Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions:
1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it? Contributed as an FDA regulatory expert witness in cases involving death and injury caused by drugs and medical devices, size of monetary awards, insurance claims, patents and merger contracts.
Expert serves as an FDA compliance expert, trainer, SAS programmer, statistician, technical writer, and auditor. He utilizes his authority on auditing, writing NDAs, PMAs, protocols and SOPs. He also employs his expertise in validation and 21 CFR Part 11 compliance.
Years: 1992 to 1994
Employer: Food and Drug Administration
Title: Drug Reviewer
Managed the drug review process. Instructed firms on how to proceed with drug approval. Summarized outstanding problems and issues with protocols and studies, and determined if deficiencies were adequately addressed. Reviewed statistical methodology of studies. Authored all written communication to the sponsoring firm and integrated comments from other reviewers. Developed techniques to evaluate submission data quality.
Years: 1989 to 1992
Employer: Marriott Hotels
Title: Director of hotel Customer Information systems
Managed a team of 25 programmers responsible for building the system supporting Marriott Hotel’s Rewards program
Years: 1992 to 1994
Agency: Food and Drug Administration
Role: Drug Reviewer
Description: Expert managed the drug review process. He instructed firms on how to proceed with drug approval. He also summarized outstanding problems and issues with protocols and studies, and determined if deficiencies were adequately addressed. Expert reviewed statistical methodology of studies. He authored all written communication to the sponsoring firm and integrated comments from other reviewers. He developed techniques to evaluate submission data quality.
Expert Witness Experience
He is an expert in searching the medical literature for all safety-related information about an FDA-regulated product. His specialties include building timelines to describe how and when the knowledge base about a product increased, and to explain the development of new conclusions about a product’s safety. He is skilled at answering three questions: What did the company know and when did they know it? What should the company have known and when should they have known it? What should the company have done and when should they have done it?
Expert has supported plaintiff attorneys with FDA regulatory information and insight in cases involving Actos, Fentanyl Sulindac and defective hip implants.
Training / Seminars
Expert has developed training for scientists in computerization and analysis of data. He created and taught instructor-led classes in SAS validation and FDA compliance. He wrote and taught over 40 different audio conference classes on a wide variety of FDA regulatory, technical and compliance topics attended by over 50,000 people from FDA regulated companies. He has taught FDA compliance to students in India using Skype.