Earlier this month, I attended  a great MIT Enterprise Forum  discussion on new medical devices designed to provide low cost tests far from laboratories or medical centers, in the developing world.

At the meeting, held by the Forum’s Health Care and Life Science Special Interest Group at the British Consulate in Cambridge,  former Mass Biotechnology Council  President Una Ryan described the paper-based  medical testing technology that her new nonprofit enterprise,  Diagnostics for All  (DFA), has licensed from the George Whitesides Lab, at Harvard.

The technology allows bodily fluid to accumulate in patterns on postage-stamp sized pieces of paper–to be used for  multiple  tests simultaneously. DFA’s first project, funded in part by the Bill and Melinda Gates Foundation, is a liver function test to monitor the effects of drugs for HIV/AIDS and tuberculosis, to help manage viral hepatitis. Such tests, which ordinarily require laboratory evaluation, will first be sold in convenience stores in Africa at a cost of approximately ten cents each, Ryan said.

Bill Rodriguez, CEO of Daktari Diagnostics, showed a handheld, point of care, battery-operated diagnostics device the size of a small lunch box or portable radio that will first be used to test for AIDS in Africa–at a cost of $1.50 per test–starting next year. He pointed out that while drugs are available to treat the  33 million people worldwide who have  HIV– “ten million of them don’t know it.”

Scientia Advisors Partner Arshad Ahmed, who  served as moderator, (and is my client) pointed out in a recent blog that emerging markets may have the opportunity to adopt the latest point-of-care products, leapfrogging developed countries, in some instances–and that “emerging markets are where we will see the first application of low cost and inovative disruptive technologies at work.” Launching in the developing world allows companies to test out and market technologies before going through the rigorous approval process required in the developed world.

I was blown away by the prospects for  devices like these and asked when and how they will affect the  costs and structure of, say, US healthcare–and whether those who make and market our costly technologies will try to keep these new testing devices out.  While Ryan, whose nonprofit will have a commercial wing, responded that she does not expect opposition from stakeholders in our current system. But can that possibly be right?

Anita M. Harris

Anita M. Harris is President of the Harris Communications Group, a marketing and public relations firm specializing in health, science and technology industries, worldwide.

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In a new blog post entitled Pharma in 2011: A Year for Big Decisions, Scientia Advisors Managing Partner Harry Glorikian (who is my client) writes that most pharma firms’ current approaches for playing in new fields are likely to fail—and makes a number of  industry predictions for the coming year.
With several major products going off –patent, and with regulatory and policy changes in the works, Glorikian writes, many large pharma companies must rethink  their current business models in order to succeed on new playing fields. 

In the coming year, pharma can expect:

  • Little growth for big caps and fewer big cap company mergers
· Need for cash generation leading to divestment of  developmental assets
  • Increased focus on therapeutics for niche and orphan diseases
  • Accelerated  need for prescription/diagnostics combinations, leading to partnerships or acquisitions.


“In our view, most pharma firms’ current approaches for playing in new fields will not succeed—and companies have many difficult decisions to make,” Glorikian writes. “A big question is whether, in making those decisions, they will try to satisfy shareholders’ immediate needs or ensure long-term company health.”

Here’s a link to the complete blog:  Pharma in 2011: A Year for Big Decisions

–Anita M. Harris

Scientia Advisors, based in Boston and San Francisco,  is a management consulting firm specializing in growth strategies for major and emerging companies in health care, life science, biotechnology and nutrition. Scientia recently launched a practice  Pricing and Reimbursement/Market Access .

Anita Harris is president of the  Harris Communications Group— an award-winning marketing and public relations  firm in Cambridge, MA. HarrisCom also publishes New Cambridge Observer, a blog covering arts, sciences, business, politics and life in and around Cambridge, MA.


Pharma execs with blockbuster drugs on the market should be up staying at night strategizing in case someone comes up with a “companion diagnostic” that the FDA requires before the blockbuster  can be prescribed.

So write Scientia Advisors authors Amit Agarwal and Jonathan Pan in “Theranostics and Already Approved Drugs: What You Don’t Know Can Hurt You,” published in the 2010-2011 Parexel Yearbook.

Disclosure: Scientia is my client.

In the article, Agarwal, partner, and Pan, senior associate, describe the situation that led the US Food and Drug Administration (FDA) to require warning labels and recommend diagnostic testing for the blockbuster drug Plavix more than 10 years after the anti-thrombotic hit the market.  Plavix is marketed by Bristol-Myers Squibb and Sanofi-Aventis to prevent myocardiofaction (MI) or strokes.

