Opportunities and Resources
- Attention, Contractors: An RFP for Clinical Materials Services
- Investigate the Role of Infection and Immune Responses in Fertility and Pregnancy
- Propose Research To Improve the HIV PrEP Treatment Continuum
In The News
- Summary of September Council Meeting, Approved Concepts
- NIAID Issues Updated Investigator-Initiated Clinical Trial Policy
- News Briefs
- Interpret NIH Data on Categorical Spending and Global Burden of Disease
- Reader Questions
New Funding Opportunities
Those of you who read our October 5, 2016 article "Small Businesses: Apply Now for I-Corps™ Entrepreneurship Immersion Program" might be wondering: Why should I apply? Is participating worthwhile? How can it help move my product to the marketplace?
We could tell you again about the benefits, but it might be more helpful to hear from people who have been through the Program. Here, the co-founders of a small business share their experience with I-Corps™, describing what it did for them to show what it could do for you.
The Jan Biotech Story
Jennifer Nichols, CEO, and Dr. Janet Huie, chief scientific officer, founded Jan Biotech in 2013. As described on its website, the company's objective is to support "the cure of infectious diseases and cancers to improve human, animal and environmental health."
To learn more, go to the Jan Biotech website.
The I-Corps™ Experience
Earlier this year, Jennifer and Janet submitted a request for an administrative supplement through I-Corps™. Given that they would have to devote 20 hours a week for eight weeks to Program activities and learning exercises, why did the two co-founders decide to apply?
"We were working on the commercialization portion of our Phase II application and thought this would help strengthen that piece of it. We talked to our advisors about the time commitment per week, and they agreed going through time-intensive customer discovery is a crucial step in building a strong company—the earlier in the life of the product, the better. The information gathered during these interviews proved essential to developing a product that will build and sustain our company."
Jan Biotech was eventually selected to participate in I-Corps™, along with 23 other companies in the same cohort. As part of the eight-week experience, teams attended a three-day Entrepreneurial Immersion Course, took part in weekly web-based conference meetings with instructors, and conducted customer discovery activities, which included interviews, as Jennifer and Janet mention above and expand upon below.
The I-Corps™ Program requires participants to get “out of the lab” and gather information by having one-on-one conversations with over 100 potential customers, strategic partners, and other third-party stakeholders. Needless to say, this can be time-consuming but worth it, as Janet and Jennifer state.
Janet says, "We had a lot of R&D to get done on our Phase I, so it was a hard decision to take the time to get potential customer feedback. But I-Corps™ got us out talking to people we’d only discussed as important to speak with and to others we didn’t know we should be talking to. I-Corps™ structured this crucial piece of business development, led to new partnerships, and the information we gathered greatly informed our R&D."
And Jennifer admits, “Talking to 100 potential customers in eight weeks seemed excessive in such a short amount of time. However, the more interviews we performed, the better we became at it. We found ourselves asking far more strategic questions than we did in the first few interviews and as a result we received inside information from large companies we never thought we would have access to."
Among the goals of I-Corps™: teach researchers how to gain a clearer understanding of the value of their inventions in the marketplace, and ultimately how to advance their technologies from the research lab into the commercial world.
Jan and Jennifer say the Program met those goals and the two of them got a lot out of the Program. They narrowed their long list of benefits to the key three:
- An enhanced idea of their technology’s value to potential customers
- A better understanding of their customer segments
- A clearer go-to-market strategy. They now have a more clear and focused vision of how they will generate and grow their business.
Though the 2016 Program ended in August, Jennifer and Janet agree that I-Corps™ will have long-lasting benefits for Jan Biotech and that taking part was important for its future.
More About I-Corps™
For further information about I-Corp™, see the August 25, 2016 Guide announcement. The upcoming application due dates are November 1, 2016, and January 9, 2017.
