Posts Tagged Cloud

Harnessing Cloud Technology to improve Customer Engagement for Medical Device


Aroon Krishna and David Judelson, co-founders at VirtuMed talked about the challenging environment for current medical device manufacturers and VirtuMed’s Synapse Mobile cloud based, on-demand, customer engagement platform solution to address the challenges, at a recent www.bio2devicegroup.org event.

Enumerating examples of challenges impacting medical device marketplace, Judelson, said Boston Scientific neuro modulation business has declined due to reimbursement challenges, Medtronic agreed to settle and stop the sales of pain med pump due to link with patient deaths, and big promise and subsequent failure of renal denervation solution has cut the growth among other device manufacturers.  There are challenges across the board from development to commercialization, said Judelson.  Hospitals are faring no better.  Nearly 40% of California hospitals received bad grade, constant M&A activity among hospitals, pressure from changing government initiatives, difficulties with privacy and security of EMR data has all led to medical device companies spending more money to get less and spending more in sales and marketing efforts is not the answer.

Five current headwinds are defining the existing environment.   Increased regulation and declining reimbursement from fee for service to bundling and changes in how CMS pays, is putting a lot of pressure on providers who pass the burden on to device manufacturers.  Second, there is a lot of variability in how different hospitals measure quality.  Third, aging population with increasing co-morbidities is leading to variability in clinical trials and making it challenging to assess the effects of interventions.  Four, challenges are increasing with decreasing hospital access for sales reps.  Five, huge global volatility with large swings in foreign exchange rates, government uprisings etc. is making it hard to estimate earnings.

Hospitals are often burdened with internal challenges of system integration, promise and challenges of mobile technology, problems of achieving seamless inter-operability, thinning margins, vendor management issues, physicians getting overburdened with administrative tasks, HIPPA issues and more.  All these challenges are compounded with sub par performance from medical device companies as they are delivering more failures in R&D, demonstrating lack of innovation with decreased ROI followed by decreasing investment in venture and M&A activity.

Currently, there are few solutions for comprehensive customer management, said Judelson.  Some general solutions like Salesforce, Oracle, imshealth, freshdesk, Veeva and Zendesk have been applied.  However, these require significant customization, often have complex pricing structure, are pricey for small to mid-sized enterprises, have complex IT integration and archaic mobile user interface, and are often based on limited knowledge of medical device econsyste.  There are no existing CRM solutions specially designed for medical device industry, said Judelson.

VirtuMed’s cloud based remote connectivity solution specifically fills in this gap, where device manufacturers can establish direct line with the customer, provide better, more timely customer support as a value added service, develop apps, and leverage knowledge of product users globally with access to real time outcomes data.  There are many gains from such timely information.  Research indicates that with timely physician access to post surgery recovery process and real-time conversation with patients, recovery occurs faster and patients remain more engaged in their recovery.  While there is a great deal of patient to patient interaction in social media, there are fewer tools for patient to provider engagement and that needs to change.

VirtuMed’s Synapse mobile solution helps build a connected ecosystem that combines commercial CRM, social networking, on demand communication, big data visualization, HIPPA compliant infrastructure, and enhances security with data changing hands while ensuring availability of data at the right time to the right people.  This solution aims to unite all key stakeholders on a single platform with primary objective for positive patient impact, said Krishna.  VirtuMed product is poised to offer support to companies of any size and its tech solutions can be applied at each stage in medical device life cycle, from early innovation to clinical stakeholder engagement, to customer engagement to CRM platform to enable growth in emerging markets; literally from ideation to discovery to clinical to commercialization, said Krishna.

The talk with followed with Q&A.

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Johan Lodenius – Opening Keynote, “Internet of Things” at TiEcon 2015


Internet of Things is a hyped up buzz word but it is not without challenges.  First and foremost it requires innovative ways to sense and deliver information from the physical world to the cloud.  Power is also a critical element.  Many IoT applications need an ability to run for years over batteries and reduce overall energy consumption.  MediaTek is one of the largest chip-design companies providing system-on-chip solutions for the global market.    Johan Lodenius, Corporate VP and Chief Marketing Officer at MediaTek, will give an opening keynote in IoT track at TiEcon 2015.

English: Mediatek MT1389DE, a chipset for DVD ...

