FDA - PDS Symposium X: Speakers


Dr. Bill Louv, PhD
Project Data Sphere





Bill Louv joined Project Data Sphere in April 2018, bringing with him broad leadership experience in statistics, epidemiology, and information technology. Since joining the pharmaceutical industry in 1986, he has held key leadership positions as head of biostatistics at Merrell Down and VP of biostatistics, epidemiology, and clinical data management GlaxoWellcome. In 1999, he made a career change and became the VP of IT for GlaxoSmithKline’s R&D organization and then joined their Corporate Executive Management team as their CIO in 2007 and then as Vice President of Core Business Services in 2011 until his retirement in 2016. Bill has consulted with many organizations on health care analytics and opportunities to leverage big data.  He is a Non-Executive Director of River Logic Inc., a leader in Prescriptive Analytics and Integrated Business Planning, and he is Deputy Chairman of ClinPal, a cloud-based clinical trial platform. Early in his career, Bill was a member of the technical staff at Bell Laboratories, where he developed forecasting algorithms for signaling networks. Subsequently, he was Associate Professor of Biostatistics at the University of Alabama at Birmingham. Bill published more than 25 academic papers while at these research organizations. He earned a bachelor’s degree from the College of William and Mary and a doctorate from the University of Florida.

Donna R. Rivera, PharmD., MSc.
Associate Director for Pharmacoepidemiology 
U.S. Food and Drug Administration (FDA)





Donna R. Rivera, PharmD., MSc., is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory purposes as well as management of the related research portfolio strategy and development of regulatory policy to support the OCE mission. As a pharmacist and pharmacoepidemiologist, Dr. Rivera has interests in observational study designs, RWD methodological approaches, and appropriate uses of RWD for drug development to increase access of effective therapies to patients as well as the use of RWD to increase knowledge of unrepresented populations and advance health equity. She is a member of the Scientific Executive Committee for the COVID-19 and Cancer Consortium (CCC19) and leads Project Post COVIDity, a collaborative RWD effort to assess outcomes and drug safety for recovered patients. In her previous role at the National Cancer Institute (NCI), she led a strategic RWD initiative to facilitate large scale, longitudinal treatment data linkages with SEER through collaborative public and private partnerships. She also has previous experience developing clinical trials at Stiefel, a GlaxoSmithKline company. Dr. Rivera earned her Doctor of Pharmacy and Master of Science in Pharmaceutical Sciences with a concentration in Pharmaceutical Outcomes and Policy from the University of Florida College of Pharmacy.  She completed a postdoctoral fellowship in Pharmacoepidemiology and Pharmacogenomics at the NCI in the Epidemiology and Genomics Research Program.  

Keynote Address

Dr. Robert Califf, MD, MACC
Head of Clinical Policy and Strategy
Verily Life Sciences and Google Health





Robert M. Califf, MD, MACC, is the head of Clinical Policy and Strategy for Verily Life Sciences and Google Health. Prior to this, Dr. Califf was the vice chancellor for health data science for the Duke University School of Medicine; director of Duke Forge, Duke's center for health data science; and the Donald F. Fortin, MD, Professor of Cardiology. He served as Deputy Commissioner for Medical Products and Tobacco in the U.S. Food and Drug Administration (FDA) from 2015-2016, and as Commissioner of Food and Drugs from 2016-2017. A nationally and internationally recognized leader in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf is a graduate of Duke Univesity School of Medicine. Dr. Califf was the founding director of the Duke Clinical Research Institute and is one of the most frequently cited authors in biomedical science. 

Panel 1: Routes to Yes

Moderator: Dr. Atul Butte, MD, PhD
University of California, San Francisco (UCSF)