You may also want to check out the September 28 webinar I-Corps™ From the Trenches. The National Cancer Institute (NCI) hosted it, and Jan Biotech's Jennifer Nichols was one of the presenters. For links to the video, transcript, and presentation slides, go to The I-Corps™ at NIH on NCI's SBIR Development Center website.
Opportunities and Resources
A recent request for proposals (RFP) may be of interest for contractors who can manage and operate a facility for clinical materials services that complies with Current Good Manufacturing Practices.
Responsibilities include receiving, storing, packaging, and disposing of the following:
- Clinical agents, e.g., investigational study products (drugs, vaccines, therapeutics, diagnostics, and devices), commercial products, placebos, and syringes
- Clinical specimens, such as sera or other protocol-mandated specimens obtained from DMID-approved clinical research sites
NIAID anticipates awarding one cost-reimbursement contract with the performance period beginning on or about May 1, 2017.
The response date is December 2, 2016, at 5:00 p.m. Eastern time. For other details, read the September 22, 2016 solicitation.
If you have questions, touch base with George Kennedy, the primary point of contact for this RFP.
NIH seeks applications in response to two companion funding opportunity announcements (FOAs), an R01 and an R21, to study trophoblast differentiation and function in relation to fertility and pregnancy, including the role of the immune system.
As one of the institutes participating in these opportunities, NIAID is particularly interested in studies on the role of the immune system and/or specific infectious agents in establishing and maintaining pregnancy, or in placental dysfunction or pregnancy loss.
Research on human trophoblasts is a priority; experimental animal studies are acceptable. Animal studies permit mechanistic analyses that provide insights into immune responses at the organ and tissue level that may be difficult or impossible to conduct in humans.
Consult the Guide notices linked below for a list of research topics to consider; you may propose others.
Budget and Application Information
Select the funding opportunity that best matches your proposed project’s requirements.
Respond to the R21 FOA if you will propose an innovative exploratory and developmental research project that can be completed within two years. Your application budget is capped at $275,000 in direct costs for the total project period and limited to no more than $200,000 in a single year.
If you envision a longer-term project, apply to the R01 FOA. Though your application budget is not capped, your request must reflect the actual needs of the proposed project. The maximum project period is five years.
Standard Due Dates for Competing Applications apply to both opportunities.
For Additional Information
Read the September 23, 2016 R01 and R21 Guide announcements for complete details. Direct questions to the relevant NIAID scientific/research contacts listed in the FOAs under Section VII. Agency Contacts.
Four NIH institutes are teaming up on a pair of funding opportunity announcements (FOAs) to sponsor research projects that explore ways to strengthen the HIV oral pre-exposure prophylaxis (PrEP) care continuum by bettering at-risk individuals’ adherence to PrEP medication programs.
The initiative will support innovative strategies to:
- Speed PrEP access and uptake among individuals at substantial risk for HIV
- Support PrEP adherence and persistence
- Address key populations or age and racial/ethnic disparities in PrEP access and compliance
NIAID will prioritize studies that propose:
- Research to delineate the PrEP cascade and identify gaps and targets for further intervention
- Research on innovative approaches for PrEP delivery
- Research to improve the PrEP care continuum and patient outcomes, e.g., medication adherence
Find a full list of responsive areas of research in the FOAs.
You’ll also see listed two nonresponsive areas of research, which if proposed will lead to your application not being reviewed:
- Research testing methods of PrEP drug administration other than oral medications
- Research testing the efficacy of non-daily oral PrEP drug regimens
You have two application options. You can apply through a FOA that uses the R01 activity code, which limits your project period to a five-year maximum and does not set a maximum budget. See the September 23, 2016 Guide announcement.
If you don’t yet have the preliminary data you need to propose an R01 research project, consider a related FOA that uses the R34 activity code, which caps proposed project periods to three years with a maximum budget of $450,000 in total direct costs, where no one year exceeds $225,000. Apply following the September 23, 2016 Guide announcement.
