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.

The New York Times doesn’t need me to provide free advertising (I hope!) –but I found today’s business section fabulous for anyone interested in social media and media relations and thought I’d share some of the wealth.

First–David Carr, in The Zeal of a Convert to Twitter writes about  how long-form magazine journalist, Buzz Bissinger,  the author of “Friday Night Lights,” got hooked on twitter… 

Then, there are Noam Cohen’s piece on Wiki Leaks: A Renegade Site, Now Working With the News Media

and Claire Cain Miller and Ashlee Vance on   Bing and Google in a Race for Features .

 Robert Cyran opines on how the growing popularity of the Ipad could present problems for many tech industries in  iPad shift may wreak havoc on parts of tech sector

and Jenna Wortham describes “tumbler,” a blogging platform that sounds like a cross of Facebook, Twitter, and WordPress, and which, supposedly, many media companies are starting to use to promote themselves.  Media Companies Try Getting Social With Tumblr .

There are also articles on the UAR’s attempt to block blackberry messaging unless BB allows government monitoring, there, and  Clarie Miller’s piece,  New Site Aims to Connect Reporters and Publicists , which describes  NewsBasis,  a site on which journalists can get queries to potential sources, which  launched today.

Founded by Darryl Siry, a freelance writer for Wired and a marketing executive,  the new site sounds much like Peter Shankman’s  Help a Reporter Out, (AKA HARO) in that it allows journalists to post questions or search for sources–  asking questions anonymously to avoid tipping off competitors. 

Speaking as former journalist, I can’t imagine giving away ideas, even anonymously–tho fishing in public is certainly easier than digging for sources.

Evidently,  on NewsBasis, sources can also add a footnote to articles across the Web, so when reporters are doing research using their Web browser, a tab will appear indicating that a NewsBasis source has offered a different point of view or corrected a fact.

I hope this wasn’t too much information for one shot…but, hey, it’s the information age, we’re talking about here.  I’ll be interested in seeing how all of this works out.

Anita M. Harris

Anita M. Harris is president of the Harris Communications Group, a marketing communications, media relations and social media firm in Cambridge, MA.

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.

                                                                               *

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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Sorry to read in today’s Boston Globe that both Business Wire and PR Newswire -which are paid to send out press releases–were hornswaggled by a media relations imposter for whom each posted fake stories.

According to Globe reporter Todd Wallach, last week, PR Newswire   sent out a fake press release claiming President Obama had ordered a probe into General Mills.

And on Friday, Business Wire sent a release falsely claiming that Javelin Pharmaceuticals had won a 5-to-4 victory before the Supreme Court with the aid of Justice Clarence Thomas.

In both cases, the releases were rescinded  before they could affect the companies’ stock prices, Wallach reports.

Both  included a New Zealand phone number at the bottom. 

When Wallach called the number,  Matt Reed, a 30-year-old database designer in Auckland told him that he’d sent the General Mills release to discredit President Obama.  And that he’d sent the Javelin release to push Business Wire and other press release companies to step up their security to prevent future hoaxes.

Odd, to say the least–but definitely a cause for concern.  And, Wallach reports, an FBI investigation.

As a media relations professional, I’ve found both Business Wire and PR Newswire (as well as Marketwire) to be above-board and careful–but can see how hoaxes like these can easily be perpetrated by anyone who has a credit card.

 Not sure if paid wire services need to require background checks before posting releases or if I‘d be willing to undergo one…but do think there’s a need for greater scrutiny of press releases–not just by the paid wire services but by bonafide journalistic wire services, as well.

Again, under my media relations hat, I was delighted when, several years ago, the Associate Press ran a press release I sent on behalf of a client verbatim–except for one minor change in wording.  (Uncredited, of course).

I like to think it was such a great release that nothing needed to be done to it–or that perhaps my reputation for honesty was known. 

But, under my journalist’s hat, I was appalled that no one from AP called me or my client to confirm that we had actually sent the release–or checked the facts– before disseminating it to the world.

Today the situation is even more serious: anyone with a computer and an Internet  can post anything to the world. 

On the one hand, this great boon to free speech and the sharing of ideas and information.

But on the other, the burgeoning of Internet use has eroded the readership, financial position and  gatekeeping power of the traditional press. In financial distress,  news organizations are cutting corners–and staff. Reporters and editors are being asked to do more, faster.  

 Not only is there less coverage, but it is becoming more to difficult trust the accuracy of what is covered. The traditional press has long been our nation’s main bastion for protecting the marketplace of ideas from the spread of disinformation. 

I hope that media organizations, bloggers, anyone in a position to disseminate information will do so responsibly. And that my readers, business owners, the American public,  will subscribe, buy ads, do what you can–to prevent a potentially dangerous situation from getting worse.

