In a recent exchange with Senator Durbin, NIH Director Francis Collins expressed his concern that the NIH would alienate potential collaborators if the NIH applied the march-in remedy to address excessive prices of drugs. Continue Reading
Attached below are the appointment calendars, with redactions by the USTR FOIA office, for USTR Ambassadors Froman, Holleyman and Punke.
Note: The files containing Ambassador Froman’s calendar are arranged alphabetically by month. Continue Reading
KEI is holding a December 2, 2016 meeting on the delinkage of R&D costs from drug prices.
The venue will be US Senate Hearing Room SD-106, Dirksen Office Building. The meeting will take place from 9:00am to 2:00pm.
A copy of the agenda is available here.
For more information about delinkage, see: http://delinkage.org.
To register for the event, please fill out this form: https://goo.gl/forms/AbP2npqLRLYneLjk1.
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KEI is holding a December 2, 2016 meeting on the delinkage of R&D costs from drug prices. The venue will be US Senate Hearing Room SD-106, Dirksen Office Building. The meeting will take place from 9:00am to 2:00pm. A copy… Continue Reading
Today, KEI submitted comments to the Notice published in the Federal Register on October 5, 2016, entitled “Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers.” KEI’s comments addressed issues with the NIH’s processes for granting exclusive licenses, and transparency in those licenses, resulting data, trials, pricing, and revenue.
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Kite Pharma is a California-based biopharmaceutical company working on various types of cell therapies for the treatment of cancer, in a bid to become the first pharmaceutical firm to gain successful FDA approval for this new class of cancer treatment.
Kite closely collaborates with the National Cancer Institute, which conducted significant early research into the forms of cell therapies that Kite is seeking to commercialize. NCI conducts clinical trials under Cooperative Research and Development Agreements (CRADAs) with Kite, and additionally has granted exclusive licenses on over a dozen patents to Kite on the same technologies.
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Kite Pharma, Inc., which is racing Juno Therapeutics and Swiss pharmaceutical giant Novartis to successfully bring the first T-cell receptor (TCR) therapy to market, relies heavily on government support in the course of its research and development.
As noted previously by KEI, in various comments to the National Institutes of Health, the NIH rarely discloses detailed information on its connections with industry, raising concerns about how the NIH licenses out taxpayer-funded technologies without regard for future prices or access for U.S. residents.
For a selected bibliography of news stories on Kite’s relationship with the National Cancer Institute, see here: /node/2644.
T-cell receptor therapy is the latest breakthrough in cancer treatment, and involves modifying a patient’s own cells to better track and destroy cancer proteins, and then reintroducing them into the body. (The NIH has a concise description for non-scientists here.)
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| Dr. Steven A. Rosenberg is the Principal Investigator for the National Cancer Institute on Kite’s 2012 CRADA. Dr. Rosenberg mentored Kite CEO and co-Founder Dr. Arie Belldegrun, and is also listed as a “Special Advisor” to Kite on their website. | Partnership for Public Service / Aaron Clamage |
According to Kite’s filings with the Securities and Exchange Commission (SEC), Kite has secured three Cooperative Research and Development Agreements (CRADAs) with the National Cancer Institute (NCI). In exchange for quarterly cash payments, the NCI conducts clinical trials and laboratory work on many of its own patented technologies, with the understanding that Kite will have the rights to commercialize any successful products developed through the CRADA.
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On Monday morning, 17 October 2016, the United States Trade Representative, Michael Froman, delivered a lecture at the Graduate Institute entitled, The WTO in a Time of Change: Some Reflections.
17 OCTOBER 2016
CONTACT: Zack Struver, zack.struver@keionline.org, +1-202-332-2670, or Paul Davis, pdavis@keionline.org, +1-202-332-2670
Note: Letter from Biolyse to HHS here: /wp-content/uploads/28-sept-2016-biolyse-to-hhs-letter.pdf
Letter from NGOs to HHS here: /wp-content/uploads/17-oct-2016-civil-society-letter-xtandi.pdf
Washington, DC — Today, over 50 patient, senior citizen, global health, development, social justice, and faith groups urged the United States Government to use its rights in a federally funded patented invention, and accept the request by a Canadian generic drug manufacturer (Biolyse Pharma) to enter into an agreement to manufacture and export an affordable version of the taxpayer-funded prostate cancer drug enzalutamide to South Africa and other countries with low per-capita incomes relative to the United States.
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On Wednesday, 5 October 2016, Knowledge Ecology International (KEI) delivered the following intervention at the inaugural Marrakesh Treaty Assembly.
5 October 2016
It is an important achievement for WIPO to have embraced the Marrakesh Treaty, and addressed and corrected the barriers that copyright presented for access to culture and knowledge, for persons who are blind or have other disabilities.