“Contagious” ideas that universities could benefit by catching from health care

While higher education and health care share some important characteristics and problems, many hospitals and clinics have achieved more thorough reforms than have colleges and universities.

This is the conclusion of an article from Trusteeship, the journal of the Association of Governing Boards of Universities and Colleges.

“I firmly believe that higher education can find valuable ideas in health care—ideas that validate what some universities are already doing, and ideas that are less familiar but may have potential for universities,” writes Ellen Chaffee.

Chaffee is an AGB senior fellow and director of AGB ’s Lumina Foundation project on Governance for Student Success. She is president emerita of Valley City State University and past president of Mayville State University, the Association for Institutional Research, and the Association for the Study of Higher Education. She also chairs the board of trustees of the MeritCare Health System in
Fargo, ND.  (Click here to go to her webpage.  )

She believes that governance of many hospitals and clinics has become more strategic, with board discussions focusing less exclusively on budget and finance and more on aligning resources to achieve well-defined goals, including improvements in quality.

Chaffee offers details on the comparison.

University leaders dealing with scarce resources often believe they need to cut academic programs based on high cost or questionable mission relevance. By contrast, cutting services in this way is not on the agenda of many financially stressed health-care systems. The ability to identify more subtle but equally effective cost savings is one of the major benefits of systematic quality improvement.

For example, some health systems assign nurses to work closely with individual patients who have chronic diseases to fine-tune their treatment and promote their compliance with medical advice. This may seem like added expense, but it often lowers costs due to early intervention and increased compliance. MeritCare Health System partnered with Blue Cross Blue Shield of North Dakota in a pilot project to explore this approach with diabetes patients. In one year, the program saved over $330,000.

Chaffee also proposes that universities could benefit from revisiting the “continuous quality improvement” approach, which sectors of health care now use to pursue evidence-based, systematic improvements.  Moreover, evidence-based medicine has become a requirement for hospital accreditation, using metrics from the government and other outside groups. Higher-education performance metrics on student learning tend to come from institutions themselves.

As a firm who has worked with universities and serves medical clients, we at Stinson Brand Innovation have seen that higher education can find potentially valuable ideas from health care.

3 steps to building your health advocacy skills

“Inspiration and ideas come from a wide variety of sources,” says Suzanne Ross of the Aerie Company.  I appreciate Suzanne’s ability to integrate new thoughts and make the strategy + communications + leadership link to elevate performance.

Recently, Suzanne’s newsletter featured an article on Health Literacy, and I asked her if I could share it with friends of Stinson Brand Innovation.

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As health care reform brings millions more people into the system over the next several years, there has never been such an urgent and dramatic need to advocate for yourself, your family and the people you love at the doctor’s office and in the hospital.

The successful champions will be those with a solid health literacy foundation – often described as an individual’s ability to read, understand and use healthcare information to make decisions and follow instructions for treatment. While it seems pretty straightforward, the complexities of chronic conditions, varied therapeutic approaches and an enormous array of drug options, let alone insurance and financial issues, require today’s patients and consumers to be prepared for even more responsibility and accountability for their health.

Health Literacy awareness draws increased attention on the importance of access to accurate, understandable health information and promoting good health. It has been well documented that limited health literacy has a direct link to worse health outcomes and higher costs, something we can ill afford today.

Among many resources available to promote greater consumer understanding of health, particularly navigating the system, is “The Empowered Patient” by CNN senior medical correspondent Elizabeth Cohen. The book is an outgrowth a career reporting on healthcare, her Empowered Patient column for CNN.com and personal and family experience as patients. Cohen takes a be-prepared-like-a-Boy Scout approach offering advice, patient stories, resources and check lists on getting the right diagnosis and plan for the best medical care, dealing with your insurance company, how to maximize prescriptions, ultimately informing patients of their vital role in creating a smarter, safer health care system.

The basic principles for becoming a personal advocate ring true for the business environment as well, whether responding to a crisis or promoting a new point of view on issues critical to your company or industry. To help pave the way to define and resolve problems, focus on advocacy skills that enable you to:

1. Be prepared – do your research to support your position, keep organized records that outline all details and have a plan for success
2. Be clear – articulate a clear, specific definition of the problem that distinguishes major issues from incidental details and always be listening to ensure you understand any response you receive
3. Be engaged – adopt a lifelong learning mindset so you are receptive and can question new information and options while remaining polite and persistent

With better understanding comes better decision-making. When it comes to a healthy and productive workforce, health literacy cannot be the sole obligation of a single stakeholder. Employers, care management programs, insurance companies and individuals alike need to be the advocates for better health and outcomes.

