Tandem and JDRF Agreement for Dual Hormone Pump

Tandem and JDRF have entered into an agreement to develop a dual hormone pump.

SAN DIEGO, Jan. 8, 2013 /PRNewswire via COMTEX/ -- Tandem Diabetes Care, Inc. ("Tandem") announced today a partnership with JDRF, the leading global organization focused on type 1 diabetes (T1D) research, to develop a first-of-its-kind, dual-chamber infusion pump for the management of diabetes. The partnership agreement is designed to accelerate the development of a next-generation, fully automated artificial pancreas system using therapies in conjunction with insulin.

Looks a lot like a JDRF IDDP. Has all the right words, performance based milestones etc, just not the IDDP letter.  Full test here:

http://www.marketwatch.com/story/tandem-diabetes-care-announces-partnership-with-jdrf-to-develop-a-novel-dual-chamber-infusion-pump-2013-01-08

@JDRF New Research #TwoBits

JDRF announced two research initiatives today. The first is a study of seeking to Reduce Cardiovascular Risk in Adults with Type 1 Diabetes. From the release:

New York, NY, December  13, 2011-JDRF-funded researchers have begun enrolling adult patients with type 1 diabetes (T1D) in the REMOVAL study, to test whether metformin-a drug commonly used to treat type 2 diabetes-could help prevent or reduce the risk of cardiovascular complications in people with T1D. 

The REMOVAL study (Reducing with MetfOrmin Vascular Adverse Lesions in T1D) is a multi-center, international trial that will study 500 patients with T1D aged 40 or older, a patient group known to be at higher risk for cardiovascular disease, one of the leading causes of death associated with diabetes. A study from the United Kingdom has shown that people with T1D aged over 40 are at much higher risk for cardiovascular disease, including heart attack and stroke.

The second is in conjunction with the firm ViaCyte and looks at Encapsulated Beta Cell Replacement Therapy for Diabetes. (This look like an IDDP but my reading of the release is not clear. I will see if I can get confirmation.) Yes it is in fact an IDDP* From the Release:

Existing cell therapies such as islet and pancreas transplantation have the potential to cure T1D by restoring normal islet function and normalizing blood glucose levels in people with T1D. Because the number of cadaveric human donors for pancreatic islets is limited, ViaCyte’s program will provide a replenishable supply of functional insulin-producing cells. Furthermore, packaging the cells in a device (“encapsulation”) creates a physical barrier around the cells and has the potential to protect the transplanted cells from immune rejection, and may eliminate the need for chronic immunosuppressive drugs. The ultimate goal of this partnership is to help patients with T1D restore their ability to regulate blood glucose, thereby reducing or eliminating the need for constant self-management and administration of insulin.
The three-year series of preclinical studies being co-funded by JDRF will help ViaCyte prepare the information necessary to apply for regulatory approvals to study the system for safety and efficacy in people with T1D.

For more see JDRF's New Room online.

Why these matter:

Most folks living with type 1 are adults. Our first goal as parents of T1D kids is to have the grow to be T1D adults pursuing their lives interest. I have heard the figure tossed around that 85% of T1Ds are adults, seems about right. So it only makes sense to study how to keep T1D adults health.

Cure can mean a lot of different things to different people. To me, in the broadest sense it is to return the biological production of insulin. That may or may not include turing off the autoimmune response that killed off the beta cells in the first place and from the little (very little) I know of how immunity works that is no small think. Encapsulation get around that problem with magic star tech like shields that protect the Starship Insulin-producing-cell from attack by evil T cells. ... or something like that. Getting beta cells is no easy matter either. This project addresses both the shield and production of beta cells form stem cells. May the Force be with you, wait wrong sci-fi flick but you get the point and the point is Live Long and Prosper.

*For some background on IDDP you can see earlier post in YDMV. 
http://www.ydmv.net/2007/07/over-last-few-months-i-have-seen-number.html
http://www.ydmv.net/2007/10/apparently-somebody-does-know-how-this.html
http://www.ydmv.net/2007/10/5-easy-pieces.html

I Was Wrong.

I know! Who would think I could be wrong?

(That should get a long list of comments consisting of “Me” and let me just say hi to Tim who will be prominent on that list.)

In addition to all the playing nice in the sand box with JDRF that I reported about in yesterday’s recounting of Scott and Bennet’s excellent JDRF IDDP adventure, we did have some specific questions. I know one of mine was about Amylin and leptin analogs.

As an aside I was not only wrong but also daft, I just finished a class, for which I memorized stuff about leptin but somehow couldn’t associate metreleptin with leptin but enough of my digression about being daft. (Which I am also sure Tim will appreciate.)

