Pharmaceutical Regulation Expert Witnesses in Texas

The SEAK Expert Witness Directory contains a comprehensive list of pharmaceutical regulation expert witnesses who testify, consult and provide litigation support on pharmaceutical regulation and related issues. Pharmaceutical regulation expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, and provide expert witness testimony at deposition and trial. The issues and subjects these pharmaceutical regulation expert witnesses testify regarding may include: Anticipation, Breach Of Contract Pharma/Biotech, Commercially Reasonable Efforts, Damages, Drug Formulation, Drug Product Safety, Ema, Enablement, FDA, Ich Gcp, Medical Oncology, Medical Safety, Nmpa/China, Obviousness, and Oncology Drug Development.

David B. Ross, MD, PhD, MBI
  • FDA Regulations & Procedures
  • Drug Safety, Clinical Trials
  • 10+ Years at FDA (CDER)
John Hosier, 30 Yrs Indust Exp
  • 50+ Products, $50M–$2B P&L
  • Adv, Promo, Mktg, Sales, CRE
  • Pharma, Biotech, Med Device
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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, 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...
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