Addendum #1 .us



Addendum #1

RFA67-32

Questions and Answers to the Pre-Application Conference for the

Request for Applications (RFA) for Nonformula Health Research

1. Question: The question is concerning the following paragraph B. Clinical research - patient-oriented research which involves direct interaction and study of the mechanisms of human disease, including therapeutic interventions, clinical trials, epidemiological and behavioral studies and the development of new technology.

Would genetic research to determine the etiology of spina bifida fall under the above statement?

Answer: This question refers to the definition of clinical research on the first page of the Preface of the RFA. The Department will not elaborate on or interpret the definition of clinical research as contained in Act 2001-77 and on the first page of the Preface of the RFA. As stated on page iv of the RFA, at least 50 percent of each grant’s funds must be spent on clinical research or health services research or both clinical research and health services research. It is unclear whether the proposed research would meet this requirement. It is also unclear whether the proposed research would be considered in scope by the peer reviewers who will review and rank the proposals and decide whether or not the proposals are consistent with the research priority as stated on pages iv-v in Part One of the RFA. However, you may submit the proposal for consideration.

2. Question: In reference to pages ii-v of the RFA, where can we find the minutes of the Health Research Advisory Committee meeting of November 4, 2014, at which the research priority was set?

Answer: The minutes of committee meetings are posted on the Department’s Web site after they have been approved by the Health Research Advisory Committee at a subsequent meeting. The Committee has not met since November 4, 2014 and has not approved the minutes. However, an unapproved, draft copy of the minutes is attached, beginning on page 12.

3. Question: The RFA states on page 3 that the applicants must be from two major research institutions. Please provide the criteria that will be used to define "major research institutions."

Answer: The Department will not define what is considered to be a major research institution. The peer reviewers, who will review and rank the proposals, will determine the extent to which proposals are consistent with the research priority on pages iv-v and with the guidance contained in the RFA on page 3.

4. Question: The RFA states on page ii that the collaborative research project will bring together established research scientists with proven records of scientific excellence. Please describe the criteria to be used to define "established research scientists with proven records of scientific excellence."

Answer: The Department will not define what are considered to be “established research scientists with proven records of scientific excellence.” The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA.

5. Question: The current Executive Level II amount is $183,300. The RFA67-32 reflects $181,500. Please confirm which rate is be used.

Answer: The salary rate cannot exceed $181,500.

6. Question: My company, which is testing a next-generation Transcatheter Aortic Valve Implantation (TAVI) device – the Optimum TAV, is very interested in pursuing the CURE Grant, but first seek your confirmation that our medical device company does, in fact, qualify under this year’s Research Priority for Nonformula Funded Research. At this time, we seek to use the CURE funds for first-in-human implantations of Optimum TAV in Aortic Stenosis patients in about 15 patients. We would greatly appreciate your written confirmation, including the specific language and section (s) that state that we qualify. We are particularly concerned because the term “Big Data” and other language in the application indicate we won’t qualify.

Answer: This RFA solicits research to develop methods, software, and other technologies designed to analyze vast data sets at the level of molecules, proteins, organelles, cells, tissues, organs, physiological systems, organisms, populations, health care systems, and ecosystems. The Department cannot answer whether a particular research proposal is consistent with the research priority as stated on pages iv-v of the RFA and will qualify. The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA. However, you may submit the proposal for consideration.

7. Question (4 parts):

(7a) See the final paragraph of the Non-formula Health Research Priority for 2014-2015 FY (p 22), the 5th sentence reads: “Collaboration with a minority-serving academic institution or a minority-serving community-based organization in Pennsylvania is strongly encouraged and should include the meaningful mentoring and training of students.” AND In the Research Proposal application forms, Section IX (Research Plan, Research Design and Methods – p 13) instructions state: “The Research Plan must contain a specific aim related to minority training. The specific aim related to minority training should be listed after the other research aims.”

Is the minority training aim required? (not all past awards include one)

Answer: Yes, a minority training specific aim is required. Section 4 on page 4 in Part One of the RFA explains the requirements for minority training.

(7b) If so, what level of trainee should be targeted (K-12, undergrad, grad, postdoc, junior faculty)?

Answer: See page 4 in Part One of the RFA, “All research applications must include the involvement of minority college students in research through the development of a minority research training program for racial and ethnic student populations that are underrepresented in biomedical, health services and clinical research, such as African Americans and Hispanics. The minority research training program must include, at a minimum undergraduate summer internships or academic semester internships or both. A graduate student training program for underrepresented minority students is encouraged, but not required.” Also, see page 5 of the RFA, “Funds may not be used for educational programs designed to interest school children in careers in biomedical, health services or clinical research.”

