Koch Institute Gallery

The Celebration  of Innovation in  Kendall Sq—held on April 29 at  MIT’s David H. Koch Institute for Integrative Cancer Research-–  definitely lived up to its title.

Among other innovations I’m still celebrating:

  • A university president (Susan Hockfield of MIT) walked over,  introduced herself and actually seemed interested in learning about ME.
  •   21 speakers got through their material in 25 minutes,  total. (Good thing, because the audience of approximately 150 stood, sipping wine, throughout).
  • Living” bronzed” statues of dead inventors Ben Franklin, Ada Lovelace, and Thomas Edison walked silently around the room–stopping, occasionally,  to pose for photos.
The event, sponsored by MIT and the Kendall Square Association,  was  introduced by Sarah Gallop of the MIT Office of Government and Community Relations and KSA.
Here’s a link to a video of the event–which Gallop sent me a few weeks after the event.
 Hockfield, the first speaker,  described some of the 150  new restaurants and corporations now populating the area.
Community leaders, scientists, technologists,  businesspeople and students then  provided brief rundowns on historic and present day scientific, economic,  community,  and  technologic advances associated with Cambridge.
Science 
  • Rudi Belliardi of the Wellington-Harrington Neighborhood Association described the development of polarizing lenses and quinine
  • Daniel Heller, a fellow at the Koch Institute, said that the Robert Langer Lab, where he works, is seeking ways to target cancer using nanotechnology.
  • Barbara Broussard, president of the East Cambridge Planning Team,  spoke about the development of  synthetic penicillin.
  • Noubar Afeyan, chair and co-founder of Joule Unlimited, explained how his company is developing renewable fuels from waste carbon dioxide.

    Tom Waggener, Physioanalytics and Susan Hockfield, MIT

Economic Development 

  • Dan O’Connell, president and CEO of the Mass Competitive Partnership, provided an overview of economic development  in the Kendall Square Area.
  • Alex Laats, partner Commonwealth Capital Ventures, outlined the origins and importance of  the Internet.
  • Bill Aulet, managing director of the MIT Entrepreneurship Center, spoke about  the rise of entrepreneurs.
  • Yi-Han Ma, co-president of the MIT Sloan Venture Capital and Private Equity Club, went into the growth of the venture capital industry.
  • Tim Rowe, Founder and CEO of  the Cambridge Innovation Center, and President of the Kendall Square Association, described the area as a “Startup Hive.”

Community 

  • Cambridge Mayer David Maher introduced the topic of  “community;”  Margaret Drury, the Cambridge City Clerk, described her pride at officiating at the nation’s first same-sex marriage ceremony.
  • John Durant, Director of the MIT Museum, told us about the upcoming weekend’s Cambridge Science Festival.
  • Program directors Rebecca Gallo and Caitlin McCormick, described their work at the East End House;  children Selena, Nubian, Ralph and Christelle acted out roles to bring out the current and historic importance of the Margaret Fuller Neighborhood House to the city’s immigrant population.
  • Jane Hirschi, Executive Director of CitySprouts, explained the importance of school gardens and kids growing food.
Technology
  • Travis McCready, Executive Director of the Kendall Square Association, described a recent low-tech camping experience in order to emphasize  the growing role of technology in daily life.
  • Gavin Kleespies, Executive Director of the Cambridge Historical Society–which provided historical background for the event– spoke on the development of microwave Radar
  • Susan Athey, Harvard Economics Professor and Microsoft’s Chief Economist, described the growth of Internet search–confessing that, perhaps for obvious reasons,  she is biased toward Microsoft’s Bing.
  • Roscoe Thomas, the Area IV Neighborhood Coordinator, told of  the trials and tribulations experienced by Elias Howe before he became  the first in the US to patent a sewing machine.
  •  Rod Brooks,  MIT Professor Emeritus  and Founder of Heartland Robotics and iRobot, spoke on the past and future of robotics.
After the event,  walking by sidewalk art by Robert Guillemin,   the Whitehead Institute, Novartis, and Amgen on the way  to my car,  I felt energized by the creativity, forward-looking spirit and excitement of the gathering. And I mused at how far Kendall Square has come since I first visited there in the 1970s–when it was inhabited mainly by run down factories and empty lots.
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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.


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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I’ve been working with Instrumentation Laboratory, a Bedford, MA company, to spread the word about its new diagnostic test that helps prevent brain injury in newborns.  Newly cleared by the FDA, it’s first-ever, rapid point-of-care, lab-quality blood test for measuring  total bilirubin (tBili) in neonates.

Bilirubin, a toxin, can, in high amounts, lead to irreversible brain injury in neonates.  The new tBili assay is performed on IL’s GEM Premier 4000 critical care analyzer.    It allows clinicians to receive lab-quality test results in 90 seconds fromwhole blood in the Neonatal Intensive Care Unit (NICU), rather than wait up to an hour for results from the lab, using traditional chemistry methods.    

 During the first few days of life, the body breaks down fetal red blood cells, producing bilirubin.  More bilirubin is produced than the liver can remove, and it remains circulating in the blood. 

This results in jaundice, the most common condition requiring medical attention in newborns, present in approximately 70%.  However, in 8-10% of newborns, jaundice progresses to severe hyperbilirubinemia.  Left untreated, hyperbilirubinemia can quickly evolve into kernicterus, a devastating, irreversible neonatal brain injury. 

IL announced that it had received the FDA clearance for the test on Tuesday, at the annual meeting of the American Association for Clinical Chemistry. For more information,  check out the Instrumentation Laboratory (US) Web site-http://www.instrumentationlaboratory.com/ilus.aspx .

—Anita Harris

HarrisCom Blog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer and Ithaca Diaries Blogs.


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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