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
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