Attachment 1 - Statement of Work_ITEP.pdf

Statement of Work (SOW) National Institute of Allergy and Infectious Diseases (NIAID)

Innovator to Entrepreneur Program (ITEP):

SBIR/STTR, Entrepreneurship and Grantsmanship Training and Resources for First Time

Entrepreneurs

(1) Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), Office of Research Training and Special Programs (ORTSP) in association with the National Heart, Lung, and Blood Institute (NHLBI) Office of Translational Alliances and Coordination (OTAC), requires a program for Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR), entrepreneurship and grantsmanship training for first time female and minority entrepreneurs. This acquisition will provide the NIAID Division of Extramural Activities (DEA), Office of Research Training and Special Programs (ORTSP), Small Business Program with a Contractor, to establish, implement and execute the ITEP.

The ITEP will include a cohort based SBIR/STTR and business training program; support for first time entrepreneurs new to the SBIR/STTR program; guide applicants though the preparation competitive SBIR/STTR proposals; teach the basics of grantsmanship & business fundamentals; and one on one SBIR/STTR application and business consultations.

(2) Background

The NIAID supports the development of biomedical innovations from small businesses through the SBIR and STTR programs. The United States Congress requires eligible governmental agencies to set aside a percentage of their extramural budget so that domestic small businesses can engage in Research and Development (R&D) activities that have a strong potential for technology commercialization. Federal Agencies are required to allocate 3.2% (FY 2023) of their R&D budget to SBIR Program and 0.45% to the STTR Program. NIAID also sets aside funds to support small business R&D of products and services that improve public health in areas relevant to NIAID.

Preparing a successful SBIR/STTR application is a lengthy and complex process that is predicated not only on scientific merit but also comprehensive business plans and operations. This presents a profound barrier to entry for applicants developing technically sound, innovative products but that have little to no experience in grantsmanship or entrepreneurship. Additionally, the cost for SBIR/STTR application assistance and consulting is often prohibitively high for first time entrepreneurs with limited operating capital. There is a gap in support for the aspiring entrepreneur. Most NIH programs that support commercialization and entrepreneurship training require an SBIR/STTR grant award. NIAID aims to support innovation at all levels by establishing the ITEP, a no-cost, cohort-based training program where first-time entrepreneurs will learn the basics of SBIR/STTR, grantsmanship and entrepreneurship. NIAID places a specific emphasis on first time entrepreneurs who are women, minorities, or part of an underrepresented community.

(3) Objectives

The overall objective of ITEP is to establish a support program designed to assist participants in making the transition from innovator to entrepreneur. The desired outcome is to provide entrepreneurial and grantsmanship training to new and aspiring entrepreneurs with an emphasis on qualifying applicants from underrepresented groups, including both Women-Owned Small Businesses (WOSBs) and Socially and Economically Disadvantaged Businesses (SDBs). The ITEP will provide no-cost, cohort-based training to first-time entrepreneurs and applicants to the SBIR/STTR Program. These services will include SBIR/STTR grantsmanship workshops, entrepreneurial coaching, one on one consulting, and business plan development. The target audience for ITEP includes prospective SBIR/STTR applicants seeking funding support for innovations that align with NIAID’s mission/research priorities. The target audience will have no prior experience in SBIR/STR grantsmanship and little to no experience in entrepreneurship.

While the ITEP program will be open to all new and aspiring entrepreneurs within the NIAID mission space, NIAID places a special emphasis on qualifying female, minority, and disadvantaged entrepreneurs.

In collaboration with the Contracting Officer’s Representative (COR) and NIAID, the Contractor will engage marketing and outreach activities to engage relevant stakeholders. Upon successful completion of the program, participants will have developed a business plan and be equipped all the necessary knowledge, tools, and resources successfully to launch and run a company and apply for the NIAID SBIR/STTR program.

(4) Scope

The scope of the ITEP will include program development, application development, SBIR/STTR training, grantsmanship training, entrepreneurial training, one-on-one consulting, and marketing/outreach actives.

(5) Technical Requirements Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work.

The ITEP shall include the program elements described below in the form of individual service areas.