English: Mediatek MT1389DE, a chipset for DVD player. (Photo credit: Wikipedia)

MediaTek excels in achieving tight integration of components, rendering technology more efficient, enabling rich set of features, with less resources, and making it more affordable.  The company began with designing chipsets for optical drives and later expanded into chip solutions for DVD players, digital TVs, mobile phones, smart phones, tablets and so on.  In about seven years from launch, the company has gained huge market share worldwide.  In 2014, the company posted revenues of 213.1 B TWD, about USD $ 6.88 B.

The company has been known to provide extensive system engineering assistance that enables many smaller players and new entrants to enter a mobile market that has been thus far dominated by large corporations.  Looking forward to words of wisdom from Lodenius on how entrepreneurs can overcome the challenges of IoT market and better understand areas of opportunities.   Register at  https://www.123signup.com/register?id=ygszb&ref=4182698 to get a $100 discount on the two-day conference at the non-member rate.  When prompted, enter the promo code VOL500 at checkout.

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Digital Health Panel Preview – EPPICon 2015


EPPIC annual conference is on March, 28 and early bird pricing will end on Monday, March 16.  Here is a sneak peek at one of the panels.  

Technology is impacting health in interesting ways and many exciting innovations in digital health are expected to change how diseases are tracked, reduce inefficiency in healthcare delivery, reduce costs, improve access to healthcare, increase quality, save resources, and make medicine more personalized.  Digital health panel at EPPICon 2015 has diverse and interesting lineup of speakers.

wpid-20150304_162558.jpgDr. David Persing, EVP, CMO, and CTO at Cepheid, had made an early resolve to have a positive impact on the world.  Guided by intellectual curiosity, while doing his pre-med, he discovered “the power of diagnostics”.  The company’s mission at Cepheid is to use the power of molecular diagnostics such that it would enable medical providers to identify and treat diseases early, increasing opportunities to improve patients’ survival and quality of life. Their cloud based platform, “The Digital Miasma” for monitoring of emerging infections earlier, is just launched and is in the implementation phase.

wpid-20150304_163547.jpgPanelist Deborah Profit is Director of Corporate Projects – Global Clinical & Business Operations for Otsuka Pharmaceutical Development and Commercialization.   OPC, is headquartered in Tokyo and is known for popular sports drink Pocari Sweat and energy drink Oronamin C.  OPC also developed Abilify, an approved drug treatment for certain mental illnesses, and as of 2013, annual sales of Abilify were over $8 billion a year, making it the highest grossing drug worldwide.  You would wonder what has that to do with digital health, until you consider the fact that patient non-compliance is one of the biggest challenges in many illnesses but specifically in mental illnesses.  Otsuka has recently made a deal with Proteus Digital Health for tracking medical adherence.  Proteus system includes sensor-enabled pills that embed intelligence into the pills so that their ingestion can be precisely tracked.  Personally, I am totally against drugs for mental illnesses, many of which do not work as expected; placebo effects are not well identified, clinical studies are often sponsored by drug companies and the list of side effects is daunting and being a psychologist, having seen side effects and heard them being discussed by my colleagues, I have developed absolute disgust for drugs for mental disorders.

Proteus “ingestible sensor” technology however, holds enormous promise for various indications, specifically for treatment and management of chronic conditions.  Otsuka plans to make use of Proteus Digital Health’s feedback system in its clinical R&D, presumably for its oncology products.

The next panelist, Dr. Marsha Rose Gillentine is Director of Biotechnology/ Chemical Group at Sterne Kessler Goldstein Fox, LLP and has intimate knowledge and understanding of patent litigation strategy in small molecules, ploymorphs, chemical synthesis, pharmaceutical formulations, methods of treatment, drug delivery devices, animal models, vaccines, polymers and more.  Her experience encompasses working with clients to implement lifecycle management strategies, specifically at it relates to personalized medicine patent portfolios.

Members of the Paris Medical Faculty (1904) An...

Members of the Paris Medical Faculty (1904) André Chantemesse (1851–1919) Georges Pouchet (1833–1894) Paul Poirier (1853–1907) Georges Dieulafoy (1839–1911) Georges Maurice Debove (1845–1920) Paul Brouardel (1837–1906) Samuel Pozzi (1846–1918) Paul Jules Tillaux (1834–1904) Georges Hayem (1841–1933) Victor Cornil (1837–1908) Paul Berger (1845–1908) Jean Casimir Félix Guyon (1831–1920) Pierre-Emile Launois (1856–1914) Adolphe Pinard (1844–1934) Pierre-Constant Budin (1846–1907) (Photo credit: Wikipedia)

Jared Heyman is founder and CEO of CrowdMed, a brilliant innovative site that takes connected health to a whole new plane.  Often individuals afflicted with rare or neglected diseases, go from doctor to doctor, from pillar to post, just to accurate diagnosis and then they face whole set of new challenges for treatment.  CrowdMed is seeking to solve most challenging medical cases, worldwide, with speed and accuracy online, by harnessing the collective wisdom of the crowd.

