Development of Next-Generation Biologics
CMC Strategies for Antibody-Drug Conjugates
August 18-19, 2014
Yilma Adem, Ph.D., Formulation Scientist, Pharmaceutical Development, Genentech, Inc.
I work in Genentech in Early Stage Pharmaceutical Development Department as a formulation scientist. Currently, I lead the formulation of ADC and Bispecific Mab development projects. I have expertise in the formulation development of high and low protein concentration Mabs leading up to IND filing. My research interests are photooxidation and physical stability of Mabs. I have MSc. in Medical Product Development Management from San Jose State University.
Xavier Despinoy, Ph.D., Process Development Manager, Piramal Healthcare Ltd.
Xavier has over 15 years of industrial experience in process development. He has worked on bioconjugation processes for over 10 years and was involved in the 1st Antibody Drug Conjugate programme transferred in 2004 to Piramal. Xavier is presently managing the team developing ADC processes at Piramal. He has responsibilities for developing, scaling-up and transferring ADC processes to the GMP production area, as well as manufacturing ADCs for early evaluation and toxicology studies To-date Xavier has developed / transferred over 100 ADC conjugation processes, with approximately 25 ADCs manufactured under GMP at Piramal for clinical trial supplies. Xavier is involved in troubleshooting, monitoring and reviewing manufacturing campaigns of all GMP processes carried out at Piramal. Xavier also supports ADC processes moving from early to late phase / commercial status. Xavier is a lead member of the Piramal team during regulatory audits.
Lily Liu, BS, Principal Associate, Formulation and Analytical Development, Agensys, Inc.
Lily Liu has over 10 years of combined QC, process, and analytical development experience. Her current role in the Analytical Development group is focused on method development and characterization in support of early R&D to clinical product development. Lily holds a dual-major BS degree in Chemistry and Biology from Emory University and is currently pursuing her MSc in Biochemistry from the University of Saint Joseph.
Steven Max, Ph.D., Associate Research Fellow, Biotherapeutics Pharmaceutical Sciences, Pfizer
Dr. Steven Max joined Pfizer (previously Wyeth BioPharma) in 2002. As a Pharm Sci Team Leader, he is responsible for leading multi-functional project teams and interfacing with project stakeholders toward the development of project strategies and execution of project plans to rapidly prepare non-clinical and clinical supplies and support rapid global CMC submissions and approvals. His current focus is on antibody-drug conjugates (ADC), having oversight of the majority of the early clinical and pre-clinical programs within the Pfizer oncology portfolio. Dr. Max received his PhD in Molecular and Cellular Pharmacology from the University Of Miami School Of Medicine. He was a Staff Fellow at the National Institutes of Neurological Disease and Stroke, NIH, Bethesda, MD.
Knut Niss, Ph.D., Senior Technical Project Leader, Novartis Pharmaceuticals Corp.
Dr. Niss completed his doctoral work at the Max-Delbrueck Center in Berlin, Germany working on developmental pathways involved in leukemic cell transformation. He holds a PhD in molecular biology and a master’s degree in biology. Following his doctorate work Dr. Niss performed his postdoctoral studies at Children’s Hospital and the Dana Farber Cancer Institute in Boston. Here, he analyzed genes involved in hematopoietic stem cell maintenance and differentiation. Following his postdoctoral work, Dr. Niss joined Pfizer’s Immunology group first in Connecticut and later in St. Louis to serve as a team leader for hematopoiesis. In this role, he oversaw the implementation of various small molecule and biologics programs into Pfizer’s preclinical pipeline. Following this, Dr. Niss was appointed as the research team leader for adult stem cells in Pfizer’s Regenerative Medicine unit in Cambridge, MA. In this role, his responsibilities included identifying and evaluating new opportunities for cell therapies as well as overseeing the research efforts within Pfizer’s clinical program. Recently, Dr. Niss was a Senior R&D program manager for EMD Millipore’s Stem Cell Initiative. There, he led the efforts on large scale stem cell expansion and downstream processing. Under his supervision, his group was the first to show stem scale expansion processes at the 50L scale. In 2013, Dr. Niss moved his career to Novartis Pharmaceuticals in Morris Plains, NJ where he serves as the senior technical project leader for Novartis’ cell therapy programs.
