactors and novel upstream systems for use within the biotech and cell therapy sectors.

R&D Bioproduction Engineer

Mégane Denu joined Polyplus-transfection® in 2016 where she is currently a R&D Engineer in the Bioproduction department. Mégane holds a Biotechnology Engineering Degree from the European School ESBS (Strasbourg, France). Within her 4 years in the company, she was involved in the development of several innovative transfection solutions, especially for biomanufacturing, and acquired expertise in viral vector upstream process optimization.

Bioprocess Field Application Specialist

No bio available.

Prof, Biotechnology and Director, centre of Excellence in Biopharmaceuticals

Alan is a molecular cell biologist working on the cell factories used for the manufacture of valuable biological therapeutics (protein- and viral vector-based). His grant portfolio includes academic and industrial funding with many collaborative projects, that support post-doctoral and PhD researchers. He has aided in the development of the UK bioprocessing strategy and agenda (member of the BBSRC/EPSRC/Industry-funded Bioprocessing Research Industry Club and co-Director of BioProNET, a BBSRC-funded Network in Industrial Biotechnology & Bioenergy Club, co-funded by EPSRC) and is a member of the Executive Committee of The European Society for Animal Cell Technology (ESACT).

Principal Engineer

Terrence has led the Upstream Process Development group for Gene Therapy programs at Biogen since 2016. His group has supported the development of multiple programs, enabled by multiple industry and academic collaborations as well as internal development. Before joining the Gene Therapy Department, he contributed to program and technical initiatives for Biogen Biologics programs including early phase development, mid-phase optimization and late-phase process characterization. Terrence earned B.S. in Chemical Engineering from the University of Notre Dame in 2005 and a Ph.D. in Chemical and Biomolecular Engineering from Johns Hopkins University in 2010 where he focused on characterizing lentiviral adhesion kinetics.

VP, CMC Regulatory

Dr. Michele K. Dougherty received her Ph.D. from Georgetown University in Tumor Biology and completed her post-doctoral training in the Laboratory of Cell and Developmental Signaling at the National Cancer Institute, where she defined novel mechanisms of c-Raf and B-Raf regulation and characterized the function of Kinase Suppressor of Ras 2, a scaffold protein for the ERK signaling pathway. Dr. Dougherty joined the FDA in 2008 as a product quality reviewer in the Office of Biotechnology Products. During her 8 years with OBP, she developed regulatory expertise across the manufacturing and product quality lifecycle, including review of early phase INDs, BLAs, post-approval manufacturing changes, and participating in GMP inspections. She managed a diverse portfolio of products including monoclonal antibodies, anti-body drug conjugates, antibody cocktails, growth factors, enzymes, and biosimilar products. She held multiple leadership roles within OBP, including Team Lead and Review Chief. In 2017, she joined the Therapeutic Biologics and Biosimilar Staff in CDER’s Office of New Drugs, where she was focused on supporting review of biosimilar products and participated in guidance and policy initiatives related to the biosimilar development pathway. Dr. Dougherty joined DataRevive, LLC as a lead CMC Biologics consultant in 2019. She advises clients on CMC regulatory strategy at all phases of development for standalone biological products, biosimilars and transition products.


No bio available.

Senior Scientist

James has been with BMS for 17 years supporting biologics manufacturing in Syracuse, NY as a scientist in the Manufacturing Technology group. He is an experienced investigator, technical transfer lead and Health Authority audit purification SME and filing author. Prior to BMS, James worked for Lonza Biologics and Regeneron. James earned a BS in Biochemistry from the University of Scranton in 1990.

President & Co Founder

No bio available.

Director of Service & Support

Dr. Rob Durham is currently the Director of Service and Scientific Support at Gyros Protein Technologies.  He has been with the company since 2010 but prior to joining the company he was a Gyros customer as a Sr. Principal Scientist in Translational Medicine at Pfizer.  Rob received his Ph.D. in Pharmacology and Neuroscience from Michigan State University and completed a postdoctoral fellowship at Parke Davis Pharmaceutical development before making the move to Pfizer.  Exploring the ways immunoassay technologies can be applied to problems in bioanalysis and biotherapeutic drug development has been a major focus in his career.    

Dir Process Dev

No bio available.


A scientist within the Upstream Process Sciences Group, I am involved in activities relating to the early-stage process development and late-stage process optimization, transfer and clinical/commercial manufacturing support for upstream processes to produce protein therapeutics. Part of my scope is being the harvest project lead. This includes overseeing all activities related to the assessment, understanding and implementation of transferable and robust harvest processes in addition to the responsibility to conduct stakeholder management on these topics.

Dir Analytical Operations

Shelley is currently the Director of Analytical Operations in Pharma Technical Development at Genentech. AO’s mission is to enable efficient process development by providing high quality analytical assays, data, and strategy to all partners. Previous to this role, Shelley has held multiple technical development roles including lead scientist for development of biological assays as well as an analytical control strategy team leader. Prior to her time at Genentech, Shelley conducted postdoctoral research on ion channel structure/function in the Maduke lab at Stanford University. She received her Ph.D. in Biomedical Sciences from Emory University and her B.S. in Biochemistry from Clemson University.

Principal Scientist & Assoc Dir Gene Therapy

Dr. Marina Feschenko is currently Director in Analytical Development at Biogen. She has been with the company for 9 years. Dr. Feschenko leads activities for development, qualification, and transfer of strategic gene therapy assays for dosing, potency, and other critical quality attributes. She also oversees evaluation and implementation of new technologies. She previously worked for Pfizer and Adolor Corporation. She holds a Ph.D. from Shemyakin Institute of Bioorganic Chemistry in Russia, where her work was focused on monoclonal antibody generation and characterization. Dr. Feschenko underwent postdoctoral training in Cell Biology and Signaling at MGH and Harvard Medical School.

Product & Marketing Manager

John Fink is Co-Chair of the Process & Product and Development subcommittee of ISCT. He is currently the Product and Marketing Manager at Pall Laboratory where he focuses on developing and marketing innovative solutions for Life Science Research workflow. Prior to this he was Cryopreservation Solutions manager at Brooks Life Science Systems where he has carried out novel thermal excursions research regarding sample warming rates, variables and their effects on post-thaw cellular viability and recovery. He used this research to advocate evidence-based best practices. Prior to this he worked at Thermo Fisher Scientific managing several product lines over 15 years including Liquid Chromatography, Lab Automation & Robotics, Instruments and Consumables. John holds an MBA from Queen’s University, Mechanical Engineering Diploma from Mohawk College and Associate of Health Science from Dean College.

Senior Scientist

Dr. Floyd is a Senior Scientist in the Drug Product Design group at Just - Evotec Biologics, Inc. While at Just, Dr. Floyd has led the work focused on finding ways to achieve room temperature stability for biotherapeutics for developing countries. She is also part of the team characterizing variants for biophysical stability, developing several assays including a low volume, high throughput chemical unfolding assay. Dr. Floyd has also been a formulation lead for numerous molecules, published several papers with many more in the works, and is an inventor on multiple patents.

Associate Scientist

Jishna Ganguly is an associate scientist in Antigen Expression Technology within Drug Substance at GSK vaccines. She is responsible for cell line development of some of the critical CHO-based vaccine candidates in the pipeline leveraging rapid high-throughput clone selection and screening strategies . Jishna holds a Master of Cell and Microbial Biology from Catholic University of America and a Bachelor of Biotechnology from West Bengal University of Technology, India. Prior to her graduate studies, she worked in Pfizer (formerly known as Hospira) in Chennai, India as a research executive in upstream process development for biotherapeutic proteins.

Sr Scientist

Senior scientist with over 12 years of industrial experience in Downstream process development in Bioprocess Research and Development, working with both early stage and late stage programs. Currently focusing on evaluating alternative capture technologies for mAb and mAb like proteins.

Prof & Chair

Raja Ghosh obtained his doctorate degree in Engineering Science from Oxford University, United Kingdom. He is currently Professor of Chemical Engineering at McMaster University, Canada. His research interests are primarily in the areas of equipment design and process development for membrane and chromatographic separations. Application areas that interest him include purification and analysis of protein biopharmaceuticals, membrane bioreactors for mammalian cell culture, and water treatment. He has authored two books, Protein Bioseparation Using Ultrafiltration and Principles of Bioseparations Engineering, and has published over 130 research papers. His awards and accolades include a Commonwealth Scholarship and a Canada Research Chair position.

Natl Research Council Canada

Team Leader

Rénald Gilbert is the team leader of Viral Vector Production at the National Research Council Canada (NRC) in Montreal. He is also an adjunct professor in the department of Bioengineering of McGill University. His research interests embrace the optimization of viral vectors for the development of vaccines and for cell and gene therapy applications, as well as the manufacturing process of these complex biologics. R. Gilbert completed his Ph.D. in Biochemistry at McMaster University (Hamilton Ontario) in 1994. Before starting his career as research officer at NRC in 2002, he trained as a postdoctoral fellow in the department of Cell Biology of Weill Cornell Medical College (New York City) and in the department of Neurology in Neurosurgery at the Montreal Neurological Institute of McGill University.


John is a 24 year biotech veteran in Cell Line Development with expertise in monoclonality and single cell isolation. He also has experience ranging from cell banking and upstream process development to Discovery efforts as a Pre-Clinical Program Lead in both large pharma and CDO/CMOs.


John is a 24 year biotech veteran in Cell Line Development with expertise in monoclonality and single cell isolation. He also has experience ranging from cell banking and upstream process development to Discovery efforts as a Pre-Clinical Program Lead in both large pharma and CDO/CMOs.

Sr Upstream Dev Engineer

Jackie Gonzalez is an upstream process engineer at Takeda Pharmaceuticals. She holds a B.S. in chemical engineering from Cornell University and a Ph.D. in chemical engineering from the University of Delaware. Her previous research focused on metabolic modelling and application of 13C-metabolic flux analysis in bacteria and CHO cells.

Vice President

Rick led the commercial launch of the Horizon system in 2017 and the Aura system in 2020 and currently supports their ongoing commercial development by assisting customers pre and post-purchase. Prior to this, Rick held similar positions at Unchained Labs, ForteBio, and Molecular Devices. Rick holds degrees from the University of Washington and the University of Maine and has scientific training in tumor immunology and cell biology.