The Digital Health Panel at EPPICon 2015, will be an exciting panel.  Agenda for the entire day looks very interesting and there will be plenty of opportunities for attendees to network and mingle with like-minded professionals.  The conference is on Saturday, March 28th at Santa Clara Convention Center, in Santa Clara, CA.  Early bird pricing has been extended till March, 16.  Please register for the event at the link http://tinyurl.com/o4cj3ow or from www.eppicglobal.org .

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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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John Mattison, CMO, Kaiser Permanente, will speak at #TiEcon and at #HealthTechForum  


While he has pursued a wide range of activities in health and wellness, Dr. John Mattison, Chief Medical Officer at Kaiser Permanente, in his own words, is an “accidental informatist”.  Very early in his own practice and prior to joining Kaiser Permanente, Mattison implemented electronic record system at his family practice, in 1984.  Soon thereafter, he was drafted with a mandate to advance Health Information Technology, at Kaiser, and to advance health policy at both state and federal levels.

Mattison firmly believes that integrated care is extremely important, though he concedes that achieving it is not simple.  However, if you are a member of Kaiser then this oft-quoted example may not appear farfetched, where an optometrist was able to make a life saving intervention.  Apparently a woman went to an optometrist and optometrist noticed that she was due for her mammogram and helped schedule it for the same day, and her abnormality was caught in time.  Time and again I have had similar experiences (though not as dramatic), at Kaiser, where I would go in for a physical and they notice that I am due for a mamo or pap and seamlessly it is scheduled and completed, in one visit.

Mattison believes that available technology can enable health providers to make seamless, integrated care possible, whether it is through Electronic Medical Records, Big Data Analytics, Cloud Computing, Mobile Health Apps, or social gaming.  Mattison also firmly believes that patient engagement is the key to superior health outcomes.  (As a health services consumer, I would say that it is so much easier to be an empowered and engaged patient, when care is integrated and seamless).  Mattison’s objective is to harvest the exponential growth of knowledge about health and use it to help individuals become more engaged in their own health, and then to go a step further and engage communities in promoting health outcomes.

CrossCity Connect, Clinical Commissioning Grou...

CrossCity Connect, Clinical Commissioning Group Patient Engagement Event (Photo credit: podnosh)

Mattison is leading many innovative and exciting projects at Kaiser Permanente, with a potential to change the dialog on health.  He is also currently launching a project to transform how complex data sets including genomic, microbiomics, exposomics, socialomics, and phenomics can be transformed through visualization, into intuitive representations, that support shared decision making and enhanced patient engagement.  If any of this seems like a mouthful or too far-fetched then see below two great opportunities to hear him speak in May, 2014 at #TiEcon and at #HealthTechForum conference.

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.

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.  Also check out & participate in code-a-thon on patient engagement, for May 8.  Over 20K+ in prizes.

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

 

 

 

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Fiona Ma (Assemblywoman & Campaigner against Hepatitis B) to speak at Health Technology Forum Conference


Hepatitis B Virus

Hepatitis B Virus (Photo credit: AJC1)

Hepatitis B (HBV) virus is a very common virus worldwide.   Approximately, 1.2 million people in the United States are affected by this virus.  Almost 350 million people worldwide, are living with Hepatitis B.  Many people with Hepatitis B are likely to be infected at birth or in early childhood, and due to lack of immediate attention, have developed a lifelong chronic infection.   Hepatitis B is a contagious liver disease that is commonly spread through blood, semen, or other body fluids.  Most people do not experience symptoms until it is too late.  The virus causes 80% of all liver cancers, if left untreated.  Hepatitis B can be prevented with vaccination.  And with immediate attention and monitoring with nutrition, fluids, and medical supervision, acute Hep B can also be effectively treated.

