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.

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Forget the Commercials, Jason Shafrin Presents the Super Bowl Edition of the Health Wonk Review

The big game–complete with the deflated balls conspiracy–is just a few days away. Who will win: Seahawks or Patriots? Trick question. The real winners are those of you who make the smart decision to read the latest Super Bowl Edition of the Health Wonk Review hosted by Jason Shafrin. It’s good stuff, people. I know, because I’ve read all of it.

 

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.

 

The definition of absurdity

Ever heard of the “plain meaning” rule?  It is not, as I first thought, an admonishment to toddlers to speak clearly, although that would be an awesome, albeit unenforceable, rule.  It is actually a real legal term that refers to a requirement that statutes under consideration by the courts generally be interpreted in accordance with their plain meaning.  In other words, Congress has said exactly what they mean.  Which it always does, of course.

The “plain meaning” rule, though, has an exception for absurdity.  This exception permits a court to depart from the plain meaning of a statute when the result would be an absurd one that Congress could not possibly have meant.  Hmm.. Second Amendment anyone?  But I digress.  The question, though, is how “absurd” a result must be before the exception kicks in.  The Supreme Court has kept the exception narrow, one presumes to avoid completely absurd chaos stemming from the meaning of the word “absurd”.

Since we all know that Congress is generally acknowledged to be absurd, by whatever definition you choose, why am I talking about this?  Because the Supreme Court is set to hear a case that challenges the Affordable Care Act and the decision could hinge on the plain meaning rule. The case concerns tax subsidies that currently help millions of people afford health insurance under the law.  The New York Times says as much as 87% of people who got insurance coverage through Healthcare.gov were eligible for subsidies. The central question in the case, King v. Burwell, No. 14-114, is how to interpret a provision in the law limiting subsidies to “an exchange established by the state.” The challengers say the provision means that only people in states with their own exchanges can get subsidies. Since most states opted to let the federal government set up the exchanges, all the people in those states wouldn’t be eligible.  In states like Mississippi that’s like 95% of all newly insured folks.

Michael Rosman, a blogger for the SCOTUS blog, explains it like this: “…the statute in question plainly provides that, in calculating the size of a subsidy, one must begin with the monthly premium of a qualified health plan offered in the individual market within a state that someone enrolled in ‘through an Exchange established by the State under Section 1311 [of the ACA].’ “State” is a defined term under the Act and plainly does not mean the federal government. In King, the federal government does not seriously argue that it would be absurd for Congress to limit subsidies to individuals in states that have state-operated exchanges (although it does argue strenuously that that is not what Congress meant). Rather, it suggests that there are other provisions of the ACA that would be rendered absurd if the phrase ‘Exchange established by the State’ were given its plain meaning. (Whether an absurdity in a different provision should be sufficient to reinterpret a phrase away from its plain meaning in the relevant section is another question).”

Clear as mud.   The name Burwell in the title of the suit would be Sylvia Matthews Burwell, the Secretary of Health and Human services.  As to King, that would be David King et. al, one of a group of four residents of the state of Virginia who don’t want to purchase insurance coverage.  At all.  From any source.  So for Mr. King, if subsidies were not available he would be exempt from the requirement to get coverage and thus also from the tax penalty.  With the subsidies, the coverage is theoretically affordable and thus he would have to pay the tax penalty if he isn’t covered.

This case is brought by four people who don’t want to pay for stuff.  Why is the Supreme Court getting involved?  Because of the supporting appellants:  Senators John Cornyn (R, Texas), Ted Cruz (R, Texas), Orrin Hatch (R, Utah), Mike Lee (R, Utah), Rob Portman (R, Ohio), Marco Rubio (R, Florida), representative Darrell Issa (R, California) and the states of Oklahoma, Alabama, Georgia, West Virginia, Nebraska, and South Carolina, all staunchly republican states that have rejected medicaid expansion (except West Virginia) and state-run exchanges.  For most of the residents of these states removal of the subsidy would likely leave them back in the ranks of the uninsured.

Oh, I see what the definition of absurd is now.