| Description |
This conference will establish dialogue and discussion among Industry and Health Authorities to inform, teach, and share product development and regulatory information in the areas of nonclinical, chemistry, manufacturing and control (CMC) and clinical development of oligonucleotide-based therapeutic drugs, including antisense, RNAi, immunostimulatory and aptamer applications.
FEATURED SESSIONS
•Mechanisms of Action and Therapeutic Potential
•General Issues in Safety Assessment
•Analytical Characterization for ODN Therapeutics
•Clinical and Regulatory Challenges of Antisense and Antisense-like Technologies in Clinical Oncology
•Specific Issues in the Safety Assessment of Olignonucleotide-based Therapeutics
•Oligonucleotides for Infectious Diseases: Issues and Opportunities
•Challenges in Process Development for Oligonucleotide Synthesis
•General Issues In the ADME Properties of Oligonucleotide Drugs
•Novel Delivery Systems
•Advances and Issues in the Development of Oligonucleotides for The Therapy of Lung Diseases
•CMC Regulatory Considerations
•Oligoncucleotides – Emerging Therapies in Treatment of Retinal Diseases
•Specific Issues in ADME
•Use of ODN TLR9 Agonists as Vaccine Adjuvants: Clinical Experience
•Non Clinical and Clinical Summary and Next Steps.
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