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STAT: Facing bottlenecks in manufacturing cell therapies, Boston leaders plan to build their own

Andy Topping

Andy Topping

CHIEF SCIENCE OFFICER, FUJIFILM DIOSYNTH BIOTECHNOLOGIES

Andy has worked in contract development and manufacture of biologics for almost 30 years. Originally trained as a molecular biologist with a Ph.D. from the University of Wales in Cardiff, he has led development and manufacturing projects bringing over 100 products from microbial and mammalian expression systems into the clinic. As Chief Scientific Officer for the global CDMO Fujifilm Diosynth Biotechnologies, he is responsible for science and innovation across the company’s sites in Europe and the US in areas spanning from large scale commercial manufacture of monoclonal antibodies to supporting first in man gene therapies. Andy is a strong believer in simplicity and standardization as the way to move swiftly in development while providing a strong underpinning for future success.

Tim Charlebois

Tim Charlebois

SENIOR FELLOW AT NIIMBL, FORMER VICE PRESIDENT OF TECHNOLOGY AND INNOVATION STRATEGY AT PFIZER

Dr. Tim Charlebois retired from Pfizer after a 30-year career with the company including legacy companies Wyeth and Genetics Institute. His technical expertise and experience included molecular biology, cell line development, characterization, cGMP cell banking and testing, cell culture and drug substance process development. He was deeply involved in the development and registration of a number of early biopharmaceutical products including Recombinate (rhFVIII), BeneFIX (rhFIX), Neumega (rhIL-11), Infuse (rhBMP2), ReFacto AF (BDDFVIII), and Enbrel (etanercept). 

Mark Namchuk

Mark Namchuk

EXECUTIVE DIRECTOR OF THERAPEUTIC TRANSLATION AT HARVARD MEDICAL SCHOOL

Mark Namchuk PhD is a professor of the practice of biological chemistry and molecular pharmacology and the executive director of therapeutics translation at Harvard Medical School.  In this later role, Namchuk works with HMS scientists to identify and harness basic insights and move them towards clinical therapies, while training the next generation of therapeutics investigators.  He has overall responsibility for the HMS therapeutics initiative which includes an on-campus Biotech incubator (the Blavatnik LifeLab Longwood), a scientific core dedicated to supporting therapeutics discovery in faculty labs at HMS and affiliated institutions and educational programs in therapeutics at the graduate and post-doctoral level.  His current research interests focus on drug discovery, in particular antivirals for the treatment of COVID-19. 

Namchuk joined HMS in 2020 after a 24-year research and development career in the biotech industry, in the arenas of drug discovery, translational science and pharmaceutical development. In 2015, he joined Alkermes as senior vice president of research and nonclinical and pharmaceutical development. Previously, Namchuk held a number of senior research positions over a 17 year career at Vertex including senior vice president of Research. 

Over more than two decades he has directed drug discovery efforts in numerous therapeutic areas, including infectious disease, oncology, neurodegenerative and psychiatric disorders, immune-mediated inflammatory disease, inflammatory bowel disease and orphan diseases, including cystic fibrosis. These responsibilities encompassed scientific oversight of the various disciplines in discovery science, DMPK, preclinical and clinical biomarker development, nonclinical safety and pharmaceutical development.  Namchuk obtained a BSc in Chemistry for the University of Alberta, a PhD in Bio-organic chemistry from University of British Columbia and was an HFSP post doctoral fellow at UCSF. 

JC Gutierrez

JC Gutiérrez-Ramos

CHIEF SCIENCE OFFICER, DANAHER CORPORATION

Jose-Carlos has served as Chief Science Officer for Danaher Corporation since January 2021. Before joining Danaher, he served for 18 years as an R&D executive for Abbvie, Pfizer, Takeda and GSK, where he was responsible for Global Discovery, Biotherapeutics R&D, and Immunology & Inflammation R&D, respectively. Teams under his direction have delivered three drugs to market and six others are currently in phase 3 clinical development. During the five years prior to joining Danaher, he was the Founding CEO and President for two Biotechnology companies: Repertoire Immune Medicine and Synlogic Inc. During his tenure as Biotech CEO, he took two pioneering technology platforms (Synthetic biology and Immune TCR pMHC decoding) to the clinic and then to the public markets. He serves as director on the board of several biotechnology companies. He started his career as an academic researcher with faculty positions at the Basel Institute in Switzerland and Harvard Medical School in Boston.

