Medical Safety Expert Witnesses

Ann Arbor, Michigan

Human Factors, Warnings & Labels - Chemical Risk Communication, Chemical Hazard Communication, Occupational Health and Safety, Consumer Product Safety and Warnings, User Response, Product Safety Evaluation, Medical Safety, Recreational Safety, Retail Safety, Occupational Safety, Premises Liability, ANSI Z535, ANSI Z129.1, ANSI Z400.1, Chemical Labeling, Warnings

Ms. Raina Shah is a Principal Consultant in the Human Factors group and directs chemical risk communication activities. She has extensive experience in litigation matters related to chemical hazard communication, occupational health and safety, and consumer product safety and warnings. Her activities have included researching user response to warnings and instructions; evaluating product safety information in consumer, medical, recreational, retail, and occupational contexts; analyzing product and occupational accidents and premises safety issues; and providing general safety and human factors consultation. Ms. Shah has played an active role in national standards for consumer product warnings and instructions (ANSI Z535), chemical labeling (ANSI Z129.1), and material safety data sheets (ANSI Z400.1), and she has regularly guest lectured at the University of Michigan on topics including hazard communication, driver distraction, and uncertain health and safety risks. Ms. Shah holds ...

Austin, Texas

Oncology, Pharmaceutical Regulation - Oncology Drug Development, Patent Validity, ICH GCP, Written description, Enablement, Obviousness, Anticipation, Pharmacology, FDA, EMA, NMPA/China, PMDA/Japan, Drug formulation, Medical Safety, Phase 1-3 Clinical Trials, Drug Product Safety, Medical Oncology, Breach of Contract - Pharma/Biotech, Commercially Reasonable Efforts, Damages

Dr. Frederick (Fred) Hausheer is a physician-scientist with over 37 years of executive leadership and management experience in US and international (EU, JP, China, others) commercial pharmaceutical research and development (Phase I-III), preclinical translational and clinical medicine, clinical pharmacology, ICH GCP compliance and commercial development strategy and risk management of novel cancer therapeutics. His commercial research and development experience includes cytotoxic agents, targeted agents, immuno-oncology therapeutics, cell therapies (BMT, CAR-T), and supportive care medicines. He is an inventor/co-inventor on more than 400 issued United States and international pharmaceutical patents, and author/co-author of more than 200 scientific/medical publications. He is an experienced former CEO and Chief Medical Officer with several biopharma companies and a former NCI-Designated Clinical Investigator, NCI-Institutional Review Board voting member, and NCI-Experimental Ther...