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For Immediate Release
DIA CONFERENCE CONVENES REGULATORS AND INDUSTRY TO ADVANCE OLIGONUCLEOTIDE SCIENCE
HORSHAM, PA, USA—FEBRUARY 22, 2010—The Drug Information Association (DIA), in collaboration with the US FDA, Health Canada, American Association of Pharmaceutical Scientists (AAPS), and Oligonucleotide Therapeutics Society (OTS), will host the 3rd Annual Oligonucleotide-based Therapeutics Conference from March 23-25, 2010 in Bethesda, MD.
Industry and regulatory stakeholders will share oligonucleotide-based therapeutic product development and regulatory information in the areas of nonclinical, chemistry, manufacturing and controls (CMC) and clinical development.
Nonclinical sessions include:
• Joint session to address CMC Issues and Impurities • Off Target Effects and Their Assessment • Delivery Issues and Oligonucleotides Therapeutics/Neuromuscular Indications • New Technologies and Regulatory Requirements • Oligonucleotide Safety Working Group (OSWG): Exaggerated Pharmacology Committee • Immunostimulation Working Group • Inhalation Working Group
Chemistry, Manufacturing, and Controls (CMC) sessions will focus on a few of the issues that provide special challenges in the development of synthetic oligonucleotides as compared to small molecules, including:
• Validation of Analytical Methods • Novel Formulations • Qualification Thresholds • Reporting and ID Threshold • Drug Substance Specifications
Clinical development sessions highlight the challenges faced, and accomplishments made, with oligonucleotide- based therapeutics to address unmet medical needs, especially:
• Liver/Metabolic Diseases • Cardiorenal and Pulmonary • Ophthalmics • Oncology • Vaccines • Neuromuscular Indications
The closing plenary session will convene regulators and industry to address the next generation of oligonucleotide-based therapeutics.
Register for the 3rd Annual Oligonucleotide-based Therapeutics Conference.
ABOUT THE DRUG INFORMATION ASSOCIATION (DIA) DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, academic, and regulatory professionals. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
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Contact: Joe Krasowski DIA 215-293-5812 Joe.Krasowski@diahome.org
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