Principal Scientist

Bharathi Govindarajan Ph.D. is a Principal Scientist working at Sanofi in Framingham, MA. Bharathi received her doctoral degree from Case Western University in Cleveland, OH, and completed her postdoctoral studies at the Schepens eye research institute, Harvard medical school, Boston, MA. She joined Alcon laboratories in 2011, with focus on development of bioassays for biologics. Through the past 9 years she has worked on developing Bioassays in the development functional in several companies. Bharathi’s current work focuses on development of impurity assays to support a number of drug development programs at Sanofi.

Assoc Principal Scientist

Christoph Grapentin studied Pharmaceutical Sciences in Kiel (2006-2011), Germany. Afterwards he obtained a PhD in Pharmaceutical Technology from the University Freiburg, Germany (2012-2016). Between July 2016 and March 2018 he researched as a postdoctoral fellow for F. Hoffmann-La oche in Basel, Switzerland. Since April 2018 Christoph works in formulation development at Lonza Drug Product Services in Basel, Switzerland.


Feny Gunawan is a technical development scientist in the Analytical Development and Quality Control group in Genentech. She was the process impurities global task force leader with the responsibilities to develop and harmonize process impurities guidance and strategies across Roche and Genentech. Currently, Feny is an analytical team leader for multiple pipeline programs. She leads a group of scientists and research associates to enable the CMC team in meeting programs' milestones and deliverables.

Associate Principal Scientist

Dr. Han is currently working on developing immunoassays for potency tests of cancer therapeutic-human monoclonal antibodies in early and late phases of the pipeline. He is uniquely qualified with an advanced degree in Biosystems/Biomedical Engineering and Biosensors, has 12 years of experience in research and semi-GLP laboratories for developing immunoassays including: binding ELISAs, lab-on-chips using micro-/nano-fabrication processes for quantifying biologics, DNA-based human proteomic diseases, pathogens, and environmental small toxins.

Childrens Natl Health System

Asst Research Prof Pediatrics & Dir

Dr. Hanley is an assistant research professor of pediatrics and director of the Cellular Therapy Laboratory at Children’s National Hospital. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, and testing of novel cell therapies for patients enrolled on clinical trials. Trained as an Immunologist, Dr. Hanley has an extensive background and interest in cellular therapy and is passionate about improving regulations for cellular therapy, training the next generation of cell therapists, and facilitating the translation of new therapeutics. Over the past 14 years he has helped to translate more than 20 cell therapy protocols – ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells – into the clinic. Dr. Hanley is on the board of directors of the Foundation for the Accreditation of Cellular Therapy (FACT), is an active inspector, is chair of FACT’s education committee, serves on their accreditation committee and is also on the immune effector cell standards subcommittee. He serves on the editorial boards of the journals Cytotherapy and Molecular Therapy: Methods and Clinical Development. In 2017, along with Drs Catherine Bollard and Russell Cruz, he founded Mana Therapeutics, a biotech company aimed at educating immune cells and eliminating cancer. In his free time he enjoys playing soccer, cooking, and traveling.

Analytical Project Lead

Dirk Haubert works as Analytical Project Lead in the Biologics Process Development Department of Novartis Pharma AG in Basel, Switzerland. He is responsible for the analytical development and overall analytical CMC strategy for biological molecules in late-phase clinical development and market application phases. Dirk holds a PhD in Biology and Immunology from the Cologne University, Germany and brings more than 10 years’ experience in the field of analytical development for classical biological molecules, biosimilars and cell and gene therapies.


Nathan earned his BS in Chemistry and Biochemistry from West Chester University in 2015. He started at GlaxoSmithKline in the BioPharm Product Science department in 2016. Since 2018 he has been focusing on automation of workflows within the department.

Product Manager

No bio available.

Product Manager

No bio available.

VP Tech

Dr. Heidaran joined PAREXEL International as Vice President of Technical in December of 2018. He has close to 9 years prior experience as a Biologist and as a Master Reviewer in OTAT, and as a facility reviewer and inspector in the Division of Manufacturing and Product Quality (DMPQ). During his tenure at OTAT, in addition to his review responsibilities, he also served as Acting Team Lead and Branch Chief briefly and as a DCGT representative to several FDA and CBER wide working groups and outside organizations such as USP. He has also been involved in various standard development activities, cell-based product manufacturing initiatives and various compliance activities. Mo is currently member of USP Bio3 Complex Biologic Expert Committee, ISCT Legal and Regulatory Affairs Committee and contributor to the A-Gene Project sponsored by the Alliance for Regenerative Medicine (ARM). Dr. Heidaran has a multidisciplinary academic and industrial background in basic and applied cell biology and innovative cell therapy and tissue engineering product development. He also has hands-on industrial experience in manufacturing of cell therapy and tissue engineering products for about 15 years in small and large size Biotech companies. His long lasting scientific interest is to understand the molecular control mechanisms that regulate growth and differentiation of stem cells in the three-dimensional microenvironments. He is also founder and first chair of prestigious Gordon Research Conference in “Signal Transduction by Engineered ECMs.” Mo received his formal training at the National Cancer Institute where he served as a Senior Staff Scientist for about 6 years and 3 years as an IRTA fellow studying signal transduction by receptor tyrosine kinases. Dr. Heidaran holds a Ph.D. in biochemistry from the University of South Carolina, and received his formal training at the National Cancer Institute. Prior to FDA, he served as R&D Director at both Celgene and Becton Dickinson. He has been an ad hoc reviewer and member of editorial boards of several peer reviewed publications. He also holds 25 issued patents and 54 pending patents and his work has appeared in more than 50 scientific publications.

Ecole Polytechnique De Montreal


Professor Olivier Henry is a member of the bioprocess group at the chemical engineering department of Ecole Polytechnique de Montreal. His main research interests are in the development of cell culture processes for the large scale production of recombinant proteins, viral vectors and vaccines. His research group works on the optimization and control of bioreactors and the development of advanced monitoring strategies for animal cell cultures. His laboratory is also conducting comprehensive metabolic engineering studies allowing detailed and quantitative characterization of cell metabolism in culture. This research is supporting the development of enhanced expression platforms for the high-yield production of bioactive therapeutic proteins.

Prof & Head

Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec addressing data science solutions for the biopharma life cycle.


Oliver Hesse is Head of Biotech Data Science & Digitalization at Bayer – Product Supply in Berkeley, Ca. He started his career in small biotech, building up and running high throughput screening systems for large molecules that generated large amounts of data and incorporated automated decision making. Since 2008 he is at Bayer and since 2011 at the Berkeley site. There he has been developing and implementing strategies and directed projects with respect to lab automation, lab informatics and data sciences for the global biological development organization and since March he is in his new role where his focus is on the application of data science and digital technologies to gain better process understanding and the seamless digital integration from process development to commercial manufacturing.

Graduate Researcher

Moo Sun Hong is a researcher at the Massachusetts Institute of Technology (MIT) in the group of Prof. Richard D. Braatz. Moo Sun received a B.S. in Chemical and Biological Engineering from Seoul National University and was the top graduate in its College of Engineering. He received an M.S. in Chemical Engineering Practice from MIT and the Jefferson W. Tester Prize for enthusiasm and leadership in the Practice School. He has constructed mathematical models for multiple bioreactor configurations and does research in the model-based design and control of continuous protein crystallization and viral inactivation.

Novartis Institutes for BioMedical Research Inc

Sr Scientist I

François Huet got his PhD on Molecular and Cellular Biology (transcriptional profiling in response to steroids) from the Strasbourg University in France. He conducted his postdoctoral work at Harvard University in Developmental Biology and Genetics (TGF-beta signaling, functional assessment of the genome with engineered transposons). He had been working in the last 20 years in several drug discovery companies establishing efficacy testing of drug candidates in neurobiology and pharmacology and toxicology assessment of small molecules and biologics in several diseases area including hemophilia, CVM, oncology, tropical diseases and ophthalmology.

Dana Farber Cancer Institute

Technical Director Process Development

Dr. Ruud Hulspas is the Founder of Cellular Technologies Bioconsulting, a company dedicated to increase reproducibility and quality of (pre-)clinical research, with a focus on incorporating reliable analytics into cell therapy manufacturing processes. Previously, Dr. Hulspas was Vice President of Scientific Affairs at Cytonome, a company originally created to develop technologies for cell sorting in manufacturing of cell-based products for cell therapies. Prior to joining Cytonome, Dr. Hulspas led the R&D and lean operations of cytometry assays and cell-sorting methods in the stem cell expansion and cord blood storage divisions of ViaCell, Inc. He received his B.S. and M.S. from Leiden University, his Ph.D. in Cell Biology from University of Amsterdam, and his technical training at the TNO Radiobiological Institute in Rijswijk, the Netherlands. As a postdoc at the newly founded Cancer Center at the University of Massachusetts, Dr. Hulspas headed the Cytometry core facility, while his research projects focused on the identification and purification of a wide range of hematopoietic and neural progenitor cell types.

Dir R&D

Akunna Iheanacho, PhD is the Director of Research and Development at Texcell – North America, Inc. where she supports novel assay development, virus purification efforts, viral clearance study design, and viral safety testing. She serves as a subject matter expert with broad biotechnology experience and expertise in areas that include process development for large-scale cGMP manufacture of vaccines, AAV gene therapies, and biopharmaceutical purification. Prior to joining Texcell, Dr. Iheanacho was a Senior Scientist at Paragon Bioservices (now Catalent) where she established critical process parameters and quality attributes for cGMP processes for biologics and reagents for diagnostics. During her graduate studies, she employed biochemical and biophysical techniques in the structural and functional characterization of proteins. Dr. Iheanacho received her PhD in Cellular and Molecular Physiology from Johns Hopkins University School of Medicine, MS in Chemistry from the University of Virginia, and BS in Biology from Oakwood University in Huntsville, AL.


