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Apr 06, 2022 10:00 AM - Apr 08, 2022 5:00 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

DIA Your Way! Join us virtually from the comfort of your home/office April 6-8 or watch later at a time that works for you. This event provides access to the materials for a full two months!


Brenda  Crowe, PhD

Brenda Crowe, PhD

Associate Vice President, Statistics, Eli Lilly and Company, United States

Brenda Crowe is an Associate Vice President in Statistics at Eli Lilly and Company. She has more than 25 years of pharmaceutical industry experience. She obtained a PhD in Statistics from the University of Toronto. She has worked extensively with both clinical trials and observational studies. She has participated in or led several expert teams. As examples, she was a co-chair of the cross-industry Safety Planning, Evaluation and Reporting team, and served as the lead editor of the Council for International Organizations of Medical Sciences report on meta-analysis of safety data. She is a fellow of the American Statistical Association.

Fairouz  Makhlouf, PhD

Fairouz Makhlouf, PhD

Deputy Director, Office of Biostatistics, Office of Translational Science, CDER, FDA, United States

Dr. Fairouz Makhlouf is the deputy director for Division VIII in the Office of Biostatistics, Office of translational science, Center for Drug Evaluation and Research, FDA. Since joining FDA in 2006, Fairouz focuses in providing support for research and regulatory evaluation of generic drug product. Fairouz received her Ph.D in Mathematical Statistics from American University, Washington D.C. in 2005.

Satrajit  Roychoudhury, PhD

Satrajit Roychoudhury, PhD

Executive Director, Statistical Research and Innovation, Pfizer, Inc., United States

Dr. Satrajit Roychoudhury is an Executive Director and a member of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical methodology in clinical trials. He has co-authored several publications/book chapters in this area and provided statistical training at major conferences. His areas of research include the use of survival analysis, model-informed drug development and Bayesian methods in clinical trials.

Yuan-Li  Shen, DrPH

Yuan-Li Shen, DrPH

Division Director, Division of Biometrics IX, OB, OTS, CDER, FDA, United States

Yuan-Li is the Division Director of the Division of Biometrics IX, Office of Biostatistics, Office of Translational Science, CDER, FDA. The division is responsible for statistical reviews of regulatory submissions of hematology products including both benign and malignant products. She received a doctorate in Biostatistics from the University of North Carolina, Chapel Hill. She has over 25 years of combined experience in clinical trial setting across academia, pharmaceutical industry and FDA.

Ruthie  Davi, PhD, MS

Ruthie Davi, PhD, MS

Vice President, Data Science and Statistician, Medidata, a Dassault Systèmes Company, United States

Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI by Medidata (a Dassault Systèmes Company) and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics in CDER at FDA. At Acorn AI Ruthie is part of a team creating analytical tools to improve the efficiency and rigor of clinical trials, an example of which is her Synthetic Control work. Ruthie holds a Ph.D. in Biostatistics from George Washington University.

Mallorie  Fiero, PhD

Mallorie Fiero, PhD

Master Mathematical Statistician, CDER, FDA, United States

Mallorie has been with FDA CDER’s Office of Biostatistics since 2016. She is a statistical team leader supporting the Office of Oncologic Diseases. She received her PhD in Biostatistics from the University of Arizona and BS in Statistics from UCLA. In addition to her review work, Mallorie’s research interests include estimands, statistical analysis of patient-reported outcomes in cancer trials, and missing data.

Lisa  Hampson, PhD

Lisa Hampson, PhD

Senior Director, Advanced Methodology & Data Science, Novartis Pharma AG, Switzerland

Lisa is a member of the Statistical Methodology group at Novartis and is based in Basel. Prior to joining the pharmaceutical industry, Lisa was a Lecturer in Statistics at Lancaster University, and held a UK Medical Research Council Career Development Award in Biostatistics. Her research interests are in clinical trials, including group sequential tests, adaptive designs for treatment selection, and Bayesian approaches for early phase dose-escalation trials. More widely, she is interested in developing approaches for leveraging existing information in trials, extrapolation, and methods to evaluate the probability of success of a drug development program. Lisa holds a PhD in Statistics from the University of Bath.

