March 2, 2015

February 27, 2015

Finance Geeks are Talking Artificial Pancreas. James Cagney Wants a Cut.

Ok, I'm a business news kinda guy. My undergrad degree is finance; I was a banker (I apologize for what I did to the American Economy, it was clearly all my fault, I'm sorry.)

Interestingly this week a number of earnings calls (aka where businesses talk about their results to analysts each quarter) Artificial Pancreas was a topic:

Here's a few I just posted about:
Tandem
Podd
Dexcom
Home Grown & Startup

Then there is Medtronic's latest not-in-the-USA-yet launch.



What I find interesting as a finance geek is the shift in tone from a kinda distant, "Hey this is some research someplace,"  to wall street asking, "Yo. Where's da product? And how'z youz gonna get a cut?" (Yes - analyst are James Cagney in some shoot 'em up film)

In my twisted mind, this is a significant sign of progress.

Keep it coming.

AP will come incrementally. These all suggest incremental steps. Like diabetes care perfection shouldn't be the Public Enemy of the good. 

Dexcom and Artificial Pancreas

From: http://seekingalpha.com/article/2951636-dexcoms-dxcm-ceo-kevin-sayer-on-q4-2014-results-earnings-call-transcript
We met with several groups utilizing G4, CGM and developing closely* and partially close with our efficient pancreas type systems. 
And a significant progress has been made by many of these groups, but the pathway to commercialization for many of these projects remains unclear and we will continually evaluate our own path to the artificial pancreas closely. 
With the world’s most accurate and reliable CGM system we intend to play in this arena. We left the meeting very confident that with execution of our plant, product portfolio we will remain the world’s leader in continues glucose monitoring 
With our new insertion system, the G6 and other advanced sensor platforms, expanding connectivity with user-friendly apps and the ability to perform advanced analytics, one CGM and other diabetes data is in the cloud we believe we are position to lead this industry for a very, very long time.

OmniPod's & Artificial Pancreas

OmniPod's CEO spoke of artificial pancreas in Q&A at the most recent earnings call:
Patrick Sullivan - President & CEO
Yes, I would say our strategy is that as it relates to the artificial pancreas, we are putting together strategy so that OmniPod is a very significant part of the artificial pancreas product offering in the future. And with that you need to have a CGM product offering, as well as an offering to put the three units together if you will, and as you know we have been working internally on our own CGM development which continues but also we have an agreement with - already have an agreement with Dexcom to use their CGM sensor along with our new PDM to integrate that those two products together, and I think with that combination used in algorithm and we're looking at opportunities to have an algorithm that we could then provide the full package. I'd also say that we would evaluate and look at opportunities with Abbott and others that would have potential CGM integration opportunities for us. So in the short term we're looking at other people that have CGM capabilities and algorithm capability, but at the same time we are continuing at a low level our own efforts in our own CGM product development.

Tandem and Artificial Pancreas

Beginning in 2013 and throughout 2014, we’ve actively supported leading investigators in advancing this development of artificial pancreas solutions by providing Bluetooth enabled pump, hardware and software. We are committed to continue advancing the clinical applications of Tandem’s technology.
To this effort, in 2014, we initiated the R&D concept phase of our artificial pancreas offering. Our first AP product will utilize Tandem’s proprietary technology platform and will partially automate insulin delivery based on CGM information and predictive algorithms to aid a user and maintaining their targeted blood glucose level and may reduce the frequency and severity of hyper or hypoglycemic events.
.... 
In the second half of 2015, we plan to file an Investigational Device Exemption or IDE with the FDA for a clinical study in rolling our first AP product. Our discussions with FDA surrounding this IDE will help decline regulatory pathway, which we anticipate will require preliminary approval and will include data from one or more clinical studies.

Dexcom - At least 5 as many as 10 product launches in 2015.

From: http://seekingalpha.com/article/2951636-dexcoms-dxcm-ceo-kevin-sayer-on-q4-2014-results-earnings-call-transcript

Kevin Sayer - President, Chief Executive Officer

Thank you, Steve. For our business update today I would like to discuss several major initiatives for 2015. Let’s start with innovation. On a worldwide basis we launched a total of five new products in 2014, compared to a total of three worldwide product launches in the previous two years combined. We are currently planning at least five more launches in 2015 and depending upon execution and regulatory time frames we can see that number go up to as many as ten product launches in 2015.
Our nearest term innovation is the DexCom SHARE Receiver. Work on the receiver of this nature commenced more than two years ago, when we received the research grant from the Juvenile Diabetes Research Foundation to develop better Juveniles to support artificial pancreas research. We want to take the opportunity to recognize JDRF support of this project. This is a great example of how industry and research collaborations can greatly benefit both parties.

