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
• 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.
Contact: Joe Krasowski
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