Leptin, is hormone produced in fat tissue that plays a key role in regulating metabolism. My text book says it does this "by affecting hunger. As your fat stores increase, leptin signals the brain to decrease your level of hunger and food intake." (Joan Blake, Nutrition and You, 2012, Benjamin Cummings, one hundred bucks but I am not bitter about the price)

Anyway, I made note of JDRF entering into an IDDP project with Amylin last November for  a study of metreleptin. I know that I was confused when Amylin and Takeda announced a suspension of trials of pramlintide/metreleptin. (Pramlintide is marketed by Amylin as SYMLIN® just in case there isn't enough name confusion.)  I was very confused, particularly when I found a JDRF newsletter in the mail that had an article on Amylin a few weeks later.

So here is the straight story. These are two different studies of the same analog, in different groups, for different reasons. The JDRF IDDP is still on.

Let me quote JDRF:

... to follow up on our conversation from last week about the recently halted metreleptin study, which you had asked about.  As we discussed, Amylin and Takeda Pharmaceutical Companies recently suspended clinical activities in an ongoing Phase 2 study examining the safety and effectiveness of an investigational combination therapy using pramlintide and metreleptin for the treatment of obesity. This is a separate trial from the metreleptin study JDRF and Amylin are collaborating on.

They go on to say:

As for the metreleptin study that JDRF and Amylin Pharmaceuticals are partnering on, we, along with The University of Texas Southwestern in Dallas (the institution where the trial is taking place) will continue to monitor trial participants in accordance with the team’s diligent safety monitoring strategy, which has been approved by the university’s Institutional Review Board and FDA.  Additionally, in light of the recent findings with metreleptin in the above-mentioned obesity trial, the team has consulted with the FDA and will continue to as the study proceeds.

So there you have it folk, I was wrong when I thought they were the same investigation. I don't think I wrote anything here about that confusion but I am sure I was confusing none the less. On the plus side, I now know how to get fast answers to questions like, “Hey was that the Amylin study JDRF did an IDDP with?“ when I am reading the news.


There you have it, YDMV - fairly accurate-ish.



p.s. I don't think either of these is the May 10th IDDP on mixing insulin and SYMLIN®.... maybe I better check.

Scott and Bennet’s JDRF Adventure

I have written periodically about JDRF’s IDDP program. Occasionally I have had conversations either via email exchanges on on the phone with JDRF’s communications staff about IDDP. For those less interested in alphabet soup, IDDP stands for Industrial Discovery and Development Partnerships. This is a smaller portion of JDRF’s activities as measured in dollar terms, maybe 10% of their funding budget. The goal of IDDP is to help transition discoveries from the lab to therapeutic options in the clinic.

I think the IDDP program is valuable. I am added a link in my sidebar with the Newbie link and Teens that can help anyone interested find more about what I have said about IDDP. (I realize that is probably a very small group.) In time I’ll ad a post that includes other good pieces on the projects.

There is a wide series of gaps between the discoveries we read about in laboratories and the options our care team can prescribe. Each gap being another step along a regulatory process from lab to pharmacy. This path will be followed by better care options and it will be true of any incremental steps to a cure.

Here is what those gaps cumulatively look like.  Bringing a pharmaceutical treatment to market is estimated in one research study cost $1.3 billion, yes with a “B” and take 7.9 years.¹

IDDP helps bridge gaps at strategic points. These may be points where industry is less inclined to do take some of the steps along that 1.3 billion dollar process or possibly steps where a type 1 application for a product is not seen by a pharmaceutical company. You can think of it as JDRF helping to push the processes along at key sticking points.

Even representing a fraction of JDRF’s funding budget the amounts involved are substantial. So I believe there is a need for clear communications on what these partnerships entail. I think this is one way that bloggers can serve our community. (This post is about Scott and Bennet's excellent JDRF  adventure, for a primer on IDDP here is a link.)

Last week Scott Strumello and I had the opportunity to to meet with JDRF in their New York offices for an extended conversation on IDDP. I was anxious to have Scott participate. He and I share an interest in writing about the business side of diabetes. We have both written about the IDDP process.

I think he writes in deeper detail while I write try to translate business writing into a more common vernacular. Somewhere in there, between the two of us, I hope folks get an insight they may not otherwise have. I respect and admire Scott’s writing. I consider him a friends and am proud to join him in writing about IDDP. In fact I would not have scheduled a meeting at JDRF without him as every Andy Sipowicz needs a Bobby Simone. I am not sure who is which.

Scott and I with Rachel Steingardt, Joana Casas and Gary Feit of JRFD’s communications team first. We talked about social media and more transparent means of JDRF sharing information in general and the IDDP program specifically.

