I try to be for stuff.

I am not a scientist, a researcher or epidemiologist. I was a banker, and my undergrad degree is in finance, so I have a little bit of a feel for portfolio management.  From that, I have some appreciation for the idea of balancing risks.

Pharmaceutical development is spectacularly risky. Most drug candidates fail. The costs are HUGE. Estimates are the average new drug cost well over a billion dollars.  To a finance guy, high costs and high failure rates is the very definition of risk.

Risk is mitigated by diversifying. Hell, we all know don’t put all your eggs in one basket right? I doubt there will be “a” cure for type 1, as in one treatment that works for all. I suspect there will be a variety of cure-ish advancements. Each, hopefully, is relatively independent or the others so a lack of success in one area does not preclude success in another.

Vaccination against T1D would be great. I’m not sure how you figure out who needs it. Or how to get the anti-vacs community to accept it.  Those are way smaller issues than finding an effective vaccination for some portion of the possible population.

That would leave a lot of people with T1D. Mostly adults. Many of who are looking to destress their lives with insulin. I’m all for a variety of possible solutions to parts of the puzzle. Because - Your Diabetes May Vary.

I am for closing the gap between the lab bench and the practical world of high volume production of clinical treatments. Scaling up from one-offs studies to mass production is not trivial. That is at time difficult where the potential market is limited, like type 1 diabetes.

I am for people with diabetes working to the ends that they see as valuable and giving where they feel called to give. Part of you call to action is to be knowledgeable. No small task. In that regard, I find Joshua Levy blog an excellent read on the science. Even reading there and from other sources I am not confident that I would know what bets to place. What cure like opportunities will succeed in both the science and the market. Make no mistake both are required.

Living well till there are steps to a cure matters too. Accurate blood testing matters, access to strips and insulin matters. CGM’s matter. Psychosocial issues matter - a lot.  Type 2 medications may help some type 1 and type 1 devices may help some type 2s. Stigma does not help anyone, and that includes parents of type 1 kids (like me) realizing that type 2 is a disease not a character fault. Just like type 1 type 2 is rooted in physiological responses.

I am for a diversified approach to living better, finding steps to incrementally more cure-like treatments that diversify risk and in doing so fosters successful outcomes. I am wary of any one set of best things being the solution in five and particularly ten years. I'm for creating new things were you see a gap that need filling, without name calling those who prioritize differently. I'm for diversified investments in diabetes: basic research, better living while research happens, psychosocial support, successful life transitions, empowering patients and more.

I am for JDRF
I am for ADA
I am for CWD
I am for DSMA
I am for the DOC
I am for #WeAreNotWating and for and effective FDA and don't see that as a conflict.
I am for DCAF
I am for StripSafely
Through all of that I am for YDMV as I try to be for PWD.

CeQur announces financing to scale up T2D wearable three-day insulin-delivery device.

CeQur Type 2 Insulin Patch  

I wrote about this and other devices for dLife.

http://www.multivu.com/players/English/7615051-cequr-financing-insulin-diabetes/

PR Newswire, LUCERNE, Switzerland and MARLBOROUGH, Mass., 1 September, 2015  

CeQur SA (“CeQur” or the “Company”), a leader in simple insulin infusion for people with diabetes, today announced a Series C financing of $100 million. The financing will support further clinical and regulatory activities, manufacturing scale-up and commercial operations for the 2016 first commercial launch of PaQ®, the Company’s fully optimized second-generation three-day insulin infusion device.

“We are very excited to work with such experienced investors who share our views about the significant opportunity PaQ brings to transform the lives of millions of people with type 2 diabetes,” said Doug Lawrence, CEO of CeQur. “Today when people with type 2 diabetes progress to insulin they need to inject, and current alternatives have cost and complexity limitations. CeQur’s second-generation PaQ will provide a superior alternative to injection therapy and allow us to build a high-growth business in the emerging category of simple and cost-effective insulin infusion to benefit patients, physicians and payors.” 

We Take Hits. - Thanks Emily Coles - #DOCBurnout2015

 If life with diabetes is comparable to battle then maybe the DOC is sitting around the bar swapping war stories. Ok, that is a bit of a stretch but it lets me bring in this picture

The picture Emily Coles from Master Lab. You can see her presentation on YouTube here. She talked about the planes that came back with hits.

The places where there were not red dots is where the holes brought down the plane. No stories at the bar.

Speaking up means taking hits. In the DOC what is really sad is some of these may have been friendly fire. Christel writes about that here.

My contribution to DOC burnout day is this: know you are going to take hits if you speak up. That is part of the process. Reinforces the places where the hits may keep you from succeeding in your mission.

There was a reason missions flew in formation back in the day. Strength in numbers.

The DOC is not combat. We can take a day off. It is OK to not trade stories at the bar. My 2¢ for the day is simply; we are stronger together.

#DOCBurnout2015

Sanofi and Google Life Science Team Up

Sanofi and Google announced and agreement to work jointly on diabetes projects report Boolmberg and Wall Street Journal report and a press release. 