Amy Wagers

Amy Wagers

PROFESSOR AND CO-CHAIR OF DEPARTMENT STEM CELL AND REGENERATIVE BIOLOGY, HARVARD UNIVERSITY

Dr. Amy Wagers’ substantial contributions to science, published in more than 150 primary research and review articles, have brought to light novel regulators (both intrinsic and extrinsic) of stem cell activity in injury repair, degenerative disease, and malignancy, and highlighted key roles for specific blood-borne mediators, cellular niches, inflammatory and metabolic cues in coordinating the functions of stem cells and their progeny throughout the body.

She has also established groundbreaking methods for manipulating stem cell genomes in situ — work that opens new avenues of research and new possibilities for treating congenital and age-related diseases.

In addition to her work at the Harvard Stem Cell Institute, Wagers is a senior investigator in the section on Islet Cell and Regenerative Biology at the Joslin Diabetes Center and a member of the Paul F. Glenn Center for the Biology of Aging at Harvard Medical School.

Stacy Springs

Stacy Springs

EXECUTIVE DIRECTOR, MIT CENTER FOR BIOMEDICAL INNOVATION

Dr. Stacy Springs is the Executive Director at the MIT Center for Biomedical Innovation (CBI).  The  Center integrates the Institute’s technical, scientific, and management expertise to solve complex  biopharmaceutical challenges.  CBI leads multi-stakeholder, multidisciplinary research and  educational initiatives with real world impact, including MIT’s Biomanufacturing Consortium,  (BioMAN), and it’s Consortium on Adventitious Agent Contamination in Biomanufacturing,  (CAACB).  Dr. Springs is a principle investigator on several research programs in biologics  manufacturing, from application of data analytics and PAT in the continuous production of  monoclonal antibodies, viral vectors and vaccines; to development of innovative rapid sterily tests and new approaches to adventitious agent contamination through long read sequencing.  Dr.  Springs is part of the leadership of SMART CAMP, an interdisciplinary research group focused on  Critical Analytics for Manufacturing Personalized-Medicine at the Singapore-MIT Alliance for  Research and Technology (SMART) and serves as the Chair of Landmark Bio’s Science and  Technology Committee.  

Dr. Springs’ research interests include biopharmaceutical development and manufacturing, risk  management, regulatory and translational science and food safety and food supply chains.  She  holds a PhD in Chemistry from the University of Texas at Austin and gained postdoctoral training in  protein and biophysical chemistry at Princeton University.

Laurence Cooper

Laurence Cooper

FORMER PROFESSOR MD ANDERSON, FORMER CHIEF EXECUTIVE OFFICER ZIOPHARM ONCOLOGY

Dr Laurence Cooper has contributed to the development of many therapies and cutting-edge technologies including in immuno-oncology where he developed and implemented novel immunotherapies raising large amounts of capital through grants, philanthropy and investors. He established relationships with academia through a Collaborative Research and Development Agreement (CRADA) with Dr. Steven Rosenberg at National Cancer Institute and a comprehensive Research Agreements with MD Anderson Cancer Center.

While a public CEO and Director at Ziopharm Oncology, Laurence helped develop viral-based therapies using genetic switches to control interleukins as monotherapy and in combinations as well as T-cell therapies based on non-viral gene transfer and cytokine-driven cell biology.

Brett Geiger

Brett Geiger

BOARD MEMBER, ASSOCIATE SCIENCE & TECHNOLOGY, ALEXANDRIA REAL ESTATE EQUITIES INC, ALEXANDRIA VENTURE INVESTMENTS

Brett Geiger, PhD, is an Associate on the Science & Technology team at Alexandria Real Estate Equities, Inc. and Alexandria Venture Investments. He contributes to venture investments, tenant underwriting, and business development in Alexandria’s Greater Boston region. Dr. Geiger also leverages his technical background and deep understanding of the life science industry, including emerging trends in novel therapeutic modalities, to support Alexandria’s real estate strategy.

He received his PhD in Biological Engineering from MIT, where he was a National Science Foundation (NSF) Fellow, served as President of the MIT Biotechnology Group, and published research in top journals, including Science Translational Medicine. He received a Bachelor of Science degree in Biomedical Engineering from The Ohio State University.

Martin Meeson

Martin Meeson

BOARD MEMBER, CHIEF EXECUTIVE OFFICER, FUJIFILM DIOSYNTH BIOTECHNOLOGIES

Martin Meeson is a seasoned executive who brings extensive global experience to the Biotech and Pharmaceutical markets. Martin was named Chief Executive Officer on April 1st, 2020 after serving as Chief Operating Officer and President at of our US FDB operations (North Carolina and Texas). Previously Martin served as Chief Financial Officer for the US. Prior to this, Martin worked for the Fujifilm Diosynth organization for over 6 years, holding leadership positions at the United Kingdom site, including Head of Finance and IT. Before joining Fujifilm Diosynth he was Finance Director at Oxford Chemicals where he was responsible for all aspects of Finance, IT, and Purchasing. He has also held leadership positions at Hibernia Foods, ICI/Dupont and KPMG.

