This morning, both sides agreed, the industry is at an “inflection point.” The phrase was first used by Gil Van Bokkelen, CEO of Athersys and immediate past chair of ARM, for which CIRM is a founding member. He was one of eight industry executives who uniformly predicted 2013 would be marked by significant advances in bringing stem cell and other regenerative therapies to patients. In the investor analyst panel that followed the execs, two of the speakers said they agreed the year could be an inflection point.
The speakers on both sides of the fence sited many reasons for why this year would be special, but the number one reason seemed to be data. Many companies are poised to release extensive data on clinical trials this year, and not just data from phase one trials that are designed to show safety, but also from later stage trials that are predicted to show benefit, and most important, measurable, well defined benefit.
Other reasons for optimism from the panelists included:
- Early trials have shown a consistent record of safety from cell transplants;
- Most of the companies are aiming for patient populations where there are large and clear unmet medical needs and this point is starting to register with investors and big pharmaceutical companies that have the capacity to take therapies to the market;
- The impact of already approved products, such as the wound healing skin cells from Organogenesis and Shire, are having a growing impact on medical practice;
- The number of products making into approved clinical trials has improved the regulatory landscape so firms have a clearer idea of what the federal Food and Drug Administration wants to see before they approve clinical trials.