Pharmaceutical Regulation Expert Witnesses in New York

New York

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

Mr. Hosier is a strategic advisor to the life sciences industry drawing on 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 commerci...

New York City , New York

Medical Devices, Pharmaceutical Regulation - Medical Device FDA Regulation, Biologics FDA Regulation, FDA Compliance, FDA Warning & Labels, Product Liability, FDA Regulations, Medical Device Product Liability, Clinical Trials FDA Regulation, Medical Device FDA Approvals-Clearance, Medical Device Recalls, Medical Device Complaints, Biomedical Engineering

Dr. Ediuska Laurens is a highly credentialed biomedical engineer and expert in FDA regulation, compliance, and product liability for medical devices and biologics. She provides expert witness services to both plaintiff and defense counsel in litigation involving medical device and biologics FDA approval and clearance, labeling and warnings, quality systems, adverse event reporting, clinical trials, and post-market surveillance. Dr. Laurens brings over 20 years of combined industry, research, and regulatory experience. She has led regulatory and quality efforts across the entire medical device lifecycle, from concept through commercialization, supporting product development, regulatory submissions, and quality compliance for a wide range of technologies, including cranial and orthopedic implants, spinal and neural devices, tissue engineered-biologics and combination products, hydrogel biomaterials, as well as pediatric and women’s health innovations, among others. Attorneys rely on...