Industry Experts And Global Regulators To Discuss Oligonucleotide-Based Therapeutics Issues

Main Category: Pharmacy / Pharmacist
Also Included In: Pharma Industry / Biotech Industry;  Biology / Biochemistry;  Conferences
Article Date: 17 Aug 2008 - 0:00 PDT

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The Drug Information Association (DIA), in collaboration with the FDA, Oligonucleotide Therapeutics Society, Health Canada, and the American Association of Pharmaceutical Scientists, will host the 2nd Conference on Oligonucleotide-based Therapeutics (September 22 - 24; Falls Church, VA).

"Attendees can share product development and regulatory information in the areas of nonclinical, chemistry, manufacturing and control (CMC), and clinical development of Oligonucleotide-based therapeutic drugs with industry experts and international regulators," says Program Co-chair David H. Schubert, Vice President of Regulatory Affairs, Logical Therapeutics, Inc.

Sessions will discuss:

-- siRNAs
-- Non-Hybridization Dependent Oligonucleotides
-- Antisense Oligonucleotide Discovery and Development
-- Emerging Oligonucleotide Issues
-- Starting Materials and GMP Synthesis
-- Formulations and GMP
-- Establishing Proof of Structure
-- Stability of Drug Substance and Drug Product
-- Novel Chemistry
-- Clinical Applications of siRNAs
-- Clinical Opportunities for Manipulating MicroRNAs Pathways
-- Clinical applications of Antisense Oligonucleotides
-- Clinical Applications of Aptamers
-- Clinical Opportunities for Immunostimulatory Oligonucleotides
-- Delivery of Oligonucleotides
Keynote speakers will include Craig C. Mello, PhD, University of Mass Medical School and 2006 Nobel Laureate, and Alan B. Sachs, MD, PhD, Merck Research Laboratories.

The final day will feature a panel discussion with representatives from the EMEA, FDA, Health Canada and PMDA.

About the Drug Information Association (DIA)

DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, and Mumbai, India, the Association is led by its volunteer-based Board of Directors and executive management team. www.diahome.org

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