# Presentation: 199303

## Office of Technology Transfer and DevelopmentNational Institute of Diabetes and Digestive and Kidney Diseases

**  ****MISSION****:**
** ****	****  *****TO PROMOTE THE DEVELOPMENT, DISSEMINATION AND ***
***  ******COMMERCIALIZATION OF INNOVATIVE TECHNOLOGIES ***
***  ******THROUGH COLLABORATIONS WITH ACADEMIA AND INDUSTRY ***
***  ******FOR THE BENEFIT OF THE PUBLIC HEALTH***
**Office of Technology Transfer and Development**
**National Institute of Diabetes and Digestive and Kidney Diseases**
**Of the National Institutes of Health and the Department of Health and Human Services**
**12 South Drive, MSC 5632, Bethesda, MD  20892-5632**
**Tel: (301) 451-3636 ****●  Fax: (301) 402-7462**
***http://TechDev.NIDDK.NIH.gov***

## Objectives

*PROMOTE ****DEVELOPMENT OF NEW TECHNOLOGIES**** FROM NIDDK INTRAMURAL RESEARCH*
*PROMOTE ****TRANSFER OF NEW TECHNOLOGIES**** FROM NIDDK INTRAMURAL RESEARCH ACTIVITIES TO INDUSTRY*
*PROMOTE ****COLLABORATIONS**** BETWEEN NIDDK ****INTRAMURAL INVESTIGATORS AND INDUSTRY***
*PROMOTE ****COLLABORATIONS**** BETWEEN NIDDK ****EXTRAMURAL PROGRAMS  AND INDUSTRY***
*PROMOTE ****COMMERCIALIZATION**** OF NEW TECHNOLOGIES FOR THE BENEFIT OF THE PUBLIC HEALTH*

## Technology Transfer

- Government, Academia and Industry collaborating for the public benefit

**Notes:**
Technology Transfer has increasingly become a priority over the past ten years...not only at NIH, but throughout the government and academia.  For the government, and particularly for NIH, the objective is to place technology in the hands of the public... not only through publication, but also in a form that makes a difference in the lives of people: the goal of “bench to bedside”.

## Collaboration - Intramural

- University Collaborators
- Industry Collaborators

**Notes:**
One way to accomplish this is to collaborate with universities, since they can be the source for spin-off companies that produce products and bring them to the market – the bedside.

We can also cooperate with industry – by actual intellectual collaboration: an exchange of intellectual contributions such as proprietary materials, special expertise or facilities. 

## Materials Transfer

***Material Transfer Agreement (MTA) ***
***	***See _[Material Transfer Agreements ](http://techdev.niddk.nih.gov/MTA.pdf)_and _[Simple Letter Agreement ](http://techdev.niddk.nih.gov/SLA.pdf)_
- If exchange involves *ONLY* proprietary material (preferably not commercially available) from Industry, and resultant data from NIDDK/NIH, a _[materials CRADA](http://techdev.niddk.nih.gov/M-CRADA.pdf)_ may be appropriate
- If materials are transferred from NIDDK/NIH to Industry, a _[License](http://ott.od.nih.gov/NewPages/license.html)_*** ***may be required
***For additional information on MTAs, see ***_[MTAs](http://techdev.niddk.nih.gov/MTAs.ppt)__[ – the Process](http://techdev.niddk.nih.gov/MTAs.ppt)_

**Notes:**
Even if the only contribution from the industry collaborator is a proprietary material or one that is otherwise unavailable commercially in the needed formulation, we can collaborate under a materials CRADA.  The materials CRADA has many of the same features of the full CRADA, but since the contemplated intellectual exchange is considerably simpler, the document can be as well.

When the intellectual exchange is simply a compound that may or may not be proprietary to a company, sometimes, a company will be willing to provide the compound for our research without the option for licensing developed technology.  When this is the case, and most investigators at NIH are familiar with the documents, we have the materials transferred under a Material Transfer Agreement or a Simple Letter Agreement.  These are generally used when exchanging materials with academia and other non-profits. 

## CRADA -  Cooperative Research and Development

- Exchange of Intellectual Contribution

**Notes:**
We may collaborate with industry through a CRADA – a Cooperative Research and Development Agreement.  During a CRADA, our investigators may develop the technology to a stage with commercial applications.  These may take form of the basis for an assay, a compound, or a therapeutic, for example.  Having the CRADA in place allows us to offer a license to the company without having to advertise its availability.  Companies like this because it removes a layer of competition in obtaining the license.  It’s similar to a right of first refusal.  The government likes it because the technology has a greater chance of being commercialized – that is, getting into public use – reaching the bedside.

## CRADAs

**Cooperative Research and Development Agreements** are authorized under U.S. Statute (15 U.S.C. § 3710a)
- Require *Intellectual Exchange* between Collaborator and NIDDK/NIH
- For Collaborator contributions of only proprietary material, (preferably not commercially available) see M-CRADAs also known as Materials CRADAs)
- Provide Industry Collaborator with option to license inventions made solely or jointly by NIDDK/NIH investigator during performance of Study or Trial
- May be used for Clinical Trials
- Allow for industry funding of all or part of a Study
- Submitted to the CRADA sub-committee of the NIH Technology Transfer Policy Board for approval before Institute can execute agreement
***For additional information on CRADAs, see CRADAs – the Process***

## Clinical Trial Agreement

- Publication
- Data (e.g. for regulatory filings)

**Notes:**
Another type of collaboration with industry is a through a Clinical Trial Agreement.  This is most appropriately in the situation in which a company has a proprietary drug and we have or can enroll an appropriate human population for study.  It may also apply to equipment or other medical devices.  Often, but not always, the data is used for regulatory filings.

## Clinical Trial Agreements (CTAs)

**Primary Purposes:**
***Establishes drug or device supply***
- Amount
- Distribution
- Placebo
***Establishes data rights and data flow***
- Data may be provided to Industry Collaborator
- Pre-print of publication
- Data for Regulatory Filings, if applicable
- Summary Data, in some circumstances
- Personally Identifiable Data under certain limited circumstances
- Data may be required of Industry Collaborator by NIDDK
- Cross-referencing FDA files if NIDDK holds IND for the Protocol
- Investigator’s Brochure
***For additional information on Clinical Research, see the NIDDK website***

## Extramural Multi-Center Trials

**Cooperative Group**
- 	Group of Investigators having central operations and statistical offices for supporting administrative requirements of the common research, and for performing central data collection and analysis
**Steering Committee**
- 	Committee of PIs from each funded Clinical Center in the Cooperative Group and representatives from NIDDK.

## Confidential Disclosure Agreements(CDAs)

- Establishes agreement concerning:
- Exploratory discussions exchanging proprietary information between NIDDK/NIH investigators and potential Collaborators:
- Patentable inventions
- Protocols
- Investigator’s Brochures
- Sharing of information amongst cooperative agreement members (extramural multi-center trials)
***.***

## NIDDK Collaborative Opportunities and Novel NIH Technologies

- NIDDK Technology Transfer and Development website at http://TechDev.NIDDK.NIH.gov
- NIH Office of Technology Transfer website at http://ott.od.nih.gov/db/tech.asp
- Federal Register at http://www.fedreg.gov
- Federal Business Opportunities (formerly Commerce Business Daily) at http://www.fedbizopps.gov
- TechEx at http://www.techex.com
- Knowledge Express at http://www.knowledgeexpress.com
- 	*********************
- International Conferences
- Publications