Frank Rockhold Bio

Frank is a Professor of Biostatistics and Bioinformatics at Duke University Medical Center (Scholars at Duke), Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Managing Partner of HunterRockhold, Inc.  His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance.  He has also held faculty appointments at six universities.    Dr. Rockhold 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 currently on the boards of the Frontier Science and Technology Research Foundation, Datavant, and an advisor to EMA.

Dr. Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.    Frank is widely published in major scientific journals across a wide variety of research topics.

Frank holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. Frank is an Elected Fellow of both the American Statistical Association and the Society for Clinical Trials, an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.

About HRI Statistical Consulting

Most statistical consultants and experts can plan and perform statistical analyses, but few are experienced in the strategic considerations that are essential components in the development of a new medicine.  Even fewer are experienced and expert in safety, pharmacovigilance and benefit to risk.  Dr. Rockhold brings more than 40 years of global experience in the statistical aspects of drug development and the regulatory process.  He will work with you to design research plans, clinical trials, pharmacovigilance, safety and benefit to risk strategies.

Dr. Rockhold’s experience base includes directing statistical and clinical aspects of global submissions for more than 500 new molecular entities in every therapeutic area including vaccines and consumer products, new indications, and combination products.  He has presented personally at FDA advisory committee meetings, Japanese and European regulatory agencies, National Academy of Science, Institute of Medicine, White House Office of Technology and Science and is currently an to the Patient Centered Outcomes Research Institute as part of the Affordable Care Act.   Frank has been involved in over 2000 clinical trials and also has unique and international recognized experience in the areas of public data disclosure and scientific transparency.

Dr. Rockhold has served on and chaired more than 30 data monitoring committees≥

This diverse and unique set of experiences will add significant value to your research projects.

Qualifications and Experience

ACADEMIC QUALIFICATIONS

  • PhD in Biostatistics
  • ScM In Biostatistics
  • B.A. in Statistics
  • More than 100 Publications in peer reviewed scientific journals (see selected publications)
  • More than 100 presentations at Scientific Symposia (see Full CV)

ACADEMIC EXPERIENCE

  • Full Professor of Biostatistics and Bioinformatics, Duke University School of Medicine (current)
  • Affiliate Professor of Biostatistics, Virginia Commonwealth University Medical Center (current)
  • University of Pennsylvania, Adjunct Scholar, Epidemiology and Biostatistics
  • Penn State College of Medicine, Adjunct Professor, Department of Public Health Sciences
  • Medical College of Virginia/Virginia Commonwealth University, Graduate Faculty, Department of Biostatistics
  • Indiana University School of Business Administration, Lecturer, Department of Quantitative Business Analysis
  • Butler University School of Business Administration, Lecturer, Department of Management Science

INDUSTRY EXPERIENCE (all with top 5 Pharmaceutical Companies)

  • Chief Safety Officer and Head of Global Clinical Safety and Pharmacovigilance
  • Chaired Global Safety Board and internal Data Monitoring Committee
  • Head of Cardiovascular Research
  • Head of Biostatistics, Epidemiology and Health Informatics with groups in US, Asia and Europe and a staff of 1500
  • Head of Clinical Operations
  • Worked on more than 500 new molecular entities in every therapeutic area including vaccines and consumer health
  • Involved in the design or analysis of more than 2000 clinical trials
  • Led the development of the worlds first protease inhibitor for AIDS from clinical trials to market.

PROFESSIONAL SERVICE

  • President Society for Clinical Trials
  • Pharmaceutical Research Manufacturers of America – Chaired Biostatistics Committee
  • ICH:   Member, ICH Expert Working Group (E1) on Extent of Population Exposure,  ICH Expert Working Group (E9) on Biostatistics Guidelines for Clinical Trials, and ICH Expert Working Group (E10) on Choice of a Control Group.
  • World Health Organization – Scientific Advisory Group for the International Clinical Trials Registry Project
  • Clinical Data Interchange Standards Consortium (CDISC), Chair and Member Board of Directors
  • National Library of Medicine Board of Regents Clinical Trial Working Group.
  • Patient Centered Outcomes Research Institute Advisory Panel on Clinical Trials
  • Frontier Science and Technology Research Institute, Board of Directors (current)

HONORS & AWARDS

  • Fellow, American Statistical Association.
  • Fellow, Society for Clinical Trials
  • Fellow Royal Statistical Society
  • ACCREDITED PROFESSIONAL STATISTICANTM, PStat®  ,2012
  • Chartered Statistician, CStat
  • Career Achievement Award, PhRMA
  • Named Outstanding Alumnus from Medical College of Virginia, Graduate School of Health Sciences, 1993