DDI Risk Assessment: Approaching Global Convergence and Understanding Emerging Innovation

Monday, April 25, 2022

8:00 AM – 1:30 PM ET

Chair(s)

Rajanikanth Madabushi, PhD

Associate Director, Guidance and Scientific Policy
US Food and Drug Administration
Venkatesh Pilla Reddy, PhD

Director, Clinical Pharmacology and Pharmacometrics
AstraZeneca

Speaker(s)

Megan Gibbs, BSc, PharmD, PhD

VP, Global Head, Clinical & Quantitative Pharmacology
AstraZeneca
Niresh Hariparsad, PhD

Senior Director
AstraZeneca
Akihiro Ishiguro, PhD

Division Director
Pharmaceuticals and Medical Devices Agency
Nina Isoherranen, MSc, PhD

Professor and Chair, Milo Gibaldi Chair
University of Washington
So Miyoshi, PhD

Head of Clinical Pharmacology
Pfizer R&D Japan
SP

Sheila Annie Peters, PhD

Early Asset Lead
Boehringer-Ingelheim
Kellie Schoolar Reynolds, PharmD

Director, Division of Infectious Disease Pharmacology
US Food and Drug Administration
Andrew Rowland, BSc, PhD

Associate Professor and Beat Cancer Mid-Career Research Fellow
Flinders University
Vikram Sinha, PhD

Vice President, Global Head Quantitative Clinical Pharmacology
Takeda
MV

Manthena Varma

Pfizer
Carolien Versantvoort, PhD

senior clinical pharmacology assessor
Medicines Evaluation Board
Xinning Yang, PhD

Policy Lead
US Food and Drug Administration
Ping Zhao, PhD

Senior Program Officer
Bill & Melinda Gates Foundation

Session Description

Different regional regulatory agencies have published Drug-Drug Interaction (DDI) guidances to assist drug developers in the evaluation of DDI potential during drug development. The formation of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Multidisciplinary Expert Working Group (ICH M12 EWG) is an important step toward achieving harmonization across the different regulatory agencies and allow for a global approach to assess DDI liabilities of new drugs. As we approach global regulatory convergence, we are at a time when scientific advancements and new technologies are emerging and are poised to innovate the approaches to assess DDI risk. More than ever, its critical to understand the role and value of the emerging areas to ensure timely adoption.

The first part of the session focuses on ICH M12 EWG activities which include providing updates on in vitro and clinical DDI expectations, emerging areas, projected impact of the draft guideline to industry and future steps. The second part of the session focuses on emerging areas of research such as, potential utility of plasma-derived exosomes (liquid biopsy biomarkers) to predict the DDI, emerging role of Organ‐on‐a‐Chip in DDI research and application of endogenous biomarkers that might be useful to elucidate metabolic pathways that are involved DDIs. This session will also touch upon best practices and future directions of quantitative methods for predicting DDIs and extrapolating DDI study results.

Learning Objectives

1. Upon completion, participants will be able to identify the gaps across regional DDI guidelines and describe the ICH M12 EWG harmonization efforts.

2. Upon completion, the participants will be able to discuss the utility of emerging innovative techniques to assess DDI risk and describe the best practices in applying quantitative methods for predicting DDIs.

Session Schedule

Session 1: Global Convergence in Drug-Drug Interaction Assessment

8:00 AM - 8:05 AM ET
Welcome and Opening Remarks
Rajanikanth Madabushi, PhD

8:05 AM - 8:28 AM ET
ICH Harmonization Update on In-Vitro Drug Interactions
Xinning Yang, PhD

8:28 AM - 8:45 AM ET
ICH Harmonization Update on Clinical DDI Studies and PBPK
Kellie Reynolds, PharmD

8:45 AM - 9:05 AM ET
ICH M12’s Emerging Areas on Drug Interaction Guidance
Carolien Versantvoort, PhD

9:05 AM - 9:30 AM ET
Impact of ICH M12 Guidance to Industry
Vikram Sinha, PhD

9:30 AM - 9:40 AM ET
ICH M12 DDI Guidance Summary and Next Steps
Akihiro Ishiguro, PhD

9:40 AM - 9:55 AM ET
BREAK

9:55 AM - 10:40 AM ET
Panel Discussion and Live Q&A
All Session 1 Speakers; Sheila Peters, PhD, and So Miyoshi, PhD

10:40 AM - 11:00 AM ET
BREAK

Session 2: Emerging Areas of DDI Research in Industry and Academia to Support Clinical Pharmacology Regulatory Decision-Making

11:00 AM - 11:05 AM ET
Opening Remarks
Venkatesh Pilla Reddy, PhD

11:05 AM - 11:25 AM ET
Emerging Role of Organ‐on‐a‐Chip Technologies in DDI Evaluation
Nina Isoherranen, PhD

11:25 AM - 11:41 AM ET
Industry Trends, Gaps and Development of Best Practices in Quantitative Modeling of Enzyme Induction: Considerations From the IQ Working Group
Niresh Hariparsad, PhD

11:41 AM - 11:57 AM ET
Plasma Extracellular Nanovesicle (Exosome)-Derived Biomarkers for Drug Metabolism Pathways
Andrew Rowland, PhD

11:57 AM - 12:15 PM ET
Emerging Strategic and Translational Modeling Tools in DDI
Ping Zhao, PhD

12:15 PM - 12:30 PM ET
BREAK

12:30 PM - 1:30 PM ET
Panel Discussion, Live Q&A and Closing Remarks
All Session 2 Speakers; Megan Gibbs, PhD, and Manthena Varma, PhD