As early as 2001, when Plavix had been on the market for four years, studies began to show that Plavix helped certain patients more than others, the authors write. By 2008, genetic testing by a competing pharmaceutical company showed that nearly one-third of Plavix users did not fully benefit from the drug.  Based on these and other trial results, in 2010 the FDA required that the manufacturers include a “black box” warning label and a diagnostic testing recommendation for the product.

In 2009, Plavix had worldwide sales of $9.5B including $5.6 B in the US. As a result of the FDA diagnostic testing recommendation, the authors project that by 2012, BMS and Sanofi Aventis will lose $450M to $575M in sales in the US alone– and more if regulators in other nations add requirements. “Given the need to maximize revenue in the face of generic competition across their portfolios, it is a significant amount to offset.” Other drugs, prescribed in conjunction with Plavix, will also most likely be impacted.

Agarwal and Pan recommend a number of actions that pharmaceutical executives can take to mitigate such potential post-launch losses.

  • Expand competitive landscape and threat assessment coverage to monitor the diagnostic environment for new research and clinical trials which could potentially impact the sales of marketed drugs
  • Upgrade skills, capabilities, reporting relationships and the organizational clout of the theranostic function
  • Develop organizational structures that allow knowledge of new biomarkers and clinical trials to reach commercial decision makers

Scientia Advisors’ article is available in the PAREXEL’s Bio/Pharma R&D Statistical Sourcebook 2010/2011 at Barnett Educational Services.

—Anita M. Harris, President, Harris Communications Group

Scientia Advisors, located in Boston and San Francisco, is a management consulting firm specializing in growth strategies for major and emerging companies in health care, life sciences, biotechnology and nutrition.

HarrisComBlog is a publication of the Harris Communications Group, an award-winning public relations and marketing communications firm in Cambridge, MA.


Ever wait anxiously for days to get the results of medical tests?  Such periods may eventually become passe as new methods for analyzing blood and other tests increasingly allow quick turnaround times in doctors offices, “rapid clinics,” and even in patients’ homes.

According to a new review of the global “point of care” testing industry released today by Scientia Advisors, a Cambridge, San Francisco strategy consulting firm (yes, my client!)–the market for point-of -care medical tests (those analyzed in close proximity to patients)–is growing at 8 per cent–and even faster for certain types of tests and in the developing world.

Harry Glorikian, Scientia’s managing partner, points out that this growth is fueled in part by a trend toward decentralization of health care—in which testing and treatment are migrating from hospital labs to settings such as emergency rooms, outpatient, doctor’s offices, rapid and urgent care clinics, and homes.

But, he points out,  “companies bringing point-of-care (POC) tests to market must consider not only accuracy, reliability and ease of use, but also the challenges of gaining clinical acceptance and meeting sometimes-onerous regulatory and reimbursement requirements.”

Based on primary and secondary research and proprietary analysis, Scientia projects that the POC testing market, which includes professional and over-the-counter segments, will experience compound annual growth of 8%, from $11.6B in 2008 to $18.4B through 2013 —with additional potential for growth in emerging economies.

While diabetes is the largest segment of the POC testing market, infectious disease testing, a smaller segment, has high growth potential due to (1) increasing awareness of public health problems such as flu, chlamydia and hospital-acquired infections (2) potential availability of disruptive, point-of-care molecular diagnostics and (3) increased adoption of POC testing in emerging markets.

Scientia also found that:

  • While the US is a major influencer in the global POC testing market, the developing world will experience the fastest growth—especially in China and India, where the governments plan to open thousands of rural clinics.
  • In the current economic slowdown, US retail giants such as CVS and Wal-Mart have closed many rapid clinics. As a result, rapid clinics may need new strategies, such as partnering with hospitals, to remain viable.
  • Next-generation, portable, easy-to-use technologies, which promise greater accuracy, convenience and clinical impact, will fuel the growth of many POC segments.
  • Stringent regulatory and reimbursement requirements and a need for pharmaco-economic studies remain barriers to widespread POC adoption in the US and abroad.

Scientia’s review, “The Point-of-Care Diagnostics Market: Growth Drivers and Challenges to Widespread Adoption”, is available for download at no cost at www.scientiaadv.com.

—Anita M. Harris

Harriscom blog is a publication of the  Harris Communications Group is a marketing communications and public relations firm located in Boston, MA.


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My client, Scientia Advisors,  has found that the market for certain advanced medical testing methods is poised for accelerated growth.

