Now Accepting Letters of Intent
About the Program
- Letter of Intent (LOI) Deadline: JUNE 16, 2023 at 11:59 PM CDT
- For Accepted LOI’s only – Full Proposal Deadline: JULY 28, 2023 at 11:59 PM CDT
- Award Notice: AUGUST 31, 2023
The Needleman Program for Innovation and Commercialization (NPIC), committed to the urgent development of new life-saving and life-enhancing therapeutics on the Washington University campus, is an integral element of a school-wide campaign to support investigators committed to advancing WashU-generated therapeutics.
NPIC supports investigators transitioning promising discovery-phase therapeutic leads to pre-clinical drug development, carrying them through Investigation New Drug (IND) submission. Funded by Philip and Sima Needleman, NPIC accelerates pre-clinical drug development within the School of Medicine fence-line by providing significant financial assistance, expert project management, drug development support, and business mentoring. This is a follow-on funding program from discovery-phase drug development support provided through the WashU Center for Drug Development (CDD) and Office of Technology Management (OTM).
NPIC is pleased to announce a new funding opportunity of up to $4 million for the successful candidate to take promising therapeutic leads through IND. Funding will vary based on individual targets, and will be allocated contingent on agreed-upon milestones and timelines. Initial awards within NPIC are estimated at approximately $700K over an initial two year award period contingent on successful progress on agreed upon milestones. NPIC is designed to aid and provide resources to expedite pre-clinical stage drug development. Time urgency and execution will be expected; ongoing funding will be dependent on meeting agreed-upon progress at scheduled reviews.
Projects funded through NPIC are subject to an alternative licensing/royalty distribution plan which reallocates a portion (~20%) of license/royalty revenue received from the NPIC funded technology to replenish the funding in the Needleman Program. Details of the alternative distribution plan will be available to the selected awardees.
The successful application will have a validated target, a therapeutic lead with drug-like properties, animal models that validate efficacy and mechanism, and a clear description of the therapeutic and business potential.
Anticipated Funding Amount
NPIC is committed to provide the necessary support to allow a candidate to advance to IND within 3-4 years. As such, funding and renewal will be based on the approved project plan, with milestones and timelines and annual review of progress that trigger tranche funding.
Who May Submit Proposals
PIs must be Washington University faculty within any School or Department with appropriate experience or expertise. However, it is acceptable to include collaborators outside of the University as part of your proposal.
Use of Funds
Funds are to be used for research expenses. Funds may not be used for salaries, administrative staff, course buyouts, seminar speakers, consultants, conferences, or travel.
- Qualifications/Expertise of the Investigators
The Principal Investigator(s) should be a recognized senior investigator with sufficient experience to accomplish the proposed work in concert with an experienced pharmaceutical industry expert.
- Scientific Excellence
Proposals should reflect the clarity and pertinence of the objectives, as well as the credibility of the proposed approach.
- Quality and Viability of Plan
Coherence and effectiveness of the research plan, including appropriateness of the allocation of limited tasks and resources.
- Ability to capture Intellectual Property (IP) from the project
A goal of this endeavor is to produce and capture IP that may result in future licensing revenue that can be returned to the NPIC fund.
The reviewers are selected from different disciplines; the names of the reviewers are confidential. Please note that the review committee is comprised of senior scientists and pharmaceutical industry experts that are not necessarily experts in your specific field of research. Therefore, it is in your best interest to define all acronyms, to keep your research plan free of jargon, and to ensure that it is understandable and compelling to a non-specialist.
Alternative Income Distribution Program
IP resulting from this program is subject to an alternative distribution mechanism to facilitate evergreen investment in promising technologies. A portion (20%) of royalties generated from IP funded under this RFP will be reinvested in the NPIC program.
Letter of Intent (LOI) Instructions
We encourage applicants to work with their support team partners at the Office of Technology Management and Center for Drug Development on this Letter of Intent (LOI). LOI’s should be 3-5 pages in length and include the following elements:
- Executive Summary – (1-2 paragraphs) State the importance and uniqueness of this work and how it will solve an issue or contribute to public health, provide an overview of the current state of the research, indication targeted, and envisioned next key steps.
- Detailed current state summary – (1-2 pages providing a clear explanation of what has been done or is in progress, including an emphasis on the following areas):
- Validated Target – Identification, rationale and impact to specific disease,
- Mechanism of Action (MOA) – Clear explanation on impact to disease
- Assays – Assays developed or in plan to prove MOA in experimental animals and humans
- Animal and Cellular models – Plan for accessing and developing these models
- Therapeutic Lead – Describe compound and its drug-like properties
- Therapeutic and business potential
- List IP/patents to be used in the project (if any)
- Project Plan – (1-2 pages providing a clear explanation of what is planned and how the NPIC program will aid in therapeutic development, with a goal of identifying primary candidate within three years and beginning first in human trials within five years. Emphasis on the following areas):
- Preclinical Plan: In Vitro Pharmacology, Safety Assessment; Drug Metabolism and Pharmacokinetics; Optimize Medicinal or Protein Chemistry, Manufacturing and Controls; Clinical and Regulatory
- Screening Approach (if applicable to the stage of development) – Plan for candidate optimization, HTS, protein, biologics, etc.
- Description of specific clinical/therapeutic target
- Continuing Science and Investigation – Other mechanistic studies that are planned around the target, patent opportunities, etc.
- Explanation on what experiments are planned that will validate or invalidate the program and timeline for execution (Go-no go experiments and results)
- Assessment of competing targets / Business Analysis in the marketplace
- Strategy for proof of MOA and proof of concept
- Strategy for managing the program – internal resources and external resources (CRO’s etc.)
- Amount Requested – up to $700k over 2 years, with potential additional funding up to $4M over tenure within the program
- Biosketch – NIH Format is preferred
*LOI’s should be submitted via e-mail by JUNE 16, 2023 at 11:59 PM CDT, to email@example.com