Posts Tagged www.bio2devicegroup.org

Medical Device Innovation & Pressure Ulcer Monitoring Technology


Dr. Barrett Larson, physician at Stanford University School of Medicine, Co-founder of Leaf Healthcare, and director of the Stanford Anesthesia Innovation Lab (SAIL), talked about the medical device innovation process and shared stories about his experience developing new medical technology at http://www.bio2devicegroup.org event.

A recipient of numerous medical technology and innovation awards, Dr. Larson emphasized that the innovation process begins with clinical observations and problem identification.  The next step is to define the clinical need, which should initially be defined in broad terms in order to maximize the number of potential solutions that can be conceived.

His company, Leaf Healthcare, is expanding the applications for wireless patient monitoring by introducing inexpensive, disposable, and easy to use wireless sensors.  One of the first application areas for the technology has been to address hospital-acquired pressure ulcers (HAPUs). Pressure ulcers, commonly referred to as bedsores, are injuries to the skin that result from prolonged surface pressure. Pressure ulcers put an enormous strain on the healthcare system and upwards of $9B is spent annually treating pressure ulcers in the US.   Since pressure ulcers are considered “never events”, they are not reimbursable and are a source of fines, penalties, and litigation exposure. The Leaf system has been shown to dramatically improve compliance with patient turning schedules, improve nursing efficiency, and reduce the incidence of pressure ulcers.

Dr. Larson also talked about a new device he developed that enables non-optical, magnetically-guided endotracheal intubation. The technology has won first place at the regional level (Western Anesthesia Residents’ Conference) and the national level (Society for Technology in Anesthesia). Dr. Larson also talked about other award-winning projects that he is working on in the context of the Stanford Anesthesia Innovation Lab (SAIL).

The talk was followed by Q&A.

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High Performance Computing Solution to Overcome Current Limitations in Mass Spectrometry


Jeff Peterson, Chairman at Veritomyx and CEO of parent company, Target Discovery, talked about how Veritomyx is focusing on convergence of high performance computing and state-of-the-art signal processing algorithms, to deal with the challenges encountered in identifying protein/isoform and metabolite biomarkers, due to limitations in mass spectrometry and supporting software.  The talk was in Sunnyvale, at event hosted by www.bio2devicegroup.org .

Modifications of proteins are responsible for exerting about 90% of the control of biochemical pathway changes. Accurate detection and validation of these changes offers hope for much stronger diagnostic insights into disease status and valuable treatment guidance decisions, enabling new effectiveness to advance the field of personalized medicine.  In turn, this is expected to help determine specific potential responses of therapeutic compounds in individual patients, allowing for more customized and successful treatment regimens.  Selection of properly validated therapies would save huge amounts of resources, money, and most importantly improve patient outcomes.

In the US, healthcare expenditure currently averages around $3T per year, said Peterson.  About 85% of that is spent on doctors, hospitals, ER, and end of life management.  Drugs make up only 12-15% of the total expenditure and diagnostics represent 2-3%.  The dawn of personalized medicine diagnostics now allows the right diagnostic to better select for the right therapeutic, and to minimize the patient’s descent into the chasm of other healthcare expenditures.  This paradigm shift is upending the value proposition in favor of newly recognized value in personalized medicine diagnostics leveraging overall healthcare expenditure decreases with improved outcomes.

A Shimadzu Ion Trap-Time of Flight mass spectr...

A Shimadzu Ion Trap-Time of Flight mass spectrometer (center), HPLC-UV (left). (Photo credit: Wikipedia)

The search to find, identify and characterize new biomarkers across life science R&D efforts typically employs mass spectrometry.  In MS, ions from the unknown are accelerated and detected electro-magnetically, and software attempts to assemble puzzles of component ions into information identifying the unknown parent.  The output is typically analyzed in the form of a diagram, with X axis reflecting the masses of the individual ions, and the Y axis showing the  “relative abundance” of the ions detected.

 

However, current limitations in mass spectrometry, signal processing and identification algorithms often limit the availability of useful information.  Frequently, critical information remains hidden among overlapping peaks.  Overlapping peaks cause misdirection in mass and abundance results, delivering lower mass and abundance precision, and making it vastly harder or completely failing to correctly identify biomarker compositions.

English: Isotopic pattern of an peptide. Mass ...

English: Isotopic pattern of an peptide. Mass spectrum recorded by Q-TOF mass spectrometer. Polski: Obwiednia izotopowa peptydu zmierzona przy pomocy spektrometru Mas Q-TOF (Photo credit: Wikipedia)

The “PeakInvestigator™” software from Veritomyx, helps enhance the quality of science, saving critical time and R&D resources.  PeakInvestigator typically triples the effective resolution and reveals and precisely deconvolves overlapping peaks that go unnoticed by current mass analyzers and software.

Precision problems in the data not only waste a great deal of time, but they can misdirect attention and decrease the effectiveness of R&D efforts.  Abundance and mass errors produce spurious biomarker candidates and incorrect isotopic ratios for peak identification, said Peterson.  The PeakInvestigator software delivers up to 10X improvements in mass and abundance precision across a wide dynamic range when deconvolving previously hidden overlapping peaks.