Scientia, a management consulting firm, recommends that many diagnostics companies reexamine their portfolios and  business models to position themselves for growth.
Immunoassays are laboratory tests used to identify and quantify blood components associated with particular diseases. Immunoassays are a key growth area within in vitro diagnostics (tests conducted in laboratories, as opposed to those carried out in living organisms).

Based on  a review released on June 28, 2010, Scientia Advisors Founding Partner Arshad Ahmed said: “Most current immunoassay technologies focus on detecting one or several proteins in a patient’s blood/serum or other samples.

 “However, novel markers and new technologies that can detect and measure multiple markers simultaneously will become increasingly available in the next several years.”

 Such advanced technologies—already used in diagnosing and treating infectious diseases, cancer, and kidney injury—are faster, more accurate and more cost-effective than many “traditional” tests. As a result, they may command higher prices and are driving growth in the overall immunoassay market.

What is more, for diagnostics players, marketing and business models are changing, according to Ahmed. Pharmaceutical companies are beginning to incorporate diagnostic tests into their sales processes. And certain diagnostics companies are adopting a “sole service provider” model—in which tests are marketed directly to physicians and performed in company-run laboratories.

 In light of these changes, “it is crucial that companies in the diagnostics space re-examine their business strategies in order to compete successfully in the coming years,” Ahmed said.

Review highlights:

  • The $7.7B immunoassay market, which comprises one fifth of the $37B in vitro diagnostics (IVD) market, grew approximately 6% a year between 2005 and 2007. The immunoassay market has since shown 9% compound annual growth — a rate that is expected to continue through 2012, largely due to technology advancements.
  • Growth in the immunoassay market will be driven by the emergence of (1) ultra-sensitive platforms, which enable detection of analytes at minute concentrations; (2) multiplex technologies, which allow simultaneous analysis of multiple compounds and (3) novel biomarkers that increase the accuracy and efficiency of diagnosis or treatment.
  • Emerging economies, such as China’s, are experiencing robust immunoassay market growth.
  • Personalized medicine and new business models such as the bundling of immunoassays with marketed drugs and the sole service provider areare changing industry paradigms.

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Scientia’s study, Strategic Review of Immunoassays: Seeing Beyond the Market Inflection Point”. is available for download at no cost at www.scientiaadv.com.

—Anita M. Harris

Harriscom Blog is a publication of the Harris Communications Group of Cambridge, MA.

Scientia Advisors, based in Boston and San Francisco,  is a management consulting firm specializing in growth strategies for major and emerging companies in health care, life sciences, biotechnology, and nutrition.
 

 

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A new review by my client, Scientia Advisors, finds that, with the market for biologic  drugs growing much faster than that of drugs based on chemical compounds, many biopharma companies are repositioning and forming new alliances in order to succeed in a rapidly changing pharmaceutical landscape.

In the review, released today, Scientia reports that revenue growth for the small molecule (chemically-based) drug segment has slowed and will begin to decline within three years as numerous blockbuster drugs go off patent and are replaced by less expensive generic substitutes.

In contrast, the market for biologics (based on living matter) which comprises approximately one-third of the overall pharmaceutical market, increased at a 21% compound annual growth rate (CAGR) between 2003 and 2008, to $110B.

While the CAGR for biologics has since slowed to 8%, Scientia projects 2013 revenues of $165B, due largely to rapid growth in monoclonal antibodies. Scientia also projects growth opportunities in the vaccine and cell therapy segments.

Many biologics command relatively high prices and require complex and expensive manufacturing processes. To keep costs down, biopharmaceutical companies are increasingly seeking to outsource their manufacturing to contract manufacturing organizations (CMOs).

 In addition, “numerous biologic therapies with total revenues of $37B will have lost patent protection by 2017, promising considerable opportunity in biosimilars (government-approved new versions of branded biopharmaceutical products following patent expiration),” Glorikian said. “As a result, pharmaceutical, generic drug, and contract manufacturing companies are joining forces to enter the biosimilars space. To be successful, they must take into account the considerable technical, competitive, and regulatory hurdles that will be involved.”

Scientia Advisors’ review, entitled “Assessing the Biopharmaceutical Market: Promises and Challenges,” is available for download at no charge from www.scientiaadv.com.

–Anita M. Harris

HarriscomBlog is a publication of the Harris Communications Group–a public relations, content and thought leadership firm in Cambridge, MA.  We also publish New Cambridge Observer.


A kazoo that records the air composition  in your lungs? Pill bottle caps that tell your doctor if you’ve take your medication?  A headband that measures how well you sleep? A gadget that relays your blood sugar  level to your doctor’s office—through your Smart Phone? Those are just a few of the new devices in the growing field of “local health monitoring” —through  which people can keep track of their own health conditions without setting foot in a hospital or doctor’s office.

