Fellows of DIA

Judith Ng-Cashin, MD, previously served as Chief Medical Officer at AOBiome Therapeutics, leading end-to-end asset development strategy and medical governance. She also served as Chief Scientific Officer and led the Safety & Pharmacovigilance business unit for Syneos Health. Before Syneos, she spent nearly a decade in R&D for a top five pharmaceutical company spanning early assets to marketed products, global development, and franchise/portfolio strategy/prioritization. Dr. Ng-Cashin earned her MD from Rush Medical College, trained in Internal Medicine at the University of Chicago, and received infectious diseases and hematology fellowship training (and subsequently served on the clinical faculty) at the University of North Carolina.

Martin Harvey is Head of International Affairs at the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He headed the Office of the Executive Director, served as Head of Communication, and then moved to the Agency's International Affairs team. He took an 18-month career break with Unitaid, the WHO-hosted partnership dedicated to innovation in global health from 2019-2020. Martin has served on the DIA Advisory Council for EMEA; and as program advisor for DIA's EuroMeeting and Global Annual Meeting. He holds law degrees from the University of Dundee (UK) and the Vrije Universiteit Brussels (Belgium). He is a Fellow of DIA since 2018.

Peter Bachmann is acting as the German NtA Member, a Member of the European Union Network Data Board and the EU IDMP/SPOR Task Force, the HMA WG ‘Better Use of Medicines’/'ePI Task Force', the International Pharmaceutical Regulators Programme (IPRP) Management Committee, and the European Lead of the ICH IGDG (Informal Generic Discussion Group). He has studied biology and chemistry and has a PhD in Pharmaceutical Biology, University of Wuerzburg (Germany). Following a JSPS postdoctoral fellowship at Kyoto University and a DFG Fellowship at the Institute of Food Research Norwich/UK, he has worked at the Institute of Pharmaceutical Biology, TU Braunschweig/Germany, until he joined in 1999 the BfArM, Department of Drug Approval.

Minnie Baylor-Henry, JD, is President of B-Henry and Associates, and previously served as Worldwide Vice President for Regulatory Affairs, Johnson & Johnson. Minnie has served as a Consultant in the Life Sciences Regulatory Practice at Deloitte & Touche LLP based on her extensive expertise as Johnson & Johnson Vice President for Global Regulatory Affairs, OTC Products; and as Senior Director, Regulatory Affairs. Minnie previously served as the Director of the FDA Division of Drug Marketing, Advertising, and Communications, and as the FDA’s National Health Fraud Coordinator. A pharmacist and an attorney, Minnie received her Pharmacy Degree from Howard University and her JD from Catholic University.

Stephanie Crawford, PhD, MPH, is Executive Associate Dean for Faculty Affairs & Strategic Initiatives and Professor in the Department of Pharmacy Systems, Outcomes and Policy at the University of Illinois at Chicago College of Pharmacy. Her research focuses on access, disparities reduction in the medication-use process, and pharmacy systems evaluation. She chairs the United States Pharmacopeia Expert Committee on Nomenclature and Labeling. She was a charter member of the FDA Advisory Committee on Drug Safety and Risk Management and continues to serve as a consultant and ad hoc voting member. Previously, she was Director of Scientific Affairs for the American Society of Health-System Pharmacists in Bethesda, MD.

Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the WHO Advisory Committee on the Safety of Medicinal Products, he served on the Council of International Organization of Medical Sciences and the International Council on Harmonisation. He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. Before joining FDA, he was a faculty member in Neurology at Johns Hopkins.

Gaby Danan, MD, PhD, was the EU QPPV for Sanofi until his retirement in 2010. He has served on the Council for International Organizations of Medical Sciences and International Conference on Harmonisation Expert Working Groups, as the European Federation of Pharmaceutical Industries and Associations Clinical Safety E2B topic leader and co-chaired the EudraVigilance Expert Working Group from its inception until 2009. Dr. Danan co-published the Roussel Uclaf Causality Assessment Method for drug-induced liver injury, has authored papers on pharmacovigilance definitions and methodologies, chaired the DIA 2010 Annual Meeting, serves on the DIA Safety Training Committee, and instructs several DIA training courses.

Professor Richard Day, AM (MBBS, FRACP, MD), is internationally recognized for his research, leadership, and advocacy in support of quality use of medicines. He has been deeply involved in Australia’s National Medicines Policy, culminating in his Chairmanship of the Pharmaceutical Health and Rational Use of Medicines Committee for the Federal Government (1999-2008), and is an active contributor to national resources such as the Australian Medicines Handbook and Therapeutic Guidelines. Professor Day has published over 500 peer-reviewed papers and been cited more than 21,000 times. He was the first non-US President of DIA, and his many awards include Member of the Order of Australia AM (2000) and the AMA Distinguished Service Award (2009).

