Featured Speakers

Amy Xia is Vice President, Center for Design and Analysis at Amgen, providing leadership for strategic drug development and driving innovative program/study designs across Amgen’s portfolio for evidence generation and decision-making. Amy has extensive experience in biopharmaceutical and medical device industries in the past two decades across all development phases and a variety of disease areas. Amy is a recognized industry expert in innovative Bayesian applications, adaptive designs, pediatric extrapolation, meta-analysis and safety evaluation in drug development, and pioneers work in design optimization, evidence synthesis and product/portfolio decision-making. She is currently a member of the ICH E20 Expert Working Group on Adaptive Clinical Trials and previously served as the Vice-Chair for the DIA Bayesian Scientific Working Group. Amy is an elected Fellow of American Statistical Association. She received her PhD in Biostatistics from the University of Minnesota, and her medical degree from Peking University, China.

John Scott is director of the Division of Biostatistics in the US Food and Drug Administration's Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and cellular, tissue, and gene therapies. Prior to joining the FDA in 2008, he worked on psychiatric clinical trials at the Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center.

Scott holds a PhD in biostatistics from the University of Pittsburgh, an AM in mathematics from Washington University in St. Louis, and a BA in liberal arts from Sarah Lawrence College. He is a fellow of the American Statistical Association and is a past editor of Pharmaceutical Statistics.

Frank Bretz, a distinguished quantitative research scientist, joined Novartis in 2004. He has a keen interest in advancing drug development practices and has supported the methodological development of various areas of pharmaceutical statistics, including adaptive designs, dose-finding, estimands, and multiple testing.

Bretz holds adjunct professorial positions at the Hannover Medical School (Germany) and Medical University of Vienna (Austria). He was a member of the International Council for Harmonization’s E9(R1) expert working group on estimands and sensitivity analysis in clinical trials and currently serves on the ICH E20 expert working group on adaptive clinical trials.

Among other professional services, Bretz is a co-founding editor of the Springer Series in Pharmaceutical Statistics and past editor of Statistics in Biopharmaceutical Research. He has authored or co-authored five books and more than 200 methodological articles in peer-reviewed journals. Bretz is a recipient of the Susanne-Dahms-Medal from the German Region of the International Biometric Society and a fellow of the American Statistical Association.

Frank Pétavy is head of methodology for the European Medicines Agency’s Task Force on Data, Analytics, and Methods. He and his team provide statistical advice for medicine development and the assessment of marketing authorization applications across therapeutic areas. Frank was a member of the International Council for Harmonization’s expert working group for E9(R1) on estimands and sensitivity analysis and is currently helping develop the ICH E20 guideline on adaptive designs and the ICH M11 structured trial protocol. He also oversees EMA projects on submission of raw data and knowledge management based on AI.

Pétavy first studied mathematics and physics in Paris. He completed a post-graduate diploma in biostatics in Rennes, France, and has 14 years’ experience in clinical development in the pharmaceutical industry in Spain and the UK.

Yuki Ando is a principal senior scientist for biostatistics at the Pharmaceuticals and Medical Devices Agency in Japan. She has more than 20 years' experience as a biostatistics reviewer and is responsible for the biostatistics review and consultation in the new drug and device review offices at the agency. She also works for the Office of Advanced Evaluation with Electronic Data, which is responsible for the electronic study data submission. Finally, she is a member of the Real World Data Working Group and Global Clinical Study Working Group, projects that span multiple offices at the agency.

Ando has experience in the development of ICH guidelines such as E14, E9(R1), E8(R1), and E20 as an EWG member and has advised from the statistical viewpoint during discussions about other ICH guidelines. She earned a master’s degree in engineering from Tokyo Science University and PhD in health science from Osaka University.

Lisa LaVange is professor and chair of the department of biostatistics in the Gillings School of Global Public Health at The University of North Carolina at Chapel Hill. She is former director of the department’s Collaborative Studies Coordinating Center, overseeing faculty, staff, and students involved in large-scale clinical trials and epidemiological studies. She also serves as coordinating center principal investigator for large-scale studies in a variety of disease areas, including pulmonary and cardiovascular medicine, schizophrenia, chronic lower backpain, severe asthma, and HIV/AIDS.

Since early 2020, LaVange has been involved in the National Institutes of Health public-private partnership Accelerating COVID-19 Therapeutic Interventions and Vaccines, collaborating on master protocol design and implementation. From 2011 to 2017, she was director of the Office of Biostatistics at the US Food and Drug Administration's Center for Drug Evaluation and Research. There, she oversaw more than 200 statisticians and other staff members involved in the development and application of statistical methodology for drug regulation. She was a leader in developing and assessing the effectiveness and appropriateness of innovative statistical methods intended to accelerate the process from drug discovery to clinical trials to FDA approval and patients’ benefit. She continues to advise on strategic initiatives today.

Prior to her government and academic experience, LaVange spent 16 years in nonprofit research and 10 years in the pharmaceutical industry. She is a fellow of the American Statistical Association and served as its president in 2018.

Kelly H. Zou, PStat^®, is head of global medical analytics and real-world evidence at Viatris. Previously at Pfizer, she was vice president and head of medical analytics and insights, senior director of real-world evidence, group lead of methods and algorithms, lead of analytic science, and senior director of statistics.

