Appendix B
Biographies of Planning Committee Members, Speakers, and National Academies of Sciences, Engineering, and Medicine Staff
PLANNING COMMITTEE MEMBERS
Gintaras V. Reklaitis (NAE, Chair) is the Gedge Distinguished Professor of Chemical Engineering and courtesy professor of Industrial and Physical Pharmacy at Purdue University. His recent research interests include continuous manufacturing of pharmaceutical substances and products, including process monitoring, control, and modeling. Areas of long-term research are systems engineering applications to support batch and continuous operation and methodologies for plant- and enterprise-wide planning and optimization. His awards include the Warren K. Lewis Award of the American Institute of Chemical Engineers (AIChE) and the Pruitt Award of the Council of Chemical Research He has served on the AICHE Board of Directors and as Editor-in-Chief of Computers & Chemical Engineering. He is a member of the National Academy of Engineering and received his PhD from Stanford University.
Liuquan Chang is a group leader in the Global Regulatory Chemistry Manufacturing Controls (CMC) biologics at Merck, where she is responsible for providing regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions for biologics. She has more than 15 years of industry experience in CMC development, manufacturing, and regulatory submission of biological products in multiple global pharmaceutical companies. She had previously worked as the global regulatory lead for multiple investigational and marketed products at Sanofi regulatory CMC biologics. She received her PhD in Pharmaceutical Sciences from the University of Connecticut.
Charles Cooney is a Professor Emeritus at the Massachusetts Institute of Technology (MIT). His research and teaching span many aspects of biochemical engineering and pharmaceutical manufacturing. He holds more than 30 patents, has published more than 250 research papers, and has co-authored or edited 5 books. His honors include the 1989 Gold Medal of the Institute of Biotechno-
logical Studies (London); the Food, Pharmaceutical, and Bioengineering Award from the American Institute of Chemical Engineers; the James Van Lanen Distinguished Service Award from the American Chemical Society’s Division of Microbial and Biochemical Technology; and election to the American Institute of Medical and Biochemical Engineers and the Fellows of the American Chemical Society. He received his PhD in Biochemical Engineering from MIT.
Eva Gefroh is a Principal Scientist at Just Biotherapeutics, an integrated design company with a mission to improve global access to biotherapeutics by driving low-cost process development and manufacturing. She has almost 20 years of bioprocess development experience, including 15 years at Amgen in the Purification Process Development group. She was a group leader at Amgen, managing a filtration process development team for early and late stage molecules, and a commercial process development team leader. She was also a key member of the team that developed and implemented innovative technologies for a Manufacturing of the Future initiative with a focus on connected downstream processing, which included developing process control strategies for connected unit operations and devising viral clearance strategies to support validation of connected processes. In her current position, she continues to drive low-cost process development and manufacturing platforms through the assessment of new technologies, plant and equipment design, and process and economic modeling. She received her BS in Chemical Engineering from the University of Minnesota.
Ken Lee is an early and late-stage bioreactor scientist and Chemistry Manufacturing Controls functional lead at MedImmune. He joined MedImmune UK in 2011, where he introduced the site to the ambr15 technology and later perfusion technology in 2014. In 2015, Dr. Lee relocated to MedImmune US where he continued to work on continuous cell culture and integrated processing. He received his PhD in Biochemical Engineering from the University of Birmingham.
Keith Roper is the Charles W. Oxford Professor of Emerging Technologies in the Ralph E. Martin Department of Chemical Engineering at the University of Arkansas. His research examines advanced functionalities offered by active electrodynamics to next-generation nano-, bio-, and meta-materials, as well as frameworks for innovation such as nanoplasmonics and nanolithography, graphene, and van der Waals 2D materials, and functional membranes for biofuels and fuel cells. He is a fellow of the American Institute for Medical and Biological Engineering and a member of the Arkansas Academy of Science. He is an Associate Editor for Institute of Electrical and Electronics Engineers Transactions in Nanotechnology. He received his PhD in Chemical Engineering from the University of Wisconsin.
SPEAKERS
Lindsay Arnold is a downstream process scientist in the BioProcess Engineering Department at MedImmune. The primary focus of her group is technology scale up, new technology evaluation, and continuous processing development. Dr. Arnold received her doctorate from the Chemical and Biomolecular Engineering Department at the Georgia Institute of Technology.
