Faculty – 2nd Innovative Regulatory Pathways Summit

Mike Fahmy
Senior Director Global Regulatory Affairs, OTSUKA

Brian E. Harvey, M.D., PH.D.
Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE

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Brian E. Harvey, M.D., Ph.D. is a physician and biochemist with academic research, clinical practice, U.S. FDA regulatory, bio-pharmaceutical industry and non-profit experience. He currently is Principal Consultant at Brian E Harvey LLC (https://www.facebook.com/brian.harvey.3348) providing regulatory advice for biologics, drugs and medical device development programs. In addition, he volunteers as the Executive Vice President, Science and Regulatory at the non-profit Global Liver Institute (www.globalliver.org) based in Washington, DC. Prior to his current activities, Dr. Harvey held positions as Vice President of U.S. Regulatory Strategy at Pfizer and Vice President of U.S. Regulatory Policy at Sanofi-Aventis, including during the period of the Genzyme merger (https://www.linkedin.com/in/brian-harvey-14788910/).

Dr. Harvey also held several senior roles at FDA, serving in the medical device (CDRH), biologic (CBER) and drug (CDER) Center from 1995 to 2007. As Director of CDER Division of Gastroenterology Products Office of New Drugs (OND), he headed the regulatory review teams for NDA and BLA submissions and chaired FDA meetings with regulated industry on a regular basis. As Director, he created the Inborn Errors of Metabolism Team within the GI division to focus on rare disease product approvals. Prior to this, he served as Deputy Director of the Office of Drug Evaluation 5 (CDER) and CBER Associate Director for Policy, Office of Therapeutics Research and Review (OTRR).

Brian graduated with honors from Middlebury College in Vermont. After college, he received his Ph.D. in biochemistry, followed by his MD at the University of Connecticut. In his last year of medical school, he began post-doctoral research on colorectal cancer and the role of sialic acid in site-specific metastasis at Harvard University. He completed his internship and residency in internal medicine at Harvard’s Beth Israel Hospital, which included clinical rotations at Dana-Farber Cancer Institute, West Roxbury Veterans Hospital, clinical research at Brigham and Women’s Hospital and the Harvard School of Public Health. His bench research activities resulted in several publications in peer reviewed journals. This was followed by a three-year gastroenterology fellowship at Johns Hopkins Hospital, Baltimore, MD, which included hepatology training and being a member of the Liver Transplant Service.

Camille Jackson
Associate Vice President, Science and Regulatory Advocacy, PHRMA

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Camille Jackson is a leading international regulatory policy professional with particular knowledge and expertise in international regulatory harmonization initiatives. An experienced strategic scientific and regulatory program manager, Camille has worked with academia, government, non-profit organizations, and the pharmaceutical industry on large biomedical research funding and policy initiatives. Currently, Camille is Associate Vice President of Science and Regulatory Advocacy at PhRMA, a US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. In this role, she manages PhRMA’s engagement in the International Council for Harmonization (ICH) and serves as industry coordinator for the research-based industry coalition within the APEC Regulatory Harmonization Steering Committee (RHSC). She is based in Washington, DC.

Lawrence Liberti

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Dr Liberti has worked in the fields of pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. He began his
career at Wyeth Laboratories working in product development, then as a regulatory writer in clinical R&D, and manager of safety surveillance in
medical affairs. He served as the editorial director for the North American operations of ADIS international after which he founded PIA Ltd, a company
specialising in regulatory writing and consulting; he co-founded Astrolabe Analytica under which he helped develop, patent and commercialise the
Astrolabe Message Mapping SystemTM.

Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics).
He has been actively involved in promulgating best practices in the regulatory aspects of medicines development, especially in the emerging markets.

Dr Liberti received his doctorate in International Regulatory Policy through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation
based in the Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands, where his research centred on expedited regulatory pathways with applicability in the emerging markets. He received both his bachelor of science in pharmacy and master’s degree in pharmacognosy from the Philadelphia College of Pharmacy and Science (now the University of the Sciences in Philadelphia). He attained the status of Regulatory Affairs Certified (RAC) with the Regulatory Affairs Professional Society and was awarded an honorary Doctor of Science degree by his alma mater. He is a Fellow of the American Medical Writers Association and is a recipient of their Golden Apple award for excellence in teaching. Dr Liberti is a co-founder of the Erudee Foundation, a non-profit dedicated to supporting local post-secondary educational opportunities for students in the Caribbean
and East Africa.