James Prudent, Ph.D., President & CEO, Centrose
Dr. James Prudent is currently the CEO and Chairman of the Board at CENTROSE, a biotechnology company focused on developing targeted therapies for diseases with high unmet need. At Centrose, Dr. Prudent invented EDC technology that allows small molecule drugs to remain active while attached to antibodies. The technology allows for the precise delivery of drugs to disease specific cell surface protein complexes. Prior to CENTROSE, Dr. Prudent served as CSO and Board Member at EraGen Bioscience (now Luminex) where he invented GENE-CODE, a technology that incorporates an entirely new genetic code into real-time and multiplexed genetic diagnostics. Before EraGen, Dr. Prudent invented Invader Technology while at Third Wave (now Hologic) a complimentary method to PCR that does not lead to contaminating amplified DNA. Prior to Third Wave, Dr. Prudent worked for IGEN International where he pioneered new methods of rapidly producing monoclonal antibodies. Dr. Prudent received his Ph.D. in Chemistry at the UC - Berkeley under the direction of Professor Peter G. Schultz and his B.S. in Bacteriology and Medical Microbiology at the University of Wisconsin - Madison. He has over 100 publications, patents and patent applications. He is a recipient of the Frost and Sullivan Product of the Year Award and Biotechnology Industry Organization Innovation Award.
Christian Schoneich, Ph.D., Takeru Higuchi Distinguished Professor and Chair, Pharmaceutical Chemistry, University of Kansas
Dr. Schöneich received his Ph.D. in Chemistry in 1990 from the Technical University Berlin, Germany. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institut in Berlin, Germany. His research focuses on oxidation reactions of peptides and proteins in vivo and in vitro, and their potential consequences for the development of stable protein pharmaceuticals, biological aging and age-related pathologies. He has published > 200 papers in the field of peptide and protein oxidation reactions
Ian Schwartz, Ph.D., Senior Engineer, Process Development, Agensys, Inc.
Ian Schwartz joined Agensys in March 2012 as a Senior Engineer where he leads Agensys’ Antibody Drug Conjugate Process Development and Technology Transfer group. Before joining Agensys, Ian was employed by MedImmune where he led a team introducing downstream purification processes into the clinical GMP manufacturing facility. Prior to joining MedImmune, Ian held positions of increasing responsibility for 5 years within ImmunoGen’s Process Science and Engineering group. Ian began his career at Biogen Idec before joining ImmunoGen. Ian holds a Bachelor of Science and Master of Science in Biomedical Engineering from the University of Rochester.
Karan Shah, MSc., Analytical Associate III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.
Karan received a Master of Science Degree in Pharmaceutical Sciences from Northeastern University. He is an experienced analytical chemist with several years experience in the Biopharmaceutical industry. His R&D experience includes formulation development as well as analysis and characterization of antibody drug conjugates (ADCs). He has expertise in method development for characterization of antibodies and ADCs using imaged capillary isoelectric focusing (icIEF) and in the application of these techniques to support ADC development.
Mark Tardie, MSc., Sr. Regulatory Manager, Global Biotherapeutics CMC, Pfizer, Inc.
Mark Tardie joined Pfizer in 2001, as a biophysical chemist. He is now a Senior Regulatory Manager within Global Biotherapeutics CMC, managing a variety of development programs. His primary focus is on bioconjugates and clotting factors. Prior to this, Mark was a formulation scientist at Regeneron Pharmaceuticals. Mark received an MS in Biochemistry at the University of Connecticut in 2000.
Vincent Turula, Ph.D., MBA, Director, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Vincent Turula is currently in the External Affairs and Outsourcing function in the Pfizer Biotherapeutics pharmaceutical sciences organization. Responsibilities include the establishment and management of strategic vendor relationships for the production of clinical trial drug substance and drug product for antibody drug conjugates (ADCs), monoclonal antibodies, adjuvants, vaccines and general Biotherapeutics. In this role he oversees CMO technical evaluations and audits, management of contracts, technology transfer and business relationships. His primary responsibility is the support of Pfizer’s ADC portfolio. Prior to this role and while in the Wyeth Vaccine Development organization he led a group of scientists to generate in process, release and stability assays as well as executed product characterization in support of regulatory filings (IND/BLA). Vaccines included the Prevenar franchise, meningococcal serogroup B and Staphylococcal aureus vaccines. He has also worked at Baxter International, North American Vaccine and Bristol Myers Squibb in similar capacities. Vincent has a Ph.D. in chemistry from the University of Georgia, MBA Biosciences Management from North Carolina State University and Bachelors of Science from the College of New Jersey.
Aditya Wakankar, Ph.D., Associate Director, Formulation & Analytical Development, Stem CentRx LLC.
Dr. Aditya Wakankar is the Associate Director of Formulation and Analytical Development at Stem CentRx Inc. Prior to joining Stem CentRx, Aditya was a Scientist and Technical Development Team Leader at Genentech for 6+ years and was responsible for developing the commercial formulation for Kadcyla® (T-DM1). Also serving as an Assay Sub-Team leader for the T-DM1 program, his team was responsible for developing the analytical control system for the BLA filing. Aditya has obtained his M.S. and Ph.D. from The University of Kansas in the department of Pharmaceutical Chemistry.
