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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

  • Pharmacologist
  • FDA, United States
Gabriel J. Robbie

Gabriel J. Robbie

  • VP 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

  • Staff Fellow
  • FDA, United States
Yanfeng  Wang, PhD

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

Yanfeng Wang, PhD

  • Executive Director
  • Ionis Pharmaceuticals, United States
Bahru  Habtemariam, PharmD

Evaluation of Oligonucleotide Therapeutics in Patients with Renal and Hepatic Impairment

Bahru Habtemariam, PharmD

  • Senior Director, Clinical Pharmacology
  • Alnylam Pharmaceuticals, United States
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

  • Reviewer
  • FDA, CDER, United States
Faraz  Kazmi, PhD

In Vitro/In Vivo

Faraz Kazmi, PhD

  • Senior Scientist, Drug Metabolism and Pharmacokinetics (DMPK)
  • Janssen Research & Development, United States
Venkateswaran  Chithambarampillai, PhD, MS

Evaluating Clinical Drug Interactions for Oligonucleotide Therapeutics

Venkateswaran Chithambarampillai, PhD, MS

  • Senior Staff Fellow, Office of Clinical Pharmacology
  • CDER, FDA, United States
Panel  Discussion

Panel Discussion

Panel Discussion

  • All Session Speakers, United States