ITHS/cGMP Therapeutic Manufacturing Ignition Award

The ITHS is pleased to sponsor a new Ignition Award, focused on development of cell and protein-based therapeutics. The purpose of this Ignition Award is to support the production of cellular or biologic protein products needed to conduct IND-enabling studies in animals or clinical studies under an Investigational New Drug application. These grants will cover costs associated with the provision of services to you through the UW and FHCRC Therapeutic Manufacturing Facilities. Please pay close attention to the submission instructions and due dates. All faculty members (or those with equivalent titles) are eligible to apply. All applicants must join ITHS prior to submitting an application. Applications for awards of up to $50,000 will be considered during this review cycle. These awards are eligible for one no-cost extension, if the proposed experiments have not been completed in the first year of the award. An extension may be requested but is not guaranteed.

Purpose

This program is designed to support innovative, translational studies utilizing resources within the ITHS, including the UW and FHCRC Therapeutic Manufacturing Facilities. The biologic products produced by these facilities will be used to support IND-enabling preclinical studies or human clinical trials. This program will facilitate use of these resources within the ITHS and provide information applicable to subsequent grant and/or clinical studies. This program will advance research programs through the translational process of therapeutics diagnostics or device development.

Examples of types of projects include, but are not limited to:

Protein Therapeutics. Biological products from established cell lines could include: (1) clinical grade proteins, intended for intravenous administration in humans or (2) non-clinical grade for use in preclinical research models. Manufacture and purification of products are performed in dedicated clinical and non-clinical areas of the facility in compliance with regulatory standards. The facility maintains stringent quality control standards for each step of the production process. Production of biological agents includes: monoclonal antibodies, fusion proteins, plasmids, formulation of peptide vaccines, and various other products derived from both eukaryotic and prokaryotic culture systems.

Cellular Products. The resource provides support for reproducible production of human hematopoietic or immuno-competent cells under stringent quality control and safety conditions required for therapeutic studies. Cell production services include enrichment or depletion of specific cell subsets, provision of normal donor feeder cells, maintenance of transformed feeder cell lines, cloning, ex-vivo antigen priming, cytokine and antibody-based activation, genetic modification, expansion, cryopreservation and/or preparation for infusion of many different types of extensively manipulated cell populations.

Additional Services include:

  1. Large scale cell culture and harvest
  2. Modification of proteins with biotin or fluorochromes
  3. Characterization of cell lines
  4. Process Development
  5. Regulatory Support

Therapeutic Manufacturing Ignition Award information:

Up to $50,000 per selected applicant will be directly applied to the costs of the Therapeutics Manufacturing facility.

The ITHS will pay the Therapeutics Manufacturing Facility directly.

Eligibility and review criteria

All faculty members (or those with equivalent titles) are eligible to apply.  Applicants are encouraged to contact the managers of the Therapeutics Manufacturing Facilities (rmanger@fhcrc.org or lindgren@u,washington.edu) to discuss the scientific components of their projects and general costs of the services to be provided. Final budgets are only required for the invited Full Applications and must be developed in collaboration with the Director, Translational Technologies and Resources Core for the ITHS (mpeters1@u.washington.edu ).The budgets for full applications may only be used for costs within the Therapeutic Manufacturing Resource. The total amount requested cannot exceed $50,000. The proposed research MUST be readily identifiable as addressing issues in either translational or clinical research.

  1. It will be the responsibility of the PI to clearly demonstrate how the proposed research has the potential to positively impact the quality or the conduct of clinical and translational research.
  2. The investigator should clearly describe how the proposed project fits within their current funded programs including plans for utilization of the services or information to be provided.
  3. The investigator should clearly describe how the proposed evaluation methodology provides an innovative approach to conducting the proposed research.
  4. Up to $50,000 per selected applicant will be directly applied to the costs of the Therapeutic Manufacturing Resource.
  5. The ITHS will pay the Therapeutic Manufacturing Resource directly. 

