DIA, Bethesda, MD 20814
Mar 23 2010 8:00AM - Mar 25 2010 5:00PM
Location: DoubleTree Hotel and Executive Meeting Center 8120 Wisconsin Avenue Bethesda, MD 20814
Interest Area(s): CMC, Clinical Research, Clinical Safety/Pharmacovigilance, Nonclinical
Overview:
FEATURED TOPICS · Non-Clinical · Chemistry, Manufacturing, and Controls (CMC) · Clinical Development · Oligonucleotide Safety Working Group Updates 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 challenges • 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
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Invited Speakers:
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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
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