3 Telephone interview survey

Telephone Script and Survey Instrument for Survey given over telephone

NIH/NIAID/ DMID Partnerships Program Survey

OMB Control #: 0925-0668 - Expiration Date 01/31/2016
	Burden Disclosure: Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays q currently valid OMB control number. Send comments regarding this burden estimate or any aspect of this collection of information, including suggestions for reducing this burden, to; NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA# 0925-0668. Do not return the completed form to this address.
Your participation in the survey is voluntary and you are free to skip any particular question you do not wish to answer for any reason. If you are 18 years of age or older and freely consent to participate in the survey, please begin…

TELEPHONE INTERVIEW

Thank you for agreeing to participate in this telephone survey. We appreciate your honest feedback. I will now read each question and response options to you. Please let me know if you would like me to repeat anything. As a reminder, your participation in the survey is voluntary and you are free to skip any particular question you do not wish to answer for any reason, or you may ask to end this survey at any time. The information you provide about your Partnerships award and your experiences with it will have no effect on current or future grant awards. All information obtained in the survey will be reported in aggregate. Your responses are very important to NIAID. They will help NIAID enhance administration of the Partnerships program and the support the program provides to the scientific community. Information you provide will be kept secure to the extent permitted by law. Do you freely consent to participate in this survey?

͟ Yes

͟ No [Interviewer, record response.]

Your responses should reference your Biodefense Translational Research grant number (AI-######). Do you have any questions before we begin? Let’s start.

WE WILL BEGIN WITH SOME GENERAL QUESTIONS

1. Which of the following best describes the general product (countermeasure) focus of your project funded by the award referenced in your invitation email?  [Interviewer: Reference Grant # and Title as a reminder to the PI.] (PLEASE SELECT ONLY ONE.)

• Vaccine/Vaccine Technology/Adjuvant

• Therapeutic

• Diagnostic/Diagnostic Platform Technology

• Immunotherapeutic

• Research Resource/Service/Process

2. What was the primary pathogen targeted in the project?

3. If the Partnerships program was not available, would the project funded by the referenced award still have been pursued?

• Yes

• No

• Not Sure/Don’t Know

4. Overall, how important has Partnerships support been, or how important will it be, in research and development of this candidate product, process, or service? (PLEASE SELECT ONLY ONE.)

• Very important

• Important

• Somewhat important

• Not important

5. Was there financial support from other sources for the project?

• Yes

• No

• Not Sure/Don’t Know

5a. If yes, please identify the source(s) of parallel support.

6. Which one of the following best characterizes the product, process, or service that was planned under this project? (PLEASE SELECT ONLY ONE.)

• A totally new product, process, or service

• A new use for an existing product, process, or service

• An improvement to an existing product, process, or service

• A combination of products, processes, or services

• Other (please specify: )

7. Did Partnerships support provide technical validation (e.g., scientific concept vetted, proof of concept, manufacturability)?

• Yes

• No

• Not Sure/Don’t Know

8. Did Partnerships support provide data that led to acquisition of follow-on funding?

• Yes

• No

• Not Sure/Don’t Know

8a. If yes, please identify the source(s) of follow-on funding.

9. Did Partnerships support contribute to publications?

• Yes

• No

• Not Sure/Don’t Know

9a. If yes, please provide citation(s).

10. Did you develop an animal model, assay, reagent, or product used by other investigator(s)?

• Yes

• No

• Not Sure/Don’t Know

10a. If yes, please identify the animal model, assay, reagent, or product developed:

10b. If yes, please describe the purpose of the animal model, assay, reagent, or product:

11. Did the studies conducted with Partnerships support influence the decision to move forward?

• Yes

• No

• Not Sure/Don’t Know

11a. If No, please describe how the studies influenced your decision not to move forward:

12. Please describe the most significant outcome of the supported research.

THE NEXT QUESTIONS RELATE TO PROJECTS INVOLVING A CANDIDATE PRODUCT (if applicable)

13. Did the projects involve a candidate product (as evidenced by proof of principle)?
Examples of a candidate product include countermeasures against NIAID Category A, B, or C priority pathogens defined as a vaccine, therapeutic, immunotherapeutic, diagnostic, adjuvant, or related platform technology.

• Yes (If yes, answer questions 14-24.)

• No (If no, skip to question 25.)

