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FasterCures' Margaret Anderson presents at the 2009 BioEconomy Summit Healthcare Policy Session 2: Affordability and Access. Presents new business models to accelerate research.
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Margaret AndersonMargaret AndersonCOOCOO
June 25, 2009June 25, 2009
BioEconomy SummitHealthcare Policy Session 2: Affordability
and Access
Fostering innovation while delivering affordable treatments and technologies to
large markets
• Research roadmaps • New technology applications• Patient data utilization in research• Human capital• Clear federal guidance on technologies & approaches• Guidelines for public-private partnerships• Global perspective of the drug discovery and
development process• Collaboration on patient registries and
recruitment for clinical trials
• Online tools to facilitate collaboration & interaction
• Increased awareness of the importance of translational research programs
• Effective communication of the complexity and value of medical research to the public
• Advocacy behind key public policy issues (i.e., privacy, IP)
• Organizational transformation to address emerging research needs
• Risk-sharing on pre-competitive tools
• More focus on translational research at NIH
• Increased funding and predictable rewards structure for very novel, high-risk research
• Standardization of clinical terms
•Information portal for best practices•Goal-oriented intellectual property arrangements
Components Essential to Successful Components Essential to Successful Innovation in Disease ResearchInnovation in Disease Research
RESEARCHRESOURCES
RESEARCHINFRASTRUCTURE
RESEARCHENVIRONMENT
Addressing Challenges Addressing Challenges within the Traditional within the Traditional
Research SystemResearch System
Key Issues Affecting ProgressKey Issues Affecting Progress
Infrastructure• Institutional stakeholders’ resistance to
changing infrastructure and rewards systems – in areas such as publication, tenure, grants, and intellectual property – to promote collaboration and innovation;
• Lack of institutionalized communication and data exchange between basic and clinical researchers;
• Inadequate opportunities for cross-disciplinary training and practice
Key Issues Affecting ProgressKey Issues Affecting ProgressResearch Environment
• Highly specialized, reductionist approach to scientific inquiry
• Little funding or reward available for high-risk research• Limited collaboration on “big picture” problems• Conflict-of-interest challenges in public-private
partnerships• Lack of public understanding of the disease research
challenges• Insufficient focus on translating basic research into
clinical application;• Inadequate dissemination of previous research efforts –
especially failures;• Failure to aggregate funding across organizational lines
to achieve larger scale impact
Valley of DeathValley of Death
Basic research is the earliest stage of research, carried out for the advancement of knowledge, without necessarily any regard to its application to practical problems.
Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment and prevention of human disease – the critical bridge between basic research and clinical research.
Clinical research is research in human subjects aiming toward approved treatments for patients.
Finding Big Ideas in Small Finding Big Ideas in Small Spaces: New Business Spaces: New Business
Models to Models to Accelerate ResearchAccelerate Research
Philanthropic Research Funding: Philanthropic Research Funding: Small in Size, Unique in its RoleSmall in Size, Unique in its Role
25%
32%
16%
8%
8%2%
2%
7%
Foundations and other private funds($2.5B)
Estimated health research expenditure in the US by source, 2006
USD billions, percent (100%=$116.1B)
Pharmaceuticals ($37.0B)
Medical device industry ($9.5B)
Biotech($18.2B)
NIH($28.5B)
Universities ($8.3B)
State and local funds ($2.9B)
Other federal funds ($9.2B)
Source: “2006 Investment in U.S. Health Research”, Research!America; Moses, H. et al, “Financial Anatomy of Biomedical Research,” Journal of American Medical Association, vol.294, No.11, September 21, 2005
Philanthropic money accounts for only 2% of total funding; however, it fills a unique niche by:• Filling gaps in funding research that is high risk but also with potential of high return • Being virtually the only source of funding for innovative research in the current environment of flat NIH funding
Finding Big Ideas in Small Finding Big Ideas in Small SpacesSpaces
The Redstone Acceleration and Innovation NetworkThe Redstone Acceleration and Innovation Network
Passion Capital De-Risking Investments
Patient AccessClinical Trial and Research Networks
Intellectual CapacityResearch Discipline
Science ManagementAdvocacy
TThe he RRedstone edstone AAcceleration and cceleration and IInnovation nnovation NNetworketwork
Venture Philanthropies’ Innovative Venture Philanthropies’ Innovative PracticesPractices
• Strategic use of capital• Building collaborations• Streamlining the grantmaking process• Sharing information
High-Risk, High-Reward VenturesHigh-Risk, High-Reward VenturesNew Business Models to Accelerate ResearchNew Business Models to Accelerate Research
• Funded $126 million in research to date, 2/3 for translational research
• Funded testing of over 100 therapeutic targets for Parkinson’s Disease
• Partnership with Elan Corp. gives them first look at promising projects
• Funded more than $66 million since 2005
• Actively supports more than 30 new treatments in development – 4 FDA-approved
• Partners include Vertex Pharmaceuticals, Parion Sciences, PTC Therapeutics, Inspire Pharmaceuticals, Gilead Sciences, Altus Pharmaceuticals
• Raised $102 million to fund 70 labs worldwide
• 4 new treatments approved in 4 years
• 10 clinical trials facilitated by Multiple Myeloma Research Consortium
• 30 MMRF-funded compounds now in preclinical studies and clinical trials
Separating what we Separating what we need to do in scienceneed to do in science
and what we need to doand what we need to doin the culture of sciencein the culture of science
to accelerate curing to accelerate curing diseasesdiseases
Urgent Need to Refocus the Urgent Need to Refocus the GlobalGlobalMedical Research EnterpriseMedical Research Enterprise
Current research infrastructure has led to great advances in knowledge of human health and disease;
but it is not a good system for developing therapies for patients
studying biologystudying biology curing diseasescuring diseases
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