Firma Clinical, a niche service provider to clinical research organizations, recently commenced a Scientific Advisory Board for its clinical services, including biometrics/data. The board includes scientific experts from Harvard University, Stanford University and the University of Connecticut and the FDA’s former Director of the Division of Biostatistics. The board members provide Firma with strategic advice and education and are resources for the latest statistical methodology and regulatory requirements.
The Firma Clinical Scientific Advisory Board includes:
- Greg Campbell, Ph.D., President, GCStat Consulting LLC, and former Director of the Division of Biostatistics in the S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
- Ming-Hui Chen, Ph.D., Professor and Head of the Department of Statistics, University of Connecticut
- Ying Lu, Ph.D., Professor, Biomedical Data Science, Stanford University
- J. Wei, Ph.D., Professor, Biostatistics, Harvard University T. H. Chan School of Public Health and Professor of Biostatical Science and Computational Biology, DanaFarber Cancer Institute
- Eugenia Henry, Ph.D., former President of Firma Clinical Research and Co-Founder of H20 Clinical (now Firma Clinical Research)
- Earl Webb Henry, M.D., former Chief Medical Officer, Firma Clinical Research, and Co-Founder of H20 Clinical (now Firma Clinical Research)
The Scientific Advisory Board offers biometrics and data strategy to Firma and provides additional consultative resources for Firma’s clients. The members of the board present lectures and training to Firma’s team and extend connections to external professionals and business partners. Overseeing the board’s activity for Firma is DJ (Dejun) Tang, Ph.D., Senior Vice President, Data Services.
“Firma is honored to have Drs. Campbell, Chen, Lu and Wei work with Dr. Tang and our biostatistics team and serve on our Scientific Advisory Board to advance biometrics for new drug and device studies,” says Michael Woods, CEO, Firma Clinical Research. “This group of distinguished scientists bring extensive experience in clinical research, biometrics and the regulatory environment, and they help validate and differentiate Firma’s scientific services.”
Firma delivers high-quality and scientifically sound data services, including fast and efficient database integrations and summary analyses for clinical studies, regardless of phase, therapeutic area, size of study or method of data capture. Firma has provided biometric services to 1,180+ studies spanning therapeutic areas, 16 oncology indications, 70+ medical device/imaging studies and 55+ NDA submissions.
Firma Clinical’s Scientific Advisory Board
Greg Campbell, Ph.D.
Dr. Greg Campbell is President, GCStat Consulting LLC, providing expertise in clinical trial design and statistical analysis as well as regulatory advice for clients in the pharmaceutical and medical products industry. He also currently sits on several Data Monitoring Committees (DSMBs). For 20 years, Dr. Campbell was Director of the Division of Biostatistics in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). In that role, he was responsible for important contributions to public health, the FDA and the medical device industry by leading the Division in providing statistical support to the entire CDRH and statistical review of the FDA’s pre-market device submissions, bringing important and innovative medical devices to the marketplace. He led efforts at the FDA to write guidance documents for medical devices on Pivotal Clinical Study Design, Bayesian Statistics and Adaptive Designs. He is a Fellow of the American Statistical Association and the Society for Clinical Trials. Dr. Campbell holds a doctoral degree in mathematical statistics from the Florida State University.
Ming-Hui Chen, Ph.D.
Dr. Ming-Hui Chen is Professor and Head of the Department of Statistics at University of Connecticut. Dr. Chen is an internationally renowned researcher in Bayesian methods, cancer research, nutritional research, clinical trials, survival analysis, competing risks analysis, joint models of longitudinal and survival data and Bayesian computation. He has served as a statistical consultant or analyst in network meta-analysis, design of clinical trials, data analysis, joint modeling of longitudinal and survival data and development of statistical software for several pharmaceutical companies in the past 20 years. Dr. Chen has published more than 410 peer reviewed articles in statistics and medical journals and has published five books, including two advanced graduate-level books. His article entitled “Monte Carlo Estimation of Bayesian Credible and HPD Intervals” with Q.-M. Shao, published in Journal of Computational and Graphical Statistics (1999), is a widely used method for computing highest posterior density (HPD) intervals in Bayesian estimation. This method has been implemented in the most popular commercial statistical software SAS (version 9.2 or above). Dr. Chen holds a doctoral degree from Purdue University.
