Overview

Conference: October 28-30, 2024 | In-Person

Co-sponsored with FDA!

DIA Virtual Conference

The DIA/FDA Oligonucleotide-Based Therapeutics Conference brings together leading experts to inform, educate, and share advancements in oligonucleotide-based therapeutic product development. Developed collaboratively by regulators, industry professionals, and academics, the program covers a wide range of topics from the nonclinical, CMC, and clinical areas, including emerging CMC guidances and considerations, learnings from recent regulatory filings, extra-hepatic and CNS delivery of oligonucleotides, toxicology testing, gene editing, and safety assessments. The conference offers a unique three-day experience with multiple perspectives presented, and the opportunity to interface with regulators from around the globe.

Need Approval in Order to Attend?

Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Download Letter

Participant Testimonials

Event was well organized and of very good quality. Especially, the participation from members of regulatory authorities (FDA, EMA, BfARM) was extremely helpful and interesting. – Sabrina Eisheuer, BioSpring GmbH

Speakers are well selected in this conference. A great opportunity to talk to people knowledgeable in this field.! – Zheng Li, FDA

Keynote Address!

October 28 | 9:30-10:30AM

Peter Stein, Director, Office of New Drugs, CDER FDA

Featured

Want to learn more about DIA/FDA Oligonucleotide-Based Therapeutics Conference? You've come to the right site!

Check out the great content lined up for the Clinical, Nonclinical, and CMC tracks at the DIA/FDA Oligonucleotide-Based Therapeutics Conference.

Program Chair Video

Learning objectives

Learning Objectives:

At the conclusion of this activity, participants should be able to:
- Analyze the latest strategies for clinical use of oligonucleotide therapies and explain the specific challenges of developing RNA-based therapeutics
- Describe the chemistry, manufacturing, and controls challenges associated with the development of oligonucleotides, including formulation and specification issues
- Describe the technology landscape, CMC challenges, and regulatory considerations associated with novel oligonucleotide delivery approaches
- Explain the latest global regulatory updates in oligonucleotide therapeutic developments

Program Committee

Joel D Parry, PhD Director, Nonclinical Safety Project Specialist
GlaxoSmithKline R&D, United Kingdom
Scott Henry, PhD Senior Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
Ronald Wange, PhD Associate Director for Pharm/Tox OND
FDA, United States
Barry Ticho, MD, PhD Chief Medical Officer
Stoke Therapeutics, United States
Benjamin Stevens, PhD, MPH Director CMC Policy and Advocacy
GlaxoSmithKline, United States
Louis St. L. O'Dea, MD Independent Consultant
United States
Hobart Rogers, PharmD, PhD Pharmacologist
FDA, United States
Andrew Slugg, MBA, MS Senior Vice President, Global Head of Regulatory Affairs
Alnylam Pharmaceuticals, United States
Amy Kao, MD Medical Officer, Division of Neurology 2, OND, CDER
FDA, United States
Dan Swerdlow, MD, PhD Senior Director, Early Clinical Development
GSK, United Kingdom
Scott Vafai, MD Vice President, Translational Medicine
Verve Therapeutics, United States
Patrik Andersson, PhD Senior Director, RNA Therapeutics Safety
AstraZeneca R&D, Sweden
Elena Braithwaite, PhD Toxicologist
FDA, United States
David Cantu, PhD Biological Reviewer, CBER
FDA, United States
Xuan Chi, PhD Supervisory Pharmacologist
CDER, FDA, United States
Jeffrey Foy, PhD Senior VP, Toxicology
PepGen Inc., United States
Arthur A. Levin, PhD Distinguished Scientist
Avidity Biosciences, United States
Daniel Capaldi, PhD Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States
Ramin Darvari, PhD, MS Research Fellow
Pfizer Inc., United States
Brian Doyle Senior Director, Technical Development
Moderna, United States
Ramesh Raghavachari, PhD Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER
FDA, United States
René Thürmer, PhD Quality Assessor
Federal Institute for Drugs and Medical Devices, Germany
Fran Wincott, PhD President
Wincott & Associates, LLC, United States
Christian Wetter, PhD Senior Regulatory Portfolio Director
Roche, Switzerland
Dominik Altevogt, PhD Associate Director Regulatory Affairs CMC
Novartis, Switzerland
Representative Invited DIA, United States
Paul C. Brown, PhD Associate Director for Pharmacology and Toxicology, OND, CDER
FDA, United States
James Wild, PhD, MS Pharmacologist, CDER
FDA, United States