A big pharma perspective on clinical research with reflections on the Nordic region - threats and opportunities

Transcription

1 A big pharma perspective on clinical research with reflections on the Nordic region - threats and opportunities Anders Ekblom AstraZeneca R&D Nordic Trial Alliance Stakeholders Meeting Towards a Nordic Clinical Research Collaboration, January 31, 2013 Hilton, Copenhagen Airport Kastrup

2 AstraZeneca is a global innovation driven biopharmaceutical company Discovery Research Development Production Marketing Sales

3 Therapy Areas Focused Research Cardiovascular Gastrointestinal Oncology Respiratory and Inflammation Neuroscience Infection

4 R&D productivity challenge A problem for us and a problem for society Costs keep going up. Outputs aren t improving.

5 Development Success Rate % 75% 70% 60% 50% 40% 63% 45% 53% 30% 20% 20% 10% 0% Preclinical Phase I Phase II Phase III Registration

6 World class capabilities Personalised healthcare Clinical trial design and interpretation Predictive science Integrated payer strategy Impact Probability of success of success Cycle time Cost / launch

7 Personalized Medicine Unselected patient population Stratified patient population Good responders Poor responders Adverse events

8 # of started clinical trials in Sweden LIF rapport 2012:1, LIF:s FoU-enkät Maj 2012

9 Clinical trials in Sweden # started CTs 262 # engaged units 1063 # patients 8207 # patients per trial 59 # ongoing CTs % % % 39-34% % LIF rapport 2012:1, LIF:s FoU-enkät Maj 2012

10 ClinicalTrials.gov A service of the U.S. National Institutes of Health World, industry-sponsored interventional studies

11 Europe, industry-sponsored interventional studies (n=totals)

12 Number of clinical trials per million of inhabitants Total Open

13 Global trends in pharma industry Established regions Emerging regions 1 Established regions Good quality and logistics Well established health care Well educated Good IT/IS structure Higher cost Time constraints C. Fellenius, May 9, Emerging regions Large untapped, less well treated populations Increasingly good quality, logistics and IT/IS structure Well educated Lower costs Get more per invested dollar Studies with larger study populations and/or later study phases are shifting to emerging regions to secure rapid study delivery and to lower cost with maintained quality Smaller study programs in personalized medicine indications, but less studies and patients are still allocated to established regions

14 What is important for the industry? Access to excellent science and committed investigators Expert clinicians and scientists A willing healthcare system that asks for innovations Supportive national innovation strategies/policies Access to the right patients Effective screening Find the right patients quickly. PHC look for patients with correct biology ; Volumes large cities/regions needed to provide enough patients Phase III not always possible in Sweden/Scandinavia Phase I CRO s - location in larger countries Regulatory requirements and capability Quality, speed and cost Qualified investigators and staff. infrastructures Short start-up time and efficient recruitment.

15 Hurdles are getting higher Efficacious Efficacious Safe Efficacious Safe Differentiated Safe Differentiated Reimbursable

16 CLINICAL TRIALS AT AZ Critical to the development of new medicines Global programs will have to reflect a global population Many countries require documentation on their national population Cost, speed and quality & payers

17 What can industry do? Precompetitive Collaboration: AstraZeneca 22 compounds for MRC-funded academic studies Translational research AZ patents for tropical disease R&D Finding new uses for existing molecules Jointly-funded ID research

18 What can Industry do? TransCelerate BioPharma Five Initial Projects Shared investigator site portal Site training and qualification Risk-based monitoring approach and standards Clinical data standards Comparator drug sharing for trials

19 What can institutions/hcps do? No, we have other priorities! Prioritize clinical research part of strategy and goals Establish smooth agreement processes and finding the right patients for studies One common template, fee for service, overhead cost, one portal for recruitment.. Build on your strengths what is your niche? Complex studies, genetics, equipment, expertise

20 Clear trends in pharmaceutical development Early intervention and modification of disease Biomarkers More specific treatments Combined with diagnostics Personalized healthcare Biologics Antibodies, vaccines Life science Pharmaceuticals Global market and payers Collaborations