Ying Lu, Ph.D.
Dr. Ying Lu is Professor of Biomedical Data Science at Stanford University. He is Professor (by courtesy) of Radiology, Rad/Molecular Imaging Program and Professor (by courtesy) of Epidemiology and Population Health, both at Stanford. He is a member of the Stanford Cancer Institute and Co-Director of its Biostatistics Core and Co-Director of the Center for Innovative Study Design. He previously served as Director, U.S. VA Cooperative Studies Program, Palo Alto Coordinating Center. Dr. Lu is Associate Editor of JCO Precision Oncology and is a member and past President of WNAR (Western North American Region) of the International Biometric Society. Dr. Lu has received numerous awards, including the Advisory Committee Service Award from the U.S. Food and Drug Administration and the International Chinese Statistical Association Outstanding Service Award. He is an Elected Fellow of the American Association for the Advancement of Science. Dr. Lu holds a doctoral degree in biostatistics from the University of California, Berkeley.
L.J. Wei, Ph.D.
Dr. L.J. Wei is Professor of Biostatistics at Harvard University and Professor of Biostatical Science and Computational Biology, DanaFarber Cancer Institute. He joined Harvard in 1991 and was the co-director of the Bioinformatics Core at the Harvard School of Public Health from 2003 to 2007. From 2003 to 2004, he served as the acting chair of the Department of Biostatistics at Harvard University. Before joining Harvard, Dr. Wei was a professor at University of Wisconsin, University of Michigan and George Washington University. His main research interest is in the clinical trial methodology, especially in design, monitoring and analysis of studies. He has developed numerous novel statistical methods that are utilized in practice. He received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology. Dr. Wei is a fellow of the American Statistical Association and the Institute of Mathematical Statistics. In 2014, to honor his mentorship, Harvard School of Public Health established a Wei Family scholarship to support students studying biostatistics. He has more than 220 publications and served on numerous editorial and scientific advisory boards for governments and industry. Dr. Wei holds a doctoral degree from the University of Wisconsin.
Eugenia Henry, Ph.D.
Dr. Henry is the former President of Firma Clinical Research and co-founder of H2O Clinical, LLC (now doing business as Firma Clinical Research). She currently serves in a consulting role with Firma. Dr. Henry has worked in the pharmaceutical industry for more than 30 years and was involved in 72 new drug applications. Her regulatory submission experience includes oncology, CNS, metabolic, endocrine, immunology, dermatology, gastrointestinal, cardiovascular, vaccine, infectious disease therapeutic areas, imaging and medical devices. Dr. Henry has both hands-on and senior-level clinical research experience in large pharmaceutical companies, biotechnology companies and contract research organizations. She serves as a consultant to communicate about study design and statistical analysis issues with the FDA on behalf of many companies. Dr. Henry also is a DSMB member for many studies. Dr. Henry holds a doctoral degree in statistics from the University of Missouri – Columbia. She also received a master’s degree in Statistics from the University of Arkansas and a bachelor’s and a master’s degree in Economics from Soochow University, Taipei, Taiwan.
Earl Webb Henry, M.D.
Dr. Henry is the former Chief Medical Officer for Firma Clinical Research and co-founder of H20 Clinical (now doing business as Firma Clinical Research). He currently serves in a consulting role with Firma. Dr. Henry provides medical expertise for Firma’s clinical programs. Prior to H2O, Dr. Henry served as the Co-Chief Medical Officer of InVentiv Health and Chief Medical Officer of InVentiv Clinical Solutions. Dr. Henry’s previous positions include: Head of Clinical Research and Regulatory Affairs at Cephalon, Inc.; Head of Clinical Research at Guilford Pharmaceuticals; and Global Head of Central Nervous System Clinical Research at the Sandoz Research Institute. He started his pharmaceutical career at Pfizer Central Research after being on staff at Boston Children’s Hospital and Harvard Medical School. Dr. Henry received his medical degree from the University of Chicago (Pritzker) School of Medicine and his bachelor’s degree in Chemistry from the University of Illinois. He was a medical intern at the University of Chicago Hospitals and Clinics and trained in neurology and neuropathology at the Longwood Neurology Program in Boston, which included the Peter Bent Brigham Hospital, Beth Israel Hospital and Boston Children’s Hospital.