Here’s a link to the Globe article:  http://www.boston.com/business/healthcare/articles/2010/06/23/cambridges_javelin_is_latest_target_of_hoax/

Anita M. Harris, president of the Harris Communications Group of Cambridge, MA, is a former national journalist who has taught journalism at Harvard, Yale and Tufts Universities and at Simmons College.

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

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!  

A new global review from my client, Scientia Advisors , predicts rapid growth in molecular diagnostics and that,  with traditional pharma companies slow to innovate, a myriad of new entrants vying for market share will change the healthcare landscape.

(Molecular diagnostics are genetic tests used to judge the effectiveness of  particular treatments for individual patients–key to the burgeoning new field of personalized medicine).

Released earlier this month  (and available for download at no charge at www  scientiaadv.com)  the review projects that MDx will grow at  an annually compounded rate 15% to approximately $7.5B in 2013.

Currently, molecular tests used for oncology and critical care infectious diseases are experiencing the fastest growth among MDx segments.

“Ultimately, MDx will enhance care, cut health care costs and make personalized medicine a worldwide reality,” said Scientia Advisors Managing Partner Harry Glorikian.

Among other major findings:

  • The industry is transitioning away from low-cost, low-margin tests. New, “high-value” MDx tests are changing the health care paradigm by providing critical information to physicians more quickly and accurately than was previously possible.
  • While most MDx revenue is currently generated in the US and Europe, future growth will be most pronounced in the developing world.
  •  New, easy-to-use, random access and fast-turnaround-time MDx platforms are enabling widespread adoption of MDx in small and mid-sized hospitals, worldwide.
  • Companies seeking to enter the MDx field must be cognizant that, with the growing impact of MDx, government oversight and regulation will likely increase and reimbursement policies will evolve to reflect added value.

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

—Anita M. Harris

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

 On Wednesday, July 15, 2009, media consultant Doug Bailey wrote in an  op ed column entitled  ”Got a comment? Keep it to yourself” that space for comments at the end of online newspaper articles should be eliminated because they downgrade the quality of news. 

Bailey,  who does not disclose that he’s a  former Globe editor, suggests that rather than enhance communication, newspapers online forums are “insidiously contributing to the devaluation of journalism, blurring the truth, confusing the issues, and diminishing serious discourse beyond even talk radio’s worst examples.”

He  points out (without naming names) that  the comment sections allow  ”anonymous”, “unverified,”  “agenda-driven”  ”boneheads” to post inaccurate information that  can be picked up by bloggers and then by legitimate traditional reporters who publish “missives” –unaware that the bloggers’ information came from their newspapers’ own Web sites.

Yes, this is a problem–and  it is, as Bailey puts it, a bit  ”insane”. But rather than ban readers’ comments, wouldn’t it make more sense for reporters to verify all sources?  Certainly, real reporting takes time–and traditional journalists are increasingly harried in these days of cost-cutting and layoffs.

But it is verfication and objectivity that separate  independent journalism from  disinformation. And, it is truth, and allowing readers a stake in it–that, in the end, will give us a reason to  pay for news.

Bailey ends his column saying, “By the way, don’t bother posting any comments directly to me when this article appears on the Web. I won’t see them. Instead, go start your own website or blog or buy a legitimate newspaper or write a letter to the editor, or an op -ed (and sign your own name to it). If  you really have something interesting to say, I’ll find you.”

(I was  amused–and glad–to see 168 comments after the online posting.

  • “Kachunk” says he’s posting for “the irony”
  • “Oldpink ”says it’s “ nice for ordinary citizens to be given an opportunity to add something that should have been in the original column, while allowing others to rebut.Messy? Often a bit mean? Commonly inaccurate? Absolutely. Isn’t democracy grand?”
  •  ”Sensibleman,”  writes that he’s using  the first amendment to tell Bailey “to stop submitting articles so if intelligent life ever scans our internet to determine how critical it is to stop at Earth they don’t pass over us due to stupidity.”)

I read Bailey’s column in the print edition–which is delivered  to my door (late, but that’s another story)  every day.   But the Globe allows almost no print space for letters to the editor which, in days past, might have helped keep reporters and columnists on their toes.  Hence, this posting–and comment #169 after Bailey’s piece, online.

But if  I did write in, I’d  include my name and  prior affiliations– and make  clear that like Bailey’s,  my not-so hidden agenda is to attract customers to  my consulting business.  

 Hint, hint:  Anita Harris, a former national journalist,  is president of the Harris Communications Group, of Cambridge, MA.

PS  Comments welcome!

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