Faculty – 2017 DMC Optimization Summit


Amit Bhattacharyya, Ph.D.
Vice President, Biometrics, ACI CLINICAL

view speaker profile

Dr. Amit Bhattacharyya is currently the Vice President of Biometrics at ACI Clinical, a niche service provider in the various committee support in the safety domains for clinical trials. In his current role, Dr. Bhattacharyya oversees ACI’s Biometrics service delivery in the Safety monitoring committees for all clients in various therapeutic areas. In addition, Amit leads the Statistical Consultancy services for small pharma and biotech companies in the industry.

Prior to joining ACI last year, Amit has spent more than 2 decades at GSK, leading statistics and programming groups in nonclinical, clinical and health outcome teams across the U.S., UK, and India. Amit has been very active in many professional activities internationally for many years, and especially at the American Statistical Association and the International Society for Biopharmaceutical Statistics. Amit has presented in many national and international statistical conferences on statistical and leadership roles.

Dr. Bhattacharyya received his Ph.D. in Statistics from the University of Maryland.


Robert Bigelow
Associate Director, DUKE CLINICAL RESEARCH INSTITUTE

view speaker profile

Bob has extensive experience in the design, conduct, and analysis of clinical trials in academic and industrial settings. His industrial experience includes the development of new treatments in a wide range of therapeutic areas, interactions with regulatory agencies in endpoint selection and program design, and evaluation of interim data supporting go/no-go decisions. Bob has held senior positions at DuPont Merck, having established and led an international biostatistics group, and at Sanofi where he was the statistical leader for the development of numerous oncologic therapies and led a variety of initiatives related to safety evaluation.

Bob is currently Associate Director in Clinical Trials Statistics at Duke Clinical Research Institute and also serves as Director of Data and Safety Monitoring Board (DSMB) operations. His interests include evaluation of safety data, benefit-risk methodology, evidence-based medicine, and development of targeted therapies. Bob earned an M.S. and Ph.D. in Biometry at the University of Texas School Public Health in Houston.


Marc Buyse, Sc.D.
Founder and Chief Scientific Officer, IDDI

view speaker profile

Marc Buyse holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He worked at the EORTC in Brussels and at the Dana Farber Cancer Institute in Boston. He is the founder and Chief Scientific Officer of the International Drug Development Institute (IDDI) and of CluePoints.

http://publicationslist.org/marc.buyse


Joseph Massaro
Statistical Consultant, BOSTON BIOMEDICAL ASSOCIATES

Professor, Biostatistics, BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH

view speaker profile

Joe Massaro received his Ph.D. in mathematics from Boston University in 1994. He is a Professor in the Department of Biostatistics at the Boston University School of Public Health, focusing on teaching statistical methods for clinical trials. He has received Excellence in Teaching awards for these courses. He has 30 years of experience in the design and analysis of clinical trials and has been involved in interim analyses and in applications of and methodology development for adaptive designs. Prior to joining Boston University, he was Assistant Director of Data Management and Biostatistics at Quintiles, a contract research organization providing services to the pharmaceutical and biotechnology industries.


Pranab K. Mitra, Ph.D.
Associate Principal Scientist (Biostatistician), MERCK

view speaker profile

Pranab K. Mitra is currently working as a lead clinical trial biostatistician for several studies/programs in Merck. He has an extensive experience of more than 10 years in the pharmaceutical industry. In this role, he is responsible for study design, data analysis, CDISC submission, regulatory response, and primary publications. In addition, he gets involved in clinical trial data sharing (regulatory or academia) process. He is involved with several working group initiatives in Merck. He is a member of American Statistical Association.

Pranab holds Ph.D. in Statistics. Prior to Merck, he worked in Bristol-Myers Squibb.


Michael Pencina
Director, Biostatistics, DUKE CLINICAL RESEARCH INSTITUTE

view speaker profile

Dr. Michael Pencina is a Professor of Biostatistics and Bioinformatics at Duke University and Director of Biostatistics at Duke Clinical Research Institute. He serves as a key institutional leader overseeing the strategic and operational direction of the Biostatistics talent and resources at the DCRI which includes a team of over 100 statisticians and programmers. Dr. Pencina is an internationally recognized expert in risk prediction model development and evaluation. He is actively involved in the design, conduct, and analysis of clinical trials with a particular focus on novel and efficient designs and applications of machine learning for medical decision support. He has served on numerous Independent Data Monitoring Committees and is an expert in IDMC function and conduct. Dr. Pencina has been an invited speaker at numerous national and international symposia and workshops and interacts regularly with investigators from various academic and industry institutions as well as with the Food and Drug Administration. Dr. Pencina has co-authored over 250 manuscripts in peer-reviewed journals and serves as Deputy Editor for Statistics at JAMA-Cardiology and Associate Editor for Statistics in Medicine.


Murali Reddi, M.D.
Manager, Global Safety, EDWARDS LIFE SCIENCES


Frank Rockhold, Ph.D.
Professor of Biostatistics, DUKE CLINICAL RESEARCH INSTITUTE

view speaker profile

Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.

Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute and Managing Partner of HunterRockhold, Inc., (www.hunterrockhold.com). His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he recently retired as Senior Vice President of Global Clinical Safety and Pharmacovigilance. He has also held faculty appointments at six different universities. Frank served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials. He is a past member of the PCORI Clinical Trials Advisory Panel and is on the board of the Frontier Science and Technology Research Foundation.

Frank holds a B.A. in Statistics from The University of Connecticut, a ScM in Biostatistics from The Johns Hopkins University, and a Ph.D. in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. Frank is a Fellow of both the American Statistical Association and the Society for Clinical Trials and an Accredited Professional Statistician, PStat®. He is widely published in major scientific journals across a wide variety of research topics.


Joseph Scherer
Sr. Associate Director Biostatistics, BOEHRINGER INGELHEIM PHARMACEUTICALS

view speaker profile

Joe Scherer earned his MSc in Statistics in 1999 from the University of Nebraska. After attending Oregon State from 1999-2003 he joined Boehringer-Ingelheim and has worked there for 14 years. Joe has led several submissions in HIV and HCV and is currently working towards a submission in Immunology. Joe has led the statistical support of DMCs for several projects while at BI, including his current program involving over 10 trials. In addition to serving as a lead statistician, Joe is a Senior Associate Director, leading a team of clinical statisticians.


Jonathan Seltzer
President and CEO, ACI CLINICAL

view speaker profile

Jonathan Seltzer, M.D., MBA, M.A., FACC, is President of ACI Clinical, a recognized industry leader in Data Safety Monitoring Committees, Clinical Endpoint Adjudication Committees and other safety services. He chairs the scientific programs committee for the Cardiac Safety Research Consortium and serves on the steering committee for the Clinical Trials Transformation Initiative where he has led efforts in Data Monitoring Committees as well as Endpoint Adjudication in collaboration with FDA and other regulators, industry and academic partners. He has received board certification in both cardiology and internal medicine and holds degrees from Haverford College, the University of Michigan and the University of Pennsylvania, with postgraduate medical training at the Universities of Michigan, Maryland and Chicago. He is past president of the Academy of Physicians in Clinical Research and currently serves as the Director of Clinical Research for Lankenau Heart Institute.


Keith Usiskin
Executive Director, CELGENE

view speaker profile

Keith Usiskin is the Executive Director of the GI therapeutic in the Clinical Research and Development department at Celgene Pharmaceuticals. Prior to joining Celgene Keith has held leadership positions in medical affairs and Clinical R&D at Sanofi Aventis and Janssen Pharmaceuticals. Trained as an internist and endocrinologist prior to joining the pharmaceutical industry Keith was the Chief of Endocrinology at Morristown Medical Center in New Jersey. A graduate of Cornell University and Rutgers Medical School he has done his post-graduate training in internal medicine and endocrinology at the Medical College of Virginia. Keith has been involved in the setup and execution of a number of Data Monitoring Committees across various Phase 2 and 3 late development programs.


Peter Zhang, Ph.D.
Head of Biostatistics Department, OTSUKA

view speaker profile

Peter Zhang, Ph.D. has over 25 years of experience in the Pharmaceutical Industry with a diverse experience in Drug Development including preclinical, Phase I/II/III/IV and also life cycle management (LCM). He has also supported more than 15 NDAs/sNDAs/MAAs/NDS/PMDA. and several INDs across various therapeutic areas including CNS (Alzheimer’s disease, MDD, Schizophrenia, Bipolar, ADHD), Cardiovascular (BP, ACS, Intermittent Claudication), Respiratory disease (Asthma, COPD, RDS), Gastrointestinal Disease (Ulcerative Colitis, IBD, Crohn’s Disease), Anti-Infection (UTI, LRTI, MDR-TB), Oncology (Advance colorectal cancer, MDS, AML, Cancer Pain, and CML), and Ophthalmology (Dry eye, Dry AMD). The hallmark of his career is his successful leadership in biostatistics, programming, quantitative analytics, statistical reporting, global drug development, and global medical affairs/HEOR, and CMC & QC at several pharmaceutical companies in the United States such as Procter & Gamble Pharmaceuticals, Novartis Pharmaceuticals, Forest Laboratories (now Allergan), and Otsuka Pharmaceutical Development and Commercialization, Inc. Peter is currently Head of Biostatistics Department at Otsuka Pharmaceuticals (US) that focusses on collecting, integrating, analyzing, interpreting and providing insight from the many data sources that exist across various functions.

Peter has published over 110 abstracts and manuscripts in various international statistical and medical Journals. He has also written several book chapters. His research interest areas are the nonparametric Bayesian method, meta-analysis/network meta-analysis, missing data, enrichment clinical trial design, and SPCD/re-randomization design. He graduated with a Ph.D. in Statistics from Purdue University, an M.S. in Computing Statistics from Chinese Academy of Sciences, and a B.S. in Mathematics from Peking University.