Showing posts with label manufacturing. Show all posts
Showing posts with label manufacturing. Show all posts

Wednesday, May 09, 2018

Removing the Barriers to Widespread Use of Stem Cell Treatments

If you are really interested in delivering stem cell therapies to the marketplace, the place to be early next month is in Los Angeles at a major, international conference that will examine the bottlenecks that stand in the way of bringing the treatments to the public at large.

The California stem cell agency, which is spending $3 billion to create therapies, says that "key unresolved issues" must be addressed before safe and effective therapies reach the mainstream.

The stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), is co-sponsoring the two-day event June 5 and June 6 with the The International Alliance for Biological Standardization.  The session is drawing speakers from around the world. 

Abla Creasey, CIRM photo
Earlier this year, Abla Creasey,  vice president of therapeutics and strategic infrastructure at the agency, said, 
“The field of stem cell research and regenerative medicine has matured to the point where there are over 900 clinical trials worldwide. It is critical to develop a system of effective regulation of how these stem cell treatments are developed and manufactured so patients can benefit from future treatments.”
Her comments appeared on the agency's blog, The Stem Cellar, in an item written by Geoff Lomax, senior officer for CIRM strategic initiatives. Lomax also quoted Martin Pera, a professor at the Jackson Laboratory in Maine and who also directs the International Stem Cell Initiative Genetics and Epigenetics Study Group, and Robert Deans, chief technology officer of Blue Rock Therapeutics, Inc.,  of Cambridge, Mass.

Pera said,
“Participants at this meeting will survey and discuss the state of the art in the development of definitive assays for assessing the safety of pluripotent stem cell based therapies, a critical issue for the future of the field. Anyone active in cell therapy should attend this meeting to contribute to a dialogue that will impact on research directions and ultimately help to define best practice in this sector.”
Deans said,
“I believe standardization will be an increasingly crucial element in securing commercial success for regenerative cell therapies. This applies to all facets of development, from cell characterization and patent protection through safety testing of final product. Most important is the adherence of players in this sector to harmonized standards and creation of a scientifically credible market to the capital community.”
Here is a link for registration.

Search This Blog