Janet L. Wolfe, Ph.D., President, Wolfe Laboratories, Inc.
Janet Wolfe is president and founder of Wolfe Laboratories, Inc., a biopharmaceutical development services company located in Watertown, Massachusetts. Dr. Wolfe’s scientific and business career has focused on the intersection of the critical path activities in CMC, DMPK, preclinical and clinical development. Hundreds of biopharmaceutical companies seek the expertise of Wolfe Laboratories’ scientific team to facilitate the translation of their compounds from late-stage discovery into clinical studies. The company designs and executes development programs for small molecules, biologics and antibody drug conjugates across therapeutic areas such as CNS, cardiovascular, metabolic diseases, immunology and oncology. Wolfe Laboratories has contributed to the advancement of molecules through all stages of development and commercialization. Prior to starting Wolfe Laboratories in 1999, Dr. Wolfe was on the faculty of the Department of Pharmaceutical Sciences at the University of Tennessee, Memphis, which followed her postdoctoral fellowship in the Warren G. Magnuson Clinical Center Pharmacy at the National Institutes of Health. Dr. Wolfe is the author of numerous articles and presentations, and she has mentored undergraduate and graduate students and postdoctoral fellows over the course of her career. Dr. Wolfe received her Bachelor of Science from the University of Sciences in Philadelphia and doctorate in pharmaceutical chemistry from the University of Kansas.
Michael S. Wolfe, Ph.D., Professor, Neurology, Center for Neurologic Diseases, Harvard Medical School/Brigham and Women’s Hospital
Michael S. Wolfe is Professor of Neurology at Harvard Medical School and Brigham and Women’s Hospital and Scientific Advisor to Wolfe Laboratories, Inc. With a Ph.D. in medicinal chemistry from the University of Kansas, Prof. Wolfe has published extensively on the design of nucleoside analog and peptidomimetic enzyme inhibitors. He is also an internationally recognized leader in the study of the molecular basis of Alzheimer’s disease and targets for its prevention and treatment. His recent work brings together his expertise in small molecule drugs and protein biochemistry for ADC discovery and development.
Cristina Voss, Ph.D., ADC Project Manager, Heidelberg Pharma GmbH
Cristina Voss has 20+ years of experience in R&D in the fields of molecular biology and oncology. She joined Heidelberg-Pharma 2006 as a lab head in preclinical ADC development, focusing on assay development and biological background research, and recently moved to ADC project management. Cristina received her PhD from the Ruprecht-Karls-University in Heidelberg in collaboration with the German Cancer Research Centre for identifying a new protein toxin with potent antineoplastic activity.
Qun Zhou, Ph.D., Principal Scientist, Protein Engineering, Genzyme Corp., a Sanofi Company
Received in Ph.D in biochemistry (University of Georgia) and did post-doctoral research (University of Oklahoma Health Science Center) with Dr. Richard Cummings, and did another post-doctoral research with Dr. Patricia Steeg at National Cancer Institute. Worked at Genzyme on glycoprotein characterization and engineering.
Process Development for Novel Biotherapeutic Formats
August 20-21, 2014
Lex Bakker, Ph.D., Chief Development Officer, Merus, The Netherlands
Lex Bakker joined Merus in 2010 as Chief Development Officer. Merus is a Dutch biotechnology company focusing on the discovery and development of common light chain bispecific antibodies in oncology. Prior to joining Merus, he was Program Director at Crucell where he directed the preclinical and clinical development of CL184, a human antibody combination for rabies post-exposure prophylaxis. From 1996 to 2000, he performed fundamental immunology research at the DNAX Research Institute of Molecular and Cellular Biology, a Merck subsidiary in Palo Alto, California, USA. Lex Bakker holds a Ph.D. in tumor immunology from the University of Nijmegen, the Netherlands.
Amardeep Bhalla, Ph.D., Principal Scientist, Vaccine Research, Early Development, Pfizer
Amardeep Bhalla is a Principal Scientist in early vaccine R&D for Pfizer. Prior to this, he joined Merck and Co., Inc. in 2007 as a Senior Scientist in the Sterile Product Development group. As a Formulation/Product Development scientist, Amardeep has experience in QbD driven formulation and process development of various parenteral candidates, including small molecules and monoclonal antibodies (novels and biosimilars), in early as well as late development stages. Besides his current role, Amardeep has had a short stint in the Cell Culture and Purification disciplines, understanding aspects of upstream and downstream development. Amardeep graduated from the University of Minnesota, Twin Cities, with a PhD in Pharmaceutics in 2007. His Bachelors (B. Tech) was from the University of Mumbai, with a major in Pharmaceuticals and Fine Chemicals.