Shiowjen  Lee, PhD

Shiowjen Lee, PhD

Deputy Director, Division of Biostatistics, OBPV, CBER, FDA, United States

Lisa  Lupinacci, PhD, MS

Lisa Lupinacci, PhD, MS

Senior Vice President, Biostatistics and Research Decision Sciences, Merck and Co., Inc., United States

Lisa Lupinacci holds a B.S. in Mathematcis from Villanova Univeristy and M.S. and Ph.D. degrees in Statistics from Virginia Tech. She is currently the Senior Vice President of Biostatistics and Research Decision Sciences at Merck. In this role, she has oversight for end to end statistical, epidemiology and health economics support for all of Merck's product development. During her 25 year career, Lisa has worked on multiple products in the vaccine, oncology and infectious disease areas. She has spent 21 years as a statistician and 4 years as a drug development team leader for several large infectious disease programs, an opportunity which gave her a much broader knowledge of drug development and much deeper insights into leadership.

Judith C. Maro, PhD, MS

Judith C. Maro, PhD, MS

Assistant Professor, Department of Population Medicine, Harvard Medical School, United States

Dr. Maro is an Assistant Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is also the Operations Lead for the Sentinel Operations Center (housed at Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute) as part of the U.S. Food and Drug Administration’s Sentinel System. The Sentinel Operations Center is responsible for the coordination of data curation, management, and utilization activities among multiple data partner sites covering data on several hundred million patients.

Venkat  Sethuraman, PhD, MBA, MS

Venkat Sethuraman, PhD, MBA, MS

Senior Vice President, Global Biometrics and Data Sciences, Bristol Myers Squibb, United States

Venkat is Head of Biometrics and Data Sciences at BMS. Prior to BMS, Venkat was a partner at ZS, a mngt consulting firm, where he led R&D clinical services. Prior to ZS, Venkat held leadership roles at BMS, Novartis Onc. and GSK. Venkat joined BMS in 2012 leading the early dev. biometrics and in 2016, took responsibility for the specialty pipeline, leading early and late stage biometrics. Prior to BMS, Venkat led the biometrics at Novartis Onc, and was involved with several dev. programs including Tasigna and Affinitor. Venkat has a PhD in Statistics from Temple Univ. and an MBA from Wharton Business School. Venkat is a member of Statistical and Data Science community and has served on the board of Biopharm. Section of American Stat Assoc.

Li  Wang, PhD

Li Wang, PhD

Senior Director, Head of Statistical Innovation, AbbVie , United States

Li Wang, PhD, is currently Senior Director and Head of Statistical Innovation group in AbbVie. Li is leading Design Advisory which provides strategic and quantitative consulting as requested to all Development teams in all Therapeutic Areas to facilitate innovative thinking and complex innovative design evaluation. Li also co-leads Development Advanced Analytics capability in AbbVie to drive Machine Learning and Advanced Analytics research and application in Development. He led Immunology and Solid Tumor statistical design and strategy discussions and multiple ML, RWE and Bayesian innovation projects from 2017 to 2019. From 2006 to 2017, he contributed to and subsequently led several submissions for Eliquis, Onglyza and Rinvoq.

Yueqin  Zhao, PhD

Yueqin Zhao, PhD

Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States

Yueqin Zhao is a lead mathematical statistician in Office of Biostatistics, Center for Drug Evaluation and Research, FDA. Her research interests include benefit-risk assessment, signal detection, and statistical methods in observational studies.

Stella C. Grosser, PhD, MS

Stella C. Grosser, PhD, MS

Division Director, Office of Biostatistics, OTS, CDER , FDA, United States

Dr. Stella Grosser has over 25 years of experience in statistical consulting, biostatistics, and biomedical research. Since 2015, she has been division director of the division of biometrics VIII in FDA/CDER, which conducts statistical reviews of abbreviated new drug applications as well as carrying out related research as part of CDER's generic drug program. She has worked as a reviewer and team leader across multiple therapeutic areas in CDER. Prior to joining FDA, she was an adjunct assistant professor of biostatistics at UCLA.