Atul Butte, MD, PhD is the Priscilla Chan and Mark Zuckerberg Distinguished Professor and inaugural Director of the Bakar Computational Health Sciences Institute (bchsi.ucsf.edu) at the University of California, San Francisco (UCSF). Dr. Butte is also the Chief Data Scientist for the entire University of California Health System, the tenth largest by revenue in the United States, with 20 health professional schools, 6 medical schools, 6 academic health centers, 10 hospitals, and over 1,000 care delivery sites. Dr. Butte has been continually funded by NIH for 20 years, is an inventor on 24 patents, and has authored over 200 publications, with research repeatedly featured in the New York Times, Wall Street Journal, and Wired Magazine. Dr. Butte was elected into the National Academy of Medicine in 2015, and in 2013, he was recognized by the Obama Administration as a White House Champion of Change in Open Science for promoting science through pubicly available data. Dr. Butte is also a founder of three investor-backed data-driven companies: Personalis (IPO, 2019), providing medical genome sequencing services, Carmenta (acquired by Progenity, 2015), discovering diagnostics for pregnancy complications, and NuMedii, finding new uses for drugs through open molecular data. Dr. Butte trainined in Computer Science at Brown University, worked as a software engineer at Apple and Microsoft, received his MD at Brown University, trained in Pediatrics and Pediatric Endocrinology at Children's Hospital Boston, then received his PhD from Harvard Medical School and MIT. 

Panelist: Najat Khan, PhD
Chief Data Science Officer, Janssen R&D Data Sciences Global Head, Janssen R&D Strategy and Operations 
Janssen Pharmaceutical companies of Johnson & Johnson 





Najat Khan, Ph.D., is the Chief Data Science Officer and the Global Head of Strategy & Operations for Janssen Research & Development. In these roles Najat leads a team of 100+ data scientists and data engineers to drive deep impact across Janssen's pipeline and portfolio and shapes Janssen's R&D strategy, spanning key pipeline and portfolio decisions to new strategic initiatives to deliver on transformational medicines for patients. Najat co-chairs the Johnson & Johnson Data Science Council and is a member of Janssen's Development and Investment Committees. Najat was a Senior Principal at The Boston Consulting Group and received her Ph.D. in Organic Chemistry from the University of Pennsylvania and her B.A. in Chemistry with a minor in Economics from Colgate University. 

Panelist: Dr. Harlan Krumholtz, MD, SM

Harold H. Hines, Jr. Professor of Medicine 

Yale School of Medicine 





Harlan Krumholz, a cardiologist, is a leading expert in the science to evaluate and imrove the quality and efficiency of care, reduce disparities, improve integrity in medical research, and avoid wasteful practices. His team has led successful national and international quality improvement initiatives, architected national quality measures and measurement strategies in partnership with the Centers for Medicare & Medicaid Services, promoted patient-centric approaches to research and care, created strategies and tools to enable open science and advance scientific integrity, and advanced regulatory science in partnership with the Food and Drug Administration. Dr. Krumholz co-founded the Yale Open Data Access Project (YODA), a platform promoting open science and distributing clinical trial data, and is a co-founder of medRxiv, a non-profit preprint server for the medical and health sciences. He has published more than 1,000 scientific articles and was named one of the top-cited scientists, with an h-index of almost 200. Dr. Krumholz received a BS from Yale College, an MD from Harvard Medical School, and a Masters in Health Policy and Management from the Harvard School of Public Health.   

Panelist: Professor Steven Kern, PhD

Deputy Director, Quantitative Sciences 

Bill & Melinda Gates Foundation





Steven E. Kern, PhD is Deputy Director of Quantitative Sciences at the Bill and Melinda Gates Foundation. The Quantitative Sciences group is focused on quantitative analysis to support program strategies for therapeutic projects that the foundation funds across multiple disease domains. Prior to this, he was Global Head of Pharmacology Modeling at Novartis Pharma AG based in Basel Switzerland where he led a team focused on providing model based drug development support to therapeutics in many disease conditions across all stages of drug development. He joined Novartis in 2010 from the Univsersity of Utah in Salt Lake City, Utah where he was Associate Professor of Pharmaceutics, Anesthesiology, and Bioengineering, and served as co-investigator for their NIH funded Pediatric Pharmacology Research Unit. He has designed, conducted, and served as a principal investigator for clinical pharmacology studies in adults and children that spanned the population from preterm infants to elderly adults. 

Panel 2: Sustainability Practices in Sharing and Reuse

Moderator: Dr. David Chambers, DPhil.