Brian Doyle, Senior Research Associate, Gilead
Brian is a member of Gilead’s Cell Culture Process Development group in Oceanside, CA, where his work has focused on upstream process development and clinical manufacturing of therapeutic proteins in CHO. Prior to joining Gilead in 2012, he worked in the Vaccine Process Development department at Merck Research Laboratories in West Point, PA, emphasizing on upstream process development for early stage vaccines and novel expression system research for fermentation and cell culture applications. Brian holds a B.S. in Chemical-Biological Engineering from the Massachusetts Institute of Technology.
Rory Finn, Principal Scientist, Conjugate and Polytide Process Development, Biotherapeutics Pharmaceutical Sciences, Pfizer
Rory Finn has been employed by Pfizer and Pfizer legacy companies (Monsanto/Searle/Pharmacia) since 1984 working primarily in the discovery and development of peptide and protein therapeutics. For the past 15 years, his work has focused on novel approaches to biotherapeutic protein/peptide PK/PD enhancement through PEGylation or conjugation to other scaffold molecules. Currently, he is working on early to late stage process development for the clinical manufacture of therapeutic peptide- and protein-based bioconjugates.
Alan Gilbert, PhD, Senior Engineer, Biogen Idec
Alan received his bachelor’s degree in chemical engineering from the University of California – Berkeley, and his doctoral degree from the University of Minnesota also in chemical engineering. He began his industrial career in upstream process development at Mascoma Corporation in Lebanon, NH. In 2010, Alan moved to Biogen Idec and joined the Cell Culture Development group in Cambridge, MA. His work at Biogen Idec has been focused on optimizing upstream process development with a focus on robust processes and the connection of the process to product quality.
Pratik Jaluria, Ph.D., Associate Director, Alexion Pharmaceuticals
Pratik Jaluria is the Associate Director of the Upstream Development group at Alexion Pharmaceuticals. In this role, he leads a department of 15 scientists developing the cell culture manufacturing process for Alexion’s therapeutic biologics. Prior to this position, he worked for several organizations focused on vaccine development for infectious diseases. Dr. Jaluria received a Ph.D. in Biomolecular Engineering from Johns Hopkins University and B.S. in Biochemical Engineering from Rutgers University. In addition, Dr. Jaluria was awarded an Intramural Training Fellowship allowing him to conduct research at the National Institutes of Health, where he studied modulating cellular properties including growth, adhesion, and adaptation with the use of bioinformatics tools. Dr. Jaluria is the author of numerous peer-reviewed journal articles and other publications. In addition, he is a co-inventor on two distinct patents relating to targeted gene expression and cell culturing.
Michael Kuczewski, Ph.D., Scientist, Purification Process Development, Bluebird Bio
Michael Kuczewski is a Scientist I in the vector process development group at bluebird bio. Prior to joining bluebird he was the group leader of the Downstream Process Development team at PERCIVIA, LLC, and an engineer in Applications R&D at Millipore Corp. He holds a BS in chemical engineering from WPI.
Steven Lang, Ph.D., MBA, Scientific Director, Biologics Research J&J Biotechnology Center of Excellence
Dr. Steven Lang leads the Biologics Research Analytical Discovery and Cell Line Development groups at Janssen R&D. His groups are responsible for analytical characterization during lead optimization of biological candidates and developing high expressing cell lines for clinical and commercial protein production. His responsibilities span preclinical enabling, regulatory filings and late-stage support. Dr. Lang received his Ph.D. in Molecular Microbiology from State University of New York Stony Brook. He then undertook post-doctoral work at Stony Brook and Johnson & Johnson Pharmaceutical R&D. He received his MBA from Rider University.
Hong Li, Ph.D., Principal Scientist, Purification Process Development, Merck
Dr. Hong Li is a principal scientist and group leader in the process development and engineering department of Biologics BioProcess organization, Merck Research Laboratory in New Jersey. She came to the USA in 1997 and obtained her PhD of Biochemistry at Virginia Tech in 2002. She continued her postdoctoral training working on expressing, purifying and characterizing different recombinant proteins till 2006, when she joined Laureate Pharma (now Gallus) and then moved to Merck. She has been in Merck for six and half years. She and her group focus on purification process development for therapeutic proteins including monoclonal antibodies for early and late stage, and technology transfer of the manufacturing processes.
