Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments

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.)

Dr. Steven Rosenberg
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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56 NGOs ask US Government enable export of low cost generic versions Xtandi to developing countries

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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5 October 2016: Statement of Knowledge Ecology International at inaugural Marrakesh Treaty Assembly

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.

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KEI statement at WIPO GA 2016 on the Inter-governmental Committee (IGC) on genetic resources, traditional knowledge

KEI is interested in how regimes proposed in the IGC impact the economics of stewardship, curation and sharing of Traditional Knowledge (TK) and Genetic Resources (GR).

KEI generally opposes the creation of exclusive rights that can block innovations and access to knowledge and materials, in the context of Traditional Knowledge or Generic Resources.

However, benefit sharing does not require the granting of exclusive rights. Liability rule approaches seem to offer a better model.

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WIPO GA 2016: Statement by India on behalf of Asia Pacific Group – Report on the IGC

On Thursday, 6 October 2016, India delivered the following statement on behalf of the Asia Pacific Group in relation to the General Assembly’s deliberations on WIPO’s work on genetic resources, traditional knowledge and traditional cultural expressions.

Position Statement by India on behalf of Asia- Pacific Group on Agenda Item 16 – Report on the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), delivered by Dr. Sumit Seth, First Secretary(Economic Affairs)

Thank you Mr. Chairman

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WIPO General Assembly 2016: Statement of Knowledge Ecology International on the Report of the SCCR

On Wednesday, 5 October 2016, Knowledge Ecology International delivered the following intervention on the agenda item concerning the Report of the Standing Committee on Copyright and Related Rights (SCCR).

Agenda item 11: Report on the SCCR

244 words

Thank you Chair.

Congratulations to Sylvie Forbin, the highly qualified new DDG for the Copyright and Creative Industries Sector.

KEI welcomes the entry into force of the Marrakesh Treaty, and look forward to additional work at WPO to expand access to knowledge and knowledge based goods.

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WIPO General Assembly 2016: Opening Statement of Knowledge Ecology International

On October 4th, 2016, Knowledge Ecology International (KEI) delivered this opening statement on the occasion of the Fifty-Sixth Series of Meetings of the Assemblies of the Member States of the World Intellectual Property Organization (WIPO).


KEI General Statement – WIPO General Assembly – 2016

October 4th, 2016

Thank you Chair for providing Knowledge Ecology International (KEI) the opportunity to speak today.

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General Assembly 2016 – Opening Statement of Bangladesh on behalf of the LDC Group

On Monday, 3 October 2016, Bangladesh delivered the following opening statement on behalf of the LDC Group at the World Intellectual Property Organization’s (WIPO) General Assembly.

General Statement on behalf of the LDC Group at the 56th Session of the Assemblies of the Member states of WIPO
[3 October 2016]
Delivered by Ambassador H.E. Mr. M Shameem Ahsan,
Permanent Representative of Bangladesh to the United Nations
( Suggested time: 5 minutes)

Mr. President,
Director General,
Distinguished representatives,
Good morning.

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