JP Morgan Healthcare Conference Becomes A Shopping Mall For Wall Street

The past week, San Francisco was overrun with more neckties than the city has ever seen at one time. In customary form, the annual JP Morgan Healthcare Conference kicked off a global, multiday shopping spree and advertising expo for large and small, traditional and boutique, biotech and life science companies, and the investors who love them. It even draws thousands of entrepreneurs who head to San Francisco in spite of not gaining entry to JP Morgan, in the hope of rubbing some meaningful elbows at the numerous after-parties.

Like malls need big name department stores to anchor the venue and draw not only shoppers but also complementary retail and boutiques, JP Morgan has turned the once small and focused Hambrecht & Quist (H&Q) conference into a shopping center of options.  Anchor companies such as AbbVie, Pfizer, Merck and Johnson & Johnson support and aid in building a sustainable market around Union Square, while small and trendy events pop up in every nook and cranny in the city limits. One can even book a coffee shop table beginning at 6:00am for a meeting.

Billions of dollar under management, pensions, endowments and foundations – with mandates to invest in life science, biotech and health companies – are in one mall-like area to gather insights on market dynamics, hearing firsthand from the movers and shakers that claim to impact the market. Strategic meetings are arranged, CEOs spread the word, and new technology licensing deals are showcased as the next big thing.

“However, over the years, CEOs have found that they are not always satisfied with the audience for the presentations, which generally consisted of their own competitors, often trying to assess IP and third party service providers aiming to sell the CEO their services. Therefore, this year saw a plethora of new entrants,” says Dennis Ford, President and CEO of Life Science Nation (LSN), who joined the mix for the first time in 2015. LSN, whose conferences have previously existed in Boston, accelerates the funding of early stage life science firms via a Match.com-like sourcing platform for private investment, likely making CEOs more efficient in their capital raising efforts.

At the same time, major investment firms and marketing firms bought entire hotels for the week to host meetings on each floor, in each room, where beds were removed and folding tables set up in their place like Halloween pop-up stores.  The Trout Group did this on several floors of a hotel, hosting 1×1 off-the-record Management Access meetings with more than 70 companies. This year AirB&B also made a strong presence, as homes were rented for the same purpose due to lack of space in the hotels.

In it’s 33rd year as a conference, the only noticeable thing missing from the shopping spree were women and minorities, who seemed to be primarily concentrated in certain sectors and at certain events. One in particular was the Biotech Showcase, launched seven years ago by Demy-Colton Life Science Advisors and EBD Group. Their creation was in response to a demand from investors for a venue that showcased innovative private and public therapeutic companies, specialty pharma, platform and molecular diagnostic companies as investment opportunities. This year’s event had 230 presenting companies.

“We are seeing a strong uptake, especially with public companies. With more than 2,000 attendees, Biotech Showcase has become the place where innovative small to mid-sized public and private life sciences companies tell their stories to the investor community and build their profiles in order to attract funding and strategic partners,” says Sara Demy of Demy-Colton. Anna Chrisman, Group Managing Director of EBD Group added, “We are thrilled to provide a platform for investors and R&D companies to collaborate and pleased to see Biotech Showcase play a role in the growth of the industry.”

As the city of San Francisco takes back its casual demeanor, and the suited men of Wall Street head home, two things are for sure, there appears to be optimism and excitement for the year ahead in health investment, and the shopping center’s hotel bookings for 2016 are already getting slim.

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Hospital Cost Reduction Efforts Benefitting From New Tech

According to the Centers for Medicare & Medicaid Services (CMS), almost one out of the every five dollars in America is spent on health care, resulting in close to $3 trillion spent in 2014. Of that, an estimated $765 billion was lost to waste in inefficiency, redundancy, errors, overutilization and unnecessary variation in clinical practices. In addition to revenue loss from waste, hospitals are simultaneously confronted with payments that are not rising as fast as costs, and in many cases, payments that are actually declining. The American Hospital Association even contends that one-third of hospitals presently have a negative operating margin.

Because of these troubling trends, it is no wonder that reducing the total cost of care ranks as the number one overall strategic concern for hospital leadership. Reducing cost is any industry is a difficult task, but in health care, the difficulty is compounded by the need to maintain, or in many cases, improve the quality of care, health outcomes, and patient satisfaction.

Given the difficulty and complexity, it is also not surprising that hospital executives often turn to expensive consultants for answers, only to hear the same “one size fits all” solutions to drive cost savings, that are often unattainable or unsustainable.

Hospitals Are Failing To Meet Their Targets

A July 2014 independent survey of hospital finance professionals by Strata Decision Technology concluded that 88% of hospitals claimed to have cost-saving strategies in place. However, only 17% of hospitals were able to realize their targets. Another 70% achieved “some savings,” but not the level they needed to hit financial targets.

Health care organizations cited that cost reduction efforts often fell short because they were too time-consuming and data intensive. Additionally, while some were able to “identify savings opportunities,” they found that the actual savings realized was much less than expected because ideas could not be put into action and there was a lack of accountability for results system-wide. Hospitals also cited that accurately tracking “hard dollar” cost savings was too labor intensive since they had no technology to rely on, aside from messy, overgrown excel spreadsheets.

As large health systems across the country – especially those serving large Medicare and Medicaid populations – focus on identifying in-house savings that don’t sacrifice quality or patient satisfaction and meet ACA requirements, financial executives must take the lead for their organizations, but they can’t do it alone. The most successful cost-saving strategies are those that are grounded in a meaningful collaboration among finance, operational leaders, and physicians. The process should be informed by finance, but led by operational and clinical leaders. Reducing cost is not just a ‘finance problem’ as it was considered in the past.

The Cost Of Savings Costs

Liz Kirk, Vice President for Cost Improvement Solutions at Strata Decision Technology, drove a major cost improvement initiative in her prior role at Northwestern Memorial Hospital. Under her leadership over a two-year period, Northwestern reduced their cost per case mix index (CMI) adjusted case by over 15%. However, Kirk also learned that there is cost for taking out cost. She estimates that Northwestern’s cost improvement initiative ran the organization about $11 million, in terms of staff time.