Submit optional letters of intent by December 6, 2017. The application deadline for both FOAs is January 6, 2017.
Direct questions to NIAID’s scientific/research contact for this initiative, Dr. David Burns.
In The News
You may have missed last month's advisory Council meeting, but that doesn't mean you missed your chance to learn what transpired.
Thanks to videocasts, you can watch remarks from NIAID Director Dr. Anthony Fauci and a presentation by the new director of the Division of Intramural Research (DIR) Dr. Steve Holland, as well as proceedings from subcommittee sessions. Find links below.
Other ways to catch up on the meeting: this article and the September NIAID Council Meeting Minutes, which will be posted soon.
As part of his opening remarks, Dr. Fauci presented plaques to acknowledge the service of four members whose terms end on October 31: Maria Laura Acebal, J.D.; Robert B. Belshe, M.D.; Norman W. Baylor, Ph.D.; and Diane E. Griffin, M.D., Ph.D. We will introduce their replacements in an upcoming issue.
Dr. Fauci then went on to cover many bases, including staff appointments and honors, meetings and events, and of course, the budget.
In addressing "one of our sometimes favorite, sometimes least favorite subject," Dr. Fauci touched on a topic he mentioned at the June meeting: the President’s Budget for Fiscal Year 2017.
It requests an increase of 2.6 percent or $825 million over the FY 2016 level. This increase would go entirely to the National Cancer Institute for the National Cancer Moonshot Initiative and to NIH's Office of the Director for the Precision Medicine and BRAIN Initiatives. NIAID received no increase in the President’s budget.
Dr. Fauci also spoke about the budget situation concerning Zika virus research. Given that he described it as being "a little complicated," we encourage you to watch the videocast or read the minutes for his comments.
Note: On September 29, the President signed into law the spending package that provides supplemental funding of $152 million to NIAID for combatting Zika in FY 2017.
Predicting that NIH would operate under a continuing resolution—which it now is—Dr. Fauci described NIAID's interim financial management plan, which sets the payline at the 10 percentile for established investigators and the 14 percentile for new investigators.
The Institute does not plan on programmatic cuts for noncompeting and competing grants. Success rates for research project grants are likely to be between 20 and 22 percent.
Other Noteworthy Items
Dr. Fauci's remarks also included:
- Key appointments—several people have new roles at NIH and NIAID:
- Dr. Diana Bianchi, director of the National Institute of Child Health and Human Development
- Dr. Joshua Gordon, director of the National Institute of Mental Health
- Dr. Jill Harper, director of NIAID's Office of Biodefense Research and Surety
- Dr. Bob Eisinger, special assistant for scientific projects in the Office of the Director (OD)
- Dr. Catharine Paules, clinical associate in OD
- Dr. Ruth Ebiasah, chief of the Pharmaceutical Affairs Research Branch, Office of Clinical Site Oversight, Division of AIDS
- Meetings and events, including a visit to NIH by Cuban Minister of Public Health Dr. Roberto Tomás Morales Ojeda
- Staff legislative activities, for example, briefing the Senate Democratic Steering and Outreach Committee on NIAID's efforts to address the Zika virus.
Watch the Meeting Online
To watch the entire Council presentation, go to NIAID Advisory Committee Meeting—September 2016.
For useful insight into NIAID's priorities and initiatives, tune into Council subcommittee meetings, where our staff discuss extramural research programs with advisory Council members.
Watch subcommittee open sessions:
- AIDS Research Advisory Committee
- Division of Allergy, Immunology, and Transplantation Subcommittee
- Division of Microbiology and Infectious Diseases Subcommittee
The subcommittee meetings also covered concepts for clearance.
As you may know, before NIAID announces a new initiative, such as a request for applications (RFA), a program announcement (PA), or a request for proposals (RFP), our advisory Council must first approve a corresponding concept.
