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Boosting drug development through public private partnerships (Laverty OECD Paris Feb 2013)
The document discusses the Innovative Medicines Initiative (IMI), which aims to enhance drug development through public-private partnerships (PPPs) in Europe. It highlights the challenges in reaching international agreements, funding obstacles, and the need for collaboration in addressing health care and societal issues. IMI fosters industry collaboration, engages various stakeholders, and promotes intellectual property agreements to improve innovation and reduce time to market.
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Boosting drug development through public private partnerships (Laverty OECD Paris Feb 2013)
- 1. Boosting drug developmentthrough Public- Private Partnerships: The IMI Model Hugh Laverty Senior Scientific Project Manager Science Diplomacy in Action - Paris Feb 2013
- 2. The Challenges Difficulties reachinginternational agreement on common priorities Insufficient modalities of funding Obstacles to the transfer of science, technology and innovation into practice Insufficient participation of relevant actors in society The lack of integration of countries with weak scientific infrastructure Problems of intellectual property mangement for applications of new technologies
- 3. The role ofPublic-Private Partnerships in driving international science co-operation PPPs originated in areas focusing on neglected or orphan diseases, or helping poorer countries The approach to PPPs has evolved and the model is being applied to other areas e.g., chronic diseases, and more mature economies The emergence of PPPs has been helped by a convergence of different pressures such as societal, health care and economic
- 4. Challenges for societyand industry Society Industry • Healthcare challenges • Costs for developing new drugs continue to raise around the continue to increase world • Pharma incentive systems and profitability are under pressure • A lot of these challenges are not addressed • We are pushing towards Personalized Medicine but in • Pressure on healthcare general, progress in basic science systems and budgets continue is not translated to medical to rise innovation and benefits to patients
- 5. Innovative Medicines Initiative The European Union and the pharmaceutical industry have joined forces to make drug R&D processes in Europe more innovative and efficient and enhance Europe’s competitiveness in the sector & address key societal challenges by forming the biggest PPP in Life Science
- 6.
- 7. IMI Project Architecture A Typical IMI Consortium Private EFPIA 40 Projects Investment Pharma 1 Pharma 4 in kind Pharma Pharma 2 5 362 EFPIA teams (€ 1 billion) Pharma Pharma 3 6 557 Academic & research teams SMALL AND ACADEMIA MEDIUM-SIZED EU Public ENTERPRISES 91 SMEs Funding PATIENTS’ cash ORGANISATIONS 16 Patient organisations (€ 1 billion) HOSPITALS REGULATORS 6 Regulators
- 8. Value Chain Coverage- Calls
- 9. Antibiotic drug development: ‘NewDrugs 4 Bad Bugs’ Challenges of AB R&D: • Unique scientific bottlenecks • Challenging regulatory environment • Low return on investment Challenges too great for any single entity to solve, collaboration is essential
- 10. Antibiotic drug development: Majorchallenges Scientific challenge: screening approaches often fail, difficult to obtain needed spectrum & safety—challenge increased for Gram-negative pathogens due to inherent penetration barriers Regulatory challenge: large trials needed, non- inferiority designs, etc. Economic challenge: (low Return on Investment) ABs expensive to develop, often give cure in days, new ABs will be used only when truly needed
- 11. European Lead Factory Joint European Compound Library Joint European Compound Library accessible for private and public lead discovery projects JECL is comprised of a Pharma Consortium Collection (≥ 300.000 compounds) and a Public Collection (up to 200.000 cpds.) The Screening Centre – as an independent novel business entity – takes responsibility for cpd. logistics, HTS (internal and out-sourced), data analysis & handling, and project mgtm. Screening Centre functions as a market place to broker public-private discovery projects with the Pharma Consortium
- 12. How IMI makesa difference Fosters large scale industry collaboration and engagement with scientific community Promotes active involvement of patients, regulators and payers Enables innovation via join effort where singular approach has failed so far Facilitates Intellectual Property agreements
- 13. One IMI IPpolicy, multiple interests Direct exploitation rights (academia /SME) Facilitating Fair and reasonable terms Terms known at outset access for Research Use purposes (Pharma) for third parties Dissemination Incentive to of information participate Dissemination Innovative Medicines within a year Support for Compensation EU for IP Industry Terms accommodate the needs of Only necessary background included a spectrum of interests - large and Compensation within fair and reasonable small terms
- 14. The Evolution ofIMI From bottlenecks in industry to bottlenecks in society From push to pull – business & HC impact + Drive Regulatory Change What: translate science into regulatory Need for a neutral platform pathways: real life data How: Collaborate with regulators and payers Since 2012 + Facilitate ‘pull’ incentives What: Reconcile research and health care agendas How: Engage with regulators and payers Since 2011 Reduce Attrition and Time to Market What: Decrease risk by developing improved tools and methodologies, secure sustainability of outputs How: Large scale industry collaboration and engagement with scientific community Since 2008 R&D cycle: From inventive to innovative steps
- 15. The Challenges Difficulties reachinginternational agreement on common priorities Insufficient modalities of funding Obstacles to the transfer of science, technology and innovation into practice Insufficient participation of relevant actors in society The lack of integration of countries with weak scientific infrastructure Problems of intellectual property mangement for applications of new technologies
- 16. The Challenges Difficulties reachinginternational agreement on common priorities Insufficient modalities of funding Obstacles to the transfer of science, technology and innovation into practice Insufficient participation of relevant actors in society The lack of integration of countries with weak scientific infrastructure Problems of intellectual property management for applications of new technologies
- 17. Ensuring success fromfuture global initiatives Mechanisms to allow individuals and institutions to engage internationally Inclusive and flexible approach Clearly defined IPR Policy Focus on addressing societal needs Neutral broker