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Monday, June 28 • 4:00pm - 5:00pm
#148 SL: Challenges and Opportunities in Early Development of RNA Therapeutics

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-552-L04-P; CME 1.00; IACET 1.00; RN 1.00

RNA molecules play a variety of important roles in cells, including structural (ribosomal RNA), enzymatic (small nuclear RNA), and information transfer (messenger RNA). The relatively large size and well-known instability of RNA would make it an unlikely vehicle for drug development. However, in recent years, it has become clear that RNA molecules are an emerging as a class of therapeutics of relevance to multiple diseases, most recently including vaccines. In this session, we will be discussing different examples of RNA based therapeutics, as well as some regulatory considerations.

Learning Objectives

Describe different types of RNA therapeutics; Discuss some of the unique challenges involved in the production of RNA therapeutics.

Chair

Philip (P.J.) Brooks, PhD

Speaker

Messenger RNAs as Drugs
Philip Santangelo

Nonclinical Development of Oligonucleotide Therapeutics
Girish R Chopda, PhD

Regulatory Preclinical Considerations for mRNA Therapeutic Products
Christopher Saeui, PhD


Speakers
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →
avatar for Girish Chopda

Girish Chopda

Associate Director, Nonclinical Development, Dicerna Pharmaceuticals, United States
Dr. Chopda is a an Associate Director in the nonclinical ADME group at Dicerna Pharmaceuticals for over 7 years. He received his PhD at Northeastern University and worked at Abbvie Worcester, MA for a year prior to transitioning to Dicerna. At Dicerna, he has worked towards transitioning... Read More →
CS

Christopher Saeui

Biologist, Pharm/Tox/OTAT, CBER, FDA, United States
Christopher Saeui has over 15 years combined experience working in the pharmaceutical, biomedical research, and regulatory review space. He currently serves as a pharmacology/toxicology reviewer for cellular and gene therapy products in the Division of Pharmacology/Toxicology in the... Read More →
PS

Philip Santangelo

Professor, Coulter Department of Biomedical Engineering, Georgia Institute of Technology & Emory University School of Medicine, United States

Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session