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Background: The FDA and DIA have expressed a willingness to leverage their combined strengths for the joint development of this conference that will incorporate dialogue between regulators and industry from Chemistry Manufacturing and Controls (CMC), Nonclinical, Clinical Pharmacology, and Clinical disciplines to address the developmental advances, safety, and challenges in the field of oligonucleotide-based therapeutics. The 2024 conference will address quality risk management, manufacturing advances, specifications, formulation issues, CMC strategies, oligonucleotide pharmacokinetics, nonclinical assessments in support of drug development and clinical advances in therapeutic targets, trial design and safety for antisense, siRNA, mRNA, and microRNA therapies.

This program has been designed for chief scientific officers, vice presidents, directors, senior management, group/team/project leaders, scientists, investigators, and researchers working in the following areas of oligonucleotide science: Biotechnology, Clinical Pharmacology, Clinical Research, Chemistry, Manufacturing and Control, Clinical, Regulatory, and Business Development, Delivery Technologies, Drug Discovery, Preclinical, Quality Assurance, Antisense, RNAi, mRNA, microRNA, and Vaccines.

Goals and Objectives:

• Provide a forum for open discussion between industry, academic, and government scientists regarding challenges and experiences encountered in oligonucleotide drug development.
• Seek feedback from industry, academia, and other stakeholders on the current progress and challenges in oligonucleotide research and drug development.
• Assess the impact of regulations and guidance on oligonucleotide drug development and discuss possible avenues for changes and improvements.
• Facilitate open discussions among all industry researchers and regulatory agencies regarding oligonucleotide drug development.

Who Should Attend: The 2024 DIA/FDA Oligonucleotide-Based Therapeutics Conference is intended for a diverse group of scientists responsible for the evaluation of safety and efficacy of oligonucleotide products including interested industry, academic and government parties involved in ongoing efforts in the research and development of oligonucleotides.

The primary audience includes leading academic experts, interested pharmaceutical companies, regulatory agencies, patient advocacy groups, non-profit organizations, scientists, clinicians from regulatory, academic, industrial and other healthcare sectors, scientists involved in drug development in those same industries, regulatory scientists, experts and leaders from industry, academia, regulatory government agencies in the US and abroad, patient representatives, healthcare providers, and pharmacokinetics (clinical, preclinical, and toxicokinetic) who are involved in oligonucleotide drug development or supporting research.

Contact:
If to DIA:
Damisha White, Project Manager
Drug Information Association (DIA)
1300 Connecticut Avenue, NW
Washington, DC 20036
Tel: +1 (888) 257-6457
Email: CustomerService@DIAglobal.org

If to FDA:
Ronald Wange, Ph.D. Associate Director for Pharmacology and Toxicology
Food and Drug Administration, Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring, MD 20993
Tel: +1 (301) 796-1304
Email: Ronald.Wange@fda.hhs.gov