1-NEI Solicitation Information Sheet .pdf

Information Sheet - Eye Product Assistance Center

- Subject Matter Experts National Eye Institute’s Eye Product Assistance Center

The solicitation for Subject Matter Experts for the Eye Product Assistance Center is open from September 2, 2026 through December 18, 2026. Interested proposers must submit a proposal here. Submissions will be reviewed on a rolling basis, and qualified proposers may be assigned to projects beginning in Fall 2026.

Description VentureWell is seeking subject matter experts with experience in the areas described below to support the National Eye Institute’s (NEI) Eye Product Assistance Center.

The Eye Product Assistance Center (EPAC) is a consulting service provided by the National Eye Institute (NEI). It is available to all investigators developing regulated products for diseases or disorders of the visual system. VentureWell is seeking to identify qualified subject matter experts that will support EPAC recipients with support in the following areas*:

● Needs assessment

● Device design, and prototyping

● Chemistry, Manufacturing, and Controls (CMC)

● Assay development and Biostatistics

● Pharmacokinetics/Pharmacodynamics (PK/PD) and ADME

● Toxicology and Quality Assurance/Quality Control (QA/QC)

● Regulatory affairs and operations

● Medical writing and first-in-human trial planning

*Submissions need not have experience in all of these areas, rather experience in one or more of these categories, and experience specifically related to the visual system is preferred.

Eligibility Requirements

● Must have a UEI (for entities contracted with an EIN)

● Bachelor’s degree and 10+ years of relevant professional experience OR Master’s degree and

7+ years relevant professional experience

○ Companies/vendors should be prepared to provide qualifications for team members demonstrating they meet the experience requirements above

● Relevant professional certifications applicable to the selected area(s) of expertise (e.g., Regulatory Affairs Certification (RAC)), where applicable

● Must not have a conflict of interest with the NEI performer team(s) they would support

Capability Requirements

● Must have demonstrated expertise in one or more of the EPAC support areas listed above

● Must have demonstrated experience advising on the development of regulated medical products (biologics, devices, diagnostics, or combination products) toward a specific indication or intended use

● Must have demonstrated ability to translate complex technical and regulatory guidance into clear, actionable recommendations for investigators who may be new to product development

Strongly Preferred Experience

● Experience specifically related to the visual system or ophthalmic products

● Experience with Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) submissions and FDA interactions

● Experience with medical devices and software as medical device (SaMD) and clearance pathways

● Experience supporting SBIR/STTR or other early-stage translational academic and small-business teams

Required Documentation

● Resume, CV, or biosketch (for individuals)

● Capabilities Statement - vendor capability statements should include personnel details which meet the stated eligibility requirements

● Completed solicitation questionnaire

● Relevant certifications, where applicable

Responsibilities Subject Matter Expert - NEI Eye Product Assistance Center (EPAC): A Subject Matter Expert typically has significant experience in the development of regulated medical products for a specific indication or intended use. The scope of this role would be to provide targeted, in-kind consulting to assigned NEI performer teams in one or more areas of expertise, helping them reach a defined regulatory or product-development milestone. Responsibilities include:

● Provide expert consultation to assigned NEI performer teams within the areas of expertise for which the SME is qualified

● Assess team needs and deliver clear, actionable recommendations within the agreed level of effort

● Participate in related presentations or decision meetings as necessary

● Attend Program meetings as requested; provide project updates to Program Leadership and Commercialization Center

● Submit timely invoices per specifications from the Commercialization Center

Deliverables Specific deliverables will be defined at the time of opportunity based on specific performer needs. Deliverables are due in accordance with the schedule agreed for that engagement, structured as shown below:

Milestone payment number

Subtask number Deliverable description

Due date (after contracting)

Amount

Total

Note: Invoicing will take place after deliverables are accepted by NEI. Approvals will be facilitated by VentureWell.

Time Commitment and Process The Subject Matter Expert will be compensated for the time they spend supporting the NEI Eye Product Assistance Center (EPAC) up to a maximum compensated time as detailed in the rate and Level of Effort section

Subject Matter Expert time may vary depending on the number and needs of projects to which they are assigned.

Rate and Level of Effort Qualified experts may be offered scopes of work for one or more performers, based on availability, and may be structured as Time and Materials or Firm Fixed Price contracts.

For Time and Materials, requests for a single performer will be a maximum of ~30 hours and rate capped at $275/hr.

Contractors will be responsible for tracking hours and will be held to a firm cap for Time and Materials contracts. Any hours worked outside of a delivery order are considered at-risk and are not guaranteed to be approved or paid.

Period of Performance Term: Fall 2026 – June 30, 2027

How To Submit a Proposal for Subject Matter Expert Positions Interested proposers must submit a proposal through VentureWell’s online solicitation platform, Euna, no later than December 18, 2026. Proposal information is available here. To submit a proposal for the role, a VentureWell account is required. If you are not yet signed up, you can create an account by clicking the “Sign Up” button found in the link above and following the required steps.

For help with the procurement process, watch our step-by-step video here: Unlocking Opportunities:

Navigating VentureWell’s Procurement Process.

Proposers will be notified of the committee’s selection decision on or about January 21, 2027.

If you have questions or need further assistance, please contact vendormanager@venturewell.org.

Background The National Eye Institute (NEI), part of the National Institutes of Health (NIH), leads the federal government's research into diseases and disorders of the visual system. The Eye Product Assistance Center (EPAC) is an in-kind consulting service provided by NEI to help investigators advance regulated products for eye and vision conditions. Through EPAC, investigators developing a regulated medical product for a specific indication can access targeted expertise across product development, from proof-of-concept through clinical trials, without needing active NEI or NIH funding. VentureWell administers the EPAC consultant pool on behalf of NEI, matching qualified subject matter experts to investigator needs and managing the resulting engagements.

About VentureWell:

VentureWell supports the cultivation of science and technology inventors and the innovation and entrepreneurship ecosystems critical to their success. Since its founding in 1995, VentureWell has funded or trained over 20,500 early-stage science and technology inventors and innovators, resulting in the emergence of more than 6,700+ ventures with groundbreaking technological advancements in fields like biomedicine and healthcare, sustainable energy and materials, and solutions for low-resource settings. The ventures it has supported have raised subsequent funds totaling more than $9.0 billion and are reaching millions of people globally.

Visit venturewell.org to learn more.

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