Amith Naik, Ph.D., RAC, Senior Scientist, Biomanufacturing Training and Education Center, North Carolina State University
Dr. Amith D. Naik is a Senior Scientist at Biomanufacturing Training and Education Center at North Carolina State University. He has expertise in development of chromatographic processes for purification of biopharmaceuticals, in particular antibody, antibody fragments and vaccines. His research includes developing affinity ligands for proteins and viruses which involves identification of ligands based on rational and combinatorial screening strategies, coupling of ligands to different supports, characterization and optimization of affinity supports and finally their application in purification and diagnostics. Dr. Naik earned his PhD in Chemical Engineering (2007) and Masters in Bioprocess Technology with specialization in downstream processing (2003) from Institute of Chemical Technology, Mumbai, India. He joined the Chemical and Biomolecular Engineering Department at North Carolina State University as a postdoctoral fellow in 2008. He has received the US-Regulatory Affairs Certification (RAC, US) from Regulatory Affairs Professional Society.
Eugene Nebelitsky, Senior Scientist, Integrated Biologics Profiling (IBP), Novartis
Eugene Nebelitsky is a Senior Scientist at Novartis Pharma where he works in a Biologics Profiling unit responsible for developability assessment of protein-based therapeutics as they progress from research into development. Eugene completed his undergraduate studies in biology from University of Massachusetts and obtained a master’s degree in chemistry/biotechnology from Tufts University, where he is currently pursuing a master of engineering degree in biomedical engineering. At Novartis, he works in a protein chemistry group responsible for purification of mAbs, Fabs, and therapeutic proteins.
Timothy Pabst, Ph.D., Scientist II, Purification Process Sciences, MedImmune
Dr. Pabst is a process development scientist in the Purification Process Sciences department at MedImmune. Dr. Pabst has extensive downstream process development experience and supports pre-clinical through late stage drug development projects. Prior to joining MedImmune in 2010, Dr. Pabst worked as process development scientist for Pfizer Global Biologics. Dr. Pabst received his Ph.D. in Chemical Engineering from the University of Virginia.
Hugh H. Russell, Ph.D., Director, Antibody Technologies, Excelimmune
I joined Excelimmune, Inc. in 2007 as a founding member of the company's original research team. I have overseen the development of the antibody discovery and screening platforms, and initiated functional in vitro studies for characterization of anti-S. aureus antibodies. My current focus is on the pre-clinical development of antibody technologies and on intellectual property for Excelimmune. I received my Ph.D. in Infectious diseases from the Imperial College London using molecular and biochemical methods to study Gram positive bacterial pathogens.
Benjamin Wang, Ph.D., Senior Bioprocess Engineer, Merrimack Pharmaceuticals
Benjamin Wang is a Senior Bioprocess Engineer at Merrimack Pharmaceuticals in Cambridge, MA. He received his Ph.D. in Chemical Engineering at the Massachusetts Institute of Technology in 2009. He joined Merrimack’s upstream process development group in 2013 where he works on both the cell line and process development of novel molecules and leads the cell culture efforts on one of these products. Before joining Merrimack, Dr. Wang worked at MedImmune in Gaithersburg, MD from 2009-2013 performing cell line and early stage process development in the Process Cell Culture department. In this role, he gained expertise in the areas of automated high throughput fed batch screening and cell line stability.
Cell Therapy Bioproduction
August 21-22, 2014
Mark Angelino, Ph.D., Vice President, Pharmaceutical Sciences, Bluebird Bio
Dr. Angelino joined bluebird bio in May of 2012 from Baxter Healthcare for which he led their Cambridge, MA R&D site focused on novel haemophilia programs, including evaluation of gene therapy assets. He currently leads the Pharmaceutical Sciences function at bluebird bio. His experience spans the regulated environment from development through commercialization including lead roles on validation of Integrilin™, validation and commercial supply chain for generic enoxaparin (Lovenox™), and the ANDA submission for generic Copaxone™. He has worked on small-molecule, peptide, biologic, bioconjugate, oligonucleotide, and complex mixture development programs through various companies including Archemix Corporation, Bristol-Myers Squibb, Millennium Pharmaceuticals, and Momenta Pharmaceuticals. Mark holds a Ph.D. in Chemical Engineering and an M.S. in Chemical Engineering Practice from MIT, as well as a B.S. in Chemical Engineering from The Cooper Union.
