Fiscal Year 2013 NIH SBIR Technology Transfer Contract Topics (NIH TT

Supplementary Information for NCI SBIR Contract Topics 317 and 318

General Questions

1. Who should I contact with questions on technical matters, contract administration, co-development research, or licensing issues for NCI SBIR Contract Topics 317 and 318?
2. Can I directly contact the NCI inventors with questions about NCI SBIR Contract Topics 317 and 318?
3. How is an NIH-TT SBIR contract topic different from a regular SBIR contract topic?
4. Where do I find the actual materials (forms) used to prepare a contract proposal?
5. If an NIH-TT SBIR contractor invents something while under the NIH-TT contract and wants to file a patent, must any patent rights be assigned to NIH or the Federal government?
6. How is the joint generation of new intellectual property (IP) handled under SBIR-TT contracts?
7. When will an offeror be notified of the outcome of peer review and notified whether it has a chance of being funded?

Topic 317: Wound Healing Preparations Incorporating Nitric Oxide-Releasing Materials

8. What triggers NO release from these materials?
9. Will this invention bond to organic material?
10. Can polymer processing occur first and then NO reaction? Or processing and NO has to be simultaneous?
11. With regards to the kinetics of NO delivery - is this related to the type of p(AN) (i.e., MW, side chains, etc) used, or to the processing following conversion to a NO-carrying p(AN)?
12. Are we expected to use the formulations only as developed by NCI or is new R&D for formulation modification allowed?
13. How much material will be provided to the awardee? Are there costs associated with obtaining the material?
14. Is the polymer biodegradable or bioabsorbable? Is this a potential concern?
15. Can the NCI team provide varying forms of the material (e.g. films, fibers, etc)?
16. Has the PAN-NO technology been licensed previously? If so, what market sector was the company involved in?
17. What molecular weight of PAN has been used/tried?
18. If the company processes PAN into a particular form factor, can it then be returned to NCI to be loaded with nitric oxide?

Topic 318: Test to Predict Effectiveness of Docetaxel Treatment for Prostate Cancer

19. Other than drug response, is the CYP1B1*3 variant correlated to any other pathobiology, eg. metastatic potential?
20. Are array based techniques the only platform under consideration? Could CYP1B1*3 be detected via non-array technology, such as immunology methods?
21. Can extending the proof-of-concept for CYP1B1*3 interference be done using only cellular assays (without involving any tumor-bearing mice)?
22. Among marketed drugs, are there any known inducers or inhibitors of CYP1B1*3 activity?
23. Is any interaction of the variant known with other microtubule interacting proteins like stathmin?
24. Do you have any evidence about additional markers that might help identify CYP1B1*3 patients that may still respond to docetaxel?
25. What percentage of CYP1B1*3 positive patients are responsive to docetaxel?
26. Is the simple presence of the mutation sufficient to drive a treatment or is there a level of penetrance that can occur?
27. Has there been any correlation done between RNA expression level of CYP1B1 and disease severity?
28. Are you aware of any antibodies against the CYP1B1*3 specific protein product? Are they specific for detection of *3 vs other 1B1 proteins?
29. Since the subject test will function as a companion diagnostic for the drug Taxotere (docetaxel) made by Sanofi Aventis, to what extent is Sanofi aware of and cooperating with this effort?
30. For our testing during Phase I, will this drug Taxotere (docetaxel) be made available to us by Sanofi or otherwise?
31. Since the applicability of the subject test is to also be examined for the drug Jevtana (cabazitaxel), which is also made by Sanofi Aventis, is Sanofi aware of and cooperating with this part of the effort, too?
32. Will this drug Jevtana (cabazitaxel) also be made available to us by Sanofi or otherwise?
33. How many retrospective samples from patients with CRPC undergoing therapy with docetaxel can the NCI intramural laboratory help us get?
34. Within the nine-month time constraints of Phase I, will it be practical to get retrospective samples from patients with CRPC undergoing therapy with cabazitaxel and from where (if not from the NCI intramural laboratory)? If the answer is yes, do we need to establish an IRB or could the samples be obtained under an established IRB that we would be added to?

