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Grand Hyatt Washington at Washington Center

2015 年 09 月 09 日 7:00 上午 - 2015 年 09 月 11 日 12:00 下午

1000 H Street, NW, , Washington, DC 20001-4310 , USA

DIA/FDA Oligonucleotide-Based Therapeutic Conference 2015

Interact with renowned investigators and key health authorities to learn about the latest developments in oligonucleotide-based therapeutics. New for 2015—Enhanced poster session.

概览

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:

  • 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.

Featured

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Continuing-Education

谁应该参加?

Chief Scientific Officers, Vice Presidents, Directors, Senior Management, Group/Team/Project Leaders, Scientists, Investigators, Researchers and Regulatory professionals 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

学习目标

At the conclusion of this meeting, 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

项目委员会

  • Robert T. Dorsam, PHD
    Robert T. Dorsam, PHD Associate Director, Pharmacology/Toxicology, Office of Generic Drugs, CDER
    FDA, United States
  • Jim  Zisek
    Jim Zisek Director, Global CMC Regulatory Affairs
    GlaxoSmithKline, 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
  • Scott  Henry, PHD
    Scott Henry, PHD Senior 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
  • Arthur A. Levin, PHD
    Arthur A. Levin, PHD Distinguished Scientist
    Avidity Biosciences, United States
  • Jennifer  Marlowe, PHD
    Jennifer Marlowe, PHD Senior Director, Preclinical Development
    bluebirdbio, United States
  • Saraswathy V. Nochur, PHD, MSC
    Saraswathy V. Nochur, PHD, MSC Chief Regulatory Officer
    Alnylam Pharmaceuticals, United States
  • Ramesh  Raghavachari, PHD
    Ramesh Raghavachari, PHD Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER
    FDA, United States
  • Rosanne  Seguin, PHD
    Rosanne Seguin, PHD
    McGill University, Canada
  • James D. Thompson, PHD
    James D. Thompson, PHD CMC Therapeutic Area Lead
    Moderna Therapeutics , United States
  • James  Wild, PHD, MS
    James Wild, PHD, MS Pharmacologist, CDER
    FDA, United States

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