Ravinder Bhatia, Associate Director, Pharmaceutical Development and Manufacturing Sciences, Johnson & Johnson
Ravi is an Associate Director of Cell Technology department at Janssen R&D, where he is leading a process development team to develop and scale-up cell therapy, and viral vaccines based products. Previously at Janssen R&D, Ravi led a team to develop and implement industry’s first large-scale single-use bioreactor (1000L) and a single-use fluidized bed centrifuge technology for biopharmaceutical manufacturing. Before joining Janssen R&D, Ravi worked at Human Genome Sciences, where he led a team to develop an upstream commercial process for Benlysta® (an antibody approved by FDA for treatment of SLE). Over the years, Ravi has also developed expertise in cell culture process development and scale-up (up to 10,000L bioreactor), and development and implementation of single-use technologies for clinical material production. Ravi received his BSc and MSc. in Chemical Engineering from University of Pittsburgh. Ravi has delivered many invited presentations on development and implementation of single-use technologies for biopharmaceutical manufacturing and he has authored publications on cell physiology and single-use technologies.
R. Lee Buckler, BEd, LLB, Managing Director, Cell Therapy Group
Lee is the founder and managing director of Cell Therapy Group – a business development consultancy focused on the cell therapy and regenerative medicine industry. He is also a member of the Board of Directors for the Canadian-Israeli cell therapy company Hemostemix. Since early 2000, Lee has been an executive in cell therapy regenerative medicine industry. He is a frequent speaker, author, analyst, and commentator on the cell therapy sector at industry conferences, in trade publications, and on social media. Lee was Executive Director of the International Society for Cellular Therapy (2000-2006), founded Cell Therapy News, launched and continues to manage the LinkedIn Cell Therapy Industry Group, and created Cell Therapy Blog where he continues to blog. Lee serves on the Editorial Advisory Boards for both BioProcess International and Regenerative Medicine journals. Lee founded and served as Chair of ISCT's Cell Therapy Commercialization Committee from 2006 to 2009), serves now as the co-chair of the Alliance for Regenerative Medicine’s Communications and Education Committee and serves on several corporate advisory boards. Publications include numerous book chapters and articles in trade publications.
Gary C. du Moulin, Ph.D., M.P.H., former Senior Director, Quality Aseptic Control, Genzyme (A Sanofi Company)
Gary C. du Moulin, Ph.D., M.P.H. recently retired as Senior Director of Quality Aseptic Control for Genzyme (A Sanofi Company) where he participated in the development and execution of robust quality systems for Genzyme’s products including cell and tissue engineered therapeutics. Dr. du Moulin joined Genzyme in 1995 after working for six years developing quality systems for cellular therapies for the treatment of renal cell carcinoma. Prior to his industrial experience, he spent 15 years on the faculty of Harvard Medical School in the Department of Anaesthesia at Beth Israel Hospital. He has more than 150 publications in the areas of microbiology, epidemiology, and the regulation and quality control of living cells as a therapeutic modality. Dr. du Moulin received his B.S. in 1969 from Norwich University, an M.S. degree from Northeastern University, and M.P.H. and Ph. D. degrees from Boston University. Dr. du Moulin currently serves on U.S. Pharmacopoeia’s expert committee for Biological Analysis and formerly on the Gene Therapy, Cell Therapy, and Tissue Engineering Expert Committee and chaired the ad hoc advisory panel for fetal bovine serum. He serves on the editorial board of Regenerative Medicine and is RAC certified and past Chairman of the Editorial Board of the Regulatory Affairs Professionals Society Magazine, RAPS Focus and was appointed to the Grants Review Working Group of the California Institute for Regenerative Medicine. He is retired from the U.S. Army Reserve at the rank of Colonel after 38 years of service.
Robert J. Deans, Ph.D., Exec VP of Regenerative Medicine, Athersys Inc
Dr. Deans is responsible for regenerative medicine technology development at Athersys Inc. and its European subsidiary, ReGenesys. Athersys is developing cell therapeutics based on adherent stem cells (MultiStem) isolated from adult bone marrow. Athersys has active Phase I and II clinical development activity in acute myocardial infarct, stroke, ulcerative colitis, and for adjunctive therapy of allogeneic bone marrow transplant. Dr. Deans is also chairman of the ISCT Commercialization Committee, co-Chair of the Science and Technology Committee of ARM, and serves on the ISSCR Clinical Translation Committee. Dr. Deans has more than 20 years of experience in stem cell therapeutics, having previously served at Osiris Therapeutics as VP of Research. Dr. Deans was previously Director of R&D at Baxter Healthcare, where he developed biological components of the Isolex300i hematopoietic stem cell purification platform. In addition, Dr. Deans served on the faculty at USC Medical School from 1984 to 1992. He holds degrees from MIT and the University of Michigan, and postdoctoral training in molecular immunology at UCLA.
Stephen J. Duguay, Ph.D., Associate Director, Process Development, Aastrom Biosciences.