Hana  Lee, PhD

Hana Lee, PhD

Senior Statistical Reviewer, OB/OTS/CDER, FDA, United States

Hana Lee, PhD, is a Senior Statistical Reviewer of the Office of Biostatistics in the CDER, FDA. She leads and oversees various FDA-funded projects intended to support development of the agency’s RWE program including multiple Sentinel projects to develop causal inference framework for conducting non-randomized studies, to enhance analytic capacity using machine learning-based methods, and to implement sensitivity analysis for RWE studies at the study design stage, and the BAA project on Targeted Learning. She is currently a co-lead of RWE scientific working group of the American Statistical Association (ASA) Biopharmaceutical Section.

Pabak  Mukhopadhyay, PhD

Pabak Mukhopadhyay, PhD

Executive Director, Late Statistics, Head of Breast Cancer Strategy, AstraZeneca, United States

Dr. Mukhopadhyay currently leads the breast cancer biostatistics group at AstraZeneca and is responsible for leading biometrical strategic, scientific and operational aspects of the entire breast cancer folio. Prior to joining AstraZeneca, he oversaw key oncology development programs at Daiichi-Sankyo and Novartis and oversaw the development and approval of key products such as Enherru, Kisqali and Afinitor. Prior to Novartis, Dr Mukhopadhyay was leading biostatics teams at Schering-Plough corporation, overseeing HCV therapeutic area. Dr. Mukhopadhyay obtained a Ph.D. degree in statistics from North Carolina State University.

Elena  Rantou, PhD

Elena Rantou, PhD

Lead Mathematical Statistician, OB, Office of Translational Sciences, CDER, FDA, United States

Elena Rantou was awarded her Ph.D. in Statistics from American University, Washington DC. She has worked in academia and as a statistical consultant for many years. She joined FDA/CDER in 2013. Her work focuses on generics and biosimilars review as well as research related to assessing bioequivalence of complex generics, using machine learning for anomaly detection and other clinical trials issues, as well as, of pharmacokinetic profiles.

Andrew  Potter, PhD

Andrew Potter, PhD

Mathematical Statistician, OB, OTS, CDER, FDA, United States

Andrew Potter is a mathematical statistician in the Division of Biometrics I at the Center for Drug Evaluation and Research of the US Food and Drug Administration, supporting the review work in the Division of Psychiatry. He also leads digital health technology initiatives in the Office of Biostatistics at CDER. His research interests include the use of digital health technologies in clinical trials and the analysis of high-frequency outcome data. He is involved in FDA working groups on this topic.

Paul  Schuette, PhD, MA

Paul Schuette, PhD, MA

Mathematical Statistician, Scientific Computing Coordinator, FDA, United States

Paul Schuette joined the FDA in 2008 and has served as the Scientific Computing Coordinator for the Office of Biostatistics in CDER since 2010. Paul serves on the FDA’s Scientific Computing Board, Modelling and Simulation Working Group and multiple other working groups and boards. Paul is the Principle Investigator (PI) for a Cooperative Research and Development Agreement for data anomaly detection and participates in other FDA efforts to assure data integrity and data quality. Paul received his bachelor’s degree in mathematics from Kansas State University and earned his masters and Ph.D. degrees from the University of Wisconsin-Madison, with a specialization in probability theory.

Robert M. Califf, MD

Robert M. Califf, MD

Commissioner, FDA, United States

As Commissioner, Dr. Califf oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products. Dr. Califf has had a long and distinguished career as a physician, researcher, and leader in the fields of science and medicine.

Xun  Chen, PhD

Xun Chen, PhD

Global Head of Biostatistics and Programming , Sanofi, United States

Xun Chen is the Global Head of Biostatistics & Programming at Sanofi. She oversees statistical strategy and implementation of all clinical development programs at Sanofi, which encompass a number of successful products and rising candidates in a variety of therapeutic areas, including Oncology, Immunology, Hematology, Rare disease, and Neurology etc. Graduated from Columbia University with PhD in Biostatistics, Xun has always been passionate about promoting statistical leadership to bring more effective health care solutions to patients worldwide. She is also a recognized thought leader in a variety of innovative clinical trial design topics.

Joyce  Cheng, PhD

Joyce Cheng, PhD

Lead Mathematical Statistician, FDA, United States

Jolyon  Faria, PhD, MSc

Jolyon Faria, PhD, MSc

Data Science Director, AstraZeneca, United Kingdom

I am a Data Science Director at AstraZeneca (AZ) in the Oncology Machine Learning (ML) and Artificial Intelligence (AI) group, within Oncology R&D. At AstraZeneca, I work cross-program in early and late development, with a focus on immunotherapy in lung indications. My projects include developing statistical and ML/AI models to predict and explain key patient outcomes and adverse events, and cross-functional application of models and findings. I have a PhD in Biology, subsequently an MSc in Applied Statistics, experience in software development, and I’m a Chartered Statistician with the UK Royal Statistical Society. Previous to AZ, I’ve worked in target validation and discovery using genomics and proteomics.

Paul  Frewer, MS

Paul Frewer, MS

Senior Director, Early Oncology Statistics, Oncology Biometrics, Astra Zeneca, United Kingdom

Paul has been a statistician in the industry for over 20 years. His initial experiences were as a statistician on post-marketing studies and since then has slowly moved backwards through the phases to his current role in early clinical development. He has worked across most therapeutic areas and has specialized solely in oncology for the past 13 years. He joined AstraZeneca in 2012 and is now a Biometrics Team Leader in the Early Oncology Statistics team. He supports multiple different compounds in the oncology therapeutic area across many studies from Phase I up to Phase IIb. He has published on the AZ decision making framework and presented several times on the topic at conferences over the last few years

Miguel  Hernan, DrPH, MD

Miguel Hernan, DrPH, MD

Professor, Department of Epidemiology, Harvard T.H. Chan School of Public Health, United States

Miguel Hernán conducts research to learn what works to improve human health. Together with his collaborators, he designs analyses of healthcare databases, epidemiologic studies, and randomized trials. Miguel teaches causal inference methods at the Harvard T.H. Chan School of Public Health, where he is the Kolokotrones Professor of Biostatistics and Epidemiology. His edX course “Causal Diagrams” and his book “Causal Inference: What If”, with James Robins, are freely available online and widely used for the training of researchers. Miguel is an elected Fellow of the American Association for the Advancement of Science and of the American Statistical Association, Editor Emeritus of Epidemiology, and past Associate Editor of Biometrics and JASA.

Rima  Izem, PhD

Rima Izem, PhD

Associate Director Statistical Methodology, Novartis, Switzerland

Dr. Rima Izem joined Novartis in February 2021 where she supports statistical methodology development and use in all phases of therapeutic development. In her prior roles in academia and the US Food and Drug Administration, she designed or reviewed clinical studies across a wide range of therapeutic areas and data sources (clinical trials and observational data; efficacy and safety). She also developed new methods for causal inference and signal detection in claims databases and electronic healthcare data. Her current methodological interests include causal inference, hybrid designs (clinical trials data and real world data), and statistical methods in small samples (e.g., rare diseases or pediatrics).

Michele  Jonsson Funk, PhD, FISPE

Michele Jonsson Funk, PhD, FISPE

Associate Professor of Epidemiology; Director, Center for Pharmacoepidemiology, University of North Carolina at Chapel Hill, United States

Dr Jonsson Funk is an Associate Professor of Epidemiology and Director of the Center for Pharmacoepidemiology at UNC. Her research focuses on improving methods for the study of drug safety and effectiveness using real world data including understanding the impact of measurement error in studies using claims and EHR data, methods for generalizing treatment effects from clinical trials to real world populations, and evaluating treatment effect heterogeneity. As principal investigator for the DETECTe Demonstration Project, she led a team that evaluated the performance of approaches to assessing and addressing the threat of unmeasured confounding. Dr Jonsson Funk has 120 peer-reviewed publications spanning multiple therapeutic areas.

