Scott Berry, Ph.D.

Scott Berry, Ph.D.

Principal Investigator (PI)/Project Director (PD)

Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. He has led Berry Consultants to be widely regarded as the premier Bayesian consulting company in the world.  Since 2000, he has been involved in the design of hundreds of Bayesian adaptive clinical trials of pharmaceuticals and medical devices and has become an opinion leader in the field of Bayesian adaptive clinical trials. Some of these trials have been groundbreaking trial designs, setting new standards for innovation and flexibility in trial design. These include the trials supporting the first fully Bayesian approval by the center for drug evaluation of the United States FDA (Pravastatin-Aspirin combination) and the statistical design for Time Magazine’s #2 Medical Breakthrough of 2007 (Veridex’s GeneSearch BLN Assay).

Roger Lewis, M.D., Ph.D.

Roger Lewis, M.D., Ph.D.

Co-Principal Investigator (PI)/Co-Project Director (PD)

Roger J. Lewis, MD, PhD, is the Senior Medical Scientist for Berry Consultants. He received his PhD in Biophysics in 1986 and his MD in 1987 from Stanford University. He completed clinical training in emergency medicine in 1990 and is currently a Professor at the David Geffen School of Medicine at UCLA and Chair of the Department of Emergency Medicine at Harbor-UCLA Medical Center. Dr. Lewis’s expertise centers on clinical research methodology, including adaptive and Bayesian trial design, and he participates in the design and analysis of numerous laboratory, clinical, and health services research studies. His areas of interest include adaptive and Bayesian clinical trials; platform trials; translational, clinical, health services and outcomes research; emergency department crowding and disaster preparedness,
interim data analysis; the role and function of data monitoring committees; and difficulties surrounding informed consent in emergency research studies. Dr. Lewis has served as a research mentor for numerous fellows and junior faculty and frequently lectures on the topics of clinical research design and the statistical analysis of clinical trials.

Kristine Broglio M.S.

Kristine Broglio M.S.

Director, Consulting

Kristine Broglio is a Director & Senior Statistical Scientist at Berry Consultants with interests in adaptive clinical trials, Bayesian statistics, and survival analysis. First studying economics, she spent two years at RTI International where she was involved in CMS demonstrations studies and CDC sponsored studies related to the prevalence and cost of diabetes. After earning her MS in Biostatistics from the University of Washington in 2003, she joined The University of Texas M.D. Anderson Cancer Center.  As a Senior Statistical Analyst, she specialized in breast medical oncology, authoring more than 80 papers in the medical and statistical literature. Kristine joined Berry Consultants in 2010 where she has been involved in the design of Bayesian adaptive clinical trials and comparative effective studies using Bayesian hierarchical modeling for pharmaceutical and medical device companies.

Kert Viele, Ph.D.

Kert Viele, Ph.D.

Director, Education

Kert Viele is a Director and Senior Statistical Scientist with Berry Consultants, where he leads Berry Consultants’ research enterprise. He is a leader in clinical trial implementation of Bayesian hierarchical modeling, with expertise in platform and basket trials as well as clinical trials incorporating the use of historical information. Prior to joining Berry Consultants in 2010, he was a faculty member at the University of Kentucky, where he received the Provost’s Award for Outstanding Teaching and was an investigator for NSF and NIH funded research. He has developed over 100 custom Bayesian adaptive clinical trials for clients in industry, government, and academia, and currently serves on several data safety monitoring boards for randomized clinical trials. A former editor of the journal Bayesian Analysis, Dr. Viele is also an author of FACTS (Fixed and Adaptive Clinical Trial Simulator), clinical trial simulation software currently licensed to multiple pharmaceutical, academic, and government organizations.

Ashish Sanil, Ph.D.

Ashish Sanil, Ph.D.

Director, Web Services and Products

Ashish Sanil is a Senior Statistical Scientist & Software Architect at Berry Consultants, where he is responsible for the development and packaging of the core statistical components of FACTS software. He received his Ph.D. in statistics from Carnegie Mellon University and was a postdoctoral fellow at the National Institute of Statistical Sciences. Also prior to joining Berry Consultants, he was a Quantitative Analyst at Google, Inc. and a Senior Research Biostatistician at Bristol-Myers Squibb. He has authored more than 20 papers and book chapters in the statistical literature.

Additional team members will support the various awardee projects.

To contact the ICTR Team, please email the Project Manager at Berry Consultants, Doray Sitko.