Kirk describes undergoing cost savings initiatives at hospitals today, as being a lot like ice fishing. “Organizations tend to go to the tried and true fishing holes to find savings. Then, it requires a lot of hard work to drill into the cost savings idea to determine how much can be saved, if anything at all,” explains Kirk. “After all that hard work, there may be a big fish. Or there may not be any fish, or maybe just a small fish. Unfortunately, to find more cost savings, you have to try another fishing hole and go through the same, arduous manual process, again and again.”

For the last 15-20 years, hospitals have focused on growing their top line revenue through technology to maximize reimbursement and decrease uncompensated care. Cost is rarely scrutinized and managed to the same level of detail as revenue has been. Strata Decision’s StrataJazz Continuous Cost Improvement potentially changes that for entire systems. The application contains pre-built algorithms that identify and quantify opportunities to eliminate waste, inefficiency, and variation across the organization, then provides on-going tracking and workflow to build accountability for results.

Rather than ice fishing, cost savings becomes more like net fishing – hospitals can choose the best opportunities to pursue for their organization, then actually spend time designing improvements, rather than doing math.

Health Systems And Strata Join Forces

Although physicians are often rightly skeptical when financial leaders share data on practice variation, patient interactions and cost per case, the new world of health care reform demands that the two sides learn to work together. To remedy this at Yale New Haven, the leadership developed a common language with the clinicians that uses agreed upon metrics that they call quality variation indicators (QVIs), in which speaking the same language can help hospitals redesign practices and improve quality.

Yale New Haven partnered with Strata and achieved great success at driving out costs because each step of an encounter could be recognized and tracked, creating an accurate picture of an entire episode of care. Yale primarily focused on reducing variation in clinical practice that may result in adverse outcomes, which resulted in an estimated $125 million cost savings – or about a 20% reduction in cost per case.

Another Strata client is CentraCare, a five-hospital system based in Minnesota. The health system recently deployed Continuous Cost Improvement for one of its 500-bed hospitals. Leveraging just one module of Continuous Cost Improvement, CentraCare was able to identify supposed $11.3 million in potential cost savings for the one hospital.

 

4 Things To Understand About Youth, Mental Health & Juvenile Justice In The US

Almost 2 million youth – those under the age of 18 – are arrested each year in the US, which is more than 5,000 delinquency cases per day. Of those, approximately 95% are not accused of violent crimes (murder, rape or aggravated assault). Yet, these youth are often incarcerated in the juvenile justice system, causing more harm than good to the academic, social and personal growth of our youth, despite best efforts from experts to reduce incarceration. According to University of Chicago professor and Co-Director of the University’s Crime Lab Harold Pollack, PhD, rightly notes, “There is good reason to believe that economical, evidence-based interventions are helpful. We need to develop and deploy–at-scale–good interventions outside the criminal justice system that prevent youth violence.”

Currently, lack of capacity and resources contributes to high recidivism rates and skyrocketing taxpayer burden. As we enter a new year, with a new Congress, it is important as a country that we think about the mental, physical and financial health of our country’s most vulnerable individuals: children. Here are four things to understand about our juvenile justice system, and our children that live within the system.

1. A large majority of youth in the juvenile justice system (70%) has one or more diagnosable mental health or substance use disorders, not to mention the prevalent comorbidities such as poverty, victimization, post-traumatic stress disorders (PTSD) and poor education opportunities that contribute to untreated mental health issues. Current literature suggests that the prevalence of mental health disorders in the juvenile justice system is more than three times higher than in the general youth population.

Furthermore, more than 75% of youth in the system have experienced traumatic victimization such as physical abuse, domestic violence, and traumatic neglect, leaving them vulnerable for mental health disorders and PTSD. NIMH research indicates that half of all lifetime cases of mental illness begin before the age of 14, sometimes with decades between onset and treatment, leading to more severe, compounded, and difficult to treat co-occurring mental illnesses.

There are also significant repercussions that follow youth who have been diagnosed with a disorder, both within the system and with integration back into society. One model that has been creating collaboration between systems is the WrapAround Milwaukee program where child welfare, juvenile justice, mental health and education systems jointly tailor treatment plans to individual children in an attempt to provide holistic care. Another has been the University of Chicago Crime Lab work by Sara Heller and others who have found that improving social-emotional skills and obtaining summer jobs can reduce violent offending in youth.

2. Research indicates that the human brain develops throughout adolescence into ones mid-twenties. The particular part of the brain responsible for complex reasoning and executive function – the pre-frontal cortex – is not fully developed until then. This is one reason that age restrictions have been imposed (or are in debate) on the age of voting, drinking, driving and military activity until late teens or early twenties.

Because adolescent brains are not entirely matured, risk is inherently less frightening and peer influence is more persuasive for those under the age of 25. Yet, on any given day in the US, more than 70,000 juvenile offenders are in residential placement (juvenile detention facilities, corrections facilities, group homes or shelters) for crimes. However, not only are youth not able to assess risk like adults, competency to understand, participate in and make decisions in the judicial process are not equivalent.

Additionally, beyond developmental influences, multifaceted risk factors such as low school involvement, poverty, homelessness and cognitive deficits contribute to decision-making and risk-taking for youth. This often includes the young parents of those in the justice system. Kenneth Dodge and collaborators at Duke University have been working with young mothers to improve parenting skills, with the idea that some of the same strategies used to address cognitive errors and biases, can also be used in preventing poor parenting.

3. Both public and private prisons are ill prepared to truly help the youth in our juvenile justice system. Whether anxiety disorders, PTSD, drug abuse or sexual victimization, disorders among youth are much harder to diagnose and treat than adults, as they evolve and need ongoing assessment throughout adolescence. Additionally, facilities are particularly ill equipped to assist girls, despite a 49% increase in girls being placed in detention centers (compared to a 7% increase in boys) over a decade. National Center for Mental Health and Juvenile Justice (NCMHJJ) research indicating youths who receive a mental health screening immediately are more likely to have problems identified and treated. However, in many US jurisdictions screening only occurs after a juvenile has been assigned to a correctional facility.

