Johns Hopkins Technology Transfer
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Translational Biomedical Research: Moving Discovery from Academic
Centers to the Community
Daniel E Ford, MD, MPHDavid M Levine Professor of MedicineDirector, Institute for Clinical and Translational ResearchVice Dean for Clinical InvestigationJohns Hopkins School of [email protected]
Translational Research
T1 The process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans (as well as the process of applying bedside observations to inform laboratory discoveries)
T2 Research aimed at enhancing the adoption of best practices in the community.
Translational Research Activities
T1 activities included: 1) the translation of basic discovery into mechanistic studies in cell lines or animals, 2) the translation of mechanistic studies into initial human testing, and 3) the translation of initial human testing into proof of efficacy.
Translational Research Activities
The T2 activities included 1) the translation of proof of efficacy into proof of effectiveness in a usual care setting, and 2) research aimed at enhancing the adoption of best practices in the community
2010 Survey
All faculty and fellows at Johns Hopkins (SOM, SON, SPH, Engineering)
Objectives • proportion of investigators involved in early
(T1), late (T2), and reverse translational (RT) research
• barriers to translational research • attitudes about translational research• involvement in interdisciplinary collaboration• barriers to collaboration.
Results of Survey
Majority of researchers indicated they did translational research• Highest in engineering faculty• About 60% of basic lab scientists• Lower percentage in young researchers
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Barriers to Translational Research
Translational research is not part of my research agenda or is not central to the goals of my research program
I don’t have the resources (funding, space, equipment, technology) for making my research more translational
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Barriers to Translational Research
I have not yet identified an appropriate translational research question to pursue
I am not sure what the next translational step is
I don’t have the training or expertise I need
I have not found the correct collaborators
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Mission Statement
JHU Institute for Clinical and Translational Research will accelerate improvement in the health of the population by utilizing team driven science to translate basic discoveries into new interventions that optimize health promotion and treatment of disease.
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Clinical and Translational Sciences Award (CTSA)
Program based in the new NIH National Center Advancing Translational Sciences (NCATS)
Johns Hopkins University is one of 60 Universities with awards
http://www.ncats.nih.gov/
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Translational Research Communities
Establish three new Translational Research Communities (TRC’s) - integrated, interdisciplinary, University-wide research and education teams - who will prioritize important clinical problems, develop new technologies and methodologies to solve them, and speed their translation into practice.
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Translational Research Communities
1. Drugs, Biologics, Vaccines and Devices
2. Biomarkers and Diagnostic Tests
3. Behavioral, Social and Systems Interventions
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ICTR Studio
The Studio is both a place and a process, much like a music studio. In simplest terms, The Studio will be a coordinated, multidisciplinary service center with a goal to provide integrated, multidisciplinary research to facilitate translation.
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Importance of Data
Expand our integrated platform of Cores and Resources with a renewed focus on data. The emergence of “big data” has created new challenges, and success in all research protocols is dependent on the quality and interpretation of data whether “big” or “small”.
Johns Hopkins Medicine IRB Approved Protocols
2007 2008 2009 2010 2011 2012
Total NewProtocols 1457 1620 1809 2005 2056 2025
Total PIs 944 1011 1081 1215 1248 1247
New RCTs 247 376 405 422 452 459
Johns Hopkins Clinical Research Network
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FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011
Invention Disclosures 244 282 305 352 355 409
Agreements Signed 57 79 92 98 104 159
US Patents Issued 33 43 40 46 44 49
Royalty & License Fees 7,734$ 9,663$ 11,163$ 12,220$ 11,948$ 15,249$
Net Income 1,897$ 2,071$ 3,612$ 4,059$ 3,847$ 5,519$
Distributions
Inventor's Share 1,207$ 3,487$ 2,559$ 3,539$ 3,610$ 3,651$
Inventor's Research 504$ 1,694$ 1,072$ 1,423$ 1,409$ 1,451$
Startup Companies 4 5 12 10 10 19
Promising Results So Far
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What do academic researchers need to translate?
An ecosystem that includes academic support, federal grant support and commercial partners
Believe they can maintain their academic credibility while still commercializing their work
Access to pilot funds Access to experts to develop
business plans19