- October 28 - 30, 2019
8:00 AM - 5:00 AM ET
Co-sponsored by the:
U.S. Food and Drug Administration (FDA) and
Drug Information Association (DIA)
October 28-30, 2019
Bethesda Norht Marriott Hotel and Conference Center
North Bethesda, MD 20852
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 2019 event 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 2019DIA/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 pharmacokineticists (clinical, preclinical, and toxicokinetics) who are involved in oligonucleotide drug development or supporting research.
Dwayne Keels - firstname.lastname@example.org