(7c) If so, what proportion of the budget is expected to be dedicated to minority training?

Answer: The Department has not established a specific required percentage for the amount of funds for minority training.

(7d) Does the example budget given on p 17 of the instructions serve as an appropriate guideline ($400K for minority training out of $3.2M total requested)?

Answer: No. The example on p. 17 of the Research Proposal, which is Appendix A, Attachment 2 in Part Two of the RFA, is not intended to serve as a guideline for the amount of funds that should be directed to minority training. It is intended to serve only as a guideline for the format of the table in which applicants must provide a breakdown of costs by specific aims and subaims and by categories of research.

8. Question: (Section XVII, Item A, p 21): Does research involving data from previously collected (under an IRB_approved protocol & informed consent) biospecimens, research questionnaires, and/or electronic health records “involve human subjects” (Item A question) and /or require approval by the Pennsylvania Department of Health Institutional Review Board (Section VIII, p 22)?

Answer: See Part One on page 16, item i of the RFA, “all research involving human subjects must be approved by the applicant’s IRB prior to the initiation of the research involving human subjects and prior to the use of grant funds to pay for research involving human subjects.” If the project proposes to use only previously collected data from human subjects for which IRB approval has been obtained from the applicant’s Institutional Review Board (IRB) and the IRB approval is up to date, that is, the expiration date occurs after the start date of the grant, the applicant does not have to resubmit the project to the applicant’s IRB for review and approval. However, the applicant must adhere to all federal guidelines concerning the conduct of research, including the requirement that IRB approvals are kept up to date in accordance with federal guidelines. Further information about the requirements regarding human subjects research are explained in item i on page 16 and items k and l on page 17 of the RFA and in Part Two of the RFA, Appendix D, Attachment 2 and Appendix D, Attachment 5.

Research involving previously collected biospecimens, research questionnaires and/or electronic medical records requires approval by the Pennsylvania Department of Health’s Institutional Review Board. In making its decision to approve the conduct of research involving human subjects, the Department will review the information contained in the Research Proposal, Appendix D, Attachment 2 and Appendix D, Attachment 5, and documentation of IRB approval from the applicant’s IRB.

9. Question: We are developing a new technology - a Transcatheter Aortic Valve (TAV) - to replace the aortic valve without open heart surgery in patients with aortic stenosis.  Preclinical tests on the technology have been completed, and the next step is to perform first-in-human feasibility studies (before clinical trials.) Can the (nonformula) CURE Funds be used for the implantation of our TAV in first-in-human studies in 15 patients?

Answer: This RFA solicits research to develop methods, software, and other technologies designed to analyze vast data sets at the level of molecules, proteins, organelles, cells, tissues, organs, physiological systems, organisms, populations, health care systems, and ecosystems. The Department cannot answer whether a particular research proposal is consistent with the research priority as stated on pages iv-v of the RFA and will qualify. The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA. However, you may submit the proposal for consideration.

10. Question: The applicant and collaborating organizations must be separate institutions. What is the definition of “separate”?

Answer: This question refers to pages 2 and 3 in Part One of the RFA. Organizations must be owned and operated by different entities. If two organizations are owned or operated by the same entity, they would not qualify as separate organizations.

11. Question: At least two of the collaborators must be major research institutions which are located in Pennsylvania. What are the major research institutions in Pennsylvania?

Answer: This question refers to page 3 in Part One of the RFA. The Department will not define what is considered to be a major research institution. The peer reviewers, who will review and rank the proposals, will determine the extent to which proposals are consistent with the research priority on pages iv-v and with the guidance contained in the RFA on page 3.

12. Question: Research areas that will not be considered include “Focus on data collection/generation”. Does that preclude ANY data collection/generation. Please define “focus” for the RFA.

Answer: This question refers to page v in Part One of the RFA. Data collection and generation is not precluded. However, if any data collection and generation efforts are proposed, they should be minimal. See page iv of the RFA, the research priority is the development of methods, software, and other technologies designed to analyze vast data sets. The focus of the research project should be on the development of methods, software and other technologies to analyze vast data sets. The Department will not further define “focus” or “minimal.”