According to a Youth Services International (YSI) investigation, one private prison company alone – that spans 16 states – has a traceable consistent record of abuse and neglect for more than 25 years. This neglect ranges from lack of care and services to actual mental and sexual exploitation. Shockingly, an estimated 9.5% of adjudicated youth in state juvenile facilities and state contract facilities (about 1,720 youth) reported experiencing one or more incidents of sexual victimization by staff or another offender within the last 12 months. In 2013, Polk County, Florida (and its Sheriff) were sued, alleging that children have been systematically abused and mistreated in jail, including dangerous conditions of confinement and pepper-spraying kids for failing to obey orders.

Because of issues like those, the NCMHJJ urges the use of community-based and holistic treatment interventions as more appropriate and effective responses to the needs of these youth. Further, direct collaboration between child welfare and juvenile justice centers is encouraged.

4. State variation in juvenile justice assessment, treatment and conviction is significant. Almost 40 states in the US have laws or pending legal language ensuring that those aged 17 and younger convicted of felonies are tried in a juvenile court, with Illinois and North Carolina being the most recent additions. However, even in states where youth are tried as juveniles the screening metrics and treatment options are disparate.

Since 2008 all young people in Pennsylvania detention centers are carefully screened for mental health issues, while in Virginia and Arizona a juvenile need not necessarily be assigned with a diagnosable disease, but instead are charged based on perceived competency. North Dakota and Oregon have passed laws requiring youth who have committed alcohol-related offenses to enroll in alcohol and drug educational courses.

In contrast, some states have made little progress in mental, emotional or physical health requirements for youth. However, throughout the last 20 years even states with bad reputations are being forced to revisit policies, testing and treatment of our nations most vulnerable. Louisiana, previously had the reputation of being the worst juvenile justice system in the country, and still comes under fire for the massive amounts of youth incarceration over the last few decades. However, recent steps have been taken that are getting good reviews. For example, went as far as to allow an entire judicial district to assign one of its divisions solely as a mental health court.

 

Steve Blank And I-Corps Lean LaunchPad

Steve Blank is well known for informing entrepreneurs that, “The safest bet about your new business is that you’re wrong.” He contends, “A startup is not about executing a series of knowns. Most startups are facing a series of unknowns — unknown customer segments, unknown customer needs, unknown product feature set, etc…”

As a serial entrepreneur, academic, veteran, author and one of Forbes 2013 30 Most Influential People in Tech, Blank has carved out a well-documented career teaching others success in the startup world using his Lean LaunchPadÒ curriculum. At its core, the Lean method teaches innovators that: 1) startups are not smaller versions of large companies. This means startups need different tools than those used in existing companies, and 2) there are no facts inside of their building. Therefore, they need to get outside to test whether their hypotheses are correct.

It’s a big idea – one that in 2011 caught the eye of the federal government, a prominent backer of technical innovation and the country’s second-biggest leader in research and development funding. The theories were so highly regarded, it led to an unlikely partnership with the National Science Foundation (NSF), the $6.8 billion government agency that supports research in all nonmedical fields of science and engineering. And, while many argue that inefficiency, redundancy and regulatory burden of government agencies can hinder innovation, the Small Business Innovation Research (SBIR) offices at the National Institutes of Health (NIH) and the Department of Energy (DOE) have also partnered with Mr. Blank to incorporate his methodology into their agency practices.

Can Federal Agencies Be “Innovative”

NSF requested Mr. Blank modify the Lean LaunchPad course he developed at Stanford to a curriculum for the NSF’s Innovation Corps (I-Corps). The first fruits from this cross-pollination with the NIH came in October with the launch of the pilot I-Corps at NIH program, concluded this week with final presentations.

The National Cancer Institute is participating in I-Corps at NIH through the SBIR and Small Business Technology Transfer (STTR) Programs along with the National Heart, Lung and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Center for Advancing Translational Sciences. The institutes have jointly sponsored 19 teams ranging from therapeutics to medical devices, hoping that the companies can change the world by bringing their research from laboratories to patients in a cost-effective and efficient manner.

“The SBIR Programs have a unique role in the federal government fostering small businesses and investing in early stage research,” said Michael Weingarten, NCI SBIR Development Center Director. “Together with I-Corps, the SBIR Programs have an opportunity to take our efforts to the next level and provide our companies with the tools to develop medical technologies faster, better and with greater success.”

The NIH SBIR/STTR Programs serve as an engine, helping small businesses develop the next generation of medical technology breakthroughs, while also filling a critical funding gap in early stage research and high risk technology development. The Center also recently led a matchmaking effort (NCI SBIR Investor Forum) to bring together investors, strategic partners, and the most promising NCI small business awardees developing targeted cancer therapies, diagnostics, and medical devices.

According to the NCI SBIR Program I-Corps coordinator, Christie Canaria, PhD, “All the teams selected are already funded companies that have received an NIH SBIR Phase 1 Grant through an extensive peer review process by industry experts. This I-Corps pilot initiative is part of a suite of targeted efforts by the NCI SBIR Development Center and other programs across NIH to go beyond funding to help accelerate the translation of research concepts into technologies that will improve patient care.”

When asked how his first cohort of students at NIH compares to his Stanford students, Mr. Blank laughs and tells me they are remarkably similar. “All the teams came in lacking a link between an idea and making an actual company,” he says. “Most often, the idea is a small part of the overall company. That’s what has been screwed up with the last 30 years of grant funding. A good idea is not going to help anyone unless it succeeds in getting to the commercialization stage.”

Blank observed, “By the end of the class the 19 NIH teams spoke to 2,120 customers, tested 695 hypotheses and pivoted 215 times. That’s an amazing amount of work. We’re proud that each and every one of the teams left the program with evidence, urgency and velocity they didn’t have coming into the class.”

The class was best summed up in a final video made by BCN Biosciences here.

The I-Corps Approach

Blank asserts that the current medical school curriculums and grant funding cycles are more focused on the science than the business sense and methods of starting a successful company. “I-Corps provides an efficient way to teach the teams working with the government the distinction between an idea and a company.”