You can contact Suzanne Ross at www.aeriecompany.com.

3 university programs using WCG to accelerate research

How could you make supporting medical research more gratifying than writing a check?

One initiative is including volunteers in a greater part of the scientific journey toward a life-changing solution.

Meet a new breed of innovator: a citizen researcher.

On IBM's World Community Grid (WCG), there is an unprecedented effort to deploy ordinary people's idle computers to create a free, open-source lab for researchers around the globe.

Since the tech giant launched the nearly $2-million-a-year project in November 2004, more than half a million people in 218 countries have volunteered some 1.5 million laptops and desktops.  Massive computational research is broken down into discrete problems and distributed across a vast network. In raw computing power, the grid is comparable to a top-10 supercomputer. The average PC would take more than 328,000 years to complete the grid's calculations so far.

Three university research programs were featured in Fast Company in relation the project.

1. Researcher Alán Aspuru-Guzik, an assistant professor of chemistry at Harvard, says WCG "gives you the opportunity to do something nobody else has done. Something disruptive." 
2. Scientists at the University of Washington are using WCG to compile a comprehensive map of rice proteins, which could help developing countries grow more nutritious, higher-yield crops.
3. Stanley Watowich, a biochemist at the University of Texas Medical Branch in Galveston, uses WCG to model in algorithms what happens between a small molecule and a protein related to dengue fever, West Nile virus, and hepatitis C. His virtual experiments analyze millions of possibilities in months, as opposed to more time-consuming and expensive wet-lab experiments that might examine only hundreds. The first stage winnowed the molecules to several thousand that plug into binding sites on a dozen proteins, like puzzle pieces, says Watowich. The second stage narrows the field again, evaluating the binding energy of those candidates and the proteins, a highly complex computation that's practical only on a large grid. The idea is to reserve lab time for the molecules with the greatest chance of becoming effective drugs. "This has the potential to be a game-changing approach," says Watowich.  Without WCG, he couldn't have pursued this path. "We've worked with supercomputers before," he says, "but there's no way we could say, 'We'd like half your supercomputer for the next six months. Would that be a problem?' " Watowich conducted experiments on a 1,000-computer test grid of his own, but even a network that small took six months to get up and running and proved demanding to maintain. "Now," he says, "IBM does the heavy lifting."

Click here to learn more about the WCG project – and even how to join the effort.

$4 billion-a-year market for drug-coated stents gets a disappearing act from Abbott

Abbott’s experimental heart stent, a scaffold-like device the size of the spring in a ballpoint pen, was inserted into the first patient in March 2006 and inflated under pressure to prop open the passage, which had been clogged by fatty plaque. Unlike metal stents, Abbott’s is made of polylactic acid and designed to dissolve within two years after implant.

If studies confirm the device helps arteries and disappears without causing clots or other risks linked to metal models, the product may take the lead in the $4 billion-a-year market for drug-coated stents, as it would be safer for patients, said John Capek, Abbott Park, Illinois-based Abbott’s executive vice president of medical devices.

The dissolving stent is designed to confer the benefits of existing devices without leaving behind the “metal spider,” the image that appears during an X-ray of a patient whose coronary arteries are fully stented. Current stents don’t shrink and expand with the artery’s natural movement. The metal devices can trigger deadly clots, and may interfere with future tests and surgeries, Capek said.

There haven’t been any cases of clots in people getting Abbott’s bioresorbable stent, Capek said. Data on 45 patients, who were followed for nine months after treatment, were presented at the Transcatheter Cardiovascular Therapeutics meeting in Washington Sept. 21-25.

Abbott’s approach is part of an evolution, said Patrick Serruys, chief of interventional cardiology at Erasmus Medical Center in Rotterdam, who has been a pioneer of the technology.  Doctors first cleared clogged arteries with a balloon, inflating it inside a blockage to allow blood to flow. The arteries often snapped shut or reclogged, leading researchers to craft metal tubes that were left behind to prop open the vessels.

Abbott’s main competitors in the stent market are in the early stages of evaluating dissolving devices. Most of their work is in places such as the leg where the larger size of an absorbable stent isn’t a problem.

Here’s what BusinessWeek reported on the competition.

Boston Scientific

While Natick, Massachusetts-based Boston Scientific is working on bioresorbable stents for leg and heart arteries, the company’s emphasis in research is something else: metal devices with coatings that dissipate over time, said Keith Dawkins, chief medical officer for the cardiology, rhythm and vascular group.