Dr. Donald J. Jacobs (Don) is a Professor of Physics at the University of North Carolina at Charlotte. His expertise is in statistical and computational physics (B.S. 1985, Union College; Ph.D. 1992, Purdue University). With 4 U.S. utility patents, 100+ papers and over 4400 citations, Don has developed novel models for protein flexibility and stability since 1997. Major contributions to protein science include: identifying mechanically rigid/flexible regions in proteins using FIRST (Floppy and Rigid Substructure Topography); fast and accurate predictions for helix content in the helix/coil transition and protein stability that accounts for solvent conditions and non-additivity of conformational entropy. He co-introduced the concept of QSFR (Quantitative Stability/Flexibility Relationships) to characterize proteins for protein design and elucidating protein evolution. A novel perturbation/response method that overcomes the collinearity problem was developed to predict dynamical allostery from molecular dynamics simulation. Don also led the development of an accurate nonparametric probability density estimation method for high-throughput applications that handles extreme statistics. Don also developed a novel machine learning method called SPLOC (Supervised Projective Learning with Orthogonal Completeness) to discriminate molecular dynamics simulations representing digital twins of protein mutants in structure/function studies for molecular function recognition in protein design and drug discovery applications. Don is Focus Leader for the Molecular Engineering and Design subgroup within the Center for Biomedical Engineering and Science, the Graduate Program Director for the Applied Physics MS program, and Founder of a departmental mentoring program for students.

Cambridge Biostrategy Associates LLC

Managing Partner

Michael is a founding Partner at Cambridge Biostrategy Associates, LLC (CBA). With over 20 years’ industry and consulting experience, Michael has a strong business, scientific and technical background as well as pharmaceutical product development experience. He has led multiple engagements in the areas of pharmaceutical development and commercialization, contract services, diagnostics, medical devices, and life science tools. Product areas include oncology, immunology, bleeding disorders, cardiovascular, psychiatry, surgical devices, molecular diagnostics, and pathology. In addition, he has extensive experience in corporate and product strategy; new product development; and partnering, market entry, geographic, and market access strategies.

Head of Research

Stuart is the Head of Research at CPI Biologics. He has over 17 years of experience in process development, scale-up, and clinical manufacture for early- to late-phase products. Stuart joined CPI in 2014 to help establish the new National Biologics Manufacturing Centre and build the downstream science technical team. Stuart now leads the research and technical development teams, encompassing upstream, downstream, and analytical development.


Dr. Jia has 20 years of combined experience in biologic drug development and regulatory review. Dr. Jia spent 10 years in the biopharmaceutical companies working on monoclonal antibody engineering, humanization, affinity maturation, expression, and purification. During her time in US FDA, Dr. Jia was a full time CMC reviewer for IND/BLA review of biological products including antibody fragments, fusion proteins, antibody drug conjugate, combination products, and radiolabeled antibodies. She performed many IND reviews, BLAs (including post approval reviews), and several US and international cGMP pre-approval inspections (PAIs). She is specialized in both novel proteins/antibodies and biosimilar products reviews.

High-Throughout Mass Spectrometry Analysis in Forced Degradation Studies

Yan Jiang received her PhD in Chemistry from Boston University. Since joining Sanofi in 2013, she has been working on the development of analytical methods for the release and characterization of therapeutic proteins, with a focus on the PTM characterization to support developability assessment, clone selection, formulation development, and comparability assessment.

Sr Principal Scientist

Xiaoying Jin has been working at Genzyme/Sanofi for 20 years after she obtained her Ph.D. from the University of Michigan. She is leading a group specialized in protein characterization of recombinant glycoproteins, antibodies and adeno-associated virus vectors to support development including comparability studies, structure and function relationship studies, reference standard qualification, and forced degradation studies for CMC filings.

Asklepios BioPharmaceutical Inc

Grp Leader

Jeremy is currently serving as Group Leader of Analytical Development at Asklepios Biopharmaceuticals, Inc. in RTP, North Carolina. Jeremy has more than 20 years of experience in the development and manufacturing of therapeutic proteins, and has overseen analytical biopharmaceutical development for recombinant proteins at all stages of development and commercialization. He is working to update analytical methodology utilized in structural characterization of AAV vectors by utilizing Q-TOF LC/MS for quantitation and peptide analysis.

VP Global Bioservices

Rob Jones is an accomplished supply chain executive with 30 years of commercial development experience and 10 years’ experience in the blood transfusion industry. Qualified in Hematology and Blood Transfusion Medicine, he originally worked at the UK National Blood Service at the Birmingham Laboratories. He then took up a technical support role at DuPont Virology Diagnostics before moving into commercial roles at Sorvall Inc. and Kendro Laboratory Products.

Prof & Head, Biotechnology

Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Deputy 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. For more than 10 years he is working on continuous manufacturing of biopharmaceuticals. As a proliferate researcher he has more than 340 publications on recombinant protein production and bioseparation, 17 patents and 12 book contributions and recently 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. He acts also a the vice president of research of the European Society of Biochemical Engineering Science.

Assoc Dir

Dharmesh Kanani is a chemical engineer with 10+ years of post-PhD experience in bioprocessing. He supports CMC development of biologics pipelines (innovatives and biosimilars) for IND and BLA submissions by leading team and projects in multidisciplinary matrix organization at Teva Pharmaceuticals. He has received 2019 Mission & Values award, from Teva's CEO and his executive management team in the category of "Innovating Where We Create Value". He has published 10+ articles in peer-reviewed journals and gave several invited talks at various international conferences.

KTH Royal Institute of Technology


Sara Kanje has a Ph.D. in Biotechnology from the Royal Institute of Technology (KTH), Stockholm, Sweden, where she is currently active as a researcher. Her research is focused on engineering of small protein domains for protein purification with mild elution. This work has resulted in the Ca-dependent antibody binding protein ZCa that can be used to purify IgG antibodies with a mild calcium-dependent elution. Sara’s current research projects are focused on the optimization and further development of ZCa for antibody purification while also working as the responsible scientist for protein purification in a high throughput protein production project, the Human Secretome Project, that aims to produce and purify all human secreted proteins as full-length.

Senior Engineer III

Dr. Sarwat Khattak has 14+ years of experience in the biopharmaceutical industry and has been with Biogen since 2016. She currently manages a group developing cell culture processes for early and late stage programs and leads a team focused on integrated continuous manufacturing for biologics. Sarwat received her Ph.D. in Chemical Engineering from University of Massachusetts at Amherst.

Lead Scientist, phD

Beomkyu Kim is a lead scientist in downstream process development at Samsung biologics. He has 4 years of experience in biologics downstream process development at Samsung Bioepis and Samsung biologics. His current research interests include the developments of a two-step purification platform and non-Protein A purification process for antibody production.


Part Lead, phD

No bio available.

Head Bioprocess Support & PAT Platform

Marina Kirkitadze, Ph.D, MBA has 18 year experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Process Support and PAT Platform, Analytical Sciences Toronto. Marina is focusing on selection and implementation of PAT solutions for in-line monitoring of media components, protein concentration and conformation, process-related residuals, and protein adsorption. Her contributions went towards CMC section in eBLA application for Adacel, approvals for new manufacturing facility and its extension, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 36 manuscripts.

University of Natural Resources & Life Sciences

PhD Candidate

Daniel Komuczki received a Master of Science in Biotechnology at Wageningen University and a Double Degree (MM.Sc) in Material and Energetic Exploitation of Renewable Raw Materials (NAWARO) from BOKU and the Technical University in Munich (TUM). He is currently a PhD Candidate at BOKU in the group of Alois Jungbauer and embedded in the Marie Sklodowska-Curie ITN “Analytics 4 Biologics” (A4B). His research is focused on fully integrated continuous bioprocessing of recombinant proteins using mammalian cells. Thereby, he emphasizes on the improvement of up- and downstream processes using rapid prototyping by the means of 3D-printing.

Research Application Scientist

Aly earned her B.S. in Biochemistry, Cell and Molecular Biology from Drake University. She has more than a decade of experience in a variety of GMP & R&D biotechnology settings with an expertise in immunology and flow cytometry. 

Principal Consultant

Dr. Krawitz, Principal Consultant at CMC Paradigms LLC, is based out of the San Francisco Bay Area. With over 15 years of strategic and technical CMC development experience, Denise provides consulting expertise to large and small biotechnology companies to move products from late-stage research to commercialization efficiently. Denise’s skill set is the product of working directly as a bench scientist, group, leader, project team leader, and project manager. She has broad process development experience, with an emphasis in analytical development and impurity analysis.

Marketing Manager

No bio available.

Marketing Manager

No bio available.

Sr Research Investigator

Greg started working at Bristol-Myers Squibb Company in the year 2000 as a PhD organic chemist in the small-molecule API Process Technology department. During that time, he developed scaleable syntheses and utilized process analytical technology (PAT) to monitor reactions and crystallizations from the lab to the pilot plant. In 2016, he moved to the Drug Product Science and Technology department at BMS, with a focus on oral solid dosage forms as well as biologics production. His efforts involve using Raman and other PAT to monitor and control upstream bioreactor production. Further work has been done in the use of FTIR spectroscopy to monitor downstream unit operations. Given the advances in spectroscopy in the bioprocessing space, PAT can reliably be used to monitor processes and enable real-time feedback control, particularly with upstream bioreactors.

Chair & AP Colburn Prof

No bio available.