Stephen J. Duguay has 15 years experience in the biotechnology industry, with a focus on cell therapy using fibroblasts, keratinocytes and chondrocytes. His group currently supports commercial production of three cell therapy products globally: Carticel, Epicel and MACI. In recent years he has led development of an improved MACI manufacturing process, and development of novel identity, potency and viability assays for the cartilage repair cell therapies. His responsibilities have also included designing and executing technology transfers and comparability studies between manufacturing sites, and authoring CMC sections of MAA and BLA submissions. Steve earned his Ph.D. at the University of Washington and did post-doctoral research with the Howard Hughes Medical Institute at the University of Chicago.
Don Healey, Ph.D., CSO, Opexa Therapeutics
Dr. Healey has over 25 years experience in cellular immunology and immune regulation in both academic and biotech environments. Prior to joining Opexa in April 2010, Dr. Healey was Director of Immunology for Argos Therapeutics, and was responsible for the development of novel autologous dendritic cell therapies for the treatment of renal carcinoma and HIV; both products are currently in Phase II/III clinical trials. He is a former lecturer in immunology at the University of Leicester, UK, and held post-doctoral positions in the Department of Pathology, Cambridge University, UK, conducting studies on immunoregulation in animal models of autoimmunity, including Type I Diabetes and Multiple Sclerosis. Dr. Healey obtained his PhD at the Hunterian Institute in London, UK, and BSc in the Department of Pathology, Bristol University, UK.
Ohad Karnieli, Ph.D., MBA, Vice President, Development and Manufacturing, Pluristem Therapeutics, Israel
Dr. Ohad Karnieli earned his PhD in Biotechnology and genetic engineering from the Sackler School of medicine at Tel Aviv University. Furthermore, Dr. Karnieli earned an MBA from the graduate school of Management at the Haifa University. In his PhD, Dr. Karnieli developed insulin secreting cells from human mesenchymal stem cells using genetic modulations. Prior to joining Pluristem, Dr. Karnieli served as the general manager of High Tech Lipids, an innovative IV nutrition company; the vice president of research and development in an innovative nano-biotechnology startup; and as the vice president, head of the Biomedical division at Goji solutions, where medical devices are developed using radio frequency technology. Dr. Karnieli is the founder of Karnieli Ltd., a leading molecular diagnostic and development lab.
Jeffrey M. Karp, Ph.D., Associate Professor of Medicine, Brigham and Women’s Hospital, Harvard Medical School
Jeff Karp’s research uses nano/microscale materials and bioinspired biology to solve medical problems. Tissue adhesives that he developed were selected as one of Popular Mechanic's "Top 20 New Biotech Breakthroughs that Will Change Medicine” and he has invented several technologies that have been internationally recognized including a new neonatal adhesive that can be quickly removed without damage, inflammation responsive materials for treatment of proteolytic disease, nanosensors that can be used to visualize cell-cell communication in real-time, and a nanoparticle prophylactic approach to prevent contact dermatitis. He is also a leading authority on mesenchymal stem cell therapy and bioengineered strategies to control cell fate and function following transplantation.
Hari Kamaraju, Ph.D., Senior Associate Scientist, Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development
- Over 5 years of experience in Cell Therapy processes.
- Worked on multiple cell therapy projects in different phases
- Worked in various roles: process development, scale-up, technology transfer.
- Prior to joining biopharmaceutical industry, have about 4 years of experience in petrochemical industry
Bernadette Keane, BSc., Vice President, Quality, Bluebird Bio
Bernadette Keane has over 25 years’ experience in the biopharmaceutical industry. She currently leads Quality Assurance and Quality Control activities for all bluebird bio programs. Prior to joining bluebird, she held the position of Senior Director Quality Control at Tolerx, where she led Tolerx’ Quality Control program for Otelixizumab from early stage clinical research into preparation for BLA filing. Before that, Bernadette worked as a consultant in the New England area for over 12 years, providing Quality Assurance/Control, Analytical and CMC Regulatory support within the biopharmaceutical industry, working on biologics, small molecule and oligonucleotide programs. She has held positions in Quality Control, Process development and Analytical development at T Cell Sciences, ImmunoGen and Genzyme. Bernadette obtained her BSc. in Chemistry and Mathematics at the National University of Ireland, Galway.
