Ed will be speaking at a conference. No big deal but when ya look at the surrounding cast of characters it just reiterates that we are really on top of the game.
What does it take to get to the clinic?
What are key regulatory considerations?
Approaching the Agency as a partner
Edmund Mickunas, Vice President, Regulatory Affairs, Advanced Cell Technologies (ACT)
I have sneaking suspician that our legitamcay will become ever more recognized as 2011 progresses. What steps will be taken and at what speed remain to be seen. An affirmation to those who are eager to validate the science of embryonic stem cell research. We are a major player here. hell we practically are the player here. The eyes of pharma and biotech are watching. I believe there is a fear throughout the big name companies of attaching themselves to a science that is not seasoned in human trials.They are unwilling to aggresively stick their neck on the line. But they are waiting in the wings ready to jump agresssively into it if suceeses begin to occur. A rush to acquire preclinical programs, intellectual property, iniate trials in an expediated fashion. Of course merger and acquisition action.
We on the other hands are the renegedes of the industy. We never caved. We fought and perservered. We explored many options in attempt circmnavigate bureacratic red tape. We hung in tooth and nail and we have an extensive patent portflio, 2 Embryonic trials expected to commence in 2011 to show for it.
We have politicians dictating the rules and regulations of a science most don't fully understand. Some act not on the best interest of the people but in their own personal ambition. They turn a blind eye to the overwhelming majority of the scientific community thats supports giving this research every opportunity afforded any other research.
Those days will hopefully be put behind us. If the science progresses and promise is shown we will have a huge shift in mindset. They will never stop tring to dictate their perceived morality on us. But their perception will change.
We have a long road ahead and an interesting one at that.
Ya can't forget about the Feb. meeting.
And Bio Europe in March.
another sat. night
I thought that little information was rather eye opening. Companies shouldn't be calling the FDA all the time; but when they have carefully done all the essential work --- and double and triple check it --- the FDA will respond EXPEDITIOUSLY.
This was what ACT got, when it took the FDA only 5 or so weeks to approve its AMD IND application, something I thought exceedingly expeditious. And it meant, again, only ONE THING: Advanced Cell has done a very thorough job in its PRE-CLINICAL activities.
The only time injecting something into a human being -- much less into the EYE --- can be reviewed/approved in a month's time with the FDA is when a COMPANY has shown the agency it has done QUALITY WORK (1) in theoretical planning & successful actual proof of concept; (2) in actual physical, preclinical planning & design; (3) in the selecting of appropriate animals and testing them soundly AND successfully; and (4) in toxicology, tumorigenicity, possible ingredient/cell break down/"half life", and biodistribution...
The past two years, ACT and CHA have been working extremely quietly on their blood and platelet program; and now that it is peer reviewed and published in a Nature consortium pubilcation, I think they are close to finishing and readying to filing for the first ever artificially *created* platelet program in the world...
Preclinical development plans for gene therapy products
Preclinical study designs
Selection of animal species and animal models
Preclinical support of clinical trial design
When to engage FDA
Dr Steven Fleischer, Biologist, US Food & Drug Administration, Center for Biologics Evaluation & Research
Agreed, as Aunt Miriam would say; "they have the darkness in their eyes", these self rightious politicians, that is. Hopefully, reason and logic will win out. Why would God give you a brain, if not to use it?
OK boys, guess the band from whence I pulled those lyrics?