Alex  Morozov, MD, PhD

Alex Morozov, MD, PhD

Vice President, Head of Digital Health - Global Drug Development, Bristol Myers Squibb , United States

Alex Morozov is VP and Head of Digital Health, Global Drug Development at BMS, building a team of Digital Health Leads with responsibility to develop and implement digital health strategy within each therapeutic area to enhance care and reach broader patient communities. Prior to this role, Alex led clinical oncology programs at BMS, Pfizer, ImClone/Lilly and Novartis, contributing to the development of Opdivo/Yervoy, Bavencio, Lorbrena, Cyramza and Jakavi, in addition to spearheading digital innovation initiatives. Alex trained in internal medicine at Columbia Presbyterian Medical Center, medical oncology at Memorial Sloan-Kettering Cancer Center, and served as volunteer faculty in the Division of Oncology at Weill Cornell Medical Center.

Mary Elizabeth Ritchey, PhD

Mary Elizabeth Ritchey, PhD

Principal and Owner, Med Tech Epi, LLC, United States

Mary Beth Ritchey, PhD, FISPE is an innovative epidemiologist with more than 15 years experience across government, industry, and academia in real-world study design and implementation. She is adept with scientific, technical, and logistical aspects of conducting regulatory-grade postmarket surveillance as well as feasibility, utilization, safety, and effectiveness studies of medical products across the lifecycle. Dr. Ritchey is the Principal and Owner of Med Tech Epi, LLC, Associate Research Professor in the Center for Pharmacoepidemiology and Treatment Science at Rutgers University, Fellow and Board member (2019-2022) of the International Society of Pharmacoepidemiology, and Associate Editor for Pharmacoepidemiology and Drug Safety.

John  Scott, PhD, MA

John Scott, PhD, MA

Division Director, Office of Biostatistics, CBER, FDA, United States

John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and a past Editor of the journal Pharmaceutical Statistics.

Xiang  Yin, PhD

Xiang Yin, PhD

Vice President, Data Science, Medidata Solutions, A Dassault Systèmes Company, United States

Dr. Xiang Yin is currently a Vice President and biostatistician in Statistical Innovation Group at Acorn AI by Medidata, a Dassault Systèmes company. Dr. Yin has years of experience on clinical trials in several large pharmaceutical companies, across various therapeutic areas and throughout the lifecycle of the drug development. Before moving to industry, Dr. Yin had worked in academia as a biostatistics research faculty in the fields of clinical trial designs and large epidemiology studies. Her current interest is the statistical methodology to utilize historical or external controls in optimizing the design and analysis of clinical trials. Dr. Yin holds a Ph.D. in Biostatistics and a M.S. in Biomedical Science from University of Colorado.

Christoffer  Boshoff

Christoffer Boshoff

Chief Development Officer – Oncology, Prizer, Inc., United States

Yeh-Fong  Chen, PhD

Yeh-Fong Chen, PhD

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, United States

Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug applications for many diseases in psychiatry, cardiovascular and renal systems, gastroenterology, liver and inborn errors and hematology. Her research interests focus on two-stage enrichment designs and small-size clinical trials.

Sylva Heghinian  Collins, PhD

Sylva Heghinian Collins, PhD

Director, Office of Biostatistics, FDA, CDER, FDA, United States

Dr. Collins, Director of the Office of Biostatistics at FDA/CDER, leads a staff of statisticians responsible for statistical review of regulatory submissions promoting innovative, science-based, quantitative decision-making throughout the drug development life cycle. Prior to FDA, she led global operations in statistics, data management and statistical programming in the pharmaceutical industry. She led global teams in pioneering electronic data capture in several large companies and established unified worldwide strategies for efficient and faster drug development. She received her BS in Mathematics from the American University of Beirut, her PhD in Statistics from Boston University and completed a MS in Computer Science from NYU.

