January 26, 2010

My Two cents on JDRF & For Profits

This started as a From the News Wire bit but I got long winded.

A JDRF milestone payment to Osiris was just announced yesterday (Jan 25.) JDRF has been in the news a lot this month. The artificial pancreas agreements with J&J and BD have been in the news recently. They are the topic of a JDRF video tomorrow. The J&J and BD agreements are generating talk in the type 1 on line communities. To put it nicely folks are concern that these relationships be appropriate to JDRF’s mission.

Like many people I when I first heard of JDRF’s Industry Discovery &
Development Partnerships (IDDP) program I was initially curious and a little concerned. I had a view of JDRF in white coated labs doing science to boldly make insulin where it had once been made before. This science would somehow make it to the local pharmacy and presto - No more T1. I wasn’t particularly realistic in that view.

Diabetes varies. So will eventual cures. So will the things that make living with type 1 less difficult along the way to those cures. Treatments and cures will need to get from the lab to the pharmacy. There is a very large and costly bridge to cross in between that is proving treatments are safe and effective. Trials.

JDRF feels that some promising discoveries in the previously mentioned white coated lab aren't making it to the market. In part this is because the process of trials is crazy expensive. It is a big risk for any business to go into trials.

JDRF’s motivation for IDDP is to help lower the cost and risk of regulatory approval and so move treatments from the lab and into our lives that may not otherwise get the investment needed for the trip.

There is a specific range of therapies that interest JDRF:
• Restore pancreatic beta cell function by regenerating beta cells
• Restore pancreatic beta cell function by beta cell replacement
• Reverse autoimmunity and restore immunoregulation
• Restore metabolic control
• Prevent and reverse diabetic complications
• Development of biomarkers linked to beta cell mass/regeneration, islet inflammation, and progression of diabetic complications

To help these discoveries make it to the lives of people with type 1 JDRF forms development agreements with for profit firms that have promising lab discoveries. Some firms are big some are small.

There are some basic components to the agreements that we as supporters should know. The firms need to be investing as much or more in the specific project as JDRF. JDRF investments in the project are based on milestone accomplishments. That is the firm gets money from JDRF for reaching specific steps. You can see that in the Osiris announcement below. (Remember Osiris? This is a post about Osiris.)

Like making investment payments to the company, IDDP agreement also set commercialization milestones that trigger returns of invested funds from the firm to JDRF. In short the JDRF gets money back when the firm starts selling the product they partnered on. JDRF also maintains some rights to commercialize the intellectual property if the partner does not. This being Diabetes all these details vary. I am SURE JDRF say this to prospects, Your Details May Vary.

OK maybe not those exact words…

I don’t know if the J&J and BD agreements over the past few weeks fall into the same IDDP structure as the Osiris announcement that is news today. I will try to find out. In the mean time I believe that the IDDP process JDRF has developed is a responsible and practical use that deserves informed support.

The informed part matters. I hope this helps.


Now as to Osiris:

Jan. 25, 2010 (Business Wire) -- Osiris Therapeutics, Inc. (NASDAQ:OSIR)today announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for completing enrollment in a Phase II clinical trial evaluating Prochymal, an adult mesenchymal stem cell (MSC) therapy, as a treatment for patients recently diagnosed with type 1 diabetes. The milestone is the fourth in a series of payments resulting from JDRF’s partnership with Osiris for the development of a therapy for type 1 diabetes.

Full release here

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