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 Medicinedford@jhmi.edu

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