February 19, 2015

Dexcom Announces Continued Partnership with NASCAR Driver Ryan Reed

from Dexcom:

Dexcom Announces Continued Partnership with NASCAR Driver Ryan Reed

Raising Awareness of the Benefits of Continuous Glucose Monitors for People with Diabetes
SAN DIEGO--(BUSINESS WIRE)-- Dexcom, Inc., (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM), announced today that they are continuing their partnership with NASCAR driver Ryan Reed, the face of the American Diabetes Association's national diabetes awareness initiative, Drive to Stop Diabetes℠ presented by Lilly Diabetes. Through the collaboration, Dexcom will continue its support of Ryan Reed while reinforcing the partners' common quest of creating awareness of CGM among people with diabetes. The campaign highlights the importance of daily monitoring and tracking of glucose trends in the management of diabetes.
With nearly 10 percent of the American population currently living with diabetes, education on disease management is necessary.1 The rise of continuous glucose monitoring systems, like the Dexcom G4® PLATINUM, has helped patients with both type 1 and type 2 diabetes to understand valuable information about their glucose levels and trends.
"This initiative has made it possible for me to educate people who may be living with type 1 or type 2 diabetes about managing their disease and understanding their glucose levels. As an advocate for patients fighting the disease, it's been important for me to actively inspire those who feel that they have to give up on their dreams after diagnosis," says Ryan ReedNASCAR driver. "With the help of my Dexcom G4®PLATINUM, I've never let diabetes slow me down." more

February 18, 2015

Want a Cure? Join Team Biobank!

Join the T1D Exchange Biobank - Be a Part of the Team 

Everyone who lives with type 1 diabetes (and their brother) wants a cure. 

To become a reality cures will take more than wishing to becme a reality. They will take research. Research needs people with diabetes to participate and maybe give a little blood. (Yes cures - I want variety of them - y'a know 'cause YDMV)

Seriously a little blood to the right researchers can help, only how do we know who needs the bio sample?

Enter the T1D Exchange. 

They have been pilot testing a biobank. It connects researchers and bio samples. The Exchange says, "To date, through the generous efforts of those willing to participate in this research, there are over 1,600 people enrolled and more than 450 test kit collections have been completed."

Full disclosure, my family are part of that 1,600. Yay Team Biobank!

The Exchange is moving from pilot test to public enrollment. Yay Team Biobank! 

Who doesn't like being part of a great team? Ok so it is tough to be part of the Patriots ball deflation squad but anyone with T1D can join Team Biobank.

Learn more and get started on sign up here: T1DExchangeLivingBiobank.org


Yay Team Biobank!

Artificial Pancreas News: DIYP, Bigfoot and Medtronic

#WeAreNotWaiting has become very well know in the diabetes data space. As I read about it, the next steps are slowly starting to come tantalizingly into view. Some even have hastags and Facebook pages. Others come from the usual suspects.


#DIYPS

Do It Yourself Pancreas System the fascinating collaboration of Dana Lewis & Scott Leibrand. A lovely couple if there ever was one. Their story is outlined at Median.com (1).  What is clear is their DIYPS is doable. Some folks wonder why hack your diabetes? Dana's 2¢ is, "I have to make about 300 decisions per day on average. It’s really fatiguing." Brilliantly understated Dana.

Having had the great pleasure of talking with them over the past year, doable was never in doubt.  It was more about about when. So my big question after reading the Median piece was simply, are they moving up the wedding date? Read it and see why.

Another piece that makes the connections from Nightscout to AP in Wired. (2) It goes from Nightscout to #DIYPS and then on to tease about Bigfoot.


There is a Bigfoot?

Bigfootbiomedical (3) is on Facebook where former JDRF leader Jeffrey Brewer is listed as CEO.  Some other very interesting folks, who are less public about it, are said to be working there as well. I trust they will confirm those rumors in their own good time. In the meanwhile Jeffery is playing a fun game of cat and mouse with Bigfoot on his Facebook timeline today.