The PeakInvestigator is based on statistically robust and reproducible methodologies, said Peterson and it enhances identification of unknown proteins, peptides, and metabolites to improve the ability to correctly detect and validate biomarkers.  Further, it’s advanced signal processing algorithms automatically adjust for differences in instruments and tuning variations.  These algorithms provide adaptive baselining and signal-to-noise thresholding.  This easy to use software solution eliminates the need for manual estimation of centroiding parameters or visual inspection of data before processing.  When summing up the advantages, Peterson also added that PeakInvestigator is being designed to be 21CFR11 and HIPAA compliant.

For companies interested in PeakInvestigator software-as-a-service solution, it can be easily integrated into the existing workflow.  Their simple public application-programming interface (API) inserts directly into company’s existing mass spectrometry workflow.  While already validated workflow remains intact, the PeakInvestigator algorithms can be leveraged on the existing data.  Currently Veritomyx has launched Free Beta Services collaborations for its PeakInvestigator deconvolution and centroiding software.  Free Beta Services will allow collaborators to apply certain PeakInvestigator high performance computing capabilities to their own mass spectral raw datasets at no charge.   Please contact www.veritomyx.com for further information.

 

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2014 – Year-end Review ——- Theme: Confront Reality & Get Things Done!


English: Biosafety level 4 hazmat suit: resear...

English: Biosafety level 4 hazmat suit: researcher is working with the Ebola virus (Photo credit: Wikipedia)

Year 2014 is coming to a close.  As I see it, it has been a year to confront the reality and get things done.  Affordable Care Act became law in January, increasing the accessibility of healthcare, in the US.  TIME declared Ebola as the defining issue of the 20th century. It was no more in remote regions of Africa but in the capitals and it landed in the USA.  The reality is that we are living in a global world.  

And then President Obama reminded us that even though some of our neighbors entered the border illegally, they have made their home here, are working hard, supporting their families and they should have NOT amnesty, but an opportunity to make it right with the law, and live here temporarily, AND pay their share of the taxes, because people can’t live in the shadows, in a global world of visibility and accountability.   Long overdue immigration reform will enable many people to come out of the shadows and add to the national treasury – a win-win – what’s not to like?

The same applies to our gay neighbors.  They should not have to live in the shadows.  Majority of the states this year, legalized same sex marriages and US supreme court refused to hear appeals from states seeking to keep same sex marriage ban in place.  Many states also legalized marijuana.  But what about our veterans living in the shadows?  Department of Veterans Affairs got more resources (as house passed the bill, at the end of the year, averting shutdown), and it now has to get its act together and make it right with those who defend our freedom and values.

And what about skin color?  We are confronting the reality that more than 50 years after Dr. King laid out his vision for color-fair society, people are still being judged on the basis of the color of their skin and paying with their lives.  This does not just happen when young men turn 22 but prejudice hits in childhood  http://bit.ly/15EInJ4 and it splinters society.  We can heal and move ahead, but scars made by history, and distrust can only heal when there are no new wounds, when there is real dialog, when each side gets to even briefly experience the reality that the other lives with, and have compassion.  We are confronting the reality and lot of dialog is happening.  Much work remains to be done but the issue can’t be ignored any longer.

And then the lowest of the low, terrorists and those plotting terror.  How do we deal with them?  Report on CIA’s use of “enhanced interrogation techniques” in the post-9/11 era reveals that “CIA detainees were tortured”.  When we lose sight of our values, when the boundaries between moral and immoral gets blurry, then we lose, regardless of what we were seeking to gain.  This is a true moment for national soul searching. (the fact some people may be only suspected of being terrorists is whole other story).

Globally, also we are confronting realities.  World’s largest democracy, India, elected controversial Mr. Narendra Modi as Prime Minister.  Mr. Modi has reached out to leaders across the world and declared campaigns to clean up India.  My birthplace has so much to offer to the world and if it cleans up its act, under the helm of Mr. Modi, I couldn’t be happier.  Our neighbors need to clean up their act too, even as they rightfully blame the US for its insatiable appetite for drugs.  Capture of “El Chapo” Guzman in Mexico was a HUGE victory that got overshadowed later by disappearance and ruthless murder of 43 Mexican college students.  “#YaMeCanse12”!  Abduction of 270 high school girls by Boko Haram in Nigeria #BringBackOurGirls and scores of Yazidi women bought, sold, raped, and murdered, underscores the need to define rape during conflict as a war crime and not a woman’s issue.  By some estimates, more than 7 million (50% are children) are displaced by war in Syria (200,000 are killed) and 100,000+ Yazidis are displaced by ISIS.  Let us continue to keep theses issues in the spotlight.

The year is ending on a rather sad note of the children who lost their lives in #PeshawarSchoolAttack in Pakistan.  Here is my short poem in their memory – http://bit.ly/1wfp47D .  It was heart warming to see India support its neighbor in the hour of grief as #IndiawithPakistan was a popular hashtag on twitter. And also deeply heartwarming to see Pakistan echo the sentiments when #PakistanwithIndia and sepecially #PakistanwithIndiaNoToLakhviBail became trendy topics on twitter as overwhelmingly Pakistani people reacted negatively to their government’s decision to give bail to Mumbai terror mastermind Lakhvi.  May the balanced sentiments always prevail over extremism, because the reality is that we live in a global world and terror can’t be nurtured and targeted because sooner or later it would hit home.  Global world also demands secularism.