“There is very little evidence that the long-term presence of a metal scaffold is detrimental,” J&J’s Rogers said. “There are millions and millions of patients with metal scaffolds in their arteries and are doing fine.”

Reva Medical

Founded in 1998, Reva is working on a stent that starts to resorb after 90 days. The company redesigned its prototype after patients who received it in a 2007 study needed repeat treatment. Reva, whose investors have included Boston Scientific and Medtronic, aims to start another trial by next year. Now closely held, the company plans a public sale of securities to be traded in Australia, according to a regulatory filing on Aug. 13.

Biotronik

Biotronik’s bioresorbable drug-coated metal stent, made from magnesium and dubbed Dreams, was implanted in its first patient in August, in Germany, said Sandy Hathaway, a company spokeswoman. Biotronik, founded in 1963 by the developers of a heart pacemaker, is closely held.

Medtronic

"The legs, where the arteries run close to the surface of the skin, present anatomical dynamics that may warrant this kind of biomaterials innovation," says Sean Salmon, general manager of Medtronic's coronary and peripheral division. "The clinical need to reduce pain and amputations remains largely unmet."

Johnson & Johnson

At New Brunswick, New Jersey-based Johnson & Johnson, officials say they aren’t sure how much promise there is in dissolving stents.

“For coronary stents, there is an incredible premium on stent performance,” said Campbell Rogers, chief scientific officer for J&J’s Cordis unit. “You need a Ferrari. The bioresorbable stent is a larger, bulkier stent. The likelihood of it being a significant advance for patients and clinicians in coronary use is not great.”

8 steps to document your brand’s persona in a social media style guide

These days, it seems as if brands are transforming so rapidly – often on a whim of based on a social media concept.  So, consider way to adapt the proven tool of “brand style guide” to guide the way the brand socializes in all mediums.  Print. TV. Experiences. And of course, digitally.

In a recent issue of Advertising Age, guest contributor Brian Solis suggested eight steps to reflecting on your brand and laying the foundation for a new, more socially inspired and relevant corporate culture and value system.

1. Core Values:  The audience, surrounding environment, and the circumstances in which we are summoned contribute to our disposition and character. At the beginning, we need to form a common center of gravity to support the orbiting characteristics that support our mission and purpose. Essentially, we need to specify what we stand for and weave it into all we do.
2. Brand Pillars:  Pillars are the support objects that serve as the foundation to sustain and fortify the brand. It is these pillars that establish the principal, central themes that convey our uniqueness and value, fortified through the social objects we develop and distribute.
3. Promise:  The pledge that paves the way to brand meaning and direction is the brand promise. It should answer a simple, yet powerful question: What is our mission and how does it introduce value to those who align with our purpose?
4. Aspirations:  No brand is an island, nor is it inanimate. As such, the attributes we define today must continually evolve. Our aspirations are representative of the stature and mission we seek today and over time. This is how we compete for the future.
5. Brand Characteristics:  Defining the brand characteristics will help us establish the traits we wish to associate with the brand represented through our actions, words and overall behavior.
6. Opportunities:  As we complete this exercise, the identification of the attributes that are not embodied allows us to find a path to greater relevance. It's a combination of who we are and what we offer today and also the opportunities that emerge that allow us to connect to those seeking solutions we had yet to identify.
7. Culture:  The brand team must examine the culture of the company, not only what it is today, but ultimately how it should embody our aspirations so that it is readily identifiable in social media. People need something they can align with, and it is our culture that serves as the magnet to our purpose and aspirations. We are all in this together. 
8. Personality:  It is crucial that we contemplate, review and designate the elements that we wish the brand to illustrate and represent. This final step is to identify and bring to life the personality and character of the brand through conversations, social objects and stories. If the brand was a person, how would it appear? How would it sound? How would it interact with others? How would others describe it?

I agree with Brian when he says, “The opportunity to update the brand style guide is so much more than a mere exercise. It renews our sense of purpose. It is a chance to breathe new life into everything we create, where and with whom we share it and how we engage in online societies that contribute to the brand's universal legacy and the brand graph that weaves everything together.”

• Here are a few elements proposed for a social-media style guide.
• What the brand represents in the social web
• Its characteristics
• Brand personality traits
• The voice of the brand
• Attributes and voice necessary at the representative level 
• Procedures and guidelines for representation, accountability and workflow
• Metrics for quantifying activity and the intended results

Click here to see the complete article.

