Wednesday 29th January Jump to: Thursday 30th January

Chair: Dr Liz Madichie, Senior Regulatory Affairs Leader

09:20   Welcome and Introductions
Speaker: Professor Atholl Johnston, President, Clinical & Contract Research Association
09:30   The Industry Response to Brexit Uncertainty
Speaker: Steve Hoare, Quality, Regulatory Science & Safety Policy Director, ABPI

Industry trade associations and government departments have a tradition of collaboration for the benefit of the UK Life Sciences economy and the 2016 referendum has added a new dimension and focus to this engagement. As we move to greater regulatory certainty [and an improved relationship], Steve will present a summary of the past year’s work that got us to this point, and the platform from which to look forward to 2021 and beyond.
10:05   Questions & Discussion

An Operational Update from the MHRA
Speaker: Dr Martin O’Kane, Head of Clinical Trials Unit, MHRA

10:50   Questions & Discussion
11:00   COFFEE
11:20   Whose Trial is it Anyway?
Speakers:   Dr David J Collier, Clinical Director, Clinical Trials Centre, QMUL
  Paul Bowers Isaacson, Trials Patient and Co-Developer of TrialsConnect

David and Paul have been developing the use of patient stories to communicate with groups from school children to cabinet ministers since 2010. The TrialsConnect group has presented unscripted patient stories to mass live audiences at companies such as PAREXEL quarterly engagement, IQVIA townhall, IQVIA IET, Novartis cardiovascular UK investigators, Novartis medical department annual offsite. We have developed events with sponsors such as Novartis UK national patient trials experience meeting looking at digital innovation with the global digital team and a Closed Loop Medical Forum Theatre trial development workshop with professional actor/film-crew/patients and sponsor. The Barts NIHR Biomedical Research Centre frequently reports impacts on companies we have worked with improving their patient involvement and public engagement. We are proud of delivering events and supporting trials in ways which would have been impossible without active, and sometimes expert patient input, such as Chiaroscuro about 70 years from the Nuremberg Trials where trials regulation was born, the last interview with Ralph Koltai CBE, by Simon Callow.
11:55   Questions & Discussion

UK – Wide Activity – An Update from the HRA
Speaker: Dr Janet Messer, Director of Approvals, HRA

12:40   Questions & Discussion
12:50   LUNCH
13:40   NIHR Clinical Research Network - Improvement and Innovation
Speaker: Dr Matt Cooper, Business Development and Marketing Director, NIHR

The NIHR Clinical Research Network has been the driving force behind the ability of the NHS in England to facilitate patients entering into clinical trials in greater numbers than ever before. The Network is constantly innovating and improving to make UK Plc one of the destinations of choice for clinical research. Enabling efficient and effective setup and delivery of clinical trials at scale in the NHS. The presentation will explore the work of the NIHR CRN and new programmes such as Patient Recruitment Centres.
14:15   Questions & Discussion
14:25   Implementing an eTMF-Considerations for Sponsors and CROs
Speakers:   Sarah Fryer, Director, QRC Consultants
  Alex Gage, Head of Clinical Operations, QRC Consultants

Implementing an eTMF -Considerations for Sponsors and CROs’ Sarah Fryer and Alex Gage from QRCC will provide practical guidance on the selection, implementation and management of electronic Trial Master File systems, focusing on the Veeva Vault eTMF platform which has been implemented recently as QRCC’s in-house eTMF solution. Topics will include an overview of the types of eTMF system available to Sponsors/CROs, considerations related to Computer Systems Validation (specifically in relation to ICH/GCP and regulatory inspectorate requirements), process implementation if switching from a paper-based system and general pros and cons of eTMFs versus traditional paper TMFs
15:00   Questions & Discussion
15:10   TEA
15:30   Successful Collaborations between Start-up/Emerging Pharmaceutical Companies and CROs – A Sponsor Perspective
Speaker: Stuart Evans, Associate Director, Clinical Development, AMO Pharma

What are the key attributes that lead to successful collaborations between start-up/emerging pharmaceutical companies and vendors in the execution of clinical programs and clinical trials? Are these key attributes the same, or do they differ from those that mid size and large pharmaceutical companies want and need? Are there differences between what pharmaceutical companies and what vendors think is needed for a successful collaboration? Results from two surveys completed in Spring 2019 (Vendor perspective) and Summer 2019 (Sponsor perspective) on what makes an effective Sponsor-Vendor relationship and best working practices will also be presented and discussed.