Licensing

35. What is a commercialization license?
36. What is the difference between an exclusive and a non-exclusive commercialization license?
37. Why are NIH-TT SBIR contractors automatically granted a "royalty-free, non-exclusive" internal use license concurrent with the NIH-TT contract?
38. Do I have to pay for the royalty-free, non-exclusive internal use license mentioned in NCI SBIR Contract Topics 317 and 318?
39. How is a commercialization license different from a royalty-free, non-exclusive internal use license?
40. Why do NCI SBIR Contract Topics 317 and 318 state that NIH-TT SBIR offerors are strongly encouraged to apply for a commercialization license at the same time they submit an NIH-TT contract proposal?
41. NCI SBIR Contract Topics 317 and 318 mention applying for an NIH commercialization license. How do I apply for a commercialization license from NIH?
42. What is the process for obtaining an exclusive commercialization license?
43. What are the criteria considered when OTT evaluates exclusive commercialization license applications?
44. Do I have to submit a detailed development plan with my exclusive commercialization license application?
45. Is public notice of my exclusive commercialization license application required?
46. What terms are included in a commercialization license agreement with NIH, and is there an example commercialization license?

Collaboration

47. NCI SBIR Contract Topics 317 and 318 state that: "[t]he inventor will provide assistance in a collaborative manner with reagents and discussions during the entire award period." Do I have to apply for any formal collaborative agreement in order to receive this benefit?
48. As an NIH-TT SBIR contractor, when might a formal collaborative agreement, such as a Cooperative Research and Development Agreement (CRADA) or simple Collaborative Agreement, be helpful to me?
49. As an NIH-TT SBIR contractor, can I collaborate with the NCI Intramural research staff?
50. Who do I contact if I want to discuss a formal collaborative agreement?
51. How do I collaborate with NCI Intramural research staff?
52. What is the NCI Technology Transfer Center, and how can it assist a small business concern interested in submitting a proposal for NCI SBIR Contract Topics 317 and 318?

General Questions

1. Who should I contact with questions on technical matters, contract administration, co-development research, or licensing issues for NCI SBIR Contract Topics 317 and 318?

   All questions on technical issues or contract administration issues related to both topics should be addressed to:
   Ms. Bette Shanahan
   Office of Acquisitions
   Epidemiology, Therapeutics, and Sciences Branch
   National Cancer Institute
   6120 Executive Blvd, Suite 6054
   Rockville, MD 20892
   Phone: (301) 435-3782
   E-mail: eshanahan@mail.nih.gov

   All questions related to commercialization licenses should be directed to the responsible Licensing and Patenting Manager (LPM) in the NIH Office of Technology Transfer (OTT). For NCI SBIR Contract Topic 317, the responsible LPM is:
   Betty Tong, Ph.D.
   Licensing and Patenting Manager
   Office of Technology Transfer
   National Institutes of Health
   6011 Executive Boulevard, Suite 325
   Rockville, MD 20852
   Phone: (301) 594-6565
   Fax: (301) 402-0220
   Email: tongb@mail.nih.gov

   For NCI SBIR Contract Topic 318, the responsible LPM is:
   Sabarni Chatterjee, Ph.D.
   Licensing and Patenting Manager
   Office of Technology Transfer
   National Institutes of Health
   6011 Executive Boulevard, Suite 325
   Rockville, MD 20852
   Phone: (301) 435-5587
   Fax: (301) 402-0220
   Email: chatterjeesa@mail.nih.gov

2. Can I directly contact the NCI inventors with technical questions about NCI SBIR Contract Topics 317 and 318?

   No. In the interests of ensuring that all potential offerors receive (before proposal submission) the same information in response to the same question, all questions should go to Ms. Bette Shanahan (eshanahan@mail.nih.gov), and she will work with technical personnel to develop an answer and return a response to the potential offeror.

3. How is an NIH-TT SBIR contract topic different from a regular SBIR contract topic?

   An NIH-TT SBIR contract topic is based on a specific technology from the NIH Intramural Research Program for which the NIH has filed for patent protection or has been issued a patent. In contrast, regular SBIR contract topics are based on innovative, high impact, and high priority technologies not necessarily developed in NIH laboratories, and for which the NIH is not pursuing patent protection.

4. Where do I find the actual materials (forms) used to prepare a contract proposal?

   The full solicitation is available online: http://grants.nih.gov/grants/funding/SBIRContract/PHS2013-1.pdf

   The forms are also available online: http://grants.nih.gov/grants/forms.htm#contracts

5. If an NIH-TT SBIR contractor invents something while under the NIH-TT contract and wants to file a patent, must any patent rights be assigned to NIH or the Federal government?

   No. Small business concerns normally retain the principal worldwide patent rights to any invention developed with Government support. See Part I, Section 8.5 of the PHS 2013 Solicitation for SBIR Contract Proposals for further details: http://grants.nih.gov/grants/funding/SBIRContract/PHS2013-1.pdf.