Shawn Barrett is the Associate Scientific Director of United States Pharmacopeia in the Continuous Manufacturing Skill Center at Sanofi in Framingham, MA. He has more than 20 years of experience at various organizations in the biopharmaceutical and biotech industry, including Life Technologies BioProduction, Centocor Johnson and Johnson Research and Development, Eli Lilly, and the National Research Council Canada Biotechnology Research Institute. His bioprocess expertise includes fed batch and perfusion cell culture process development and scale up, cell culture medium development, bioreactor and facility design, and process control. He currently leads a team of scientists and engineers tasked with the optimization and intensification of a perfusion platform process for the enablement of integrated continuous manufacturing of protein therapeutics. He received his Bachelors of Applied Science in Chemical Engineering from the University of Waterloo in 1994.
Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at the Massachusetts Institute of Technology (MIT) where he does research in the design and control of continuous (bio) pharmaceutical manufacturing systems. He leads the Quality-by-Design and control systems activities in many (bio) pharmaceutical manufacturing efforts at MIT. He has consulted or collaborated with more than 20 companies, including Novartis, Pfizer Inc., Merck, Biogen, and Amgen.
Rick A. Bright is the Deputy Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority (BARDA), which is a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. He oversees the advanced development and procurement of medical countermeasures against an array of threats to national security and the public’s health, including chemical, biological, and radiological threats, nuclear threats and pandemic influenza, and emerging infectious diseases. He began his career in vaccine and therapeutics development at the Centers for Disease Control and Prevention, with a focus on influenza viruses, antiviral drugs, and the development of novel assays for high throughput surveillance for resistance to antiviral drugs. For this work, he was a recipient of the Charles C. Shepard Science Award for Scientific Excellence. He has extensive experience in the biotechnology industry, where he served in senior leadership and executive
management roles. He has also held senior scientific leadership positions in nongovernmental organizations where he championed innovative vaccine development and international vaccine manufacturing capacity expansion in developing countries. He serves as an international subject matter expert in vaccine, drug, and diagnostics development and has served as an advisor to the World Health Organization and the U.S. Department of Defense. He joined BARDA in 2010, and prior to becoming Director in late 2016, he served as Director of BARDA’s Influenza and Emerging Infectious Diseases Division. He received his PhD in Immunology and Virology from Emory University and his BS in Biology and Physical Sciences from Auburn University.
Mark Brower is a Principal Scientist at Merck. His specialties include protein purification, process development, downstream processing, protein chromatography, expanded bed adsorption, simulated moving bed chromatography, and protein chromatographic modeling. He received his PhD in Chemical Engineering and Biotechnology from the University of Cambridge.
Lisa Connell-Crowley is Director of Downstream Process Design at Just Biotherapeutics, leading innovative groups of scientists and engineers to drive down the cost of biotherapeutics through streamlined, cost-effective process and plant design. She has 15 years of downstream process development experience, including 12 years at Amgen as a downstream group leader and Chemistry Manufacturing Controls process team leader for early and late stage antibodies and Fc fusion molecules. She is also a recognized expert in developing viral clearance strategies for monoclonal antibody processes, including understanding key parameters for retroviral clearance by low pH inactivation and various chromatography operations and designing strategies to assess viral clearance of continuous manufacturing processes. She received her PhD in Biochemistry from the Baylor College of Medicine.
Mauricio Futran (NAE) is the Vice President of Advanced Technology in the Global Tech Services group of Janssen Supply Chain at Johnson & Johnson, focusing on manufacturing process understanding and reliability. This is done by incorporating predictive modeling, in line measurements, data analytics, and other technologies into the full range of activities from research and development (R&D) through scale up, tech transfer, and life cycle management. The ultimate goal is model predictive control and Real-Time Release. Before joining Johnson & Johnson, he was Professor and Chair of Chemical and Biochemical Engineering at Rutgers University after working for 28 years in various positions in pharmaceutical product and process development at Merck and Co. and Bristol-Myers Squibb, where he was Vice President of Process R&D. His areas of expertise include all aspects of process development, technology transfer, validation, regulatory compliance, new product registration, external manufacturing, and partnership development. He is a member of the National Academy of Engineering, where he has been chair of its Chemical Engineering section,
and has served on its peer committee, the Board of Chemical Sciences and Technology, and a National Research Council panel. As an American Institute of Chemical Engineers member, he has served on the awards committee. He has been a member and chair of the Princeton Chemical and Biological Engineering external board, and has been a member of the external boards for the University of Illinois at Urbana-Champaign, the Georgia Institute of Technology, and Rutgers University. He has Chemical Engineering degrees from Rice University and Princeton University.
