Even a cursory glance at general media over recent weeks would have indicated an increased amount of coverage dedicated to immunotherapy. Partly linked to recent developments in the filed, most major outlets have, in the past few months, chimed in, in one way or another, in a response to the major headlines.
As an example, this week, the New York Times asked “What Is Immunotherapy?” in an article that followed on from recent NY Times reports commenting on the recent stem cell clinic data and the temporary halt of Juno Therapeutics’ CAR-T trials.
Others have followed suit, reflecting what the media appears to perceive as a momentum that the field is currently enjoying. Yet there is optimistic caution, with the field and its treatments being called “controversial” in some reports. Such claims are understandable, especially due to the reactory nature with which the media operates.
But positives have emerged from these media reports as well.
These recent developments have renewed discussions about topics as varied as the operation of stem cell clinics as well as, more generally, the safety and efficacy of cell and gene therapy-based treatments.
Spurred by recent developments, questions about regulations and the role of the FDA in overseeing and approving these immunotherapies have been raised – these questions aim at tackling issues with respect to the regulatory landscape that accompanies cell and gene-based immunotherapies.
On one hand, the FDA has been praised for the speed with which it has kept up with these fast-developing discoveries in the CAR-T and 3D printing arena as they pertain to clinical therapy, while on the other, the Agency has been called to provide tighter oversight and more regulation to the field.
These discussions have renewed interest in new initiatives that have emerged aimed at easing the path to market for these new therapies.
Some are looking to Japan for inspiration: new regulations accelerating the approval of regenerative therapeutics in Japan took effect Nov. 25, 2014. These are The Act on the Safety of Regenerative Medicine and The Pharmaceuticals, Medical Devices Act. The main benefit of these new regulations is that they enable companies to receive conditional marketing approval and generate revenue from regenerative products while trials are being conducted.
And just like Japan, a controversial proposal, which we wrote about recently, by the Bipartisan Policy Center—to open up a conditional approval pathway for the FDA to conditionally approve—at its discretion— conditionally approve certain cell therapies that have a lower risk profile—for a limited period of time prior to the full clinical trials are complete.
Whether this the right path forward is for a separate discussion, but a greater awareness of the therapeutic frontiers of cell therapy will ultimately fuel a greater involvement—from both the public and regulatory sectors—to push these frontiers forward, which can only be a good thing.