13. Question (2 parts):

(13a): Research areas that will not be considered include, “Secondary statistical or epidemiological analysis of single large data sets (or multiple comparable data sets of the same type of data)”. Does that mean secondary statistical or epidemiological analysis of large datasets composed of different data types is allowed?

Answer: No. This RFA is not intended to support secondary statistical or epidemiological analysis of data sets.

(13b): What types of data are considered “comparable”.

Answer: The Department cannot answer this question based on the information provided.

14. Question: Research areas that will not be considered include, “Design and development of registries, tissue banks, and other health data systems”. The RFA instructions also state: Funds may not be used to establish registries, patient databases or tissue banks unless the research project includes at least one specific hypothesis-driven research study that uses the registry, patient database or tissue bank and is completed within the grant period. Please clarify.

Answer: This question refers to page v and page 5 in Part One of the RFA. All proposed research projects must be consistent with the research priority, see pages iv and v in Part One of the RFA. The priority states that the design and development of registries, tissue banks, and other health data systems will not be considered (p. v) and that all research projects submitted in response to this RFA must be consistent with the following research priority (p. iv). The Department cannot determine whether a particular research proposal is consistent with the research priority as stated on pages iv-v of the RFA and will qualify. The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA.

15. Question: Research in the following areas will not be considered: Focus on enhancing computing infrastructure. The RFA instructions also state: Funds may support personnel and services directly related to the research project and may be used to purchase computer hardware and software. Please clarify.

Answer: This question refers to page v and page 5 in Part One of the RFA. See page iv of the RFA, the research priority is the development of methods, software, and other technologies designed to analyze vast data sets. Computer hardware and software can be purchased in order to carry out this work. However, the focus of the research project should be on the development of new software and technologies to analyze vast data sets, rather than on the purchase of existing software and hardware to enable an organization to analyze vast data sets.

16. Question: My question pertains to the research priority areas. Our research team is considering several areas of clinical and health services research focus that will be of interest to the Department of Health. At least one area of focus will be a prevalent health condition(s) that will has wide health impact across the Commonwealth. We are additionally considering an area of focus on a rare disease, idiopathic pulmonary fibrosis (IPF). Our research team has been expanding the work of the Pennsylvania-wide IPF patient registry (PA-IPF) that was initially funded by the PA DOH (). We believe that we could greatly advance the work initiated out of the PA-IPF though the CURE funding, but would only do so if there was interest from the DOH.

Answer: This question refers to the research priority on pages iv and v in Part One of the RFA. Your organization must determine which area is most consistent with the research priority. Peer reviewers will review and rank the proposals and decide whether or not the proposals are consistent with the research priority. We will not comment as to whether there is interest from the Department.

17. Question: I was wondering if we could submit 2 Letters of Intent for the Nonformula funds. This question is regarding the Letter of Intent which is in the cover letter of the RFA. We will probably need a downselect to choose which application we will be submitting. We realize we will only be submitting 1 application.

Answer: An applicant may submit only one Letter of Intent. See page 3 in Part One of the RFA, “An organization may submit only one application as a lead agency in response to this RFA.” As the Letters of Intent are used to begin the peer review planning process, it is critical to minimize efforts spent on multiple letters of intent submitted by one applicant.

18. Question: In regards to RFA 67-32, can you please provide the definition of a major research institution?

Answer: The Department will not define what is considered to be a major research institution. The peer reviewers, who will review and rank the proposals, will determine the extent to which proposals are consistent with the research priority on pages iv-v and with the guidance contained in the RFA on page 3.

19. Question (2 parts):

(19a): Regarding the requirement to train minority students. The RFA states that: “These requirements shall be achieved only by one or more of the following approaches: (1) collaborating with Pennsylvania’s Historically Black Colleges and Universities (HBCU), which are Cheyney University and Lincoln University, to develop a minority research program, or (2) developing a minority research program at the applicant’s institution, or (3) expanding an existing minority research program at the applicant’s institution.” For options 2 and 3, does this have to be at the lead applicant’s institution or can it be at a collaborating institution?

Answer: This question refers to page 4 in Part One of the RFA. For options (2) and (3) the minority research program must be at the lead applicant’s institution.

(19b): For example, is a collaboration between two major research institutions in which one is the lead applicant but the other has the minority training program acceptable?

Answer: No. The lead applicant must have a minority research program that meets the requirements described on page 4 in Part One of the RFA. The collaborating organization is not required to have a minority research program.

20. Question (2 parts):

(20a): Can the lead applicant and one of the collaborating organizations be an affiliated organization that roll under the same highest level parent company? Note, each organization has its own FEIN.

