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Case Studies

Project Team: Rapid CMC and Clinical Development Review to Support a Complex Go / No-Go Decision

In building the project team for this review it was important to identify individuals with experience in a variety of pre-clinical and clinical development issues. The team deployed included experience of:

Project Challenge

Advisors Profile

ADMEPharmaceutical executive with 25 years experience including leadership of Clinical Pharmacokinetics and Pharmacodynamics
Biopharm. Analytics and DevelopmentFormer Vice President with expertise in biopharmaceutical development, formulation, quality systems and operations
Biopharmaceutics DevelopmentFormer Senior Vice President and CSO with extensive experience in development of biopharmaceuticals
Clinical Development and PharmacologySenior Physician-Executive with 16 years industry experience including as Senior Vice President of Global Drug Development
Clinical and Regulatory AffairsFormer Senior Vice President of Pharmaceutical Research and Development with relevant clinical expertise
Drug DeliveryExperienced pharmaceutical consultant with background in drug delivery technology
ToxicologySenior executive with 30 years experience. Former Senior Vice President with global responsibility for toxicology, pathology and metabolism