We were then joined by Richard Insel, MD, JDRF’s Chief Scientific Officer and Karin Hehenberger, MD, Ph.D. Senior Vice President of Strategic Alliances. Jeffery Brewer JDRF’s CEO was going to join us but he was ill. (Insert your joke about me making people sick here.) Jeffery has since followed up with an email which was very gracious. I greatly appreciate that as sign of his openness. My good friend Kelly Kunik speaks well of him and that is high praise in my book.

I had scores of questions going in but the question that troubled me the most was this; how could I approach JDRF with detailed and potentially tough questions about IDDP projects and be seen as an advocate of people living with type 1 and not simply a critic? In fact that I think was the real goal. To open lines of communications that could facilitate better communications about these projects. To be able to learn on an ongoing basis share what we learn with the diabetes online community. I think Scott and I were received with respect and developed a level of rapport that will facilitate our future writing on IDDP.

I will close with one point that Dr. Hehenberger made very clear in our conversations. The IDDP program isn’t just about financial investments in specific projects with for profit businesses. More significantly is a sharing and networking of JDRF contacts in a wide variety of labs with a similarly wide set of contacts in industry to help bring the two together to get promising research out of the lab.

Hopefully our meeting was a similar opportunity to bring transparency to IDDP efforts. I hope we can help those of us who Walk with JDRF for a Cure to see IDDP projects as a positive step in the mix of efforts JDRF facilitates.

¹ Kaitin K, Clinical Pharmacology & Therapeutics (2010) 87 3, 356–361. doi:10.1038/clpt.2009.293

FTNW: JDRF and Amylin

From the News Wire: JDRF and Amylin Partner to IDDP to Investigate Co-Formulating Two Hormones for Treatment of Type 1 Diabetes

NEW YORK and SAN DIEGO, May 10, 2011 /PRNewswire/ -- The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced today that they have entered into a research collaboration agreement to provide financial support for a series of clinical studies to investigate the feasibility of mixing pramlintide, an analog of the human hormone amylin, with insulin to treat type 1 diabetes. Pramlintide, marketed by Amylin as SYMLIN® (pramlintide acetate) injection, is approved for use as an adjunct treatment in patients with diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN and insulin are currently not approved to be mixed and must be administered as separate injections.

Read the full press release here: http://www.prnewswire.com/news-releases/jdrf-and-amylin-partner-to-investigate-co-formulating-two-hormones-for-treatment-of-type-1-diabetes-121555613.html

JDRF and BD

What was old is new again.

JDRF is in the news with another industry development agreement. This time with BD. The deal is for Micro Needle sets. See the press release with with circles and arrows and a paragraph on the back.

The idea is a better set. Better as in less painful, more rapid absorption and less set site infection, inspection and negelection. As I was looking over the 27 eight by ten glossy photographs account of the agreement (Once again my apologies to Arlo Guthrie)
I was struck that this was a flash back of sorts. Like I had heard it before. Not Arlo - I love Arlo -the micro needles.

Sure enough this new release sound a lot like a 2004 press release, about micro needles. Back then Animas did a deveolpment deal with Debiotech to licence micro needle sets. The deal also included development of a 'next generation wearable micro pump.'

Regular DOC readers may rember a mention of this pump in Amy's recent State of Patch Pumping post. I went to a presentation on coming technology back in '04 and the micro needles were talked about as a key feature of the micro pump as well as groovey new sets.

I have been holding my breath since, I swear.

Just to prove how pointless a crystal ball is at predicting when diabetes stuff comes to market back in '04 these micro gems were seen as coming to market in '07.

What happened? Your guess is as good as mine. (Probably better in fact.)

The interesting thing to me isn't so much who shot Johnny Micro Needle in 04-07 but that the technology gets a second look. I can't tell you if this is a better set technology but here is the thing, it may be. YDMV.

Were I to use my guess, I may inclined to bet that the cost and special fabrication skills needed to develop the micro needle set didn't fit into the post J&J R&D budget for Animas and maybe the deal was really all about the micro pump anyway. Animas invested in developing the wireless Ping and Dexcom integration and they gotta draw a line somewhere.

So now JDRF is stepping in and helping get micro needle sets another shot at coming to market. BD is experianced at sharpened sticks and other pointy things so ya would think they can make it work if anyone can. This has the potential to improve living with type 1. (Every little but helps) I am in favor of getting interesting ideas off the proverbial shelf and into use. Given there is an appropriate mechanism to return the investment to JDRF following commercialization this is good news.

When does the press release about the micro pump drop?