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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 ImpuritiesOff 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.

 

 

 

 

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ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.