Welcome, Guest
Username: Password: Remember me
The Company
  • Page:
  • 1

TOPIC: Japan and treating Japanese patients

Japan and treating Japanese patients 10 Nov 2015 06:11 #5465

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3334
  • Thank you received: 1115
On Sunday I breezed through the transcript by Seeking Alpha of the ATHX Call- linke: HERE
to get myself up-to-date on their clinical programs- all the heavy stuff..really. :whistle:

Anyway- it was quite obvious that their main focus is on Japan and partnering there now and have the realization that clinical work is required IN JAPAN in order to get ahead there- a fact that I have always stressed and stress again...Very Important..

from the transcript:

Over the past two years, we have engaged in a systematic series of discussions and meetings with the PMDA and healthcare authorities in Japan. Based on our discussions, it became clear that consideration under the new system will require evidence to safety and efficacy from Japanese patients and clinical institutions. In addition to data from the international study we were conducting.
In our earliest discussions, we explored whether we might expand the ongoing Phase II trial to possibly include clinical sites in Japan, in an effort to utilize the new framework. As we’ve described previously, however, it became clear that we would have had to delayed of completion of the study, in order to achieve an appropriate level of enrollment in Japan which we were reluctant to do. So, as an alternative, we discussed with PMBA the possibility that we would complete the ongoing international trial first, evaluate the result of the study and then use those results to guide our subsequent clinical development efforts. We would then meet with PMBA to brief them and submit our detail plan for an additional study in Japan, in the context of our envisioned international development efforts.


The above also makes clear that Hedrick sees Japan as partially underdeveloped, since he clearly stated in the CC "And also I feel as if we must take better advantage of the opportunities that have been given to us in Japan."
On the one side an indication that he was not happy with the performance of Seijiro Shirahama, who many have seen as the driving force within Cytori- me included. Apparently that aint so- but clear is that there have been many private Investigator clinics in a myriad of application- so the fact is there that clinical data on Japanese patients is available for Cytori and the question arises what can be done with it :whistle:

To me these are opportunities which are bubbling right under the surface of Japanese regenerative law and everybody seems to be in talks.

Astellas just got themselves some technology, Athersys is in talks with others than Chugai- question is which Japanese Company is interested in JAPANESE CLINICAL DATA... Personally I sense that is a hot commodity...for which reason John D. Harris was hired.... :whistle:

Please Log in or Create an account to join the conversation.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Japan and treating Japanese patients 10 Nov 2015 06:23 #5466

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3334
  • Thank you received: 1115
John D. Harris has a profile at LinkedIn, which is interesting and you can visit... HERE



Former tyco man and also...Served as a voluntary missionary for The Church of Jesus Christ of Latter Day Saints (often referred to as the Mormon Church) in the Tokyo North Mission. Served in Ushiku (Ibaragi-ken), Chiba (Chiba-ken), Matsumoto (Nagano-ken) and Koshigaya (Saitama-ken). in his early years- 19988-1990. :yep: Admirable really.

Just to leave you all, to think and comment about John, the statement from Hedrick at the CC on him... :grin:

Source: those nice folks of seeking Alpha :yep:

So before I get into the nuts and bolts of the clinical programs, I'd like to officially recognize and welcome on this call, Mr. John Harris to Cytori. John began officially in October on the 1. And I'd like to spend a little time on the rationale for bringing John in.
John is going to be our new Representative Director in Japan, which means the highest management authority in Japan. And also on a global basis will be our GM for Cell Therapy. This is a new position for Cytori.
And John will assume the lead in Japan on the ground, but he's also going to assume a leadership and advisory role on the commercial planning activities that we have ongoing today on a global basis. For the time being, John is going to be domiciled in Tokyo, where we have regulatory approval.
We're enrolling an approval trial today. It's where majority of our sales are coming from. And in our view it's greatest opportunity to grow revenue over the next couple of years. So from my perspective this is a very significant addition to our team. And that's why I'm highlighting it.
It's fully consistent with our vision to lead the way and bringing cellular therapies to market for the patients that need them. And also I feel as if we must take better advantage of the opportunities that have been given to us in Japan.
We've recruited John over the course of 2015 from his role as President, Representative Director, Becton Dickinson in Japan, where he led a substantial sales and marketing-focused organization of over a $300 million a year in annual sale. But more importantly, he's been really on the inside of the regenerative medicine cell therapy activities in Japan, not only at his leadership role at BD and in selling into this exact customer base, but also on the Board of Governors of the American Chamber of Commerce in Japan.
And as I mentioned on previous calls, we actually were very involved in writing the position paper for the new regenerative medicine law for the ACCJ. And John also is on the Executive Committee of the American Medical Device and Diagnostics Association, and actually led their working group for regenerative medicine as chairs.
So despite the fact that John is a seasoned U.S. Executive and he gets the whole U.S. multinational expectation situation, John does know Japan. He speaks fluent Japanese. He knows the medical industry. He knows the regulators. He knows the customers.
And on a personal level, John is a great guy and he might be the perfect person to build upon the progress of our previous leader there, Shirahama. Shirahama founded our K.K. about 13 years ago and I want to formally thank him for his great efforts in getting us to this point. And Shirahama will assume the new role as Head of Customer Acquisition in Japan.
So the bottomline here is this hire is indicative of our full commitment to the Japanese market and what we think can be made out of that opportunity. And also it shows our full commitment to ongoing development of our commercial preparatory activities.

The following user(s) said Thank You: fatboy

Please Log in or Create an account to join the conversation.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
  • Page:
  • 1
Time to create page: 0.095 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites