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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

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

DIA/FDA Oligonucleotide-Based Therapeutics Conference


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


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

Continuing Education


Highlights & Features

Who should attend?

Professionals involved in:
  • Biotechnology
  • Clinical Pharmacology
  • Clinical Research
  • Chemistry, Manufacturing, and Control
  • Clinical, Regulatory, and Business Development
  • Delivery Technologies
  • Drug Discovery
  • Preclinical
  • Quality Assurance
  • RNAi
  • Vaccines

Learning objectives

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

Program Committee

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

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