As a ray of light and hope, Malala Yousafzai, courageous young lady from Pakistan, spearheading girls’ right to education and Kailash Satyarthi from india, a brave and dedicated activist for children’s rights and against child labor, shared the Nobel Prize, sending strong messages that fight to honor children’s rights will continue.

Personal

wpid-20140920_173123.jpgHard as it is to confront the reality that one’s parents may not be there forever, I was very happy to spend wonderful time with my mother and my aunty (her sister).  I tried to focus on giving them a break from their routines and enable them to have some fun, some unusual experiences.  Isn’t it amazing that when a mother gives, she gives with her heart and soul, but when she receives from her children, she receives with a feeling of enormous debt and gratitude!  Both my children are focused on their careers; wpid-20140805_201145-1.jpgNeil is working with Cisco in IT and Neesha is finishing college this coming year.  Both are my pride and joy :).  It has also been fun hosting my daughter’s friend from UCSD, originally from Palestine, during the holidays, and alternately being “naughty” with the girls, and playing aunty-mom to two daughters :).wpid-20141221_150415.jpg

wpid-20141221_161442.jpgThis year, I also visited Japan (we were hosted by many amazing friends and you can see all details in my travel blogs), an amazingly polite and most efficient culture, with world’s most interesting toilets http://bit.ly/1sYL5qs.  This year I also started travel blogs and you can see my many blogs at www.darshanavnadkarni.wordpress.com.

And finally, here are links to some of the most amazing things that I blogged about, this year.
Best movie – “Last Days in Vietnam” http://bit.ly/1qFIL28
Best play – “Truce” http://bit.ly/1trGhEG and “Andhera Hone Tak” http://bit.ly/1Aij5Rz
Best book – “The Glass Castle” http://bit.ly/1fchcIo
Best biomedical technologies — so many exciting technologies in early to mid stages of development for — treatment of ALS http://bit.ly/1AP2Yd0, for technology for early detection of cervical cancer http://bit.ly/1jalqEz, technology that aims to deliver drugs via inhalation for AFib, point of care solution to minimize prescription filling errors http://bit.ly/1jdfmgr

Wishing my readers, family & friends, and my clients and colleagues, peace and joy in the year 2015.  Best wishes to my many friends in fantastic groups that I am routinely affiliated with (each of them enhance life for many, personally and/or professionally) http://www.bio2devicegroup.org, http://www.eppicglobal.org, http://www.citylights.org, http://www.thestage.org, http://www.theatreworks.org, http://www.naatak.org, http://www.enacte.org, http://www.iwings.org .

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Aligning value proposition: From Preclinical to Market for Medical Devices


Tim Pelura, CEO, Surpass Preclinical CRO talked on how medical device companies can align their strategy, from preclinical to market, with a focus on the value proposition, at www.bio2devicegroup.org event.

We are operating under a new reality now where power has shifted to the payers and the providers, said Pelura.  Medical device companies are evaluated based on safety and procedural efficacy as well as cost and value.  Increasingly heightened regulatory scrutiny and tightening FDA regulations have led to increase in audits (which were up 40% in the last year) and warning letters are (which were up 24% over the last 2 years).  Due to regulatory and reimbursement challenges, medical device companies are focusing their R&D efforts on improving already approved devices, rather than developing innovative new products.  Meanwhile startups are finding the landscape challenging due to funding challenges and increasing costs of bringing new products to market.

Healthcare Infostep

Healthcare Infostep (Photo credit: Wikipedia)

Inkeeping with the reality of pressures on payers that are transmitted down, new healthcare delivery models are emerging, and therefore, patient pathways are being modified to obtain to obtain better outcomes, with less cost.  Medical device companies will need to work with new business models, that solve significant problems and reduce overall costs.  Companies seeking growth will need to expand their offerings to target underserved populations and lower socioeconomic classes.

In essence, it is about the value proposition offered by the new product or service, “what benefit you provide for who and how you do it uniquely well”, said Pelura.  He advised, these “must-haves” in a business pitch, “describe your target buyer, the problem you are seeking to solve, and why you do it better than the alternative”.

Pelura walked the audience through the process of arriving at the value proposition.  First, companies must define the problem they are seeking to solve and identify correctly the need to solve the problem.  Next, they should try to go after obvious problems, rather than aspirational or “good to solve” problems.  And finally, they should try to address acute or critical problems.

In defining a solution, they should try to generate many ideas and then measure the viability of customer adoption of each idea using gain/pain ratio; what the customer stands to gain versus the cost of adoption of the new solution.  The best solutions are those that offer game-changing benefits, with minimal modifications to the existing process or environments, said Pelura.  Go for “Disruptive Innovations, that are Non-Disruptive to Adopt”, advised Pelura.   Medical device companies must visualize the entire process or patient pathway to ensure that the new solution would cause minimal disruptions, in the whole process.

