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Post by cgiscgis on Feb 19, 2016 3:25:52 GMT -5
Oxytocin dry powder research
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Post by kc on Feb 19, 2016 3:43:46 GMT -5
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Post by kc on Feb 19, 2016 3:46:16 GMT -5
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Post by fofos2000i on Feb 19, 2016 4:06:54 GMT -5
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Post by fofos2000i on Feb 19, 2016 5:04:35 GMT -5
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Post by matt on Feb 19, 2016 10:11:35 GMT -5
Probably not Monash. They are a well-respected university, but Australia has it own fairly active and reasonably well-funded biotech sector so it would be strange to commercialize university research in the United States, at least not until they get to Phase II.
Distance and time zones matter when doing research and Australia is one heck of a long flight from Seattle!
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Post by wmdhunt on Feb 19, 2016 11:55:49 GMT -5
Many deaths by bleeding could be prevented by an immediate intravenous injection of the drug oxytocin. However, oxytocin is unstable in warm climates and trained staff are not always available to give injections. With MannKind Corporation (USA), we have formulated oxytocin in a dry, stabilized form which can be loaded into a robust, very inexpensive, disposable inhaler, eliminating at the same time the need for injection. Administration by inhalation at last makes treatment possible outside centres with trained medical staff.
The Mintaka Foundation for Medical Research
14 chemin des Aulx
1228 Plan-les-Ouates
Switzerland
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Post by kc on Jul 9, 2016 15:45:33 GMT -5
Interesting tie in to Mintaka (Robin Offord) Mintaka Foundation and Monash University which is doing the research that is funded by GSK? There is a Round Six funding program in Washington, DC on July 28th, 2016. But first read this press release from 2014 regarding funding of the Inhaled Oxytocin project: www.gsk.com/en-gb/media/press-releases/2014/international-collaboration-to-develop-inhaled-form-of-oxytocin-to-manage-bleeding-after-childbirth-in-developing-countries/
Excerpt: Technology, originally developed at the Monash Institute of Pharmaceutical Sciences, is being licensed to GSK as part of a collaborative agreement to co-develop, register and distribute the product in regions of high maternal mortality. A US $16.6 million early phase development program will be delivered, combining financial support and R&D expertise from GSK with funding from the McCall MacBain Foundation, Grand Challenges Canada, which is funded by the Government of Canada, and Planet Wheeler Foundation.
The alliance brings together innovative science, development capability of inhaled medicines and specialist philanthropic commitment in a collaborative effort to accelerate progress towards potential implementation of an affordable product in those countries with greatest need.
Every year nearly 300,000 women die due to pregnancy-related causes, with the risk of a woman in a developing country dying from a maternal-related cause during her lifetime around 23 times higher than a woman living in a developed country. The single biggest cause of death is excessive bleeding during or after birth,1 a condition that is effectively managed in developed countries using the gold standard therapy, oxytocin, a manufactured form of a natural hormone. However, accessibility to quality oxytocin in resource-poor settings is limited as current products are only available in an injectable form requiring supply and storage under refrigerated conditions and trained personnel to administer the product safely.
This new collaboration aims to address these issues through the development of a heat-stable, affordable and easy-to-administer inhaled form of oxytocin. Formulated as a dry powder, inhaled oxytocin eliminates the need for refrigerated storage conditions, while delivering oxytocin via a powder inhaler could facilitate its administration by health workers, birth attendants and mothers themselves. Combined, this novel approach has the potential to support women in low-resource settings or who give birth outside of medical facilities.
NOW BACK TO JULY 2016.
The Gates foundation, USAID and other world health organizations competition in Washington, DC July 26 -28, 2016
In its sixth round, 50 promising finalists from nearly 650 applications will come together to compete in the final stage of the 2016 Saving Lives at Birth Grand Challenge. The finalists will gather at the DevelopmentXChange in Washington DC, from July 26-28, 2016. There, they will learn from each other, interact with potential collaborators, and meet technical advisors in a number of discussion groups and one-on-one meetings designed to facilitate further innovation and impact.
