Gillian Woollett, M.A., D.Phil.
Chair, IGBA Biosimilars Committee
VP, Head Regulatory Strategy and Policy, Samsung Bioepis US (SBUS)
Dr. Gillian Woollett joined Samsung Bioepis in November 2021 as VP, Head Regulatory Strategy and Policy, US (SBUS), to stand up a US presence for science-based regulatory strategy and policy in the leading global market for biologics, including but not limited to biosimilars.
Prior to this recent move, she was SVP and Principal Regulatory Scientist at Avalere Health where she created and led the FDA Policy and Regulatory Strategy Practice. Avalere, an advisory services firm of ~250 people, supported clients across the healthcare spectrum, from patients to biopharma companies and payers/providers. She provided the “prequel” of scientific and technical expertise to support drugs, biologics and devices gaining approval at the FDA in a manner that allows them to be commercially successful. She led on peer reviewed publications supporting regulatory reliance globally, including harmonization (US)/ convergence (EU) to facilitate access and affordability. She created the Avalere FDA Fellows Program to enable scientists to transition effectively into the policy environment with >40 having used this steppingstone to transition their careers.
Previously, Dr. Woollett was Chief Scientist, and Administrator, at the law firm of Engel & Novitt, LLP – a boutique food and drug law firm that fully integrates sound science into all its services, and notably won an unreasonable delay suit against FDA during her tenure. Prior to that, she was VP, Science and Regulatory Affairs at BIO, where she established a new Department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biologic medicines from a scientific, technical and policy perspectives. She joined BIO after serving as AVP at PhRMA, where her group led on the negotiation and creation with FDA of the comparability protocol in support of manufacturing changes to already licensed biologics (that became the conceptual basis of biosimilarity). At both trade associations, Dr. Woollett managed the interface between bio/pharma companies and the US Government in a manner that enabled their collective ability to expedite product development. In her PhRMA capacity, she testified before Congress on human cloning, and with four Ambassadors on biothreat issues.
Dr. Woollett has represented the biopharma industry in the media as the industries’ voice on international, as well as US, regulatory and scientific issues. She has been appointed to Federal Advisory Committees; for example, she represented industry on CDC’s Board of Scientific Counsellors to the National Center for Infectious Disease. She currently represents biotechnology on the Material and Engineering Technical Advisory Committee (METAC) at the Department of Commerce and chairs the Biotech Work Group. She also provides a point of scientific interface with academic and professional organizations. She is an appointee to the Nomenclature and Labeling Expert Committee of the United States Pharmacopeia (USP), was on the Board for the Foundation for The Accreditation of Cellular Therapy (FACT) for almost a decade, and served on the Science Board of the Pharmaceutical Education Research Institute (PERI).
Dr. Woollett earned her B.A., M.A. in Biochemistry from the University of Cambridge, and her D.Phil. in
Immunology from the University of Oxford in the UK. She was a post-doc in the Department of Molecular Biology at the University of Edinburgh, and at the Biomedical Research Institute, Rockville, MD funded by USAID. She is well published in the peer reviewed literature.
Vice-Chair, IGBA Biosimilars Committee
Vice President of Sciences and Regulatory Affairs, Association for Accessible Medicines (AAM)
Giuseppe Randazzo is Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines and has worked in the pharmaceutical arena for over 20 years. Prior to joining AAM, Giuseppe worked on Novartis’ Policy team, where he collaborated in multiple regulatory policy areas including drug and policy development, UFA negotiations, and trade association relations. Before Novartis, Giuseppe spent nearly 15 years at the Food and Drug Administration (FDA), where he was most recently an Office Director within the FDA’s Center for Drug Evaluation and Research/Office of Pharmaceutical Quality. During his time at FDA, Giuseppe also worked in the Office of New Drugs, the Office of Compliance, and helped stand up the Office of Product Quality in coordination with the Office of Generic Drugs.
Giuseppe holds a B.A. in Chemistry and Physical Science Education from The Pennsylvania State University and an M.S. in Regulatory Science from The Johns Hopkins University.
Chair, IGBA International Trade and Intellectual Property Committee
Associate Secretary General, Indian Pharmaceutical Alliance (IPA)
Archana Jatkar is an Associate Secretary General (International Trade and Regulatory Affairs) at Indian Pharmaceutical Alliance (IPA) (www.ipa-india.org) where she is responsible for developing and executing strategies on international trade policy and regulatory issues.
Archana will be the Chair for International Trade and Intellectual Property Committee of International Generic and Biosimilar Association (IGBA) for 2023-24. She is also an active StartUp Mentor at Indian Institute of Health Management Research (IIHMR) StartUps, fostering and stimulating health and health-based innovators.