Kenneth J. Koury, PhD

Kenneth J. Koury, PhD

Vice President, Head of Vaccine Clinical Research Biostatistics, Pfizer, Inc., United States

Stefanie  Kraus, JD, MPH

Stefanie Kraus, JD, MPH

Senior Regulatory Counsel, Office of Regulatory Policy, CDER, FDA, United States

Stefanie is a Senior Regulatory Counsel in the CDER, ORP at the FDA. She received her JD from Brooklyn Law School and her MPH from the Harvard School of Public Health. In her position, she leads ORP’s work on clinical trials and drug development standards, real-world evidence, and regulatory science research. She works on developing policy and regulatory standards and serves on several key steering committees at CDER, including the Real-World Evidence Subcommittee, Artificial Intelligence Steering Committee, Research Governance Council, Complex Innovative Trial Design Steering Committee, and Model Informed Drug Development Steering Committee. She serves as one of the leads for ORP’s COVID-19 pandemic response efforts.

Sandeep  Menon, PhD

Sandeep Menon, PhD

Chief Scientific Officer of Artificial Intelligence and Digital Science and SVP,, Pfizer Inc, United States

Dr. Menon is currently the Chief Scientific Officer of Artificial Intelligence and Digital Science and SVP, Head of Early Clinical Development at Pfizer Inc. and Indian Institute of Management. He is a regular invited speaker and short course instructor at FDA/Industry forums, Academic and Business Management institutes internationally. He is on the advisory board for the M.S. program at Boston University. He has published more than 50 scientific original publications and book chapters and co-authored /co-edited 7 books.

May F Mo, MBA, MS

May F Mo, MBA, MS

Executive Director, Biostatistics, Amgen, United States

May Mo is an Executive Director of Biostatistics and the Head of Design and Innovation (D&I) group within the Center of Design and Analysis (CfDA) at Amgen. In her role, she leads an internal statistical consulting team with Directors of Statistical Innovation and Modeling and Simulation statisticians to provide strategic consultation and analytic expertise to product teams and promote innovative clinical trial designs and enable simulation-guided development program planning. May has many years of drug and device development experience across disease areas including oncology, hematology oncology, inflammation, neurology and nephrology.

Kannan  Natarajan, PhD

Kannan Natarajan, PhD

Senior Vice President, Head of Global Biometrics and Data Management, Pfizer, Inc., United States

Kannan Natarajan is the Global Head of Biometrics & Data Management and Chief Statistical Officer of Global Product Development at Pfizer. He is a member of the Global Product Development Leadership Team and Deputy Chair of the Clinical Development Board, a governance body that provides strategic, scientific advice and oversight of clinical development strategy of medicines. He has been in the pharmaceutical industry for over 25 years across various therapeutic areas. He holds a PhD in Statistics from the University of Florida and a Masters in Statistics from the Indian Statistical Institute.

Coline  Zeballos, MSc

Coline Zeballos, MSc

R Strategy Lead, Roche, Switzerland

Coline is R Strategy Lead at Roche Pharma and as part of this role drives strategic topics around the use of open source programming languages such as R Package Validation for clinical submissions. Coline is Swiss and French, based in Switzerland. After obtaining her MSc in Business Management from the University of Lausanne, she quickly oriented herself towards Data Science using Python. Before joining Roche, she worked several years in the finance sector, created a tech company where she was leading a team of data scientists and data architects in developing analytical solutions for SME.

Di  Zhang, PhD

Di Zhang, PhD

Associate Director, RWE Statistics, Teva, United States

Di Zhang, Ph.D., is a Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. She holds a Ph.D. degree in Biostatistics from the University of Pittsburgh. Di specializes in causal inference using real-world data and leveraging real-world evidence in clinical studies. She oversees several FDA funded projects for drug safety signal detection using real-world data.

Mehmet  Burcu, PhD, MS

Mehmet Burcu, PhD, MS

Senior Director, Epidemiology, Merck & Co., Inc., United States

Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database studies, molecular epidemiology studies, global multi-country real-world data studies as well as various cross-sector collaborative policy and methods projects pertinent to real-world data/evidence (RWD/E). He received his doctoral training with a focus on Pharmacoepidemiology at the University of Maryland, Baltimore. He has published extensively on a wide range of pharmacoepidemiology, drug safety, policy, and real-world evidence methods topics.

