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Enhancing Translational Research Through Public-Private Partnerships Third Annual Meeting of the Indiana CTSI April 25, 2011. Barbara Alving, M.D., MACP Director, National Center for Research Resources National Institutes of Health. Goals of the CTSA Program. - PowerPoint PPT Presentation
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National Center forResearch Resources NATIONAL INSTITUTES OF HEALTH T r a n s l a t I n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t I e n t c a r e
Enhancing Translational Research Through Public-Private Partnerships
Third Annual Meeting of the Indiana CTSI April 25, 2011
Barbara Alving, M.D., MACPDirector,
National Center for Research ResourcesNational Institutes of Health
NCRR
Improve the way biomedical research is conducted across the country
Reduce the time it takes for laboratory discoveries to become treatments for patients
Engage communities in clinical research efforts Train a new generation of clinical and
translational researchers
Led by the National Center for Research Resourcesthe CTSA program supports a national consortium of medical research institutions that work together and share a common vision to:
www.ncrr.nih.gov/ctsa
Goals of the CTSA Program
NCRR
CTSA Consortium Goals: Promoting Efficient Translation from Laboratory to Community
NCRR
CTSA Consortium – Building Connections at University of California, Davis
Dynamics of the commercialization process of new inventions Moving along the path of research to market Purpose of intellectual property in the commercialization
process When is an idea worth protecting and why Options for faculty, students, and staff in commercializing
their research Resources available to navigate the journey from research to
commercialization
Center for Entrepreneurship seminars to explore links between research and inventions. Topics include:
NCRR
Columbia CTSA and Merck Collaboration
Establishment of a seminar series developed to introduce Columbia investigators to drug development by scientists from Merck Pharmaceutical
NCRR
Gender Differences in Patenting in the Academic Life Sciences
Lack of exposure to industry contacts
Concern that pursuing commercialization will hinder academic career opportunities
Failure to include patenting into research strategy, especially among senior researchers
Ding WW, Murray F, and Stuart TE. Gender differences in patenting in the academic life sciences. Science 2006; 313: 665-667
Reasons for Lower Likelihood for Patenting Among Women Faculty:
NCRR
Interdisciplinary Team Science at Columbia CTSA
Columbia CTSA pilot funding enabled neurologist Petra Kaufmann, M.D., M.Sc.* to develop an apparatus for children with spinal muscular atrophy (SMA)
Partnered with Elisa Konofagou, Ph.D., Assistant Professor of Biomedical Engineering and Radiology
Outcome: Patent IR 2380: Limb motion capture and rehabilitative assist device
* = Currently Associate Director for Clinical Research at the National Institute of Neurological Disorders and Stroke, NIH
Gravity Neutral Orthotic (GNO) Device: a novel rehabilitation device for people with severe physical disability
NCRR
CTSA-Related Translational Efforts at the University of Pennsylvania
http://www.itmat.upenn.edu/ctsa/caet/index.shtml
Exploring business practices and best management models in developing collaborations in the pre-competitive space
Developing workgroups to address barriers to collaboration
Engaging both the private and non-profit sector to identify gaps and opportunities for partnership and collaboration with CTSA institutions.
Commercialization and Entrepreneurship Program (CAEP)
NCRR
2010 CTSA Industry Forum Highlights:Models of Collaboration Between CTSAs and Industry
Students from various disciplines form teams
• Spend a few weeks in the hospital observing in order to develop lists of clinical needs
• Develop a need statement based on a market analysis, current products and competition, and customer specifications
• Brainstorm a technology to solve a problem, screen solutions, develop a prototype,
• Present it to the companies that sponsor the course
Northwestern University: Medical Device Innovation Course
NUCATSClinical and Translational Sciences Institute
NCRR
Stanford Biodesign Program - mission is to develop leaders in biomedical technical innovation Yearlong fellowship program for doctors in their residency and
graduate engineers Fellows work in teams and spend two months in clinical immersion to
develop a ranked list of 200 unmet needs Teams then brainstorms solutions and develops implementation
strategies that address areas such as IP, regulatory strategy, and clinical trial design
Graduate Course in Biodesign Outside experts (venture capitalists) teach and advise the teams Teams work on highly-ranked needs that are identified but not
pursued by the biodesign fellows Fifteen companies have already formed based around fellow and
student innovation
Models of Collaboration Between CTSAs and IndustryStanford University
NCRR
Stanford Also has two programs to fund more than $1 million
annually in proof-of-concept research:
the CTSA program Grant from the Wallace H. Coulter Foundation
A request for proposals for the CTSA program received more than 80 proposals, of which 8 were funded
Models of Collaboration Between CTSAs and IndustryStanford University
NCRR
Models of Collaboration Between CTSAs and Industry
University of California, San Francisco – T1 Catalyst Program Brings together academic-industrial teams Winning proposals work with consultants to make a
development plan Make presentations to potential partners Activities have resulted in seven funded projects
UCSF is testing whether the program could be a model for the entire university
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Pfizer Collaboration
$9.5 million, three-year collaboration with Pfizer Research activities are evenly divided between UCSF and
Pfizer UCSF maintains intellectual property rights to inventions
made on its campus, with Pfizer receiving the right to first negotiation
100 proposals have been reviewed and 7 funded Too early to judge success and the intellectual property
negotiations have not yet begun
Models of Collaboration Between CTSAs and IndustryUniversity of California, San Francisco
NCRR
CTSA Translational ProjectsThe Scripps Translational Science Institute
CTSA program served as the catalyst that connected Scripps to Qualcomm and other technology firms