Massachusetts Institute of Technology

J. Spencer Standish (1945) Prof

Retsef Levi is the J. Spencer Standish (1945) Professor of Operations Management at the MIT Sloan School of Management. He is a member of the Operations Management Group at MIT Sloan and affiliated with the MIT Operations Research Center. Levi also serves as the Faculty Co-Director of the MIT Leaders for Global Operations (LGO). Before coming to MIT, he spent a year in the Department of Mathematical Sciences at the IBM T.J. Watson Research Center as the holder of the Goldstine Postdoctoral Fellowship. He received a Bachelor's degree in Mathematics from Tel-Aviv University (Israel) in 2001, and a PhD in Operations Research from Cornell University in 2005. Levi spent almost 12 years in the Israeli Defense Forces as an officer in the Intelligence Wing and was designated as an Extra Merit Officer. After leaving the Military, Levi joined an emerging new Israeli hi-tech company as a Business Development Consultant. Levi's current research is focused on the design of analytical data-driven decision support models and tools addressing complex business and system design decisions under uncertainty in areas such as health and healthcare management, supply chain, procurement and inventory management, revenue management, pricing optimization and logistics. He is interested in the theory underlying these models and algorithms, as well as their computational and organizational applicability in practical settings. Levi has been leading several industry-based collaborative research efforts with some of the major academic hospitals in the Boston area, such as Mass General Hospital (MGH), Beth Israel Deaconess Medical Center (BIDMC), Children’s Hospital, and across the U.S. (e.g., Memorial Sloan Kettering Cancer Center, NYC Presbyterian Hospital System and the American Association of Medical Colleges). Levi was the PI on an MIT contract with the Federal Drug Administration (FDA) to develop systematic risk management approach to address risk related to economically motivated adulterations of food manufactured in global supply chains. With a multi-million award from the Walmart Foundation, Levi currently leads a multi-year U.S.-China collaborative effort to develop new predictive risk analytics tools and testing technologies and platforms to address core food safety challenges in China. Levi has also been involved in developing operational risk and process safety management methodologies for various organizations in the healthcare, pharmaceutical and oil industries. Levi received the NSF Faculty Early Career Development award, the 2008 INFORMS Optimization Prize for Young Researchers, the 2013 Daniel H. Wagner Prize and the 2016 Harold W. Kuhn Award. Levi teaches regularly courses on operations management, analytics, risk management, system thinking and healthcare to students from various degree and non-degree programs including MBA, Executive MBA, PhD, Master and Undergraduate students as well as Executive Education programs. His Healthcare Lab course attracts students from across the MIT campus and engages major industry partners and leaders. Levi has graduated 10 PhD students, 34 Master students and 6 postdoctoral fellows. He was also awarded several prestigious teaching awards.

Assoc Dir Global MSAT

Gloria Li has over 13 years of leadership experience in the biotech industry. She specializes in technical operation, manufacture operation support, process development, analytical development and validation activities. She is leading frozen drug substance platform efforts in Sanofi Genzyme and implementing the process on commercial assets. Prior to Sanofi, Gloria led the process analytics group of PD organization in Bristol Myers Squibb. She also had extensive experience at PPD Inc. previously leading analytical QC functions on multiple modality therapeutics. Gloria obtained a Ph.D. degree from the University of Wisconsin Madison in Food Science.

Assoc Principal Scientist

Dr. Xuanwen (Shawn) Li is an Associate Principal Scientist in the Analytical Research and Development (AR&D) Mass Spectrometry group at Merck & Co., Inc. His research focuses on mass spectrometry-based structure elucidation of biotherapeutics and bioprocess-related impurity characterization for preclinical and clinical development. Prior to Merck, he worked as a scientist at Eli Lilly after postdoctoral training and working as Director of a mass spectrometry facility at the University of Pennsylvania.

Group Leader

Xue (Shelly) Li is a Group Leader at Bristol Myers Squibb in New Jersey and has been leading the development and validation of analytical methods for release & stability testing of biologics. Shelly worked for Novartis Pharmaceuticals and Amgen before joining BMS, where she led the analytical development of various biologics candidates. Shelly received her Ph.D. degree in Bioanalytical Chemistry from Michigan State University and conducted postdoctoral research in the Department of Cell Biology at Harvard Medical School. Her academic training focused on the application of LC-MS in protein analysis and characterization.


Hsin-Wei Liao is a research scientist at Sanofi specializing in cell-based potency assay development since 2018. Prior to Sanofi Hsin-Wei worked as a postdoctoral researcher focusing on investigating cell signaling pathways that involve in drug resistance in colorectal cancer patients, as well as immuno-oncology studies by using genetic mouse models. Hsin-Wei earned her PhD in molecular and cellular oncology from University of Texas MD Anderson cancer center, MS in microbiology from National Chiao Tung University, and BS in biology from National Chang-Hua University of Education. She was also a research fellow at Mass General Hospital /Harvard Medical School.

Senior Research Engineer

Thomas Liao started at Sanofi in 2018 as a Senior Research Engineer. He received his BS in Biochemistry and BA in Chemistry from The University of Chicago, and received his MS in Chemical Engineering from University of California – Berkeley.


Dong-Qiang Lin, professor at Zhejiang University. He graduated from Zhejiang University in 1992, and then obtained Ph.D. in 1997. Since 1998, he work for Zhejiang University, and became a professor in 2007. He was the director of the Institute of Bioengineering, Zhejiang University. He also worked as post-doctor in Germany and visited Germany and USA several times as visiting professor. Till now he has published three books and more than 150 peer-reviewed papers in international journals, and was authorized 38 patents. In recent years he focused on downstream processing, including new bioseparation technology, molecular simulation and bioprocess design.

Dir Analytical Dev

No bio available.


Athanasios (Sakis) Mantalaris is Professor in the W.H. Coulter Department of Biomedical Engineering at Georgia Tech & Emory since August 2018. Prior to his move to Atlanta, he was Professor of BioSystems Engineering in the Department of Chemical Engineering at Imperial College London. He received his PhD (2000) in Chemical Engineering from the University of Rochester. His expertise is in modelling of biological systems and bioprocesses with a focus on mammalian cell culture systems, stem cell bioprocessing, and tissue engineering. He has published over 170 original manuscripts, co-edited one book, and holds several patents with several more pending. He has received several awards including the Junior Moulton Award for best paper by the Institute of Chemical Engineers (IChemE) in 2004. In 2012, he was elected Fellow of the American Institute for Medical & Biological Engineering and in 2013 he was awarded a European Research Council (ERC) Advanced Award. In 2015, he was awarded the Donald Medal by the Institution of Chemical Engineers (IChemE) for his contributions to biochemical engineering.

Assoc Dir Analytical Dev

Dr. Manuilov graduated from University of Massachusetts Amherst, where he focused on ribosome structure and protein translation. He spent over 11 years in Analytical Development at AbbVie, characterizing mAbs, ADCs, fusion proteins, and VLPs. Recently, he joined Analytical Development at Acceleron Pharma, where he is working on late-stage characterization of highly complex ECD-Fc fusion proteins.

Dir New & Enabling Technologies & Head

Damian Marshall is the Director of New Technologies at the Cell and Gene Therapy Catapult and has almost 20 years of industrial experience in ATMP development working for SME’s and large companies. He leads a team of ~70 scientist who collaborate with a wide range of cell and gene therapy companies to integrate innovative technologies to improve the manufacture of viral vectors and cell-based therapies. The team also focusses on high content analytics for product characterisation and has established a leading position in in the integration of Process Analytical Technologies (PAT) for advanced bioprocess control.

Development Engineer/Scientist

Adam McLeod is a Cytiva Development Scientist.  His focus is lentiviral vector downstream purification; developing a workflow that is closed, scalable, uses single-use consumables, and is completed at ambient temperature.  Adam earned his Hon. BSc. from the University of Toronto, and his M. Apl. Sci. from the University of Sydney.

Sr Research Scientist & Assoc Dir

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 90 peer-reviewed publications and 12 book chapters to date in research areas related to proteomics, bioprocessing and cancer.

Scientist I

Emily Menesale is a scientist in the bioassay and gene therapy analytical development group at Biogen where she has worked for the past 12 years. Emily’s work focuses on bioassay development, specifically HCP assay development and characterization methods. Her work also focuses on mitigation strategies for individual HCPs. She received a Master of Science in Pharmaceutical Sciences from Northeastern University and a Bachelor of Science in Psychology and Neuroscience from UMass Amherst.

Product Manager, Microfluidics

Guangnan Meng is a product leader of microfluidics technologies at PerkinElmer, Inc. He holds a Ph.D. in physics, and has years of experience in applied physics, analytical instruments, and nano-engineering industries.


Dr. Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a Ph.D. in Cell Biology and Biochemistry. Dr. Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr. Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech, and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.

Associate Professor

Inna Miroshnyk, PhD, is currently an Associate Professor of Pharmaceutical Sciences at the Lake Erie College of Osteopathic Medicine. Prior to pursuing academic career, she spent four years in the pharmaceutical industry as a licensed pharmacist. Then she decided to advance her professional career and earned her PhD degree in Pharmaceutical Sciences from the University of Helsinki, Finland. Her doctoral project was focused on elucidating structure – pharmacokinetic properties relationships among peptidomimetic drugs. Dr. Miroshnyk’s research was further expanded after she joined Novartis-MIT Centre for Continuous Manufacturing, where she gained extensive experience in pharmaceutical thin film development and manufacturing. Furthermore, Dr. Miroshnyk received an extensive training in nanotechnologies and microfluidics when working at the Harvard School of Engineering and Applied Sciences. Overall, Dr. Miroshnyk’s research resulted in over 30 peer-reviewed articles and conference proceedings.

Sr. Research Fellow

Sabiruddin Mirza is currently a Senior Research Fellow at the School of Engineering and Applied Sciences at Harvard University, Cambridge, MA, USA, and an Adjunct Professor at the University of Helsinki, Helsinki, Finland. After several years in full-time industry, he escaped to academia and earned his Ph.D. degree in pharmaceutical technology from the University of Helsinki in 2007. His dissertation research has been awarded the 2008 American Association of Pharmaceutical Scientist’s Outstanding Graduate Research Award in Pharmaceutical Technologies. Dr. Mirza’s current research is focused on engineering of advanced nanosystems for drug delivery applications. In addition, his areas of expertise include pharmaceutical crystallization, cocrystallization and nanocrystallization, droplet-based microfluidics, and nanomedicine, preformulation, formulation, and drug delivery. Overall, his research has attracted around $550 000 in sustained funding from the Academy of Finland, private foundations, and industries. He is the author/coauthor of over 70 peer-reviewed articles and conference proceedings.

VP Chemistry & Mfg & Controls

Ali Mohamed, Ph.D., Vice President, CMC, Immatics US Inc. was formerly the Senior Director of Manufacturing Operations/Manufacturing Development at PCT (now HCATS). Dr. Mohamed has nearly 20 years of experience in process development and GMP manufacturing of regenerative medicine, cell and gene therapy products at various CMOs and clinical-stage companies, including Lonza, Osiris Therapeutics, and AlloCure. The speaker holds a Ph.D. in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in Neuroscience and Neurobiology from Georgetown University.

