Speaker Spotlight: Phase Appropriate Design Controls for Combination Products During Clinical Development

Tuesday, October 18, 2022

2:30 PM – 3:30 PM ET

Location:Spotlight Stage 3, Exhibit Hall A&B

Manufacturing and Analytical Characterization

Spotlight Speaker(s)

Shrinivas (Cheenu) Murti, PhD, MBA

Head, CMC Business Process Excellence & Systems
Takeda Pharmaceutical Company Limited
Cambridge, Massachusetts

Moderator(s)

Kim Huynh-Ba, MS, PMP, FAAPS

Managing Director
Pharmalytik
Newark, Delaware

Phase appropriate design controls for combination products is an area of evolving regulatory expectations. The Speaker Spotlight will provide an overview of technical/regulatory issues pertaining to design controls for combination products in clinical development. Focus areas will include prefilled syringe design control needs in early phase development, knowledge build of Essential Performance Requirements (EPRs) and non-EPRs from clinical to commercial image and design controls for not-to-be-commercialized clinical monitoring tools/software.

Learning Objectives:

Demonstrate awareness of current regulatory expectations on device constituent bridging in clinical development for combination products
Understand challenges of engineering design of simple and complex device constituents of combination products
Define key considerations for phase appropriate control strategy and analytical development from the regulator and industry standpoint.