Amanda Halford

Amanda Halford

BOARD MEMBER, VICE PRESIDENT COMMERCIAL US, CANADA, EUROPE AND SERVICES, CYTIVA

Amanda Halford has her eyes on growth. A chemist, she combines the scientific view with business acumen and experience. She commands a strategic view of how to expand Cytiva business through customer intimacy, mergers and acquisitions, licensing, and technology transfer.

Amanda joined Cytiva in January 2019 as General Manager, Strategy and Business Development. She quickly transitioned to Senior Vice President, Sales,Service and Commercial Operations. Passionate about enabling customers to deliver the right therapy tothe right patient at the right time, she is focused on guiding the bioprocess, cell & gene therapy, and genomics & cellular research businesses to be even stronger partners to researchers, clinicians and medical professionals.

Before coming to Cytiva, she held the roles of Executive Vice President, Life Sciences Division and Chief Commercial Officer at EAG Laboratories, a San Diego, California-based scientific services company. There she oversaw a business strategy to diversify the customer base, extend market share and accelerate growth.

For 15 years she served in various executive capacities at Sigma Aldrich across both the research and SAFC businesses, leading a number of global businesses including the Chemistry franchise, the industry leadinge Business platform and the Academic Research business portfolio.

Amanda is a fierce believer in developing girls to be leaders of the future. To that end, she served as a Board Member of the Girl Scouts of Eastern Missouri from 2016-2019, where she was a Member of the STEM committee and advisory member of the strategic planning committee.

She graduated top of her class with an Executive MBA from EM Lyon and holds a BSc Honours in Chemistry from Imperial College, London. Amanda is fluent in French and English and brings a truly global perspective having lived, worked and travelled extensively around the world.

Cynthia Barnhart

Cynthia Barnhart

BOARD MEMBER, PROVOST MIT

Cynthia Barnhart is Provost, Professor of Operations Research, and Ford Foundation Professor of Engineering at MIT. Barnhart has served as MIT’s Chancellor, as the Associate and Acting Dean for the School of Engineering, and as co-director of the Operations Research Center and the Center for Transportation and Logistics.

Barnhart’s teaching and research are in the areas of large-scale optimization and analytics, with a focus on applications in transportation and logistics systems. She has supervised scores of graduate and undergraduate theses across a range of disciplines, and has published widely in the flagship journals of her field.

Barnhart is an elected member of the National Academy of Engineering and the American Academy of Arts and Sciences, and is a fellow of the Institute for Operations Research and Management Science (INFORMS). She has served as the President of INFORMS, the President of the INFORMS Women in Operations Research and Management Science, and the President of the INFORMS Transportation Science and Logistics Society. Barnhart’s awards include the INFORMS President’s Award, the INFORMS Franz Edelman Prize for Achievement in Operations Research and the Management Sciences, the National Science Foundation Presidential Young Investigator Award, and honorary doctorates from the École Polytechnique Fédérale de Lausanne and the University of Toronto.

Barnhart received her SM in transportation in 1986 and her PhD in 1988 from MIT.

Alan Garber

Alan Garber

BOARD CHAIR, PROVOST, HARVARD UNIVERSITY

Provost Alan M. Garber serves as Harvard University’s chief academic officer. He is also the Mallinckrodt Professor of Health Care Policy at Harvard Medical School, a Professor of Economics in the Harvard Faculty of Arts and Sciences, Professor of Public Policy in the Harvard Kennedy School of Government, and Professor in the Department of Health Policy and Management in the Harvard T.H. Chan School of Public Health. An economist and physician, he studies methods for improving health care productivity and health care financing.

As Provost, Dr. Garber oversees academic activities throughout the university, with direct responsibility for inter-school initiatives, faculty development, research policy, international affairs, and advances in learning. The Harvard Art Museums, the Harvard Library, Harvard University Health Services, HarvardX, the American Repertory Theater, and the Arnold Arboretum are among the organizations reporting to the Provost.

Before becoming Provost at Harvard in 2011, Dr. Garber was the Henry J. Kaiser Jr. Professor and a Professor of Medicine, as well as a Professor of Economics, Health Research and Policy, and Economics in the Graduate School of Business (by courtesy) at Stanford University. At Stanford, he founded and directed the Center for Health Policy and the Center for Primary Care and Outcomes Research, and served as a Staff Physician at the Department of Veterans Affairs Palo Alto Health Care System.

