NCI

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Laboratory Representative

Description

The National Cancer Institute (NCI) is a component of the National Institutes of Health (NIH), one of eight agencies that compose the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). The NCI, established under the National Cancer Act of 1937, is the Federal Government's principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice.

The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

Accomplishments in Technology Transfer:

AIDS test kits, Fludara®, Gardasil®, HIVID®, Kepivance®, Multi-replica blotting kit for proteins, NeuTrexin®, PathVysion® HER-2 DNA probe kit, PhenoSenseTM HIV phenotype tests, PixCell® Laser Capture Microdissection system (LCM), Prezista®, soluble IL-2 receptor assays, Squirrel-Free capsaicin-treated birdseed, Taxol®, Velcade®, Videx®, Bavencio®, Unituxin®, YESCARTA®, Vitravene® and Zevalin®. More information on NCI success stories can be found at https://techtransfer.cancer.gov.

Mission

The National Cancer Institute supports and coordinate research projects conducted by universities, hospitals, research foundations, and businesses throughout this country and abroad through research grants and cooperative agreements; conducts research in its own laboratories and clinics; supports education and training in fundamental sciences and clinical disciplines for participation in basic and clinical research programs and treatment programs relating to cancer through career awards, training grants, and fellowships; supports research projects in cancer control; supports a national network of cancer centers; collaborates with voluntary organizations and other national and foreign institutions engaged in cancer research and training activities; encourages and coordinates cancer research by industrial concerns where such concerns evidence a particular capability for programmatic research; collects and disseminates information on cancer; supports construction of laboratories, clinics, and related facilities necessary for cancer research through the award of construction grants.

Technology Disciplines

Technologies
Displaying 1 - 10 of 944
1,2-Dihydroellipticines with Activity Against CNS-Specific Cancer Cell Lines
15kD Granulysin for Monocyte Differentiation: A New Immunotherapeutic for Both in vivo and ex vivo Applications
15kD Granulysin for Monocyte Differentiation: A New Immunotherapeutic for Both in vivo and ex vivo Applications
17-AAG Treatment of Diseases Sensitive to c-KIT Down Regulation
2-Amino-O4-Substituted Pteridines: Improved Chemotherapy Adjuvants
3-Deazaneplanocin, Intermediates for It, and Antiviral Composition and Method of Treatment Using It
3D Image Rendering Softwarefor Biological Tissues
5-Substituted Derivatives of Conformationally Locked Nucleoside Analogues
888-mel: A Target for Anti-Tumor Immune Responses
89Zr-Oxine Complex for In Vivo PET Imaging of Labelled Cells and Associated Methods

Pages

Facilities
Displaying 1 - 6 of 6
Advanced Technology Research Facility (ATRF)
Division of Cancer Treatment and Diagnosis
Frederick National Laboratory for Cancer Research
Laboratory of Molecular Technology
Nanotechnology Characterization Lab
The NCI Experimental Program NeXT
Equipment

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Successes

For Peter Blumberg, coming up with a better birdseed while investigating a compound that acts on neurogenic inflammatory pathways is not serendipitous.

"Serendipity suggests that one stumbles on something by chance, but in discovery research, which is the core mission of NIH [National Institutes of Health], one does not simply start with a problem and try to come up with a solution," said Blumberg, an NCI section chief whose group explores the molecular mechanisms of tumor promotion. An integral part of discovery, he said, is recognizing when one's findings represent a solution to a problem that is not on one's list of problems to be solved. A second key element is appreciating that this solution might well be translated into a product—and alerting the Office of Technology Transfer (OTT) to that possibility.

Blumberg has had frequent interactions with the OTT in the course of his long-term studies of phorbol esters—tumor-promoters derived from medicinal plants in the poinsettia family (Euphorbiaceae) first described in 40 B.C. by Euphorbus, court physician to King Juba II of Mauritania. One structurally related compound, called resiniferatoxin, which proved highly potent (the ability to turn rodent ears red) in a screening assay for this class of tumor promoters, also proved to have a different mechanism of action from others of its class.

"Because of its extraordinary potency and our sense that it could not fail to tell us something important about inflammation, we tried to identify its target, and we found that it acted the same way as capsaicin, the hot ingredient in red peppers," Blumberg recalled.

That was the first step in creating one of NIH's more unlikely inventions: squirrel-proof birdseed.

The second step emerged during a species-specific hunt for receptors to the capsaicin-like compound. It turned out that mammals had the receptors; birds did not. Voila!

"As the owner of a horse farm," Blumberg said, "I know the kinds of problems animal people have, and squirrels eating birdseed is one of them." And as a laboratory scientist, he reasoned that birds would eat capsaicin-coated birdseed, blissfully unaware of its fiery qualities, while rapacious squirrels would back off.

