Presentation Transcript

1. Partnershipwith the Pharmaceutical IndustryFrances Macdonald, PhD,

2. Partnership
3. Presentation Outline Elephants in the room? Policy support for partnership Examples of Successful Collaborations R&D In the marketplace A Common Understanding Conclusion
4. Profit
5. No other industrial sector invests more in R&D Biggest investor in health research in UK – 61% 9% of global biopharma R&D invested into the UK 67,000 jobs £6bn trade surplus
6. Risky Business.... For every marketed medicine that makes enough money to pay for its development, about 25,000 chemical compounds were tested, on average 25 of these will have gone into clinical trials and five received approval for marketing.
7. Trust & reputation?
8. ESHLSG
9. ESHLSG - Guidance on Collaboration
10. Health and Wealth in Scotland : A Statement of Intent for Innovation in Health : Scottish Government, June 2012 Vision : ‘Scotland is a world-leading centre for innovation in health through joint-working between government, NHSScotland, Industry and the Research Community.’ Benefits of strong partnerships with industry include: - ensuring that the people of Scotland receive higher quality care and more effective interventions -ensuring that Life Sciences businesses in Scotland have a better knowledge of the needs of NHSScotland for innovative solutions and better access to the NHS during development The Statement is an important bridge between key NHSS and industry strategies Quality Strategy for the NHS in Scotland , May 2010 Scottish Life Sciences Strategy 2011
11. What is Partnership? Various definitions: Egorganisationin which 2 or more individuals pool skills and resources and share profit and loss, in accordance with the partnership agreement It is challenging to have a true partnership – in any context Possibly works best in the ‘pre-competitive space’ ‘Joint working’ can be an easier option to manage in some circumstances Implies a narrower remit eg a specific project, with each partner having a pre-defined role. Transparency and a knowledge of each other’s aims is critical
12. Examples Basic Research Increased collaboration in the pre-competitive space eg the Biomarkers Consortium ( Pharma companies, patient charities, government agencies egNiH) eg I-SPY 2 trial Various partnerships and joint working between the Industry and Academic centreseg via the IMI (EU), TSB (UK), Clinical Development Clinical trial programmes – more joint working than partnership After EMA/MHRA Approval Industry membership of the SMC , including the NDC Joint working examples.
13. Relationships within Pharmaceutical R&D THE INNOVATIVE MEDICINES INITIATIVE Aim - to make Europe a world leader in pharmaceuticalresearch, to the benefit of society The Innovative Medicines Initiative (IMI) is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Defined scientific research agenda Predicting safety, predicting efficacy, knowledge management, education and training IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA. 2 Billion Euro budget ( 50% from each party) IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. Annual calls for proposals
14. The Innovative Medicines Initiative The Main Challenges (to speeding up the development of more effective and safer medicines) Industrial : insufficient R&D investment Scientific : technological complexity Within Europe : research within Europe is fragmented (often lacks collaboration) IMI Expected effects: Modernise the development of medicines Expand EU knowledge & know-how to attract R&D research Anchor R&D jobs in Europe ( reverse brain drain) Enhance Europe’s economy by strengthening the position of smaller companies, enabling them to collaborate with multiple stakeholders Annual calls for proposals
15. University of Dundee and BioCity Scotland IMI launch of the European lead Factory – co-located in Scotland with BioCity providing logistics and Univ. of Dundee staff undertaking screening and medicinal chemistry Seven participating pharma companies will allow access to their chemical compound libraries Academia and SMEs will contribute further compounds Results in at least 500,000 compounds accessible to all project partners , as the ‘Joint European Compound Collection’ Gives European researchers unprecedented access to industry chemical collections andwillfacilitate the translation of their findings into actual treatments for patients European Screening Centre will assist collaborators – Dundee staff based in BioCity ( Lanarkshire)
16. MRC-ABPI academic-industry consortia Research – equal partnership funding Addressing challenges of joint interest, working towards better treatment a. MRC-ABPI COPD consortium Growing global health burden, highly heterogenous disease Four work packages, from developing a knowledge management platform to targeting skeletal muscle dysfunction. Many collaborators Role of infection Tissue injury and repair Co-morbidities b. MRC-ABPI Rheumatoid Arthritis consortium Curing early arthritis Immunological toolkit
17. In the marketplace, at a more local level
18. A Common Understanding 2012 -Working Together for Patients Outlines: Values Principles Transparency and good business standards Good Governance Data, confidentiality and Intellectual property Process- very useful template and checklists Terms of Reference Project Initiation Documents Joint Working Agreement
19. ACommon Understanding 2012 – Working Together for Patients CHIEF EXECUTIVE’S FOREWORD Appropriate and constructive joint-working between NHSScotland and the pharmaceutical industry has the potential to encourage the development of new products and services that are evidence-based, that better match the needs of patients and that make a greater contribution to sustainable, quality improvement in care. This document seeks to support NHS staff in taking forward ideas for joint-working projects, from assessing the idea, through delivering the programme of work,tomeasuring its benefits, to evaluating it and bringing the programmeof work to a close.
