FDA Seeks Advice Re: Human Clinical Testing

[mhinds]

I have asked several friends to use the link given to contact the FDA and they have reported that they get a message from the FDA site that says Page Not Found. Any suggestions? I was able to get to the correct site by going directly from CareCure, but not when I put the URL in the address bar.

[Leo]

hi hminds,

i just tried it in both explorer and firefox and it worked,

http://www.accessdata.fda.gov/script...ID=&AGENCY=FDA

try this

[JenJen]

Holy ^%$ how did I miss this? Good find Chas!

I copied your post and forwarded it on to others including some bloggers and posted it on my blog as well. Here's hoping!

[Karen M]

Thank you, Chas. I'll will write to the FDA today and pass the message to everyone on my list.

[chasb]

The FDA needs to hear from those interested in advancing these cells. Anyone else have additional idea(s) of how to reach a greater audience, with potential responses to the FDA?

What about attempting to utilize the following organizations?

(1) Apparelyzed.com

(2) New Mobility

(3) Christopher and Dana Reeve Foundation

(4) Miami Project

1,2 - Anyone her have an account to post the story and links on their board?

3,4 - I plan to send them an email. Those interested should do the same. Both Reeve Foundation and The Miami Project have extensive email contact lists.

THANK YOU TO EVERYONE WHO HAS RESPONDED TO THIS THREAD.

[Sue Pendleton]

Maybe send it on to CAMR? This docket is not specific to SCI but to hESC research and therapies.

[chasb]

I bumped this thread because the FDA scheduled meeting date is comming up. Anyone willing to swing by and write up a short (or whatever length your heart desires) report?

Gerons OPC1 cells are ready and waiting. This pivotal meeting will help determine when their human clinical trial begins. Who is going to represent? Here is the information.

Anyone who lives in or around Gaithersburg, MD.
___________________________

The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet April 10 in Gaithersburg, Md.,

Location: Hilton DC North/Gaithersburg ,Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-82 7-03 14, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512389. Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register aboutlast minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.

Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot linelphone line to learn about possible modifications before coming to the meeting.

Agenda: On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting.

http://www.fda.gov/OHRMS/DOCKETS/98f...71-nm00001.pdf

[Karen M]

Just thought that I'd add Don Reed's post from stemcellbattles.com.
----------------------------------------------------------------
Dear Friend of Stem Cell Research:

As you know, the world’s first human trials with embryonic stem cells is (or should be) underway this year.

But first, there is a crucially important FDA hearing to be held, on April 10th and 11th.

It has the harmless sounding title, “Scientific Considerations for Safety Testing for Cellular Therapy Products Derived from Human Embryonic Stem Cell”.

I hope it will be just about science. But I worry that it may be politicized.

The Food and Drug Administration is highly respected; famous for being above political pressures. That standard of excellence is vital now, for they face a crucial decision.

At stake is the human trials of the Keirstead/Geron spinal cord injury embryonic stem cell experiment to remyelinate damaged nerves. The experiment was originally funded by the Roman Reed Spinal Cord Injury Research Act of 1999: a law named after my paralyzed son, the first state funding of embryonic stem cell research in the nation.

March 1, 2002, six years ago… in the Reeve/Irvine Research Institute, UC Irvine, I held in my hand a rat which had been paralyzed, but which now had regained some measure of its walking ability, thanks to human embryonic stem cells. This was the work of Dr. Hans Keirstead.

The next step, to turn theory into therapy, is hugely expensive; America is fortunate that Geron Corporation was willing to invest many millions in the new endeavor.

Between that time and this, the Keirstead/Geron work has been going through the FDA safety wringer. As is only right and proper, the FDA has made Geron, the funding corporation, go through test after test after test, and the months dragged on, and became years.

The patients wait.

The reasons for six years of safety checking are legitimate; anything to be tried on people must be given every reasonable safety check.

As one top scientist told me privately: “…it is really important that people understand that there really hasn’t been a delay. It is important for the future of stem cell trials—this is just how long it takes. Rushing things is dangerous, and in the long run counterproductive because a single adverse event could set things back many years. We all have to remember that this will be a trial for recently injured people. If something goes wrong, even something trivial, it could be a long time before there is another stem cell trial for spinal cord injury.”

But six years of waiting—and a 25,000 page paper trail—seems long enough to me.

The hearing will be held April 10-11, next month, in Bethesda, Maryland, home of the Food and Drug Administration, the world-famous FDA.
Written comments from the public will be allowed, but only until March 26th.

If you or your organization would like to write a letter (better yet, attend the hearings) just to say, let science and safety be the issue, not politics—here is the address.

If you want your testimony to be part of the considerations, time is running short. I am sending mine by overnight mail.

to see the letter I will be sending, visit www.stemcellbattles.com. Click Archives. It is in # 426 Tuesday, March 18, 2008 - WORLD’S FIRST HUMAN EMBRYONIC STEM CELL TRIALS?

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
DATE AND TIME: April 10-11, 9:00 a.m. (8:00 on the 11th)
LOCATION: Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD
CONTACT: Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research, 301-827-0314. On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. On April 11, 2008, the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) FDA's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents.

[chasb]

Bump.....Anyone? I believe it is important to get an impartial impression of the FDA's position. It is my concern that the FDA is under political pressure (from the current administration in the U.S.) to suppress hESC advancement. Any formal response from Geron, therefore will be measured.

With all the traffic this site receives, there has to be someone that could go by and listen. I doubt it will be that difficult to get a sense in the meeting to hear which way the wind is blowing. After 25, 000 pages of submission, how many more questions really need to be addressed?

[Schmeky]

Originally Posted by chasb

Bump.....Anyone? I believe it is important to get an impartial impression of the FDA's position. It is my concern that the FDA is under political pressure (from the current administration in the U.S.) to suppress hESC advancement. Any formal response from Geron, therefore will be measured.

With all the traffic this site receives, there has to be someone that could go by and listen. I doubt it will be that difficult to get a sense in the meeting to hear which way the wind is blowing. After 25, 000 pages of submission, how many more questions really need to be addressed?

Agreed.