Perspectiva general

DIA Oligonucleotide-Based Therapeutics Conference

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.

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Objetivos de aprendizaje

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

Comité del programa

James D. Thompson, PhD CMC Therapeutic Area Lead
Moderna Therapeutics , United States
James Wild, PhD, MS Pharmacologist, CDER
FDA, United States
Paul C. Brown, PhD Associate Director for Pharmacology and Toxicology, OND, CDER
FDA, United States
Daniel Capaldi, PhD Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States
Xuan Chi, PhD Supervisory Pharmacologist
CDER, FDA, United States
Robert T. Dorsam, PhD Associate Director, Pharmacology/Toxicology, Office of Generic Drugs, CDER
FDA, United States
Scott Henry, PhD Senior Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
Aimee L. Jackson, PhD Chief Scientific Officer
Atalanta Therapeutics, United States
Arthur M. Krieg, MD CEO and CSO
Checkmate Pharmaceuticals, United States
Arthur A. Levin, PhD Distinguished Scientist
Avidity Biosciences, United States
Jennifer Marlowe, PhD Senior Director, Preclinical Development
bluebirdbio, United States
Saraswathy V. Nochur, PhD, MSc Chief Regulatory Officer
Alnylam Pharmaceuticals, United States
Emily Place, PhD, MPH Senior Consultant
Aclairo Pharmaceutical Development Group, United States
Ramesh Raghavachari, PhD Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER
FDA, United States
Kim Tyndall President
CMC Tyndall Consultant LLC, United States

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DIA/FDA Oligonucleotide-Based Therapeutics Conference