To see a list of approved concepts, go to Concepts: Potential Opportunities. Find our most recent concepts on the following pages:
- September 2016 DAIDS Council-Approved Concepts
- September 2016 DAIT Council-Approved Concepts
- September 2016 DMID Council-Approved Concepts
It's important to check out concepts since you can use them as clues to NIAID's research interests and potential topics for future investigator-initiated applications.
Keep in mind that there's no guarantee that a concept will become a published initiative. For more on the planning process, read Concepts May Turn Into Initiatives.
Want to Know More About Council?
You can no longer submit an application that proposes a clinical trial through a funding opportunity announcement (FOA) that does not explicitly state it accepts clinical trials. To include a clinical trial as part of an investigator-initiated application, you must apply through one of NIAID’s Investigator-Initiated Clinical Trial (IICT) FOAs in accordance with our IICT procedures. For example, you cannot submit a clinical trial to NIAID using any parent investigator-initiated FOA (e.g., R01, R21).
We previously discussed NIAID’s IICT policies and procedures in the NIAID Funding News articles “Initiate the Investigator-Initiated Clinical Trial Process Soon” and “NIAID Reissues Investigator-Initiated Clinical Trial FOAs” from our February 20, 2016 and June 1, 2016 issues, respectively.
As explained in those articles, there are four NIAID IICT FOAs through which you can apply:
- Milestone-driven Clinical Trial Implementation Grant (R01)—for investigators who are ready to begin a clinical trial that is not high-risk.
- Clinical Trial Implementation Cooperative Agreement (U01)—for investigators who are ready to begin a high-risk clinical trial.
- SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)—for small business investigators who are ready to begin a clinical trial.
- Clinical Trial Planning Grant (R34)—for investigators planning, designing, and preparing the documentation necessary for implementing an IICT.
At least 10 weeks before you submit an IICT application, we strongly encourage you to complete NIAID’s prior consultation process—see Requesting Prior Consultation. Program staff can then help you optimize your application idea, ensure you meet any unique programmatic requirements, explain additional considerations for setting your milestones and budget, and instruct you to apply for the right activity code.
Our new policy lists which supporting documents you should have prepared when you contact NIAID for prior consultation. For example, investigators who plan to propose an IICT using the R01 activity code should already have prepared:
- The complete clinical protocol
- Informed consent and, if applicable, assent forms
- A statistical analysis plan
- A listing that includes identification and qualifications of clinical trial sites, pharmacies, and laboratories
- A Table of Contents for the Manual of Operations
- A comprehensive laboratory plan
- A data safety monitoring plan
- A site quality management plan
Staff can review these documents to verify, continuing the example, that the R01 activity code is the best mechanism, rather than the U01 or R34. If you don’t have all these documents ready, you might want to consider applying for the R34 Planning Grant first, although you should discuss that decision with your programmatic contact.
To read the policy itself, go to the September 28, 2016 Guide notice.
For more information about NIAID’s IICT policies and procedures, go to Investigator-Initiated Clinical Trial Resources.
NIH To Operate Under Continuing Resolution, NIAID Sets Interim R01 Payline
NIH is currently funded by a continuing resolution that keeps the government operating through December 9, 2016, at 99.504 percent of the FY 2016 enacted level. All legislative mandates that were in effect in FY 2016 remain in place, as stated in the October 7, 2016 Guide notice.
Meanwhile, NIAID has set interim R01 paylines at the 10 percentile for established investigators and 14 percentile for new investigators. Read NIAID’s Paylines and Budget Information Changes Throughout the Year to learn more.
New RFI Seeks Community Feedback on Interim Research Projects
NIH is considering whether including interim research products in applications and progress reports could increase the rigor and impact of NIH funded research. Let us know your thoughts by responding to Request for Information (RFI): Including Preprints and Interim Research Products in NIH Applications and Reports before the November 29, 2016 deadline.