As in the Lean LaunchPad for Life Sciences pilot course at UCSF, I-Corps teams learn how to define clinical utility, understand customers and recognize downstream commercialization. The primary difference is that most NIH participants are already well-accomplished experts in a particular field. Dr. Hobart Harris, Chief of General Surgery at UCSF, was in the first UCSF cohort, and claims his business could not have succeeded without lessons in bringing his, “idea to the marketplace,” and that is exactly the model being replicated at the NIH.

Using a nine-week course that ended with final team “Lessons Learned” presentations this week, Blank is working with business experts and NIH SBIR officials to help the teams explore potential markets for their federally supported technologies in development. The course began with a three-day “Entrepreneurial Immersion” Blank describes as, “A real eye opener. They struggled to tell what business they were in on day one. Instead, they would describe what they were making. By day three we got almost all of them able to articulate what problem they were solving and for which users.”

At completion, the companies have each engaged with 100 potential customers and he claims, “Regulation, reimbursement, clinical trials, potential partners and intellectual property (IP) are all top of mind now.” However, he also says that his greatest hope for next steps not only includes more cohorts of companies that go through NIH I-Corps and DOE’s Lab-Corps, but also with curriculum for medical schools and large research centers with life science communities.

Who Is Learning From Whom

Although Blank’s methods have proven effective for startup companies in various sectors worldwide, his theories on how to take companies to market product improvement and commercialization, is a different and untested challenge within the government. Until now.

This new I-Corps model is about making a viable business, which is a necessary step to ensuring that patients – taxpayers – will ultimately benefit from the federally supported SBIR technologies. For real victory, not only will the individuals and companies be learning about regulation, reimbursement, trials, partners, and IP in ways they never have before, but the government will also be learning about how to continue to create a bridge with the private sector that will lead to novel technologies and to prevent the challenges and burdens that stifle innovation.

There is hope. While Mr. Blank’s model is only one way for potential startup success, other agencies such as DOE have launched its own $2.3 million “Lab-Corps,” commercializing clean energy technologies using the same lessons as NIH. Moreover, Blank is in talks with NYU and Johns Hopkins in addition to UCSF, Georgia Tech and University of Michigan medical and bioengineering departments about adding the Lean LaunchPad methodology.

Perhaps, the greatest outcome of the I-Corps and Lab-Corps cohorts will be the lessons they share with the federal government about IP, scaling and regulation. That is the kind of “change the world” approach Mr. Blank and I-Corps hope to create.

Syllabus for the class can be found here.

Presentations and videos of all the teams videos and presentations can be found here.

Twitter feed for the course and events can be found here.

 

Global Health Development Looks To BRAC And Gates Foundation For Mobile Money

Bangladesh is going digital. Not in smart watches, sensor-based clothing or electronic health records, but in money. Mobile money. Money, that according to BRAC and the Gates Foundation could improve the economic and health outcomes of the country, especially of women and children. With a healthy appreciation of the complexities in scaling digitally, faith in innovation at the grassroots level and years of planning, these organizations just might make mobile money the future of finance.

Throughout the country, like all countries in the world, there are citizens that are “unbanked,” meaning that they do not possess a bank account and cannot share funds person-to-person, even within families, without cash. For these people, a significant portion of Bangladesh’s population (estimated 70%), access to formal financial services for starting businesses, paying for children’s education and health services, and paying salaries for community health workers could translate to millions of improved and saved lives.

For Bangladesh’s large rural population, transportation and infrastructure challenges, combined with a weak banking infrastructure, financial inclusion remains a tall order. However, increases in cell phone utilization in these areas mean that mobile money – instead of cash – could make payment to individuals, schools, health care providers and businesses seamless and easily accessible.

Digital Money

It is well documented and understood that men and women accumulate and spend money differently. For example, women earn smaller, more regular streams of income than men. Further, globally, women tend to have less ownership of cellphones due to allocating their finances for shelter, nutrition and education, almost always for children first. However, those kinds of investments do not lend themselves to establishing credit, building a business or maintaining a bank account.

Innovation, often coming from those in greatest need, has taken root throughout Bangladesh – with women center stage in development. This trend has also been seen in countries such as Kenya and Tanzania, where mobile money has a successful track record, and presently accounts for more than 50% of adult transactions in those countries. In Kenya, for example, one study concluded that households that adopted M-PESA, their most popular mobile money system, saw incomes increase by 5-30%.

BRAC, a Bangladesh-based organization working in 12 countries, “is no stranger to taking radical ideas to scale,” says Maria May, senior program manager for the BRAC Social Innovation Lab. And, with growing acceptance by international organizations including the World Bank that, “digitizing payments, transfers and remittances contributes to women’s economic empowerment,” support for such efforts has been moving quickly since 2010.

In 2014, BRAC announced its first Innovation Fund for Mobile Money Challenge, in which seven winners were selected from over 100 submitted ideas. From those, initiatives such as Mobile Micro-Insurance to secure low premiums on insurance and Honorarium Disbursements to Community Health Workers through the health, nutrition and population programme were approved to lead the way. Additionally, mobile insurance for credit shielding has been established at 20 branches, while exploring opportunities to offer additional types of insurance in 2015.

The Bill and Melinda Gates Foundation also committed its 10th Grand Challenge to “Putting Women and Girls at the Center of Development,” with a strong focus on financial services. Because significant correlation exists between empowering women and improved outcomes in health, agriculture and finance, the goal of the Challenge is to “accelerate discovery of how to most effectively and intentionally identify and address gender inequalities and how this relates to sectoral outcomes; scale-up approaches known to work.” And to date, mobile money is working.

Mobile Technology Makes Access Possible

Although there is great promise in mobile financial services, there are significant up-front and maintenance costs. However, Bangladesh presents a unique environment in South Asian in which to test the potential programs. Not only does Bangladesh boast a strong microfinance market, but it also has access to more mobile devices and accounts than other South Asian countries. In 2014, cell phone ownership in Bangladesh on GrameenPhone alone is over 50 million strong in a country with 160 million people.

