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Capital Hilton

28 oct 2024 7:00 a.m. - 30 oct 2024 7:00 p.m.

1001 16th Street NW, , Washington, DC 20036-5794 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Call for Posters and Roundtables Ends

DAYS

HOURS

MINUTES

SECONDS

Perspectiva general

Conference: October 28-30, 2024 | In-Person

Co-sponsored with FDA!

DIA Virtual Conference

The DIA/FDA 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.

While we develop our 2024 agenda, please take a moment to review the 2022 final agenda

Need Approval in Order to Attend?

Download and fill out our Justification Letter to demand to supervisor why this is a must-attend event.

 

Participant Testimonials

Event was well organized and of very good quality. Especially, the participation from members of regulatory authorities (FDA, EMA, BfARM) was extremely helpful and interesting. – Sabrina Eisheuer, BioSpring GmbH

Speakers are well selected in this conference. A great opportunity to talk to people knowledgeable in this field.! – Zheng Li, FDA

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Highlights & Features

¿Quiénes deben asistir?

  • Conference Designed for:

    Professionals involved in the following areas of oligonucleotide science:

    • Drug Discovery
    • Preclinical
    • Clinical
    • CMC
    • Quality Assurance
    • RNAi
    • Vaccines
    • Biotechnology
    • Delivery Technologies
    • Clinical Pharmacology/Research
    • Safety and Toxicology
    • Regulatory
    • Diagnostics

Objetivos de aprendizaje

  • 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

Comité del programa

  • 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
  • Barry  Ticho, MD, PhD
    Barry Ticho, MD, PhD Chief Medical Officer
    Stoke Therapeutics, United States
  • Benjamin  Stevens, PhD, MPH
    Benjamin Stevens, PhD, MPH Director CMC Policy and Advocacy
    GlaxoSmithKline, 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
  • Andrew  Slugg, MBA, MS
    Andrew Slugg, MBA, MS Senior Vice President, Global Head of Regulatory Affairs
    Alnylam Pharmaceuticals, United States
  • Amy  Kao
    Amy Kao Medical Officer, Division of Neurology 2, OND, CDER
    FDA, United States
  • Dan  Swerdlow, MD, PhD
    Dan Swerdlow, MD, PhD Senior Director, Early Clinical Development
    GSK, United Kingdom
  • 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
  • David  Cantu
    David Cantu Biological Reviewer, CBER
    FDA, United States
  • Xuan  Chi, MD, PhD
    Xuan Chi, MD, PhD Supervisory Pharmacologist
    CDER, FDA, United States
  • Jeffrey  Foy, PhD
    Jeffrey Foy, PhD Vice President, Toxicology
    PepGen Inc., United States
  • Arthur A. Levin, PhD
    Arthur A. Levin, PhD Distinguished Scientist
    Avidity Biosciences, United States
  • Daniel  Capaldi, PhD
    Daniel Capaldi, PhD Vice President, Analytical and Process Development
    Ionis Pharmaceuticals, Inc, United States
  • Ramin  Darvari, PhD, MS
    Ramin Darvari, PhD, MS Research Fellow
    Pfizer Inc., United States
  • Brian  Doyle
    Brian Doyle Senior Director, Technical Development
    Moderna, 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
  • Fran  Wincott, PhD
    Fran Wincott, PhD President
    United States
  • Christian  Wetter, PhD
    Christian Wetter, PhD Technical Regulatory Advisor
    Roche, Switzerland
  • Representative Invited
    Representative Invited DIA, United States
  • Paul C. Brown, PhD
    Paul C. Brown, PhD Associate Director for Pharmacology and Toxicology, OND, CDER
    FDA, United States
  • James  Wild, PhD
    James Wild, PhD Pharmacologist, CDER
    FDA, United States

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