Answer: This question refers to the first page of the Preface of the RFA. Organizations must be owned and operated by different entities. If two organizations are owned or operated by the same entity, they would not qualify as separate organizations.

(20b): Are there any restriction when proposing lead or collaborating organizations that roll to the same highest level parent company for this application?

Answer: If the lead applicant and the collaborating organizations are owned and operated by the same entity, they would not qualify as separate organizations. If the application does not include a separate collaborating organization the application would not meet the requirement that the “applicant and collaborating organizations must be separate institutions,” which is stated on pages 2 and 3 of Part One of the RFA.

21. Question: Does a rapid point-of-care diagnostic assay for detection of tobacco use qualify as a topic for the RFA?

Answer: This RFA solicits research to develop methods, software, and other technologies designed to analyze vast data sets at the level of molecules, proteins, organelles, cells, tissues, organs, physiological systems, organisms, populations, health care systems, and ecosystems. The Department cannot answer whether a particular research proposal is consistent with the research priority as stated on pages iv-v of the RFA and will qualify. The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA. However, you may submit the proposal for consideration.

22. Question (3 parts):

(22a): Do the minority students who participate in the training program have to be students at the applicant organization?

Answer: No. Students who participate in the minority research training program may be recruited from organizations outside of the applicant’s organization.

(22b): Or can they also be students from around the Commonwealth?

Answer: Yes.

(22c): Or from outside of the Commonwealth?

Answer: Yes. The students can be from outside of the Commonwealth.

23. Question (2 parts):

(23a): Who will be peer reviewers?

Answer: Peer reviewers must meet the requirements of the Tobacco Settlement Act, Act 2001-77, i.e., they must be nationally recognized physicians, scientists or researchers from the same or similar discipline as the research grant proposals under review. Peer reviewers will be selected from outside of Pennsylvania to minimize the potential for conflict of interest. Peer reviewers cannot be an employee, officer or board member of an applicant whose grant application is under review. Peer reviewers cannot have a financial interest in, or otherwise be affiliated with, an applicant whose grant application is under review.

(23b): How are they selected?

Answer: Peer reviewers must meet the requirements of the Tobacco Settlement Act as described in the answer to question 23a. The Department of Health contracts with Oak Ridge Associated Universities to select peer reviewers who reside and work outside of Pennsylvania.

24. Question (4parts):

(24a): How will peer review be performed?

Answer: After peer reviewers have been selected, they must complete a confidentiality and conflict of interest statement before receiving access to a grant application. In a face-to-face meeting, peer reviewers evaluate each application individually against the following criteria: scientific and technical merit on the basis of scientific need, scientific method, research design, adequacy of the facility and qualifications of the research personnel, see page 8 in Part One of the RFA. If, after reading an application, the peer reviewer finds that he/she has a conflict of interest the peer reviewer does not participate in the evaluation of the application.

(24b): How will the peer reviewers be selected?

Answer: Peer reviewers will be selected by Oak Ridge Associated Universities from within the U.S., but outside of Pennsylvania to minimize the potential for conflict of interest.

(24c): What will be the pool of potential reviewers?

Answer: The pool consists of nationally recognized physicians, scientists or researchers from the U.S., but outside of Pennsylvania.

(24d): What criteria will be used for the peer review process?

Answer: See page 8 in Part One of the RFA, “Each application will be evaluated individually against the following criteria: scientific and technical merit on the basis of scientific need, scientific method, research design, adequacy of the facility and qualifications of the research personnel.”

25. Question (2 parts):

(25a): Did you say applicant needs to be from 2 institutions?

Answer: Yes. The application must include a lead applicant organization and a collaborating organization. The requirements for applicants and collaborating organizations are stated in Section 2 – Who May Apply on pages 2-3 in Part One of the RFA.

(25b): Does a medical-device start-up company qualify for CURE grant to conduct feasibility studies in patients?

Answer: A medical device start-up company is an eligible applicant. See Section 2 – Who May Apply on pages 2-3 in Part One of the RFA.

26. Question: Would data integration, analysis, and modeling be considered clinical or health services research to comply with the RFA requirement. (see first paragraph of RFA.)

Answer: The Department cannot answer this question based on the information provided.

27. Question (2 parts):

(27a): Would CURE fund a clinical trial outside the U.S. under the current RFA?