1) Service Area 1: Curriculum Development & Training Schedule

a. Within one week of contract award, contractor will schedule a one (1) hour kick off meeting with the COR and NIAID Staff.

b. Within two (2) months of contract award, the Contractor will develop and deliver to the COR and NIAID Program staff two (2) comprehensive training curriculums that provides participants with robust, comprehensive and hands on training in SBIR/STTR grantsmanship and entrepreneurship. One curriculum shall be designed for prospective entrepreneurs with no business experience (Basic Track) and the other shall be designed for new entrepreneurs seeking additional business training (Advanced Track). Topics will include:

1. SBIR/STTR program basics

2. SBIR/STTR policy, eligibility & requirements

3. How to write robust SBIR/STTR specific aims

4. How to develop an SBIR/STTR budget

5. NIH SBIR/STTR grant review process

6. How to manage an SBIR/STTR grant award

7. Overview of SBIR/STTR grants vs contracts

8. Successful SBIR/STTR application case studies

9. Overview of NIH Funding Opportunity Announcements (FOA).

10. How to identify and address weaknesses in an SBIR/STTR application

11. Subject matter expert panels

12. How to write a business plan

13. Pitch presentations

14. Business risk identification and mitigation

15. How to launch a company & startup operations

16. Building effective leadership, operations, and mentorship teams

17. Startup financing, investors, and loans.

18. Investment deal structures

19. Basics of market research/intelligence and discovery interviews

20. Networking & industry conferences

21. Startup incubators, accelerators, and state specific programs

22. Intellectual property and technology transfer

23. Overview of Food and Drug Administration regulatory pathways for biomedical products and medical devices.

24. Clinical trial basics, strategy, funding, and regulation

25. Overview of Centers for Medicare & Medicaid Services (CMS)

26. Overview of medical/pharmaceutical sales strategies

27. One on one SBIR/STTR & business plan development consulting sessions

c. Training sessions will be collaborative where participants interact with subject matter experts (SMEs), panelist, and other program participants. However, the Contractor will ensure that all open interactions/discussions are general in nature and not disclose participant intellectual property or business strategy.

d. Each cohort shall be four (4) months in duration. NIAID suggests that each cohort be structured with three (3) months of training and one (1) month of one-on-one business consulting. However, NIAID will consider and evaluate alternate structures proposed by the Contractor.

e. The Contractor will implement this training curriculum twice during the period of performance in five (5) month cohorts.

f. During the final month of each cohort, ITEP participants will use what they have learned in the training sessions to develop a mock pitch presentation and business plan that includes plans and provisions to apply for NIAID SBIR/STTR funding. See Service Area 7 for additional details.

2) Service Area 2: ITEP Tool Kit Development

a. Within two (2) months of contract award, the Contractor will develop, maintain, and provide an online/electronic toolkit of resources and training content complementary to the training curriculum established in Service Area 1. All content must be available by website or other online platform methods. The Contractor must ensure Section 508 compliance of all content. The Contractor is responsible for creating, hosting, and maintaining the website or online platform to store all the online resources and training content. All the online content should be password protected and the password can be shared electronically with ITEP participants. The topics covered must be reviewed and approved by the COR prior to creation to ensure the most relevant topics are included to maximize the assistance to applicants.

3) Service Area 3: ITEP Online Application, Promotional Webinars and Marketing

a. Within two (2) months of contract award, the contractor shall design, implement, and maintain an online application form. The vendor shall submit the application form for review and approval by the COR prior to implementation. The application form shall clearly state that ITEP is intended for innovators developing products that are within scope of the NIAID SBIR/STTR portfolio. These innovators should have no prior experience with SBIR/STTR grants and little to no to little previous experience in entrepreneurship. The Contractor shall work with the COR and NIAID staff to establish a comprehensive list of eligibility requirements. The online application page shall be hosted on Contractor owned website and will be monitored, managed, and maintained by the Contractor.

b. The online application form shall collect basic demographic information, a description of the product under development, current status of business incorporation, intent to submit an SBIR/STTR application, prior experience in SBIR/STTR, prior participation in other NIAID/NIH small business support programs (including but not limited to Application Assistance Program, I-Corps, etc.) and a description of what the applicant hopes to learn and how participation in ITEP will assist in achieving their entrepreneurial goals.