Exec Dir

Ganapathy Mohan leads the Global External Advocacy for Global Quality in Merck Manufacturing Division. Prior to this until April 2017, he was the head of Small Molecule Development Quality, which is responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials.Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Mohan has a Ph.D. in Analytical Chemistry from Kansas State University. Mohan was past Chair of the AAPS Regulatory Sciences Section in 2014 and has served in the Council of experts for the United States Pharmacopeia till 2015. He currently serves as the vice chair of the Quality Coordinating Committee of IQ Consortium. He is also the Topic Lead representing PhRMA in the ICH Q13: Continuous Manufacturing of Drug Substances and Drug products Expert Working Group (EWG) and represents Merck in the GQM WG of PhRMA.

Massachusetts Institute of Technology

Graduate Researcher

Bachelor: RWTH Aachen University, Germany, business engineering with a focus on mechanical engineering (2013-2017) Master: Imperial College London, United Kingdom, chemical engineering (2017-2018) PhD: Massachusetts Institute of Technology, USA, chemical engineering (2018-present) Research focus: Smart data analytics for chemical manufacturing processes

Sr Dir Analytical Sciences

Andrea Moore is the Senior Director of Analytical Sciences at Tmunity Therapeutics. After joining the team in July 2018, Dr. Moore has been leading the development of all core analytical functions for Tmunity. Previously, she was Associate Director of the Analytical Development group at WuXi Advanced Therapies, where she led an integrated team to develop novel assays for a wide variety of cell and gene therapies. She earned her Bachelor’s in Biology from King’s College in Wilkes Barre, PA, and her Ph.D. in Microbiology and Immunology from Temple University.

Senior Research Investigator I

Haresh More is a Sr. Research Investigator at Bristol-Myers Squibb and works in Drug Product Development organization. His work at BMS is focused on late-stage formulation development and process development for biologics.


No bio available.

Head Process Dev

Dr. David Narum is Head of the Process Development Unit in the Laboratory of Malaria Immunology and Vaccinology, NIAID, NIH in Bethesda, Maryland. He is also responsible for coordination and oversight of CMOs and CMC development. He joined LMIV (formerly the Malaria Vaccine Development Branch) in 2003. The focus of the unit is development of pilot-scale processes for cGMP production of recombinant malaria vaccine candidates using microbial expression systems. Dr. Narum has been part of a team at LMIV that has filed 11 successful INDs and supported multiple phase 1 safety and immunogenicity trials in the US and Mali, West Africa. Prior to joining LMIV, he worked for 6 years (1997-2002) at EntreMed, Inc., a biotechnology company in Rockville, MD, departing as the Associate Director of the Malaria Program. He has worked in the field of malaria vaccine development for over 30 years. He completed a PhD in Immunology in 1994 from the University of Maryland at Baltimore, School of Medicine, a MS in Parasitology in 1988 from Tulane University, New Orleans, Louisiana and a BS in Microbiology from Washington State University. He completed post-doctoral work at the Biomedical Primate Research Centre in the Netherlands and at the National Institutes for Medical Research in London, England.

Prof & Head

Prof. Neubauer is head of the Bioprocess Engineering Laboratory at TU Berlin which is leading in bioprocess scale up and automated bioprocess development. The laboratory has been selected as a German key laboratory in AI. He is co-author in more than 250 publications and 20 patents and cofounder of the companies BioNukleo, Enpresso and Cell-tainer.

Chief Technology Officer

Dr. Knut Niss, Ph.D. has been Chief Technology Officer at Mustang Bio, Inc. since March 2018. He 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.

Senior Scientist

Michelle is involved in various iCELLis bioreactor projects that include next generation bioreactor design and viral vector production optimization (AAV and Lentivirus). Prior to Pall Corporation, Michelle graduated from Texas A&M University in 2018 with a PhD in Chemical Engineering. During her PhD, she focused on fungal biofilm formation with gut microbiome and biomedical applications. In her free time, Michelle enjoys hiking, traveling, and making sourdough bread.

Scientific Leader

Prasad Oruganti’s interests lie in automating biologics and small molecule workflows and he currently leads the automation and data management efforts in large molecule drug product development at GlaxoSmithKline.

Assoc Dir UGT Upstream Process Dev

Jan Panteli is an upstream process development lead at Ultragenyx Pharmaceutical with 5 years’ experience in developing AAV gene therapies, three AAV-technology patents, and multiple peer-reviewed publications. Prior to joining Ultragenyx, he earned his BS in chemical engineering from SUNY Buffalo (2009) and PhD from UMass Amherst (2015) where he focused on diagnostic and therapeutic approaches for cancer by genetically modifying microbes to overcome transport limitations phenomena in solid tumors.


Jeehae Park, Ph.D., is a Scientist in Analytical Development of Sanofi, where she is developing CE-SDS methods for gene therapy, synthetic proteins, and mAbs products. She obtained a Ph.D. in Biophysics from University of Illinois at Urbana-Champaign. During her Ph.D., she developed numerous quantitative methods for detecting molecular structure and dynamics of proteins. She then conducted her postdoctoral research at Harvard Medical School, where she studied mechanism of gene regulation and control. She authored 10 research publications, including Cell, Molecular Cell, Elife, JACS and EMBO. She led projects that awarded a competitive NIH grant ($2.5M).

Associate Director, Process Development & Manufacturing

Shabnum Patel, PhD is the Associate Director of Process Development and Manufacturing in the Center for Cancer Cell Therapy at Stanford University. Her interests are in the scale-up and translation of immuno-oncology research into Phase I/II clinical trials, with a focus on novel manufacturing platforms, product characterization technologies, and gene editing. She has worked extensively in the GMP field for cell therapy, focusing on the development and characterization of virus-specific T cell therapies and gene-modified cell therapies, and has published in each of these fields with an emphasis on HIV and cancer. She has experience building CMC operations, working with CMOs and academic GMP facilities to tech transfer programs, conducting engineering and process qualification runs, and setting up the infrastructure to support clinical manufacturing programs. Finally, she has worked with clinical and regulatory teams to contribute to CMC sections, develop appropriate documentation and SOPs to support clinical manufacturing needs, and train employees on critical procedures.

Dir Bioprocess Dev

Naveen Pathak is Director in Bioprocess Development at Takeda (formerly Shire). He currently leads a team that owns deployment of QbD (Quality-by-Design) and Process Validation. Prior to joining Takeda (formerly 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 support 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 the U.S. and is an Adjunct Faculty at Keck Graduate Institute in California.

Sr Scientist

Jai has 12 years of experience in biotech industry. His core expertise lies in GMP drug product manufacturing, process design and scale-up tech. transfer etc. He started his career in MedImmune/AZ (8 years) where he first worked on PFS and AI development, followed by early stage passive vaccine formulation at the Vaccine Production Program (NIH/NAID) for two years, and he has been at MacroGenics since Apr. 2018. His research interest lie in protein stability/thermodynamics/phase transitions and rheology.

Principal Scientist

Dr. Sanket Patke is a Senior Scientist in the Biologics Drug Product Development and Manufacturing group at Sanofi. Sanket has been involved in formulation development activities for several biologic molecules, including monoclonal antibodies, fusion proteins, PEGylated proteins etc. He is responsible for developing clinical and commercial formulations, supporting manufacturing and technology transfer, and providing support for toxicology and clinical studies. His expertise lies in the area of early and late-stage drug product development and drug product process development. Sanket completed his PhD in chemical engineering from Rensselaer Polytechnic Institute, Troy, NY and undergraduate studies in chemical engineering from University Institute of Chemical Technology, Mumbai, India.

Science and Standards Liaison

Niomi began her career in biotechnology at IBI/Kodak in New Haven CT. She obtained her B.S. from the University of Connecticut and Master’s degree from SUNY Stony Brook. Niomi went on to Enzo Diagnostics in Farmingdale NY, and then to Analytical Research and Development and later Bio-Process Research and Development at Pfizer in Groton CT. Niomi joined Alexion Pharmaceuticals in 2003 where she was responsible for development, validation, transfer, and then lifecycle management of analytical methods for biopharmaceuticals with a focus on plate-based and electrophoretic methods. In 2019, she moved to the United States Pharmacopeia where she is part of Global Biologics Pipeline Development, working to develop standards for Biologics.


Maarten Pennings is Chief Technology Officer at BiosanaPharma, a company developing biosimilar antibodies produced with a continuous manufacturing platform from perfusion bioreactor to bulk drug substance formulation. He has an M.Sc. in Bioprocess Technology from Wageningen University in The Netherlands. He has 20 years of experience in the development of biopharmaceuticals. He spent 12 years at Xendo (now ProPharma) as a consultant process development in projects on antibiotics, antibodies and viral vaccines. He has also been working on the development of continuous manufacturing in biopharma since 1999 and is a co-inventor of the BioSMB®.

Deputy CTO

Tania D. Pereira Chilima is Deputy Chief Technology Officer at Univercells Technologies where she focuses on optimizing the technology portfolio to increase affordability and accessibility of biologics globally. Prior to this role, she was Product Manager for the NevoLine™ platform at Univercells, and previously worked as a post-doctorate researcher for the ULTRA grant sponsored by the Bill and Melinda Gates foundation, concentrated on design manufacturing strategies to deliver vaccines at low COG. Tania holds an engineering doctorate from the University College London in partnership with Pall Life Sciences entitled, Decisional Tools for Enabling Successful Manufacture and Commercialization of Cell Therapy Products, and is a frequent contributor to industry publications and journals.


Biomedical Engineer

Laura Pierce is a Biomedical Engineer in the Biomaterials Group at the National Institute of Standards and Technology. She is responsible for technical planning and conducting studies to support development of the ISO standards for Cell Counting. In that capacity, she routinely performs cell counting measurements on a variety of lab instrumentation typically used in the Regenerative Medicine field, and she supports analysis and dissection of data with collaborators to define the points in their experimental workflow which introduce measurement error and uncertainty, and offers recommendations to improve precision and robustness of measurements. 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 assay development. She received her B.S.E. degree in chemical engineering from Princeton University and she holds an M.S. degree from Northeastern University.