Scripps and other CTSAs are conducting a 1,200-patient randomized clinical trial to evaluate a wireless monitor (size of large adhesive bandage) that monitors heart and breathing rates, fluid status, posture, and activity data in patients with chronic heart failure
Wireless Health Care Research Scripps Translational Science Institute has partnered with wireless telecommunications company Qualcomm to use wireless technology to potentially decrease health care cost
Pictured: Dr. Eric Topol (left), director of the Scripps CTSA and Gary West, a philanthropist
NCRR
Providing New Ways to Speed TranslationHarvard Catalyst & InnoCentive Prize for Innovation
February 1, 2010 Harvard launched a search for new solutions for type
1diabetes by posting a challenge on their internal websites Cash prizes awarded for winning hypotheses or concepts Harvard investigators will then take these solutions to the next
level by conducting experiments to see if they work
Using American Recovery and Reinvestment funding Harvard and InnoCentive launched a series of contests aimed at investigating whether new approaches might be useful in sparking novel research directions and collaborations
NCRR
Provides investigators with access to
“shelved” compounds that can be repurposed for other indications
Has generated strong interest among
both researchers and pharma community
• Pfizer initiated agreement with UC Davis to further develop Portal site
• UC Davis is also in talks with other industry groups who also wish to list their available compounds
http://ctsapharmaportal.org/index.html
CTSA Pharmaceutical Assets PortalUC Davis CTSA
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CTSA Public-Private PartnershipsIntellectual Property Portal
Aggregates and markets technologies from CTSA institutions and NIH
Enhances research activity and private partnerships across the CTSA consortium
Currently there are 15 CTSAs contributing information on their technologies to the site
http://www.rochesterctsa.org/ip/
NCRR
Two Web-based initiatives bring power of Internet-based tools, exemplified by social networking to biomedical research
Harvard Medical School eagle-i: Networking Research Resources Across America Will create a federated national informatics network 9 institutions participating Goal is to enable any investigator across America to discover research
resources that are presently invisible
University of FloridaVIVO: Enabling National Networking of Scientists Will create a social network to enable connections among the scientific
community and create pathways that lead to others they know 6 institutions participating
NCRR Recovery Act Funds to Enhance Scientist and Resource Networking
www.ncrr.nih.gov/u24
NCRR
Collaborative Development of New Technology:NCRR-DOE-Agilent
• Integration of NCRR and DOE-supported technology into a single platform
• Collaboration with mass spectrometry instrument company (Agilent)
• Collaboration with OHSU CTSA : First population scale proteomics experiment
• Instrumental methods
• Sample handling
• Data management and analysis
Next Generation Proteomics Platform: Prototype liquid chromatography-ion mobility spectrometry- mass spectrometry (LC-IMS-MS)Proteomics Research Resource Center for Integrative BiologyPacific Northwest National Laboratory (PNNL)
NCRR
NCRR- fundedTranslational Technology Development:National Resource for Biomedical Accelerator Mass Spectrometry (AMS)
AMS is a highly sensitive technology for metabolic studies
Allows safe microdosing with toxic or experimental molecules in humans
An integrated HPLC-AMS system will make quantitative analysis of metabolism and metabolic networks routine, analysis times will decrease from 36 hours to 30 minutes
Licensed patents to 3 commercial entities Workshop with Pharma held Nov 19, 2009
• Explored uses and barriers to the use of AMS in pharmaceutical research• Planning second workshop focused on Academia and CTSAs
Establishing international user’s group Working with Pharma
• NIAID contract ($27M/5 yrs) for taking broad-spectrum antibiotics to phase 1 with Trius Therapeutics
• Access through on fee-for-service ; provides education and training
Lawrence Livermore National Laboratory (LLNL)PI: Ken Turteltaub
NCRR
Thomas Edison: A Design Thinker
Design Thinking Methodology imbues the full spectrum of innovation
activities with an understanding of what people want and need
Edison’s Approach Team-based Multidisciplinary Good business sense Nimble budget Full product launch — light bulb, electric power
system, etc.
Source: Brown T. Design thinking. Harvard Business Review. June 2008.
NCRR
Taking a Global View of Design Thinking:Aravind Eye Care System in India Largest and Most Productive Eye Care Center in the World
More than an eye hospital, Aravind is:
A social organization committed to the goal of elimination of needless blindness through comprehensive eye care services
An international center for research and implementation of sustainable eye care programs as well as manufacturer of world class ophthalmic products available at affordable costs
NCRR
Proposal for FY 2012: Creation of theNational Center for Advancing Translational Sciences (NCATS)
To advance the discipline of translational science and catalyze the development and testing of novel diagnostics and therapeutics across a wide range of human diseases and conditions
NCRR
NCATS: Challenges & Opportunities
Deluge of new discoveries of potential targets
Unmet therapeutic needs for many conditions, especially rare and neglected diseases
Need to view drug development pipeline as a scientific problem – ripe for experimentation and process engineering
NCRR
NCATS: Functions
To improve processes in the therapeutics development pipeline by:Experimenting with innovative approaches along the pipeline utilizing an open-access modelChoosing therapeutic projects to test innovative approachesPromoting interactions to advance regulatory science
To catalyze development of novel diagnostics and therapeutics by:Encouraging collaborations, partnerships across all sectorsProviding resources to enable therapeutic developmentEnhancing training in relevant disciplines
NCRR
NCATS will:
Facilitate – not duplicate – other translational research activities supported by NIH
Complement – not compete with – the private
sector
Reinforce – not reduce – NIH’s commitment to basic research
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