c. Within two (2) months of contract award, the contractor shall write a one (1) to two (2) page Program Description that will be used in conjunction with application. It shall provide details regarding program background, objectives, structure, format, and eligibility. The contractor shall submit the Program Description to the COR, who will review and approve it prior to implementation. The Program Description will be hosted on a Contractor owned website.

d. The online application shall open forty-five (45) days prior to start of each ITEP cohort.

e. Within two (2) months of contract award the Contractor shall work with the NIAID staff to develop a one (1) hour promotional webinar with a Power Point Presentation (PPT) prior to each ITEP cohort to provide introduction to the ITEP and the eligibility criteria for participation. The Contractor is responsible for introducing the scope of the one-on-one ITEP assistance and the online resources provided by ITEP. The Contractor is also required to answer applicants’ inquiries regarding ITEP, if applicable. The Contractor is responsible for setting up and managing technical logistics of all ITEP promotional webinars.

f. The Contractor shall assist NIAID program staff and NIAID marketing & outreach staff to launch a robust marketing campaign to raise awareness of the ITEP program.

4) Service Area 4: Application Review & Cohort Formation

a. ITEP application review and acceptance will occur on a rolling basis.

b. Upon receipt of an application, the Contractor will verify the application is complete and establish an application database. The Contractor will then transmit the application to the COR and NIAID Program staff. The COR and NIAID Program staff will review each application and accept, deny, or waitlist the application then notify the Contractor.

c. NIAID SBIR/STTR program will prepare program announcement in advance and streamline the ITEP application and reviewing process to ensure the applicants will be enrolled promptly after they submit their applications. The Contractor shall work with

NIAID SBIR/STTR program staff to provide ITEP informational webinars before each ITEP cohort to ensure applicants engagement and notifications.

d. The Contractor shall notify applicants of their acceptance, denial, or addition to the waitlist.

e. The Contractor shall coordinate and execute a one-way CDA (Confidential Disclosure Agreement) with each ITEP participant. All Contractor personnel involved in ITEP, including consultants, management, panelists, and subject matter experts shall be bound by the CDA.

f. Each cohort shall consist of up to twenty-two (22) participants. Twenty (20) slots will be available to participants that align with NIAID mission priorities. Two (2) slots will be made available for participants that align with NHLBI mission priorities.

g. Each cohort shall be further split into two (2) tracks based on business progress to date.

1. The Basic Track shall consist of participants with no experience with entrepreneurship and who have not yet started a company.

2. The Advanced Track shall consist of new entrepreneurs who have started a new company within the last two (2) calendar years. These entrepreneurs should be operating a for-profit organization (including sole proprietorships) and have limited/no history of prior fundraising.

h. NIAID does not mandate a specific number of participants per basic and advanced cohort tracks. Track sizes will be dictated by the specific needs of each cohort.

5) Service Area 5: Cohort Training Sessions

a. The Contractor will manage and deliver the training content according to the curriculum developed in Service Area 1.

b. Training sessions shall occur on a weekly basis throughout the training phase of the program.

c. All training session shall be virtual.

d. The Contractor shall develop a PPT to accompany each training session.

e. All the training materials including PPT are required to be approved by the COR prior to implementation.

6) Service Area 6: One on One Consultations for SBIR/STTR application preparation and Business Plan Development

a. Upon acceptance into the ITEP program, the Contractor will engage each participant and schedule an initial consultation. During the initial consultation, the Contractor will discuss the participants goals for the ITEP program and gauge the participant’s baseline understanding of the SBIR/STTR Program, grantsmanship and entrepreneurship.

b. Through the duration of the training sessions, the Contractor will schedule a monthly check-in meeting with each cohort participant. Each monthly check-in meeting shall be

(1) hour in duration. The Contractor will assess each participant’s progress in the program, answer participant questions, and address any challenges/unmet needs.

c. The Contractor shall provide up to fifty (50) consulting hours per participant to support each participant in business plan development phase of each cohort.