Before joining IPA, Archana was the Deputy Head for a think tank working on International Trade issues. She works with governments, research and policy community in India, Geneva, USA, South Asia, EU, and with intergovernmental agencies such as the WTO, UN organisations, industry associations and consultants, globally. She has written several policy research papers and regularly writes in newspapers on contemporary issues of international trade. She has been guest speaker at law colleges and has also been judging moot court competitions including at National Law College, Gandhinagar, Gujarat in India.
She is an Alumnus of Harvard Kennedy School, Harvard University (USA) and an LLM (International Economic Law) from University of Kent, UK. Archana has practiced as an advocate in corporate and constitutional law before the Hon’ble High Court of Judicature at Bombay and has an excellent understanding of the legal and institutional environment in regard to trade development and economic laws in India.
José Luis Cardenas
Vice-Chair, IGBA International Trade and Intellectual Property Committee
Sr. Director Government Affairs & Market Access LATAM, Teva Pharmaceuticals
Pharmaceutical industry executive with over 16 years of experience in complex public policy and market access negotiations and management in Latin America and beyond.
Well understanding of market dynamics and business, legal and political implications and angles of decision-making process. Strong and proven communications and leadership skills.
Deeply Involved in representing both trade associations and companies in public policy discussions and free trade agreements like Trans Pacific Partnership or the Pacific Alliance regarding Intellectual Property issues and pharmaceutical regulatory standards. Active in global fora such as the International Generic and Biosimilar Medicines Association (IGBA). Also playing critical role in negotiation of ethics standards of the Asia-Pacific Economic Cooperation.
Leading role in designing and implementing strategies for international tenders (eg Pan American Health Organization and United Nations Office for Project Services).
Experience in Oncology, Multiple Sclerosis, HIV, Migraine, Respiratory, Transplant, among others.
Juris Doctor (U. Chile), Master and Doctor in Laws (U. Freiburg, Germany), Pharmacology diploma (U. of Chile), Health Technology Assessment diploma (Catholic University of Chile).
He has been visiting professor at the Law School of Universidad de Chile and autor of several books and articles on health-related topics published in Chile and abroad.
Chair, IGBA Science Committe
Chief Executive Officer and Principal Regulatory Consultant, Pharmaceutical Intellectual Resource Services LLC
Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic and Biosimilar Medicines Association (IGBA) and represents IGBA on the ICH Management Committee and the ICH Assembly. Dr. Cappuccino is the Chief Executive Officer and Principal Regulatory Consultant of Pharmaceutical Intellectual Resource Services LLC, in Lambertville, NJ USA. Dr. Cappuccino has held the positions of Vice-President, Quality and Scientific Affairs, in Princeton NJ and Head of Global Quality for Dr. Reddy’s Laboratories Ltd., located in Hyderabad, India. Prior to these positions, Dr. Cappuccino was the Chief Scientific Officer of Eagle Pharmaceuticals Inc. in Woodcliff Lake, New Jersey, USA. Dr. Cappuccino was formerly the Executive Vice-President, Chief Scientific and Technical Officer of Andrx Pharmaceuticals and Watson Laboratories in Weston, Florida, USA. Prior to Andrx, Dr. Cappuccino was the Vice-President of Research and Development and a member of the Executive Management Committee for Sandoz Inc. in Princeton, NJ. Prior to joining Sandoz he was Vice-President of R&D for Apotex, Inc., Toronto, Canada, responsible for world-wide generic drug development at Apotex. He has also worked for Geneva Pharmaceuticals in Broomfield, Colorado, Hoechst-Roussel Pharmaceuticals, Bridgewater, NJ, and Schering-Plough Corporation in Bloomfield, NJ during his forty+ year career in the pharmaceutical industry.
Dr. Cappuccino holds a Ph.D. in Organic Chemistry from Stevens Institute of Technology, Hoboken, NJ, USA and an MBA from Fairleigh Dickinson University, Madison, NJ, USA.
Vice-Chair Chair, IGBA Science Committe
Interim CEO, Association for Accessible Medicines (AAM)
David Gaugh is the Interim CEO of Association for Accessible Medicines. David has over 25 years of leadership experience in the health care and pharmaceutical business.
David joined the Association for Accessible Medicines in 2012 as the Senior Vice President for Sciences and Regulatory Affairs, where he is responsible for the professional liaison functions between member companies, agencies of the U.S. government and legislative bodies for all responsible areas. Prior to joining AAM, David was Vice President and General Manager of Bedford Laboratories, a Division of Ben Venue Laboratories and a wholly owned subsidiary of Boehringer Ingelheim.
David was previously the Senior Director, Pharmacy Contracting and Marketing at VHA/Novation (now Vizient). Before joining VHA/Novation, David was System Director of Pharmacy for St. Luke’s Health-System, a tertiary-care hospital in Kansas City, MO.
David is a registered pharmacist and has been engaged in several board-level pharmacy-related activities such as the American Society of Health-system Pharmacists Education and Research Foundation Board of Directors, USP Council of Convention, and American Foundation for Pharmaceutical Education Board of Directors.