概要

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. The conference offers a unique experience with multiple perspectives presented, and the opportunity to interface with regulators from around the globe.

While we develop our 2024 agenda, please take a moment to review the 2022 final agenda

Need Approval in Order to Attend?

Download and fill out our Justification Letter to demand to 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

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Highlights & Features

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

プログラム委員会

Scott Henry, PhD Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
Ronald Wange, PhD Associate Director for Pharm/Tox, OND, CDER
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 O'Dea, MD Chief Medical Officer and President
BIORCHESTRA (USA) Inc, 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 Medical Officer, Division of Neurology 2, OND, CDER
FDA, United States
Dan Swerdlow, MD, PhD Senior Director, Early Clinical Development
GSK, United Kingdom
Patrik Andersson, PhD Senior Director, RNA Therapeutics Safety
AstraZeneca R&D, Sweden
Elena Braithwaite, PhD Toxicologist
FDA, United States
David Cantu Biological Reviewer, CBER
FDA, United States
Xuan Chi, MD, PhD Supervisory Pharmacologist
CDER, FDA, United States
Jeffrey Foy, PhD Vice President, Toxicology
PepGen Inc., United States
Arthur A. Levin, PhD Senior Consultant
Levin BioScience, United States
Daniel Capaldi, PhD Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States
Ramin Darvari, PhD, MS Associate Research Fellow
Pfizer Inc., United States
Brian Doyle Director, LNP Process Development
Moderna, United States
Ramesh Raghavachari, PhD Chief, Branch I, DPMA1, OLDP, OPQ, CDER
FDA, United States
René Thürmer, PhD Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Federal Institute for Drugs and Medical Devices, Germany
Fran Wincott, PhD President
United States
Christian Wetter, PhD Technical Regulatory Advisor
Roche, Switzerland
Representative Invited DIA, United States
Paul C. Brown, PhD Associate Director for Pharmacology and Toxicology, OND, CDER
FDA, United States
James Wild, PhD Pharmacologist, CDER
FDA, United States