Review committee

 The Research Review Committee (RRC) for this Ignition Award will be made up of the Managers of the UW and FHCRC Therapeutics Manufacturing Facilities, selected members of the ITHS Drug and Device Advisory Committee (DDAC). In cases where the materials are for clinical trial supplies, the review may also incorporate the Scientific Review Committee for the Clinical Research Network or the Steering Committee for the FHCRC Cancer Center. For review of full applications, the RRC will also invite representation from the Technology Transfer Office of the applicants’ institution for guidance on innovation represented by the technology. Where potential conflict of interest may exist, ad hoc reviewers may augment the RRC membership. Members of the committee are reappointed on an annual basis and membership is designed to provide a diverse cross-section of research interests with representation from both core and affiliate researchers.

Two rounds of reviews are performed with each project scored against the criteria listed above. The first review of Pre-Applications is designed to narrow the field for further, in-depth review. A second round of review will be performed on the Invited Applications allowing for a more substantial project description. Each full application will be critiqued and scored. It is anticipated that the project with the lowest score/highest priority will be funded. Based on funding levels, it is anticipated that only one project will be funded during this 2009-2010 review cycle.

Reviews are performed according to the following standards:

  1. Applicability to the ITHS mission
  2. Scientific merit
  3. Proposed activities conducted on site at the WaNPRC
  4. Innovation
  5. Potential impact on human health
  6. Potential for commercialization
  7. Probability of future grant funding and/or clinical studies
     

Application form and process

Step 1 –  Submit the two-page Pre-Application by January 20th, 2010

Send Pre-application form to ithsapps@u.washington.edu. (DO NOT COMPLETE THE FULL APPLICATION UNLESS INVITED TO DO SO). Pre-applications are solicited from the local and regional (WWAMI) biomedical research communities via an electronically distributed official announcement. You may increase the space allotted for the Pre-application by one additional page, if needed.

Step 2 – Review of Pre-Applications and selection of invited applications

  • Reviews are performed using the standards described above
  • RRC narrows the field to approximately 4 applications
  • ALL pre-application applicants will be notified of their status by February 12, 2010
  • Invited applicants will be asked to submit expanded applications and draft budgets using the ITHS Ignition Award Application
  • Investigators are offered ITHS assistance (mpeters1@u.washington.edu) for preparation of budgets

Applicants are encouraged to contact the managers of the Therapeutics Manufacturing Facilities (rmanger@fhcrc.org or lindgren@u,washington.edu) to discuss the scientific components of their projects and general costs of the services to be provided.

Step 3 –Invited investigators submit full Ignition Award Application by March 23, 2010

Step 4 – RRC reviews invited applications and selects 2010 Awardees

  1. RRC meets to discuss merits of the expanded applications and budgetary information
  2. Selected Projects assigned to Core Staff sponsor
  3. Applicants notified of award by: April 16, 2010
  4. All final applicants will receive a detailed critique of the application

Applications will be reviewed and submitters notified within 1 month of the application deadline. Unsuccessful applicants may resubmit their applications for the next round up to a total of two (2) times, unless the reviewers determine that the application does not meet the intent of the program.

Reporting requirements

 Ignition awards are an investment in translational research to improve human health. Meetings with ITHS representatives to assess the effective utilization of ITHS resources and reporting the progress and results of funded programs are important aspects to evaluate the success of this funding mechanism.

ITHS requires the following reports and presentations: pre-award meeting with the DDAC and establishment of a project timeline with milestones, semi-annual progress report, final work summary and presentation to DDAC. Quarterly in-person meetings with an ITHS representative may be requested as a tool to track the progress of funded activities. 

Publicity

ITHS reserves the right to publicly disclose information about its granting activities. ITHS communications to the public may include lists of funded applications, the names of principal investigators and applicant institutions and departments, titles of proposed activities and reports about progress and outcomes.

Contact

For more information regarding the application process, please contact the Preclinical Research Development Network Core or the Director, Translational Technologies and Resources Core for the ITHS.

 Appendix

Definitions of Clinical and Translational Research

Last modified: February 12, 2010