Answer: No. Page 3 in Part One of the RFA states that “Lead applicants and collaborating organizations must conduct 98% of the research proposed in the grant application at Pennsylvania-based facilities.”

(27b): Can the PI be part of the Applicant Organization?

Answer: Grant applications may include multiple principal investigators and they may be employed by the lead applicant organization and collaborating organizations. However, the application must specify one person as the Contact Principal Investigator. See the RFA, Appendix A, Attachment 2 – Research Proposal, VIII. Key Research Personnel, page 9: The Contact Principal Investigator must be employed by the lead applicant organization. The Contact Principal Investigator is the principal point of contact for all grant-related reports and is responsible for ensuring compliance with all grant provisions. The Contact Principal Investigator must be listed as Grant Coordinator (Principal Investigator) on Appendix A, Attachment 1, Cover Page.

28. Question (4 parts):

(28a): What are the criteria for choosing peer reviewers?

Answer: Peer reviewers must meet the requirements of the Tobacco Settlement Act, Act 2001-77, i.e., they must be nationally recognized physicians, scientists or researchers from the same or similar discipline as the research grant proposals under review. Peer reviewers will be selected from outside of Pennsylvania to minimize the potential for conflict of interest. Peer reviewers cannot be an employee, officer or board member of an applicant whose grant application is under review. Peer reviewers cannot have a financial interest in, or otherwise be affiliated with, an applicant whose grant application is under review.

(28b): Have they been chosen?

Answer: No.

(28c): Please detail the review process.

Answer: After peer reviewers have been selected, they must complete a confidentiality and conflict of interest statement before receiving access to a grant application. In a face-to-face meeting, peer reviewers evaluate each application individually against the following criteria: scientific and technical merit on the basis of scientific need, scientific method, research design, adequacy of the facility and qualifications of the research personnel, as stated on page 8 in Part One of the RFA. If, after reading an application, the peer reviewer finds that he/she has a conflict of interest the peer reviewer does not participate in the evaluation of the application.

(28d): Will feedback be provided regardless of successful funding?

Answer: Yes. See page 9 in Part One of the RFA, applicants who do not receive funding may request a report containing the peer reviewer panel’s written comments on their application. All requests for peer review comments must be in writing and must be received by the Office of Health Research within 30 calendar days of the written official notification of the status of the application.

29. Question: In Preface under B – patient oriented research which involves direct interaction including therapeutic interventions, clinical trials, and development of new technology –we do qualify – but if it does not involve big data – do we still qualify?

Answer: All research projects must be consistent with the research priority as stated on page iv of the Preface to the RFA. The Department cannot answer whether a particular research proposal is consistent with the research priority as stated on pages iv-v of the RFA and will qualify. The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA. However, you may submit the proposal for consideration.

30. Question: Other than the reviewers, please identify who will have access to the grant proposals.

Answer: Only authorized Department of Health personnel will have access to the grant proposals and auditors from the office of the Auditor General, which conducts an annual audit of the Health Research Program.

31. Question: Given that secondary statistical or epidemiological analysis of large datasets, either single large datasets or large datasets composed of different data types is NOT allowed how does development of methods, software, and other technologies fit with the requirement that 50% of the funds be used for clinical research or health services research?

Answer: See the first page of the Preface of the RFA, the definition of clinical research includes the development of new technology. The development of methods, software, and other technologies would be considered clinical research. The requirement that at least 50 percent of the funds be spent on clinical research or health services research or both clinical research and health services research is stated on page iv of the Preface of the RFA.

Correction to the RFA: The last sentence in Section XIII (Allocation of Costs for Biomedical, Clinical and Health Services Research) of Appendix A, Attachment 2 in Part Two of the RFA is hereby amended to read: “Such studies are considered biomedical research. Biomedical research is allowable.”

DRAFT Minutes of the Health Research Advisory Committee held November 4, 2014

Health and Welfare Building, Room 129, Commonwealth Avenue and Forster Street, Harrisburg, Pennsylvania

Committee Members Present:

Attendance in person

Michael Wolf, Secretary of Health and Chair of the Committee, Commonwealth of Pennsylvania

Participation via teleconference

Dwight Davis, MD, Professor, Pennsylvania State University College of Medicine and Director of Cardiac Rehabilitation, Hershey Medical Center

Karen Wolk Feinstein, PhD, President and Chief Executive Officer of the Jewish Healthcare

Foundation

Lewis Kuller, MD, DrPH, Professor of Epidemiology and University Professor of Public Health, Graduate School of Public Health, University of Pittsburgh