14. Did Partnerships support advance a candidate product along the product development pathway?

• Yes

• No

• Not Sure/Don’t Know

15. What was the developmental status of the candidate product prior to the award period? (PLEASE SELECT ONLY ONE.)

• Basic Research

• Early Translational (e.g., assay development, screening, target identification)

• Translational (e.g., efficacy testing, model development, medicinal chemistry)

• Preclinical Activities (e.g., safety, tox, production)

• Pre-Investigational New Drug (Pre-IND)

• Investigational New Drug (IND)

16. What was/is the developmental status of the candidate product at the end of the award period? (PLEASE SELECT ONLY ONE.)

• Basic Research

• Early Translational (e.g., assay development, screening, target identification)

• Translational (e.g., efficacy testing, model development, medicinal chemistry)

• Preclinical Activities (e.g., safety, tox, production)

• Pre-Investigational New Drug (Pre-IND)

• Investigational New Drug (IND)

17. Was the candidate product acquired by or licensed to a partner/industry?

• Yes

• No

• Not Sure/Don’t Know

18. Was there a transfer of technology/candidate product to other investigator(s)?

• Yes

• No

• Not Sure/Don’t Know

19. Did Partnerships support contribute to pending intellectual property rights application?

• Yes

• No

• Not Sure/Don’t Know

20. Did Partnerships support contribute to acquisition of intellectual property rights?

• Yes

• No

• Not Sure/Don’t Know

21. Did Partnerships support contribute to FDA submission?

• Yes

• No

• Not Sure/Don’t Know

21a/b. If yes, please identify what type of submission was made___________________________________and provide the current status of the submission: (PLEASE SELECT ONLY ONE.)

• Under FDA review

• Product has FDA approval

• Product is on clinical-hold

• Other (please specify: )

22. Did Partnerships support lead to a label change for new indication?

• Yes

• No

• Not Sure/Don’t Know

23. What is the current status of the candidate product developed by the referenced Partnerships award? (PLEASE SELECT ONLY ONE.)

• Under development

• Commercialization stage

• In use by target population

• Discontinued (If discontinued, answer question 23a)

• Other (please specify: )

23a. If the current status of the candidate product is DISCONTINUED, did the reasons for discontinuing development of the candidate product include any of the following? (CHECK ALL THAT APPLY.)

• Idea failed due to insufficient efficacy

• Idea failed due to inadequate safety margin

• Market demand too small

• Level of risk too high

• Not enough funding

• Company shifted priorities

• Principal investigator left

• No FDA approval

• Licensed to another company

• Product, process, or service not competitive

• Other (please specify: )

24. Has the PI/company obtained any other NIH awards, in addition to the referenced award, for products, processes, or services that are related to this project? (The awards may have different principal investigators, and they may have come before or after the referenced award and from different NIH agencies.)

• Yes

• No

• Not Sure/Don’t Know

24a. If yes, please list the NIH institute(s) from which the PI/company has obtained any other NIH awards. Remember, the awards may have different principal investigators, and they may have come before or after the referenced award or from different NIH agencies.

THE NEXT FEW QUESTIONS ARE ABOUT INDUSTRIAL APPLICANT/INDUSTRIAL PARTNER (if applicable)

25. Did you have an industrial partner for your Partnerships during the award period?

• Yes (If yes, answer questions 26-27.)

• No (If no, skip to question 28.)

26. Which of the following best describes this company’s (or industrial partner’s) major field of business? (PLEASE SELECT ONLY ONE.)

• Biotechnology

• Pharmaceuticals

• Diagnostics

• Non-Profit

• Healthcare

27. What is the current status of the company (or industrial partner)? (PLEASE SELECT ONLY ONE.)

• Actively engaged in the same business

• Merged with another company

• Sold

• Closed

• Other (please specify: )

THIS QUESTION IS ABOUT NIAID PARTNERSHIPS PROGRAM

28. Thinking now just about the referenced award, please indicate how satisfied you were with your experiences going through the Partnerships application, review, and award process. (PLEASE SELECT ONE IN EACH ROW.)

	Very Dissatisfied	Mostly Dissatisfied	Mixed	Mostly Satisfied	Very Satisfied	Not Applicable
a. Obtaining information about the Partnerships program
b. Instructions for preparing applications
c. Review process
d. Award process
e. Post-award administration

28f. Please provide any additional information about the Partnerships application, review, and award process that you think may be helpful to us:

That marks the end of our survey. Thank you for your participation! We appreciate your feedback.

END OF INTERVIEW.