|
|
Post by jckrdu on Jul 19, 2014 23:44:11 GMT
Legislation fast-tracking regenerative medicine therapies in Japan was passed in November 2013. In this article, it states the laws will be implemented in 1 year. Could hear something on this new accelerated pathway by the end of 2014.
The CEO of Athersys (ATHX) is doing the groundwork (already contracted with a Japanese CRO) to take advantage of this accelerated pathway for their MultiStem product in an anticipated accelerated trial for stroke. Wouldn't surprise me to see ACTC pursue trials in Japan as well.
Japan - Accelerated Pathway for Stem Cell Therapies |
|
|
|
Post by jckrdu on Jul 19, 2014 23:48:07 GMT
Legislation fast-tracking regenerative medicine therapies in Japan was passed in November 2013. In this article, it states the laws will be implemented in 1 year. Could hear something on this new accelerated pathway by the end of 2014.
The CEO of Athersys (ATHX) is doing the groundwork (already contracted with a Japanese CRO) to take advantage of this accelerated pathway for their MultiStem product in an anticipated accelerated trial for stroke. Wouldn't surprise me to see ACTC pursue trials in Japan as well.
Japan - Accelerated Pathway for Stem Cell Therapies An excerpt... Japan has passed two regenerative-medicine laws on 20 Nov. 2013. One law would speed approval of stem cell treatments by no longer requiring candidate therapies to pass rigorous (and very expensive) phase III clinical trials to prove efficacy. A different law would require physicians to report the clinical use of unapproved stem cell therapies to the Japanese health ministry. Both laws are reportedly going to be implemented within a year, according to Nature Medicine (19:510 (2013)).
|
|
|
|
Post by JHam on Jul 20, 2014 1:57:00 GMT
Legislation fast-tracking regenerative medicine therapies in Japan was passed in November 2013. In this article, it states the laws will be implemented in 1 year. Could hear something on this new accelerated pathway by the end of 2014.
The CEO of Athersys (ATHX) is doing the groundwork (already contracted with a Japanese CRO) to take advantage of this accelerated pathway for their MultiStem product in an anticipated accelerated trial for stroke. Wouldn't surprise me to see ACTC pursue trials in Japan as well.
Japan - Accelerated Pathway for Stem Cell Therapies An excerpt... Japan has passed two regenerative-medicine laws on 20 Nov. 2013. One law would speed approval of stem cell treatments by no longer requiring candidate therapies to pass rigorous (and very expensive) phase III clinical trials to prove efficacy. A different law would require physicians to report the clinical use of unapproved stem cell therapies to the Japanese health ministry. Both laws are reportedly going to be implemented within a year, according to Nature Medicine (19:510 (2013)).
Good stuff Jckrdu. I'd love to see these kind of laws passed in the USA, but something tells me they'll be last to do so. As I know I and others have said for a while, eventually the FDA will have to re-think its trial protocol for stem cell therapies. Especially since safety and efficacy are unable to be separated in Phase I. It's a waste of valuable time and money. Breakthrough Therapy Designation is a step in the right direction though. |
|
|
|
Post by dayanand33 on Jul 20, 2014 2:26:03 GMT
phase I will be the new Phase II and phase III will be gone. Wow!
It will change the way the market evaluates a stem cell stock. Very soon the best time to get into a stock will be end of Phase I
|
|
|
|
Post by rickrick on Jul 20, 2014 8:11:28 GMT
Jckrdu,
This is something to look forward to seeing what happens, another door opening in the Reg med field.
JHam,
I agree with you. I'm impressed that we even allowed stem cell trials to take place here.
Day,
I give it a wow too.
|
|
