This document discusses establishing Cardiff University and surrounding NHS hospitals as a commercial research "hub" for cardiovascular clinical trials. It outlines why cardiovascular disease is a priority area for commercial drug development. Developing a strong reputation with industry would require accelerating trial set-up times, incentivizing staff to refer eligible patients, and providing high-quality principal investigators. The needs of clinicians include protected time, regulatory support, and infrastructure for trial delivery. The document proposes a coordination group called Cardiovascular Research Group - Cymru to facilitate collaborative translational research and multi-center trials across institutions. Establishing clear points of contact and minimizing delays could help deliver studies effectively. An example trial mentioned is the ODYSSEY trial of a P

1. Commercial Research in
Cardiovascular Disease
Colin M Dayan
Director, Institute of Molecular and Experimental
Medicine, Cardiff University

2. Why Cardiovascular Disease?
 Commonest cause of mortality in Wales
 High Priority for WG
 Focus of much commercial drug
development
 CVS RRG exists – no similar structure in
England
◦ …..”We have the patients, ….”

3. Why should CU and NHS staff be
interested in commercial trials?
1. It is part of getting new drugs to
patients
2. It supports the R&D infrastucture –
R&D, CRF, Pharmacy
3. It supports the clinical service (via the
HB)
4. It trains staff in GCP
5. Resource for academic research
6. Resource for “enhanced activities”
.......”We have the interest…..”

4. How can we develop a strong
reputation with industry
 Accelerate processing of trials to first-pt-
in
 Incentivise staff to refer potentially eligible
participants
 Provide high quality PIs
….”Good value for money”….
“…we have the patients, we have the
interest, can we deliver?...”

5. SEWAHSP Industry Workshop:
The needs of the Academic/Clinician
in practice
Julian Halcox
Professor of Cardiology,
Institute of Molecular and Experimental Medicine,
Cardiff University School of Medicine
Director Cardiovascular Research Group Cymru

6. Why Commercial Research
 Commercial clinical research is an key
driver of improved health outcomes
 Huge contributor to UK economy

7. Aligning Priorities
 Good Science
 Unmet Clinical Need(s)
 Robust Research/Trial Program
 Clinical/Cost Effective Product
 Benefits
maximised where Industry,
Clinicians and Society all stand to benefit

8. What Does Industry Need From
Clinical/Academic Infrastructure
 Expertise and Facilities
 Relevant Patient Populations
 Open and Transparent Access to Experts
and Communication framework
 Rapid TrialSet-Up
 Effective Recruitment
 High Quality Study Data
 (Appropriate Remuneration)

9. What Do Clinicians Need From
Industry
 Expertise
and Facilities
 Good Products
 Open and Transparent Access to Experts
and Communication framework
 Rapid Trial
Set-Up
 High Quality Study Support
 Appropriate Remuneration/Job Support
UK/NISCHR Portfolio

10. Commercial Clinical Trials:
Challenges Facing Clinicians?
 Protected Time
 Regulatory barriers
 Trial Delivery Infrastructure/Manpower

11. Addressing the Challenges in
Cardiovascular Research

12. CVRG-C
Cardiovascular Research Group – Cymru (CvRG‐C)
Clinical Academics ‐ NHS Clinicians ‐ Basic Scien?sts
Vascular and Arterial Disorders Myocardial and Arrhythmic Disorders
Endothelium / Atherosclerosis Heart Failure ‐ Acquired Heart Muscle
Hypertension and Arterial Disease
S?ffness Arrhythmias and Sudden Cardiac Death
Diabetes Mellitus Cardiomyopathies
Lipid Disorders
Molecular, Gene?cs and Cell Biology
(Advanced) Clinical Imaging
Nano‐Health, Devices and Modelling
Informa?cs, Epidemiology, Preven?on
Clinical Trials Coordina?on
Priori?es
• Transla?onal Collabora?ve Groups
• Prospec?ve Cohort Development
• Mul?‐Centre Clinical Trials
• Health Inequali?es in CVD
NISCHR-CRC/PCU UKCRN

13. NHS Engagement
JH + CVRG-C Coordinator Tinnu
Sarvotham
Chris Bellamy Regional NHS Research Leads
R+D Leads for Each NHS
Phil Thomas Cardiology Department
Links with R+D Departments and
NISCHR CRC and PCU
Adrian Raybould
Link with UK-CRN and Industry via
WIG Cardiology Group
Gethin Ellis

14. Establishing a Commercial
Cardiovascular Trials “Hub”
 Based in CU/C+V UHB
 Build on Established Infrastructure
 Clearly Identified Point of Contact for
Companies
 Coordination of communication/activity
between partner Institutions,
Investigators, Industry/CRO

15. Effective Study Delivery
 Close working relationship with R+D /
PCU to minimise delay
 Early engagement of Research Team(s)
including Sub-I’s, Nurses CRAs etc
 Early engagement and incentivistation of
non-investigator clinical colleagues
 Training

16. Indicator Study
 ODYSSEY
 Sanofi-Aventis/Regeneron
 Anti-PCSK9 Mab
 Post-Acute Coronary Syndrome where
LDL-C uncontrolled on Statin