Marie A. Dray is President, International Regulatory Affairs Group, specializing in US and EU biomedical product registration strategies and executive communications. She previously directed an office of Regulatory Liaison & Policy for Merck; and led high technology trade groups in their interactions with colleagues at the FDA, EMEA and other international trade groups for PhRMA. Marie served two terms, including serving as Chair, on DIA’s Board of Directors; she also received the DIA Founders Award and was one of the founding members of the DIA Fellows program. She has also received the FDA Commissioner’s Special Citation for her efforts in introducing computer-assisted New Drug Applications into the product application review process.

Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing and teaching for the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of DIA and a member of DIA's Scientific and Policy Advisory Council, a Fellow of the International Society for Pharmacoepidemiology and a member of the ISPOR RWE leadership team. She has helped advance global use of real-world evidence by medicinal product regulators, with her work cited in guidelines in the US, Europe, and China.

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on the standardized clinical protocol template, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.

Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken also holds a number of board appointments in the private and public sectors. He received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University.

Alberto Grignolo, Ph.D. FDIA formerly served as Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion within and outside Parexel. Dr. Grignolo served as Chairman of the Regulatory Affairs Professional Society, and as President of FIDIA Pharmaceutical Corporation. He is a DIA Fellow, the Editor-in-Chief of DIA's digital magazine Global Forum, and served for two decades on the faculty of DIA's Regulatory Affairs: The IND, NDA, and Post-Marketing Training Course, which he taught in Japan, China, Korea, Europe, and the US.

Yves Juillet, MD, is the Secretary General of the Foundation of the French Academy of Medicine. He is a Member of the Academy of Medicine of France and Past President of the National Academy of Pharmacy. He was Chair of the EFPIA Scientific Technical and Regulatory Policy Committee, and also served as Chairman of the IFPMA Regulatory Policy and Technical Standards Committee. Dr. Juillet represented European industry as a Member of the ICH Steering Committee, co-chaired the ICH Global Cooperation Group, and was a Member of the official Registration Committee, and Transparency and Post-Marketing Committees, of the French Health Ministry. He is a Fellow of DIA and was the first DIA Board President from Europe.

Tatsuo Kurokawa, PhD, is President of the Japan Self-Medication Industry. He previously served as Professor, International Drug Development and Regulation, Faculty of Pharmaceutical and Medical Sciences, at Keio University, after retiring as an appointed Councilor, Minister’s Secretariat on Pharmaceutical Affairs, MHLW, in 2008. Dr. Kurokawa was a key contributor to launching the International Council on Harmonisation (ICH) with colleagues from the European Commission and US, and served on the ICH Steering Committee up to ICH-3 (1995), while working to advance science and technology policy, and bilateral and multilateral international collaborations. He earned his Doctorate from Chiba University, Faculty of Pharmaceutical Sciences.

Dr. Sandra Kweder is an internal medicine expert with more than 30 years of experience in U.S. and international medical products regulation and policy. As Principal, Drug and Biological Products, with Greenleaf Health, she offers broad expertise accrued through multiple senior leadership roles at the FDA, where she oversaw significant regulatory developments during periods of transformation in the landscape of science policy and public health.

Birka Lehmann, MD joined the Eu-Commission from 2002 -2006 responsible for centralised and decentralised marketing authorisation of medicinal products for all therapeutic areas Implementation of the European Legislation for Good Clinical Practice in charge of relevant committees at the EMA. From 2006 – 2011 head the Licensing Division 3 BfArM Scientific processing and administration of all national and European licensing procedures for medicinal products including scientific and regulatory advice. From 2006-2016 she was the German member of the Paediatric Committee (PDCO) at the EMA. Dr. Lehmann studied Medicines at the Free University Berlin and trained at the Kinderklinik Norderney.

Zili oversees all R&D activities within Asia Pacific, leading over 1,400 science professionals dedicated to delivering transformational healthcare innovation across the region. Zili joined Janssen in June 2019 from the FDA where he served as Associate Director for Global Affairs at the Office of Generic Drugs. There he contributed significantly to the expansion of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to the field of generic drugs, playing a critical role in China’s National Medical Products Administration’s membership in ICH in 2017. Zili is a graduate of Peking Union Medical College and completed his residency training at Johns Hopkins in 2000.

Craig Lipset is Founder and Managing Partner of Clinical Innovation Partners, a growth advisory practice for clinical trial innovation. He is Co-Chair of the Decentralized Trials & Research Alliance, Assistant Professor of Health Informatics at Rutgers University, and adjunct faculty at the University of Rochester Center for Health and Technology. Craig serves on the Board of Directors for the MedStar Health Research Institute, Foundation for Sarcoidosis Research, and for Circuit Clinical. He is a Venture Partner with Boston Millennia Partners. Craig is a past DIA Annual Meeting Chair, and currently serves on the Regional Advisory Committee for North America.