Deputy Director for Implementation Science in the Office of the Director in the Division of Cancer Control and Population Sciences (DCCPS)

National Cancer Institute (NCI)




Dr. David Chambers is Deputy Director for Implementation Science in the Office of the Director in the Division of Cancer Control and Population Sciences (DCCPS) at the National Cancer Institute (NCI). Dr. Chambers manages a team focusing on efforts to build and advance the field of Implementation Science (IS) through funding opportunity advancements, training programs, research activities, dissemination platforms, and enhancement of partnerships and networks to integrate research, practice and policy. Prior to his arrival at NIH, Dr. Chambers worked as a member of a research team at Oxford University, where he studied national efforts to implement evidence-based practice within healthcare systems. He publishes on strategic research directions in implementation science and serves as a plenary speaker at numberous scientific conferences. He received his A.B. degree (with Honors) in Economics from Brown University in 1997, and an M.Sc. and D.Phil degree in Management Studies (Organisational Behaviour) in 1998 and 2001, respectively, from Oxford University (UK). 

Panelist: Dr. Frank Rockhold, PhD

Professor of Biostatistics and Bioinformatics

Duke Clinical Research Institute, Duke University Medical Center 





Frank is a full time Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Managing Partner of HunterRockhold, Inc. His career includes senior management positions in industry, most recently as Chief Safety Officer and head of Pharmacovigilance at GlaxoSmithKline. He has held faculty appointments at six different universities, is currently Chairman of the Board of Frontier Research Foundation, served as Chairman of CDISC, and past president of the Society for Clinical Trials. Frank holds a BA in Statistics and an ScM and PhD in Biostatistics. Frank is a Fellow of the American Statistical Association, The Royal Statistical Society, and the Society for Clinical Trials.  

Panelist: Dr. Jaime Guidry Auvil, PhD

Director, Office of Data Sharing 

National Cancer Institute (NCI) 





Dr. Jaime M. Guidry Auvil oversees the National Cancer Institute's (NCI) approach to development, interpretation and implementation of data sharing and public access policies to enhance NCI's mission. Dr. Guidry Auvil has led critical data sharing initiatives within NCI and NIH Offices of the Director, including large-scale pediactric cancer reserach through Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative, Childhood Cancer Data Initiative (CCDI), and the Gabriella Miller Kids First Pediactric Research Program. Dr. Guidry Auvil is well-published and serves on several advisory committees within and across federal agencies and international organizations to provide expertise in optimizing data for cancer reserach. 

Panelist: Dr. Yili Pritchett, PhD

Vice President, Head of Biometrics 

G1 Therapeutics, Inc 





Dr. Pritchett joined G1 Therapeutics as Vice President, Head of Biometrics (Biostatistics, Statistical Programming, and Clinical Data Management) in October 2018. Before joining G1, she was Senior Director, Biostatistics Head for several therapeutic areas at MedImmune, a member of the AstraZeneca Group. She also served at different leadership positions in Astellas, Abbott Laboratories, and Eli Lilly and Company. Dr. Pritchett has extensive experience in clinical trial design and execution across broad therapeutical areas, including oncology, infectious disease, neurology, and neuroscience. She provided strategic input and statistical leadership in multiple successful regulatory filings and approavals. Dr. Pritchett has been active in using novel statistical approaches to improve R&D efficiency and effectiveness as well as in statistical and clinical trial methodology research with 79 published manuscripts or book chapters. Dr. Pritchett obtained her Ph.D. in Statistics from the Univesity of Wisconsin - Madison and is an elected Fellow of American Statistical Association since 2013.  

Fireside Chat

Interviewer: Dr. Corrie Painter, PhD

Deputy Director

Count Me In, Broad Institute 





Corrie Painter is the Deputy Director of Count Me In and is a research scientist at the Broad Institute of MIT and Harvard. A trained cancer researcher with a Ph.D. in biochemistry, she completed her postdoctoral work in cancer immunology, focused on melanoma. In 2010, Painter was diagnosed with angiosarcoma. She has combined her cancer advocacy and scientific background to engage with patients in order to build and carry out patient-partnered genomics studies. She is also the co-founder of Angiosarcoma Awareness Inc. 

Guest: Dr. Ned Sharpless, M.D.


National Cancer Institute (NCI)





Norman E. "Ned" Sharpless, M.D., is the 15th director of the National Cancer Institute (NCI) since October 2017. He served as Acting Commissioner for Food and Drugs at the US FDA for seven months in 2019, before returning to the NCI Directorship. Prior to his appointment, Dr. Sharpless served as the director of the Lineberger Comprehensive Cancer Center at the University of North Carolina (UNC). Dr. Sharpless is a member of the Association of American Physicians and the American Society for Clinical Investigation, is a Fellow of the Academy of the American Association of Cancer Research, has authored more than 180 original scientific papers, reviews, and book chapters, is an inventor on 10 patents, and cofounded two clinical-stage biotechnology companies: G1 Therapeutics and Sapere Bio (formerly HealthSpan Diagnostics). 

