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Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS hydromorphone). Recently, Expert was instrumental in developing a…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Pharmaceuticals, Biotechnology
Expert is an independent consultant providing management solutions for science and technology in the pharmaceutical and biotechnology industries. His background includes over 25 years of pharmaceutical industry experience with positions of increasing responsibility at Astra, Warner Lambert/Parke-Davis and most recently…
Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials design and management, community-based research, educational programs’ development and…
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…
Strategic Marketing and Business Management in all Healthcare and Medical Sectors
• Successful, enthusiastic, highly motivated, strategic medical/healthcare consultant • Qualified, experienced international business manager & strategic medical marketer • Excellent track record of turning round and growing companies, products & services • Wide span of management expertise across pharmaceutical, medical…
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…
Epidemiology
Expert (Md, PhD in biostatistics and epidemiology) is a free-lance consultant in epidemiology with 25 years of experience. He was appointed in a private compagny for 5 years (CRO for pharmaceutical industry, ClinSearch), and previously in national public organizations (Southeastern…
Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. Played critical roles in several…
Pharmaceutical Licensing, Life Science Licensing, Commercialization
Expert has worked with a number of pharmaceutical and life science companies at senior level as either employee, consultant or interim manager, supporting initial public offerings and other fundraising activities and cross-border M&A. He has particular skills in due dilgence,…