Speaker Spotlight: Patient-Focused Drug Development: CMC Considerations

Wednesday, October 23, 2024

11:30 AM – 12:30 PM MT

Location:Spotlight Stage C, Aisle 2800, Exhibit Hall

Spotlight Speaker(s)

Hong Cai, PhD (she/her/hers)

Division Director
U.S. Food and Drug Administration
Silver Spring, Maryland

Moderator(s)

Josephine Aimiuwu, PhD

Lead Pharmacologist
U.S. Food and Drug Administration
Silver Spring, Maryland

The presenter will discuss quality considerations of patient-focused small molecule drug development strategies. The talk will include an overview of drug development and approval process in the US, a systematic approach in small molecule formulation design to meet the needs of various patients; CMC readiness for accelerated approvals and the OPQ effort in modernization of quality assessments of Investigational New Drug Applications (INDs) in order to timely bring new treatments to patients. Key factors and strategies to overcome CMC challenges will be discussed, including strategic planning, leveraging prior knowledge, promoting innovations, utilizing a science and benefit-risk consideration approach for assessments, and enhancing communication and collaboration between sponsors and regulatory agencies.

Learning Objectives:

Upon completion of this presentation, you should be able to understand the drug development phases, the regulatory requirements and approval process for marketing a new drug in US
Upon completion of this presentation, you should be able to understand patient-focused drug development strategies from quality perspective.
Upon completion of this presentation, you should be able to understand the KASA initiative, the OPQ/FDA quality assessment modernization effort.