6 top blog posts of the last 3 months

Every now and then, I look back to see what some of the favorite blogs have been.  And I try to review what we’re posting to learn what readers like might be interested in.

Here are a few top entries of the last three months:

10/19
Pharmaceutical Executive called biosimilars “this decade’s most disruptive technology.”  I wrote about 4 building blocks for a biosimilars strategy.

9/17
Patient access was the leading messaging focus for the majority of 2009’s best-selling prescription drugs.  And I connected you to a PharmaVoxx analysis of promotional activity for the top 20 pharmaceutical brands by revenue.

9/1
I considered the implications of “open innovation” on our mission at Stinson Brand to accelerate the adoption of new medical treatments. It’s worth going back to watch the video with MIT Professor Eric von Hippel.

8/27
I shared 2 words to improve your margin: raise price.  Read the review of The Art of Pricing by Rafi Mohammed.

8/12
I recalled flying on a late night flight from LAX to SFO.  Also on the plane was David Gergen, CNN senior political analyst and advisor to 4 US Presidents. You always imagine what you’d talk about sitting next to someone like Mr. Gergen (or if he’d just sleep on the plane, like I do).

7/10
I featured a great illustration of Noggin – a beautifully named brain protein that acts as a BMP antagonist. Exercise, says Dr. Jack Kessler, through a complex interplay with Noggin and BMP, helps to ensure that neuronal stem cells stay lively and new brain cells are born.

What would you like to see more of in our blog?  Write to me and offer your suggestions.  Everyone who does will receive a complimentary e-book.

Thanks for following us.

An accelerated path to proof-of-concept in drug development – new innovations in Phase I and IIa clinical trial designs

A recent issue of R&D Directions highlights the need for contract research organizations to truly differentiate their services for a pharma client base that, given various circumstances, has become increasingly selective.

For the clinical outsourcing provider, that means coming up with inventive and lasting solutions to help speed up drug development, while lessening the cost burden for sponsors. One area where CROs are putting that responsibility to the test is in early-stage development, particularly around smoothing the patches between first-in-human and proof-of concept studies, an admitted stumbling block for drugmakers now much more under gun to generate go/no-go decisions on their products sooner.

Early-stage CRO Cetero Research, for example, recently proclaimed success in using an innovative accelerated proof-of-concept design approach in Phase I and II trials. By combining single ascending dose, multiple ascending dose, and preliminary food effect trials into one study, Cetero says it cut study times by 50% and reduced costs by more than 10%.

The all-in-one design paid off in a recent allergy study Cetero conducted for a major pharmaceutical company. The program went from first patient, first visit, to top-line proof-of-concept results in just 16 weeks, instead of the 32-week average to run the trials separately, according to Cetero executives. In an accelerated proof-of-concept study for an obesity treatment, the time to top-line results was 12 weeks.

An editor of R&D Directions recently spoke with Cetero’s president of clinical operations, Graham Wood, Ph.D.

Accelerated POC studies sound difficult to pull off on the surface, so he explained how this approach works.  “What the accelerated proof of concept allows us to do is to take all those studies from your first-in-human study all the way to your first proof-of-concept study and put them together,” says Dr. Wood. “In some examples, it’s going to be four studies put together; it could be five studies, it could be three. It really depends on the products. Each time the design is going to be different, because in each therapeutic area and each product, we’re going to have to approach it a little bit differently.”

Dr. Wood says the key overriding protocol is really the adaptive protocol. “So, as you go, you learn from what happened in Phase I of the protocol and you apply it to what you do in parts B, C, and D. It’s really learning as you go. The key last step is establishing that proof of concept to show, is this compound going to have success when it goes out into patients?” he says.

One of the keys in speed is the use electronic case report forms for these studies. Dr. Wood says, “Our staff enters the information into the report forms and sponsors can actually review them remotely on the Web. They can, as the data is coming in from the different groups, start looking at it right away to help them make decisions.  These are adaptive designs – you are going to maybe change your dose, change different things about it before you go to the next [stage]. The sooner you can look at the data, the better informed your decision is. The electronic case report forms help us tremendously in doing that without affecting quality at all. It’s still QC’d, it still goes through the queries. It just gives that kind of instant access that the sponsors need.”

For research sponsors who clearly want to establish POC earlier in development, this approach to Phase I and II trials may be one avenue to consider.  And beyond that, trying to add biomarkers for first-in-human studies and really get as much data as possible out of those. The ideal scenario is when you have a good validated biomarker, or you can go into patients with a really sound model to assess the symptoms.

