Biochemistry Expert Witnesses: 3

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.

As a consultant in his own pharmaceutical development advisory firm for over 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to  resolve Form 483, Warning Letter, and Consent Decree issues.    

Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more

Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness  and consultant to litigation in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.

Dr. James C. Norris, Ph.D., DABT, EURT is an Expert Witness in Toxicology and Pharmacology. He has Litigation and Arbitration experience in the United States, United Kingdom and Hong Kong. Dr. Norris has given testimony to government agencies, has acted as a consultant for the media (BBC) and is an Industrial Site Crisis Team Member. He is avaliable for both Plaintiff and Defense.

Areas Of Expertise:

• Carcinogenicity and Chemicals
• Combustion or Fire Toxicolog
• General and Inhalation Toxicology
• Pesticides, and Pharmaceuticals (pharmacology)

Professional Affiliations:

• American Association of Pharmaceutical Scientists
• British Toxicology Society
• Society of Toxicology
• Editorial Boards of Inhalation Toxicology and Journal of Fire Sciences

Martin L. Lee, PhD, CStat, Csci, FIBMS has more than 42 years of experience in clinical research as the head of departments in the Management of Clinical Research and Analytical Modeling of Healthcare Data for major pharmaceutical and medical device companies, as well as start-up biotech companies.

Dr. Lee is trained as a clinical biostatistician and has consulted with numerous healthcare companies around the world in the design, management and analysis of clinical research studies. Importantly, he has helped to start up a handful of companies and has been involved in the initial planning and funding of these companies. 

In addition, Dr. Lee is an Adjunct Professor of Biostatistics at UCLA where he has taught courses in basic and advanced biostatistics and clinical research design for the past 42 years.

Litigation Support - Dr. Lee has served as an expert witness for numerous cases over the past 31 years. He is an expert in sampling techniques, clinical research design and the conduct of clinical trials. As a trained clinical and non-clinical biostatistician, he is knowledgeable in the use of statistical methods in the legal arena. 

Dr. Lee's expert witness experience includes numerous healthcare fraud cases involving Medicare / Champas (for the U.S. Department of Justice, EPA, FTC), worker’s compensation (FBI), various state health insurance agencies (California, West Virginia, Florida, New  York, etc.), as well as patent infringement and product liability cases.

Dr. Lee has written expert reports, given depositions, and testified in administrative hearings and actual trials. His experience in sampling and statistical inference has been extremely useful in the prosecution of healthcare cases.

Areas of Expertise:

View Dr. Martin L. Lee's Consulting Profile.