Background
FDA and CRCG have awarded a grant (U18FD007054; www.complexgenerics.org; Subaward 21755) to the University of Queensland, Australia, to:
- Develop and validate skin-mimetic substrates that replicate the key physical properties of human skin.
- Develop in vitro tests to compare adhesion of Topical and Transdermal Delivery Systems (TDS) on the substrates using lab manufactured or marketed TDS products to evaluate performance.
To meet the objectives outlined above, and to maximize the outcomes and impact of this collaborative agreement for supporting adhesion testing studies of TDS, CRCG is inviting interested “contributors” to contribute relevant materials (e.g., backing membranes, adhesives, release liners) to support this research, which will help to develop industry relevant tests to compare adhesive properties of TDS.
Opportunity for Materials Contribution
The successful outcome of the grant (U18FD007054 -Subaward 21755) depends heavily on access to reliable supply of materials, including adhesives, backing membranes and release liners. The consistency in supply of these materials will help in establishing a workflow and allow the grantee to compare the predictive behavior of TDS products. This, in turn, will facilitate the availability of safe, reliable, and high-quality TDS.
CRCG is inviting interested contributors from pharmaceutical industries, CROs, and other key partners who have access to materials outlined above to support the development and assessment of TDS by providing the materials listed below.
Key Dates
- Letter of interest submission deadline: January 23, 2025
- Acceptance notification: February 28, 2025
Requested Materials
Below is a list of materials that prospective contributors are invited to contribute:
Adhesives
- Polyisobutylene
- Duro-Tak 87-6908
- Acrylic
- Duro-Tak 87-9301
- Duro-Tak 87-2054
- Duro-Tak 87-235A
- Duro-Tak 387-2287
- Silicone
- Bio-PSA 7-4302
- Bio-PSA 7-4502
Backing membranes
- Mediflex 1501
- ScotchPak 9723
- ScotchPak 9733
- ScotchPak 1109
Release membranes
- ScotchPak 9744
- ScotchPak 1022
- Loparex silicone-coated polyester
Letter of Interest and Process Details
Interested contributors are requested to submit a letter of interest (LOI) by Thursday, January 23, 2025, via email to info@complexgenerics.org.
The LOI should summarize their interest in contributing to this project and include detailed information on the materials that would be provided. The letter should also indicate any restrictions or limitations of use of materials and list all information that would be required from the U18FD007054 -Subaward 21755 grantee for successful transfer of materials to the University of Queensland, Australia. The LOI should confirm contributors’ willingness and ability to transfer the materials, and provide the contact information of the point(s) of contact who will facilitate the transfer of materials. The LOI should be emailed as a single PDF file (maximum 8 Megabytes) to info@complexgenerics.org. Interested contributors will be notified of acceptance decisions by February 28, 2025.
The CRCG and FDA will have no direct access to the materials contributed. The participation of contributor(s) is not intended to change the objective of this project as defined in U18FD007054- Subaward 21755. The terms of the material transfer between the University of Queensland, Australia and each contributor will be established in an independent agreement between the selected contributor and the University of Queensland, Australia, as needed. Establishment of those independent agreements will be the responsibility of each contributor and the University of Queensland, Australia exclusively.
Consistent with the provisions for public access to the data and results generated within the scope of the U18FD007054 grant from FDA, the outcomes of the research performed under award U18FD007054- Subaward 21755 will eventually be made publicly available in the form of manuscripts, oral presentations and the GDUFA Research Report published annually.
Funding: There is no funding associated with this opportunity.
LOI Submission Contact: info@complexgenerics.org