Medtronic

It isn't only the home brew and startup crowd that are making strides. Medtronic has launched a next step with the MiniMed 640G (4). This new device shuts off insulin predictively. While that is an incremental step, it is a step. OK step / stride? You say potato..., it is somewhere in there. What is significant to me is progress. Medtronic will be sharing more about their next step their Hybrid Closed Loop system soon (do two steps make a stride?) It will be presented at the upcoming Advanced Technologies and Treatments for Diabetes (ATTD) 8th Annual Meeting being held at CNIT Paris La Defense from February 18-21, 2015 (5) At the last #MedtronicDAF, they said they were going to speed up bringing things to market. Seems they are. 

YDMV

All these are great news IMHO. Before somebody starts complaining about FDA, lets remember FDA approved the Medtronic 530G under their Artificial Pancreas guidance. Lots of folks complained that it wasn't an AP. OK you AP may vary - but FDA approved it as AP and that tells me they are looking to do just that. Well, OK. Also FDA flat to say they are looking to approve innovations under AP guidance. It may be a tad short of them saying, "Bring it on!" - So maybe the 530G is, as the saying goes, proof in the pudding.

To me this all matters because of Eggs and Baskets (6) in which I wrote:
I believe that better is better and perfect should not be the enemy of good. 
So I am all for advances in type 1 diabetes care that may fit into individual's life styles in a Your Diabetes May Vary kind of way. AP may work for some while GRI works better for others. I am fairly sure none of it will make diabetes care easy but it may be less hard and that's better.  
I support a diversified approach to making life better. There is a fable about putting eggs in more than one basket that explains modern portfolio theory better than most finance professors. 

YDMV, so should your AP options.



In case the links break:
(1) https://medium.com/access-matters/do-it-yourself-diabetes-bd1ea1adf034
(2) http://www.wired.com/2014/12/diabetes-patients-hacking-together-diy-bionic-pancreases/
(3) https://www.facebook.com/bigfootbiomed
(4) https://www.medtronic-diabetes.com.au/insulin-pumps/640g
(5) http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2017567
(6) http://www.ydmv.net/2011/10/artificial-pancreas-and-egg-baskets.html

February 17, 2015

NIH researchers reveal link between powerful gene regulatory elements and autoimmune diseases

From: http://www.nih.gov/news/health/feb2015/niams-17.htm


NIH researchers reveal link between powerful gene regulatory elements and autoimmune diseases

Findings point to potential drug targets

Investigators with the National Institutes of Health have discovered the genomic switches of a blood cell key to regulating the human immune system. The findings, published in Nature today, open the door to new research and development in drugs and personalized medicine to help those with autoimmune disorders such as inflammatory bowel disease or rheumatoid arthritis.
Healthy human T cell.
Scanning electron micrograph of a human T lymphocyte (also called a T cell) from the immune system of a healthy donor. Source: National Institute of Allergy and Infectious Diseases (NIAID). 
The senior author of the paper, John J. O’Shea, M.D., is the scientific director at NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. The lead author, Golnaz Vahedi, Ph.D., is a postdoctoral fellow in Dr. O’Shea’s lab in the Molecular Immunology and Inflammation Branch. The study was performed in collaboration with investigators led by NIH Director, Francis S. Collins, M.D., Ph.D., in the Medical Genomics and Metabolic Genetics Branch at the National Human Genome Research Institute.
Autoimmune diseases occur when the immune system mistakenly attacks its own cells, causing inflammation. Different tissues are affected in different diseases, for example, the joints become swollen and inflamed in rheumatoid arthritis, and the brain and spinal cord are damaged in multiple sclerosis. The causes of these diseases are not well understood, but scientists believe that they have a genetic component because they often run in families. 
“We now know more about the genetics of autoimmune diseases,” said NIAMS Director Stephen I. Katz, M.D., Ph.D. “Knowledge of the genetic risk factors helps us assess a person’s susceptibility to disease. With further research on the associated biological mechanisms, it could eventually enable physicians to tailor treatments to each individual.”
Identifying autoimmune disease susceptibility genes can be a challenge because in most cases a complex mix of genetic and environmental factors is involved. Genetic studies have shown that people with autoimmune diseases possess unique genetic variants, but most of the alterations are found in regions of the DNA that do not carry genes. Scientists have suspected that the variants are in DNA elements called enhancers, which act like switches to control gene activities.
More: http://www.nih.gov/news/health/feb2015/niams-17.htm