FUJIFILM Diosynth Biotechnologies

Head of Science and Innovation

Steven Pincus Ph.D.is the Head of Science and innovation for FUJIFILM Diosynth
Biotechnologies Texas. His is responsible for the evaluation of new technologies for Advanced
Viral Therapies and establishing and maintaining collaborations to foster innovation and
development of training programs for employment at FDBT. Prior to this role Steve served as
Associate VP Virology and Analytical Development where he established and lead teams
responsible for transferring, developing and qualifying methods to support multiple programs.


Professor Todd Przybycien received a BS in Chemical Engineering and a AB in Chemistry from Washington University in St. Louis in 1984. He attended California Institute of Technology for graduate education, receiving MS and PhD degrees in Chemical Engineering in 1987 and 1989. Prof. Przybycien worked for two years at Monsanto Agricultural Company as a Senior Research Engineer before joining Rensselaer Polytechnic Institute as an Assistant Professor in 1991. He came to Chemical Engineering at Carnegie Mellon in 1996 and served as the (founding) Head of BioMedical Engineering from 2002-2008. Professor Przybycien currently holds a joint appointment in Biomedical Engineering and in Chemical Engineering.


Neha Puri is a Scientist in the Process Development Analytics group at Bristol-Myers Squibb, Devens, MA. In this role, she is working on developing process analytical technology (PAT) tools for in-line real time monitoring of product quality attributes during biologics manufacturing. She earned her Ph.D. from Stony Brook University, New York, and worked at Johns Hopkins University as a postdoctoral fellow before joining BMS in 2019.

Senior Scientist

Wei Qi is a Senior Scientist in Drug Product Technologies at Amgen. His current work focuses on high-throughput formulation screening to support biological drug product development. He has also served as Drug Product Team Leader for FIH therapeutic protein programs. Prior to joining Amgen in 2015, he was a postdoctoral researcher in Professor John Carpenter's group at the University of Colorado and a Senior Scientist at Malvern’s Bioscience Development Initiative. He holds a PhD in chemical engineering from the University of Virginia.

Sr Scientist

After finishing Bachelor’s degree in Pharmaceutical Sciences and Ph.D. in Pharmaceutics, Dr. Rastogi is focused on Biologics Drug Product (DP) Development and Manufacturing in Biopharmaceutical Industry for the last 16 years. At Bayer, Dr. Rastogi has been involved in Development, Clinical manufacturing, Conformance manufacturing/ Validation, Regulatory submission & response, Pre-Approval Inspection, Approval and Launch of Biologics Drug Product. He has successfully led Manufacturing Process development for several Biologics DP and is considered a trusted Subject Matter Expert on DP Development and Manufacturing related matters. Dr. Rastogi has 9 research papers /review articles (in key journals including Pharmaceutical Research, and International Journal of Pharmaceutics), 28 Bayer internal peer-reviewed scientific research papers, and has extensively presented the research in national and international conferences (a total of 25 presentations).

Sr Scientific & Standards Liaison

Dr. Richardson is in the standards pipeline development group within global biologics at USP, leading efforts to develop standards for emerging technologies such as cell and gene therapy. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious diseases and retinal disease. Trained as a virologist, Jim has also held positions responsible for performing viral clearance testing at Viromed Biosafety and AAV vector development and characterization at Genovo/Targeted Genetics.

Sr Specialist

Anne Richelle did her PhD in the Engineering Department of the Université Libre de Bruxelles on the modeling, optimization and control of yeast fermentation processes. After a first postdoc at the same university focused on the metabolic modeling of mammalian cells, she joined the lab of Prof. N.E. Lewis at University of California, San Diego to work on the integrated modeling of genotype-phenotype relationship in CHO cells, research for which she received the Eli Lilly Innovation Fellowship Award. She is currently working at GSK on the integration of systems biology tools from a process engineering perspective.

Process Development Engineer

Matt leads the AAV Process Development group at Precision BioSciences, which is focused on designing and implementing new strategies for the production and purification of adeno-associated virus. Matt completed his Bachelor's degree in Biological Sciences at North Carolina State University and his Master's degree in Microbiology and Cell Science at the University of Florida.

Head of Biomolecule Formulation – Liquid Formulation R&D

Tobias Rosenkranz is a Laboratory Head at MilliporeSigma, based in Darmstadt Germany. He is a biophysicist by training and his lab investigates formulation challenges arising during protein formulation, with a specific focus on protein viscosity and aggregation. Prior to joining industry, he held academic positions at UIUC and UNSW Australia (Sydney).

Georgia Institute of Technology

Robert A Milton Chair & Dir

The overall goal of the Laboratory of Cell and Macromolecular Engineering is to achieve a basic understanding of how the immune system responds to genetic manipulations and how cellular fate is decided based on microenvironmental cues. Not only is this going to help us find novel treatments for diseases, but will also help us understand the fundamentals of genetic manipulations, cell differentiation, and cell-cell interactions (i.e. the complex interplay between cells and their environment).

University of California San Diego

Postdoctoral Researcher

Matt Schinn is a post-doctoral researcher in N. E. Lewis Lab at UCSD. He is interested in applying computational methods to improve bioprocess and cell-line engineering. Matt has recently spearheaded a collaboration with an pharmaceutical company to produce a tailored model of CHO metabolism. He did his PhD at Brigham Young University in Chemical Engineering.

Dir R&D

In 2002, Dr. Schmelzer joined AstraZeneca’s (then MedImmune) rapidly growing cell culture team. At AZ, he plays an active role in establishing our high-titer platform for both CHO and NS0 cell cultures. He currently leads a team developing anti-viral therapies and many of our non-monoclonal antibody projects, including oncolytic viruses and the adeno-associated virus platform, as well as multiple CMC teams. In addition, he represents Biopharmaceutical Development on AZ Governance Boards. He and his team have supported many FTIH programs and Phase 2 program from across all therapeutic areas.


Mona Schulte currently works as principal scientist in the physico-chemical characterization group at Novartis - Global Drug Development in Austria. After her studies of food chemistry and a stay abroad at the University of Oxford (UK), she obtained her PhD in the field of protein analytics at the University of Münster (GE) in collaboration with the University of Hyderabad (IN). In 2016, she joined Sandoz as associate scientist, since then she specialized in the analysis of host cell proteins by LCMS and acts as a characterization project analyst for one biosimilar project.

Dir Bioinformatics & Asst Prof

Derrick C. Scott is an Assistant Professor and Director of Bioinformatics in the Biological Sciences department at Delaware State University. Hailing from Varnville, SC, he studied Biology at Virginia State University. He then matriculated at Virginia Tech where he earned a Master’s degree in Molecular Biology. His thesis work entailed the discovery and deactivation of a fungal gene that was necessary for pathogenicity in economically important brassica plants. Afterwards, he earned his Ph.D. in Integrative Biology from the University of South Carolina by discovering a new strain of bacteria and determining the best methodology to sequence and assemble High-GC bacterial genomes. His postdoctoral work included studies on bacterial genomics and the evolutionary history of Caulobacters. He is currently assisting institutions around the globe in their bioinformatics needs while studying bacterial genomics and working with the transcriptomics of Chinese Hamster Ovary cells. He is married to Dr. LaTia Scott and they have three children together, Zoey Scott, Cameron Scott, and Jaxson Scott.

Sr. Vice President

Michael Scott joined BlueRock in 2017 to oversee the company’s product realization processes and Toronto operations. In this role, he is a key part of the team focused on cell therapy product development including cell processes, assay development and delivery devices for dopaminergic neurons to treat Parkinson’s disease and cardiomyocytes to treat congestive heart failure. Prior to joining BlueRock, Dr. Scott served as chief development officer & vice president of R&D at ViaCyte, a clinical-stage biotechnology company focused on the treatment of type I diabetes with a stem cell-based therapy product. He received a Ph.D. in medical biophysics from The University of Western Ontario, and masters and bachelor’s degrees in civil engineering from the University of Waterloo.

Saurabh Sen, PhD, is a research scientist with a domain expertise in Antibody Therapeutics, spanning over a broad depth from discovery to upstream manufacturing. His main focus is on optimizing novel technologies for antibody expression (both transient and stable CLD), using cell culture of mammalian cell lines (mainly CHO variants) in support of early discovery research, process development, scale-up, and technology transfer. Saurabh holds a PhD from the University of Helsinki, Finland and completed his postdoctoral research at Washington University School of Medicine at St. Louis and University of Alabama at Birmingham. In his current position at Boehringer Ingelheim (BI), he is primarily working on antibody therapeutics towards developing new drug for unmet medical needs.


Susan Sharfstein is a Professor of Nanobioscience at SUNY Polytechnic Institute in Albany, New York. Professor Sharfstein received her B.S. in chemical engineering with honors from Caltech in 1987 and her Ph.D. in chemical engineering from UC Berkeley in 1993. Her interests include mammalian and microbial cell bioprocessing, control of protein glycosylation, metabolic engineering, biosensing, and development of systems for high-throughput screening of nucleic acids and small molecules. She is the author of over 65 papers and book chapters in the fields of biotechnology and bioprocessing.

Senior R&D Manager

Jochen is a Biotechnologist by training and received his PhD in Bioprocess Engineering in 2012 from ETH Zurich in Switzerland. At the time, he was working as PhD student in Novartis Bioprocess Development, working on scale-up and scale-down of fed-batch bioreactor processes. He remained at Novartis for a two-year postdoc, working on perfusion process and media development. Jochen also holds an MBA degree with the focus on Innovation and Technology Management. After joining Merck in 2014, Jochen established a new perfusion laboratory and team, which steadily grew in size and scientific breadth over the years. Today, Jochen and his team are involved in a large variety of projects, including catalog product development in global project teams, technology development, and custom media development service. His focus and passion is on continuous applications and perfusion processing.

iBET Instituto de Biologia Experimental Tecnologica

Senior Scientist, Downstream Process Development

Ricardo Silva received his PhD degree in Chemical and Biochemical Engineering from New University of Lisbon in 2013. His studies focused on the development and optimization of countercurrent adsorption processes for purification of (bio)pharmaceutical products. Since 2014 he is a senior scientist 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.

