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Biotechnology, Pharmaceuticals,
Expert in Biopharmaceutical molecule development and licensure. Experience with top Biotech companies (BMS, sanofi, MedImmune, AZ, Adello, etc.). Designed successful Analytical strategy for 100s of IND and many BLA submissions in multiple countries. Expert in the following areas: Scientific writing…
Pharma/Biotech Market Access, Pricing & Reimbursement, Business Development Europe and Latin America
Pharmaceutical executive with 17+ yrs. experience in international, corporate and local/regional roles at leading pharmaceutical companies in Europe and Latin America. Strong experience in general management, business development and licensing, alliance management, project and transition leadership, marketing and sales, strategic…
Pet and Vet Industry; Specializing In Pharmaceutical, Food, Treat and Nutraceutical Formulation
Forward-looking, entrepreneurial CEO and Managing Director with stellar, 20+ year record of achievement. Sets core business strategies that deliver major professional and customer demand in competitive markets. Spurs organizational growth and excellence by proactively developing staff; nurturing and fostering strengths…
Manufacturing Technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines
Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals…
Biotechnology, Pharmaceuticals, Diagnostics, Market Research, and Writing
Expert possesses two decades' experience in consulting, market research, and medical writing experience in biotechnology. She possesses laboratory research experience in biotechnology as well. Expert has amassed two decades of consulting, market research, and medical writing experience in biopharmaceuticals and…
Microbiological Contamination Control
A principal with his eponymous consulting firm, Expert has amassed 30 years of experience in academia, industry, and consulting. The majority of his research and consulting work has been in the area of microbiological contamination detection and mitigation for pharmaceutical/biotechnology,…
Pharmaceuticals and Biotechnology
Expert is a clinical psychologist by training with over 9 years of experience in Health Economics and Outcomes Research. His area of focus is Clinical Outcomes Assessment, including Patient Reported Outcomes. Expert helps sponsors define and implement a COA strategy…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions
Expert is a consultant to the US FDA for Quality issues associated with the manufacture of pharmaceuticals. Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…