PSWE-03 - The future of clinical trials and drug development 2050

Meeting room 1.60
Organised by the FIP Technology Advisory Group in collaboration with the FIP Early Career Pharmaceutical Group, the FIP Community Pharmacy Section,, FIP Regulatory Advisory Group, the FIP Special Interest Group on New Generation of Pharmaceutical Scientists and the FIP Special Interest Group on Drug Delivery and Manufacturing

Chair(s)

Mr Brett Simmonds, Chair FIP FIP Regulators Advisory Group, Australia and Mr Lars-Åke Söderlund, Vice President FIP Bureau

Introduction

A workshop held at the 18th Annual Conference of the Pharmaceutical Contract Management Group in Poland, in 2022, gathered over 200 delegates to discuss the future landscape of clinical trials in 2050. Discussions covered evolving leadership in the pharmaceutical industry, the transformative impact of “health chips”, wearables and diagnostics on patient selection, the role of artificial intelligence in clinical trials design and control and the future roles within clinical research. The consensus was that, by 2050, if you are working in clinical trials, you will be a data scientist. As such, we can expect to see an increasing role of new technologies and a new three-phase registration model for novel therapies. The first phase will involve an aspect of quality evaluation and biological proof-of-concept, involving more preclinical modelling and reduced animal studies. Following registeration, new medicines will enter a period of adaptive clinical development, focusing on safety and tailored administration options, followed by efficacy assessment in partnership with reimbursement stakeholders. Change is coming, though its precise form will likely depend on the creativity and vision of sponsors, regulators and payers. This session will outline the path for clinical trials, from today towards 2050

Programme

 

11:00 – 11:10 Introduction by the chair
Dr Lars-Åke Söderlund, Vice President FIP Bureau, Sweden
11:10 – 11:35 The future of clinical trials: A look ahead to 2050 and the new way in New Zealand
Dr Tim Hanlon, Ministry of Health, New Zealand
11:35 – 12:05 The role of the African Medicines Agency in clinical trials and in developing new medicines in Africa
Mr. Mphako Ratlabyana, South African Health Products Regulatory Authority (SAHPRA), South Africa
12:05 – 12:25 Panel discussion
12:25 – 12:30 Closing

Learning objectives

  • To identify how clinical trials are developed by innovation and technology.
  • To describe AI’s role in developing clinical trials.
  • To explore how the future of clinical trials is powered by innovation and patient engagement.

Take home messages

  • Artificial intelligence (AI) is increasingly being used to enhance the practice of medicine, from augmenting human judgment to full task automation.
  • The potential of AI to transform clinical research and trials is significant.
  • Shaping the future impact of AI in health care requires creativity and vision from sponsors, regulators and payers.