Science and Policy Advisory Council

Since 2001 Dr. Kucherlapati is the Paul C. Cabot Professor of Genetics and Professor of Medicine at Harvard Medical School and was the first Scientific Director of the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics (HPCGG). He was a co-founder of several biotechnology companies including Cell Genesys, Abgenix, Millennium and AVEO Oncology. He served on the Board of Directors of all these companies and is now the Chair of the Board of Directors of a public traded company, Puretech Health. Raju Kucherlapati received his Ph.D. from the University of Illinois at Urbana and did his post-doctoral work at Yale University.

Member of the DIA Board of Directors and also serves as the Co-chair for the DIA Science Policy Advisory Committee. He is an accomplished global life sciences innovation executive with more than 20 years of leadership experience across three multinational corporations, GE Healthcare, Life Technologies, and Terumo BCT, delivering over $500M in career revenue. Palani has a considerable track record in breadth and depth from a medical product development standpoint, and has worked in the areas of drugs, devices, and diagnostics. Palani has a Ph.D. in the field of biological sciences from Northern Illinois University, followed on by a post-doctoral fellowship at the University of Rochester in HIV biology.

Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 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. As a thought leader on many issues related to Food and Drug Administration, regulatory strategy and healthcare policy, he is regularly published in prestigious medical journals and policy publications, and has contributed his expertise to the legislative process on multiple occasions. Dr. Allen received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelors of Science in Biology from Bowling Green State University.

Brandon Allgood, PhD, is Chief Data Officer at Parabilis Medicines, leading data science integration to accelerate drug discovery. He has 20+ years of experience applying machine learning to human health, teaches ML at UC Berkeley, and advises biotech and tech organizations. He co-founded Valo Health, Numerate, and Pharmix, developing platforms such as Opal and D4, and led 30+ collaborative drug programs across pharma and biotech. His publications span physics, biology, and AI in healthcare. He also founded and chaired the Alliance for AI in Healthcare, is a UC Santa Cruz Foundation trustee emeritus, and serves on the UC Santa Cruz Baskin Engineering Dean’s Council. He holds a BS in Physics and a PhD in Theoretical Cosmology.

Dr. Banerjee is CEO of Perspectum, a precision health company dedicated to improving the diagnosis, treatment, and management of metabolic diseases and cancer. He trained at Oxford and in London in medicine and cardiology. His interest in acquired cardiovascular disease grew from the rise of coexisting cardiovascular and liver disease linked to obesity and alcohol use. Awarded a British Heart Foundation Fellowship in 2008, he studied excess weight’s effects on the cardiovascular system. In 2011, he launched the Rapid Imaging in Liver Disease (RIAL) study, using advanced MR techniques to improve liver disease diagnosis and monitoring, now widely adopted. In 2024, Perspectum was recognised as Oxfordshire’s best-established MedTech company.

Dr. Sandra Blumenrath is the Executive Editor of Scientific Publications & Sr. Scientific Program Manager at DIA, where she oversees the organization's publications portfolio and leads research projects in rare neurological disorders. She collaborates with regulators, industry leaders, non-profits, academia, and patient advocacy groups. Dr. Blumenrath holds a Ph.D. in Biology from the University of Maryland, College Park, and an M.S. from the University of Copenhagen, Denmark. With international experience working across the U.S., Denmark, and Germany, she specializes in science communication, open science advocacy, strategic publication management, and interdisciplinary collaboration to share scientific knowledge and advance global health.

Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation of the CDER Center for Clinical Trial Innovation (C3TI). Prior to his current roles, from May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government’s HHS and DOD operation formerly known as Operation Warp Speed.

Rosa Canet-Aviles, PhD, is Chief Scientific Officer at the California Institute for Regenerative Medicine (CIRM), where she leads scientific strategy and programs to accelerate transformative cell and gene therapies. She oversees investments across discovery, preclinical, and clinical research, as well as infrastructure and education. Rosa has advanced CIRM’s Strategic Allocation Framework and initiatives to expand trial networks, build platforms, and improve equitable access, positioning California as a leader in regenerative medicine. Previously, she directed strategic alliances at Eisai’s G2D2 and led major public-private neuroscience programs at the Foundation for NIH. She holds a PhD in neuroscience and a BS in Chemistry.

Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise includes patient-generated information, electronic health records, health insurance claims, and data linkage, including collaboration with regulators and HTA. Widely published, she is a Science and Policy Advisor to DIA and a member of the Real-World Evidence Leadership Team for ISPOR. She is a Fellow of ISPE and DIA, an Adjunct Professor of Epidemiology at University of North Carolina at Chapel Hill and a Trustee of Brandeis University.

Toshio Fujimoto, MD, MBA, is CEO of iPark Institute, operating a science park with 120+ life science companies from startups to global pharma. A Kyoto University medical graduate, he trained in thoracic surgery in Japan, Germany, and the US, including the Mayo Clinic. He joined Eli Lilly in 2006, becoming VP of the Medicines Development Unit Japan. In 2017, he became GM of Shonan Health Innovation Park (iPark), later serving as Head of Global Public Affairs at Takeda. When iPark spun out in 2023, he was appointed CEO, driving biotech ecosystem growth in Japan. Since 2024, he has also been Founding CEO of Ciconia Bio Ventures, a joint incubator by Takeda, Astellas, and SMBC.