Arthur Levine, MD, Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine, University of Pittsburgh

Lisa Staiano-Coico, PhD, President, The City College of New York

Kim Smith-Whitley, MD, Assistant Professor, Department of Hematology, The Children’s Hospital of Philadelphia

Department of Health (DOH) Staff Present:

Attendance in person

Cathy Becker, MPH, Program Administrator, Health Research Program

Jamie Buchenauer, Director, Office of Policy

Keith Fickel, Esq., Senior Counsel, Office of Legal Counsel

Sylvia Golas, DMD, MPH, Program Administrator, Health Research Program

Dawn Houff, MBA, Program Analyst, Health Research Program

Elisabeth Scheneman, Chief of Staff, Office of the Secretary

Bob Shaffer, Program Analyst, Health Research Program

Alison Taylor, Esq., Chief Legal Counsel, Office of Legal Counsel

Others in Attendance

Attendance in person

John Anthony, Tobacco CURE Manager, Pennsylvania State University

Mary Webber, Consultant, Webber Associates

Call to Order

Secretary Michael Wolf called the meeting to order at 10:30 a.m. on Tuesday, November 4, 2014, in Room 129 of the Health and Welfare Building in Harrisburg, Pennsylvania. Mr. Wolf welcomed Committee members, Department of Health staff, and members of the public to the meeting. He invited all those present in person and via teleconference to introduce themselves for the record. Mr. Wolf then announced that the primary purpose of the meeting was to recommend priorities for the 2014-15 state fiscal year.

Minutes of the May 28, 2013 Meeting

Mr. Wolf called for a motion to accept the minutes of the meeting held on May 28, 2013. Dr. Kuller moved to accept the minutes of the meeting. Dr. Davis seconded the motion, and the motion passed without objection.

Review of Health Research Funding for 2013-14 and 2014-15

Secretary Wolf indicated that during 2013-14, the legislature appropriated funds for 2013-14, but the availability of Tobacco Settlement funds was in jeopardy of substantial reduction because of a lawsuit brought against the state by the tobacco companies that provide the funds. So funds for health research were never released during 2013-14. The funds for 2013-14 were reauthorized to be spent this year, however, the amount of funding was reduced from 19% in the original act to 6.8%. These funds are in budgetary reserve now because the state has not received the additional Tobacco Settlement funds from the tobacco companies and may not receive the funds until the spring when it will be too late to commit the funds to grants.

The legislature appropriated funds for health research for 2014-15, and they will be committed to research grants. The appropriation was reduced from 19% to 13.6% and unlike 2012 when the legislature took away nonformula funds, the 2014-15 funds must be appropriated according to the procedures outlined in the original act, with 30% going to nonformula funds that address priorities established by the Department.

Recommendation of 2014-2015 Formula Grant Research Priority

Mr. Wolf indicated that the research priorities for formula funds have remained unchanged since the inception of the program. Dr. Levine made a motion that the formula priorities be accepted as in the past. Dr. Davis seconded the motion, and the motion passed without objection.

Recommendation of 2014-2015 Nonformula Grant Research Priorities

Secretary Wolf stated that the amount of nonformula funds available for 2014-2015 was approximately 10 million dollars and that the Department expects to fund 3-4 grants. The funds must be committed by June 30, 2015. The Department was only notified by the Governor’s budget office in mid-October that the funds would be released for this year. The entire process from preparation of the RFA to finalizing grant agreements normally takes 12 months. The Department plans to accomplish this process in 8 months, and therefore the priorities need to be established quickly.

Secretary Wolf then reviewed the specific requirements in Act 77. According to the Act, the Department has the responsibility to “establish, in conjunction with the Health Research Advisory Committee, the research priorities.” The “priorities shall include the identification of critical research areas, disparities in health status among various Commonwealth populations, expected research outcomes and benefits and disease prevention and treatment methodologies.” The focus of the priorities must be on research. The Act also stipulates that in developing these research priorities, “the national health promotion and disease prevention objectives established by the U.S. Department of Health and Human Services, as applied to this Commonwealth, shall be considered.” These objectives are the Healthy People 2020 objectives. The Department’s Health Statistics Web site cites the objectives and shows how Pennsylvania compares to the objectives.

Secretary Wolf indicated that the Committee should also consider the five principles developed by the Committee in 2003 to guide its decisions when recommending nonformula research priorities to the Department.

