Commercially Reasonable Efforts Expert Witnesses

Aliso Viejo, California

Biomedical Engineering, Intellectual Property - Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, misappropriation of trade secrets, ITC, IPR, ITC, fiduciary duty, pacemaker, defibrillator, neurostimulator, biomedical engineering

Peter Crosby is a biomedical engineer with over 45 years experience in the medical device industry, and has served as CEO of six medical device companies, public and private, in 4 countries. He has served as a member of the Board of 13 companies, and is currently serving as a member of the Board of three companies. He has brought many medical devices from concept to market release, through R&D, clinical trials, regulatory approval (FDA and CE Mark) and market launch. He is an inventor of over 50 issued US patents and applications and foreign equivalents. He has served as an expert in multiple patent cases - infringement, ownership, validity, IPR and ITC. His clinical domain and specialty experience includes otolaryngology, cardiology, cardiac surgery, anesthesia, pain management, radiology and diagnostic imaging, in vitro diagnostic devices, orthopedic surgery devices, and oncology. His product experience includes cochlear implants, diagnostic ultrasound, mammography, implantable...

California

Marketing, Pharmaceutical Regulation - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Branded Promotion, CNS Products, Medicare, Oncology Products, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE

Mr. Hosier is a strategic advisor to the life sciences industry drawing on nearly 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; advised on commercially reasonable effort (CRE); and provided c...

West New York, New Jersey

Marketing, Pharmaceutical Regulation - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Branded Promotion, CNS Products, Medicare, Oncology Products, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE

Mr. Hosier is a strategic advisor to the life sciences industry drawing on nearly 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; advised on commercially reasonable effort (CRE); and provided c...

New York

Marketing, Pharmaceutical Regulation - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Branded Promotion, CNS Products, Medicare, Oncology Products, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE

Mr. Hosier is a strategic advisor to the life sciences industry drawing on nearly 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; advised on commercially reasonable effort (CRE); and provided c...

Pennsylvania

Marketing, Pharmaceutical Regulation - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Branded Promotion, CNS Products, Medicare, Oncology Products, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE

Mr. Hosier is a strategic advisor to the life sciences industry drawing on nearly 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; advised on commercially reasonable effort (CRE); and provided c...

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...