- Reaction score
- 2,634
Here's a video! Lee Buckler begins speaking at 16:10 if you want to skip right to Replicel.
[video=youtube;7oxDguaiEVM]https://www.youtube.com/watch?v=7oxDguaiEVM[/video]
Part 1:
https://www.youtube.com/watch?v=lNeibGSqHqM
(I can't post two videos at one, forum limit!)
Question & Answers with Lee Buckler:
Q) Are actually able to culture the DSC without losing their gene-expression signature.
A) They are continuing to explore expression in regards to phenotype.
Q) Is there already a starting date for the Shiseido RCH-01 trials?
A) The trial in Japan in Shiseido hasn't started yet, and this is no fault of Replicel's, or anyone's really. It's all to do with the relatively new regulations Japan has to offer. As great as the opportunities are for Replicel, Japan is still ironing out all the details and the committees that approve the certain trails for biotechs, in which case, a committee is being put in place for Replicel's area of work, hence the delay. But, should be a matter of weeks before trials start.
Q) How long will the Phase II trial be for the Shiseido trials? Are they shorter than the European trials that are 39 months (!), since Lee Buckler said that he expects that Shiseido's treatment will be available in 2018/2019 in Japan?
A) 24 months by Shiseido in Japan, but may or may not be accurate.
Q) I'm guessing Replicel have been focused on their other products such as the RCI-02 injector, the trials for RCT-01 (tendoins) and RCS-01 (skin). Is the development and trials for RCH-01 more complex and therefore taking the backseat compared to the other products? And will focus be shifted more towards treating male pattern baldness when their other products have been launched?
A) It's not taking a back seat by any means. RCH-01 is still one of their major goals. It may seem like they've taken a backseat, but they haven't. Note from Hellouser; their major delay was from the growth medium. If you listen to the interview from 2015 Hair Congress, you'll notice that they had to come up with their own which took a long time. There was a possibility that they would have had to restart their trials but thankfully, that didn't happen. Full interview can be heard here: https://www.youtube.com/watch?v=gnrb3LBMV64
Q) The whole dsc platform is based on the theory that the DSCs from the back of the head are dht resistant. This would lead me to believe that dscs from this region differ from dscs on the top of the scalp. Thus i am curious to see if they have ever fully examined the cells to see if that there is genetic differences between the two that could attribute to the dht resistance in one vs dht susceptibility in the other.
A) They're still exploring expressions of DHT in follicles. Note from Hellouser: I posted earlier today a speech on this from the Hair Congress. Have a listen to this: https://www.youtube.com/watch?v=5N5bMHVh3eM
Some photos from the seminar:
http://imgur.com/a/0g89h
Many thanks to the Replicel team and Lee Buckler for taking time out of their day and having another chat with me.
--
I'm likely going to be attending this. I already called in to get a spot to attend. There's a chance I may speak with Lee Buckler again so if you guys have questions, post them here!
This is the seminar:
https://www.jetro.go.jp/canada/events/rmseminar012916.html
Japan’s Regenerative Medicine Market:
Expedited Approval System Creates New Opportunities for Canadian Cell Therapy Companies and Researchers
JETRO and the Centre for Commercialization of Regenerative Medicine (CCRM) are hosting a seminar on Japan's Regenerative Medicine Market on January 29th, 2016 at the Hilton Toronto.
In 2014, Japan introduced an expedited approval system for regenerative medicine products as well as other reforms related to the supply of stem cells.
Foreign companies and researchers are now looking at Japan as a potential location for clinical trials. There are also new business opportunities emerging for foreign companies as Japan develops its regenerative medicine related infrastructure.
Speakers at this event will explain about the new expedited approval system in Japan and give examples of on-going collaborations between Canada and Japan in the field of regenerative medicine. .
Date:
January 29th, 2016
9:00 am - 12:00 pm
(registration 8:00 am)
Venue:
Hilton Toronto (York Suite)
145 Richmond Street West,
Toronto, ON M5H 2L2
Co-organizers:
- Japan External Trade Organization (JETRO)
- Centre for Commercialization of Regenerative Medicine (CCRM)
Supporting Organizations:
- Ontario Institute for Regenerative Medicine (OIRM)
- International Society for Cellular Therapy (ISCT)
[video=youtube;7oxDguaiEVM]https://www.youtube.com/watch?v=7oxDguaiEVM[/video]
Part 1:
https://www.youtube.com/watch?v=lNeibGSqHqM
(I can't post two videos at one, forum limit!)
