DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients
Robert A. Beckman, MD
- Professor of Oncology, Bioinformatics, and Biomathematics
- Georgetown University Medical Center, United States
Robert Beckman, M.D. is an oncology clinical researcher and biomathematician focused on improving the way cancer therapies are developed and utilized. He has co-invented novel clinical strategies for proof of concept studies, basket trials, and biomarker driven clinical development, as well as novel therapeutic strategies incorporating tumor evolution. In a previous 18 year industry career, he played leadership roles in forming 4 oncology clinical research groups. He has contributed approximately 300 published articles, book chapters, and presentations, emphasizing quantitative approaches to basic and applied oncology, including a recent book on master protocols. He currently leads the DIA Innovative Design Scientific Working Group.
Fanni Natanegara, PhD
- Senior Director - Statistics
- Eli Lilly and Company, United States
Dr Fanni Natanegara is currently a Principal Research Scientist and a Group Leader for the Early Phase Neuroscience Statistics team at Eli Lilly and Company. She has 16+ years of pharmaceutical experience providing statistical leadership in designing, executing, and reporting clinical trials. She was instrumental in providing Bayesian education outreach and statistical consultation at Eli Lilly while working to accelerate the organization’s clinical development transformation. She is also actively engaged in external activities, including chairing the cross industry-regulatory-academic DIA Bayesian Scientific Working Group and serving as Vice-Chair on the ASA Statistical Partnership among Academe, Industry, and Government committee.
Zoran Antonijevic, MSc
- Vice President, Statistical Consulting
- Abond CRO Inc., United States
Zoran Antonijevic is Vice President of Statistical Consulting at Abond CRO. He held executive positions in Pharmaceutical Companies and CROs and has designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. Zoran is a long-time Chair and leader of the DIA Innovative Designs Scientific Working Group. He has authored numerous papers and scientific presentations and was editor of books “Optimization of Pharmaceutical R&D Programs and Portfolios” and, with Bob Beckman, “Platform Trials in Drug Development: Umbrella Trials and Basket Trials”.
Cristiana Mayer, DrSc, PhD
- Head of Biostatistics
- Johnson & Johnson Vision, United States
Cristiana Mayer is the Head of Biostatistics at Johnson & Johnson Vision, a company dedicated to the eye care, eye health and eye products. She has 20+ years of experience in the pharmaceutical industry. After 18 years in drug development at Janssen R&D LLC working in different therapeutic areas and 5 years in Statistical Modeling & Methodology group, Cristiana is currently leading the biostatistics and data management groups across the Surgical and Vision Care businesses of JNJ Vision. Her current interests are in CID, Bayesian designs and patients’ engagement. Her recent publications are about simulation practices for innovative designs, ethics and innovation in the pandemic and patient engagement in rare diseases.
Dionne Price, PhD
- Deputy Director, Office of Biostatistics, OTS, CDER
- FDA, United States
Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section and on the Regional Committee of the Eastern North American Region of IBS. She is a Fellow of the ASA and the President-Elect of the ASA. With an MS in Biostatistics from UNC, and PhD from Emory, her research interests focus on clinical trial designs. She has co-authored papers in Statistics in Medicine, Clinical Trials, and Statistics in Biopharmaceutical Research.
Karen Lynn Price, PhD
- Senior Research Fellow, Statistical Innovation Center/Design Hub
- Eli Lilly and Company, United States
Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Research Fellow at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis of clinical trials. In 2011, Karen helped form and led the DIA Bayesian Scientific Working Group and currently serves as past-chair. This group includes members in Industry, Regulatory, and Academia. Her research interests include Bayesian design and analysis of clinical trials and master protocols. In 2016, Karen was elected a Fellow of the American Statistical Association.
Pritibha Singh, MBA, MSc
- Global Program Associate Director, Oncology Hematology Development
- Novartis AG, Switzerland
Pritibha Singh is an Associate Director - Customer Success at Novartis working in data42, where Novartis is leveraging data science to reimagine research and development. She has extensive international (Switzerland, Germany, United Kingdom, Australia and New Zealand) experience of 16 years gained in the pharmaceutical and biosimilar industry and in research. During the last 16 years, Pritibha has worked in numerous therapeutic areas: Cardiovascular, Diabetes, Neuroscience, Respiratory, Oncology, Immunology, and Hematology and she gained experience in discovery, development and late phase. Prior to this, Pritibha also worked in the FMCG industry and experienced a brief stint in banking.
Rui (Sammi) Tang
- Vice President, Global Head of Biometrics
- Servier Pharmaceuticals, United States
Rui (Sammi) Tang, PhD is currently the VP, Global Head of Biometric Oncology, leading Global biostatistics, statistical Programming and US Medical Writing Departments at Servier Pharmaceuticals US. Her research interests are primarily in adaptive clinical trial design and statistical issues in precision medicine. She authored more than 40 articles in peer-reviewed scientific journals on methodology, study design, data analysis and reporting and is a co-inventor of several patents. She is a co-founder of DahShu, a non-profit organization, founded to promote research and education of 5000 members. She is an active member in ASA and ICSA.
Amy Xia, PhD
- Vice President, Center for Design and Analysis
- Amgen Inc., United States
Amy Xia is Vice President, Center for Design and Analysis at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies over the past two decades. Currently, she heads up the Center for Design and Analysis organization which includes Biostatistics, Design & Innovation and Data Sciences at Amgen, providing leadership and holistic vision for strategic drug development and driving innovative approaches across Amgen’s portfolios for evidence generation and decision-making. Amy received her PhD in Biostatistics from the University of Minnesota, and her medical degree from Peking University, China.
Maria Apostolaros, JD, PharmD, MS, RPh
- PhRMA, United States
Dr. Maria Apostolaros is currently a Senior Director of Science and Regulatory Advocacy at PhRMA, the 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 leads PhRMA’s regulatory policy initiatives on patient-focused drug development, innovative clinical trials, and pharmacovigilance. Prior to her time at PhRMA, Maria has spent many years in a variety of leadership positions in the biopharmaceutical industry.
Yi Liu, PhD
- Executive Director Biostatistics
- Nektar Therapeutics, United States
Yi Liu is an Executive Director of Biostatistics at Nektar Therapeutics responsible for immuno-oncology clinical trials, drug discovery, CMC and biomarker statistics. Prior to that, she lead the statistical methodological group at Takeda designing and implementing innovative designs in multiple pivotal trials. Her research interests include multiple comparisons, adaptive designs, and issues with efficacy estimands for time-to-event endpoints. She is in the leadership team of the DIA Innovative Designs Scientific Working Group.
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Recent Regulatory Efforts on Complex Innovative Clinical Trial Design