Those gadgets—and others—were described at a recent panel discussion sponsored by the Medical Development Group, a Boston area organization for individuals involved  in medical technologies.

Frank McGillin, Vice President of Global Marketing for Philips Healthcare, which markets a variety of home monitoring devices, emphasized the importance these devices in light of growing health care costs.

He cited government statistics showing that  health care current accounts for 17.6 percent of the  gross domestic product in the US, and that by 2050, half of the population in the developed world will be chronically ill—making traditional medical care  fiscally overwhelming. 

Monitoring devices and telemedicine are already used for coaching patients remotely–and monitoring may also soon be available to determine measuring cancer patients’ readiness for—and the effectiveness of—chemotherapy—from home.

Ben Rubin, Co-Founder and Chief Technology officer of Zeo, in Newton, MA, described a headset and device that monitor an individual’s REM sleep and factors influencing sleep patterns.  Knowing how well you sleep is important because sleep is closely tied to health conditions like obesity, depression, diabetes and the like, Rubin said. “If you measure it, you can manage it.” 

The devices, which cost $250,  connect to  an Internet site. For an additional $100, ZEO provides email advice coaching to help individuals improve their “sleep hygiene.” 

 I’ve since learned of a Smart Phone application designed to promote better sleep:  using the Ap, you put your phone under your pillow to measure your movement (and restlessness) during sleep.

David Rose, Chief Executive officer of Vitality, Inc., in Cambridge, MA—explained that the above-mentioned pill bottle “glo-caps” can “ sense”  when a patient takes a medication, and, via a wireless Internet connection, show health care professionals whether reminder calls should be made. The caps illuminate, play a melody, and even ring a home phone to remind patients to take their pills.  The caps can send weekly emails to remote caregivers, create accountability with doctors through an adherence report, and automatically refill prescriptions. 

Glo-Caps are not currently available for purchase by individuals, but they are being used by patients enrolled in programs sponsored by certain health insurers and pharmacies.

Rose, who teaches at the Massachusetts Institute of Technology, previously founded and ran Ambient Devices, where he pioneered embedding monitoring devices in everyday objects such as:   umbrellas that can sense if it is going to rain; bathroom scales showing trend lines for weight-loss or gain; objects that measure air quality; a spirometer “kazoo” that measures the chemistry of air expelled from the lungs, and a telephone that uses an individual’s vocal qualities to measure depression. 

Devorah Klein, PhD, a principal at Continuum, in Newton, MA, designs and studies the effectiveness of self-monitoring and other devices. 

 An expert in patient adherence to therapy regimes for diabetes, asthma, arthritis, multiple sclerosis and erectile dysfunction, she described the importance of understanding how users interact with devices. Simple designs are key because “many patients are not all that interested” in devices— learning how  to use them, or how they work.

Panelists also described use of  Internet tools such as Google to measure flu trends; Healthmedia, through which Johnson & Johnson provides digital coaching for managing stress and chronic disease, Philips Direct, which provides live coaching over email, and various “calorie and other body monitors through which individuals can receive online coaching through gyms

David Barash, MD, president of Concord Healthcare Strategies and the panel moderator, pointed out that local monitoring devices are growing in popularity in sync with an aging population, increasing chronic disease, and new Internet technologies. 

According to a recent review by my client, Scientia Advisors, remote home monitoring, with a market size of 1.8B in 2007,  is growing at a combined annual growth rate of 15% per year–which makes remote monitoring  the fastest growing segment in a home health industry projected to reach $200B by 2012.

However, Barash said,  business models for many remote or local  monitoring products are, as yet, unproved.

One problem  is that, in the absence of adequate clinical trials, insurance reimbursement is limited, which makes doctors reluctant to adopt remote monitoring, Scientia found.

There are also questions about how doctors will be able to handle potentially huge quantities of data, potential liability issues,  Barash said, and  about the usefulness of  data from a myriad of individual monitors—when so many health conditions are interconnected. 

 “It’s very important for companies to ask, ‘Do people want this device? Will they use it?’” Barash said.

After the meeting, I mentioned to an  MDG board member that I don’t want all of this surveillance. “I’m just not that interested in my bodily functions,” I said.
“Just wait ten years,” she assured me.  “You will be.”

—Anita M. Harris

Anita M. Harris is the founder and president of the Harris Communications Group, a public relations firm in Cambridge, MA.  HarrisCom publishes the HarrisCom Blog and New Cambridge Observer

All rights reserved; please email us at info at harriscom.com for permission to use or reprint this material. Thanks!  

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