Yeul Hong Kim, MD, PhD is the President of R&D at Yuhan corporation, Korea. Dr. Kim was Professor of Medical Oncology at the Korea University College of Medicine from 1995 to 2023. He is certified in internal medicine and medical oncology by the Korean Association of Internal Medicine. He was a research fellow in the Department of Gastrointestinal Medical Oncology and Thoracic/Head and Neck Medical Oncology of the MD Anderson Cancer Center in Houston, TX. Dr. Kim is primarily interested in the new drug development in precision medicine era. He is former President of Asian Oncology Society and he served as the Director of the Korean Precision Medicine Enterprise from 2017 to 2022.

Dr. Kirsch received his M.D. from Harvard University Medical School, Residency at Children’s Hospital Medical Center, Boston, MA, and Fellowship in Pediatric Hematology/Oncology at the National Cancer Institute (NCI) USA. He completed a three-year postdoctoral fellowship in molecular genetics in the laboratory of Dr. Philip Leder. He continued at the NCI as a basic researcher, attending physician and, ultimately, Chief of the Genetics Branch within the Center for Cancer Research. In 2005, he joined the biotech/pharma company, Amgen, as an Executive Director in Oncology Research. He is currently the Distinguished Physician-Scientist, Translational Medicine, at Adaptive Biotechnologies, Seattle, Washington, employed there since 2012.

Prof Sir Martin Landray is CEO of Protas, a non-profit company that focuses on advancing the design and delivery of highly efficient randomized trials of treatments for major health conditions. He is Professor of Medicine & Epidemiology at Oxford Population Health and has over 20 years’ experience leading large, randomized trials particularly in common cardiometabolic and kidney disease. He co-leads the RECOVERY trial, the world's largest and most successful trial of treatments for COVID-19, estimated to have prevented over 1 million deaths worldwide. He is a global thought leader in clinical trial policy and regulation, and led the Good Clinical Trials Collaborative. In June 2021, he was knighted for services to public health and science.

Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she worked at FDA for 13 years and held positions with increasing responsibilities, including Statistical Reviewer, Team Leader, and Acting Deputy Division Director. She had extensive experience in multiple therapeutic areas for both new and generic drugs. In addition, she was a research faculty member at Johns Hopkins University and a statistical consultant at the University of Kentucky. Dr. Luan is President of Chinese Biopharmaceutical Association 2023-2024.

Dr. Mamoru Narukawa is a professor at Kitasato University Graduate School of Pharmaceutical Sciences. He has been in charge of research and education in the areas of clinical trial design and development strategy of new pharmaceuticals and related regulations since 2007. He assumed the position of Director of Center for Product Evaluation in the Pharmaceuticals and Medical Devices Agency as a dual appointment in 2025. He joined the Ministry of Health and Welfare in 1991 after graduating from the Tokyo University Faculty of Pharmaceutical Sciences. He is a pharmacist and holds Ph.D in biostatistics.

Francisco Nogueira is a highly accomplished and forward-thinking C-suite executive with over 25 years of impactful leadership in the pharmaceutical and health technology sectors. Known for his strategic insight and agility, Francisco has developed a reputation for excellence in drug development, commercialization, and regulatory affairs across a broad range of global markets. His career has been marked by a deep commitment to innovation, collaboration,and improving patient access to therapies. Currently, Francisco serves as the Chief Executive Officer of Accumulus Technologies. As the first employee of the company, he played a pivotal role in conceptualizing and building the organization from the ground up.

Dominique Pichard, MD is the Chief Science Officer at the International Rett Syndrome Foundation (IRSF). In this role, she is responsible for the research program that includes funding of basic, translational, clinical, and neurohabilitation research, the Scout program to accelerate drug development, and a clinical network. Prior to joining IRSF, she was at the NIH working in early phase clinical trials and outcome measure development for rare disorders. Dominique earned an M.D. from Georgetown University School of Medicine and a B.A. in Biological Basis of Behavior (Neuroscience) from the University of Pennsylvania.

Khushboo Sharma is the CEO of Accumulus Synergy, bringing nearly two decades of leadership in regulatory innovation and policy development. She joined Accumulus in 2022 as Chief Regulatory Innovation Officer, where she led strategic efforts to modernize regulatory frameworks and foster global collaboration. Prior to Accumulus, she held key roles at BIO, the trade association and spent 11 years at the FDA, including as Deputy Director of Operations in the Office of New Drugs in CDER. Her work has shaped major regulatory initiatives, including the New Drugs Modernization effort between FDA and industry. She holds a bachelor’s degree in biotechnology and an MBA in Biotechnology and Healthcare Industry Management from Penn State University.

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.

Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association for the Advancement of Science. She was also on the leadership teams of two health research organizations, serving as project director on multiple government contracts. Her areas of expertise include musculoskeletal, metabolic, immunity and inflammation disorders, as well as patient engagement. She received her PhD in Biochemistry and Cell Biology from Johns Hopkins.

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 25 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.

After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also spent some time in China and the USA. Max Wegner led the Therapeutic Areas organization in Pharmaceuticals Development for four years before re-joining Regulatory Affairs in 2018 as Head of Regulatory Affairs. As a special Pharmacist for Drug Information, he is a member of the examination board of the Pharmacy Association Nordrhein-Westfalen and a college lecturer and speaker for various regulatory topics.

Carolyn Shore serves as global health lead and director of the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine. Before joining the National Academies, Carolyn was an officer on Pew’s antibiotic resistance project, leading work on research and policies to spur the discovery and development of urgently needed antibacterial therapies. She previously served as a foreign affairs officer at the U.S. Department of State, working on food safety, plant and animal health, biosecurity, and agricultural trade policy. Carolyn is a former American Society for Microbiology Congressional Science Fellow and Fulbright Fellow.