Marketplace Donate Now Become a Member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Not a Member?

Create Account and Join

Global Events

Bethesda North Marriott Hotel and Conference Center

Oct 25, 2017 7:00 AM - Oct 27, 2017 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Convening industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development.

Back to Agenda

Session 6A: Thinking Ahead: Oligonucleotide Drug-Device Combination Products

Session Chair(s)

Mohan K. Sapru, PhD, MS

CMC Lead, Office of Pharmaceutical Quality, CDER, FDA, United States

The session is aimed to broadly discuss oligonucleotide drug-device combination products, an emerging trend in oligonucleotide-based therapeutics, from industry and regulatory perspectives. Specifically, the presentations and panel discussion will focus on:

Industry perspective concerning salient considerations and challenges of developing drug device combination products for oligonucleotide therapeutics

Design control, drug device verification, and validation processes

Promises and challenges in using drug/device combination approach for targeted oligonucleotide drug delivery

Strategies for ensuring product quality, including uniformity of dose delivery, under conditions of use

Regulatory perspective concerning human factors studies and related clinical study considerations in combination product design and development

Learning Objective :
Describe major technical and regulatory considerations for developing oligonucleotide drug/device combination products
List major considerations for designing and validating device combination products
Discuss underlying principles of human factors studies aimed to ensure that a device will be safe and effective for use by the intended users under the intended use environments

Speaker(s)

Bret Coldren, PhD

Director, Pharmaceutical Development , Ionis Pharmaceuticals , United States

Development Considerations for Oligonucleotide Combination Products

Quynh Nhu Nguyen, MS

Associate Director for Human Factors, DMEPA, CDER, FDA, United States

Human Factors Studies - Related Considerations in Combination Product Design and Development

Panel Discussion

, All Session Speakers, United States

Ryan McGowan

Associate Director, Combination Products, AstraZeneca, United States

Panelist

Mike Stelmah

Director, Regulatory Affairs, CMC & Combination Products, Alnylam Pharmaceuticals, United States