6. How is the joint generation of new intellectual property (IP) handled under SBIR-TT contracts?

   If new IP has already been generated under some sort of collaborative project, we look at inventorship, which is a legal determination. If there has been a joint invention between the contractor and NIH staff, we will discuss the possibility of doing an agreement to share patent costs or patent administration, and potentially issuing a license to the awardee. We are flexible, and we let the context of the project drive the nature of the agreement. If the existing invention was made solely by the contractor, then the IP belongs solely to the contractor. On the other hand, before collaborative work even starts, it is possible to arrange with the NCI technology transfer offices Cooperative Research and Development Agreements (CRADAs) or Collaboration Agreements in order to establish the rights of both parties up front. A CRADA is the best option when significant development of new IP is anticipated. If you would like to discuss a formal collaborative agreement, contact NCI Technology Transfer Center

7. When will an offeror be notified of the outcome of peer review and notified whether it has a chance of being funded?

   After the peer review step is complete (expected to occur between March and May), the Contract Office will provide those offerors/companies that do not have a chance of winning an award feedback on the outcome of peer review. Technical minutes are included in the feedback provided, and that document includes both strengths and weaknesses. For those companies selected to receive an award, those notifications are expected to go out in the summer of 2013.

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Topic 317: Wound Healing Preparations Incorporating Nitric Oxide-Releasing Materials

8. What triggers NO release from these materials?

   Preferably, just contact with moisture. For example, having a dry bandage on the shelf that is stable, but when it comes in contact with a moist wound, it would begin to generate the nitric oxide. There are many other ways to do it but that would perhaps be the easiest and most economical to pursue.

9. Will this invention bond to organic material?

   The polymer is made of organic materials.

10. Can polymer processing occur first and then NO reaction? Or processing and NO has to be simultaneous?

    Yes, the polymer processing can occur first, before the NO reaction. They do not have to occur simultaneously.

11. With regards to the kinetics of NO delivery - is this related to the type of p(AN) (i.e., MW, side chains, etc) used, or to the processing following conversion to a NO-carrying p(AN)?

    There are many different formulations and variants of polyacrylonitrile, with different ways to treat the polymer with additives to create different properties. Adding agents that can stabilize the pH buffering, for example, would be quite appropriate. For solid polymers it is only the surface that is exposed to the moisture, so physical form is a major determinant of NO release rate.

12. Are we expected to use the formulations only as developed by NCI or is new R&D for formulation modification allowed?

    Formulation modification will be allowed; the inventors would like the contractor to express all their ingenuity to create a useful product.

13. How much material will be provided to the awardee? Are there costs associated with obtaining the material?

    The amount of material will be negotiated; reasonable amounts can be supplied. There are no costs associated with acquiring the material.

14. Is the polymer biodegradable or bioabsorbable? Is this a potential concern?

    It is not biodegradable or bioabsorbable to our knowledge. Some of it can degrade eventually, but it is not a concern for topical applications.

15. Can the NCI team provide varying forms of the material (e.g. films, fibers, etc)?

    The form of the material would be developed by the contractor. This can be discussed with the inventors.

16. Has the PAN-NO technology been licensed previously? If so, what market sector was the company involved in?

    There has not been any previous licensing activity on this invention.

17. What molecular weight of PAN has been used/tried?

    The inventors' work so far has been with material of MW 150,000, but other MWs including small oligomers might be better for some applications.

18. If the company processes PAN into a particular form factor, can it then be returned to NCI to be loaded with nitric oxide?

    Yes

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Topic 318: Test to Predict Effectiveness of Docetaxel Treatment for Prostate Cancer

19. Other than drug response, is the CYP1B1*3 variant correlated to any other pathobiology, eg. metastatic potential?

    It may be, but we have not ascertained pathobiology. Others have looked, but studies vary.

20. Are array based techniques the only platform under consideration? Could CYP1B1*3 be detected via non-array technology, such as immunology methods?

    All types of approaches to detecting CYP1B1*3 are welcomed. Array-based technology is not the only platform under consideration.

21. Can extending the proof-of-concept for CYP1B1*3 interference be done using only cellular assays (without involving any tumor-bearing mice)?

    Preclinical validation should take place in vitro and in vivo. However, the Figg group has much experience in mouse xenografts and would be willing to support the in vivo efforts.