16:05   Questions & Discussion
16:15   Updates since Implementation of GDPR
Speaker: Dr Lincoln Tsang, Partner, Arnold & Porter Kaye Scholer LLP
16:50   Questions & Discussion
17:00   Meeting round-up with final questions and discussion
17:15   Close
The Landscape for CROs Tomorrow (Post Brexit)
Thursday 30th January Jump to: Wednesday 29th January

Chair: Emma Lewis, Director of Clinical Operations, PRA International
09:00   Government Statement
Speaker: Minister
09:15   A Post Brexit Perspective from the MHRA and DHSC - Where we are Now and Where we Might be Going
Speakers:   Ian King, Deputy Director, EU & International Policy, MHRA
  Sarah Testori, Research Policy Senior Manager, DHSC (Lead for Exiting the EU)
  Emma Lowe, Senior Research Policy Manager DHSC (Industry Relations & Growth)

The government is committed to making the UK the leading global hub for life sciences after Brexit. This session will provide an overview of the UK’s current position and a perspective on our future direction from the MHRA and Department of Health and Social Care.
09:45   Questions
09:55   Opportunities in the Post Brexit Environment – An Industry Perspective
Speaker: Ashlin Dunne, Director of Clinical Operations, Merck Sharp & Dohme
10:45   Questions
10:55   COFFEE
11:25   Complex Innovative Design (CID) Trials - How the UK is Researching Medicines of the Future
Speaker: Dr Ali Hansford, Head of Regulatory Strategy Policy, ABPI
12:05   Questions
12:15   Realising the Potential of the UK’s Rich Data Landscape Office for Life Sciences
Speaker: Gary Cook, Deputy Director, Office for Life Sciences

There is a huge amount of interest in the potential of data for health. Data collected as part of healthcare provision can be harnessed and used improve outcomes for patients and prevent illness, develop improvements in services, and underpin life-saving research. Patients, clinicians, researchers, charities and Government all need to work together to deliver against the promise that trusted and safe access to health data can deliver tangible benefits. This speech will outline the work of the Office for Life Sciences to ensure that partnerships between the NHS and researchers are fair and transparent, with clear patient benefit.

12:55   Questions
13:05   LUNCH
13:50   The 100,000 Genomes: Transforming Healthcare
Speaker: Sir Mark Caulfield, Chief Scientist, Genomics England

The UK 100,000 Genomes Project has focussed on transforming genomic medicine in the National Health Service using whole genome sequencing in rare disease, cancer and infection. Genomics England partnering with the NHS established 13 Genomic Medicine Centres, the NHS whole genome sequencing centre and the Genomics England Clinical Interpretation Partnership (3500 researchers from 24 countries). We sequenced the 100,000th genome on the 5th December 2019 will complete an initial analysis for all participants by the end of July 2019. Alongside these genomes we have assembled a longitudinal life course dataset for research and diagnosis including 1.6 billion clinical data points for researchers to work on to drive up the value of the genomes for direct healthcare. In parallel we have partnered the NHS to establish one of the world’s most advanced Genomic Medicine Service where we re-evaluated 300,000 genomic tests and upgraded 25% of tests to newer technologies with an annual review. The Department of Health have announced the ambition to undertake 5 million genome analyses over the next 5 years focused on new areas tractable to health gain.
14:30   Questions
14:40   Promoting the UK Life Sciences Internationally
Speaker: Dr Matthew Hallsworth, Head of External Relations, NOCRI
15:10   Questions
15:20   COFFEE
15:50   Three can Keep a Secret, if Two of Them are Dead. Drug Development in the Post-Brexit Era
Speaker: Dr Gary Acton, Captain, Pirates of Oncology and Senior Medical Advisor to Cancer Research UK
16:50   Questions
17:00   Closing remarks and wind up
Speaker: Emma Lewis, Director of Clinical Operations, PRA International
17:15   CLOSE