While new technologies often emerge with a focus on engineering and progress to bench testing and then plan preclinical, and clinical strategies and only then consider navigating regulatory, market, and reimbursement challenges; in actuality, they should invert the process.  They should begin with considering reimbursement challenges, analyze the competitive landscape, study the market opportunity, give thoughtful consideration to the regulatory challenges, then consider clinical and preclinical strategy, before embarking on prototype and bench testing.  Because if the value proposition is wrong then a company can end up with a product that no one wants or needs, resulting in considerable waste of precious innovation dollars and time, said Pelura.

Speaking of Surpass, Pelura shared that preclinical Contract Research Organization, Surpass is doing things differently.  While having deep expertise as a preclinical CRO in helping medical device companies with their preclinical in vivo and human cadaveric studies, Surpass also seeks to impact the system, by probing and assisting their clients with questions that go to the value proposition.  Surpass assists the clients in designing the most translatable preclinical study by understanding issues of clinical end points, product’s desired features and characteristics, all the while keeping in mind who would be operating the device, studies and activities that might need to be completed to demonstrate the products, performance, safety, and efficacy, as well as data that would be required to drive reimbursement and more.  This novel process ensures that any preclinical testing performed is aligned to the new product’s value proposition, hence helping save valuable healthcare innovation dollars.  

The session was followed by Q&A.

 

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Lean LaunchPad for Life Science Entrepreneurs


Recently, Karl Handelsman, Founder, Codon Capital, talked about the Lean LaunchPad Entrepreneurship program, at www.bio2devicegroup.org event.  Handelsman, with Allan May (Managing Director at Life Science Angels), are instructors in the Lean LaunchPad for Life Sciences program at UCSF and also will be teaching at NIH, in the future.  Handelsman is the Therapeutics cohort and May is the Medical Device cohort.

It is a mistake to assume that pre-clinical programs are risky and they need to focus on easier low hanging fruit or they must take 10+ years and a billion dollars to create value, said Handelsman.  We have a duty to search for the path to unlock the value of the idea as industrially relevant innovation, and there are examples of biotech startups reaching that point in 18-30 months, said Handelsman.  Lean LaunchPad program teaches scientists and clinicians in startups to do a real world assessment of their idea or technology, before plunking down millions of dollars, in an idea.  Entrepreneurs receive training in determining their product’s market viability, regulatory risk, potential clinical utility, and also likely financing vehicles before making big dollar investments in research, design, and manufacturing.

English: Molecular graphics images were produc...

English: Molecular graphics images were produced using the UCSF Chimera package from the Resource for Biocomputing, Visualization, and Informatics at the University of California, San Francisco (supported by NIH P41 RR001081). PDB rendering based on 1a8e. (Photo credit: Wikipedia)

Entrepreneurs need good operational models that build a context of value creation, said Handelsman.  Investors like value, not milestones.  “Investors want to invest money and they want to hear a business case, and operational milestones don’t get you there”,  stressed Handelsman.

Big things often have small beginnings and start with contributions from many small pockets.  Sharing the case of a company that started with collaboration and became the behemoth, Genentech,  Handelsman said, entrepreneurs need to start thinking about collaboration, not competition, and begin to look at models of collaboration that would create true value.  After all, strategic alliances built the Silicon Valley and there are many diverse and creative ways of creating partnerships.  Entrepreneurs need to talk with others and be really good listeners.

Successful entrepreneurs are not thoughtless risk takers, but approach problems in a disciplined way.  Value creation for therapeutics begins with thoughtful consideration of who would benefit from solving a certain problem; patients, payers, insurances companies or any other entity?  Once entrepreneurs can figure that out, they can go to a VC and explain the business case.  Value creation, after all, is not what entrepreneurs think or believe, but an idea or concept that gets external validation from the customer.  “Do not constantly worry about keeping the concept in the stealth mode, and talk to a lot of people”, advised Handelsman.  VCs do not count, they are not potential customers.  In the end, one could have a sexy product, but if it does not solve a pressing problem then it is not creating value.  Real answers to key commercialization questions, in the case of therapeutics, lie outside the lab, and entrepreneurs need to actively engage and talk with customers, partners, regulators and so on to figure out the value of their product.  Lean LaunchPad methodology therefore, helps to validate the product, before commercial strategy is considered, saving time, money, resources and in some cases, helping guide the change in the trajectory, for more meaningful outcome.

 

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Diabetes & Cardiovascular Disease Risk Factors among South Asians Compared to other Ethnic Groups


Dr. Alka Kanaya talked about Diabetes and cardiovascular disease risk factors in multi-ethnic groups comparison studies, at a joint event hosted by  www.eppicglobal.org and  www.bio2devicegroup.org .  Dr. Kanaya is Professor of Medicine, Epidemiology, and Biostatistics at UCSF and a principal investigator in Mediators of Atherosclerosis in South Asians Living in America or MASALA study, for short.  Primary objective of the study was to research and understand the high incidence of diabetes and CHD among people of South Asian origin.

