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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DOES YOUR BUSINESS WEB SITE NEED A MAKEOVER?
Free consultation with  the Harris Communications Group on Thursday, April 21, 2011
Social media is a wonderful outreach tool—but for landing customers, it’s only as good at the Web site it sends visitors to. During the recession, many companies and organizations neglected their Web sites —but as the economy improves, we are seeing great interest in replacing outdated content and clunky, old fashioned Web technologies with new material and functionality that is easy and inexpensive to use.
As part of Harriscom’s Third Thursday speaker series,  we will evaluate five Web sites for free.
If you’ll send your url to harriscom@harriscom.com, we’ll   meet with the first five companies to respond.
Meetings will be scheduled for Thursday, April 21, between three and five PM  at in the Cambridge (MA)  Innovation Center at 1 Broadway in a room yet to be determined.
  We’d  also be happy to look over forthcoming press releases and other marketing materials if you’ll send them ahead of time.
—Anita M. Harris
Anita  M. Harris is president of the award-winning  Harris Communications Group, a Cambridge, MA agency specializing in  strategic marketing communications, public relations and thought leadership for emerging companies in health, science, technology and energy fields.
  A former national journalist, Anita has reported for Newsday and the MacNeil/Lehrer Report of PBS, and served as a regular columnist for MSN.  She has taught communications at Harvard, Yale, Tufts and Babson and served as Public Affairs Director for the Harvard School of Public Health. 
In more than 12 years as a commumications consultant, she has developed Web content and navigation systems for  Inforonics, DIAMED, Radcliffe College, Center for the Study of Aging, and the St. Elizabeth’s Medical Center, among other clients. She has provided media relations and thought leadership services to  a variety of companies in the US and abroad. 




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.


Explaining how agencies charge for media outreach is always an interesting challenge. Most work on retainer (receiving a monthly fee in return for promised services). Some operate on a project basis, or charge an hourly fee. The other day, someone wrote in to Harvard-Startups, a list-serve to which I subscribe, asking if some public relations firms work on a “results” basis–that is, get paid only for coverage they obtain, not just hours.

I was impressed with a response from  Sylvia Scott, who has worked in public relations and is now  Creator & Director of Realizing A Vision Conference, Girl’s CEO Connection. She said it would be fine for me to share it, so here goes:

By “hours” do you mean paid by the hour? Most good ones are not paid on an hourly basis as the norm may be a specific number of hours devoted to you per month and the fee is determined by many variables.

Paid by results –well let’s see-an article in the New York Times may be valued at $10,000 for some companies. For others it may be more- if your PR firm gets you on Larry King vs. say GMA how would you differentiate. I got a client on Fox Morning show in San Diego-now
what would be the difference in fee from San Diego and say Chicago or Dallas? AND if you get editorial in the Tulsa World that is picked up by AP and then the article or or let’s say you get a call to be interviewed by the New York Times how do you pay for that?

Some results may take 3 months and then others 6 months-also, if the pitches are going on and accepted yet there is another scandal in the White House like it happened with Bill Clinton and the scheduled interview or placement is moved or forgotten-which is not the fault of the PR firm-are you going to not pay them for their work?

I know I did not answer you directly-just wanted you to see that “results” may not always be the same and some times one result leads to another even though no extra hours were put into place.

*

I  chimed in  that the Public Relations Society of America Code of Ethics frowns on promising results that can’t be guaranteed, so most PR consultants won’t work with clients on a straight contingency basis. Because it can take three-to-six months to build relationships with reporters on clients’ behalf, I prefer to work on retainer. But I have occasionally worked on a project basis–charging a minimum fee to cover time and effort with a bonus for major media “hits”.

Media relations is a tricky business–especially in today’s shifting media landscape. If you’re hiring, I’d advise paying more attention to a PR consultant’s track record than to promises, plan on a six month minimum and, for that period, at least,  keep the faith.

—Anita M. Harris
Anita M. Harris is President of the Harris Communications Group of Cambridge, MA.


I probably shouldn’t admit this, but I am a secret admirer of Building 19′s copywriters–whomever s/he/ they may be.

I have friends who won’t set foot in the bargain stores–which, according to the latest circular, were founded in 1964, when a ship originally sailed by Christopher Columbus finally arrived in Hingham.  (That does make you wonder how long some of their merchandise-aka “good stuff cheap”–has been lying around). And I admit–that even I, the penultimate bargain shopper–have been known to remark that you need to take a shower after you experience shopping there.

But how can you not be drawn in to a come-on like this:

WOULD YOU LIKE A HIGH POWERED CAREER IN ADVERTISING?

And not laugh when it goes on to say, “If so, this is not for you.”

(The ad, on the front page of Building 19’s October 8 flier, continues: …but if you want to work on the Building #19 circular in a fun atmosphere, rework a few pages from this circular and send them along with a resume (preferably yours) to Human Resources or email: hr@building19.com).

And how ’bout the ad for “Hat’s entertainment–(featuring Halloween hats such as Fuzzy Brim the Pirate, the Don Corleone  Straw, the Linda Blair special–featuring devil’s horns)?

And the one for Liz Claiborne II,  a second and  “brand new shipment” of Liz Claiborne shoes? It  includes pictures of “the ACTUAL  stickers from the boxes ” and a warning to “Hurry in to beat the madness, this time around.”

My point is that  in writing copy, you need to understand your audience and what will motivate them to get out there and buy your stuff.  Building 19 certainly does have the knack: its home page even features a link to its “Classic Ads.”   But enough of this.  Life is short and  I gotta go–those shoes won’t be there forever.

–Anita M. Harris

Anita M. Harris is president of the Harris Communications Group, a marketing communications and public relations firm in 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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