Art Hewig is a Director of Process Development at Amgen, where he leads an integrated group that is designed to deliver end-to-end drug substance processes that robustly transfer to Amgen’s commercial network. Prior to the role, he was heading Purification Process Development at Amgen. He has been with Amgen since 2002, where his initial focus was on developing purification processes for early and late stage molecules. During this time, he developed and implemented real-time process analytic technologies utilizing light scattering and connected downstream processing. He holds a PhD in Chemical Engineering from Carnegie Mellon University.
Franqui Jimenez is a Senior Director and head of Manufacturing and Technology at Sanofi. He is a senior executive with accomplished leadership, business, and people development skills in commercial biologics including process development and commercial technology transfer, startup, implementation, and production support. His work focuses on commercial biologics production, technical support, process development, mammalian-host biotechnology processes, monoclonal antibody production, and bacterial fermentation. He received his PhD in Chemical Engineering from the University of Wisconsin–Madison.
Michael R. Ladisch (NAE) is Director of the Laboratory of Renewable Resources Engineering, and Distinguished Professor of Agricultural and Biological Engineering with a joint appointment in the Weldon School of Biomedical Engineering. His BS (1973) from Drexel University and MS (1974) and PhD (1977) from Purdue University are in Chemical Engineering. His research applies principles of biological and chemical engineering to the study of proteins at interfaces for purposes of their fractionation, purification, and characterization using bioseparation techniques. This research addresses the manner in which proteins interact—with solid interfaces, with each other, or with molecules or microorganisms—principally in aqueous environments. The proteins studied include both enzymes and therapeutic molecules. A second and related thrust is development of bioprocesses by which renewable resources, broadly defined, may be transformed to low‐carbon footprint bioproducts. The foundational science and engineering has been translated into industrial practice, numerous publications, 2 textbooks, and 20 patents that have been licensed to various companies. He is a member of the National Academy of Engineering and a Fellow of the American Institute for Medical and Biological Engineering, American Chemical
Society, American Association for the Advancement of Science, American Institute of Chemical Engineers, and the National Academy of Inventors.
Kelvin Lee is the Director of the Manufacturing USA National Institute for Innovation in Manufacturing Biopharmaceuticals and he is the Gore Professor of Chemical and Biomolecular Engineering at the University of Delaware. He previously served as the Director of the Delaware Biotechnology Institute. He received a BSE in Chemical Engineering from Princeton University and a PhD in Chemical Engineering from the California Institute of Technology (Caltech). He spent several years in the Biotechnology Institute at the Eidgenössische Technische Hochschule in Zurich, Switzerland, and also completed a postdoc in Caltech’s Biology Division. Prior to his current appointment, he was on the faculty at Cornell University where he held the titles of Samuel C. and Nancy M. Fleming Chair Professor, Professor in the School of Chemical and Biomolecular Engineering, Director of the Cornell Institute for Biotechnology, and Director of the New York State Center for Life Science Enterprise.
Chris Love is a Professor of Chemical Engineering and a member of the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology (MIT). He is also an Associate Member of the Broad Institute, and an Associate Member at the Ragon Institute of Massachusetts General Hospital, MIT, and Harvard University. Dr. Love was a W.M. Keck Distinguished Young Scholar for Medical Research and a Dana Scholar for Human Immunology in 2009, a Life Sciences Research Foundation Postdoc Fellow (Gilead Sciences) in 2004, and a National Defense Science and Engineering Graduate Fellow from 1999 to 2002. He was also awarded the Foresight Distinguished Student Award in Nanotechnology in 2000, and is a Camille Dreyfus Teacher-Scholar. His team combines principles from chemical engineering, interfacial chemistry, and materials science to develop new micro- and nanotechnologies for addressing biological questions in immunology, microbiology, systems biology, and bioprocess engineering. One broad research objective is to improve the design and implementation of quantitative bioanalytical processes in order to maximize the knowledge gained about the heterogeneities and dynamics of individual cells within a complex population. The researchers employ these processes to characterize the pathogenesis and immunomodulation of complex immune responses in chronic human diseases, such as HIV/AIDS, multiple sclerosis, type 1 diabetes, food allergies, and cancer. A second objective is to develop new strategies for manufacturing biologic drugs to improve global access for patients. He received his PhD in Physical Chemistry from Harvard University.
