Colin dayan commercial research in cardiovascular disease

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SEWAHSP Industry workshop, 10th January 2013, Cardiff

SEWAHSP Industry workshop, 10th January 2013, Cardiff

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  • 1. Commercial Research inCardiovascular DiseaseColin M DayanDirector, Institute of Molecular and ExperimentalMedicine, 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 beinterested 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 strongreputation 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/Clinicianin practiceJulian HalcoxProfessor of Cardiology,Institute of Molecular and Experimental Medicine,Cardiff University School of MedicineDirector 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 FromClinical/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 FromIndustry  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 SupportUK/NISCHR Portfolio
  • 10. Commercial Clinical Trials:Challenges Facing Clinicians?  Protected Time  Regulatory barriers  Trial Delivery Infrastructure/Manpower
  • 11. Addressing the Challenges inCardiovascular 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 NHSPhil 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 CommercialCardiovascular 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