Kanaya first shared information on South Asians (will be referred here as SA) and then discussed the study results in the context of multi ethnic comparison.  Currently there are 3.4 M people from South Asia living in the US.  It is the second fastest growing racial/ ethnic minority in the US.  They constitute 20% of all Asians and 75% of them are foreign born.  Although there is little organized medical data on SAs, overall they have relatively lower body weight (BMI), have more central abdominal obesity, and experience higher rates of diabetes and indicate high risk of early heart disease.

MASALA study began in March, 2010 and constitutes a total sample of 906 people, between the ages of 40 and 84.  People with prior history of any cardiovascular disease, those in active cancer treatments, those planning to move out of the area in the next 5 years, and nursing home residents, were excluded.  Data collected included weight, height, waist, seated BP, Ankle-brachial index (ABI predicts the sevearity of PAD, peripheral artery disease), 2 hour OGTT (oral glucose tolerance test), abdominal CT, and several blood tests and extremely detailed questionnaires regarding family history and information about personal habits like alcohol, smoking, sleep, diet and exercise.

Results from MASALA study were compared to results on almost all similar measures with Whites, Latinos, African-Americans and Chinese populations in ongoing MESA study.  See the websites of MESA (www.mesa.nhlbi.org) and MASALA (www.masalastudy.org) studies to see many interesting details on several patterns that emerged.  Kanaya specifically discussed some patterns among South Asians when compared with other ethnic groups.

When adjusted by sex and age, South Asians had significantly high rates of hypertension.  However, there weren’t major or alarming differences in cholesterol.  One of the reasons could be that South Asians were overall more educated, from higher socio-economic background, and were more likely to be using statins and other cholesterol lowering drugs

Most alarming differences were observed in diabetes and pre-diabetes levels.  Almost 30% of men and almost 15% of South Asian women had Diabetes Mellitus, versus 20% or lower among other groups of men, and 13% or lower among other groups of women.  Nearly 37% of SA men and 29% of SA women had IFG (impaired fasting glucose indicative of pre-diabetes), compared to 20% or less for men and 13% or less for women from other groups.  When adjusted for many indicators including age, sex, cholesterol, triglycerides, hypertension etc., South Asians were significantly more likely to have type 2 diabetes.

When adjusted for age, sex, BMI, and waist and excluding those on diabetes meds, this high incidence of Diabetes Mellitus among South Asians seemed to be associated with higher levels of insulin resistance, lower pancreatic B-cell function, and (as confirmed by abdominal CT data) high amount of body fat around abdominal regions and in the liver.

Mercat de la Boqueria, fruits & vegetables

Mercat de la Boqueria, fruits & vegetables (Photo credit: Wikipedia)

Among lifestyle factors, the high rates of DM (Diabetes Mellitus) among SA was attributed to poor diet with less fruits and vegetables and more Western diet (including pizza, pasta etc.), sweets, refined grains, and consumption of high animal based protein in the diet and low levels of exercise.  Considering that even on a relatively leaner body, South Asians carry more fat, the study concluded that guidelines for BMI should be lower for people of South Asian origin.

The study concluded that 75% of South Asians were overweight or obese using the recommended BMI cut-points in Asians.  Compared to other racial/ ethnic groups, South Asians were from higher socio economic status, had low smoking rates, and low to moderate alcohol use.  They also indicated very low physical activity, higher diabetes prevalence (specially among men), second highest prevalence of high blood pressure, and men have more coronary calcium than other groups.

A yoga class.

A yoga class. (Photo credit: Wikipedia)

Some of the recommendations for South Asians from the study were, to know the risk factors, work towards ideal BMI goal (less than 23 kg/m2 for SA), remember waist size matters more than BMI, walk at least 30 minutes a day 5 days a week, avoid a diet high in animal protein and refined carbs, and then something interesting – do Yoga!

Kanaya also shared results from her PRYSMS study that assigned subjects with metabolic syndrome into two groups, one practicing Restorative Yoga (included lot of lying down and relaxing poses) and other, Stretching Exercises.  In 6 months, both groups improved their PA and calorie intake.  Favorable changes in the stretching group included, lowered triglycerides and improved mental health.  Restorative yoga group reduced and sustained weight loss and weight girth loss but not visceral fat area.  Finally, only yoga group indicated reduction of fasting glucose and overall favorable metabolic changes in the yoga group included lowering of fasting insulin, glucose, HbA1c and HDL.

One wonders if very determined focus on material wealth goes with more stress.  In any case, it shows once again that stress relief is a key for improved health.  This was a fascinating talk and was followed by Q&A and animated discussion.

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Treating ALS – The Story of Neuraltus


Rich Casey, President and CEO of Neuraltus (formerly Chairman and CEO of Scios), talked about treatment option for ALS (Amyotrophic Lateral Sclerosis), also known as Lou Gehrig’s Disease, a fatal neurodegenerative disorder of unknown etiology, at www.bio2devicegroup.org event.

Typically, the age of onset of ALS is anywhere between 40 and 70 years.  Life expectancy after the diagnosis is between 2 and 5 years, although in very rare cases (e.g. in case of Stephen Hawking), it could be an extremely slow progression.  No effective treatments for the disease exist.  Motor neurons degenerate and early symptoms include muscle weakness, specifically involving arms and legs, lack of hand grip, deep tiredness and it progresses to difficulty in swallowing, breathing, and garbled speech.