Product Manager Antibody Therapeutics

Anupam Singhal earned his PhD from the University of British Columbia and has over 15 years of experience in nanotechnology and microfluidics at UBC, the University of Toronto and Stanford University.  His work has been cited over 600 times and resulted in several patents for molecular disease diagnosis, antibody discovery, and development of production cell-lines for biologics. At Berkeley Lights, Anupam leads the development of next-generation platforms for the discovery and development of antibody therapeutics.

Deputy Dir Quality Control

Elena Smith, Ph.D., is Head of the Quality Control of Protein Sciences site at Sanofi Pasteur. Dr Smith joined Protein Sciences Corporation (acquired by Sanofi in 2017) in 2013 and led Quality Control for the commercialization of the new product, Flublok® (world's first recombinant Influenza vaccine) with several seasons of product scale-up on the market. Dr. Smith obtained her Ph.D. in Molecular Biology in 2004 from State Research Center of Virology and Biotechnology “Vector”, Russia on HIV antivirals and completed her postdoctoral training on HIV antiviral/host infection mechanisms at U.S. National Institutes of Health. Dr. Smith focuses her industrial operations interests on standards, pharmacopeias, QC assays implementation (development, validation, troubleshooting and comparability), manufacturing process, assay transfer, and microbiological control of manufacturing sites. Currently, Dr. Smith is Lead of International Study for the implementation of alternative potency standards for Influenza vaccines with study participants from World Health Organization Essential Regulatory Laboratories (WHO ERLs) and members of International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

Hitachi Chemical Advanced Therapeutics Solutions LLC

Dir R&D

No bio available.

COO & Head

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.

Asklepios BioPharmaceutical, Inc.


Jacob Smith has served as the Director of Process Development for Asklepios BioPharmaceutical, Inc. (AskBio) since November 2017. His team is responsible for developing large-scale production processes for gene therapy vectors and supporting manufacturing and tech transfer operations. Prior to joining AskBio, he worked as a Senior Scientist for Gene Therapy Bioprocess R&D at Pfizer, Inc., and served as upstream CMC lead for the Duchenne Muscular Dystrophy (DMD) program. He served as Senior Manager and Process Development Scientist at Bamboo Therapeutics, Inc. and was a Process Development Specialist at the UNC Chapel Hill Gene Therapy Vector Core where he was a sponsored collaborator for construct development in the Hemophilia program between AskBio and Baxter, Inc. Prior to this, he worked at Intrexon Corporation, where he manufactured Adenoviral gene therapy vectors and high-throughput plasmid DNA vectors. He holds a BS in Biology from James Madison University.

Scientist & Lecturer

Dr. Michael Sokolov is co-founder and COO of DataHow AG, a spin-off company from ETH Zurich specialized on process data analytics and modeling with a particular focus on the biopharmaceutical and chemical domains. He also holds a lecturer position for statistics for chemical engineers at ETH.

Sr Research Investigator I

Peter Soler earned a Ph.D. from the University of California at Berkeley, and holds a B.S. in Chemical Engineering from Florida State University, Tallahassee, FL, with a double major in Biomedical Engineering and Biomedical Mathematics. Currently, Peter is the Automation Lead for Drug Product Development at Bristol-Myers Squibb. Peter was instrumental in designing the automated buffer exchange workflow for BMS and has been responsible for bringing the system into production. Peter oversees all automated drug product screening workflows for both small and large molecule and seeks to better digitize the information collected during the development of an asset. Peter is a champion of new technology and working with teams to usher in digital transformation.

Editor In Chief

John Sterling has been editor in chief of Genetic Engineering & Biotechnology News since 1985. He holds a BS in biology from CCNY and a Masters in journalism from the University of Minnesota

Assoc Principal Scientist

Shuwen Sun is an Associate Principal Scientist at Merck Analytical R&D department. She received PhD degree in Analytical Chemistry from University of Michigan, Prof. Bob Kennedy’s group. Though graduated as a high throughput analytical scientist specialized in mass spec and microfluidics, Shuwen developed strong passion and expertise in separation science after joining Merck to drive pipelines. Shuwen continues to extend her skillset by moving to directly support Merck Protein Engineering group to solve challenging analytical issues. Currently, Shuwen is leading protein conjugate programs, bridging experience from both small molecules and biologics.


Zhiyuan is currently the scientist in the Analytical Development team within BioTherapeutics Development of Janssen Pharmaceutical. He graduated from Dr. Richard van Breemen’s group in the University of Illinois Chicago with master’s degree in Medicinal Chemistry. His research focus includes cell culture optimizations and process analytical technologies.

Ultragenyx Pharmaceutical Inc

Assoc Dir

Jessie has nearly 10 years of experience in fermentation and cell culture in the pharmaceutical industry. She joined Ultragenyx in 2019 and has been focusing on HEK platform, as well as late stage development. During her time in Boehringer Ingelheim and GSK, she worked on and led process development for both early stage and late stage projects, such as monoclonal antibody or other therapeutic proteins. She also led GMP clinical supply runs when she was at Boehringer Ingelheim. Jessie has been trying to apply innovative technologies to cell culture/fermentation process, i.e., metabolomics, were applied for scale-up troubleshooting. She also evaluated and integrated PAT tools (such as Raman, holographic microscopic technology) for upstream process, to gain more knowledge between process indicators vs. process productivity. She has a BS in Biological Science from Nankai University in Tianjin, China and a MS in Applied Statistics and a PhD in Biochemistry, with an emphasis in Biochemical Engineering from The Ohio State University, where she also was a postdoctoral researcher for 1 year working on fermentation bioprocess.

PhD Candidate, Doctoral Researcher

Joseph Taris is PhD Candidate finishing his final year in the Chemical and Biomolecular Engineering Doctoral Program at The Ohio State University. Working under the direction of Professor David Wood since 2014, Joe's research has primarily focused on applied protein engineering and process innovation, specifically toward development and production of biopharmaceuticals. His work has been instrumental in the development of novel self-cleaving affinity tag technologies, which are now being commercialized by Professor Wood's recently-founded startup: Protein Capture Science. Prior to returning to graduate school, Joe worked for several years as a consultant, helping startups and small businesses to develop and procure funding for innovative research in science and engineering, thus providing him with an exceptional background in intellectual property and business development, as well as a broad understanding of industrial science and technology.

Research Associate

Research associate at the Manchester Institute of Biotechnology (University of Manchester). On one hand, I've been focused understanding metabolic signatures of mammalian cell lines for the characterisation and optimisation the production of therapeutic recombinant proteins. On the other hand, I have used these molecular understanding to desing novel cell engineering strategies to enhance bioprocess effectiveness of mammalian cells.

Senior Scientist

Fateme joined BioAnalytics department in Biologics Development at Sanofi, Framingham MA in 2015. Her work is focused on mass spectrometry characterization of biotherapeutic products and processes including monoclonal antibodies (mAbs) and mAb-related modalities as well as enzyme replacement therapies during early and late stages of development. Prior to joining Sanofi, Fateme completed a post-doctoral training in Brigham and Women’s hospital & Harvard Medical School. Fateme holds a Ph.D. in Analytical Chemistry from Northeastern University.

Sr Scientist

I got my Bachelor’s in Chemistry and Philosophy at Creighton University in Omaha working in synthetic organic chemistry. I then went to the University of Minnesota, where I received my Ph.D. working under Will Pomerantz developing protein-observed fluorine NMR as a ligand discovery technique. Since then I’ve been working in the high-throughput protein engineering group at AbbVie Bioresearch Center to design, produce, and analyze proteins in high-throughput.

Children's National Hospital

Senior Scientist

Dr Stéphanie Val is a scientist with 15 years of experience in developing and characterizing various human in vitro models to study and treat diseases. She got her PhD from the University Paris Diderot Paris 7 in 2011 and then pursued a carrier in research and development in the United States, where she became Assistant Professor of Pediatrics at the George Washington University in Washington DC in 2018. She has expertise in immunology, toxicology and infectious diseases. She currently works in the Cellular Therapy Laboratory at the Children’s National Hospital, where she develops scaled up processes to manufacture antigen-specific T cells that she translates to GMP manufacturing.

Childrens Hospital of Philadelphia

Dir Clinical Vector Core

No bio available.

Manager, Process Development

Pranav Vengsarkar joined Avantor in December 2016 and is Manager- Process Development at Avantor Technology & Innovation (T&I). He is focused on product and process development for new cGMP products and excipients. He is also part of development & design teams for single-use raw material delivery systems at Avantor.  Prior to joining Avantor, Pranav worked as a researcher developing and building simulated moving bed chromatography systems as well supercritical fluid processes for oil & gas applications. These experiences have afforded Pranav the opportunity to learn various aspects of manufacturing technology, scale-up and process development. Pranav holds a B. Chem. Engg. degree from ICT, Mumbai and Ph.D. in Chemical Engineering from Auburn University.

Principal Engineer & Leader

No bio available.

Director CHO Cell Line Development

Bjørn Voldborg has more than 20 years of experience working with recombinant protein expression from both academic and industrial settings. Bjørn was team leader in the biotech company Pharmexa A/S, responsible for molecular cloning and expression of protein-based drug candidates. From this, he went to the NNF Center for Protein Research at the University of Copenhagen as Head of the Protein Production Unit, and since 2012, Bjørn has been heading the CHO Cell Line Engineering project at the NNF Center for Biosustainability at the Technical University of Denmark, a project dedicated to the engineering of improved protein production cell factories.

Sr Scientist

Dr. Wang received his Ph.D. in analytical chemistry and has over 10 years of working experience in biopharmaceuticals. His current research focuses on LC-MS based biologics characterization, Developability Assessment, impurity identification, and high throughput analytics to support upstream and downstream process development.

