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Overview

The DIA/FDA Oligonucleotide-Based Therapeutics Conference fosters open discussion with industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development. Designed for regulators and industry from CMC, Nonclinical, Clinical Pharmacology, and Clinical disciplines, the conference will address developmental advances, safety, and challenges in the field of oligonucleotide-based therapeutics. 


On-Demand Complimentary Webinar

Oligonucleotide-Based Therapeutics in Rare Diseases
On-Demand
This webinar will examine how oligonucleotide therapeutics can be designed to modulate gene expression through multiple mechanisms and beneficially impact genetically defined rare diseases.
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Insights Guide to Oligonucleotide-Based Therapeutics


This is a very targeted meeting and a "must attend" for those developing drugs based on oligonucleotides. It is a multidisciplinary meeting that is well organized and has several new and challenging topics where industry and regulatory agency attendees participate with a view to enabling getting drugs to patients. 
-Previous Attendee


This program has been developed in collaboration with the DIA Oligonucleotide Scientific Working Group and is approved by the Regulatory Affairs Professionals Society for 12 RAC credits.

 

Who should attend?

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

  • 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:

  • Identify accomplishments and challenges in the clinical development of oligonucleotide-based therapeutic drugs
  • Describe the critical issues in the nonclinical development of oligonucleotides
  • Differentiate the chemistry, manufacturing, and controls challenges associated with the development of synthetic oligonucleotides, including formulation and specification issues
  • Explain unique aspects and various scientific approaches used during the development of oligonucleotide-based therapeutics
  • Recognize the achievements made in the field to date and be able to share the vision with patients about the therapeutic potential that oligonucleotides possess across a wide range of indications
  • Discuss industry and regulatory agency efforts to partner and address the unmet medical needs of patients

Program Committee

  • James D. Thompson, PhD
    James D. Thompson, PhD Head, CMC Project Management
    Moderna Therapeutics, United States
  • James  Wild, PhD
    James Wild, PhD Pharmacologist, CDER
    FDA, United States
  • Paul C. Brown, PhD
    Paul C. Brown, PhD ODE 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 Pharmacologist/Toxicology Reviewer, Div. of Cardiovascular & Renal Products, OND
    US Food and Drug Administration, United States
  • Robert T. Dorsam, PhD
    Robert T. Dorsam, PhD Pharmacology/Toxicology Team Leader, Office of Generic Drugs, 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 Senior Director of Research
    miRagen Therapeutics, United States
  • Arthur M. Krieg, MD
    Arthur M. Krieg, MD President and CEO
    Checkmate Pharmaceuticals, United States
  • Arthur A. Levin, PhD
    Arthur A. Levin, PhD Executive Vice President, Research and Development
    Avidity Biosciences , United States
  • Jennifer  Marlowe, PhD
    Jennifer Marlowe, PhD Senior Director, Preclinical Development
    bluebirdbio, United States
  • Saraswathy  V. Nochur
    Saraswathy V. Nochur Senior Vice President, Regulatory Affairs & QA
    Alnylam Pharmaceuticals, Inc., United States
  • Emily J. Place, PhD, MPH
    Emily J. Place, PhD, MPH Pharmacologist, Office of New Drugs, CDER
    FDA, United States
  • Ramesh  Raghavachari, PhD
    Ramesh Raghavachari, PhD Chief, Branch I - DPMA1/OLDP/OPQ/CDER
    FDA, United States
  • Kim  Tyndall
    Kim Tyndall Director, CMC Regulatory Affairs
    GlaxoSmithKline, United States
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On-Demand Complimentary Webinar

Oligonucleotide-Based Therapeutics in Rare Diseases


Insights Guide to Oligonucleotide-Based Therapeutics

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