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

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, ….”

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…..”

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?...”

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

Why Commercial Research

 Commercial clinical research is an key driver of improved health outcomes

 Huge contributor to UK economy

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

What Does Industry Need From Clinical/Academic Infrastructure  Expertise and Facilities  Relevant Patient Populations  Open and Transparent Access to Experts

and Communication framework

 Rapid Trial Set-Up  Effective Recruitment  High Quality Study Data   (Appropriate Remuneration)

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

Commercial Clinical Trials: Challenges Facing Clinicians?  Protected Time

 Regulatory barriers

 Trial Delivery Infrastructure/Manpower

Addressing the Challenges in Cardiovascular Research

Cardiovascular Research Group – Cymru (CvRG‐C) 

Vascular and Arterial Disorders 

Informa?cs, Epidemiology, Preven?on 

Nano‐Health, Devices and Modelling 

Clinical Trials Coordina?on 

Myocardial  and Arrhythmic Disorders 

Endothelium / Atherosclerosis Hypertension and Arterial 

S?ffness Diabetes Mellitus Lipid Disorders 

Heart Failure ‐ Acquired Heart Muscle Disease 

Arrhythmias and Sudden Cardiac Death Cardiomyopathies 

Molecular, Gene?cs and Cell Biology 

(Advanced) Clinical Imaging 

Clinical Academics ‐ NHS Clinicians ‐ Basic Scien?sts 

Priori?es •  Transla?onal Collabora?ve Groups •  Prospec?ve Cohort Development •  Mul?‐Centre Clinical Trials •  Health Inequali?es in CVD 

CVRG-C

NISCHR-CRC/PCU UKCRN

NHS Engagement

Adrian Raybould

Chris Bellamy

Gethin Ellis

Phil Thomas

JH + CVRG-C Coordinator Tinnu Sarvotham Regional NHS Research Leads R+D Leads for Each NHS Cardiology Department Links with R+D Departments and NISCHR CRC and PCU Link with UK-CRN and Industry via WIG Cardiology Group

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

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

Indicator Study

 ODYSSEY

  Sanofi-Aventis/Regeneron

 Anti-PCSK9 Mab  Post-Acute Coronary Syndrome where

LDL-C uncontrolled on Statin