You Can Now Request Big Grant Prior Approval Through eRA Commons
A new Prior Approval Module in eRA Commons allows applicants to electronically request approval to submit an unsolicited application with a budget of $500,000 or more in direct costs in any one year, following the instructions listed in the Prior Approval User Guide.
After initial communication with NIH, program officers can initiate a request form for an applicant, who then completes the form and submits it back to the initiating program officer for review.
To learn more about big grants, check out the reader question below: What are the basic requirements for a big grant?
NIAID Clarifies Research Objectives for HIV Monoclonal Antibodies FOA
Investigators interested in Optimization of Monoclonal Antibodies for Eliminating the HIV Reservoir (R01), be sure to take note of an amendment that revises the FOA’s purpose, research objectives, and Research Strategy instructions, as explained in the October 5, 2016 Guide notice.
NIH recently updated its Research, Condition, and Disease Categorization (RCDC) categorical spending site. Learn about the newly posted mortality and prevalence data, challenges in interpreting the data, and why the change took place.
In the table Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC), you'll see two new columns on U.S. disease burden—"2014 U.S. Mortality" and "2014 U.S. Prevalence (Standard Error)." Where possible, the columns match mortality and prevalence data from CDC to RCDC categories.
For a bigger picture, see Report on NIH Funding vs. Global Burden of Disease. It examines additional measures and includes data from countries around the world. Graphs compare RCDC funding with U.S. and global mortality and Disability Adjusted Life Years. Hover your mouse over or click the dots in the graphs to see the label for each condition represented.
Challenges in Interpretation
Attempts to interpret the newly posted data's relationship with RCDC funding amounts can be problematic. For example, advocates for research on nonfatal diseases may raise concerns on whether the new data columns are meant to represent the public health need for research in these areas.
NIH emphasizes that the numbers posted on the RCDC site are not definitive measures of disease burden, mortality, or prevalence. The best way to understand disease burdens is by examining patterns—both within the U.S. and internationally—using multiple methods chosen as appropriate for each disease, condition, or research area.
Some of these challenges are described further on the pages linked above and at Mortality and Prevalence Data on NIH's Categorical Spending Page.
Hopefully the numbers posted can act as a starting point for conversations about the NIH portfolio, as well as the best and most rigorous ways to capture disease burdens and incorporate them into the priority-setting process.
Why the Change?
The two new data columns are in response to Congress's FY 2016 omnibus budget language, which specifically directed NIH to add columnar data to the RCDC funding estimate page to show the number of Americans affected by each disease category.
NIH's Office of Strategic Planning and Office of Extramural Research worked together to assess the federal data landscape on disease burden, including consultations with experts at CDC, HHS, and here at NIH. The data sources they chose, as described at Mortality and Prevalence Data, covered a broad range of RCDC categories while still approximating the Congressional request.
You can ask us a question at email@example.com. After responding, we may ask your permission to include your question in the newsletter.
“What are the basic requirements for a big grant?”—anonymous reader
NIH policy for unsolicited applications with budgets of $500,000 or more in direct costs in any year (excluding subaward facilities and administrative costs) requires that you submit documentation with your application stating you have discussed it with a program officer, and the institute has agreed to accept it.
For applications submitted in response to a request for applications (RFA), the RFA will explicitly state in Section IV.6 if an application must include the letter of acceptance from the program officer.
You must seek approval from the program officer at least six weeks before applying, as identified in the funding opportunity announcement. Your program officer will send you an acceptance letter to include with your application. See the Big Grants SOP for more details.
In addition to standard review criteria, peer reviewers look for additional information in foreign applications, such as whether they can provide expertise or resources that can't be found in the United States as noted in the “Foreign Projects and Institutions” section of our International Applications page.
Then, for second-level review, NIAID must present foreign applications as special issues to our advisory Council. See Definitions of Special Issues Presented to Council.
New Funding Opportunities
- RFA-AI-16-079, Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Tuberculosis Disease
See other announcements at Opportunities & Announcements.