Macrophage

Macrophage (Photo credit: Wikipedia)

Neuraltus’s lead product,  NP001 is in clinical development, targeted for the treatment of ALS.  While the exact cause of the disease is unknown, there is fair amount of evidence that points to increasing levels of inflammation in the macrophages.  This increased inflammatory activity results in the release of factors in the central nervous system that leads to damage of motor neurons.  Macrophages are cells produced by differentiation of monocytes in the tissues.  Macrophages are highly specialized in removal of dead cells or debris.  Additionally, macrophages also “present” antigen that plays a crucial role in initiating an immune response.  There is an increasing evidence implicating neuroinflammation with the progression of ALS.

English: Amyotrophic lateral sclerosis MRI (ax...

English: Amyotrophic lateral sclerosis MRI (axial FLAIR) demonstrates increased T2 signal within the posterior part of the internal capsule, consistent with the clinical diagnosis of ALS source:Radiopedia.org (Photo credit: Wikipedia)

Neuraltus’s novel, proprietary drug, NP001 regulates macrophage activation and converts the activated inflammatory macrophages from activated, neurotoxic inflammatory state to a neuroprotective state.  It thus normalizes the critical cellular environment.   Phase I, single dose study indicated that that there are no safety concerns and the drug is well tolerated.  Further, in a Phase II safety, tolerability and preliminary efficacy study, after administration of NP001, there occurred a close dependent reduction of inflammatory macrophages.

The dosing regimen is somewhat cumbersome, said Casey.  First time, the patients come in the hospital and need to stay for 5 days and subsequently for 3 days.  At low dose, phase II study results indicated positive trends in the ability of NP001 to slow the rate of disease progression but did not reach statistical significance.  But at high dose, the drug freezes the disease in a 3rd of the patients.  Additionally, the drug is found to be safe and well tolerated.  This clearly looks like a very exciting potential treatment for a devastating disorder, ALS.  The company is currently looking for funding.  The talk was followed by Q&A.

 

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Health Information Technology (HIT) – Hype or Promise of a Better Healthcare System?


Salim Kizaraly, Founder & SVP of Business Development at Stella Technology, a healthcare information technology start-up, talked about the promise of  Health Information Technology in solving care coordination, physician collaboration, and system integration challenges to improve healthcare, at a recent http://www.bio2devicegroup.org event.

Kizaraly began by sharing the known fact that the mounting and huge healthcare costs in the US, that do not result in significant improvement in health, are not sustainable.  According to some estimates, almost 18.3% of GDP in the US, goes towards healthcare expenditure.  If the cost of healthcare continues to rise at historical rates, the share of GDP going towards healthcare in the US, is projected to reach 34%, by 2040.  While the costs continue to rise, gains on health improvement do not keep pace.  For instance, life expectancy in the US is only 78.4 years and US ranks 27th out of 34 industrialized nations.  In this study of industrialized nations, US had highest to near highest infant mortality rates.

Kizaraly discussed the three defining historical events that got the ball rolling on healthcare transformation.  In 2004, President Bush announced that in the next 10 years, by 2014, every American would have an access to electronic health records. We have a long way to go, but certainly we are moving in that direction.  In 2009, HITECH (Health Information Technology for Economic & Clinical Health) Act, enacted as part of the ARRA (American Recovery & Reinvestment) Act, was signed into law, to promote the adoption and meaningful use of HIT and included incentives for faster adoption of EMR (Electronic Medical Records).  In 2010, the Affordable Care Act or Obamacare, with its mandate to expand coverage, cemented the case regarding the need towards transformation.

Barack Obama signing the Patient Protection an...

Barack Obama signing the Patient Protection and Affordable Care Act at the White House (Photo credit: Wikipedia)

The Affordable Care Act’s most significant contribution is to creating ACOs or Accountable Care Organizations.  An ACO can be defined “as a set of health care providers, including primary care physicians, specialists, and hospitals that work together collaboratively and accept collective accountability for the cost and quality of care delivered to a population of patients”. There are incentives to keep patients out of the extreme settings of care, including hospitals and nursing homes.  Different models are emerging of how these organizations put this into practice.  Underlying issue is that hospitals have to get better at treating patients.  Hospitals are bracing for lower revenues as they get better at keeping patients out of hospitals.  Different models of care are emerging.  Technology will be a big enabler to change workflow, rethink care, as homes emerge as places of care.  Here is link to my article on Keynote by Dr. Toby Cosgrove, CEO of Cleveland Clinic, at 2014 J P Morgan Healthcare Conference in San Francisco –http://bit.ly/1c3EyBB .  Cosgrove also said, that hospitals will not longer be epicenters of care, and while a few hospitals (e.g Cleveland Clinic) will be super high tech, they will partner and share resources with other care providers, to offset costs.  The disruptions will eventually enable us to “build a healthcare system that is humane, high quality, and sustainable”, said Cosgrove.