Tarit Mukhopadhyay is a Senior Lecturer in the Department of Biochemical Engineering at University College London (UCL). He conducted his engineering doctorate in a joint venture between UCL and the Health Protection Agency, working on two vaccines of commercial interest, a novel Meningitis B vaccine based upon the outer membrane proteins of N. lactamica and the UK licensed
Anthrax vaccine. As part of his doctoral studies in a joint project with the Health Protection Agency and Professor Gary Lye he focused on the development of a microwell platform for rapid vaccine development. This platform was applied to the development of a new Meningitis B vaccine that is now in clinical trials. The platform’s usefulness and robustness was also tested with the UK Anthrax Vaccine. He is currently working on a Japanese Encephalitis virus vaccine, hepatitis B, and the use of lentiviruses for gene therapy, with an interest in upstream and downstream processing and process analytical technology. He received his EngD in Biochemical Engineering from UCL.
Moheb Nasr is the Principal of his own consulting company, Nasr Pharma Regulatory Consulting (NPRC), which was established in February 2018. NPRC provides strategic regulatory consulting with a focus on organizational aspects, manufacturing, pharmaceutical development innovation, and Chemistry Manufacturing Controls (CMC) regulatory transformation. He continues to play a leading role in global regulatory harmonization and introduction of modern pharmaceutical manufacturing platforms, including continuous manufacturing. He also represents Pharmaceutical Research and Manufacturers of America at The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), serving as an ICH Expert Working Group Topic Lead. He retired from GlaxoSmithKline (GSK) in August 2017. At GSK, he was responsible for the development and the execution of GSK CMC regulatory strategy and served as a member of GSK leadership and governance boards accountable for product development, manufacturing and supply, quality, and regulatory oversight. In recognition of his scientific contributions and visionary leadership, he is an elected GSK Senior Research Fellow. Prior to joining GSK, he spent more than 22 years at the U.S. Food and Drug Administration (FDA). At FDA, he served as a bench chemist, regulatory scientist, director of FDA’s analytical laboratories, and FDA/Center for Drug Evaluation and Research (CDER) CMC regulatory office head. He also established and led FDA’s Office of New Drug Quality Assessment. He received his Pharmacy degree at the University of Cairo, Egypt, and his PhD in Chemistry at the University of Minnesota.
Daisie Ogawa is the head of the Upstream continuous manufacturing team at Boehringer Ingelheim, working under Jon Coffman. The group focuses on perfusion cell culture process development and scale up, with recent efforts emphasizing process intensification. The process is developed in a proprietary manufacturing platform called the iSKIDTM system; this work is performed in collaboration with Pfizer.
Satoshi Ohtake is the Senior Director of Pharmaceutical Research and Development at Pfizer, where he oversees all biotherapeutic drug product development activities. Prior to joining Pfizer, he held positions of increasing responsibility at Nektar Therapeutics and Aridis Pharmaceuticals, specializing in the
development of novel processing technologies and formulation of various modalities ranging from small molecules to live attenuated vaccines. He also serves as an executive board member of a nonprofit organization, adjunct faculty member at the University of Kansas, and Editorial Advisory Board member of peer-reviewed journals. He received his BS from the California Institute of Technology and PhD from University of Wisconsin–Madison, both in Chemical Engineering.
Douglas Richardson is a Principal Scientist in Bioprocess Development at Merck Research Labs in Kenilworth, New Jersey. His current research focuses on the evaluation and implementation of new automation and analytical technologies for the characterization of protein therapeutics. Recently, this research has focused on expanding the large molecule Process Analytical Technology (PAT) toolkit to support current and future biotherapeutic manufacturing platforms. Dr. Richardson received his PhD in Analytical Chemistry from the University of Cincinnati in the lab of Dr. Joseph A. Caruso.
Veena Warikoo is a Senior Biotherapeutics Chemical Manufacturing Controls (CMC) Development leader at Roche. She has 20 years of experience in both strategic planning and execution for big pharma and startups in early and late phase process development, manufacturing, regulatory, and pharmacokinetics. Her areas of expertise include early and late phase bioprocess development, integrated continuous biomanufacturing, pharmacology/safety/toxicokinetics, and application of computational models, scale up and scale down of bioprocesses, fill-finish, cgmp, manufacturing technical support, and organizational development. She received her PhD in Microbiology and Biochemistry from the University of Oklahoma.
