Fellows of DIA
The Fellows of DIA represent our longest standing, most highly committed members. Fellowship is an honorary recognition, bestowed on less than 1% of DIA's members, who have demonstrated active support of the advancement of global healthcare through DIA's neutral forum.
Dr. Scheeren worked in R&D in the Pharmaceutical Industry for over 35 years in the USA, China and Europe. He led the Regulatory Affairs Department in Bayer in the last 15 years. Since January 2019, he is Adjunct Professor at Peking University for Regulatory Sciences in the Department of Clinical Research. In April 2019 he joined C-Path Institute as its President and CEO. Dr. Scheeren serves on Advisory Boards at the Center for Innovation in Regulatory Science, the Regulatory Affairs Track at Yale University, the Center of Regulatory Excellence in Singapore. 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.
Martin Harvey Allchurch
Martin Harvey Allchurch serves as Principal International Affairs Officer for the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He subsequently headed the Office of the Executive Director, served as Head of Communication, and then moved to the Agency's International Affairs team. Mr. Harvey Allchurch has served on the DIA Advisory Council for Europe, Middle East, and Africa; and as program advisor for the DIA EuroMeeting and Global Annual Meeting. He earned Law degrees from the University of Dundee (UK) and Vrije Universiteit Brussels (Belgium).
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.
Gerald J. Dal Pan
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 L. Danan
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.
Richard O. Day
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 Officer and SVP at IQVIA. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health, she also serves on the Clinical Trials Methods Advisory Panel for PCORI. She was named twice to PharmaVOICE’s list of 100 most influential and inspiring individuals in life sciences, and received DIA’s 2019 Global Inspire Award for Author of the Year for “Advancing a framework for regulatory use of real world evidence: When real is reliable.” Her work has been used by global regulators, with recent reference in the new RWE Chinese guidelines for using RWE.
Ron D. Fitzmartin
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, 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
E. Stewart Geary, MD, is Global Safety Officer and Senior Vice President at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Boards for Applied Clinical Trials and 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
Kenneth A. Getz
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center for Information & Study on Clinical Research Participation, and Founder of CenterWatch, a leading publisher in the clinical trials industry. Mr. Getz serves on the editorial board of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science, and his column for Applied Clinical Trials was nominated for a Neal Award. He earned his MBA from the J.L. Kellogg Graduate School of Management at Northwestern University.
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National Academy of Sciences, on the first Executive Committee of the Clinical Trials Transformation Initiative, as Chairman of the Regulatory Affairs Professional Society, and as President of FIDIA Pharmaceutical Corporation. He is a DIA Fellow, Editor-in-Chief of DIA's digital magazine Global Forum, and serves on the faculty of DIA's Regulatory Affairs: The IND, NDA, and Post-Marketing training course, which he has 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.
Tatsuya Kondo, M.D., Ph.D., is Chief Executive Officer of Medical Excellence JAPAN and Chief Executive Emeritus of the Pharmaceuticals and Medical Devices Agency (PMDA). As the Chief Executive of PMDA from 2008-2018, he directed all operations, including drug relief services, reviews of medical products, and post-marketing safety. Dr. Kondo was a key member of the International Coalition of Medicines Regulatory Authorities (ICMRA) established by top drug regulatory agencies. A neurosurgeon in his pre-PMDA career, Dr. Kondo later became Director of the National Center for Global Health and Medicine. His experience includes a fellowship in the Max Planck Institute for brain tumor research and a visiting staff surgeon posting in Beijing.
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.
Sandra L. Kweder
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts from FDA, EMA and other medicines agencies. She previously served for over a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research. Dr. Kweder is a retired Rear Admiral of the US Public Health Service.
Birka Lehmann, MD was Head of Executive Department EU and International Affairs of the Federal Institute for Drugs and Medical Devices (BfArM) from October 2011 to March 2016. Dr. Lehmann studied Medicines at the Free University Berlin and trained at the Kinderklinik Norderney. Her working experience includes 9 years preclinical assessment in the division ‘Pharmacology and Toxicology’ of BfArM and she served as head of unit ‘Decentralised Procedure’ (1996-2002) and as deputy head of EU Division (2000-2002).
Murray M. Lumpkin
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 A. Milligan
Sandra Milligan is head of Global Regulatory Affairs and Clinical Safety (GRACS) at Merck. GRACS optimizes regulatory plans to facilitate innovative product development, regulatory approval and commercialization around the world, assures the safe use of products worldwide, and maintains registrations for over 200 products across 183 international markets. She served as program chair on DIA’s Board of Directors from 2011 to 2017, and as President of DIA from 2015 to 2016. In 2017, Sandra was recognized as a DIA Fellow for her engagement and contributions to the mission of DIA and was appointed to DIA’s 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.
Jennifer L. Riggins
Jennifer Riggins, PhD, has extensive experience in medical information, medical communications, and digital channels, and serves as Advisor, Global Medical Channels & eCapabilities, for Eli Lilly and Company, where she previously served as Director, Global Information Disclosure. She is also President of phactMI, a group dedicated to bringing medical information transparency to the healthcare community by increasing the value and availability of comprehensive drug information. Dr. Riggins has served on the DIA Board of Directors and Advisory Council of North America. A dedicated PharmD student preceptor and director of drug information residency and fellowship programs, Dr. Riggins earned her Doctor of Pharmacy from Butler University.
John A. (Jay) Roberts
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.
Jeffrey W. Sherman
Jeffrey W. Sherman, MD, FACP, is Chief Medical Officer and Executive Vice President at Horizon Pharma. Dr. Sherman has more than 25 years of pharmaceutical industry experience through engagements with IDM Pharma, Takeda Global Research and Development, NeoPharm, Searle/Pharmacia, and Squibb/Bristol-Myers Squibb. He a Past President of DIA, has served as DIA Annual Meeting Chair, received the DIA Outstanding Service Award, serves as DIA liaison to the FDA Clinical Trial Transformation Initiative Steering Committee, and was an inaugural DIA Fellow. He is 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.
Per Spindler, DVM, MBA, leads Denmark’s Life Science Cluster Biopeople, the first Life Science cluster in Europe that was awarded the Gold Label of the European Cluster Management Excellence. He is a member of the Scientific Advisory Board of the Copenhagen Centre for Regulatory Science, and of the European Cluster Excellence Expert Group of the European Secretariat for Cluster Analysis. Dr. Spindler has received DIA’s Outstanding Service Award, and has served on the Board for EUPATI Denmark, the DIA Advisory Council of Europe, and the DIA Board of Directors. He has organized hundreds of meetings and training courses, mainly within regulatory science and affairs, and non-clinical safety sciences and toxicology.
Ling Su, PhD, is Professor in Shenyang Pharmaceutical University, and a Venture Partner with Lilly Asia Ventures. Dr. Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency and US FDA, as well as in various R&D management positions in the pharma industry, including VP for Clinical Research Asia Pacific at Wyeth, and SVP and Head of Pharma Development China at Novartis. In addition, he is a Research Fellow at the Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University and an inaugural member of the Biotech Expert Advisory Panel of Hong Kong Stock Exchange. He is the past president and a Fellow of DIA.
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.
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. 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.