23 views on the community of physician-scientists

This week, I’ve been referencing some classic medical literature.  Now, there’s a recent title that I’m interested in picking up.

It is The Vanishing Physician-Scientist? edited by Dr. Andrew I. Schafer.

Dr. Schafer is the Distinguished Professor and Chair of the Department of Medicine at Weill Cornell Medical College and Physician-in-Chief at New York Presbyterian Hospital–Weill Cornell Medical Center. He is past president of the American Society of Hematology, the founding editor in chief of its publication, and President-Elect of the Association of Professors of Medicine.

According Dr. Schafer, physicians throughout history have played a vital role in medical discovery. These physician-scientists devote the majority of their professional effort to seeking new knowledge about health and disease through research and represent the entire continuum of biomedical investigation. They bring a unique perspective to their work and often base their scientific questions on the experience of caring for patients. Physician-scientists also effectively communicate between researchers in the "pure sciences" and practicing health care providers. Yet there has been growing concern in recent decades that, due to complex changes, physician-scientists are vanishing from the scene.

In this book, leading physician-scientists and academic physicians examine the problem from a variety of perspectives: historical, demographic, scientific, cultural, sociological, and economic. They make valuable recommendations that – if heeded – should preserve and revitalize the community of physician-scientists as the profession continues to evolve and boundaries between doctors and researchers shift.

Contributors to the book are:

• James M. Anderson, MD, PhD, University of North Carolina at Chapel Hill School of Medicine
• Ann J. Brown, MD, MHS, Duke University School of Medicine 
• Barry S. Coller, MD, Rockefeller University
• Fabio Cominelli, MD, PhD, Case Western Reserve University
• Paul E. DiCorleto, PhD, Cleveland Clinic and Case Western Reserve University School of Medicine
• Mark Donowitz, MD, The Johns Hopkins University School of Medicine 
• Stephen G. Emerson, MD, PhD, Haverford College
• Gregory Germino, MD, The Johns Hopkins University School of Medicine
• Stephen J. Heinig, Association of American Medical Colleges
• Margaret K. Hostetter, MD, Yale University School of Medicine
• Reshma Jagsi, MD, DPhil, University of Michigan Medical School
• Kenneth Kaushansky, MD, MACP, University of California, San Diego School of Medicine David Korn, MD, Harvard University and Harvard Medical School
• Timothy J. Ley, MD, Washington University School of Medicine
• Philip M. Meneely, PhD, Haverford College
• David G. Nathan, MD, Harvard Medical School
• Philip A. Pizzo, MD, Stanford University School of Medicine
• Jennifer Punt, VMD, PhD, Haverford College
• Andrew I. Schafer, MD, Weill Cornell Medical College and New York-Presbyterian Hospital
• Alan L. Schwartz, MD, PhD, Washington University School of Medicine
• Roy L. Silverstein, MD, Cleveland Clinic 
• Nancy J. Tarbell, MD, Massachusetts General Hospital and Harvard Medical School

Reviews of the book have been positive. Glenn Bubley, MD of Beth Israel Deaconess Hospital and Harvard Medical School writes, "In The Vanishing Physician-Scientist? Dr. Schafer makes the case that truly effective translational research can go from bench to bedside and back again in dynamic fashion; he describes a view of the future in which physician-scientists will be members of research teams. This book does an excellent job of placing physician-scientists in historical context and highlighting the fact that the problem of the endangered physician-scientist is not a new one. The Vanishing Physician-Scientist? outlines a long-term problem that is likely to get worse, and, most important, provides a number of possible solutions. Given the current constraints—on NIH-funded research and an understandable retrenchment for funding by industry and foundations—its descriptions of strategies that have been successful in the past and are likely to be successful in the future are more valuable than ever."

19th century innovation classic: Medical Essays by Oliver Wendell Holmes, Sr.

In yesterday’s blog, I shared 5 book recommendations from Dr. Verghese at Stanford University.

If you are interested in classic medical literature, I want to offer you a complimentary e-book copy of the seminal text, Medical Essays, by Oliver Wendell Holmes, Sr.

This is a collection of essays by a man who defines the persona of a “poet-doctor.”

Whether Oliver Wendell Holmes, Sr. was more poet than doctor remains debatable. He wrote poetry, prose, criticism, history, and memoir from 1830 until his death. His medical “practice” was largely confined to the training of doctors, although several of his medical research projects were path-breaking contributions to modern epidemiology.