Fiona Ma, incumbent democratic candidate for State Board of Equalization, a reputed politician and a former member of the San Francisco Board of Supervisors, California State Assembly, is a tireless campaigner and spokesperson for “San Francisco Hepatitis B Free” campaign.  San Francisco has the highest concentration of Hep B in the country.  Ma herself learned that she had Hep B, when she was 22.  She acquired it from her mother, who had acquired it from her mother.  About 1 in every 10 Asian Americans, is infected with the virus.  Ma’s mother had developed liver scars and having caught that early, had it removed.

English: California State Assemblywoman Fiona Ma

English: California State Assemblywoman Fiona Ma (Photo credit: Wikipedia)

Fiona Ma will be giving keynote address at Health Technology Innovation Forum annual conference on May, 20 at Parc 55, Wyndham Hotel, SF.  The conference is focused on exploring pathways to sustainable health through various means including “best practices for globally underserved”, through “gamification” and “patient engagement”, and through “building resilient communities for better outcomes”.  Traditionally, this conference is heavily attended by physicians from UCSF, as well as entrepreneurs focused on healthcare breakthroughs.  Please register for the conference at http://www.healthtechnologyforum.com , 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.

 

Please note other upcoming events below – dates & deadlines.

1) Register for #TiEcon at link https://www.123signup.com/register?id=dbnfb&ref=4182698  as my guest & enter promo code tievalue to get $100 discount. If you are an entrepreneur, I would say this is the conference, you don’t want to miss.  Check out great agenda, top notch speakers & panelists on #IoT, #bigdata, #cloud, and #Healthcare tracks at http://www.tiecon.org.

3) 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.  Also, do check out (in JOBS category on this blog), my job opportunities that include many Quality Engineering jobs in CA and MA and hot Software Embedded Engineer job and more.

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OncoProtein based Program for Early Detection of HPV induced Cervical Cancers  


Dr Johannes Schweizer, VP of R&D at Arbor Vita Corporation talked about Arbor Vita’s proprietary OncoE6™ Cervical Test that Predicts Development of Cervical Cancer at www.bio2devicegroup.org event.  Information on 3 great upcoming conferences EPPIC, TiEcon, and HealthTechForum with great speakers on healthcare tracks, is posted at the end of the article.

Arbor Vita was found by Dr. Peter Lu, in 1998 with an aim to apply discoveries of the role of PDZ proteins to the development of novel therapeutics and diagnostics.  Numerous pathogens have been found to cause diseases by binding to a PDZ protein and thereby disrupting normal cell signaling.  The ability to regulate PDZ/PL interactions represents new opportunities in controlling multiple signaling cascades in complex diseases and have recently been a focus for human drug targets.  Arbor Vita has identified nearly all of the PDZ domains in the human proteome and has decoded most of them.  Arbor Vita’s platform technology is targeted towards several diseases.  Its stroke treatment asset was recently sold to NoNO, Inc.  Avian flu Dx is the first FDA cleared rapid Dx test.  At this event, Dr Schweizer discussed Arbor Vita’s diagnostic and treatment technology for HPV induced cancers.

Cervical cancer is a leading cause of mortality, worldwide.  HPV induced cancers are transmitted through sexual contact and kill over 275,000 women, every year.  These do not receive as much attention because the mortality rates are lower in the US and other developed countries.  But mortality from slow progressive cervical cancers peak in developing countries.  In India for instance, every 7 minutes, a woman dies from this disease.  The current mode of detection is through pap smears, which have poor sensitivity and poor specificity.  In the US, out of 100,000 women tested, 23,000 are likely to be hr-HPV positive.  But from these, only 6 women are likely to have cancer.  This indicates that the current screening methods are sensitive but are not sufficiently specific to detect pre-cancerous and cancerous activity and low specificity leads to over treatment.  Pap tests give about 20% false positive and false negative results.  The only reason it still work is because of the frequency of testing in the case of this very slow moving cancer, said Schweizer.  Also pap tests require lot of infrastructure and set up that is often not easily available in developing regions.

Arbor Vita’s OncoE6TM Test is the only test that specifically identifies the viral E6 oncoprotein that causes cervical cancer.  And it is simple to administer with specimen captured with a polyester tipped cervical swab, which can also be captured by the woman on her own as well.  Elevated E6 oncoprotein correlates to cancerous activity and development of high-affinity anti E6 mAb is a key to feasibility.  There are 15 HPV types that cause cancer.  Among these, HPV 16 and HPV 18 are leading causes of cervical cancers, worldwide.  This test is specific to these two viruses.  Further this test is robust and lends to easy storage at ambient temperature.  The entire process from sample collection to getting the results can be completed in 2.5 hours.

