It's difficult to believe we're about to put our final issueof 2011 to press, but as we don our gay apparel, pour some celebratory eggnogand give this edition a final polish, we have a rare few moments to pause andreflect on another editorial year gone by.
This year, we produced more editorial content than everbefore, in all of the news vehicles that have become familiar to you—ourmonthly newspaper and international PDF, 24-7 website, bi-monthly e-newsletterand blog—as well as some new additions to our news organization: the ddn Cancer Research Portal, which justlaunched in October, and several multi-issue special reports on specific trendsin the pharma/biotech industries.
One of those reports, a three-part series on stem cellresearch, was a landmark and multi-faceted examination of the history andevolution of this growing area of science, as well as some of its majoracademic and commercial players. Last month, in our ongoing coverage ofdevelopments in the stem cell world, we singled out some of the sources thathave made our content so intriguing: the plaintiffs behind the controversial Sherley v. Sebelius lawsuit. Theplaintiffs and their attorneys have been especially gracious with their timeand open to discussing their opposition to human embryonic stem cell research(hESC).
This month, I would like to grant equal space and time tosomeone on the opposite side of that issue: Alan Trounson, president of theCalifornia Institute for Regenerative Medicine (CIRM)—a state research entitythat was birthed in 2004 when California voters overwhelmingly passed astatewide ballot issue, Proposition 71, and took a firm stand on thefurtherance of stem cell research—involving hESC lines as well as other cellproducts. I interviewed Trounson this month for a story on the CIRM's recentlyannounced partnership with the U.S. National Institutes of Health (see "Two heads are better than one"), andwe had a pleasant, leisurely conversation about the CIRM's short but impressiveevolution and the entity's plans for bringing various cell therapies to market.
Trounson was also vocal about discussing some of thechallenges that stem cell research is facing on a federal level, and how theyare impacting the rate at which researchers are able to make breakthroughs.Although California stem cell researchers arguably enjoy the most liberalresearch environment, "Every time a law gets introduced that would interfere withscientists working together or making significant contributions, it is aconcern to me," Trounson says.
"Most Americans would like to see these treatments evolve sothey can be used across the country," he argues.
In particular, "Dickey-Wicker is a handicap and is notbenefiting research at all. But it's difficult to change. Sometimes you have towork with these major stones in the road, and just drive around them," Trounsonsays.
He was also critical of Big Pharma's limited involvement inthis area: "We're looking at a pharmaceutical industry with a decreasinglyeffective pipeline. Cell therapy is there, but its potential is still growing.The opportunity to link these two things together is possible, but the BigPharma model doesn't suit cell therapies," he contends. "It's like oil andwater—they don't mix together. Maybe in time, they will realize the potentialof these cell therapies—especially if they are not producing new drugs."
Specifically, regenerative medicine, he notes, is "an areathe regulatory agencies are focusing on closely. I think by the time ourstudies get to clinical trials, we will have a good handle on that. We'redeveloping a lot of imaging technologies to find out where cells go, whetherthey change or become a part of a patient's cell population, etc. On theseissues, we are working intensively with the FDA, and they are helping us. It'sa very good process, and things are improving dramatically in our understandingof what our needs are. It's all a matter of deciding when you get into clinicaltrials that they are safe. Are they really safer and more effective than whatis currently available to patients? We have to have something better than whatis currently induced by physicians."
As we head into our eighth year of publishing, we expectstem cell research and oncology to remain hot topics throughout our 2012coverage. We invite you to come along for the journey. Happy holidays to you,our faithful readers, and we'll see you next year.