Greg Enas is a member of the health and life sciences team with a deep background in regulatory strategy and implementation, product approval negotiation with the Food and Drug Administration, innovative research and development plans, and statistically robust substantial evidence that meets regulatory requirements related to clinical research and development, manufacturing and marketing. He assists clients in complying with complex FDA regulations during research, development, clinical trials, review and approval, marketing and reimbursement.

Greg is skilled in helping international organizations align global implementation of regulatory strategies. He keeps clients up to date on new directions being considered by global regulators in innovative clinical trial design. As a national thought leader in personalized medicine, Greg has a highly sophisticated view of new clinical trial platforms that may be adaptive or progressive or may use new tools and mechanisms to reflect personalized response and risk to therapies.

Before joining FaegreBD Consulting, Greg held various leadership positions for almost 30 years at Eli Lilly and Company, one of the world's largest pharmaceutical companies. In his most recent capacity as Senior Director of Global Regulatory Affairs, U.S. Diabetes, he was responsible for overseeing the delivery of world-class regulatory strategies for the Diabetes Business Unit, negotiating product development and approval with FDA, and coordinating strategies for aligned global implementation. He previously served as Director of U.S. Regulatory Affairs and was responsible for the endocrinology and infectious disease product development portfolios. Prior to joining U.S. Regulatory Affairs, Greg simultaneously led the Lilly corporate functions for biostatistics and portfolio management as Director of Statistical and Mathematical Sciences and Director of Decision Sciences, respectively.

Honors

• School of Basic Health Sciences, Virginia Commonwealth University — STAR Award for Outstanding Alumnus, 2000
• American Statistical Association — Elected Fellow, 1999

Professional Associations

• Pharmaceutical Research and Manufacturers Association — Biostatistics Steering Committee, Chair, 1996-99

Civic Activities

• Harrison Center for the Arts, Indianapolis, Indiana — Board of Trustees
• Institute for Classical Schools, Virginia — Board of Trustees
• The Oaks Academy, Indianapolis, Indiana — Board of Trustees
• Justice Ventures International, Maryland — Board of Advisors

Publications

• Subgroup Identification Based on Differential Effect Search—A Recursive Partitioning Method for Establishing Response to Treatment in Patient Subpopulations
  Statistics in Medicine, co-author (2011)
• 10 Years with ICH E10: Choice of Control Group
  Pharmaceutical Statistics, co-author (2011)
• Global Harmonization of Standards for Adaptive Clinical Trial Designs
  Regulatory Focus, co-author (August 2008)
• Regulatory Interactions Necessary to Implement Adaptive Clinical Trials
  American Pharmaceutical Outsourcing (July/August 2007)
• Innovative Approaches for Designing and Analyzing Adaptive Dose-Ranging Trials
  Journal of Biopharmaceutical Statistics, co-author (2007)

Presentations

• Adaptive Design Regulatory Interactions
  IBC Adaptive Designs Conference (May 2007)
• Substantial Evidence from Subpopulations and Secondary Endpoints
  Drug Information Association Annual Meeting, Philadelphia (2006)
• A Process for Interactions Between Sponsors and FDA to Facilitate Planning/Implementation of Adaptive Designs
  PhRMA Conference of Adaptive Designs, Opportunities, Challenges and Scope in Drug Development (Nov. 14, 2006)