Location: Live Webcast from San Francisco Bay Area

Speakers:

Tao Wang (Novartis), Hong Wang (Genentech), Carol Green (SRI)

Details:

Once a drug candidate has been discovered, nonclinical safety assessment is required to ensure the safety of the drug during clinical trials and to support the marketing application. The preclinical development of small-molecule drugs and biologics will be illustrated to emphasize the cross-functional nature of  toxicology, pharmacokinetics and regulatory sciences.  The workshop will begin with a focus on small molecular-weight drug candidates, which require a sliding scale for the degree of development from relatively minimal regulatory requirements for oncology drug development to the much more stringent requirements for the development of drugs for non-life threatening conditions and chronic treatment. Next the focus will shift to large molecule biologics, and provide illustrations of the unique challenges that biologic drug candidates present for nonclinical safety assessment and clinical development.

Key topics will include:

• Small molecule drug safety assessment
• Biologic drug safety assessment
• Pharmacokinetics and toxicokinetics in the context of safety assessment