Kizraly discussed several national initiatives that are implemented or partially implemented to enhance collaboration among care providers and integration of information.  For instance, if a person experiences an emergency visiting New York, then eHealth Exchange will make it easy to get their health records from the state of their residence. Similarly, Blue Button makes it easy for Americans to get easy, secure, online access to their health records, with a single click.

Stella Technology is a self-funded health information technology services and product development company that focuses on care coordination, patient access, and information exchange projects.  Kizraly shared use cases and information on how Stella is helping providers, with great success, in integrating care.  Through aggregating data from a variety of sources, through identifying gaps in care, and with real-time, proactive analytics, Stella’s technology identifies care opportunities that can be improved and accordingly targets interventions.  In the long term these kinds of strategic technological interventions will enable care providers to curtail expenditure, while improving care. In the interim, we still have a long way to go and there are many opportunities for entrepreneurs to use technological advancements in big data, cloud, machine learning, (IOT) internet of things, and enable US healthcare system to become more efficient, with lower costs and improved outcomes.  Kizraly’s talk was followed by Q&A.

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Point-of-care Solution to Minimize Prescription Filling & Medication Dispensing Errors


Dr. Alan Jacobs, Founder and CEO of PerceptiMed talked about “preventing drug-related patient injury and death with advanced, cost-effective technology systems”, at www.bio2devicegroup.org event.

Medication dispensing error occurs when there is a discrepancy between a prescription and the medicine that the patient receives.  It can occur in pharmacies, hospitals, or nursing homes.  Such errors can occur at any stage during the long chain of events that transpire between the prescription that the pharmacy receives and the medication that the patient receives.  A prescription may be read incorrectly, transcribed incorrectly, dispensed erroneously or delivered to the wrong patient.

Pharmacies dispense enormous volumes of medications.  So, relatively low volumes of dispensing errors, in proportion to the medications dispensed, translate into huge numbers of erroneous medications that the patients receive, with serious consequences.  For instance, do you know that each year in the US, there occur almost 345 million medication dispensing errorsThese errors lead to 1.5 million patient injuries and staggering 7,000 deaths, each year.  Additionally, such mistakes are very costly.  These preventable medication errors cost $21 billion in wasteful healthcare spending, each year.

Pills (white rabbit)

Pills (white rabbit) (Photo credit: erix!)

Medical dispensing system is a complex system.  Often prescriptions are filled by technicians or others representing low skilled workforce.  After the prescription is received at the pharmacy, and the patient profile is made, the pharmacist or the technician enters the prescription in the computer.  The technician then goes to the stock room, counts out the number of pills and fills in the medicine container, and appropriately labels it.  The pharmacist makes one last check, reviews the completed order, verifies drug name, strength, dosing directions, and then visually inspects the pills.  Finally, after verification that the prescription is filled for the correct patient, the medicine is dispensed.

Prescription filling errors can occur at any stage, in the process.  There are currently 10,000+ pills on the market.  About 2633 pills are white and round, 718 are yellow in color.  Despite the fact that following FDA ruling, every pill is marked with a special insignia, given the volume of similar looking pills, this is an error waiting to happen.  Typically, in a busy pharmacy, a pharmacist may fill out 200-300 prescriptions, a day.

PreceptiMed offers a breakthrough point-of-care product, IdentRX that provides real-time identification of individual pills and checks each pill against the patient’s prescription.  This solution is built upon state of the art pill identification algorithms and machine learning technology that enables the system to learn about each new pill that is introduced.  There is 100% identification of each individual pill as it is dispensed into the pill bottle.  The optical sensor reads 120 pills a minute.  Its error detection rate is 99.9% and it requires no calibration or modification of pill or any other special packaging.  This automatic, pour and go, first in class system correctly verifies all parameters, and checks for correct medication against patient information, dosage, and quantity.  It flags when there is an error the first time, unlike mechanical errors that go undetected for long periods and get further compounded.  Built in safe guard eliminates cross-contamination with sensitive products.

PerceptiMed has a broad IP and various other products for other uses in nursing homes and so on.  This point-of-care dispensing system does not require FDA approval.    Currently, almost 25% of the technician’s time is spent on making a mistake or correcting the mistake, as restocking of erroneous products is also a complicated process, further raising the possibility of errors.  PerceptiMed system makes it easy to restock erroneous products, saving enormous amount of time.  Additional products are in the pipeline.  For instance, Scrip Clip is a simple clip with a sensor that goes on top of the pill envelope and when the patient info is entered in the system, it lights up, allowing for easy pick up from all medications waiting to be picked up.  Also it makes it easy to restock the medications that are not picked up.  There are other fail safe products for use in nursing homes (for instance, eMAR), to ensure right medication, at correct dosage and time is given to the patient, and the date is entered immediately, to avoid overdosing.

This was a very interesting talk that included several videos that demonstrated the products.  The talk was followed by Q&A.
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Upcoming Healthcare events in Bay Area

http://www.bio2devicegroup.org features top notch speakers and many events are completely free.

