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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Medicinal Chemistry/ Synthetic Organic Chemistry-Research and Patent Litigation
Experienced Medicinal Chemist and Consultant: expert at synthetic organic chemistry, pharmaceutical chemistry, pharmaceutical patent litigation, patent analysis: 1) Eight years of consulting experience, beginning in Jan. 2012, writing expert reports following patent analysis covering obviousness, claims validation, enablement; depositions given.…
Pharmaceutical Marketing, Sales, Portfolio Management, and Life-cycle Managment
Expert has over 30 years' experience in the pharmaceutical industry ranging from pharmaceutical marketing, sales, product portfolio management, life-cycle management, commercial viability of new and existing drugs, OTC drug experience and patent litigation experience in Federal, and District courts both…
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
Pharmaceutical/Biotech Marketing | Brand Marketing | P&L Management | Commercial Strategy
Expert is a strategic advisor to the life sciences industry drawing on more then 25 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has worked both as client and vendor (pharma/biotech executive and ad agency…
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…
Drug marketing, Drug intellectual property & patent, Drug benefits, Specialty pharmacy, Pharmacy benefit management, Evidence-based drug Use
Since 1989, Expert has provided consulting related to pharmacy benefits, marketing of pharmaceuticals, biotechnology and biological products, pharmaceuticals-related business strategy and new business development. Consulting engagements typically involve situation/opportunity assessment, proforma market and price modeling, business strategy and development, market…
Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development
Expert has more than 25 years of expertise in transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution, opinions, and appeals for the development and commercialization of health care, pharmaceutical, biotechnology, chemical, computer and electronics technologies. With more than…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…