Dr. Garber is an Elected Member of the Association of American Physicians, the National Academy of Medicine, and the American Academy of Arts and Sciences. He is also an Elected Fellow of the American Association for the Advancement of Science, the American College of Physicians and the Royal College of Physicians. A summa cum laude graduate of Harvard College, Dr. Garber received a PhD in Economics from Harvard and an MD with research honors from Stanford.

Aileen Baquiran

Aileen Baquiran

VICE PRESIDENT BUSINESS OPERATIONS

Aileen has over 20 years of experience in the life sciences industry. As Vice President of Business Operations, Aileen is responsible for Program Management, People Operations, IT Services and Corporate Communications. Prior to Landmark Bio, Aileen was VP Global Supply Chain & Business Operations at Orchard Therapeutics where she designed and implemented the commercial distribution and site qualification process for one of the first commercially approved gene therapies.

Aileen also held project management and supply chain management roles of increasing responsibility at Dermira, Jazz Pharmaceuticals and Johnson & Johnson. She earned her Bachelor of Science in Industrial Engineering from Cal Poly, San Luis Obispo, and MBA from the University of San Francisco.

Zhimei Du

Zhimei Du

VICE PRESIDENT TRANSLATIONAL RESEARCH & EARLY DEVELOPMENT

Dr. Zhimei Du is a leader in the fields of Cell/Gene Therapy and Biologics with significant experience in both early and late-stage development. She serves as Vice President at Landmark Bio leading the Translational Research and Early Development of next-generation cell/gene therapies for various diseases. Prior to joining Landmark Bio, Dr. Du was at Atara Biotherapeutics, as Vice President focusing on accelerating both early and late-stage cell therapy pipelines. Prior to that, she was at Merck & Co. as the Executive Director & Global Head of Process Cell Sciences. In this role, Dr. Du established various new core functions in cell therapy and biologics during early development. She has also been active in successful business development activities, including evaluating and building partnerships for CAR-T and CAR-NK programs. Dr. Du holds numerous patents and publications in cell and gene therapy, protein engineering, cell engineering, vector engineering, molecular mechanisms in autoimmune disease and cancer immunity, process optimization, and genetic/epigenetic biomarker development.

Dr. Du received her Ph.D. in Immunology from Cornell University Medical College. She was a Postdoctoral Fellow at Robert G. Roeder’s laboratory, Rockefeller University, where she focused on the discovery of genetic/epigenetic regulation mechanisms during leukemia genesis.

Michael Covington

Michael Covington

CHIEF QUALITY  & REGULATORY OFFICER

Michael Covington brings three decades of biotechnology, cellular, and gene therapy experience in areas including regulatory affairs, regulatory compliance, quality, validation, and manufacturing. He has demonstrated success in supporting innovative therapies including adeno-associated vector (AAV) gene therapies, autologous genetically modified hematopoietic stem and progenitor cell therapies for rare diseases, autologous genetically modified T cell immunotherapies, and other autologous immunotherapies, as well as recombinant protein therapeutics.

Most recently, Mr. Covington was the vice president of Regulatory Chemistry, Manufacturing, and Controls (CMC) for Novartis Gene Therapies. Prior to Novartis, he was vice president of Regulatory CMC for Orchard Therapeutics, and held leadership positions with Juno Therapeutics, Dendreon, and Amgen. He earned a B.A. in biology, cellular, and molecular biology from the University of Missouri-Columbia.

Gregg Nyberg

Gregg Nyberg

CHIEF TECHNOLOGY OFFICER

Gregg Nyberg, Ph.D., brings more than 20 years’ biopharmaceutical industry experience to his new role at Landmark Bio. Most recently, he was associate vice president at Merck, where he led the company’s biologics process development and clinical manufacturing organizations. He also spent nearly 15 years in positions of increasing responsibility at Amgen including key leadership roles in process development and cell sciences and technology.

Dr. Nyberg earned a Ph.D. in chemical engineering from the Massachusetts Institute of Technology and a B.S. in chemical engineering and petroleum refining from the Colorado School of Mines.

Ran Zheng

Ran Zheng

CHIEF EXECUTIVE OFFICER

Ms. Zheng is a biotechnology industry veteran who brings more than 25 years of experience in biotechnology operations across multiple geographies to Landmark Bio. Ms. Zheng most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company specializing in HSC based gene therapies. In this role, Ms. Zheng established the technical operations function and manufacturing network, and advanced the company’s product pipeline, including the approval of Libmeldy™ –  the first gene therapy product for metachromatic leukodystrophy. Ms. Zheng has also held leadership positions at several major biotechnology companies including Genzyme (now Sanofi) and Amgen. At Amgen, Ms. Zheng played a key role in building differentiating capabilities in manufacturing for clinical supply and commercial product launch to enable speed to clinic and speed to market strategies for Amgen’s innovative products.