UK Clinical Research: A Professional Awareness Update
Friday 28th April

Chair: Dr Virginia Acha, Associate Vice President, Global Regulatory Policy, MSD

09:30   Welcome and Introduction
Speaker: Professor Atholl Johnston, President, Clinical & Contract Research Association
09:35   Consultation on Legislative Proposals for Clincial Trials
Session information.

Speaker: Dr Marc Bailey, Chief Science and Innovation Officer, MHRA

10:05   Questions & Discussion

The O'Shaughnessy Review of UK Clinical Trials
Session information.

Speaker: Emily Hirsz, Head of Secretariat for O'Shaughnessy Review, Office for Life Sciences

10:45   Questions & Discussion
10:55   COFFEE
11:25   HRA Response to the Review
This presentation will describe some of the ongoing work that the HRA is leading or participating in to contribute to the Life Sciences Vision, and reflect on the recommendations from the independent review led by Lord O’Shaughnessy.

Speaker: Dr Janet Messer, Director of Approvals, HRA

11:55   Questions & Discussion
12:05   MHRA Response to the Review
Session information.

Speaker: Dr Marc Bailey, Chief Science and Innovation Officer, MHRA

12:35   Questions & Discussion
12:45   LUNCH
13:45   DHSC Response to the Review
Session Information.

Speaker: Emma Lowe, Head of Research Policy - Clinical Research & Growth, DHSC

14:15   Questions & Discussion
14:25   Status of UK Combined Review Process
This session will provide an opportunity to reflect on how combined review is working, particularly in comparison with experience of the new regulatory process in the EU and using CTIS. What are the lessons and opportunities for the UK?

Speaker: Dr Janet Messer, Executive Director of Approvals, HRA

14:55   Questions & Discussion
15:05   TEA
15:35   Building UK Leadership in Next Generation of Clinical Trials: RWD-enhanced Trials
This session discusses the future of data linkage in clinical trial evidence generation. The UK healthcare system and connected data infrastructures are uniquely positioned to support innovative clinical trial designs. There is a growing global demand for clinical trials that are linkable to real-world data such as electronic health records, administrative and claims data, and disease registries. Sponsors are realizing that clinical trials linked to real-world data at the patient level can enhance evidence generation beyond what is possible in traditional clinical trials and are taking steps towards making their trials linkable to RWD. There are success stories in the UK that can help navigate the linkage process, unleash this unique capacity at scale, and create a competitive advantage for the UK to attract innovative clinical trials.

Dr Mehdi NajafZadeh, Senior Director, Medidata AI
Ben McConnochie, Director of Strategic Development, Medidata AI

16:05   Questions & Discussion
16:15   Pivotal Advancements in Technological Innovation Across Clinical Trials
The impact of new technology innovations has exponentially changed our lifestyles over the past decades. Through new scientific and technological innovations, we have seen accelerated drug, device, vaccine development across the life sciences and healthcare sectors benefiting communities. This session looks at some of the patient centric innovations being adopted to digitize and in general modernize clinical trials.

The discussion will provide an overview of the evolution of decentralized clinical trials and the regulatory positions and considerations within the European/UK region.

The session will also include a brief overview of other related technologies being used in clinical trials pertaining to the 'unleashing of power of data', such as the use of artificial intelligence, use of historical data to inform trials etc, to deliver more accurate, timely, and insightful clinical outcomes that lead to transformative healthcare solutions for humanity.

Speaker: Fiona Maini, Chair, New Technologies Working Group, EUCROF

16:45   Questions & Discussion
16:55   Summing up and close
Chair and Speaker: Professor Atholl Johnston, President, Clinical & Contract Research Association