概要

Now co-sponsored with FDA!

The DIA/FDA Oligonucleotide-Based Therapeutics Conference brings together leading experts from industry and regulatory agencies to inform, educate, and share advancements in oligonucleotide-based therapeutic product development. At this conference you will learn about optimization strategies for drug design, manufacturing, delivery, and clinical testing through three tracks dedicated to covering relevant nonclinical, CMC, and clinical topics. Interface with global regulators to discuss developmental advances, safety, and challenges in the field of oligonucleotide-based therapeutics.

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.

What previous attendees have said:

"This conference is a unique opportunity to learn about the latest advances and challenges in the development of oligonucleotide therapeutics, encompassing all aspects of the development process from preclinical to regulatory."

"The event was well organized, the topics well thought out, the presenters were outgoing and interactive, and the assembly of attendees really fit the DIA mission of bringing people with common interests together in a productive way."

Want more on Oligonucleotides?

Check out our exclusive recording of the presentation, "Biogen Platform Manufacturing Process for Antisense Oligonucleotides" from our CMC Workshop in April.
View Recording

Mix and Match Sessions with Three Tracks

Featured

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

Continuing Education

Exhibits

Highlights & Features

Continuing Education

Exhibits

Highlights & Features

学習目的

At the conclusion of this conference, participants should be able to:

Analyze the latest delivery strategies for clinical use of oligonucleotide therapies
Discuss the non-clinical toxicology profile of oligonucleotide therapies and the latest improvements in predicting effects in humans
Describe the chemistry, manufacturing, and controls challenges associated with the development of oligonucleotides, including formulation and specification issues
Explain the latest global regulatory updates in oligonucleotide therapeutic developments
Evaluate the best mechanism of interactions with patients and partner organizations to address critical needs in the rare disease community

プログラム委員会

Arthur A. Levin, PhD CSO
Avidity Biosciences , United States
Emily Place, PhD, MPH Senior Consultant
Biologics Consulting, United States
Ramesh Raghavachari, PhD Chief, Branch I, DPMA1, OLDP, OPQ, CDER
FDA, United States
Paul C. Brown, PhD Associate Director for Pharmacology and Toxicology, OND, CDER
FDA, United States
Daniel Capaldi, PhD Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States
Xuan Chi, MD, PhD Supervisory Pharmacologist
CDER, FDA, United States
Scott Henry, PhD Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
Aimee L. Jackson, PhD Chief Scientific Officer
Atalanta Therapeutics, United States
Arthur M. Krieg, MD CEO and CSO
Checkmate Pharmaceuticals, United States
Saraswathy V. Nochur, PhD, MSc Chief Regulatory Officer
Alnylam Pharmaceuticals, United States
Louis O'Dea, MD Chief Medical Officer and President
BIORCHESTRA (USA) Inc, United States
Hobart Rogers, PharmD, PhD Pharmacologist
FDA, United States
Eugene Schneider, MD Vice President
Ionis Pharmaceuticals, Inc, United States
James D. Thompson, PhD CMC Therapeutic Area Lead
Moderna Therapeutics , United States
Barry Ticho, MD, PhD Chief Medical Officer
Stoke Therapeutics, United States
Kim Tyndall President
CMC Tyndall Consultant LLC, United States
James Wild, PhD Pharmacologist, CDER
FDA, United States