Pfizer takes lead role in stem cell research

Agreements with University College London, U of Wisconsin—Madison part of $100 million investment in international stem cell development program

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CAMBRIDGE, Mass.—Pfizer Inc. has jumped into the academic pool with a pair of agreements involving stem cell research—both aimed at developing new drug therapies and both having university connections.

Pfizer's Regenerative Medicine unit last month reached a sponsored research and licensing agreement with University College London (UCL) to develop stem cell-based therapies for ophthalmic conditions. In a separate agreement, Pfizer agreed to license human embryonic stem cell (hESC) patents from the University of Wisconsin-Madison for the development of new drug therapies.

The agreements come as Pfizer makes a $100 million investment in its international stem cell development program. The company's regenerative medicine unit at Granta Park will become Pfizer's No. 1 stem cell base worldwide under an initiative that provides the discipline with its largest single cash injection from the corporate sector to date.

According to Pfizer spokeswoman Elizabeth Power, the Pfizer Regenerative Medicine unit will grow to about 70 staffers in the next year.

"Colleagues based at the Research Technology Center (RTC) in Cambridge, Mass., will focus on using stem cells to develop therapies for diabetes through in-house research and a vast array of alliances and collaborations," she says. "Colleagues at the Cambridge, U.K., location focus on age-related and degenerative disorders with particular interest in common cellular mechanisms and disorders of the central and peripheral nervous system."

The UCL collaboration brings together the pioneering work of university researchers in the field of cell-based therapies and Pfizer's expertise in the design and delivery of therapeutics. The collaboration will examine how hESCs differentiate into retinal pigment epithelium (RPE) with the goal of developing stem cell-based therapies primarily for wet and dry macular degeneration (AMD). Under terms of the agreement, Pfizer's contributions will include expertise in the design and execution of clinical studies and interaction with global regulators as well as in product manufacturing techniques. Once preclinical testing has been completed, Pfizer has the option to conduct clinical testing and has commercial rights to any resulting product.

According to Ruth McKernan, chief scientific officer at Pfizer Regenerative Medicine, the UCL collaboration presents the opportunity to work with pioneers in the field of stem cell ophthalmology.

"While we have much to learn about how stem cells can be used therapeutically, we are confident that this relationship will increase that understanding and help us advance to a time when our work may benefit patients worldwide," McKernan says.

The London Project to Cure Blindness is led by Prof. Pete Coffey of UCL's Institute of Ophthalmology, who says Pfizer's involvement would help usher the technology through the regulatory process, and make it possible to manufacture the therapy "on a much larger scale."

According to Power, the collaboration with UCL and Coffey has the potential to be the first ES cell-based product for the Pfizer Regenerative Medicine RU. 

"In his studies, Prof. Coffey has developed a method to differentiate human embryonic stem cells to form retinal pigmented epithelial cells," she adds. "These cells restore sight in a blind rat."

The collaboration with the Wisconsin Alumni Research Foundation (WARF) provides Pfizer the rights to work with hES cells for drug research and discovery. WARF is a separate entity from University of Wisconsin and is a non-profit organization designed to support and instigate research at UW.

According to WARF spokesperson Janet Kelly, the dialogue between Pfizer and WARF has existed for more than a year.

"This is a great opportunity for us from a business perspective," she adds.
While terms of the agreement are confidential, Kelly notes that Pfizer is the largest of 35 companies that have signed embryonic stem cell licenses with the foundation, which holds several key stem cell patents.

"The agreements with these companies and Pfizer is perhaps a signal that large pharma is recognizing the value of the more than 10 years of research in the field and the therapeutic potential hESCs represent," she says. "WARF anticipates additional licensing activity in this sector."

The licensing agreement will help Pfizer forward its stem cell R&D goals, which McKernan adds are threefold: to use human cells as tools in its drug discovery efforts, to improve the safety of new treatments and most importantly, to move towards cell therapy.

With a recent executive order by President Barack Obama regarding stem cell research in the United States, it would seem on first blush that it has sparked a flurry of collaborations. That isn't the case with regard to Pfizer, Power says.

"At no point did federal policy place restrictions on what can be done with hES cells using private funds," adds Power. "President Obama's recent executive order allowing for government funding for human embryonic stem cell research is likely to speed stem cell research and development at government and academic institutions. The fruits of that research will ultimately benefit biopharmaceutical R&D efforts."

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