Programme | ||||||||
Chair: Dr Liz Madichie, Senior Regulatory Affairs Leader |
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09:00 |
REGISTRATION AND COFFEE |
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09:20 |
Welcome and Introductions Speaker: Professor Atholl Johnston, President, Clinical & Contract Research Association |
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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. |
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10:05 |
Questions & Discussion |
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10:15 |
An Operational Update from the MHRA |
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10:50 |
Questions & Discussion |
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11:00 |
COFFEE |
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11:20 |
Whose Trial is it Anyway?
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. https://vimeo.com/281243048 |
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11:55 |
Questions & Discussion |
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12:05 |
UK – Wide Activity – An Update from the HRA |
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12:40 |
Questions & Discussion |
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12:50 |
LUNCH |
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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. |
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14:15 |
Questions & Discussion |
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14:25 |
Implementing an eTMF-Considerations for
Sponsors and CROs
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 |
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15:00 |
Questions & Discussion |
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15:10 |
TEA |
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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. |
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16:05 |
Questions & Discussion |
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16:15 |
Updates since Implementation of GDPR Speaker: Dr Lincoln Tsang, Partner, Arnold & Porter Kaye Scholer LLP |
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16:50 |
Questions & Discussion |
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17:00 |
Meeting round-up with final questions and
discussion |
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17:15 | Close | |||||||
The Landscape for CROs Tomorrow (Post Brexit) | ||||||||
Chair: Emma Lewis, Director of Clinical Operations, PRA International |
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08:30 |
REGISTRATION AND COFFEE |
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09:00 |
Government Statement Speaker: Minister |
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09:15 |
A Post Brexit Perspective from the MHRA and
DHSC - Where we are Now and Where we Might be Going
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. |
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09:45 |
Questions |
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09:55 |
Opportunities in the Post Brexit
Environment – An Industry Perspective Speaker: Ashlin Dunne, Director of Clinical Operations, Merck Sharp & Dohme |
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10:45 |
Questions |
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10:55 |
COFFEE |
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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 |
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12:05 |
Questions |
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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. |
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12:55 |
Questions |
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13:05 |
LUNCH |
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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. |
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14:30 |
Questions |
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14:40 |
Promoting the UK Life Sciences
Internationally Speaker: Dr Matthew Hallsworth, Head of External Relations, NOCRI |
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15:10 |
Questions |
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15:20 |
COFFEE |
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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 |
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16:50 |
Questions |
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17:00 |
Closing remarks and wind up Speaker: Emma Lewis, Director of Clinical Operations, PRA International |
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17:15 |
CLOSE |