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Washington Court Hotel

Sep 25, 2013 8:00 AM - Sep 27, 2013 5:00 PM

525 New Jersey Avenue NW, Washington, DC 20001

DIA/FDA Oligonucleotide-based Therapeutics Conference

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Session 3B (CMC Track): Novel Excipients and Other Recent Advances in Formulation Development

Session Chair(s)

René Thürmer, PhD

René Thürmer, PhD

Deputy Head of the Unit Pharmaceutical Biotechnology BfArM

Federal Institute for Drugs and Medical Devices, Germany

In large part, the successful development of oligonucleotide therapeutics is predicated on the development of safe and effective drug product formulations. This session will examine recent advances in formulation development, including those in the field of liposomal, polymer and nanoparticle-based delivery vehicles. Strategies aimed at mitigating or eliminating the toxicity associated with oligonucleotide formulations will be presented. Recommendations for designing studies to determine potential toxicities of novel and functional excipients will be discussed. Two presentations will be followed by a 30 minute panel discussion.

Speaker(s)

Complex Polymeric Formulations of Oligonucleotides

Jeremy Heidel, PhD

Informulate LLC, United States

President

Solid Lipid Nanoparticle Formulations of Oligonucleotides

Bob D. Brown, PhD

Dicerna Pharmaceuticals, United States

Chief Scientific Officer

Robert T. Dorsam, PhD

Panelist

Robert T. Dorsam, PhD

FDA, United States

Associate Director, Pharmacology/Toxicology, Office of Generic Drugs, CDER

Panelist

Jeremy Heidel, PhD

Informulate LLC, United States

President

Panelist

Bob D. Brown, PhD

Dicerna Pharmaceuticals, United States

Chief Scientific Officer

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