Secretary Wolf also asked the Committee to keep the research priority somewhat narrow and focused on a disease, injury risk factor, behavior or condition to ensure that peer reviewers have expertise to review all the research proposals that are submitted for a particular priority. If the priority is broad such as child health, proposals could be submitted on a wide range of health issues and the peer reviewers recruited to review the child health proposals focused on obesity for example would not have the expertise to review child health proposals focused on childhood cancer.

Secretary Wolf presented the issue of combining the two categories of nonformula funds. There are two funding categories in Act 77: (1) clinical research and health services research and (2) “Other research”, which includes clinical research, health services research and biomedical research. If two priorities are recommended, there is more flexibility in funding proposals if these two nonformula funding categories are combined as in the past. If the categories are not combined, half of the funding must be allocated to the first category and half to the second category. Proposals submitted to the first category which only allows for clinical and health services research could not include any biomedical research. Also, if the Department did not receive enough proposals deemed worthy of funding in a category, the funds could not be used. If the two categories are combined, all of the nonformula funds can be used and all proposals can incorporate biomedical research components. In this case, at least 50 percent of the funds must be spent on clinical and health services research.

Secretary Wolf called for a motion that the two nonformula categories be combined by including these statements in the priorities: “For the purpose of priority setting, the Health Research Advisory Committee recommends combining the two nonformula funding categories of clinical and health services research and other research. At least 50 percent of the funds must be spent on clinical research and/or health services research.” Dr. Staiano-Coico made the motion as requested; Dr. Levine seconded the motion and it was passed without objection.

To start the discussion of possible priorities for nonformula funds, Secretary Wolf asked each Committee member to recommend one research priority.

Dr. Davis expressed a concern for the elderly population and the cardiovascular issues that affect this group. Dr. Feinstein stated that cancer vaccines are of enormous importance. The focus could also encompass other types of vaccines. Dr. Feinstein suggested substance abuse as a second priority. Dr. Kuller recommended two possible priorities. The first research priority is new technologies of evaluating environmental toxins that contribute to chronic disease. This is of importance in Pennsylvania because of gas drilling and the variety of toxic exposures in urban environments effect on low income populations. We need to use the new technologies that are available—proteomics, metabolomics, epigenetic markers, DNA, microRNA and link these to diseases and measurements in the environment. The second priority would be research on the prevention and detection of coronary heart disease in persons under age 50 because of the increasing prevalence of obesity, diabetes and other risk factors in younger adults. Dr. Levine recommended big data as the priority. Under the broad group of big data, many things could be considered, i.e., environmental exposures, claims data, proteomics, hospital readmission rates, and electronic health records. Within the next year, a person’s genome can be sequenced for $1200. We could add machine learning and link with IBM, Amazon, Google, and minority organizations. Secretary Wolf indicated that Dr. Parmacek could not participate in the meeting, but he emailed his recommendations, which Mr. Wolf summarized. Dr. Parmacek first mentioned the need for vaccine development for emerging infectious disease, such as Dengue fever. Dr. Parmacek acknowledged that this would be a global priority, but the lack of research in this area has contributed to the current Ebola epidemic. As another priority for consideration, Dr. Parmacek suggested a focus on neurodegenerative diseases. Given the aging of Pennsylvania’s population, this is a critically important area. Dr. Smith-Whitley recommended investigating the pharmacokinetics and pharmacogenetics associated with the non-opioid management of chronic pain syndrome. Chronic pain occurs with many chronic conditions that affect Pennsylvanians including rheumatologic and hematologic conditions. We have a unique opportunity to address non opioid management and its impact on biomarkers of chronic pain and inflammation on persons with chronic illness. Dr. Staiano-Coico expressed her preference for priorities related to neurodegenerative disease and the aging and big data because it covers so many topics.

Secretary Wolf then presented two additional priorities for consideration. The first priority is using data to address public health needs. The priority would focus on investigating information and data system technologies to help address public health treatment and wellness priorities. The second priority is research on the approaches including early treatment that could be used to reduce the causes and consequences of mild to severe traumatic brain injuries.

Secretary Wolf then asked the Committee whether they could reach consensus regarding the top two to three priorities. Dr. Levine suggested that the three priorities be (1) big data, (2) neurodegenerative diseases and traumatic brain injury, and (3) chronic pain management because these areas have not been addressed previously. Dr. Kuller expressed his concern with big data as a priority. Non-hypothesis-driven research with big data has not been very rewarding. A good example is that there have been huge expenses associated with GWAS studies with very small yields. Dr. Kuller would support a priority to evaluate and develop high quality data. Dr. Smith-Whitley expressed her support of the concept of big data because it would position the state to be leaders as national initiatives develop.

