From concept to harmonized framework: An Overview of the Draft ICH M15 Guideline on Model-Informed Drug Development

As CPMS head for Asia, Scott is in a key role in the rapid expansion of the GSK footprint in North/East Asia, given its ongoing commitment to the discovery and development of new therapies that deliver improved outcomes for patients globally.

Scott gained his Ph.D. in PK/PD modeling and simulation from the Department of Medicine and Therapeutics, University of Glasgow.  He has since had a wide range of leadership roles associated with the evolution of Model Informed Drug Development (MIDD) practice, tool, methods and process development over his 25 years at Pfizer.  He worked as a Clinical Pharmacologist (CP) and/or Pharmacometrician (PMx) across cardiovascular, sexual health, genital urinary and pain disease areas. He has published over 35 papers on the application of MIDD in development of a range of therapeutics as well as notable good practice and interdisciplinary applications integrating MIDD with statistical and pharmacoeconomic approaches.

He was lead author on EFPIA MID3 good practice white paper and co-led associated regulatory interactions.  Scott is currently the Rapporteur for the ICH MIDD Discussion group with a one-year remit to align on ICH MIDD guideline development strategy.  Notably this group of global regulatory and industry experts have now aligned on a path forward for ICH MIDD related guideline. A key output is the alignment on the scope and value of a MIDD general principles guideline which is being development  M15 IWG/EWG.  A road map covering other potential ICH guidelines and concept paper are currently available.

Scott is a member of GSK CPMS leadership team.  He has a remit which extends to supporting the integration of MIDD approaches with other quantitative disciplines and evolving the Clinical pharmacology role to help deliver on GSK’s mission with respect to efficient global drug development and simultaneous submission.

Dr. Sarem Sarem is Co-Chair of the pharmacometrics working group in Health Products and Food Branch and a senior pharmacometrics assessor at the pharmaceutical drugs directorate in Health Canada, where Sarem provides internal consultation and expert review for advanced modeling and simulation studies supporting drug claims and clinical trial designs. Sarem is a topic leader in the EWG for ICH MIDD Guidance. Sarem has a PhD in pharmacometrics from the University of Montreal and work expertise as a pharmacist and in the pharmaceutical industry.

Dr. Malidi Ahamadi is the Head of Modeling and Simulation Pharmacokinetics, Dynamics and Metabolism at Sanofi, US. Over the past 15 years, Malidi has an extensive academic and industrial experiences in applying modeling and simulation strategies within different scientific fields including the application of MIDD strategy in drug development. Malidi is the deputy topic leader representing the Biotechnology Innovation Organization (BIO: https://www.bio.org/) in the EWG for ICH MIDD Guidance.

Dr. Chien is an associate VP and a scientific lead in the Global PK/PD and Pharmacometrics Department at Eli Lilly and Company. She received her PhD degree in Pharmaceutical Sciences from the University of Washington, Seattle in 1997. She is recognized for her expertise in applying MIDD strategy in trial design optimization and dose-finding from Drug Discovery and Development. She currently serves as the PhRMA Topic Leader on ICH M15.