Sanofi's press release states the two companies will:

- Will work together on new digital technology and tools for diabetes -

- Aim to use data and miniaturized technology to provide patients with more tools to self-manage their disease, healthcare professionals with the ability to better support and treat patients -

- Strive to shift from episodic, event-driven diabetes care to continuous, value-based care

Bloomberg quote Google saying:

“Diabetes is the first disease we’re focusing on as we become an independent company,” Google said in the statement. “We’re announcing a new partnership with Sanofi to move technology out of the lab more quickly and work on better ways for patients and physicians to collect, analyze, and understand all the multiple sources of information that impact diabetes management.”

More: 

http://www.prnewswire.com/news-releases/sanofi-to-collaborate-with-google-life-sciences-to-improve-diabetes-health-outcomes-300135001.html

http://www.bloomberg.com/news/articles/2015-08-31/google-pairs-with-sanofi-to-move-diabetes-patients-to-cloud

http://www.wsj.com/articles/google-sanofi-join-forces-on-diabetes-monitoring-treatment-1441026001

FDA Approves Dexcom G5®

FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System

From: http://investor.shareholder.com/dexcom/releaseDetail.cfm?ReleaseID=928741

First and Only Fully Mobile CGM System Allows Adults and Children as young as 2 years old to Conveniently and Discreetly Monitor and Share Glucose Levels

SAN DIEGO--(BUSINESS WIRE)-- Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or "followers." These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.

"Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 PLATINUM CGM with Share, apps to enable the first CGM on the Apple Watch^TM and now the Dexcom G5® Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before," stated Kevin Sayer, President and Chief Executive Officer of Dexcom. "We are excited for the promise this new technology holds for patients and caregivers."

About the Dexcom U.S. G5 Mobile Launch

• The G5 Mobile system is anticipated to begin shipping in late September 2015.
• All purchasers of a G4 Platinum with Share system from August 1, 2015, until the G5 Mobile system is shipped, will be eligible to receive a no-cost upgrade to the G5 Mobile system.
• There will be a low cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing system.

Three Quick Things

... before I check out for the weekend.

All are about pregnancy and diabetes. So they don't apply to me but they are wonderful efforts, doing good things and they should get shout outs.

The Plaid Journal:

PLAID is cool. PLAID is an open access, peer-reviewed, research journal that aims to encourage dialogue among people living with and inspired by diabetes.

They're doing an issue on "Pregnancy & Diabetes." The deadline for submissions is September 15, 2015.
https://www.facebook.com/theplaidjournal

JDRF has a lovely toolkit for pregnancy and Type 1 diabetes. 

"This guide provides information for parents-to-be or future parents-to-be with T1D—explaining the disease management goals for pregnancy and reviewing how to obtain the best possible support from healthcare providers at every stage."







MyGlu has a survey about preconception, pregnancy, and childbearing at http://bit.ly/glusurvey  Help them out, take the survey. 

FDA Report on Targeted Drug Development: The Diabetes Section

Are you a policy geek? FDA has a white paper out on drug development and it has some background on diabetes (T1 and T2) and how they go about drug approval.

It isn't page turner like Game of Thrones (GoT) but hey let be honest GoT books 4 and 5 dragged on.  


Here is the preface of what they say about diabetes and a link to the section of the white paper on diabetes:

..our understanding of disease causation and progression is sufficient to permit our use of certain tools such as surrogate endpoints. But it is insufficient to develop others such as biomarkers to help target specific subset of patients who are less likely to suffer side effects from specific drugs. Even where scientific research has not yet identified the molecular and genetic bases for a disease and its treatment, FDA is using tools other than targeting and biomarkers to reduce the length and cost of clinical trials, including flexible trial designs, expedited development pathways, public-private research collaborations, and intensive engagement with drug sponsors. In addition, these tools can support the development of one of the most promising avenues for accelerating drug development: targeted, or precision, medicine—the ability to target the right drug to the right patient based on understanding of the genetic and biochemical basis of a disease in patient subgroups.

Diabetes : http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm454955.htm#Diabetes

Have fun reading geeks.

The reader digest version is summed up in these quotes:

• FDA has long allowed manufacturers to show that a diabetes drug works by using a simple surrogate endpoint—lowering blood sugar. 
• There have been longstanding concerns that some drugs for type 2 diabetes that successfully lower blood sugar may nevertheless increase rather than decrease the risk of heart attack.
• To minimize the impact on innovation while ensuring acceptable cardiovascular safety, FDA asks for preliminary CV safety data before approval and for detailed additional data to characterize CV effects after the product is on the market.
• FDA has approved seven new diabetes drugs in the last two years. This includes three drugs that represent entirely new drug classes—a measure of how innovative these drugs are. In June 2014, FDA approved the only inhaled insulin product. The diabetes drug pipeline is among the strongest for any disease category and includes potentially transformative advances for type 1 diabetes.

 Yeah there is more in there. If you like wanting around in Westeros, enjoy the read.

Join DiabetesPAC calling for CGM access.

Join DPAC calling for hearing on the safety of test strip bidding.