Secretary Wolf asked for committee members to volunteer to draft white papers. He asked that the white papers be limited to one page, include examples of the type of research that would be acceptable and examples of the type of research that would not be acceptable.

Dr. Levine volunteered to draft the big data white paper. Secretary Wolf asked Dr. Smith-Whitley volunteered to work with Dr. Parmacek to draft the white paper on chronic pain management and neurodegenerative disease.

New Business

Dr. Levine asked how much money has been allocated to formula funds for the current year. Secretary Wolf indicated that the amount was approximately $30 million.

Adjournment

The meeting was adjourned at 11:15 a.m.

Pre-Application Conference Attendees

John Anthony

Tobacco Fund Manage

Pennsylvania State University

110 Technology Center

University Park, PA 16802

(814) 935-1081

JTA11@psu.edu

Mike Becich

Pathologist

UPMC

861 Oak Rd.

Bradford, PA

(412) 606-6453

becich@pitt.edu

Tom Caltagirone, PhD

President & CEO

Aptagen, LLC

250 North Main Street

Jacobus, PA 17407

(717) 278-2436

tom@

Cynthia Chuang

Associate Professor of Medicine

Penn State College of Medicine

500 University Drive, H034

Hershey, PA 17033

(717) 531-8161

cchuang@hmc.psu.edu

Greg Cooper

Professor

University of Pittsburgh

Baum Building

Baum Blvd.

Pittsburgh PA

(412) 860-7972

gfc@pitt.edu

Paul DePietro

Research Associate

Dept. Basic Sciences

The Commonwealth Medical College

525 Pine St.

Scranton, PA 18509

(570) 955-1324

dpepietro@tcmc.edu

Stuart Fisk, CRNP

Director, Center for Inclusion Health

Allegheny Health Network

1307 Federal St, B110

Pittsburgh, PA 15212

(412) 359-4973

sfisk@

Glenn S. Gerhard, MD

Professor and Chair

Medical Genetics & Molecular Biology

Medical Education and Research Center

3500 North Broad Street

Philadelphia, PA 19140

(215) 707-2501

gsgerhard@temple.edu

Wenke Hwang

Associate Professor

Penn State University Hershey College of

Medicine

90 Hope Drive, Suite 2200

Hershey, Pa 17033

(717) 531-7070

whwang@psu.edu

Rebecca Jacobson, MD

Professor, Biomedical Informatics

University of Pittsburgh Medical System (UPMC)

(412 624-3310

crowleyrs@upmc.edu

Michelle Kierholz

Science Communications / Grant Writer

University of Pittsburgh

3550 Terrace St.

Pittsburgh, PA 15261

(412) 648-3093

Mlk39@pitt.edu

Carl Kingsford

Associate Professor

Carnegie Mellon University

5000 Forbes Ave.

Pittsburgh, PA 15213

(412) 268-1769

carlk@cs.cmu.edu

Jo Ann R. Lawer

Director

Government Affairs & Grants

Lancaster General Health

609 North Cherry Street

P O Box 3555

Lancaster, PA 17604-3555

(717) 544-4292

jrlawer@

William A. McLaughlin, PhD

Assistant Professor of Computational

Biology, Basic Sciences

The Commonwealth Medical College

525 Pine Street

Scranton, PA 18509

(570) 504-9633

wmclaughlin@tcmc.edu

Anton Nekrutenko

Professor

Penn State

505 Wartik Lab

University Park, PA 16802

(814) 865-4752

anton@bx.psu.edu

Crystal Quintin

Sr. Director, Competitive Grants

Geisinger Health System Foundation

100 N. Academy Ave.

Danville, PA 17822

(717) 909-3375

caquintin@geisinger.edu

Danielle Renee Reed

Member, Director of Genomics

Monell Chemical Senses Center

3500 Market St.

Philadelphia, PA 19104

(267) 519-4915

reed@

Dr. Mano Thubrikar

President

Thubrikar Aortic Valve, Inc.

537 Foundry Rd., #2C

Norristown, PA 19403

(714) 833-0383

Mano.thubrikar@

Samir Wadke

Director, Business Development

Thubrikar Aortic Valve, Inc.

537 Foundry Rd., #2C

Norristown, PA 19403

(610) 630-8284

Samir.wadke@TAVI.us

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