CLEVELAND, Ohio — Ruth McKernan helped start Pfizer Regenerative Medicine — a research-oriented business unit of Pfizer, which calls itself the world’s largest research-based pharmaceutical company — in July 2008.
“We see regenerative medicine — stem cell-based research and therapy — as an emerging area,” said McKernan, chief scientific officer for the regenerative medicine unit, during a telephone interview.
Already, McKernan’s unit has struck three collaborations: A license agreement with the University College London to better understand how to develop embryonic stem cell therapies for ophthalmic conditions; and a license for embryonic stem cell patents for the development of drug therapies from the Wisconsin Alumni Research Foundation in Madison, Wis.
On Monday, the Pfizer unit struck a development and commercialization agreement with Athersys Inc., the Cleveland biopharmaceutical company. Pfizer plans to develop and market a therapy for sufferers of inflammatory bowel disease based on MultiStem, the Athersys adult stem cell product.
MedCity News caught up with McKernan on Tuesday just after she returned home to the United Kingdom via the East Coast snow storm. The U.S. base for the Pfizer unit is in Cambridge, Mass. Its two other locations are Cambridge and Sandwich, U.K.
Q. What attracted Pfizer Regenerative Medicine to Athersys?
A. What we didn’t have in our existing portfolio was an adult stem cell program. We spent the second half of the year looking at different opportunities. And I felt it was important to partner rather than build from scratch. Athersys is a good fit. The fact that Athersys has a cell product already in the clinic gives it the look of expertise.
Q. If there is a criticism of the MultiStem product, it could be that it doesn’t have a targeted effect. Is that a problem for Pfizer?
A. We need to explore the science and biology behind adult stem cell therapies. The fact that it’s an off-the-shelf product makes it scalable. So it’s an expandable, early progenitor cell therapy, which makes it appropriate for large-scale production. If we used a more differentiated product, then it wouldn’t be so scalable. These are some of the things we will be exploring in our research. There may be opportunities for some targeting in the future.
Q. Did you also choose Athersys for developing an inflammatory bowel disease therapy because MultiStem has proven anti-inflammatory effects?
A. The observation that MultiStem cells secrete molecules that modify the immune system gives us a really good starting point. Clinical studies and research might show the cells as the preferable way to treat severe inflammatory disorders.
Q. Is Pfizer the first large pharmaceutical company to launch a regenerative medicine unit?
A. We did launch our regenerative medicine unit 18 months ago. And at that time, I was not aware — and am not aware now — of another company that has said it would work in cell therapy at a dedicated research unit. That said, I see my colleagues from other companies at stem cell meetings, so I’m pretty confident that they’re doing something in the space.
Q. Do you have a sense for what your competitors are working on?
Glaxo SmithKline has a stem cell collaboration with the Harvard Stem Cell Institute. I know that Johnson & Johnson has published work (pdf) in the area of stem cell research. Several companies have taken equity stakes in emerging biotechs in this field. My view is, there’s a growing interest.
Q. How does regenerative medicine broaden the effects of a traditional pharmaceutical company?
A. Pfizer is very keen on diversification — bringing all kinds of therapies to patients. Pfizer Biotherapeutics (the division of the drug company to which the regenerative medicine unit belongs) uses cutting-edge biology, new platform technologies and advanced research tools to discover and develop new medicines called biologics.
Wyeth Pharmaceuticals (which Pfizer bought this year), is known for its small “small molecules” — light-weight molecules that can be used as medicines to modify pathways in the body. You could see cell therapy as an extension of that. It provides a therapeutic effect that is different from the effect of modifying only one pathway.
We need all molecules and biologics to control the fate of cells. So having a connection to small molecules and the ability to use our in-house biologics to modify cell fate is going to help us make cell therapy accessible more quickly.
Q. Could this ability lead to treatments for diseases, like inflammatory bowel, that so far have not been well-controlled with conventional drugs?
A. The most valuable outcome would be that cell therapy is effective where small molecules and biologics no longer are effective. They also might provide different options for patients, particularly in later life and in later-stages of a disease.
Q. Why is Pfizer collaborating with stem cell companies rather than buying them?
A. We do have stem cell research going on in our unit. But in order to be in the front of the field, and to lead it forward as quickly as possible, we could do that more effectively by collaborating with people who have a depth of history and experience in the science.
The science is still early. We want to understand which of the many approaches would be the best for each type of indication. So that’s why we’re working on small molecules and biologics to modify cell fate, we’re working on differentiated cells produced from embryonic cell lines and we’re working with the Athersys adult MultiStem product that has potent immune-suppressing quality.
Q. What is your hope for the collaboration with Athersys?
A. It’s the same as my hope for all of our work. We want to make some new therapies that are really valuable for patients. And if we could do that with Athersys, that would be fantastic.