Guest: Dr. David Fajgenbaum, MD, MBA, MSc

Assistant Professor of Medicine

University of Pennsylvania





David Fajgenbaum, MD, MBA, MsC, is an Assistant Professor of Medicine at the University of Pennsylvania, Founding Director of the Center for Cytokine Storm Treatment & Laboratory (CSTL), Associate Director of Patient Impact for the Penn Orphan Disease Center, and co-Founder/President of the Castleman Disease Collaborative Netowrk (CDCN). He is also the national bestselling author of 'Chasing my Cure: A Doctor's Race to Turn Hope Into Action' and a patient battling idiopathic multcentric Castleman disease (iMCD). He is in his longest remission ever thanks to a precision treatment he identified, which had never been used before for iMCD. One of youngest individuals ever appointed to the faculty at Penn Medicine and in the top 1 percent youngest awardees of an NIH R01 grant, Dr. Fajgenbaum leads of 20 translational research studies, including the CORONA project to identify and track treatments for COVID-19 and a clinical trial of the drug that is saving his life. He has published scientific papers in high-impact journals such as the New England Journal of Medicine, Journal of Clinical Investigation, and Blood. To advance drug repurposing, he is co-directing an FDA/NIH/C-Path public-private partnership called the CURE Drug Repurposing Collaboratory and leading an effort for rare disease repurposing in collaboration with the Chan Zuckerberg Initiative. Dr. Fajgenbaum has been profiled in a cover story by The New York Times as well as by Good Morning America, CNN, Forbes 30 under 30, and the Today Show. Dr. Fajgenbaum earned a BS from Georgetown University, MSc from the University of Oxford, MD from the University of Pennsylvania, and MBA from The Warton School. 

Patient Power: The Untapped Resource for Accelerating Discovery

Sue Sherman, MHA

Executive Director & CEO 

The LAM Foundation





Susan Sherman, MHA, is the Executive Director & CEO of The LAM Foundation, a non-profit patient advocacy organization and with a mission to urgently seek safe and effective treatments, and ultimately a cure, for lymphangioleiomyomatosis (LAM) through advocacy and the funding of  promising research. Under Sue's eight years of leadership, the Foundation has distributed more than $3.5 M in research funding to LAM investigators, hosted seven international research conferences and LAMposiums, implemented an annual in-person scientific advisory board study section and has effectively integrated the patient voice into research design. Sue joined The LAM Foundation as Executive Director in 2013. She is a seasoned healthcare executive who has contributed to the advancement of health and the healthcare industry for more than 20 years. She holds a Master of Health Administration from Xavier University in Cincinnati, Ohio, a Bachelor of Science in biology from Indiana University, and was formerly a certified executive coach. She has diverse industry expertise including healthcare administration, non-profit management, patient advocacy, and business development. Sue is a member of the Board of Directors of The National Health Council, representative to the American Thoracic Soceity Public Advisory Roundtable, and participated on the Rare Diseases Clinical Research Network's Coalition of Patient Advocacy Groups. 

Andrea Slattery

Director of Research

Symmetry Peak Management





Andrea Slattery joined Symmetry Peak Management in January 2009 as Director of Research. From 2004 to 2008, Andrea was one of four Senior Partners at Ardsley Partners, where she co-managed the technology portion of the approximately $1 billion long/short equity fund. Prior to her tenure at Ardsley, Andrea was the second in command at Alkeon Capital Management, LLC, a technology-focused long/short equity fund, where she helped to design and build the research process and team, as the firm grew from $40 million to approximately $1.2 billion. Andrea is a CFA(R) charterholder, and graduated summa cum laude with a BSBA degree from Washington University in St. Louis, Missouri. Philanthropically, Andrea serves on the board of The LAM Foundation, a non-profit organization dedicated to finding better treatments and ultimately a cure for lymphangioleiomyomatosis (LAM), a rare lung disease that affects women. Andrea's passion is to apply her experience in the technology industry towards enhancing patient knowledge and accelerating advances in rare disease research.