3rd Oligonucleotides-Based Therapeutics Conference

Date(s) And Time(s):
Mar 23 2010 8:00AM - Mar 25 2010 5:00PM

DoubleTree Hotel and Executive Meeting Center
8120 Wisconsin Avenue
Bethesda, MD 20814

Interest Area(s):
CMC, Clinical Research, Clinical Safety/Pharmacovigilance, Nonclinical



· Non-Clinical

· Chemistry, Manufacturing, and Controls (CMC)

· Clinical Development

· Oligonucleotide Safety Working Group Updates

Featured Keynote Speakers:

Mauro Ferrari, PhD, Professor and Chairman, Department of Nanomedicine and Biomedical Engineering, University of Texas Health Science Center at Houston

Richard DiMarchi, PhD, Professor and Gill Chair in Biomolecular Science, Indiana University

Learning Objectives:

At the conclusion of this meeting, participants should be able to:
• Identify and discuss oligonucleotide-based therapeutic product development challenges and the relevant FDA, EU and Health Canada regulations
• Assess the challenges faced and the accomplishments made in the clinical development of oligonucleotide-based therapeutic drugs to meet unmet needs
• Describe and discuss the critical issues in the nonclinical development of oligonucleotides and what efforts from industry and regulatory authorities are
underway to address these issues
• Differentiate the special challenges associated with the development of synthetic oligonucleotides as compared to small molecules
• Assess properties of oligonucleotide-based therapeutics that present special challenges in development and the scientific approaches to overcoming those
• Recognize the achievements made in the field to date and share the vision of the benefits to patients that are possible

Target Audience:

This program will benefit professionals involved in

· Biotechnology

· Biologics

· Chemistry, manufacturing, and quality assurance

· Clinical, regulatory, and business development

· Drug discovery

· Vaccines

Contact Information:

Contact Joanne Wallace at the DIA office by telephone +1-215-442-6180, fax +1-215-442-6199 or

email Joanne.Wallace@diahome.org.