Assoc Principal Scientist

Fengqiang Wang, PhD, is currently a Principal Scientist in Merck Research Laboratories (MRL). He started at Merck in 2011 as a senior scientist working on the biochemical characterization of biologics and biosimilar similarity study with originator using a variety of analytical tools such as N-glycan analysis and peptide mapping. Then a major part of his work focused on the development of process- and platform-specific residual host cell protein (HCP) ELISA to support HCP impurity testing in biologics, including marketed products Keytruda, Zinplava, and Ilumya (Sun Pharm). Other than immunoassay development, he also worked on extensive detection and characterization of HCPs and anti-HCP reagents in biologics with 1D/2D SDS-PAGE, 2D-DIGE, 1D/2D-Western blot and 1D/2D-LC-MS. In addition, he is also specialized in assay development for monitoring other process residuals such as protease inhibitors, trypsin, MSX, ß-glucan, etc. He has authored more than 40 peer-reviewed scientific publications and presented at many national and international meetings including AAPS annual meeting, BEBPA HCP Annual Conferences from 2015 to 2018, BPI, and CHI's Bioprocessing Summit HCP Conference from 2016 to 2017. He also authored several book chapters on antibody engineering and ovarian cancer and had two patents on antibody-drug conjugates.

VP Pharmaceutical R&D

Nick Warne is currently Vice President of Pharmaceutical Research and Development at Pfizer. Nick has 30 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 15 biologics including clotting factors, growth proteins, mabs, vaccines and ADCs. Nick 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.

VP Pharmaceutical Dev

Dr. Warren has more than 25 years of experience in the pharmaceutical and biotechnology industry, with a focus in bioprocess development and manufacturing of viral vectors, viral vaccines, and biologics. At Ultragenyx, he leads a team of 50 scientists and engineers, responsible for all early and late stage Process and Analytical Development of viral vector products as well as Pilot Scale Manufacturing in the Woburn, MA Pilot Plant. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, and Shire. Earlier in his career, Jim spent 16 years at Merck & Co., Inc., where he led process development, technology transfer, and manufacturing sciences teams responsible for development of several clinical vector and vaccine candidates and the licensure of multiple commercial vaccines (RotaTeq®, Varivax®, ProQuad®, and Zostavax®). Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a Ph.D. in Molecular and Cellular Biology from Lehigh University.

Sr Scientist

Dhanuka Wasalathanthri, PhD is a Senior Scientist at Bristol Myers Squibb where he leads the process analytical technology (PAT) initiatives & strategies at biologic development in Devens, MA. His broad spectrum of expertise in PAT space features the utility of multi-dimensional chromatography, spectroscopy & chemometrics, microfluidic sensors, and mass spectrometry for real-time monitoring of product quality attributes and process parameters. He represents several academic and industry consortia. Dhanuka received his PhD in Analytical Chemistry from University of Connecticut in 2014, and his work is published in peer-reviewed scientific journals.

Sr Research Scientist

Jay West is a Senior Scientist at Bristol Myers Squibb in the Process Development Analytics group in Devens, MA. He obtained his BS in Chemistry from Rensselaer, MS in Chemistry from University at Albany, PhD in Biochemistry from Boston College, and performed postdoctoral research at Northeastern University. He has 8 years pharmaceutical industry experience, having worked at Regeneron Pharmaceuticals precious to BMS. His focus the past three years has been on Process Analytical Technology, particularly in downstream process development.


David Wood is currently a professor of Chemical and Biomolecular Engineering at The Ohio State University, where he continues to work on self-cleaving tag technologies for research and biopharmaceutical applications. He holds an undergraduate degree from Caltech with a double major in biology and chemical engineering, as well as a PhD from Rensselaer Polytechnic Institute in Chemical Engineering, and has experience in downstream processing and proess development at Amgen and Bristol Myers Squibb. He has published over 50 papers, book chapters and reviews in protein engineering, and holds several patents on technologies developed in his lab. Most recently, he is a co-founder of Protein Capture Science; a company formed to commercialize his split-intein technology for protein purification.

Prof & Head Proteomics & Glycomics

Manfred Wuhrer studied Biochemistry at Regensburg University in Germany and obtained his PhD in 1999 at Giessen University. Subsequently, he joined the Leiden University Medical Center for a career in analytical glycomics. In 2013, he was appointed full professor Analytics for Biomolecular Interactions at VU University. In 2015 he continued his career as Head of Center for Proteomics and Metabolomics at the LUMC. Manfred Wuhrer focuses on the development of mass spectrometric methods for glycomics and glycoproteomics, and their application in clinical research and biotechnology.

Sr Scientist

Philip Wuthrich is a Senior Research Scientist at ReForm Biologics in Woburn, MA, holding a Bachelor of Science degree in Chemical Engineering from the University of Massachusetts-Lowell. He has ten years of experience in technology development, with the last six years at ReForm Biologics.

Staff Scientist

Yuetian Yan received her Ph.D. in 2015 from Washington University in St. Louis under Prof. Michael L. Gross, after which she joined Regeneron Pharmaceuticals Inc. in Tarrytown NY. Currently, she is a staff scientist in the Analytical Chemistry Group. She has a main research focus of developing native LC/MS based methods for therapeutic protein characterization for supporting mAb drug development and regulatory filings.

Sr. Director

Dr. Yan is currently a Sr. Director at Acceleron Pharma, and he has been working in protein/ mAb therapeutics space for over 18 years. Prior to Acceleron, Dr Yan had worked for GSK, Celgene, Gilead, Genentech and Amgen. Dr. Yan has deep knowledge in mAb /ADC/protein therapeutics development and characterization, as evidenced by successful project leadership experience (mAbs, ADCs, Bi-specifics and Fc fushion proteins), and an invited speaker for several influential conferences.

Sr Scientist

No bio available.

Grp Leader & Sr Scientist

Feng received her PhD degree in Analytical Biochemistry (biological mass spectrometry) from University of Virginia. She did her postdoc training at Pacific Northwest National Laboratory (PNNL) and was a senior scientist before joining Genentech in 2013. She has extensive knowledge of CMC development, control strategy, quality by design, and lean production system for biotherapeutic drugs, and in-depth knowledge and technical expertise in mass spectrometry and related methods for proteomics and antibody characterization (LC-MS, CE-MS, etc.). Feng is the author of 57 (first author of 17) peer-reviewed publications and 1 book chapter (first author), corresponding author of PNAS and Anal. Chem. publications.


Grace received her SB and M.Eng from the Massachusetts Institute of Technology. She has worked in Upstream Bio-process development at Bristol-Myers Squibb since 2013. While there, she began a part-time Ph.D. at Tufts University and her research is focused on CHO cell metabolism.

Sr Assoc Consultant Engineer

Zhao Yu is an Associate Senior Consultant Engineer in Eli Lilly’s Bioproduct Research and Development organization based in Indianapolis, IN. His current work is focused on formulation and processes development for biological drug products and tech transfer. Additionally, his work involves modeling and simulation of manufacturing processes. Zhao received his PhD in Chemical Engineering from the Ohio State University.


Thomas Zahel is Head of Innovation at inCyght Division of Werum IT Solutions GmbH, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for our clients. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods and turn them into intuitive data science tools for consulting projects and features of our software inCyght. He has successfully helped top-ranked biopharmaceutical companies to develop, improve and validate their processes according to regulatory compliance.

Assoc Dir Large Molecule Purification Dev

Dr. Green Guihang Zhang is Director of Purification Process Science at Incyte Corporation. He has over 20-year bioprocessing experiences particularly in cell culture recovery, purification and formulation. Prior to Incyte, he was the director of Protein Science at ImaginAb and the purification group leaders in Agensys/Astellas and Human Genome Sciences. He has been a frequent presenter at bioprocessing industry events and contributed to a dozen of publications including book chapters and journal articles. He received his Ph.D. in immunochemistry from University of Copenhagen in Denmark and did his post-doctoral study as a Fogarty fellow at CEBA/FDA.

Dir Cell Line Dev

Marieke Zhao, Ph.D., is Director of Cell Line Development at Mersana Therapeutics where she leads cell line development and cell banking activities at CDMOs, Biologics technology transfer teams, and Antibody Drug Conjugate CMC and project teams. Prior to Mersana, Dr. Zhao led cell line development in the Cell Line and Upstream Engineering group of ImmunoGen, where she developed a proprietary CHO expression system. She has close to 20 years of experience in the biopharmaceutical industry with expertise in cell line and cell culture development, biologics process development, tech transfer, GMP, project management, CMO management and regulatory filings. Dr. Zhao received her Ph.D. degree in Molecular Biology from the University of Zurich in Switzerland.

Sr Principal Scientist & Lab Head

Dr. Xiaotian Zhong is currently Senior Principal Scientist and Lab Head at BioMedicine Design of Pfizer Worldwide R&D. Prior to joining Pfizer in October 2009, he was Principal Research Scientist and Lab Head at Wyeth Research from June 2002 to September 2009. Dr. Zhong has a strong scientific and technical background in mammalian cell biology, therapeutic protein production & engineering, and antibody-drug conjugation. His current and past therapeutic research focuses include Oncology, Autoimmune diseases, and Cardio-Renal diseases. Dr. Zhong received a Ph.D. degree in Molecular Genetics from Georgia State University (Atlanta, GA), an MPH degree from Harvard University, and a post-doctoral fellowship in Molecular Cell Biology at Harvard University. Dr. Zhong is an author of 35 peer-reviewed publications, and an inventor of 5 issued patents and 10 patent applications.


Professor Zhou’s laboratory applies protein chemistry, analysis and engineering to biology and medicine. One program is “Hybrid Modality Engineering of Proteins”—a platform to introduce non-canonical chemical moieties and/or scaffolds into peptides and proteins to confer novel functions otherwise unavailable, such as photomedicine. The second is to devise chemo-enzymatic methodologies to characterize protein modifications, such as crosslinking, isoaspartic acid formation (asparagine deamidation) and methylations. In collaboration with biologists and clinicians alike, we also investigate their biological effects, and moreover, as critical attributes in protein pharmaceuticals. Over the past decade, Professor Zhou has been actively collaborating and consulting with biotech and pharm companies on biotherapeutics, enzymes and protein chemistry. These collaborations have led to the elucidation of product and process-related modifications (many of which were previously unknown). He also developed and now teaches a new advanced course entitled “Chemistry and Design of Protein Pharmaceuticals,” as well as workshops on antibody-drug conjugates (ADC), and training courses for scientists from industry, academia, and regulatory agencies in the US, China, and APEC economies.