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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
Pharmacologist, CDER, FDA, United States
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.
Speaker(s)
Martina Sahre, PhD
Staff Fellow, FDA, United States
FDA Evaluation of Renal/Hepatic Impairment
Yanfeng Wang, PhD
Executive Director, Ionis Pharmaceuticals, United States
Evaluation of Renal/Hepatic Impairment on the Pharmacokinetics of Antisense Oligonucleotides
Bahru Habtemariam, PharmD
Senior Director, Clinical Pharmacology, Alnylam Pharmaceuticals, United States
Evaluation of Oligonucleotide Therapeutics in Patients with Renal and Hepatic Impairment
Panel Discussion
, All Session Speakers, United States
Panel Discussion
Oluseyi Adeniyi, PharmD, PhD
Reviewer, FDA, CDER, United States
Evaluation of Extrinsic Factors/Drug-Drug Interaction Liability In Vitro
Faraz Kazmi, PhD
Senior Scientist, Drug Metabolism and Pharmacokinetics (DMPK), Janssen Research & Development, United States
In Vitro/In Vivo
Venkateswaran Chithambarampillai, PhD, MS
Senior Staff Fellow, Office of Clinical Pharmacology, CDER, FDA, United States
Evaluating Clinical Drug Interactions for Oligonucleotide Therapeutics
Panel Discussion
, All Session Speakers, United States
Panel Discussion
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