Dean  Follmann, PhD

Dean Follmann, PhD

Assistant Director for Biostatistics; NIAID Chief Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, United States

Sajan  Khosla, MSc

Sajan Khosla, MSc

Executive Director, Head of Real World Evidence, Oncology R&D, AstraZeneca, United Kingdom

Sajan Khosla, is the Head of Real World Evidence within Oncology R&D at AstraZeneca. In this role he is responsible for the development of a unique and innovative RWE unit that focuses the spectrum of RWE capabilities upon the pressing challenges of an R&D; supporting the investment in Real World Data, Machine Learning & AI, technologies and platforms that accelerate the analysis of these data and the build out of Real World Evidence capability and enabling the innovative use of these data. Ultimately to support decision making within the pipeline and advance innovative medicines with evidence for the regulators.

Ning  Leng, PhD

Ning Leng, PhD

People and Product Lead, Genentech, Inc., United States

Ning Leng is a People and Product Lead in Product Development Data Sciences in Roche-Genentech. Ning joined Roche-Genentech in 2016 as a statistician in the oncology early development and personalized healthcare group. Ning has worked on both early and late phase oncology development, with a special interest in utilizing diverse data sources and advanced methodologies to generate insights for personalized healthcare. Ning is an advocate of automation, open sourcing and open collaboration in pharma. She serves as Roche representative on the R consortium board, co-leads the R consortium R submission working group, and co-leads the Meetup series of the Bay-area Biotech-pharma Statistics Workshop (BBSW).

Mark  Levenson, PhD

Mark Levenson, PhD

Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER, FDA, United States

Mark Levenson is currently the Director of the Division of Biometrics VII in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA). At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug safety problems. He contributes to statistical policy and guidance development in the areas of drug safety, real-world data, and regulatory evidence. He is a member of the CDER Medical Policy Program Review Committee and the FDA Real-World Evidence Committee. Dr. Levenson received a Ph.D. in Statistics from the University of Chicago and a B.A. from Cornell University in Mathematics.

Gregory  Steeno, PhD, MS

Gregory Steeno, PhD, MS

Senior Director, Research Statistics, Pfizer, United States

Gregory Steeno is a senior director of nonclinical statistics at Pfizer. Greg has 22 years of collaborations with lab scientists from early discovery through late stage and into manufacturing. Greg champions innovative designs, data analyses best practices, and statistical excellence. Greg received his PhD in Statistics at Virginia Tech, resides in Connecticut with his wife & 2 teenage daughters, loves road cycling and very dark beer.

Cesar Daniel Torres, PhD, MS

Cesar Daniel Torres, PhD, MS

Senior Mathematical Statistician, OB, OTS, CDER , FDA, United States

Cesar received his B.S. in Probability & Statistics at the University of California, San Diego, before completing his graduate studies at the University of Washington’s Department of Biostatistics. He now works at the FDA’s Center for Drug Evaluation and Research as a reviewer in the statistical team supporting the Division of Pulmonary, Allergy, and Rheumatology Products in the review of submissions regarding rheumatological conditions. Cesar’s research interests include adaptive clinical trials, estimands, missing data, and the evaluation of safety and benefit-risk.

Cara  Rabik, MD, PhD

Cara Rabik, MD, PhD

Medical Officer, FDA, United States

I am a pediatric oncologist with a focus in childhood acute lymphoblastic and acute myeloid leukemias. I joined the FDA in 2020 and am a medical officer in the Division of Hematologic Malignancies 1, where I focus on acute leukemia and bone marrow transplantation.

Mark  Rothmann, PhD

Mark Rothmann, PhD

Division Director, FDA, United States

Dr. Rothmann (Mark) is the Director of the Division of Biometrics II. He earned his Ph. D. in Statistics at the University of Iowa in 1990. He then spent the next nine years as a professor at various universities before coming to the FDA in 1999. At the FDA, when he was a reviewer and team leader he was involved in the review on Oncology, Hematology, and Metabolism and Endocrinology products. He has done research in several areas involving the design and analysis of clinical trials and co-authored the book Design and Analysis of Non-Inferiority Trials. He leads three Office of Biostatistics Working Groups and Committees in Bayesian Analysis, Drug Trials Snapshots and Pediatric Studies and has serves on many other groups.