20. Rheumatoid Arthritis – Stop Smoking Campaign NHS Fife/Fife Rheumatic Diseases Unit, National Rheumatoid Arthritis Society and Pfizer Main Aim – raise public and patient awareness of the impact of smoking on RA disease..and ..the fact that it may reduce the effectiveness of some treatments eg anti-TNFs Developed a range of educational materials ( posters, flyers, leaflets) and highlighted the services available in Fife NHS staff conducted an audit, before and after the campaign Patients benefit –egincreasde use of ‘stop smoking’ services, from RA patients Campaign rolling out to other HBs
21. SIGN Respiratory Guidelines Scottish Intercollegiate Guidelines Network (SIGN), National Advisory Group (NAG) for Respiratory Clinical Networks, Asthma UK Scotland and ABPI Scottish Respiratory Industry Group (SRIG) ( Includes 7 companies) Key Aim – implementation of the SIGN 101 /British Thoracic Society Guidelines on the management of asthma A steering group has been set up with representatives from all 4 parties, with the aim of delivering an implementation process for the guideline, including establishing regional workshops- consider priorities, benchmark best practise etc. Expected outcomes include agreement on asthma priorities and a better understanding of the various service models which could help deliver best practise
22. Conclusion – ESHLSG Core principles: Collaboration between industry and healthcare professionals has the potential to deliver significant patient benefit above and beyond what may be delivered by any party in isolation Healthcare and industry professionals are able to manage their relationships with each other without compromising clinical decision making A comprehensive and robust set of regulations, including UK law, healthcare professionals’ codes and standards and the ABPI Code of Practice for the Pharmaceutical Industry ensure professional and ethical standards are upheld
23. Investment The pharmaceutical industry globally invests more in research and development than any other industry – £12.1 million every day. The pharmaceutical industry employs around 25,000 people in R&D in the UK (Business Enterprise Research and Development (2008, 2009, 2010) 2010 released Nov 2011 – Office for National Statistics (ONS).
24. Medicines Development ​It takes over 12 years to develop a new medicine to the standards of quality, efficacy and safety laid down by legislation. It typically costs £1.15 billion to do all the research and development necessary before a new medicine can be licensed for use. The majority of medicines under development never make it to the market; following thorough studies, they may be found to have unacceptable side effects, or they don’t work any better than existing treatments.
25. Betweeen 2011 and 2015 (at list prices - OHE)... Total medicines bill for NHSScotland is projected to increase by 2.9% - 3.9% (£1.37bn - £1.43bn) Branded medicines bill for NHSScotland is projected to increase by 0.5% - 1.5% (£0.99bn – £1.03bn)
26. Market share of innovative products in the UK is behind European peers and deteriorating Market share for products -brands and generics- launched in the past 5 years by value (%)(1) Branded medicines launched in the past 5 years are expected to account for 5% of spend only by 2015, similar to previous years’ levels NICE’s ~40% rejection rate and NICE ‘blight’ lead to delays and limited access as well as poor performance in innovation uptake(2) IMS Health World Review Analyst, 2010 OHE analysis 2012
27. Data Transparency – recent announcement As per the Code, all companies are required to register a trial within 21 days of the first patient being admitted, and post the results within one year of marketing authorisation. But in his address at the debate, Whitehead conceded that compliance with the ABPI's data transparency provisions "was never properly monitored," which has prompted the introduction of a new process to ensure that pharmafulfils these obligations. Under the process, an independent, third party service provider will be appointed to ensure compliance with data transparency provisions within the Code, and the ABPI will report any breaches to its policing arm, the Prescription Medicines Code of Practice Authority.  In addition, a new toolkit will be available from the third quarter of this year to encourage greater compliance, providing good practice guidelines, compliance checklists and template standard operating procedures for pharmaceutical firms, the Association said. The ABPI will also will host workshops with relevant stakeholders to explore how to address the issue of disclosing historical data, to improve transparency and boost access to data crucial to advancing certain types of research.
28. A collaborative approach Whitehead said that the ABPI is keen to ensure a collaborative approach with all health stakeholders and international colleagues "to agree a pragmatic approach which is in the interests of patients while protecting the commercial research model". The industry has long accepted the importance of making data more transparent, "but all parties must now decide together how exactly this is achieved,” he stressed.TheEuropean Union is currently revising the Clinical Trials Directive (2001/20/EC), and proposed regulation by the European Commission will require sponsors to submit a “summary of results” to the EU’s clinical-trial database within one year of a clinical trial ending. The benefits of greater transparency are clear, but the UK’s BioIndustry Association recently warned that too stringent requirements for the publication of clinical-trial data could put investment in early-stage research at risk.
29. MRSA Management Evaluation NHS Greater Glasgow and Clyde and Pfizer The Challenge – reassess the approach to managing patients with MRSA complicated skin and soft tissue infection (cSSTI), and the clinical and financial benefits of early discharge Based on methodology agreed by the lead physicians – independent research organisation carried out 15 mth retrospective review of records, of a sample of this patient group Allowed description of their pattern of care and identification of a sub-group who could potentially have been discharged earlier on oral antibiotics or out-patient antibiotic therapy The project provided the opportunity for the clinicians to gather data and answer their question
30. NIHR Translational Research Partnerships - Hardwiring Announced by Ministers October 2010, ABPI R&D Conference Features: Single point of access to PI’s and clinical academic centres of excellence Single collaborative agreement (mICRA) Unified trusts’ R&D approval signoff Confidence in delivery, quality, speed High quality clinical input to study design, conduct and analysis > Increased attraction of UK as place for exploratory development > Reduced attrition rate in later stage studies
31. Stratified Medicine partnerships ABPI Close working with TSB and stakeholders on a business case for Stratified Medicine. Technology Strategy Board (TSB) Partnerships: £50M Innovation Platform for Stratified Medicine First competitions 2011: 1. Inflammatory biomarkers – COPD, RA 2. Tumour profiling 3. Value and business models