[Executive Summary] From Candidate to Clinic

What is the fastest way to success? It is critical that drug developers execute several elements related to planning, investment, and understanding of the risks, risk tolerance, and pitfalls inherent in the drug development program. In addition, technical expertise, the CMC development-related narrative, and team dynamics and culture must come together within a fluid, rapidly changing, and complex development environment. The development program should include priorities such as:
  • Quickly designing lead candidates with optimized physical forms, stability, biopharmaceutical and drug metabolism and pharmacokinetic (DMPK) characteristics, and minimal toxicity
  • Reproducing manufacturing and supplying the needed clinical supplies quickly
  • Rapidly solving problems that surface
  • Quickly assessing, measuring, and mitigating risk
  • Speeding up, slowing down, stopping, and changing directions as needed
  • Understanding and incorporating the required global regulatory and quality focus

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