Oligonucleotide-Based Therapeutics Conference

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Overview

Conference: April 25-27

DIA is offering both a live in-person and a live-stream virtual option for the DIA/FDA Oligonucleotide-Based Therapeutics Conference. Upon registration, please indicate via the check box which avenue you are registering for: in-person or virtual.

Co-sponsored with FDA!

DIA Virtual Conference

DIA/FDA's 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.

Keynote Address Announced!

Janet Woodcock, MD, Principal Deputy to the Commissioner

April 25 | 8:00-9:00AM
Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER. In that position, she has led many of the FDA’s groundbreaking drug initiatives. In 2020 Dr. Woodcock was asked to lend her expertise to “Operation Warp Speed” the initiative to develop therapeutics in response to the pandemic. Dr. Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021-February 17, 2022. Dr. Woodcock is now the FDA's Principal Deputy Commissioner. In this role she works closely with the Commissioner of Food and Drugs to develop and implement key public health initiatives and helps oversee the agency’s day-to-day functions.

Social distancing measures may be in place at the time of the event. Therefore, we encourage you to register and make your housing arrangements early due to potential limited capacity. If the capacity limit is reached, we will only be able to offer the virtual option. Don’t miss out on your chance to meet live again with your friends and colleagues!

We are thrilled to able to offer flexibility to our attendees to attend in-person or virtually. Please note, we are also offering that flexibility to our speakers so you will experience some speakers presenting remotely.

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Highlights & Features

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Who should attend?

Senior-level professionals and those working in the following areas of oligonucleotide science:

Drug Discovery
Preclinical
Clinical
CMC
Quality Assurance
RNAi
Vaccines
Biotechnology
Delivery Technologies
Clinical Pharmacology/Research

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

Benjamin Stevens, PhD, MPH • Director CMC Policy and Advocacy
GlaxoSmithKline, United States
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
Louis O'Dea O'Dea, MD • Chief Medical Officer and President
BIORCHESTRA (USA) Inc, United States
Hobart Rogers, PharmD, PhD • Pharmacologist
FDA, United States
Laura Sepp-Lorenzino, PhD • Chief Scientific Officer
Intellia Therapeutics, Inc., United States
Andrew Slugg, MBA, MS • Senior Vice President, Global Head of Regulatory Affairs
Alnylam Pharmaceuticals, United States
Barry Ticho, MD, PhD • Chief Medical Officer
Stoke Therapeutics, United States
Daniel Capaldi Capaldi, PhD • Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States
Monica Cooper, PhD • Review Chemist, ONDP, OPQ, CDER
FDA, United States
Ramin Darvari, PhD, MS • Associate Research Fellow
Pfizer Inc., 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
Patrik Andersson, PhD • Principal Scientist, Discovery Safety Specialist
AstraZeneca R&D, Sweden
Elena Braithwaite, PhD • Toxicologist
FDA, United States
Xuan Chi, MD, PhD • Supervisory Pharmacologist
CDER, FDA, United States
David Corey, PhD • Professor
UT Southwestern Medical Center at Dallas, United States
Jeffrey Foy, PhD • Vice President, Toxicology
PepGen Inc., United States
Aimee L. Jackson, PhD • Chief Scientific Officer
Atalanta Therapeutics, United States
Arthur A. Levin, PhD • CSO
Avidity Biosciences , United States
Emily Place, PhD, MPH • Senior Consultant
Biologics Consulting, United States

Contact us

Registration Questions?

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1.888.257.6457

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