22. Among marketed drugs, are there any known inducers or inhibitors of CYP1B1*3 activity?

    To our knowledge, none are known. However, it should be mentioned that CYP1B1 expression is driven by the estrogen receptor, cAMP, and the aryl hydrocarbon receptor. Thus, expression may be driven by a number of factors. Still, the factors that drive the tumor expression are currently unknown, and expression in the tumor is likely to be the most important factor with respect to docetaxel resistance in tumors.

23. Is any interaction of the variant known with other microtubule interacting proteins like stathmin?

    Not at this point with stathmin. Some have observed similar relationships with paclitaxel.

24. Do you have any evidence about additional markers that might help identify CYP1B1*3 patients that may still respond to docetaxel?

    Not at this point.

25. What percentage of CYP1B1*3 positive patients are responsive to docetaxel?

    This is a very difficult question to respond to. First, we did not ascertain response. Second, if overall survival is the gold-standard of efficacy, none of the patients carrying these alleles survived after 12 months of therapy – which is similar to the survival of CRPC patients without treatment. Thus, we interpret the results to suggest that none of the patients had efficacy, but cannot be sure. We did not study RECIST criteria.

26. Is the simple presence of the mutation sufficient to drive a treatment or is there a level of penetrance that can occur?

    No genetic variant is fully penetrant, so it is not possible to say that only this SNP can drive clinical decisions. This is an important question to answer with follow-up studies.

27. Has there been any correlation done between RNA expression level of CYP1B1 and disease severity

    Not that we are aware of. Nonetheless, our control population (CRPC not treated with docetaxel) did not show any relationship with overall survival. Therefore, this does not seem to be a survival predictor in the general CRPC population that was not treated with docetaxel.

28. Are you aware of any antibodies against the CYP1B1*3 specific protein product? Are they specific for detection of *3 vs other 1B1 proteins?

    There are antibodies, but none distinguish the genetic variant CYP1B1*3 vs. CYP1B1*1

29. Since the subject test will function as a companion diagnostic for the drug Taxotere (docetaxel) made by Sanofi Aventis, to what extent is Sanofi aware of and cooperating with this effort?

    We had requested a collaboration with Sanofi so that we could use DNA samples from patients treated with docetaxel; however, Sanofi did not keep a biorepository so we could not test in their samples.

30. For our testing during Phase I, will this drug Taxotere (docetaxel) be made available to us by Sanofi or otherwise

    Docetaxel is commercially available from Sigma (~$32.50/mg).

31. Since the applicability of the subject test is to also be examined for the drug Jevtana (cabazitaxel), which is also made by Sanofi Aventis, is Sanofi aware of and cooperating with this part of the effort, too?

    Sanofi has no involvement.

32. Will this drug Jevtana (cabazitaxel) also be made available to us by Sanofi or otherwise?

    We will most likely be able to acquire samples from patients treated with this drug in the coming years. However, since this is a second-line therapy, it is unlikely that we can get samples from patients that were not pre-treated with docetaxel – which will be a confounder. We currently have cabazitaxel that we can use to study basic science endpoints.

33. How many retrospective samples from patients with CRPC undergoing therapy with docetaxel can the NCI intramural laboratory help us get?

    We are in talks with cooperative groups at this point to obtain more samples. These cooperative groups have many samples (we approximate at least 1,000) from men treated with docetaxel. However, these talks are moving slowly.

34. Within the nine-month time constraints of Phase I, will it be practical to get retrospective samples from patients with CRPC undergoing therapy with cabazitaxel and from where (if not from the NCI intramural laboratory)? If the answer is yes, do we need to establish an IRB or could the samples be obtained under an established IRB that we would be added to?

    We currently collaborate with investigators who are administering cabazitaxel. It may be possible to get samples from these trials; however, we do not have any formal clinical sample source at this point. Proof-of-concept that cabazitaxel is influenced by CYP1B1 metabolites will need to be in place before we are likely to get such samples. Following the proof-of-concept, it may also be possible to initiate a clinical trial within the NCI; however, we cannot be sure at this point as there are too many variables.

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Licensing

35. What is a commercialization license?

    A commercialization license is a legal agreement, subject to Federal, state, and local regulatory authorities, by which a patent owner promises not to take action to exclude the licensed party from making, using, or selling a potential invention. A license may be for patented or patent pending technology, for unpatented biological materials, and may be exclusive or non-exclusive.

36. What is the difference between an exclusive and a non-exclusive commercialization license?

    An exclusive commercialization license limits the use of the invention to a single group or entity, while a nonexclusive license allows for use by multiple groups or entities.