Schweizer shared some of the data from its clinical trials.  The data indicates that in a head to head comparison with OncoE6TM, the DNA test results in nine fold over treatment including colposcopies and biopsies.   OncoE6 Cervical Test on the other hand, has high specificity for women with high grade disease cancers.  OncoE6 Cervical Test efficiently identifies women in need of clinical follow-up, among the many more with clinically irrelevant HPV infections.  In a one year follow up, E6TM promised to be a solid predictive marker as high specificity and high PPV are keys to lower referral rates and clinical follow-up.  This was very interesting talk and was followed by Q&A.

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Please see below information on some excellent conferences and events coming up in the Bay Area, in next couple of months.

March 29, 2014 (day after tomorrow) EPPIC (www.eppicglobal.org) is hosting annual conference at SF, Westin.  Panels include Neglected & Rare Diseases – http://bit.ly/1c1vvTR, Innovations in clinical Development of Novel Agents, Point of Care gold rush and there will be speed pitch and SIG networking opportunities.  Promises to be a great conference.

May 16, 17, 2014 TiE SV (www.tiesv.org) will host TiEcon (www.tiecon.org) , the largest entrepreneurship conference.  This year it will feature #healthcare track with focus on Disruptive Technologies in Healthcare.

May 20, 2014 HealthTech Forum (www.healthtechnologyforum.com) will host annual conference around the theme “Pathways to Sustainable Health” at Parc 55 Wyndham, SF and will feature excellent panels and speakers on Medical Research in the Cloud, Patient Engagement in Behavioral Health, Improving Health in Global Underserved Communities and more.

www.bio2devicegroup.org meets every Tuesday and next Tuesday Dr. Russell Pachynski, co-founder, CombImmune, will talk about “Novel approaches to Immune Therapy and Monitoring”.

Check out new job opportunities 1) Embedded Software Engineer – Mountain View, CA 2) Quality manager – Mt Laurel, NJ – http://bit.ly/P1H0QK

 

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Cloud-based eClinical Systems – Myths, Challenges & Opportunities


Al Gicqueau, CEO & President at Clinovo talked about Cloud-based eClinical Systems to make clinical trial process more efficient and cost-effective, at www.bio2devicegroup.org event.

Cloud has been a big buzz word, significantly impacting the economy, in the last few years.  Cloud is growing 3X faster than traditional internet infrastructure, said Gicqueau.  Worldwide public cloud services market will total to over $73 billion, by 2017.  There is also simultaneous cloud-bashing.  According to Citrix research, majority of the Americans don’t understand it and over 51% think it has something to do with the stormy weather.  Most also believe they have never used it but over 95% of us have used cloud based services.

It is therefore important to understand what constitutes cloud based services.  There are 5 essential components of cloud based services.
Self Service, On Demand: Cloud based services are available, when the consumer needs them.  Further, for the most part  they are autonomous and the user can perform the actions without going through the IT department.  They are easy to use and on-site training will increasingly become a thing of the past.  Any training required has to be available on-line and has to be very short and for the most part the service has to be intuitive and should not require training.
Broad Network Access: Cloud based services provide a broad internet access.  For instance, consider gmail.  It can be accessed through desktop, laptop, tablet, smart phone etc.  Cloud based services enable an ability to easily synchronize information over multiple devices.
Resource Pooling: Amount of traffic over the internet is rapidly growing. Because of the distributed nature of the internet, there is no single point of measurement for total internet traffic.  But it is a fact that the total global IP traffic will pass the zettabyte threshold by the end of 2015.  By the year 2017, the total internet traffic is expected to reach 5.3 zettabytes.  To put it in perspective, if the 11 oz coffee on your desk equals one gigabyte, a zettabyte will have the same volume as the great wall of China!  Cloud based services enable customers to pool their resources and save cost.

Rapid Elasticity: In the world of internet activity there are lot of peaks and valleys.  Cloud can scale based on demand peaks, without incurring penalty for the period of low traffic.
Measured Service: Cloud offers and ability to pay as you go.  People can pay for the internet infrastructure as they pay for electricity.
Some of the examples of cloud based services include, SalesForce, Netflix, Gmail and Amazon.