Question & Answers with Lee Buckler:
Q) Are actually able to culture the DSC without losing their gene-expression signature.
A) They are continuing to explore expression in regards to phenotype.
Q) Is there already a starting date for the Shiseido RCH-01 trials?
A) The trial in Japan in Shiseido hasn't started yet, and this is no fault of Replicel's, or anyone's really. It's all to do with the relatively new regulations Japan has to offer. As great as the opportunities are for Replicel, Japan is still ironing out all the details and the committees that approve the certain trails for biotechs, in which case, a committee is being put in place for Replicel's area of work, hence the delay. But, should be a matter of weeks before trials start.
Q) How long will the Phase II trial be for the Shiseido trials? Are they shorter than the European trials that are 39 months (!), since Lee Buckler said that he expects that Shiseido's treatment will be available in 2018/2019 in Japan?
A) 24 months by Shiseido in Japan, but may or may not be accurate.
Q) I'm guessing Replicel have been focused on their other products such as the RCI-02 injector, the trials for RCT-01 (tendoins) and RCS-01 (skin). Is the development and trials for RCH-01 more complex and therefore taking the backseat compared to the other products? And will focus be shifted more towards treating male pattern baldness when their other products have been launched?
A) It's not taking a back seat by any means. RCH-01 is still one of their major goals. It may seem like they've taken a backseat, but they haven't. Note from Hellouser; their major delay was from the growth medium. If you listen to the interview from 2015 Hair Congress, you'll notice that they had to come up with their own which took a long time. There was a possibility that they would have had to restart their trials but thankfully, that didn't happen. Full interview can be heard here: https://www.youtube.com/watch?v=gnrb3LBMV64
Q) The whole dsc platform is based on the theory that the DSCs from the back of the head are dht resistant. This would lead me to believe that dscs from this region differ from dscs on the top of the scalp. Thus i am curious to see if they have ever fully examined the cells to see if that there is genetic differences between the two that could attribute to the dht resistance in one vs dht susceptibility in the other.
A) They're still exploring expressions of DHT in follicles. Note from Hellouser: I posted earlier today a speech on this from the Hair Congress. Have a listen to this: https://www.youtube.com/watch?v=5N5bMHVh3eM
Some photos from the seminar:
http://imgur.com/a/0g89h
Many thanks to the Replicel team and Lee Buckler for taking time out of their day and having another chat with me.
--
I'm likely going to be attending this. I already called in to get a spot to attend. There's a chance I may speak with Lee Buckler again so if you guys have questions, post them here!
This is the seminar:
https://www.jetro.go.jp/canada/events/rmseminar012916.html
Japan’s Regenerative Medicine Market:
Expedited Approval System Creates New Opportunities for Canadian Cell Therapy Companies and Researchers
JETRO and the Centre for Commercialization of Regenerative Medicine (CCRM) are hosting a seminar on Japan's Regenerative Medicine Market on January 29th, 2016 at the Hilton Toronto.
In 2014, Japan introduced an expedited approval system for regenerative medicine products as well as other reforms related to the supply of stem cells.
Foreign companies and researchers are now looking at Japan as a potential location for clinical trials. There are also new business opportunities emerging for foreign companies as Japan develops its regenerative medicine related infrastructure.
Speakers at this event will explain about the new expedited approval system in Japan and give examples of on-going collaborations between Canada and Japan in the field of regenerative medicine. .
Date:
January 29th, 2016
9:00 am - 12:00 pm
(registration 8:00 am)
Venue:
Hilton Toronto (York Suite)
145 Richmond Street West,
Toronto, ON M5H 2L2
Co-organizers:
- Japan External Trade Organization (JETRO)
- Centre for Commercialization of Regenerative Medicine (CCRM)
Supporting Organizations:
- Ontario Institute for Regenerative Medicine (OIRM)
- International Society for Cellular Therapy (ISCT)