    A non-exclusive commercialization license provides your company the rights to use NIH IP to develop and sell a product based on that IP. We can also grant such a license to another company or companies for the same field of use. Therefore, we are not excluding any other companies from seeking such a license. An exclusive license, on the other hand, provides such rights to only one company, to the exclusion of all other companies.

37. Why are NIH-TT SBIR contractors automatically granted a "royalty-free, non-exclusive" internal use license concurrent with the NIH-TT contract?

    The NIH OTT automatically awards such licenses to allow the NIH-TT contractor to develop the patented or patent-pending technology without infringing upon the patent rights for that technology. However, the license is limited to developing the technology within the scope and term of the NIH-TT contract only.

38. Do I have to pay for the royalty-free, non-exclusive internal use license mentioned in NCI SBIR Contract Topics 317 and 318?

    No. There are no financial payments required for the royalty-free, non-exclusive internal use license.

39. How is a commercialization license different from a royalty-free, non-exclusive internal use license?

    A commercialization license allows a licensee to make, use or sell the licensed technology. In contrast, in the context of an NIH-TT contract, a royalty-free, non-exclusive internal use license allows the contractor to develop the licensed technology only within the scope of that NIH-TT award.

40. Why do NCI SBIR Contract Topics 317 and 318 state that NIH-TT SBIR offerors are strongly encouraged to apply for a commercialization license at the same time they submit an NIH-TT contract proposal?

    The goal of the NIH-TT program is to license NIH technologies to qualified small businesses with the intent that those businesses develop those inventions into commercial products that benefit the public. While an NIH-TT contractor may complete internal research and development using the NIH technology, before the technology may be commercialized a commercialization license is required if patent claims have issued and is encouraged if patent claims are pending. Thus, we expect to invite a follow-on Phase II SBIR contract proposal only if the NIH-TT contractor has already applied for and received a commercialization license via the standard NIH license application process. The time required to complete the application process for a commercialization license may vary. To give an NIH-TT contractor ample time to obtain a commercialization license before a Phase II SBIR contract proposal would be invited, we strongly encourage the NIH-TT offeror to apply for a commercialization license as soon as possible, preferably at the same time the offeror submits the NIH-TT contract proposal.

41. NCI SBIR Contract Topics 317 and 318 mention applying for an NIH commercialization license. How do I apply for a commercialization license from NIH?

    The NIH OTT negotiates licenses for NIH Intramural Research Program inventions. The first step in obtaining a commercialization license is to contact the responsible LPM in OTT. The LPM and his/her contact information are listed within the Project Goals section of the NIH-TT Contract Topic, and are also listed above in the answer to question 1

    An overview of the typical OTT licensing process is available at http://www.ott.nih.gov/licensing-process. NIH-TT contractors should begin at Step 5, contacting the LPM. NIH-TT contractors should contact the LPM for matters relating to commercialization licenses only – any questions regarding the NIH-TT contracting process or technical issues in NCI SBIR Contract Topics 317 and 318 should be directed to Ms. Bette Shanahan (email: eshanahan@nih.gov) in the NCI Office of Acquisitions, as described in question 1 of this FAQ.

42. What is the process for obtaining an exclusive commercialization license?

    Government regulations reflect a preference for nonexclusive licenses, however exclusive licenses are available when appropriate to promote successful commercial development of a licensed invention. It is anticipated that an exclusive commercialization license may be appropriate for commercial development of NIH-TT technologies. To obtain an exclusive license, a company must complete a license application and submit the application to the responsible LPM within OTT. Upon receipt of an exclusive license application, the LPM evaluates the license application using a number of criteria to determine if an exclusive license is warranted (see 37 CFR §404.7). If OTT determines an exclusive license is warranted after review of the license application, a Notice of Intent to Grant the license is published in the Federal Register for a period of 15 days.

43. What are the criteria considered when OTT evaluates exclusive commercialization license applications?

    The criteria OTT uses when evaluating an exclusive license application are based on the requirements set forth in 37 CFR §404.7. These criteria determine whether:

    1. Exclusive licensing serves the best interests of the public;
    2. Practical application of the invention is not likely to be achieved under a nonexclusive license;
    3. An exclusive or partially exclusive license is a reasonable and necessary incentive to promote the investment of risk capital to bring the invention to practical application;
    4. Exclusive license terms and conditions are not broader than necessary;
    5. Exclusive licensing will not lessen competition.

44. Do I have to submit a detailed development plan with my exclusive commercialization license application?

    Yes. Applicants seeking an exclusive license are required to submit a detailed justification addressing each of these criteria as well as a complete business development plan.