Aside from its squirrel-deterring qualities, capsaicin is therapeutically interesting: it first activates and then desensitizes C-fiber sensory neurons involved in pain perception and neurogenic inflammation. Resiniferatoxin, Blumberg said, acts like capsaicin but preferentially causes desensitization, giving it a "much more attractive spectrum of activity for therapeutic applications," a discovery made early in the course of his group's research.

In fact, birdseed is the subject of but one of the 12 patent applications Blumberg's research has generated, five of which have already been licensed to private industry. Three of these five are related to the clinical development of resiniferatoxin and its homologues, and have been licensed to a company that is now testing them for clinical use against diabetic neuropathy, postherpetic neuralgia, vasomotor rhinitis (and possibly allergic rhinitis), and urge incontinence.

The compounds act as an analgesic against neurogenic pain and also desensitize hypersensitive nerve pathways that disrupt bladder function.

Potential clinical applications in the care of cancer patients are numerous, including reducing the discomfort of cancer-drug–induced mucositis, cystitis, and emesis; and relieving postmastectomy and other surgically induced neuropathic pain.

Blumberg feels technology transfer of his inventions has worked very well, reaping royalties for NIH and the inventor from the time of issuance of a license, even before any products are commercialized. (In the case of the birdseed, which is already on store shelves, the patent is still pending.) He also feels that product development is better left to the private sector. His birdseed was licensed to a former postdoc who founded a company "specifically to license and exploit this government invention." Similarly, the company that licensed the other patents was formed by "scientists with entrepreneurial interests, one of whose principals had been at NIH years earlier, was an authority on capsaicin, read our first publication describing the spectrum of resiniferatoxin activity, and recognized, as we had, the exciting therapeutic possibilities. Both of these are examples of the spinoffs of government research leading to initiatives in the private sector."

Commercialization of his discoveries has not altered Blumberg's own career and research choices. "I came here because I thought the opportunities for doing research at NIH were even more exciting than the obviously very good opportunities I had had at Harvard Medical School. NCI is the foremost institution in the world for cancer research, and, so far I've been able to afford to remain here."

Royalties have not altered his standard of living. "It's really not very significant," he said. "I've earned $24,000 in royalties over the total number of years I've been here, since 1981. So this is not going to buy me too many horses.

"On the other hand," he added, "a lot of these patents are still in the early stages of development." 

This story originally appeared in Volume 5, Issue 2, March–April 1997 of The NIH Catalyst: A Publication for NIH Intramural Scientists. To view the original story, visit https://nihsearch.cit.nih.gov/catalyst/1997/97.03.01/page1c.html.

This bird eating birdseed at a feeder does not have to compete with squirrels to enjoy its afternoon snack. (Image courtesy of NCI. Photo credit: iStock)

The National Cancer Institute Formulary

The National Cancer Institute (NCI) agent formulary (NCI Formulary) was launched on January 11, 2017 as one of the first efforts of the Cancer Moonshot initiative. To develop the NCI Formulary, the Cancer Therapy Evaluation Program (CTEP), DCTD, NCI negotiated specific NCI Formulary Clinical cooperative research and development agreements (CRADAs) with pharmaceutical company collaborators that agreed to expand the use of their proprietary agents for studies supported by the NCI Formulary. The NCI Formulary CRADAs provide NCI-audited academic institutions access to these proprietary agents, thus eliminating the often-lengthy agent access process that occurs between such institutions and pharmaceutical companies.

Agents within the NCI Formulary are available to investigators at NCI-audited clinical sites for the conduct of clinical trials under investigator-held investigational new drug applications (INDs), as well as for pre-clinical research. CTEP’s clinical trial infrastructure will facilitate the conduct of the trials, from proposal submission and timely review by the collaborating pharmaceutical companies to agent distribution, serious adverse event submission, and clinical data reporting, while providing a coordination mechanism between the clinical investigators and the pharmaceutical company collaborators. A clinical Material Transfer Agreement between NCI and the clinical sites will formalize the expectations of each party.

CRADA Outcome

To date, CTEP has successfully negotiated CRADAs with 9 different pharmaceutical companies to bring 27 different agents into the NCI Formulary. All of these potential cancer treatments are now available to over 300 different cancer centers and clinical trial sites that have been audited by NCI. One of the big advantages of the program is the ease with which combination trials can be set up using the Formulary. In addition, applications can be made by academic investigators to use the agents in non-clinical research.

The NCI Formulary allows for:

  • Negotiation-free access to investigators through the NCI template agreement with the participating companies
  • Less time to acquire the agents
  • Unique opportunities to obtain agent from multiple companies to combine in one study
  • The distribution of agents to occur at no cost to the investigator
  • Enhances the clinical trial implementation process
  • The Investigator to have control over the initial publication and presentation of the results
  • An evolving list of agents from collaborating companies (see nciformulary.cancer.gov). 
Licenses

No Licenses