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Overview

April 25-27, 2022: Forum

Your safety is our priority. We are working diligently with our partners and vendors to ensure the necessary safety measures are in place to create a safe and healthy environment for all those who attend our meeting.

DIA is following all recommendations made by the U.S. Centers for Disease Control (CDC) as well as legal mandates, hotel policies, and the expertise of certified Pandemic Compliance Advisors. We will continue to update our practices to ensure they are current at the time of the meeting, and will share our plans with you as we continue to prepare for the meeting.

We are hosting the meeting in person, and we will offer a virtual option for those who are interested in the content and are unable to travel to join us in person. Our omni-channel event will ensure a great experience for all attendees, regardless of how you join us.

Registration for this meeting will open in September to allow us time to finalize and share our health and safety plans so we can take excellent care of you.

The 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.

As we work to develop our agenda, please view our 2019 agenda

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
  • 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

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 L. Wange, PhD
    Ronald L. Wange, PhD Associate Director for Pharm/Tox ODE3, CDER
    FDA, Office of New Drugs, United States
  • Louis  O'Dea, MD
    Louis O'Dea, MD Executive Vice President, Chief Medical Officer and Head, Regulatory Affairs
    Akcea Therapeutics, 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 VP, Regulatory Affairs
    Alnylam Pharmaceuticals, United States
  • Barry  Ticho, DrMed, PhD
    Barry Ticho, DrMed, 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
    Monica Cooper Review Chemist
    FDA, United States
  • Kim  Tyndall
    Kim Tyndall President
    CMC Tyndall Consultant LLC, 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
  • Susan  Srivasta, PhD
    Susan Srivasta, PhD President
    ElixinPharma, United States
  • René  Thürmer, PhD
    René Thürmer, PhD Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
    Federal Institute for Drugs and Medical Devices, Germany
  • Fran  Wincott, PhD
    Fran Wincott, PhD President
    Wincott & Associates LLC, United States
  • Elena  Braithwaite, PhD
    Elena Braithwaite, PhD Toxicologist
    FDA, United States
  • Paul C. Brown, PhD
    Paul C. Brown, PhD ODE Associate Director for Pharmacology and Toxicology, OND, CDER
    FDA, United States
  • Xuan  Chi, MD, PhD
    Xuan Chi, MD, PhD Pharmacologist/Acting Team Leader
    CDER, FDA, United States
  • David  Corey, PhD
    David Corey, PhD Professor
    UT Southwestern Medical Center at Dallas, United States
  • Jeffrey  Foy
    Jeffrey Foy Senior Director of Toxicology
    Dicerna Pharmaceuticals, United States
  • Arthur A. Levin, PhD
    Arthur A. Levin, PhD Executive Vice President, Research and Development
    Avidity Biosciences , United States
  • Emily J. Place, PhD, MPH
    Emily J. Place, PhD, MPH Pharmacologist, Office of New Drugs, CDER
    FDA, United States
  • James  Wild, PhD
    James Wild, PhD Pharmacologist, CDER
    FDA, United States
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