Clinical Data Trends

Spiraling costs have been a grave concern in healthcare.  Typically, efficiency has not been very high in the area of healthcare. Costs of clinical trials is likely to increase even more significantly, in future, on account of increasing costs of medical research and changing and tightening regulations, among other things.  Increased costs for clinical trials will push the cost of drugs higher.  On the other hand, there is strong public criticism of higher costs of medicines and there is a lot of pressure on drug companies to contain costs.  Companies have pressure to cut the middle layers and manage clinical trials on their own.  Citing CISCRP (Center for Information & Study on Clinical Research Participation) study, Gicqueau said, currently, only 6% of clinical trials are completed on time, whereas 72% run late by over a month.

Compliance issues and regulations specified in 21 CFR, part 11, prohibit use of public cloud, for clinical data.  Clinical data has to be stored in a private cloud.  Clinovo’s ClinCapture is a cost-effective EDC (electronic data capture) system.  It is tailored to specific clinical studies teams and offers intuitive navigation and one-click access to routine functions.  It reduces time for data entry.  ClinCapture is also flexible and can be customized and deployed rapidly.  “We validate our software like medical devices are validated”, said Gicqueau.

Mobile is next major trend, as more data entries are happening through tablets and smart phones.  Tables are also very useful in remote regions of the world where cell phone reception may be spotty or non existent, where information can be easily synchronized later.  Data entries can also be structured  by getting patients involved.  Data integration is another big challenge.  Everyone hopes to make sense of the data and make meaningful use of the data.  However, making sense of the data and putting it to good use remains expensive.  Gicqueau said, meaningful data integration is another promise of the cloud.

Clinovo is launching CloudClinica, next generation, cloud-based eClinical platform.  With its easy to use, pay as you go platform, CloudClinica will eliminate IT dependency and allow small companies  to manage clinical studies in a sophisticated manner, without high level programming skills.  About 30% of cost and 60% of time associated with clinical trials is about data management, and almost 80% of clinical trials are still conducted on paper, said Gicqueau.  Paper has many pitfalls.  Paper can get lost, it is inefficient, there is challenge of mis-reading someone’s handwriting, it has regulatory risks and other hidden costs.  CloudClinica is FDA compliant and it can scale.

HomeClinovo had revenues of over $4 million in 2013 and raised $500,000 from business angels over the last few months to execute on their business strategy.   The company is profitable, and has 30+ clients that include Gilead, Roche and others.  Clinovo is now targeting small to mid-size companies, said Gicqueau.  Current market of $2.3 billion can be rapidly growing in the coming years.  MediData and Oracle are two dominant players but are relatively more pricey.    Clinovo’s CloudClinica will fill in the gap and broaden the use of eClinical systems and will empower and bolster the biotech, pharmaceutical, and medical device companies, said Gicqueau.  The event was followed by Q&A.

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How to take a Biotech company from Idea to Exit


Mahendra Shah, Partner with Vivo Ventures & Ravi Mistry, President of EPPICGLOBAL (www.eppicglobal.org) talked about how to take a biotech company from idea to launch, at www.bio2devicegroup.org event.  Here is some of the comments made by Shah and Mistry.

Entrepreneurs starting a biotech company must start with a disease target, said Shah.  First and foremost there should have a good understanding of the disease and at which stage in the disease progression is the biotech seeking to interfere.  Second, one should have a good understanding of the market opportunity and about existing treatments.  Entrepreneurs need to ask the hard question regarding “clinical meaningfulness”; and whether or not the possible treatment developed by the biotech will lead to significant enhancement in patient care.  Payers will not pay for little improvements, said Shah.  Companies need to identify gaps in the treatment, and find a niche market.  Patients need to be identified for who the prescribed treatments do not work well and that could be a niche market for entrepreneurs, said Shah.  Shah said that during his career, he found such niche markets through repurposing, taking old drugs and finding new indications.  He also cautioned about the importance of ensuring secure Intellectual Property to protect the proposed solution.  With currently available internet tools and database resources, that is not hard to do.  Even speed browsing on Google can give you a quick idea of who owns the IP and if there are ways to get around it, said Shah.  Biotechs based on developing Orphan drugs are a great opportunity for a new startup, because once approved, you cannot have competition for up to 7 years in the US, and up to 10 years in Europe.

