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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Session 6 Track A & B: Evaluation of Intrinsic Factors/Organ Impairment Studies and of Extrinsic Factors/Drug-Drug Interaction Liability

Session Chair(s)

Hobart  Rogers, PharmD, PhD

Hobart Rogers, PharmD, PhD


FDA, United States

Gabriel J. Robbie, PhD

Gabriel J. Robbie, PhD

Senior Vice President, Clinical Pharmacology and Pharmacometrics

Alnylam Pharmaceuticals, Inc., United States

Oligonucleotide therapeutics have unique characteristics that often require differential pre-clinical and clinical assessment compared to small molecules. This session will address two of these topics: Topic One will focus on the evaluation of both renal and hepatic impairment; Topic Two will focus on the assessment of drug-drug interactions liability with oligonucleotides. Both topics will have perspective presentations from industry and regulatory speakers. Following the presentations, a joint panel will convene to further discuss these topics with implications for guiding future regulatory oversight.


Martina  Sahre, PhD

FDA Evaluation of Renal/Hepatic Impairment

Martina Sahre, PhD

FDA, United States

Staff Fellow

Yanfeng  Wang, PhD

Evaluation of Renal/Hepatic Impairment on the Pharmacokinetics of Antisense Oligonucleotides

Yanfeng Wang, PhD

Ionis Pharmaceuticals, United States

Executive Director

Bahru  Habtemariam, PharmD

Evaluation of Oligonucleotide Therapeutics in Patients with Renal and Hepatic Impairment

Bahru Habtemariam, PharmD

Alnylam Pharmaceuticals, United States

Senior Director, Clinical Pharmacology

Panel  Discussion

Panel Discussion

Panel Discussion

All Session Speakers, United States

Oluseyi  Adeniyi, PharmD, PhD

Evaluation of Extrinsic Factors/Drug-Drug Interaction Liability In Vitro

Oluseyi Adeniyi, PharmD, PhD

FDA, CDER, United States


Faraz  Kazmi, PhD

In Vitro/In Vivo

Faraz Kazmi, PhD

Janssen Research & Development, United States

Senior Scientist, Drug Metabolism and Pharmacokinetics (DMPK)

Venkateswaran  Chithambarampillai, PhD, MS

Evaluating Clinical Drug Interactions for Oligonucleotide Therapeutics

Venkateswaran Chithambarampillai, PhD, MS

CDER, FDA, United States

Senior Staff Fellow, Office of Clinical Pharmacology

Panel  Discussion

Panel Discussion

Panel Discussion

All Session Speakers, United States

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