Three new cancer therapies recently approved by the Federal Drug Administration (FDA) – avelumab (BAVENCIO®), axicabtagene ciloleucel (YESCARTA®) and moxetumomab pasudotox (LUMOXITI™) – are the result of significant efforts by researchers from NCI’s Center for Cancer Research. Read more about these examples of technology transfer at work in the May - June 2019 issue of The NIH Catalyst, a publication about NIH Intramural Research.
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“NCI and Industry: Moving Innovations from the Lab to Patients” was the feature article in March 2019 edition of MedNous, a European biomedical publication.
Illustrated by success stories, the article highlights the potential for NCI discoveries to make a positive impact for the patient. It also details how partnerships between the NCI Labs, TTC, and industry partners accelerate the commercialization process to bring NCI technologies from the lab to the market. MedNous, a publication of Evernow Publishing Ltd., is available via print and online. Read: "NCI and Industry" from MedNous
NCI TTC and the Frederick National Laboratory for Cancer Research (FNLCR) will host the 2019 Technology Showcase on June 12. The third annual event will highlight technologies being developed at the NCI and FNLCR to encourage startup company formation, technology licensing and collaborations. Richard Bendis, President and CEO of BioHealth Innovation, a Maryland public-private partnership focused on accelerating the growth of commercially relevant science, will provide the keynote address. The half-day event will take place at the Advanced Research and Development Facility in Frederick, Maryland. Learn more @ 2019 Technology Showcase.
Advances in the rapidly growing field of immunotherapy are being realized as evidenced by several ground-breaking, new therapies brought to market in the last year. A new type of fellowship program conceived by the NCI - the NCI Immunotherapy Fellowship Program - was designed to help train the next-generation of physicians to meet the demands of this quickly expanding field. At its 2018 annual meeting, the Federal Laboratory Consortium (FLC) MAR presented NCI with its “Educational Institution and Federal Laboratory Partnership Award” for “NCI Immunotherapy Co-sponsored by Society for Immunotherapy of Cancer.”
James Gulley, M.D., Ph.D. of the NCI Center for Cancer Research (CCR), recognized the need to train the next generation of physicians to develop and conduct immunotherapy clinical trials. For today’s up-and-coming oncologists, the basics of immunotherapy taught to them in medical schools does not provide the in-depth preparation needed to meet the demanding and rapid advancements of this high-technology field; however, the breadth and depth of opportunities for training in clinical immunotherapy at the NCI CCR are unsurpassed. One of the major issues in making this immunotherapy fellowship a reality concerned finding funds to support the fellowship. Though the novel use of the CRADA mechanism, a partnership with the Society of Immunotherapy in Cancer (SITC), and support by an existing CRADA partner, NCI created a new fellowship program to meet an unmet training need. To date, two fellows have successfully completed the NCI Immunotherapy Fellowship, and both transitioned into roles where they can make a positive impact in the field of cancer immunotherapy.
Congratulations to the following award winners:
NCI Scientific Team:
Drs. James Gulley, Marijo Bilusic, Ravi Madan, and Christian Hinrichs
NCI TTC and NCI Ethics:
Drs. Michael Pollack, Laura Henmueller, Kathleen Carroll and Mr. Eric Hale
Dr. Howard Kaufman
TTC's Sidra Ahsan, Ph.D., received the FLC MAR 2018 "Rookie of the Year Award," presented at the FLC MAR regional meeting. This FLC award recognizes the efforts of an FLC laboratory technology transfer (TT) professional who has demonstrated “outstanding work in the field of technology transfer in a manner significantly over and above what was called for in the normal course of their work during the past year.” The nominee must be new to technology transfer, with three years (or less) experience in a TT position.
Notable Technology Transfer Contributions
In less than two years with TTC, Sidra Ahsan, Ph.D., is making a significant, positive impact on behalf of NCI. Dr. Ahsan, a technology transfer manager and TTC fellow, has diligently endeavored to increase her knowledge and application of technology transfer. The volume and scope of projects that she has tackled in her short tenure has helped position NCI to meet its mission today and in the future. Dr. Ahsan has taken on a wide-range of projects involving both extramural partnerships and intramural labs and managed several clinical trial agreements that helped advance testing of important, new therapies. Dr. Ahsan supports investigators from NCI’s Center for Cancer Research (CCR) and the NCI Division of Cancer Prevention (DCP). In the last year, Dr. Ahsan negotiated several CRADAs, Clinical Trial Agreements, and amendments for CCR and DCP. These agreements made possible the initiation of four important clinical trials examining: therapies for breast cancer, a rare brain cancer, colon cancer prevention, and ovarian cancer development and progression.