Barbara Lopez Kunz serves as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s largest, most respected R&D organizations. She has also served as Senior Vice President/General Manager for Thermo Fisher Scientific’s Biosciences Division, as SVP for DuPont, and head of R&D for ICI. A dedicated volunteer for children's health, Barbara chairs the board of Children's National Research Institute, serves as advisor to the UC I4H Fellowship, and as Director for Aptevo Therapeutics.

Murray M. Lumpkin, MD, serves as Deputy Director, Integrated Development, and Lead for Global Regulatory Systems Initiatives, for The Bill & Melinda Gates Foundation, working to improve the efficiency and effectiveness of regulatory processes in low- and middle-income countries. He served at the FDA, including ten years as Deputy Commissioner for International Programs, eight years as Deputy Direct of CDER (Review Management), before joining The Gates Foundation. Dr. Lumpkin was one of the initial members of FDA’s representation to the International Conference on Harmonization, and served for nine years as FDA’s representative to the WHO’s Council for International Organizations of Medical Sciences drug safety working groups.

Sandra Milligan is the executive vice president and head of Research and Development, Organon, focused on improving the everyday health of every woman. Prior to this role, she served as senior vice president and head of Global Regulatory Affairs and Clinical Safety (GRACS), consisting of global Regulatory, Safety and CMC functions at Merck & Co., Inc. From 2011 to 2017, Sandy served on the board of directors and executive committee of the DIA. In 2017, Sandra was recognized as a DIA Fellow and was appointed to the Science Advisory Council in 2018. She is a graduate of George Washington University School of Medicine and Georgetown University Law Center.

Noriaki Murao is an independent regulatory consultant who spent four decades working in new drug development in national and global companies such as Otsuka Pharmaceutical Co. Ltd. and Aventis. While conducting clinical research in Germany, he was invited to the DIA EuroMeeting and to serve on the DIA Steering Committee for Europe. These experiences helped support the growth of DIA Japan upon his return: He served as speaker, chairperson, and on the program committee for numerous DIA Japan meetings, and has contributed as a chairperson and speaker to the DIA EuroMeeting and Global Annual Meeting. In 2015, Mr. Murao was recognized as a Fellow of DIA. He earned his BS and MS degrees in Pharmacy from Fukuoka University and Kyushu University.

Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member of its Management Board in the three years prior to this. He was Director-General of the Italian Medicines Agency (2008-2011) and member of the Management Board (2004-2008). He was made full professor of microbiology at the University of Rome 'Tor Vergata' in 2008. He holds a degree in medicine and surgery, with specialisations in internal medicine, allergology and clinical immunology, from the University of Rome.

Dr. Jennifer Riggins has extensive experience in medical affairs, medical information, medical communications, and digital channels. She is the President of JSR Medical Affairs Consulting and also serves as the Partnership and Technology Strategist for phactMI, a non-profit organization that is both an industry Medical Information center of excellence and the single source of industry medical information. Dr. Riggins, a DIA Fellow, has served on the DIA Board of Directors and Advisory Council of North America among other activities. A dedicated PharmD student preceptor and former director of drug information residency and fellowship programs, Dr. Riggins earned her Doctor of Pharmacy degree from Butler University.

Jay Roberts, MBA, is President and Chief Executive Officer of Cancer Genetics, Inc., a leader in enabling precision medicine in oncology, where he previously served as Chief Operating Officer and Executive Vice President of Finance. Mr. Roberts also served as Chief Financial Officer for VirMedica, Inc.; as Chief Financial Officer and Treasurer for InfoLogix, Inc., a publicly-traded healthcare-centric mobile software and solutions provider acquired by Stanley Healthcare with Mr. Roberts leading the transaction; and as Chairman of the Board of Directors for AdvantEdge Healthcare Solutions Private Limited. He formerly held senior executive roles with MEDecision, Inc., HealthOnline, Inc., and the Center for Health Information.

Dr Saint-Raymond is a French paediatrician. In 1995, she joined the French Medicines Agency, and in 2000 she joined the EMA where she was the Head of Special Areas (Paediatrics, Orphan Drugs, Scientific Advice, SME Office and Scientific Projects). She implemented the European Orphan Drug Regulation then the Paediatric Regulation. She has been an expert for the European Commission, the European Developing Countries Trial Partnership, the Canadian Council of Academies, and the US National Academies of Science, Engineering and Medicine, a member of the UN Commission on Life-Saving Commodities for women and Children and Associate Prof of Paediatrics at Tor Vergata University Rome.

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She also worked in U.S. FDA as a guest reviewer from 2002-2003, and in EMA as the Japan Liaison Officer from 2012-2014. She is actively involved in many academic societies, and contribute them as counselor, committee member, and a board member.

