october, 2018

16octalldayalldayWorkshop Drug-Drug Interactions: Preclinical Risk Assessment and Review of the new FDA Guidance


Event Details

About the Topic

The potential for clinical drug-drug interactions (DDIs) continues to be of key liability for the development of new medicines.  This comprehensive workshop will review techniques and strategy to assess the potential for DDI\’s from early discovery to clinical development. In addition, clinical case studies will be explored highlighting interactions with regulatory authorities and accompanying strategies to understand and mitigate risk and expedite compound advancement.

Specific topics to be covered:
  • Assessment of enzyme-based DDI\’s (induction/inhibition) and reaction phenotyping
  • Large molecule therapeutic protein interactions with small molecules
  • Recent strategies to utilize physiologically-based modeling for risk assessment
  • Update on transporter-mediated DDI\’s and clinical assessment
  • Design and interpretation of clinical DDI studies
  • Clinically relevant biomarkers for the assessment of transporter-mediated DDI\’s
  • Update and commentary on recent (2017) FDA draft guidance for DDI\’s


Workshop Agenda

8:45-8:50   PBSS Welcome – Simon Wong (Genentech)

8:50-9:25   1. Introduction and DDI Basics on Inhibition, Induction and Reaction Phenotyping – Simon Wong (Genentech)

9:25–10:00   2. Assessment of Therapeutic Protein Drug-Drug Interactions with Small Molecules – Jing Wang (Genentech)

10:00-10:10   Major Sponsor Presentation – TBD

10:10-10:35   Break & Vendor Show

10:35-11:20   3. Physiologically-Based Modelling and DDI Risk Assessment – Jialin Mao (Genentech)

11:20–12:00   4. Design and Interpretation of Clinical DDI Studies – Kari Morrissey  (Genentech)

12:00-1:00   Lunch

1:00–1:45   5. What Can Be Learned from Recent NDAs? Key Findings on Drug Interactions for Drugs Approved by the FDA – Jingjing Yu (University of Washington)

1:45–2:30   6. Update of DDI Draft Guidance – Xinning Yang (FDA)

2:30-2:40   Major Sponsor Presentation – TBD

2:40-3:00   Break & Vendor Show

3:00-3:45   7. Transporter-mediated DDIs – What’s new in 2017 FDA draft guidance and industry application and risk assessment – Ilaria Badagnani (Theravance)

4:00-4:45   8. Clinical Biomarkers for Transporter Mediated DDI – Yurong Lai (Gilead)

4:45-5:15   Panel Discussion – All


All Day (Tuesday)


Crowne Plaza Hotel

San Francisco Airport - Burlingame