Jonathon J. Vallejo, PhD

Jonathon J. Vallejo, PhD

Mathematical Statistician, OB, OTS, CDER, FDA, United States

Jonathon Vallejo is a lead mathematical statistician in the Office of Oncologic Diseases at FDA. His team reviews protocols and applications for the treatment of malignant hematologic malignancies. Jonathon is involved in regulatory efforts surrounding dose optimization as well as trial design. In addition, his research interests include meta-analysis, biomarkers, and development of endpoints within hematologic malignancies.

Christina  Webber

Christina Webber

General Engineer, FDA, United States

Dr. Christina Webber works with the Digital Health Center of Excellence on efforts to advance the appropriate use of digital health technologies in the regulatory space. She is a Regulatory Science Program Manager in the Center for Devices and Radiological Health at the U.S. Food and Drug Administration. Prior to joining the FDA, she completed her Ph.D. in Biomedical Engineering and Physiology at the Mayo Clinic Graduate School of Biomedical Sciences. Her doctoral research focused on upper extremity biomechanics, characterizing arm function of adults with traumatic brachial plexus injuries. Dr. Webber also holds an M.S. in Biomedical Engineering from the University of Akron and a B.S. in Bioengineering from Pennsylvania State University.

Christopher  Miller, MS

Christopher Miller, MS

VP, Biometrics - Late-State Respiratory & Immunology, Astrazeneca, United States

Chris Miller is the Vice President of Biometrics for Late-Stage Respiratory & Inflammation at AstraZeneca in Gaithersburg, MD. Chris, a statistician by training with an MS from NC State University, has held several leadership positions at AstraZeneca since joining the company in 1993, including appointments in Biostatistics, R&D Strategy, Regulatory Affairs, and Health Economics & Outcomes Research. In his current position, Chris is responsible for all Biostatistics, Statistical Programming and Information Practice contributions in his Therapy Area, from Phase 3 through Commercialization and Lifecycle Management.

Stacy S Shord, PharmD

Stacy S Shord, PharmD

Deputy Division Director, Division of Cancer Pharmacology II, OCP, CDER, FDA, United States

Dr. Shord is Deputy Director in Division of Cancer Pharmacology II within US FDA. She received a Doctor of Pharmacy from University of Maryland School of Pharmacy and completed Pharmacy Practice residency at UPMC, Oncology Pharmacy Practice residency at UNC Hospitals, and fellowship in Oncology Pharmacotherapy at UNC Eshelman SOP. Dr. Shord was assistant professor at UIC COP where her research focused on drug metabolism in patients with cancer and hematological diseases before joining the US FDA. She has served as a primary reviewer and Lead Pharmacologist in Office of Clinical Pharmacology and Associate Director of Labeling in the Office of Oncologic Diseases.

Jiawen  Zhu, PhD

Jiawen Zhu, PhD

Senior Principal Statistical Scientist, Genentech, a Member of the Roche Group, United States

Jiawen Zhu is a Senior Principal Statistical Scientist in Data Science, Product Development, Roche/Genentech. Jiawen has broad experience across statistical method research, CDx development, early and late oncology molecule development. She has been a key contributor to numerous strategic, scientific and operational topics ranging from clinical development plan, fast-to-market strategies, incorporation of synthetic controls, novel clinical trial designs etc. Jiawen has been focusing on statistical metrologies of Bayesian adaptive designs including phase I dose escalation designs and designs incorporating external control in both single arm and RCT settings. Jiawen holds a Ph.D. in Statistics from SUNY-Stony Brook.

Lilly  Yue, PhD

Lilly Yue, PhD

Deputy Director, Division of Biostatistics, CDRH/FDA, U.S. FDA, United States

Dr. Lilly Yue is Deputy Director, Division of Biostatistics (DBS), CDRH/FDA, and oversees statistical reviews of therapeutic and diagnostic devices. She also leads DBS’s efforts on advancing regulatory science by developing, implementing, and promoting innovative statistical methodology in the design, analysis, and evaluation of clinical evidence. She serves as an Editor-in-Chief of Pharmaceutical Statistics and is a Fellow of the American Statistical Association.

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