2023-2025 BITC Request for Proposals (RFP23-25)

RFP23-25 requests proposals that focus on biophysical characterization techniques for one or more of the following focus areas, although other related topic areas may be considered:

1. Measuring key quality attributes of new or emerging biopharmaceutical modalities:
   1. Cell-based therapies
   2. Gene therapies and delivery vectors that are practical for human therapeutics
   3. Antibody-drug conjugates
   4. Bispecific and other non-natural antibodies

More specifically, key quality attributes include but are not limited to: chemical stability, physical stability, physical properties at high concentrations (e.g., solution viscosity, solubility), heterogeneity of chemical and physical properties of therapeutically active components.
 

2. Dynamics, structure, and interactions of CAR-T cells with their target(s).
3. Quantitative measurement of bivalent binding (avidity), cooperative binding, including in vitro and in vivo models relevant to the mechanism of action involving, but not limited to cell surfaces, monoclonal antibodies, and emerging biopharmaceutical modalities.
4. Software development for prediction of protein-X interactions (X= protein, excipient, surfaces) ultimately including predictions of aggregation rates / longterm stability, solution viscosity, and manufacturing performance.

Proposals that are co-developed with one or more co-principal investigators from BITC member company (or companies) will be given priority. Funded projects that do not include a co-PI from a BITC members company may be assigned a subject matter expert (SME) from one or more BITC members to serve as a liaison and assure that the project outcomes are best aligned with BITC member priorities. The PI for a given project will need to agree to include such an SME in regular updates during the project period. Funded projects will be required to submit semiannual reports electronically to BITC, and may be required to participate in online webinars to present results and take questions from the BITC industry board (frequency typically no more than once per year).

Proposals are be accepted on a rolling basis, and evaluated by an independent group of SMEs from the member companies.

Prior to submitting a proposal, contact the BITC Director (Dr. C. J. Roberts, email: cjr@udel.edu) for a pre-proposal review electronically or by phone appointment. Proposals submitted without a pre-proposal review may be returned without further review if they are not aligned with BITC goals.

Typical project period is two years, with a maximum budget for RFP23-25 of $90,000 USD over the two years. Budgets are approved on a year-by year basis for each project, subject to sufficient progress and BITC board approval. No indirect costs / F&A will be paid by BITC. Additional details regarding allowable expenses are given below. Intellectual property created pursuant to BITC-sponsorship may be subject to a non exclusive, royalty-free (NERF) license to BITC members. For additional details or questions, contact the BITC Director.

Proposal Formatting:

• document length should be no longer than 5 pages, including figures and tables, but not including references or appendix for budget and budget justification (see below).
• 1-inch margins
• Single space, minimum 11-point Arial or Times New Roman font

Proposal Contents:

1. Title
2. Name of PI and Institution
3. Requested Start Date
4. Project Summary:
   1. A concise statement of the proposed work, motivation, and expected outcome(s)
5. Project Description:
   1. A discussion stating the background and proposed approach, novelty of the approach, and a timeline of the methods development and deliverables.
6. List of key personnel, as applicable
7. References (not included in page limit)
8. Appendix for annual budget (not included in page limit): Template available upon request (email: Judi Smith, jkpsmith@udel.edu). Maximum annual budget is $45,000. Budgets may incorporate the following:
   1. Salaries and benefits, student stipend and/or tuition, supplies, travel (travel expenses are limited to $2,000 per project year unless otherwise approved by the BITC Director)
   2. No indirect costs / F&A are allowed
   3. Initial project duration is up to 2 years, subject to approval of the BITC board at the end of year 1 based on completion of year one deliverables. For successful projects, funding beyond year 2 will be considered by the BITC board
9. 1-page budget justification (not included in page limit)

Proposal Submission: Sections 1-9 should be submitted as a single pdf. Submit via email to: Judi Smith (jkpsmith@udel.edu)