Scientific Input and Expertise Needed for Successful Drug Discovery and Drug Development Teams in La

• 作 者: Robert Sigler
• 机 构: Vet Pathology and IND Services USA
• 出 处: BIT‘s2nd Annual World Cancer Congess-2009 (2009第二届癌症大会)
• 发表日期: 2009年12期

　　The team approach is a time-tested method for guiding new biologics or chemical entities through the early stages of drug discovery-before the drug is at a stage for testing in man, and drug development from Phase 1 to the NDA submission.Several types of expertise are required for success.Consequently, companies will seek talent and help individuals grow their careers in the process.Drug discovery teams have multiple challenges requiring a broad range of talents.The roles and inter-relationships of input from the synthetic chemist, analytical chemist, formulation chemist, scale-up chemistry expert, pharmacologist, pharmacokineticist, clinical pharmacologist, toxicologist, therapeutic area expert, regulatory liasion, MD clinician, and marketing expert need to be optimized by the team project manager and team chair, Each member of the discovery team will be challenged into problem-solving and time-critical activities during the selection of a lead compound and construction of proper documents for regulatory submissions.One weak link in the process can translate into major delays.However, the process at its best is exciting, rewarding and a fertile field for career development.New challenges always arise as a drug candidate reaches the clinical stages of development.Meanwhile the development project takes on ever-increasing importance in the company, pressuring scientists and managers to collaborate and perform at their peak to achieve success.This talk will touch on the skills needed and challenges posed to each team member within the process.