Between 2011 and 2014 there have been two networks that emerged as strong frontrunners in the mobile money market: bKash and Dutch Bangla Mobile, of the Dutch Bangla Bank. While these entities have a combined 75 million customers, bKash has cornered a significant portion of the market. Like many other markets around the world though, Bangladesh is still waiting on international remittances and cashing out from mobile phones.

Nevertheless, it is widely accepted that mobile money will develop organically with person-to-person transfers followed by scaling to formal providers, and that countries around the world are hungry for the opportunity. As the trend continues, the ability to access mobile money can empower women one at a time to fund their own work, pay for their family’s educational and health needs, and for community workers to receive payment for their services. Whether small or large scale, the ability to bank the unbanked and transfer funds, could change education, health and wellness around the world in ways other digital health products cannot.

As an early step, BRAC University’s Institute of Educational Development, also part of BRAC’s Innovation Fund for Mobile Money, is transitioning to mobile-based payments for its secondary schools. Its director, Erum Mariam, has big plans for going digital. “I think this is an excellent pilot since it ensures transparency. I have asked my group to explore the possibility of the mobile transaction for providing teachers’ salaries as well.”

Additional, personal stories from bKash recipients can be found on the website.

 

7 Global Life Science Trends for 2015

There are presently massive shifts occurring in the competitive global landscape of health, and particularly in the life sciences. As we approach 2015, it is imperative that leaders in the health space understand the trends and shifts happening around them, not only in the US, but also in international markets, cities and service lines.

With unparalleled connectivity, evolving demographics, impressive growth in patent applications in emerging markets and pharmaceutical demand changes worldwide, there is no doubt that hospital leadership, policymakers, manufacturers, inventors and clinicians in America need to know what is in the pipeline for 2015 and beyond. Using the 2014 Global Life Sciences Cluster Report from JLL, here are the top 7 trends you need to know for success in 2015.

1. Global Innovation: While both North America and Europe continue to have the most life science Patent Cooperation Treaty (PCT) applications per year (41% and 31% share, respectively), major shifts are occurring. PCT applications, an international measure of innovative output, in Asia, Latin America and the Caribbean are increasing, with the gap forecasted to continue closing. This trend, in part, can be attributed to the shift from broad, chronic disease biological maturity in developed countries to developing countries. In turn, many advanced cities and companies are transitioning to specific, personalized biologics and care. For example, biosimilars are taking root in the US and EU, while diabetes has become a primary focus of the Middle East and North Africa.
2. An Aging Workforce And Population: Between 1993 and 2010, the percentage of the scientific and engineering workforce over the age of 50 increased from 20% to 33%. Further, before 2020 it is estimated that 2 million engineering and life science jobs will become open, mostly due to retirement. Per the 2014 ManpowerGroup’s annual global survey of 38,000 employers in 42 countries, 35% of employers report difficulty in filling jobs. Of those, 54% report this difficulty in filling jobs has a direct impact on their ability to meet client needs. For example, in China, the one-child policy has made the current health care workforce unable to manage its aging population, a problem Intel is hoping to solve. With the aging of America’s workforce compared to youth in developing countries, Harvard Business Review contributors have suggested “retiring retirement” in the US. Flexible work hours, new technology, new training programs and varied skill sets are going to cause major shifts in corporate America, especially within the health ecosystem in areas such as pharma and medical device. While STEM (science, tech, engineering and math) programs targeting women have become increasingly popular in the US, females are still greatly under-represented in this area (only 23% of the engineering workforce in 2008), and could possibly help meet health and tech demands.
3. Differences In Labor Productivity: Between 2003 and 2012, there was a 5% increase in the labor productivity in developing countries, compared to a 1% increase in labor productivity in developed countries. This measure indicates how many goods and services are produced in one hour of labor, and therefore, a continued trend (tracked since 2007) consistently shows that year-over-year shifts in labor productivity are benefiting developing countries. As wealth grows, so too does opportunities to produce specialization and cost-effective output.
4. Regulation And Taxation: Not surprisingly, Japan and the United States have the highest corporate statutory tax burdens (39.5% and 39.1%, respectively). While many argue this drives down innovation, others claim it merely keeps companies from having investments in the US. For example, Medtronic recently committed to purchasing Covidien, with speculation that the move is to keep funds in Ireland, with its low tax rate. However, the US and Japan also have some of the best regulatory systems and high political and transparency rates in the world, making production and sales easier for many. And, according to Roger Humphrey, Executive Director of JLL’s Life Sciences group, “Federal policy, such as corporate tax structures and regulatory frameworks, directly impacts life sciences companies’ ability to establish roots and flourish over time.”
5. Education: The highest percentage of the working population (25-64 years old) with bachelor’s-type degrees still belongs to the United States. However, that can no longer be said for younger generations. For example, the percentage of 25-34-year-olds with bachelor’s degree is higher in Korea (39%), The Netherlands (38%), the United Kingdom (38%) and Australia (34%) than in the US (33%). According to the OECD 2011 Report, “Because of the rapid expansion of tertiary education both in the industrialized world and in emerging economies, the US is fast losing its advantage.”
6. R&D Funding And Concentration: Presently, 10 countries account for 80% of global R&D. Because businesses are the biggest source of R&D funds, investor confidence and broader economies can have major impacts on funds appropriated for both research and development. However, The Burrill Report claims confidence in biotech seems to have returned, with 2013 being a banner year for life science IPO activity in the US with 52 deals resulting in $7 billion, compared to $1 billion for 16 deals in 2012. However, on a country-level, by the early 2020’s, China’s R&D spending could surpass that of the US.
7. Declining Barriers For Entrepreneurs: Barriers to entry in entrepreneurship have declined in most countries, especially among the more developed global cities. This is in contrast to the emerging life sciences clusters. Mr. Humphrey notes, “We are consistently seeing that the countries with the lowest barriers to entrepreneurship are the UK and The Netherlands, while China and India presently have the highest barriers to entry.” He claims this is due to difficulties with collaboration and the shared risk models in these emerging markets.