7) Service Area 7: Participant Final Presentations

a. At the conclusion of each cohort, the Contractor shall schedule and coordinate a virtual final presentation for each participant.

b. Due to the confidential/propriety nature of the final presentation, attendance to each final presentation will be limited to relevant Contractor staff, the COR and HHS and/or NIAID staff as determined by the COR.

c. Each Basic Track presentation shall be up to thirty (30) minutes in length include a five

(5) minute mock elevator pitch, a briefing of next steps, a discussion of key takeaways from the ITEP and question & answer session.

d. Each Advanced Track presentation shall be up to thirty (30) minutes in length include a fifteen (15) minute mock pitch, a discussion of key takeaways from the ITEP and question & answer session.

e. The Contractor shall provide a comprehensive panel of SMEs to evaluate, respond and give feedback for each participant final presentation. The panel shall consist of at least three (3) SMEs with expertise in pitch presentations, biotechnology entrepreneurship and startup operations/growth.

f. Within one (1) week of each Final Presentation the Contractor will develop a 1–2-page end of project summary for each participant indicating the type of assistance received, consultants’ feedback, additional comments, and other relevant information. The Contractor will submit the summary to the COR and NIAID staff. Upon approval by the COR, the Contractor will send the summary to the respective participant.

8) Service Area 8: Conduct Exit Surveys

a. The Contractor shall develop, manage, and implement an exit survey to assess program outcomes. The survey will also collect participant feedback and satisfaction. The Contractor will communicate to participants that completion of the exit survey is strongly recommended. To ensure maximum completion of the exit survey, the Contractor will follow up with each participant via email and/or phone until the survey is completed.

b. NIAID expects a participant minimum 80% satisfaction rate from the exit survey. Should exit survey results fall below 80% satisfaction, the Contractor is required to adjust the program for future cohorts to increase participant satisfaction.

9) Service Area 9: Progress Reports, Cohort Reports, Final Program Summary

a. The Contractor will prepare and submit to the COR a monthly status report. The monthly status report shall provide an overview of work completed and updates on the status of the ongoing program. The monthly report is due by 5:00 pm EST on the final business day of each month.

b. At the conclusion of each cohort, the Contractor will prepare and submit to the COR a report the provides an overview of the completed cohort. This report shall include, overall summary, deliverables, successes, challenges/roadblocks, lessons-learned and next steps. The report is due ten (10) business days after the conclusion of the respective cohort.

c. Ten (10) days prior to the conclusion of the base year and any exercised option years, the Contractor will prepare and submit to the COR an annual report. The report shall provide a summary of work completed in previous year, key findings, program analysis and suggested improvements. The Contractor will also prepare an accompanying Power Point presentation and present the findings of the report to the COR and NIAID staff in a one

(1) hour virtual session.

10) Service Area 10: Contract Quality Control and Management

a. The Contractor shall develop, implement, and maintain an effective and efficient project management and planning process for the Small Business Program marketing operations to ensure quality performance of all requirements of this contract. This process shall include the planning, identification, evaluation, execution, and assessment of methods to control costs incurred in the performance of this contract. Changes in key personnel, including the Project Manager/Director and support staff, must be approved by the NIAID Office of Small Business Programs COR and the Contracting Officer.

6) Schedule of Project Deliverables and Reporting

The Contractor shall propose a schedule of deliverables based on its proposed technical approach, and will incorporate the final deliverable schedule, as approved by the COR, into the Project Work Plan. The table below is included as reference and the Contractor will propose exact dates. The deliverables schedule for the option year will be discussed, revised, and approved by the COR before the start of the option year. All deliverables in this SOW will be in digital format only. NIAID does not accept any physical prints of the deliverables.

Service Area Due Deliverable SA1a Within 1 week of

Contract Award Kick off call

SA1b 2 Months After Contract Award

Curriculum & Training Schedule

SA2 2 Months After Contract Award

Electronic Tool Kit

SA3a-b 2 Months After Contract Award

Online Application

SA3c 2 Months After Contract Award

Program Description

SA3d 45 Days Prior to Cohort

Open Online Application

SA3e 2 Months After Contract Award

Develop 1-hour Promotional Webinar

SA4 Rolling Application Review and Cohort Formation SA5 TBD Manage and deliver training content and curriculum to participants SA6a Upon participant acceptance Conduct initial consultation

SA6b Monthly Participant check in meeting SA6c TBD Provide business plan consulting hours to each participant SA7 TBD Virtual final presentation for each participant SA7f Within 1 week of each final presentation

Participant final summary

SA8 TBD Conduct Participant Exit Survey SA9a Last business day of every month Monthly program status report.

