PD_ Assay RFI – S09-205 – Issued 8-11-09
Follow the link above if you’re interested in helping NCI-Frederick develop novel, PD tests for point of care cancer diagnostics. The link is a download (Word Doc) of the entire RFI.
Here’s the gist:
The purpose of this Request for Information (RFI) is to provide potential subcontractors an overview of one strategic goal of the Division of Cancer Treatment and Diagnosis (DCTD) at NCI which is to promote the introduction of promising cancer therapeutics through the integration of appropriate pharmacodynamic (PD) tests into Phase 0 clinical trials with the focus on gathering evidence of targeted drug action that enables early Go/NoGo decisions. Information is requested from non-profit organizations, academics, clinical centers, and industry on the following topics:
1. Provide comment on the technologies and key cancer related pharmacodynamic targets for the next generation of PD assays that are to be developed using readily clinically adoptable state-of-the-art tools.
a. Utilization of multiplexed assay platforms that enable multiple PD readouts from small amounts of specimens coupled with robust annotation and data management to include: multi-channel microscopy, ELISAs, Laser Capture, PCR, etc. The goal is to maximize the amount of PD information that can be obtained from a single specimen. Combinatory markers have the greatest potential for providing valid and clinically relevant drug action and patient response information in genetically diverse populations.
b. The next generation of PD Assays must query multiple validated cancer specific analytes simultaneously to include the following categories:
1) Interrogate multiple targets within a molecular pathway, such as PTEN/Akt/PI3K/mTORC1 & 2.
2) Measure informative analytes that span across multiple core signaling pathways, of which the specific pathways driving the disease are often unique for different cancers.
3) Quantify multiple molecular events on the same target molecule, for example, activating and suppressing modifications of individual Akt isozymes or multiple phosphorylation sites on the MET receptor.
4) Identification of tumor stem cells using multiple known or novel stemness markers.
5) Filter target detection and quantitation to allow measurement in specific cellular compartments (e.g. plasma membrane and nucleus).
6) Develop assays for multiple new or known markers that are indicators of apoptotic commitment of tumor cells upon therapeutic treatment.
c. Establish an infrastructure to provide access to key reagents (antibodies, primers & probes, calibrators, references, etc), specimens (repositories, storage, processing, etc)), and accessory technologies (software, robotics, etc) that are essential for development of robust, sensitive, reproducible tests. This topic includes quality controlled production of critical reagents, regulatory (FDA/CLIA/CAP) knowledge and compliance, antibody diagnostic imaging, pattern recognition software, data analysis software that gives easily interpretable results, nanotechology for biopsies, and much more.
2. To provide institutions the opportunity to indicate their level of interest in responding to, and participating in, any future subcontracting opportunities in support of the pharmacodynamic assay initiative.
3. Provide institutions the opportunity to elaborate on their specific expertise in the core areas listed above.
Let me know if I can help or introduce you to the right people, if interested.
UPDATE 8/13 I should also point out that all of these “Business Opportunities” are available on SAIC-Frederick’s web site.
Here’s what’s there today:
A list of current business opportunities is provided below.
||Blanket Purchase Agreement covering Chemicals, Water Treatments, Parts, Supplies, and Services
||C. Jean Eyler
||Blanket Purchase Agreement for Recycled Paper
||Solicitation/Contract/Order for Commercial Items
||Solicitation/Contract/Basic Ordering Agreement
||Solicitation/Contract/Order For Commercial Items
||RFI: Insect Cell Based Biopharmaceutical Development
||HIV Vaccine Strategies
||RFI – Pharmacodynamic (PD) tests into Phase 0 clinical trials
||Howard Souder, Jr.