Pranay Khare, Ph.D., Director, Research, Cancer Immunotherapy and Gene Therapy cGMP Facility, Roger Williams Medical Center
Pranay Khare, PhD has fifteen years of experience in biologic discovery and their development to early stage clinical trials in immunotherapy and gene therapy field. Presently, Dr. Khare is the Director at cancer immunotherapy and gene therapy cGMP facility of Roger Williams Medical Center, Providence, RI and involved in genetic modification of T-cells with chimeric antigen receptor (CAR) and bispecific antibody conjugated armed T-cells based clinical trials. Dr. Khare's primary role is to direct the clinical scientific collaborative studies, responsible for overall modified T cell manufacturing, quality assurance and quality control processes. Dr. Khare’s educational background is viral immunology and always fascinated with T cell and their role in disease development and protection. After finishing his Ph.D. in T cell biology in dengue virus disease, Dr. Khare strengthen his understanding of T cell and its modification process in molecular oncology center at Fukuoka University, Japan and molecular medicine program at Mayo Clinic, Rochester, MN. Before moving to his current position he was Scientific Director at Neuroscience, Inc where he developed several T cell based clinical diagnostic tests for chronic diseases. Dr. Khare also has several patents on eukaryotic display technology that could be used to identify the novel receptors, ligands, biomarkers and antibodies. Through our his career Dr. Khare has received funding from the National Institute of Health (NIH), Susan G. Komen Breast Cancer Foundation, Leukemia Research Foundation, and other funding agencies.
Brian Majors, Ph.D., Process Engineer/Manager, Engineering and Manufacturing Sciences, Novartis Pharmaceutical Corp. (Roundtable Moderator)
Brian Majors is currently a Process Engineer in the Engineering and Manufacturing Sciences groups at Novartis. He is responsible for process development and commercial automation implementation for Novartis' growing cell therapy portfolio. Prior to joining Novartis, Brian worked at Biogen Idec as a lead in the cell engineering group focusing on process development and automation. Brian received his B.S. in Chemical Engineering from Cornell University and his Ph.D. in Biochemical Engineering from Johns Hopkins University.
Mark McCall, Ph.D., Enterprise Fellow, Loughborough University, United Kingdom
Mark McCall received his Ph.D. at Loughborough University and became an Enterprise Fellow in October 2013. Mark has a degree in physics with medical physics, and is completing his PhD in cell therapy manufacturing, studied through the EPSRC DTC. His research addresses the prediction and reduction of cell therapy cost of goods and regenerative medicine manufacturing technology. Mark has secured a Loughborough University Enterprise Fellowship to further develop a novel manufacturing system designed during his PhD.
Julie R. Murrell, Ph.D., Program Manager, Collaborations; R&D Manager, EMD Millipore Corporation
Dr. Julie Murrell is the Program Manager for Collaborations and R&D Manager of the Stem Cell Biology Lab at EMD Millipore Corporation, a leader in bioprocess and bioscience products. Dr. Murrell has led an EMD Millipore early technology assessment group for the past 7 years. Initially involved in integrating microbe detection and identifying new detection technologies for critical quality attributes in biopharmaceutical manufacturing, Dr. Murrell has been part of the Stem Cell group for 3 years. Through that time, she has led the efforts to establish closed, scalable systems for large scale stem cell manufacturing, with a special focus on hMSCs. Dr. Murrell’s background is in Cell and Molecular Biology. Her multi-disciplinary background has led to innovative team-driven approaches in the field of stem cell production.
Sagi Nahum, Ph.D., Manager, Analytical QC Department, Pluristem Therapeutics, Israel
Dr. Nahum earned his Ph.D. in Medical Science from the Faculty of Medicine, Technion Institute, Israel where he specialized in the areas of gene expression of coronary heart disease and acute coronary syndrome, biostatistics and bioinformatics. After joining Pluristem in 2012, Dr. Nahum incorporated his knowledge at Pluristem as a member and then the leader of the Method Development team that developed and transferred new bioassays for product release and research use as well as build a data base for future potency measurements to determine the biological activity and Mechanism of Action (MOA) assumptions. Prior to joining Pluristem Dr. Nahum was a researcher at the laboratory of molecular dermatology, Rambam Medical Center where he was involved in the discovery and publishing of numerous articles on genetic rare mutations that cause bone, skin and hair diseases. Dr. Nahum also served as a paramedic supervisor for 14 years and was responsible for establishing and implementing field quality control know-how and ISO standards at Israel's national emergency medical services (aka MDA).
Jon A. Rowley, Ph.D., Chief Executive and Technical Officer, RoosterBio
Jon has recently started RoosterBio as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues, and tomorrow’s medical devices. Jon holds a PhD from the University of Michigan in Biomedical Engineering and has authored over 30 peer reviewed manuscripts and 15 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. Jon started his industry career at BD as a scientist and R&D manager in a Cell & Tissue Technologies group focused on applying high throughput screening technologies to cell therapy media development and tissue engineering. Jon then contributed to the clinical development of Aastrom Biosciences’ Tissue Repair Cell product, where he was Sr Manager of Process Development responsible for manufacturing process improvements and cell delivery to the patient. Jon most recently spent 5 years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business, and currently resides in Walkersville, MD with his wonderful wife and their 3 young children.