Model-Informed Drug Development (MIDD): Steps Towards Harmonised Guidance

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.

Kristin Karlsson has been employed as a pharmacometrician/ pharmacokinetic assessor at the Swedish Medical Products Agency since February 2016. In her role as a senior assessor, she has been involved in assessing questions related to modelling and simulation in various procedures such as initial marketing authorization applications, new indication pediatrics, and scientific advice. Kristin is the vice-chair of the newly formed EMA Methodology Working Party, and was the chair of the former Modelling and Simulation Working Party 2018-2022. Kristin is also the regulatory chair of the ICH M15 informal working group (Model Informed Drug Development), and a previous member of the ICH E11A expert working group (Pediatric extrapolation). June 2022 – March 2023, Kristin was the Swedish delegate of the EMA Pediatric Committee (PDCO).  

Kristin Karlsson has been part of the pharmacometric community for almost 20 years and has experience with modelling and simulation within regulatory agencies, academic research and within the pharmaceutical industry. Kristin Karlsson has an MSc in Chemical Engineering and earned a PhD in Pharmacometrics at Uppsala University, Sweden. During her PhD studies and academic career, Kristin worked on methodology and application of non-linear mixed effects modelling and clinical trial simulations.