In terms of drug development, one needs to also get clarity on development pathway to determine whether it will require 10 thousand patients or few hundred, since that can make a huge difference in the amount of financial capital that will be required to bring the product to market.  Companies need to identify how quickly one can progress to phase 2 and bring it to a meaningful endpoint.  Also it is important to get an understanding if the endpoint is subjective or objective.  A subjective endpoint will have significant placebo effect and will require much higher number of patients, said Shah.  In order to do successful fund raising, companies need to have approximate idea of time and costs of bringing the product opportunity to a meaningful endpoint.  Companies also need to have clarity on the various product development milestones and inflection points.  Finally, an experienced Team is extremely important to bring the idea to fruition.  However in this, two members of the team are particularly important; the CEO and the Medical Director.  Other members of the management team can be hired as consultants but these two team members of the team need to be identified early and brought on board and should be people one can trust and those who feel passionate about the technology and who buy into it.

A biotechnology company requires significant money for its operations, so it is important to make sure that the first time investors have deep pockets, very sane advice from Shah.  He told the budding entrepreneurs to be careful and make sure they have synergy with the investors.  “Some of the investors’ money is not good, it will give you ulcers”, warned Shah, since money can have many strings attached to its return on investment.  Referring to reimbursement, Shah emphasized that the payer is very important and entrepreneurs should do a quick survey of physicians and Key Opinion and Thought Leaders and get a clear idea about existing and current modes of treatment and who will be paying for the new product opportunity.

Mistry shared some statistics on activity in the life science space.  2013 has been a banner year for life science IPOs.  Out of a total of 82 total IPOs in 2013, 46 were in the life science industry.  Life science industry also enjoyed a substantial investment of dollars.  The increase was certainly more significant in biotechnology, while medical device industry actually saw fewer dollars invested.  Mistry talked about how to prepare for an M&A exit and provided some advice to entrepreneurs to keep diligent documentation with respect to company’s IP.  He also commented that when it comes to negotiation, there is no “one size fits all” and best deals can be made if entrepreneurs remain can remain flexible throughout the process.

At the start of the talk Mistry put in a plug for EPPICGlobal and their upcoming annual conference, on March 29, 2014.  The conference has an exciting lineup of speakers and panels addressing neglected and rare diseases, point of care diagnostics, and innovations in clinical development of novel agents.  The talk ended with Shah sharing information on exciting speed pitch session, at the EPPIC conference, where entrepreneurs will have an opportunity to pitch their company to a panel of VCs and receive real-time feedback.

I would encourage my readers to attend the EPPICon 2014 conference, and avail of the opportunity to listen to various industry renowned speakers.  To register for the conference and/or register for the speed pitch, please go to www.eppicglobal.org.
            Bio2Device Group

 

 

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Manoj Bhargava, CEO of 5-Hour Energy to give Keynote Address at TiEcon 2013.


“Is it useful?  If not, it better be entertaining.  Else, it goes into the basket called useless”.  With this simple mantra and simple philosophy for life, Manoj Bhargava, possibly the wealthiest Indian in America, leads 5-Hour Energy, the company that makes tiny bottles, packed with nutrients.  Most of the company meetings last 30 seconds to a minute, says Bhargava, who leads the $1 billion+ company, with a lean, non hierarchical staff, of 60 people.  “We are not efficient, we just don’t do useless stuff”, he says.  Good advice!  I can see how my efficiency would get a boost, if I stop doing useless stuff on my blog, twitter, facebook and take a big gulp of the 5-hour energy drink!

5-Hour-Energy

5-Hour-Energy (Photo credit: NathanaelB)

 

Bhargava’s approach to marketing and advertising is just as simple.  With the belief that one may not be thirsty and need the energy jolt at the same time, tiny 2 oz. energy bottles packed with functional nutrients, B vitamins and amino acids, are strategically designed to be placed at the check-out counters and at easy point-of-sale locations; and are believed to have covered 90% of the energy shot market.  Explaining one of their first ad that was nominated as one of the worst ads on TV, he says, “we don’t tell a joke and then name our product; our approach is to tell what it is”.   This ad increased sales by 50% in 3 months.

 

Bhargava started plastics raw material company in 1990 that grew to $20 million in sales, before he sold it to a private equity firm.  He then started a consumer products company, Living Essentials, out of which came 5-Hour Energy.  His stake in Living Essentials is over $3 billion.  Bhargava is as generous a philanthropist, as he is successful at entrepreneurship.  He has contractually pledged a billion dollars to charities that fund medical research.  Bhargava was awarded “2011 Newsmaker of the Year” award and was named Ernst & Young’s “Entrepreneur of the Year for 2012”.

 

TiEcon is around the corner.  Register before the event is sold out at www.tiecon.org.

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