Biochemistry Expert Witnesses: 4

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist with over 43 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 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), 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 over 20 cases in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Antitrust, Patent, and Product Liability.

View Timothy Anderson's Business Consulting Profile.

Gary D. Fletcher, PhD,  is the Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm founded in 2015, focused on Industrial Mechanical Engineering and Biomedical Engineering and Research and Product Development.  In his 30 years of experience, he has been co-inventor on 23 patents for devices and methods in blood collection and processing.

Litigation Support - Dr. Fletcher has subject matter expertise in Medical Device Mechanical Engineering and subject matter expertise in Medical Devices for blood and specimen collection and sample processing for in vitro diagnostics, point of care diagnostics, and therapeutics, including glucose monitoring. He serves as an expert witness in patent infringement cases involving medical device and diagnostic biomedical engineering, blood collection, separation, fluidic preparation, glucose monitoring, and cell therapy preparation devices.

Dr. Fletcher offers patent litigation services to law firms and lawyers supporting medical device and diagnostic industry clients, who need physical science and mechanical and biomedical engineering expertise for District Court, PTAB, and ITC patent cases. As an industry consultant, his ideal clients are R&D, product development, and innovation leaders in startup, emerging, and established medical device and diagnostic companies, who face product development and competitive challenges.

Areas of Expertise:

Dr. Fletcher is an entrepreneurial executive with expanding R&D roles in business, technology, and new product development leadership and execution, building and guiding teams in both Fortune 500 and startup companies. With a PhD in physics from Yale, he has a proven record of leadership in creating innovative new businesses and products in healthcare, medical devices, diagnostics, life, materials, and optical sciences.

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

Dr. Glenn Prestwich  is a National Academy of Inventors fellow with over 45 years of experience as a professor, entrepreneur, and biotech startup C-suite executive. Dr. Prestwich specializes in Biomedical Intellectual Property. He has been a prolific inventor since 1977, and an expert witness in IP law cases since 2007. He is an inventor on over 95 patents and patent applications, including 48 issued patents.

Litigation Support - Dr. Prestwich brings to all legal and technical cases a deep appreciation for how chemistry informs the invention and development of products that offer solutions to problems in the life sciences and medicine, ranging from disease detection and treatment to tissue healing and regeneration. He’s been involved in intellectual property litigation that concern medical devices, diagnostics, new pharmaceuticals, drug delivery, agrochemicals, and consumer products.

As an expert witness, Dr. Prestwich enjoys the challenges of dissecting the validity (or invalidity) of patents in litigation. He appreciates the subtleties of claim construction and works collaboratively with attorneys to identify successful arguments based on sound science and legal principles. He has drafted over 40 expert reports, declarations, and affidavits in support of his attorney clients.  He has been deposed 18 times and testified in Court four times.

Glenn D. Prestwich on Accessible and Experienced Expert Witnesses

Areas of Expertise:

Publications - Dr. Prestwich is an organized, clear, and effective writer. He has co-authored  over 610 additional peer-reviewed articles in the scientific literature, and written over 50 single-author scientific publications, reviews and book chapters. His publications encompass areas such diverse topics as anti-cancer drugs, gels for wound repair, cell therapy, and regenerative medicine, insect and pest control agents, cholesterol-lowering agents, lipids and cell signaling tools, and anti-inflammatory agents.