 

1 Way To Save Lives And Money

Each year, Sepsis kills far more people than AIDS, prostate cancer, and breast cancer combined. Sepsis is one of the top three causes of death globally as patients are five times more likely to die from Sepsis than heart attacks or strokes. Sepsis is also responsible for 70-90% of the organ failure deaths related to Ebola, yet it goes unrecognized, is poorly understood, and has very low public awareness.

Treatment for Sepsis often involves a prolonged stay in the ICU, requiring complex therapies costing the US health system over $5,000 per patient/day, or $20 billion/year. Globally, Sepsis is estimated to exceed costs of $90 billion/year. Even worse, the mortality rate for Sepsis is approximately 35% – higher in developing countries – with patients who survive often struggling with physical impairment, muscle and nerve damage, cognitive changes and chronic organ failure.

According to Patrick Maguire, MD, PhD, MBA and CMO of HemoLife Medical, “Currently the greatest need for fighting Sepsis is the ability to manage (reduce) cytokine cascade/storm (hypercytokinemia), and thus prevent the devastating secondary effects of organ compromise and failure. Where we currently have the greatest need is for technologies that can effectively and efficiently decrease cytokine burden. Even if we could detect sepsis earlier, we will always need to effectively treat a run-away cytokine storm in order to help return the patient to a more normal, healthier state.”

The Silent Killer

According to the Centers for Disease Control (CDC) the hospitalization rates for Sepsis more than doubled in the US from 2000 to 2008, with those patients staying much longer and costing significantly more than those who do not develop Sepsis.

The inflammatory response is the mechanism our body uses to recognize and defend against an infection. When bacteria, trauma, toxins, heat and other injuries occur to tissue, the body’s automatic response is to fight it. The damaged cells release chemicals that cause blood vessels to leak fluid into the tissues, causing swelling. This helps isolate the foreign substance from further contact with body tissues. However, after a patient’s infection has been controlled, Sepsis – or Septic shock – can continue in two ways: 1. By the presence of endotoxins (dead bacteria), and 2. Cytokines that are released by the body.

In fact, in most cases, the inflammatory response component of Sepsis is the true killer because, even after antibiotics have been successful and the patient has been properly hydrated, clinicians can do very little to improve a patient’s odds of surviving.

HemoLife Could Save Lives – And Money

In addition to improved diagnosis and awareness, new products are entering the market that could forever alter the way Sepsis is treated, first and foremost by simply providing a more direct “treatment”. One such proposed treatment entering the market that filters toxins from the blood stream is the IMPACT System® by HemoLife. The company, HemoLife Medical, believes that by effectively removing cytokines and endotoxins from a patient’s blood stream, their system reduces the primary triggers driving a patient’s destructive inflammatory response that occurs during Sepsis. In most cases, patients can be effectively treated with as few as three HemoLife treatment cycles.

The IMPACT® ‘HemoFilter’ minimizes electrolyte and protein depletion from the treated plasma, effectively removing both free and protein-bound toxins. The toxin removal device works by separating red blood cells, white blood cells, and platelets from the plasma, followed by filtering out specified toxins from the plasma. After filtration is complete, ‘clean blood’ is infused back into the body, reducing the toxins that fuel the life threatening inflammatory response called Sepsis.

Although the clinical success of the IMPACT System has been shown and approved for sale in the European Union (EU), Canada, India and Australia, “FDA approval is expected in the US during the fourth quarter of 2016,” says Mike Ward, President of Mainbridge Health Partners, the company taking HemoLife to market. Mainbridge’s goal with HemoLife is to “improve health care providers’ understanding of the IMPACT System’s effectiveness on Sepsis, so we can more rapidly make it standard of care as it enters the US market. Our investors are helping us make that happen right now, so we can start saving lives both domestically and abroad.”

The IMPACT Could Be Global

According to Lon Stone, President and CEO of HemoLife, “The IMPACT System®, as an adjunct treatment is currently distributed to several international hospitals, has the potential to improve patient survival and reduce the length of stay in ICUs, resulting in cost savings from $5,000-$10,000 per day.”

The statistics showing the devastation of Sepsis in these countries are staggering. Approximately every three seconds a patient dies of Sepsis, and more than 6 million of these deaths every year occur in children. In those locations Sepsis is also the second most common case of maternal death – second only to bleeding.

Just like the US and other developed nations, developing countries could use products like HemoLife’s for cost savings and life savings. The IMPACT System® would need to access equipment that is presently not available in some parts of the world, but the utilization and training for the product could potentially become universal as hospitals, clinics and mobile facilities grow around the world.

Dr. Maguire believes, “As more providers, clinics and traditional hospitals become comfortable with the IMPACT System’s safety profile and results, the opportunity to move this treatment earlier in the patient’s clinical course, should enhance patient outcomes, further reducing morbidity and mortality. The possibility to intervene in the treatment of graft versus host disease (GVHD), acute pancreatitis, acute respiratory distress syndrome (ARDS), avian influenza, and systemic inflammatory response syndrome (SIRS) remain applications to be explored, and the ones for which we have the greatest hope.”

 

The Most Interesting Man Revolutionizing The Health World

He wrote his first world-renowned book at the age of 26. On weekends he recites love poems (ghazals) on Voice of America. He casually – and humbly – references his more than 70 patents that range from aging wine to chewing gum to bioreactors to air scrubbing systems at his infamous Chicago wine parties. And his mustache rules his twitter feed. Dr. Sarfaraz Niazi might just be the most interesting man in the world, but he is certainly the most interesting man pursuing biosimilars in the United States. And many others say the same thing about him; a mostly widely blogged photographer Steve Huff says, “An amazing man, in fact the most interesting man in the world!” He is also an avid photographer, a poet and plays classical guitar. In 2013 he was awarded Star of Distinction, the highest civil award by the Government of Pakistan for his inventions that are making significant impact in the developing countries. He has written over 50 books and well over 100 research papers and hundreds more articles in the field of science, philosophy, rhetoric, poetry and religion and draws thousands of hits per day on his blog.

