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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…
BioPharmaceutical Commercialization
New product planning, business development, and marketing professional with transactional, launch, and expert witness experience. Expertise in new product commercialization, licensing, valuations, deal structure, strategic brand planning, long range forecasting, pricing & reimbursement, HEOR strategies, payor communications, tactical program implementation,…
Pharmaceutical Processing and Packaging
Expert has over 20 years of experience in engineering and technical services. He has lead teams of engineers working in development, material qualification process development/ qualification, as well as lifecycle management for both new and existing combination/ non-combination products. Expert…
Delivery Systems: Pharmaceutical and Consumer Products
Accomplished chemist with a Ph.D. in Pharmaceutical Chemistry and the proven ability of leading, coordinating and successfully executing the complete project lifecycle from initial idea through to final implementation and closure combined with a strong ability in creating international partnership…
Pharmaceutical, Drug, Medical Device, and Management
Expert is a Pharmacist and an Attorney with a MBA and has worked in the pharmaceutical/biotech/medical device industry for 25 years.
Healthcare Strategy, Technology & Innovation
Expert has 20+ years of experience in the healthcare industry. He is currently a Principal at a healthcare consultancy focused on health care strategy, technology, and innovation. He offers advising services like topic-specific research, environmental/market assessments, strategic planning, operations/workflows design…
Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement
Expert is a classically trained biochemist with 30 years of experience in the biopharmaceutical industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment. During his long tenures at…
Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing…
Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief…
Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…