William Whitford is the Strategic Solutions Leader of GE Healthcare in Logan, Utah, with more than 20 years of experience in biotechnology product and process development. He joined the company as an R&D Leader developing products supporting protein biological and vaccine production in mammalian and invertebrate cell lines. Products he has commercialized include defined hybridoma and perfusion cell culture media, fed-batch supplements, and aqueous lipid dispersions. An invited lecturer at international conferences, he has published more than 300 articles, book chapters, and patents in the bioproduction arena. He now enjoys such activities as serving on the editorial advisory board for BioProcess International.
Janet Woodcock is the Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), making sure that safe and effective drugs are available to improve the health of people in the United States. Her center evaluates prescription and over-the-counter drugs before they can be sold and oversees their testing in clinical trials, provides health care professionals and patients with the information that they need to use medicines
wisely, ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks, and takes action against unapproved, contaminated, or fraudulent drugs that are marketed illegally. Since joining FDA in 1986, she has led many of FDA’s drug initiatives and introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the Pharmaceutical Quality for the 21st Century Initiative, FDA’s highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA’s “Critical Path” Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently. She received her medical degree from Northwestern University Medical School, and her undergraduate degree from Bucknell University. She has held teaching appointments at The Pennsylvania State University and the University of California, San Francisco.
Andrew Zydney is the Distinguished Professor of Chemical Engineering and the Director of the Center of Excellence in Industrial Biotechnology at The Pennsylvania State University. He served as Head of the Department of Chemical Engineering from 2004-2014. He received his BS in Chemical Engineering from Yale University in 1980 and his PhD from the Massachusetts Institute of Technology in 1985. He was also a faculty member in the Chemical Engineering Department at the University of Delaware from 1985-2001. His research is focused on membrane science and technology, with a particular emphasis on applications of membranes in bioprocessing. He is the most recent recipient of the Gerhold Award for Excellence in Separation Science from the American Institute of Chemical Engineers (AIChE) and is a past recipient of the Excellence in Biological Engineering Publications Award from AIChE. He is the Editor-in-Chief of the Journal of Membrane Science, and he serves on the Editorial Boards for Separation and Purification Reviews, Separation Science and Technology, Current Opinion in Chemical Engineering, and Biotechnology and Bioengineering.
NATIONAL ACADEMIES STAFF
Elizabeth Boyle has more than 15 years of experience in environmental health and epidemiology. She currently works as a Program Officer on the Board on Environmental Studies and Toxicology within the National Academies’ Division on Earth and Life Studies. Formerly, she was an Environmental Health Scientist at Westat, where she supported the Environmental Protection Agency, the National Institute of Child Health and Development, and the National Cancer Institute by completing other environmental epidemiology related projects. Prior to her tenure at Westat, she was a student epidemiologist at the Minnesota Department of Health and an Industrial Hygienist at a consulting firm in Cincinnati. She serves as Chair of the Nominations Committee for the International Society of Exposure Science. She is also a fellow of the Bloomberg American Health Initiative at the Johns Hopkins Bloomberg School of Public Health,
where she is pursuing a doctor of public health in environmental health. She has an MPH in Environmental Epidemiology, a BS in Biology, and she is a Certified Industrial Hygienist.
Marilee Shelton-Davenport is a seasoned science policy program director who joined the Board on Chemical Sciences and Technology at the National Academies of Sciences, Engineering, and Medicine in 2016 after 17 years with the National Academies’ Board on Life Sciences. She has an extensive portfolio of work at the intersection of chemistry, biology, and health including impactful activities that serve a variety of federal agencies. A natural at building bridges and working across traditional siloes, her work includes Consensus Study Reports and the development of innovative activities and communication approaches to engage a wide breadth of scientists and stakeholders in impactful dialogues related to emerging technologies, environmental health and toxicology, and chemical and biological defense. She received her PhD in Pharmacology from the University of North Carolina at Chapel Hill and her BS in Biochemistry from Clemson University.
Jarrett Nguyen is a Program Specialist in the Office of the President at the National Academy of Medicine. Formerly he was a Senior Program Assistant for the Board on Chemical Sciences and Technology. Mr. Nguyen began working for the National Academies of Sciences, Engineering, and Medicine in October 2016. He graduated from James Madison University in May 2015 with a BS in Geology and Environmental Science with a minor in Geographic Science.
