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Bethesda North Marriott Hotel and Conference Center

Apr 25, 2022 7:00 AM - Apr 27, 2022 12:00 PM

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

DIA/FDA Oligonucleotide-Based Therapeutics Conference

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!


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.

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.


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

Highlights & Features

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
    Benjamin Stevens, PhD, MPH Director CMC Policy and Advocacy
    GlaxoSmithKline, United States
  • Scott  Henry, PhD
    Scott Henry, PhD Vice President, Nonclinical Development
    Ionis Pharmaceuticals, Inc., United States
  • Ronald  Wange, PhD
    Ronald Wange, PhD Associate Director for Pharm/Tox, OND, CDER
    FDA, United States
  • Louis  O'Dea, MD
    Louis O'Dea, MD Chief Medical Officer and President
    BIORCHESTRA (USA) Inc, United States
  • Hobart  Rogers, PharmD, PhD
    Hobart Rogers, PharmD, PhD Pharmacologist
    FDA, United States
  • Laura  Sepp-Lorenzino, PhD
    Laura Sepp-Lorenzino, PhD Chief Scientific Officer
    Intellia Therapeutics, Inc., United States
  • Andrew  Slugg, MBA, MS
    Andrew Slugg, MBA, MS Senior Vice President, Global Head of Regulatory Affairs
    Alnylam Pharmaceuticals, United States
  • Barry  Ticho, MD, PhD
    Barry Ticho, MD, PhD Chief Medical Officer
    Stoke Therapeutics, United States
  • Daniel  Capaldi, PhD
    Daniel Capaldi, PhD Vice President, Analytical and Process Development
    Ionis Pharmaceuticals, Inc, United States
  • Monica  Cooper, PhD
    Monica Cooper, PhD Review Chemist, ONDP, OPQ, CDER
    FDA, United States
  • Ramin  Darvari, PhD, MS
    Ramin Darvari, PhD, MS Associate Research Fellow
    Pfizer Inc., United States
  • Ramesh  Raghavachari, PhD
    Ramesh Raghavachari, PhD Chief, Branch I, DPMA1, OLDP, OPQ, CDER
    FDA, United States
  • René  Thürmer, PhD
    René Thürmer, PhD Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
    Federal Institute for Drugs and Medical Devices, Germany
  • Patrik  Andersson, PhD
    Patrik Andersson, PhD Senior Director, RNA Therapeutics Safety
    AstraZeneca R&D, Sweden
  • Elena  Braithwaite, PhD
    Elena Braithwaite, PhD Toxicologist
    FDA, United States
  • Xuan  Chi, MD, PhD
    Xuan Chi, MD, PhD Supervisory Pharmacologist
    CDER, FDA, United States
  • David  Corey, PhD
    David Corey, PhD Professor
    UT Southwestern Medical Center at Dallas, United States
  • Jeffrey  Foy, PhD
    Jeffrey Foy, PhD Vice President, Toxicology
    PepGen Inc., United States
  • Aimee L. Jackson, PhD
    Aimee L. Jackson, PhD Chief Scientific Officer
    Atalanta Therapeutics, United States
  • Arthur A. Levin, PhD
    Arthur A. Levin, PhD CSO
    Avidity Biosciences , United States
  • Emily  Place, PhD, MPH
    Emily Place, PhD, MPH Senior Consultant
    Biologics Consulting, United States

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