To date, Dr. Niazi, a former tenured professor at the University of Illinois at Chicago (UIC), is taking nine molecules to market and written over 100 widely recognized pieces on biologics. Then, like now, his driving principle is to make things simpler. He did this while at Abbott Labs, in universities, in developing countries and presently throughout his independent career at Therapeutic Proteins International, LLC (TPI) where he is working on biosimilars – or “copies” of current biologic pharmaceuticals that are about to lose their patents. Although only 17 biosimilars have been approved to date worldwide, though none in US, Dr. Niazi and TPI have nine in the pipeline to transform the entire market.

Flexibility Is Key To Innovation

When asked his advice to other inventors in a recent interview, Dr. Niazi explained his philosophy that, “You should never get enamored by your thoughts. If the idea does not solve a problem or move the quality of life farther, there are many more things to be invented.” With that mentality, he is filing two products this year alone, similar to Amgen Inc.’s $6 billion molecule white blood count product, due to its expiring patent in the cancer market. Next year, the two molecules he plans to take to market are similar to AbbVie’s expiring $12 billion product Humira.

With movement like that, it’s no wonder Dr. Niazi claims that the U.S. Food and Drug Administration (FDA) is his “friend.” Nevertheless, he notes extreme complications with the rolling submission model, which can cost up to $4 million per submission in fees alone. Additionally, the four levels of the FDA’s “analytical similarity” benchmarking can be troublesome if one has a new biologic entity. This benchmarking, however, allows scientists and the FDA to work together in a predictable, step-wise fashion to move products to market quickly that have fingerprint-like similarity to existing US-licensed biologic products.

Dr. Niazi’s strategy is to create an analytical and clinical equivalent to biologics with expiring patents, which is preferred even over a Phase 3 clinical trial. By doing this, the cost of production is reduced drastically and the speed of development increases by 2-3 times. Dr. Niazi estimates an overall reduction in production costs for his biosimilars of up to 50% or even higher compared to market competitors.

By being flexible, his products are proving to be bio-revolutionary.

Can The United States Catch Up?

Additionally, thanks to the Affordable Care Act (ACA), a shorter licensing path for lower-cost versions of cell-derived drug is now possible, giving inventors like Dr. Niazi another pathway for approval and distribution.

While he claims that the ACA will not reduce health costs, he does believe that independent shocks to the health market will. By this, he believes that making biosimilars easier, faster, cheaper and better translates directly into his mission of making all things simpler. Further, cost-effectiveness in the US and European Union (EU) can directly convert into worldwide distribution and scalability that is safe.

Although a friend of the FDA, Dr. Niazi is not hesitant to note the tough decisions US-based companies face to stay in the states. Having FDA approval carries weight around the world, but the financial and regulatory burden can be great for inventors and business owners. In contrast, he asserts that the EU has moved ahead of the rest of the world, with the most established and advanced regulatory framework for the authorization and marketing of biosimilars, which has since been adopted by the World Health Organization (WHO).

Additionally, Dr. Niazi says that it is difficult to raise money in the US. Venture capitalists and corporate investors are less likely to take risk and have notoriously poor track records with the health sector.

Investing In The Windy City

In 2003, the TPI founder committed that his work and company would stay in Chicago. He believed that from creation to manufacturing and testing to going to market, that TPI would excel in the Midwest due to Chicago’s health care ecosystem, experts and manufacturers.

Through a focus on creating “generic equivalents,” Dr. Niazi is proving that TPI can be wildly successful in the Midwest, and further, that in the same way generics revolutionized how people access pharmaceuticals, biosimilars can revolutionize the way those around the world access lifesaving treatments.

As his biosimilars enter the market with FDA approval, the ability of Dr. Niazi to impact the entire health sector grows because his biosimilars can be substituted for its reference product without provider or patient intervention. However, the FDA has not yet finalized these guidelines, and only 17 biosimilars have been approved internationally to date, of which none are by the FDA.

Ultimately, with numerous billion-dollar biologics coming off patent over the next six years, and the exorbitant cost for specialty drugs, the nine biosimilars TPI has in the pipeline stand to make a huge impact in the health sector. While Dr. Niazi could be doing many interesting things these days as an international man of mystery, he has devoted his research, time and energy to bringing high quality, cost-effective treatments to the US, and beyond. So long as he maintains his wine parties and poetry readings, its certain no one will complain.

 

8 Things CFOs Must Know About Health Reform

Whether a Chief Financial Officer is running the fiscal operations of a hospital system, an insurance company or a company that simply employs individuals with health coverage, the decision-making process for sustainability is changing at a rapid pace. However, after years of hearing about reformation in the health system, broad, sweeping and revolutionary changes are finally happening. Major shifts are also occurring in the population, as well as technological advances that will disrupt the entire premise of a four-walled institution for care and the very model we use for health delivery.

Health care in the US is a business – a multi-billion dollar business – and understanding the financial implications of health reform will make or break every CFO. Knowing that health access, demand, quality and payment changes are inevitable there is an immediate need for CFOs across the ecosystems to embrace and plan for transformation.