SA9b Within 10 days after each cohort

Cohort program report.

SA9c 10 Days prior to the conclusion of the Base year and any exercised Option years

Annual Report and presentation.

7) Contractor Qualifications and Requirements

The Contractor shall provide personnel with the necessary skills and levels of expertise required to support the tasks to be performed under this SOW.

a. The Contractor must demonstrate the following experiences:

A minimum of 10 years of experience in assisting applicants to prepare Federal SBIR/STTR grant proposals with a minimum of 5 years of experience in assisting applicants to prepare NIH SBIR/STTR proposals.

A minimum of 10 years of experience in assisting aspiring and new entrepreneurs with business development, startup operations and product commercialization in biotechnology, pharmaceuticals, and related fields.

At least 5 years of experience with United States pharmaceutical and medical device regulation and regulatory pathways.

Strong familiarity with SBIR/STTR program policies and application process.

Experience in creating SBIR/STTR application and business development related online webinars, resources, toolkits, and templates.

Experience in creating, hosting, and maintaining websites and online application forms.

Experience in the bio-pharmaceutical startup industry with a focus on vaccines, therapeutics, and diagnostics.

b. Preferred experiences from the Contractor:

Has previous experience working with federal agencies, especially NIH.

Assisted applicants to apply and receive federal SBIR/STTR grants funding, especially from

NIH SBIR/STTR program.

Familiarity with NIH SBIR/STTR program policies, especially with NIAID specific program policies.

Demonstrated experience working with women-owned and socially-economically disadvantaged-owned small businesses.

c. The Contractor shall appoint project lead within the Contractor’s organization and other necessary backup personnel to ensure accessibility during normal business hours (Mon-Fri, 9am-5pm).

8) Acceptance Criteria for Deliverables and Content Ownership

All deliverables in this SOW will be in digital format only. NIAID does not accept any physical prints of the deliverables.

a. The COR shall inspect and accept the deliverables listed in the schedule table above.

b. All deliverables created in support of this SOW shall be considered the property of NIAID. This includes, but not limited to, tool kit materials, application, surveys, web content and program data.

At the conclusion of this contract the Contractor shall ensure that all content is fully transferred to the COR and NIAID staff.

9) Government Furnished Information (GFI).

GFI is to be provided in conjunction with required performance under this task order as determined by mutual agreement between the Contractor and the NIAID COR at the beginning of the project. GFI for this SOW includes:

a. Current publicly available NIAID SBIR/STTR applicant resources and training content created by NIAID staff. The Contractor shall update this available content and create additional new content independently.

b. Publicly available NIAID specific SBIR/STTR program policies.

c. Additional information requested by the Contractor that is deemed relevant by the NIAID COR.

d. In support of market research/intelligence training activities, NIAID can provide the Contractor access to business intelligence resources. Should the Contractor elect to utilize these resources, NIAID will coordinate training and account access to one (1) Contractor staff member. Program participants will not be granted access to the NIAID business intelligence resources. The selected Contractor staff member will serve as the market research/intelligence point of contact and will be responsible for accessing the database, running queries, and providing data/results at the request of program participants and the COR and NIAID staff. Alternatively, the Contractor can leverage other comparable market research/intelligence databases and resources. Should the

Contractor elect to use other resources, the Contractor will be responsible for all associated costs, training, and usage.

10) Section 508: Accessibility of electronic and information technology.

The Contractor must make sure the online resources and training content complies with Section 508 requirements. Accessibility checklists, guides, and standards for 508 compliances can be found at https://ocio.nih.gov/ITGovPolicy/NIH508/Pages/default.aspx.

11) Place of Performance and Travel

The tasks outlined above will be performed at the contractor’s site and no travel cost is anticipated.