Usha Ramesh
Executive Director, Regulatory Affairs, CMC and Ad. Promo, PHARMACYCLICS

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Dr. Usha Ramesh is currently Executive Director of Regulatory Affairs, CMC at Pharmacyclics. In this role, she heads up the worldwide CMC regulatory strategy and execution for all development stage and marketed products at Pharmacyclics. Dr. Ramesh led the CMC regulatory activities that contributed to the market approval for the company’s lead oncology drug, Imbruvica®, which was approved under Breakthrough Therapy Designation. The drug is currently approved in nearly 90 countries worldwide for multiple indications. Dr. Ramesh has over 25 years of pharmaceutical industry experience in both large pharma companies (Schering Plough, Glaxo Wellcome, Upjohn) and smaller biotech companies (Rigel, Teikoku, and Affymax).

Dr. Ramesh has 20 patents, several publications; and has been an invited panelist and speaker at several conferences. Dr. Ramesh’s extensive experience spans across the spectrum of drug development including medicinal chemistry, process chemistry, clinical development, quality and regulatory affairs. Dr. Ramesh obtained her Ph.D. in Organic Chemistry from Michigan State University.

William K. Sietsema, Ph.D.
Executive Director, Global Regulatory Affairs, CALADRIUS BIOSCIENCES

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Dr. Sietsema is Executive Director, Global Regulatory Affairs at Caladrius Biosciences, a company that focuses on innovative cell therapies for difficult-to-treat diseases. Prior to Caladrius, he was Global Regulatory Lead at Amgen where he provided strategic guidance to a portfolio of early stage projects in oncology and inflammation. He was also Vice President, Global Regulatory Consulting and Submissions at Kendle International/INC Research and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati, College of Pharmacy. He has 33 years of experience in the pharmaceutical industry. He received his BA, magna cum laude, in Chemistry from the University of Colorado, Boulder in 1977 and his PhD in biochemistry from the University of Wisconsin, Madison in 1982. He is the author of 24 journal articles, 4 book chapters, 42 presentations and posters and is an inventor on 6 patents. He has published six books on regulatory topics ranging from strategic planning to practical aspects of preparing CTAs and MAAs. He is a member of the American Chemical Society, the Regulatory Affairs Professional Society, and the Association for Regenerative Medicine.

Mark Stewart
Vice President, Science Policy, FRIENDS OF CANCER RESEARCH

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Mark Stewart is a senior science policy analyst at Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients. During the past 20 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible.

Prior to joining Friends, Mark worked at the National Academies of Sciences, Engineering, and Medicine. At the Academies, he assisted with a congressionally-mandated study that resulted in the report titled Ovarian Cancers: Evolving Paradigms in Research and Care. This report identified gaps in ovarian cancer knowledge and care and provided recommendations to overcome these gaps. Mark also helped workshops for the National Cancer Policy Forum.

At Friends, Mark leads the development of evidence-based policies that will improve care for cancer patients and survivors, facilitates dialogue between stakeholders through the organization of conferences and symposia, and advocates on behalf of cancer patients and survivors.

Mark has served on several committees, including the Associate Member Council of the American Association for Cancer Research (AACR) and the North Central Alabama Race for the Cure Committee. During his tenure on the Associate Member Council, Mark served as the 2015-2016 Chair and helped direct efforts to ensure the unique needs of early-career investigators were known and addressed through resources and programming at AACR. Mark continues to advocate for sustained biomedical research funding to maintain a predictable funding environment to allow for continued innovation and novel discoveries in cancer research.

Mark received his Ph.D. in cancer biology from the University of Alabama at Birmingham and was a recipient of NCI’s Ruth L. Kirschstein National Research Service Predoctoral Award.

Ronald Szumigala
Director – RAI HQ – Biologics, Oncology, MERCK

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Ronald H. Szumigala, M.S., is currently a Director in the Regulatory Affairs International – Oncology & Biologics Department at Merck & Co., Inc. Mr. Szumigala leads a team of Liaisons responsible for international regulatory activities, including both Clinical Trial and Marketing Authorization Applications, for several of Merck’s Oncology programs and collaborations. Mr. Szumigala has over 20 years of experience in the Pharmaceutical Industry with over 14 years of experience in Regulatory Affairs.

Dr. Long Wang
Director, Global Regulatory Team Leader, Vaccines/Infectious Disease, MERCK

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Long Wang, M.D., Ph.D., is currently a Director in the Vaccines & Infectious Disease Regulatory Affair Department at Merck Co. In this capacity, Dr. Wang leads the global regulatory team responsible for Vaccines & Infectious Disease projects. Dr. Wang has over 10 years of experience in the Pharmaceutical Industry, and he was a Clinical Development Leader in GSK Vaccines prior to joining Merck Co.

Martine Zimmermann
Senior Vice President, Global Regulatory Affairs, ALEXION PHARMACEUTICALS, INC.

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Martine Zimmermann is Senior Vice President and Head of Global Regulatory Affairs at Alexion. Dr Zimmermann has over 20 years of combined R&D and global regulatory strategy experience. She joined Alexion in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. She received her PharmD from the University Louis Pasteur in Strasbourg (France) and is based in Zurich.