Dr. Ahsan also contributed to several TTC working groups and passed the USPTO registration exam to become a registered patent agent in 2018. “I believe that Sidra’s notable accomplishments reflect the high-level of TT work taking place in our office every day,” commented TTC Director Dr. Thomas Stackhouse. Congratulations to Sidra on a well-deserved accomplishment, and thanks to those in TTC who have mentored her and supported her success.
The Food and Drug Administration (FDA) approved moxetumomab pasudotox (Lumoxiti), a bacterial toxin–based drug, for the treatment of some patients with hairy cell leukemia (HCL). Technology Transfer played an important role in facilitating the development path of moxetumomab, which was originally discovered by Ira Pastan, M.D., and colleagues in NCI’s Center for Cancer Research (CCR). NCI Technology Transfer facilitated the licensing of the technology to a commercial partner to further develop it into a product, as well as the collaborative agreements necessary to support NCI-investigator-lead clinical trials. FDA approval of moxetumomab is an excellent example of Technology Transfer at work. To learn more about this innovative technology advancement for the treatment of HCL, a rare cancer, see:
NCI TTC's new start-up license program makes it easier and more financially attractive for start-ups to license a technology from NCI or any of the ICs supported by the TTC Service Center. Launched in October 2017 in response to feedback from companies, "NCI Startup 2.0" updates and enhances previous licensing options for start-up companies.
The program offers a term-limited, exclusive Start-up Evaluation Option License to start-up companies developing early-stage vaccine, therapeutic, device, and diagnostic technologies. To learn more about the program – including the criteria that companies need to meet to qualify, the license features, and the process for startups to obtain a license, please see Tech Transfer Start-up Licenses.
Launching the updated start-up licensing program was the result of months of work by two separate project teams. The teams were comprised of a variety of TTC staff who considered and analyzed the original program that was established by the Office of Technology Transfer. The goal was to develop an enhanced program that met the unique needs of a start-up company versus the licensing options available to larger companies and organizations.
“From some very diligent work and analysis of the original program, our two project teams were able to identify key issues that our original start-up licensees found problematic,” commented TTC Associate Director Richard Rodriguez. “One key factor was the original term of the start-up option license, which was 12 months. This was clearly insufficient time for our licensees to raise capital or concurrently conduct pre-clinical experiments. The new program provides 24 months, which we believe will better assist our licensees in meeting their obligations. Other changes will make it easier for our start-up licensees to bring a product to the market.”
The 2018 Technology Showcase featured technologies from the National Cancer Institute and the Frederick National Laboratory for Cancer Research available for licensing and/or collaboration. Held at Frederick National Laboratory’s Advanced Research Facility in Frederick, MD, the event brought together biotechnology stakeholders from across the region for a second year. To learn more about the featured inventions, presenters, technology posters and the event agenda, see 2018 Technology Showcase.
Also, read: "The 2nd Annual Tech Showcase Reflects New Culture at NCI & FNLCR” by BioBuzz.
Mark your calendars! The 3rd Technology Showcase is scheduled for June 12, 2019.
The Federal Laboratory Consortium (FLC) for Technology Transfer has recognized three National Cancer Institute accomplishments with Excellence in Technology Transfer Awards. This award category honors employees of FLC member laboratories and non-laboratory staff who have accomplished outstanding work in the process of transferring federally developed technology toward commercialization.
Among the accomplishments being honored are the roles of CCR teams in developing two recently approved anti-cancer drugs and a production method for an anti-HIV microbicide: “Avelumab, New Therapy for Metastatic Merkel Cell and Urothelial Carcinomas,” for a Cooperative Research and Development Agreement (CRADA) to expedite the regulatory approval of the checkpoint inhibitor avelumab; “Development of Large Scale Production, Anti-HIV Microbicide in Soya Beans” for the development of a production method of CV-N in soy beans to address the lack of commercially sold HIV microbicides and access to other HIV prevention techniques in developing countries; and “FDA Approval: Personalized Cancer Treatment to Cure Deadly Blood Cancers” for the drug axicabtagene ciloleucel that received FDA approval of CD19-directed genetically modified autologous T cell immunotherapy for the treatment of adult patients with relapsed or treatment-resistant large B-cell lymphoma.
