Phase 1 3 Clinical Trials Expert Witnesses

Phase 1 3 clinical trials expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on phase 1 3 clinical trials. The phase 1 3 clinical trials expert witness listings on this page are typically from fields/areas of expertise such as: Oncology and Pharmaceutical Regulation.

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Frederick H Hausheer, MD, FACP

Oncology Drug R & D, ICH GCP, Drug Patent Validity

HAUSHEER BIOMED, LLC USA

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
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...