Gold Standard Postpartum Hemorrhage Prevention to Women in Greatest Need
Organization: Monash University
Organization Location: Melbourne, Victoria, Australia
Over 300,000 women die each year due to pregnancy-related causes with hemorrhage being the leading cause. Oxytocin is the gold standard therapy to prevent postpartum hemorrhage and is recommended by the WHO to be used at every birth. Oxytocin is currently available as an injection that requires refrigeration to maintain quality and skilled healthcare workers to safely administer the product. These factors significantly limit the availability and impact of this medicine, particularly in resource poor settings. This project seeks to substantially expand access to oxytocin through the development of an affordable, simple to administer inhaled oxytocin delivery system. Using innovative technology, inhaled oxytocin is formulated as a fine powder that can withstand the climatic conditions common in tropical regions without the need for refrigeration. The product therefore removes the requirement for cold chain supply and storage, potentially allows task-shifting to lower tier healthcare and community workers and has the potential to save 146,000 lives over 8 years (.ic2030). This proposal recognizes that the successful implementation of innovations in global health relies not simply on technical effectiveness but also adaption to meet the needs of the local environment to which the innovation is applied. The planned work will ensure that the product design, presentation and implementation will facilitate maximal access and uptake by end users of greatest need.
Round six will be in Washington, DC on July 26, 2016 and it seems to be open to the public.
The Gates foundation competition in conjunction with USAID and several other World Health groups in Washington, DC July 26 -28
Mintaka Foundation in Switzerland. Robin Offord Mentions development with "OUR INDUSTRY PARTNER" (no mention of MannKind or Technosphere). 
Robin Offord refers to the Inhaler being developed by an INDUSTRY PARTNER? Why does it not mention MannKind or the formulation process? Does this involve Andrea Leone Bay and here departure to RLS? Anybody in DC on July 28th can register for the Saving Lives at Birth event. Perhaps we might see if they are truly using our Technosphere device
You can register to attend at this link: www.surveygizmo.com/s3/2727482/2016-Saving-Lives-at-Birth-DevelopmentXChange-General-Registration
An RSVP is required to attend events throughout the day. Please register via the survey below.
About Saving Lives at Birth: In 2011, the Saving Lives at Birth program called upon the brightest minds across the globe to identify and scale up transformative prevention and treatment approaches in rural, low-resource settings for pregnant women and newborns around the time of birth. Building upon the success of the past five years, at the beginning of this year, the program launched its sixth call and received an impressive set of applications that continue to push the boundaries of innovation. We are narrowing our pool of innovators, and these finalists, along with our existing grantees, have been invited to the DevelopmentXChange in Washington, D.C., to participate in the final stage of the competition and actively network their ideas with businesses, funders, development experts, non-governmental organizations and each other.
When: 11:30am to 6:00pm July 28th 2016
Where: Ronald Reagan Building and International Trade Ctr
1300 Pennsylvania Avenue NW
Washington, DC 20004
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Post by Deleted on Jul 9, 2016 17:04:34 GMT -5
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Post by kc on Jul 9, 2016 17:24:51 GMT -5
You don't know what you don't know. And none of us know! Especially me!
The only people who know are Mintaka, Monash , Possibly Monash research investors like GSK? And of course somebody at MannKind.
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Post by kc on Jul 9, 2016 17:25:47 GMT -5
I agree with you on that as they would have to get FDA approval for USA usage. |
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Post by mnholdem on Jul 9, 2016 18:43:17 GMT -5
I doubt that the Bill & Melinda Gates Foundation wants this for the U.S. so much as for poor third world countries. FDA approval can wait, but I would think that something like this may get fast-tracked. I'm not certain whether this has been posted yet, but the National Institute of Health has the abstract on file, Pulmonary Delivery of an Ultra-Fine Oxytocin Dry Powder Formulation: Potential for Treatment of Postpartum Haemorrhage in Developing CountriesLink: www.ncbi.nlm.nih.gov/pmc/articles/PMC3871608/ |
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Post by wmdhunt on Jul 9, 2016 21:05:56 GMT -5
Often these new therapies are tried in developing nations first before having to navigate the regulatory bodies in more "advanced" countries. Not being too cynical but the "trial bar" in these places are less pernicious too. Admittedly, damages are often less if unanticipated consequences occur also. Please don't take offense. I'm just trying to be realistic.
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Post by wmdhunt on Jul 9, 2016 21:17:15 GMT -5
This NIH abstract is fantastic. It makes the case for this therapy and MNKD SHOULD be doing this if it is not.
In the "CONCLUSIONS" portion appears:
"This is the first study to demonstrate that oxytocin can elicit uterine contractions after absorption as an aerosolised powder from the lungs, highlighting the potential for development of a safe, inexpensive and effective delivery system for the treatment of PPH in the developing world."
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Post by kc on Jul 10, 2016 21:32:00 GMT -5
Interest tweet exchange i had with Monash University regarding their Inhaled Oxytocin inhaler. My question and their response back to me.
Their response back to me. A very interesting response.
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