Overview
For the sixth time in eight years, DIA and FDA have convened industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development. This conference will continue to focus on dialogue between regulators and industry from CMC, Nonclinical, Clinical Pharmacology, and Clinical disciplines to address the developmental advances, safety, and challenges in the field of oligonucleotide-based therapeutics.
The 2015 conference will address a variety of topics on CMC, nonclinical, clinical pharmacology, clinical, and regulatory aspects of antisense, siRNA, and microRNA therapies, as well as feature expert speakers from industry and regulatory agencies.
The format for this conference has been reconfigured and in 2015 will feature: general sessions consisting of state-of-the-art presentations, panel discussions, and abstracts highlighting the latest in oligonucleotide-based therapeutic research; while concurrent sessions feature three (3) educational tracks designed to promote discussion between industry and the regulators. An enhanced poster presentation session, spanning a multitude of topics, will be available for viewing throughout the conference.
EVENT HIGHLIGHTS:
The 2015 conference will feature a variety of session types:
Plenary Sessions
The speakers have been chosen from among the renowned investigators in clinical, nonclinical and CMC.
Concurrent Sessions (tracks)
The concurrent sessions are designed to focus on three main areas within the study of oligonucleotides: clinical, CMC, and nonclinical:
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Nonclinical
The nonclinical sessions are designed to provide updates and discussion on recent advancements in nonclinical development of oligonucleotide therapeutics. This track will address emerging approaches for development of oligonucleotide therapeutics. -
Clinical Development
These sessions will provide updates on the recent progress made with oligonucleotides in the clinic. Programs in various stages of development will highlight the challenges faced, lessons learned, and offer potential solutions and innovative ideas for clinical development of oligonucleotide therapeutics. -
Chemistry, Manufacturing, and Controls (CMC)
The CMC track will cover a wide range of current oligonucleotide science and feature expert speakers from industry and regulatory agencies. Each session will comprise presentations and panel discussions in an interactive format designed to promote discussion between industry and the regulators.
Poster Session
The Poster Session is an important and indispensable educational event of this conference and will be featured in a permanent location throughout the meeting. View outstanding science encompassing a multitude of topics with ample opportunity for discussion with authors, both formally and informally.
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Program Committee
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Robert T. Dorsam, PhD Associate Director, Pharmacology/Toxicology, Office of Generic Drugs, CDER
FDA, United States -
Jim Zisek Director, Global CMC Regulatory Affairs
GlaxoSmithKline, 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 -
Scott Henry, PhD 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 CSO
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 -
Ramesh Raghavachari, PhD Chief, Branch I, DPMA1, OLDP, OPQ, CDER
FDA, United States -
Rosanne Seguin, PhD
McGill University, Canada -
James D. Thompson, PhD CMC Therapeutic Area Lead
Moderna Therapeutics , United States -
James Wild, PhD Pharmacologist, CDER
FDA, United States
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