Healthtechnology Forum conference http://www.healthtechnologyforum.com, focused on exploring pathways to sustainable health, is on May 20 in SF. Please register for the conference as my friend, with the discount code “HTF14-FriendOfOrganizer” and send me your first & last name at wd_darshana at hotmail dot com, to get $150 off the price of the ticket.

www.tiecon.org – If you are a professional  in #healthIT, #digital health,  #internetofthings, #cloud, #bigdata or related, I would say this is the conference, you don’t want to miss – It offers a fabulous opportunity to network with 3000+ professionals and listen to top notch speakers and panelists.  You can register for #TiEcon (May 16 & 17 at Santa ClaraConvention Center) at link http://tinyurl.com/kr2hkcw  as my guest & enter promo code tievalue to get $100 discount.

http://www.wsgr.com/news/medicaldevice/ – #WilsonSonsini, #WSGR annual medical device conference in San Francisco, June, 12.

JOBS: are posted at the link http://bit.ly/1o85CTM

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Genetically Engineered Oncolytic Virus to Treat Glioblastoma


Glioblastoma or GBM is the most aggressive brain tumor for which currently there exists no cure.  Michelle Chen talked about targeted oncolytic virus therapy for these tumors.  These tumors are highly malignant because the cells reproduce quickly and they are supported by a large network of blood vessels.  There are approximately 25,000 new cases in Europe and US, each year.  Median survival in newly diagnosed patients who receive the best treatments is less than 14 months.  Most patients experience quick relapse and survival after 5 years is very dim.

Following the diagnosis, the current standard of care consists of surgery, radiotherapy, and chemotherapy with temozolomide.  FDA has recently also approved Avastin for recurrent GBM.  But new therapies for GBM are urgently needed.  There is a lot of activity in this space but currently active drugs have lot of safety concerns.

English: TAC_Brain_tumor_glioblastoma-Coronal_...

English: TAC_Brain_tumor_glioblastoma-Coronal_plane Italiano: Immagine TAC della zona cerebrale, identificando un tumore di tipo glioblastoma (Photo credit: Wikipedia)

DNX-2401 may be an elegant genetic engineered solution.  DNX-2401 is an engineered virus that is capable of selectively and effectively killing a broad range of tumor cells with defects in the retinoblastoma (Rb) pathway.  The virus enters cells by binding to specific types of integrins highly expressed on tumor cells and tumor endothelial cells.  Once it gets in, the virus replicates rapidly and the replicating viruses in turn kill host tumor cells.  Further cell killing is done by triggering of anti tumor immune response which is capable of eliciting tumor destruction.

DNX-2401 therapy has shown to improve survival in animal models.  Relapse of GBM is attributed to recurrence and persistence of tumor stem cells.  Is it possible that the virus kills the stem cells as well?  Indeed, results indicate that brain tumor stem cells are also susceptible to being killed by DNX-2401, said Chen.  Additionally, Delta 24 RGD + temozolomide seem to provide enhanced therapeutic benefit in combination therapy.

Early safety profile of DNX-2401 looks very good and early indication suggests it to be very efficacious and capable of selectively and effectively killing a broad range of tumor cells.  Expectations are that DNX-2401 will demonstrate therapeutic effects in a wide variety of cancers.  Currently DNX-2401 is delivered by direct injection into the tumor bed, guided by the MRI through the cranium or through surgical resection, into the walls of the resection cavity to kill residual tumor cells.

Chen went into more detailed explanation of the mechanism of action, and her talk was followed by Q&A.

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Other information and events below.

Jobs: There is a huge uptick in JOBS.  Check out new jobs posted for May at http://bit.ly/1o85CTM .

TiEcon: If you are a professional  in #healthIT, #digital health,  #internetofthings, #cloud, #bigdata or related, I would say this is the conference, you don’t want to miss – It gives fabulous opportunity to network with 4000+ professionals. Check out great agenda, top notch speakers & panelists at www.tiecon.org.  Register for #TiEcon (May 16 & 17 at Santa Clara Convention Center) at link http://tinyurl.com/kr2hkcw  as my guest & enter promo code tievalue to get $100 discount.

Healthtechnology conference & Code-a-thon http://www.healthtechnologyforum.com, focused on exploring pathways to sustainable health, is on May 20 in SF. Please register for the conference as my friend, with the discount code “HTF14-FriendOfOrganizer” and send me your first & last name at wd_darshana at hotmail dot com, to get $150 off the price of the ticket. There are $20K+ in prizes at the code-a-thon.

Dr. Sarvajna Dwivedi, founder of Pearl Therapeutics will talk on Tuesday, May 6.  Notice venue change & pre-register at  http://www.eppicglobal.org . Pearl Therapeutics was acquired by Astra Zeneca last year, for $1.15 B and was a winner of TiEcon’s TiE50 awards, two years in a row. It will likely be sold out event, so please pre-register.

http://www.bio2devicegroup.org meets every Tuesday in Sunnyvale, CA.  Morning meetings are free, wealk-ins welcome. Dr. Alan Jacobs, Founder & CEO, PerceptiMed will talk on “Preventing Drug-Related Patient Injury and Death With Advanced, Cost-Effective Technology Systems“.

Feel free to send me an email for any of these events at wd_darshana at hotmail dot com and you can follow my updates on Twitter @DarshanaN.

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