Dr. Scheeren worked in R&D in the Pharmaceutical Industry for over 35 years in the USA, China and Europe. Former Chair of DIA. Currently , he is a Board Member of VacciTech plc. He recently founded a consultancy company ScheerenHeathCare LLC. Since January 2019, he is Adjunct Professor at Peking University for Regulatory Sciences. He was President and CEO of the C-Path Institute from 19-21. Dr. Scheeren serves on the Forum of the NAS, on Advisory Boards at the CIRS, the Regulatory Affairs Track at Yale University, the CoRE in Singapore, the College of Pharmacy at the UA. He is also a foreign member of the Academie Nationale de Pharmacie in France, and a lecturer at Yale University. Dr. Scheeren studied pharmacy at the University of Leiden.

Jeffrey W. Sherman, MD, FACP, is CMO and EVP at Horizon Therapeutics. Jeff has more than 30 years of biopharmaceutical industry experience at IDM Pharma, Takeda Global Research and Development, NeoPharm, Searle/Pharmacia, and Squibb/Bristol-Myers Squibb. He, a Past Chairperson of the Board of Directors of DIA, has served as DIA Annual Meeting Chair, received the DIA Outstanding Service Award, and served as DIA liaison to the FDA Clinical Trial Transformation Initiative (CTTI) Steering Committee, as well is an inaugural DIA Fellow. Jeff is also a member of the Global Genes Medical and Scientific Advisory Board and serves on the Board of Advisors of the Center for Information and Study on Clinical Research Participation (CISCRP).

Per Spindler, DVM, MSc (Applied Toxicology), Executive-MBA; on top of various senior positions in biotech & pharma, and in the public-private health care system, he now leads the GCP, GVP and GLP inspection teams at the Danish Medicines Agency in support of national activities and European / international collaborations. He has been active in IMI, ICH and EMA/CHMP activities. Dr. Spindler received DIA’s Outstanding Service Award in 2002, was DIA Board Member 2007-2016 and served as President 2014-2015.

Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry, including Medical Director at MSD, Pharma Development Director at Roche, VP for Clinical Research Asia Pacific at Wyeth, and SVP and Head of Pharma Development China at Novartis. Prior to that, he worked in the Chinese regulatory agency and CDER, US FDA. He is a Fellow of DIA and was the President of DIA (2012-2013). Ling holds BS in pharmacology from Shanghai Medical University and PhD in Epidemiology from University of North Carolina at Chapel Hill, USA.

Lingshi Tan, PhD, is Chairman and CEO of dMed Global, a Next Generation global clinical development partner, with strengths in China and the US, that is committed to helping companies accelerate delivery of solutions to patients worldwide. Prior to founding dMed, Dr. Tan was Pfizer’s VP of Worldwide Development Operations, and Chairman and General Manager of Pfizer (China) Research & Development Co., Ltd. He was the inaugural Chair of Research & Development-based Pharmaceutical Association’s R&D committee and the inaugural Chair of Pharmaceutical Innovation and Research Development Association’s Innovation R&D Services Committee. He earned his PhD in Biostatistics from the University of Pittsburgh.

Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference on Harmonisation Technical Coordinator; as ICH E15 and E16 topic leader; as Division Director, Regulatory Science Research; as Division Director, Review Planning and Pharmaceutical Affairs Consultation; as Director, Division of Epidemiology; and as Rapporteur of the International Conference on Harmonisation E17 Expert Working Group. Dr. Uyama earned his PhD from Nagoya City University and his post-doctoral research focused on promoting science within Japan.

Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons, Patient Partnership, Digital Health, and Six Sigma, in her 28 years of healthcare industry experience, and has been responsible for creating global standards for information exchange with healthcare professionals and patients. Rebecca is currently Chair of the DIA Board of Directors, Chair of the Healthcare Businesswomen’s Association Corporate Board of Directors, and serves on the Patient Focused Medicine Development Advisory Committee.

Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices Agency. Christa is the elected Chair of the EMA Management Board.

Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER. In that position, she has led many of the FDA’s groundbreaking drug initiatives. In 2020 Dr. Woodcock was asked to lend her expertise to “Operation Warp Speed” the initiative to develop therapeutics in response to the pandemic. Dr. Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021-February 17, 2022. Dr. Woodcock is now the FDA's Principal Deputy Commissioner. In this role she works closely with the Commissioner of Food and Drugs to develop and implement key public health initiatives and helps oversee the agency’s day-to-day functions.

Dr. Xu is currently the Executive Vice President and Head of Clinical Development and Regulatory Aff airs at Zai Laboratory. Dr. Xu has 25 years of experience in drug clinical development, and has been the Chairman of the Advisory Council of DIA China and DIA Global Board of Directors from 2011 to 2015. Dr. Xu got his MD from Peking Union Medical Colleague and MBA from the University of Illinois at Chicago.