Biotechnology Expert Witnesses: 8

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 Anti-trust, Patent, and Product Liability.

Shishir V. Shah, DO, is an award-winning Wound Care Physician in active clinical practice. Dr. Shah has 20 years of wound care clinical, safety, and leadership experience in acute care, skilled nursing, rehabilitation, and home health settings. A Certified Wound Specialist (CWS) with additional Board Certifications in Hyperbaric Medicine and Family Practice.

Dr. Shah is a National Key opinion leader, CMO for 9 outpatient wound clinics, and experienced as a Medical Director at several level 1 Hospital Programs. Dr. Shah is on faculty at Midwestern University Medical School where he trains students on skin and soft tissue procedures. He has significant private equity, medical device, startup, and consulting experience (with biomedical, consumer products, and device-related wounds.) He earned his undergraduate degree in Aeronautical Engineering from Rensselaer Polytechnic Institute.

Litigation Support - Dr. Shah serves as a Hyperbaric Medicine / Wound Care Causation expert witness, with deposition and trial experience. His nationwide services are available to defense attorneys, device companies, physicians hospitals, skilled nursing facilities, and for consumer product liability. Dr. Shah is timely, professional, articulate, and accessible.

Areas of Expertise:

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.

Rouzbeh R. Taghizadeh, PhD, is a Regenerative Medicine and Biomedical Engineering Expert offering more than 20 years of expertise as a Scientist, Innovator, and Entrepreneur in the development, processing, manufacturing of tissues, including bone marrow, umbilical cord (blood & tissue), amnion, chorion, placenta, adipose (fat), and other organs for clinical and non-clinical use, while considering the complex regulatory, trade secret, patent claims that arises from these areas.

Litigation Support - Dr. Taghizadeh provides subject matter expertise and expert witness testimony for scientific, technical, regulatory, trade secret and patent claims in the areas of:

Dr. Taghizadeh specializes in adult stem cells, primarily human hematopoietic and mesenchymal stem cells, the regenerative cells involved in successful bone marrow and umbilical cord blood transplantations, uniquely positions him to approach science and business with the same keen powers of insight that have consistently reaped success surmounting scientific and medical barriers in the field. 

He earned his Ph.D. in Stem Cell Bioengineering in 2006 from the Massachusetts Institute of Technology (MIT) and co-founded AuxoCell Laboratories, Inc. as Chief Scientific Officer in 2008 after completing his post-doctoral training from MIT and the Boston Biomedical Research Institute.

View Dr. Rouzbeh R. Taghizadeh's Consulting Profile.

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.

Peter Crosby has over 45 years experience in the Medical Devices Industry. He has served as  CEO of six medical device companies (public and private) in four countries, and has been a member of the board (including chairman of the board) of over 10 companies. Mr. Crosby is an accomplished entrepreneur and company builder, and has brought many medical device products to the world market. He is an inventor on over 50 US patents and applications.

Education includes a Bachelor of Engineering (Electrical) and Master of Engineering Science (Biomedical Engineering).

Litigation Support - Mr. Crosby has served as an expert  in many cases including product liability, intellectual property (patent disputes including infringement, validity, IPR and ITC), alleged misappropriation of trade secrets, fiduciary duty of directors, and commercial contracts disputes (including commercially reasonable efforts"). 

Product Expertise:

View Peter Crosby's Consulting Profile.

William R. Acorn is founder of Acorn Consulting Services, LLC, an engineering firm. As a consulting mechanical engineer, Bill provides project analysis, forensic reconstructions and litigation support services relating to the design, delivery, and functioning of high-tech manufacturing facilities, semiconductor fabrication facilities, institutional laboratories, data centers, health care facilities and a variety of commercial buildings. He is a recognized expert in the evaluation of deficiencies in HVAC systems, cleanrooms, piping systems, refrigeration systems, construction defects, building and fire code compliance, and patent and trade secret disputes. He represents both plaintiffs and defendants.

Bill has more than 40 years of experience as a professional engineer and is a recognized expert in assessing, evaluating, remediating and providing testimony on complex project design, construction and operational matters. His consulting expertise has been influential in shaping approaches to code compliance and life safety in semiconductor and similar advanced technology facilities.

Certifications and Designations:

• Registered as a Professional Mechanical Engineer in the States of Arizona, California, Colorado, Illinois, Iowa, Nevada, New Hampshire, New Mexico, Oregon, Texas, Utah and Washington.
• Registered with the National Council of Examiners for Engineering and Surveying NCEES (Certificate No. 6999)
• Fellow in the HVAC industry leading organization ASHRAE
• Visiting lecturer at the Arizona State University Del E. Webb School of Construction in Tempe, AZ
• Advisor to CREATE, ACE – Alliance for Construction Excellence and the IAB – Industry Advisory Board, all affiliated with ASU

Building Systems Analysis:

Litigation Support: Bill’s pragmatic approach to both forensic and litigation consulting as well as project consulting is based on more than 40 years of real-world experience as a design professional, mentor and forensic analyst, as well as many years as an instructor in professional and academic settings. Represented both plaintiffs and defendants in a variety of jurisdictions throughout the US and Asia. Bill’s ability to explain complex issues to non-technical audiences, including juries, mediators and judges, is a key to successfully solving your litigation challenges.

• Forensic Analysis
• Strategic Litigation Consulting
• Trial Demonstratives
• Expert Testimony

Acorn Consulting Services

Consulting Services: Services range from peer review to conceptual design to development of strategies and programs for expedited project delivery.

Bill frequently acts as an owner’s agent and mentor, functioning as an extension of the owner’s project team. On other projects, Bill serves as a subject matter expert assisting project delivery firms in their development of viable solutions and review of construction documents.

As a project consultant, Bill assures the project gets off to the right start and provides his expertise through completion and operation to maximize return on investment.

Consulting Expertise Includes:

• Project Design and Management Consulting
• Forensic Analysis and Litigation Consulting
• Mentoring & Advanced Education