Zou earned both MA and PhD degrees in statistics from the University of Rochester and completed her postdoctoral fellowship at Harvard. Her research interests include health policy, real-world evidence, signal detection, and artificial intelligence, and she has written 150 professional articles and five books. She was featured as an outstanding woman in data analytics by Forbes, an inspirational woman in statistics and data science by Wiley, and an accomplished woman in statistics and data science by the American Statistical Association, of which she is also a fellow. Zou also won the Chief Data and Analytics Officers’ Forum’s Future Thinking Award and Reuters Events Pharma USA’s Most Valuable Data and Insights Initiative Team Award.

Matthew Diamond is the chief medical officer at the US Food and Drug Administration’s Digital Health Center of Excellence. Serving as the senior clinical expert for digital health medical devices at the Center for Devices and Radiological Health, he provides clinical leadership for policy development on digital health technologies, including artificial intelligence–enabled medical devices. He represents the FDA for national and international digital health initiatives, including as chair of the International Medical Device Regulators Forum Artificial Intelligence Working Group.

Prior to joining the FDA, Diamond served on leadership teams of large and small technology companies—including as chief medical officer at Nokia—and on advisory boards such as the Center for Personalized Health Monitoring at the University of Massachusetts, Amherst, and the venture firm NGP Capital. As vice chair of the Consumer Technology Association Health and Fitness Technology Board of Directors, he promoted public health applications of mobile technology and established an ANSI-accredited standardization committee to develop standards in digital health for wellness-related products.

Diamond earned his MD and PhD (biophysics) from the Mount Sinai School of Medicine and is board certified in rehabilitation medicine and certified in medical acupuncture. A faculty member at New York University, he is passionate about helping people improve their mobility and performance through a holistic approach to rehabilitation and technology that promotes wellness.

Jennifer C. Goldsack founded and serves as the CEO of the Digital Medicine Society (DiMe), a 501(c)(3) non-profit organization dedicated to advancing digital medicine to optimize human health. Her research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, health care, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering, and Medicine and serves on the World Economic Forum Global Leadership Council on Mental Health.

Goldsack earned her master’s degree in chemistry from the University of Oxford, England; her master’s in the history and sociology of medicine from the University of Pennsylvania; and her MBA from The George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and Certified Professional in Healthcare Quality. She is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.

Frank Pétavy is head of methodology for the European Medicines Agency’s Task Force on Data, Analytics, and Methods. He and his team provide statistical advice for medicine development and the assessment of marketing authorization applications across therapeutic areas. Frank was a member of the International Council for Harmonization’s expert working group for E9(R1) on estimands and sensitivity analysis and is currently helping develop the ICH E20 guideline on adaptive designs and the ICH M11 structured trial protocol. He also oversees EMA projects on submission of raw data and knowledge management based on AI.

Pétavy first studied mathematics and physics in Paris. He completed a post-graduate diploma in biostatics in Rennes, France, and has 14 years’ experience in clinical development in the pharmaceutical industry in Spain and the UK.

Yuki Ando is a principal senior scientist for biostatistics at the Pharmaceuticals and Medical Devices Agency in Japan. She has more than 20 years' experience as a biostatistics reviewer and is responsible for the biostatistics review and consultation in the new drug and device review offices at the agency. She also works for the Office of Advanced Evaluation with Electronic Data, which is responsible for the electronic study data submission. Finally, she is a member of the Real World Data Working Group and Global Clinical Study Working Group, projects that span multiple offices at the agency.

Ando has experience in the development of ICH guidelines such as E14, E9(R1), E8(R1), and E20 as an EWG member and has advised from the statistical viewpoint during discussions about other ICH guidelines. She earned a master’s degree in engineering from Tokyo Science University and PhD in health science from Osaka University.

Vinay Pai is a digital health specialist in the US Food and Drug Administration’s Center for Devices and Radiological Health, Office of Strategic Partnerships and Technology Innovation, Division of Digital Health, having joined the FDA in September of 2019. Prior to that, Pai was at the National Institutes of Health, first as a staff scientist in the National Heart, Lung, and Blood Institute (working on MRI and CT technology development and image processing and researching cardiac function in humans and mice models) and then as a program officer and division director for biomedical imaging informatics and health informatics at the National Institute of Biomedical Imaging and Bioengineering.

Pai holds a PhD in mechanical engineering from Florida State University and an MBA from Johns Hopkins University.

Sandeep Menon is the chief scientific officer of AI Digital Science and senior vice president and head of early clinical development and biomedicine AI at Pfizer. He also holds adjunct faculty positions at Boston University School of Public Health, Tufts University School of Medicine, and the Indian Institute of Management. He earned his medical degree from Bangalore (Karnataka) University and later completed his master’s in public health and PhD in biostatistics at Boston University. He was also a research fellow at Harvard Clinical Research Institute.

At Pfizer, Menon is on the Worldwide Research, Development, and Medical Leadership Team and leads a multi-functional global team that includes experts in the clinical sciences, machine learning and computational sciences, precision and translational medicine, diagnostics, digital medicine, translational imaging, and early scientific planning and operations. His responsibilities span multiple therapeutic areas, including inflammation and immunology, oncology, rare disease, anti-infectives, and cardiovascular and metabolism. He also leads the Digital Medicine Pfizer Innovation and Research Lab with a remit to leverage state-of-the-art technology to enable dynamic and remote monitoring of human behaviors to develop meaningful novel quantitative digital endpoints.

Menon is a fellow of the American Statistical Association. He was awarded the Young Scientist Award by the International Indian Statistical Association, received the Statistical Excellence Award in Pharmaceutical Industry by the Royal Statistical Society, and recently received the Distinguished Alumni Award from Boston University School of Public Health. He has more than 60 publications and book chapters and has co-authored /co-edited eight books.