1. You have too many beds.
   While many hospital leaders won’t accept this at face value due to lengthy wait times, surgical demands and desire to shift beds, the truth is there are too many beds in a lot of hospitals. Between transferals to the outpatient setting and telemedicine, the need for expensive inpatient beds is declining. Additionally, hospital leadership are increasingly finding that they face problems with state authorities when they apply to move beds. Most recently at the University of Chicago, where 338 beds were being used for a 304-person utilization pattern, the state rejected a University application to move surgical beds.
2. Food, housing and transportation of patients is your problem.
   As Americans begin to define and attempt to tackle community and population-based care, the access individuals have to quality food, affordable housing and efficient transit matter.  No one living in a food desert will have the same health outcomes as someone living next door to a Whole Foods, just as an individual with a new car will always be more consistent in making appointments and picking up prescriptions than someone who has to access three public transit buses for the same activities. Real patient engagement and activation begins with understanding the environment of each patient.
3. Your patient demographics are shifting, and so too should your leaderships. As the US continues to brown, hospital leadership must be representative of the population to understand and meet need. At a recent Modern Healthcare Top 25 Minority Executives session, an awardee remarked that the United States is now a country of minorities, and “our leadership as minorities is our future for health outcomes.” With this in mind, it is inevitable and paramount to success that the leadership of any organization resembles and represents those it serves, so it makes the financial investments and decisions that influence the community.
4. More bodies in beds will never work again.
   Value-based purchasing means that a warm body in a bed not only drives costs higher for the payer, but that the longer a patient remains in the hospital – or the more often they return – the more penalties that accrue. Therefore, the goal should not be for more bodies, but for cost-effective bodies. Depending on the community serviced, this can mean desire for more Masters Athletes, specialized services or elective services. Additionally, as we shift to a world where technology enables more clinical procedures and recovery to be done in the outpatient setting, or at home, and expensive inpatient procedures decrease in volume and reimbursements, hoping to fill beds is futile.
5. Alignment with physicians is nonnegotiable.
   No leader can effectively attain a goal without buy in from those who carry out the work.  However, it is important to be aware that “physician alignment” is a term that causes almost all physicians to turn and walk the other direction out of fear that this indicates buying their autonomy and dictating their day-to-day, moment-to-moment ability to practice. According to Healthcare Financial News the implications of physician behavior are so important in 2014 that more revenue than ever will be spent recruiting physicians who see the world the same way you do, which is not very different from how corporation CFOs think about their employee hires.
6. As consumers take on more and more pay responsibility, unexpected payment shifts will keep occurring.
   Many experts estimate that defined contribution, health insurance exchanges and the growing individual health insurance market means that patients will become more informed about spending their health care dollars, and therefore, more unwilling to spend. The future of reimbursements and pricing strategies is presently a puzzle wrapped in an enigma because of extreme uncertainty. However, it is general knowledge that Medicare and Medicaid reimbursements are going to continue decreasing, with the American Hospital Association and Moody’s already estimating an, “unequivocally negative” outlook for hospitals on the reimbursement fronts.
7. Technology and data utilization can save you money.
   While the learning curve with new technology can be excruciating and the meaningful utilization of collected information seems daunting, everything from workflow to health activities and employee/patient engagement can be monitored – and altered in real time – using new technology. Moreover, the more information that is known today, the better predictive analytics and behavioral change that can be made tomorrow. However, as the amount of technology available to leadership continues to grow exponentially, the purchasing of new tech will be a balancing act between what is a passing fad versus what is sustainable and transferable.
8. Your EHR is going to cost you. Big time.
   Now this seems obvious to most hospital CFOs, as they have already seen the initial price tags that come with implementing a “holistic” electronic system. However, the most costly elements may not yet be realized. As mergers and acquisitions continue, technology advances and EHR capabilities increase, the need to refresh systems will continue.  At present there is not one system that meets end-to-end patient or provider needs, leaving the ecosystem open for further disruption, which inherently includes more interoperability, more upgrades, more plugins and more costs.

 

Health Insurance Benefits – Can You Have It Your Way?

As the percentage of large employers that consider a shift to defined contribution and/or private exchange increases, the number of options – and flexibility in those options – must also increase. Consideration for those options rose last year from 14% to 18% among large employers (500+ employees). Further, those who are considering the move to a private exchange want to because of their desire to offer more and better plan options, as well as realize cost-savings. Shifting to the defined contribution framework allows employers to moderate their subsidies to employees, and employees to make better trade-offs among plan options. Additionally, by increasing choices, defined contribution makes it easier for employers to integrate their health incentive and wellness programs by layering them “on top” of the defined contribution.

With this economic opportunity in the market, it is imperative that health plans and enrollment become more tailored to individual and company needs, in addition to the one-size-fits-all solutions of the past and present.

Private health exchanges, according to bswift, like their new Springboard Marketplace, could be the platform to give consumers that greater choice and increase individual decision-making. Given that most large employers who are considering a defined contribution will remain self-insured, bswift is taking a calculated gamble that employers will continue to invest in cost management solutions such as incentives, wellness programs, consumerism as opposed to simply shifting costs to employees under the “fix it and forget it” cost sharing approach suggested by some competitors.

Customize Your Cart

The Springboard Marketplace that bswift has created has the online functionality healthcare.gov could only have dreamed of, and the choice construction of a grocery store.  In fact, the terminology the company uses alludes to “Stocking the Shelves” with your benefit choices and “Shopping” for your ideal group of benefits. This is all done through the interactive benefits advisor, Emma, who walks employees through an online step-by-step process to fill their cart with health care options.

For those aware of bswift’s background as a tech company it may not be a surprise that the software and services offered are aimed at streamlining a very sophisticated system, and making the user experience easy. And for those that know the company’s Executive Director of Exchange Solutions Brad Wolfsen, the shopping experience and ease of transition into a new set of consumer options will easily resonate. Mr. Wolfsen, before joining the team, built and led Safeway’s wellness and retail strategy programs, and was the President of Safeway Health.

According to Mr. Wolfsen, the real benefit he sees to bswift’s products are that they, “allow employers to focus on equity for employees and shift to a retail view on providing health benefits.”  Or, as the Society for Human Resource Management labels it, From Parenting To Partnering.

New Plans Equal New Decisions

With a growing demand for health benefit options that resemble a choose your own adventure book, but with a set amount of money to spend, the development of software must also be functional for employers and employees. The Springboard Marketplace has been constructed so that functionality can simply be turned on and off, so that choices are simplified. Additionally, since there is not a standard approach to benefit choices and many legacy systems that have to be revamped due to mergers, acquisitions and partnerships, greater automation for employers means less paperwork for HR departments. By making workflow, reporting and administrative work more efficient through automation, cost-savings increase even further.

“The best and brightest clients are currently driving what is in the bswift system now,” says Mr. Wolfsen. “As we move towards expanding the suite of benefit options and meeting compliance standards, we are also investing in the shoppers experience.”

He, along with his colleagues at bswift, believe that their tech company is nimble in ways that others are not, and that with the help of their platform and Emma, more and more employers will begin the migration to defined contribution and private exchanges. If true, that growing shift could redefine how health benefit decision-making is done by employees in the future.