The FLC will present a total of 30 awards to 24 laboratories representing 10 federal agencies during the FLC National Meeting on April 25, 2018 in Philadelphia, PA. To learn more about how to partner with NCI researchers, visit the Partnering section of this web site.
In November 2017, the Federal Laboratory Consortium (FLC) for Technology Transfer Mid-Atlantic Region (MAR) honored NCI with three awards at its annual meeting. The FLC is a formally chartered organization mandated by Congress to promote, educate and facilitate technology transfer among more than 300 federal laboratories, research centers and agencies. “These awards honor the individuals who work hard to move forward life-saving innovations into products, supporting world health,” commented Dr. Thomas Stackhouse, TTC associate director.
Congratulations to the following awardees, recognized Nov. 15, 2017:
1. Rookie of the Year Award: "Establishment of the First Federal Technology Transfer Ambassadors Program”
Drs. Alan Alfano, Laura Prestia, and Robert Sons, technology transfer rookies at the National Cancer Institute’s (NCI) Technology Transfer Center (TTC), established the first federal Technology Transfer Ambassadors Program (TTAP). The TTAP is a year-long, hybrid training/mentoring program for NCI post-doctoral scientists seeking professional and career development about invention development, commercialization, and entrepreneurship.
- Alan Alfano, Ph.D., NCI, TTC
- Laura Prestia, Ph.D., NCI, TTC, Invention Development and Marketing Unit (IDMU)
- Robert Sons, Ph.D., NCI, TTC, IDMU
2. Excellence in Technology Transfer Award: “Avelumab, New Therapy for Metastatic Merkel Cell and Urothelial Carcinomas”
Through a Cooperative Research and Development Agreement (CRADA) with EMD Serono, NCI played an instrumental role in developing and expediting regulatory approval of EMD Serono’s checkpoint inhibitor, avelumab. Avelumab received FDA approval in 2017, only four years after EMD Serono and NCI added the study of avelumab to their CRADA. This a remarkably fast developmental and regulatory approval timeline.
- Andrea B. Apolo, M.D., Investigator and Head of the Bladder Cancer Section, NCI, CCR, Genitourinary Malignancies Branch (GMB)
- Kevin Brand, J.D., Technology Transfer Manager (TTM), CDC, formerly NCI, TTC
- Isaac Brownell, MD, Ph.D., Investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), formerly Investigator, Dermatology Branch, NCI, CCR
- Renee N. Donahue, Ph.D., Staff Scientist, NCI, CCR, LTIB
- John Greiner, Ph.D., Staff Scientist and Head of Cytokine Group, NCI, CCR, LTIB
- James Gulley, M.D., Ph.D., NCI, CCR, GMB
- Ravi A. Madan, M.D., Associate Research Physician and Clinical Director, NCI, CCR, GMB
- Michael Pollack, Ph.D., Supervisory TTM, NCI, TTC
- Jeffrey Schlom, Ph.D., Chief, NCI, CCR, LTIB
- Julius Strauss, M.D., Staff Clinician, NCI, CCR, LTIB
3. Excellence in Technology Transfer Award: “Development of Large Scale Production, Anti-HIV Microbicide in Soya Beans"
HIV microbicides are not currently sold commercially, and many other HIV prevention techniques remain unavailable or unfeasible in developing countries where the disease is most prevalent. The technology transfer effort of developing large scale production methods of CV-N in soy beans helps to address this issue. The ability to produce CV-N in large quantities at low cost affords researchers the potential to develop effective HIV prevention methods worldwide.
- Michael R. Boyd, Ph.D., M.D., formerly NCI Chief, Laboratory of Drug Discovery, Research and Development (LDDRD) (retired)
- Rachel Chikwamba, Ph.D., Council for Scientific and Industrial Research (CSIR Biosciences)
- Mike Currens, Ph.D., NCI Developmental Therapeutics Program, formerly NCI TTC
- Bjarne (BJ) Gabrielsen, Ph.D., formerly NCI TTC (retired)
- Melissa Maderia, Ph.D., MSM, formerly NCI TTC
- James B. McMahon, Ph.D., formerly Chief, Molecular Targets Laboratory (MTL), NCI, CCR (retired)
- Barry R. O’Keefe, Ph.D., Deputy Chief, Molecular Targets Laboratory, NCI, CCR, and Chief, Natural Products Branch, NCI, DCTD, DTP
- Elíbio Rech, Ph.D., E Genetic Resources department of EMBRAPA