45. Is public notice of my exclusive commercialization license application required?

    Yes. Notice of a proposed exclusive license (other than those resulting from a CRADA) is required by law. Notice will be published in the Federal Register, to provide an opportunity for public comment and submit a competing license application. The competing license application generally must be received within 15 days from the publication date of the Federal Register Notice of Intent to Grant an exclusive license. Any such comments will be evaluated and a final decision will be made as to whether or not an exclusive license is warranted.

46. What terms are included in a commercialization license agreement with NIH, and is there an example commercialization license?

    OTT has developed several model license agreements that serve as the basis for license negotiation. These can be found at http://www.ott.nih.gov/forms-model-agreements#MLA. The business development plan submitted as part of the license application process serves as the basis for establishing performance benchmarks that are included in the license agreement.

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Collaboration

47. NCI SBIR Contract Topics 317 and 318 state that: "[t]he inventor will provide assistance in a collaborative manner with reagents and discussions during the entire award period." Do I have to apply for any formal collaborative agreement in order to receive this benefit?

    No. The royalty-free, non-exclusive internal use license will grant the right to the specific hardware and/or reagents described in each topic as well as the right to collaborative discussions with the inventor(s). The NIH-TT SBIR contract may be fulfilled without additional formal collaborative agreements.

48. As an NIH-TT SBIR contractor, when might a formal co-development agreement, such as a Cooperative Research and Development Agreement (CRADA) or simple Collaborative Agreement, be helpful?

    A formal collaborative agreement will be helpful if the NIH-TT contractor wishes to work more directly with the inventor of the technology, and utilize NCI inventions and/or resources not contained within the SBIR contract. A simple Collaboration Agreement allows the two parties confidentiality and opens the door to a research partnership where both parties are involved in the development of the NCI technology Collaboration agreements and Cooperative Research and Development Agreements (CRADAs) can be executed relatively quickly depending on what is negotiated. CRADA is used when NIH and Industry collaborate to further develop a technology for commercialization. There are 3 different versions of the CRADA; see http://ttc.nci.nih.gov/forms/ for details.

49. As an NIH-TT SBIR contractor, can I collaborate with the NCI Intramural research staff?

    Yes, but not until you have been awarded an NIH-TT SBIR contract.

50. Who do I contact if I want to discuss a formal collaborative agreement?

    All questions related to collaborative agreements should be directed to the responsible Technology Transfer Specialist (TTS) in the NCI Technology Transfer Center.

    For NCI SBIR Contract Topic 317, the responsible TTS is:

    Michael Currens, Ph.D.
    Technology Transfer Specialist
    Technology Transfer Center
    National Cancer Institute
    8560 Progress Drive
    Frederick, MD 21701
    Main Phone: (301) 846-5465
    Phone: (301) 846-1831
    Fax: (301) 846-6820
    Email: currens@mail.nih.gov

    For NCI SBIR Contract Topic 318, the responsible TTS is:

    Laura Henmueller
    Technology Transfer Specialist
    Technology Transfer Center
    National Cancer Institute
    Rockville, MD 20852
    Phone: (301) 402-6429
    Fax: (301) 402-2117
    Email: HenmuelL@mail.nih.gov

51. How do I collaborate with NCI Intramural research staff?

    Once the NIH-TT SBIR contract has been awarded, there are a variety of different mechanisms available to engage NCI research capabilities. The bottom line is that collaborations provide early access to NCI research materials and expertise that may be available to assist in the development of the technology. NIH-TT contractors interested in formal collaborative agreements are encouraged to contact the responsible Technology Transfer Specialist in the NCI Technology Transfer Center for more information once the award is made. See question 23 above for contact information

52. What is the NCI Technology Transfer Center, and how can it assist a small business concern interested in submitting a proposal for NCI SBIR Contract Topics 317 and 318?

    The NCI Technology Transfer Center (TTC) is the component of the NCI committed to supporting the National Cancer Institute's technology development activities. A large part of TTC's responsibilities includes the day-to-day negotiations of transactional co-development agreements between the NCI and outside parties, including universities, non-profits, and pharmaceutical and biotechnology companies. General information on NCI's co-development agreements can be found at http://ttc.nci.nih.gov or by contacting the TTC Specialists indicated above. Questions on technical issues or contract administration issues related to the SBIR topics should be addressed to Bette Shanahan (email: eshanahan@mail.nih.gov), as described in question 1.

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