Holmes became distinguished for his articles written on such medical issues as treatment for malaria, though his passion for writing verse was expressed in his Poems of 1836. Later, Dartmouth College appointed him professor of anatomy, but he moved to Harvard to teach and rose to the position of Dean at the Harvard Medical School.

A man of contrasts and contradictions, Holmes lived his life between the poetic and the realistic. He is a bundle of contradictions: an old-fashioned modern; a primitivist scientist; a Protestant sympathetic to Roman Catholicism; a gossipy man. In short, he was the poet-doctor of 19th-century America. He is largely, and somewhat inaccurately, remembered today as a consummate aristocrat who opposed women’s rights and believed blacks to be physiologically inferior; he also supported the admission of women to Harvard medical school and believed African-Americans to be victims of history.

Click here to download the complimentary e-book. 

5 best books on doctors' lives, as prescribed by Dr. Abraham Verghese

Dr. Verghese is a professor of medicine at Stanford University. His own books include the novel Cutting for Stone and the memoir My Own Country.  Earlier this summer, he listed his choices for the five best books about doctors' lives in The Wall Street Journal, along with his first-person commentary.

1. The Life of Sir William Osler
By Harvey Cushing
Oxford, 1925

This two-volume work tops my list not just because William Osler is endlessly fascinating but because his biographer was the pioneering neuro surgeon Harvey Cushing, himself the subject of more than one biography. Cushing won the 1926 Pulitzer Prize for this meaty but immensely readable work. It captures not only the character of the charismatic physician and teacher who shaped American academic medicine but also a late 19th-century era when Europe and America were waking to germ theory and antisepsis. Osler went from naughty Canadian schoolboy to Regius Professor at Oxford, his last position. He was brilliant, inspiring and kind but also a practical joker: Under the pseudonym of Edgerton York Davis of Caughnawaga, Quebec, he once submitted a case report of "penis captivus," claiming that an amorous couple was unable to disengage. It astonished Osler no end that a medical editor published the piece.

2. Mortal Lessons
By Richard Selzer
Simon & Schuster, 1976

I read Mortal Lessons as a medical student and was astonished by the prose, the introspection, the lyricism of this practicing surgeon. Richard Selzer is the model "physician-writer," if there is such a thing, in that he does so much more than cater to readers' sometimes prurient interest in things medical; his language is baroque and musical, his epiphanies profound and personal. Here he is writing about the stomach: "Yet, interrupt for a time the care and feeding of this sack of appetite, do it insult with no matter how imagined a slight, then turns the worm to serpent that poisons the intellect for thought, the soul for poetry, the heart for love."

3. The Puzzle People
By Thomas Starzl
University of Pittsburgh, 1992

From humble beginnings in Le Mars, Iowa, where he was born in 1926, Thomas Starzl became one of the most recognizable names in American medicine, truly the father of modern transplantation, the liver transplant in particular. As he recalls in this engrossing memoir—which is essentially a history of transplantation itself—his first few liver transplants were failures, and he was vilified by the media as engaging in human experimentation. Had Starzl given up at that point, hundreds of patients now living with a new liver wouldn't be. He perfected the technically complex operation to remove the damaged liver and put in the new, but he also advanced our understanding of rejection and how to overcome it.

4. Adventures in Two Worlds
By A.J. Cronin
McGraw-Hill, 1952

Doctors often speak of a book that "called" them to medicine. The novels of A.J. Cronin, such as The Keys to the Kingdom and The Citadel, had that effect on many budding doctors of earlier generations. Even better is Cronin's Adventures in Two Worlds, a memoir by this gifted writer and doctor. As a young physician in the 1920s, he worked in a gritty Welsh mining town and became a medical inspector of mines. The hard lives of the coal miners sharpened his sense of injustice. But we also learn that he was concerned with matters of faith and temptation. Retiring from medicine in 1926 due to ill health, he began writing novels—work with themes that were also the themes of his life.

5. Henry Kaplan and the Story of Hodgkin's Disease
By Charlotte Jacobs
Stanford, 2010

Charlotte Jacobs, an oncologist and biographer, tells the story of the man who was instrumental in making Hodgkin's lymphoma, a cancer of the lymph glands, a curable condition. In Dr. Jacobs's capable hands we experience the thrill of clinical research and the hard slogging of clinical trials, which are the only way to tell if treatment is beneficial. We also meet the maverick doctors—Kaplan's colleagues and rivals—who helped bring about the cure's discovery. Most people know about Jonas Salk and the polio cure, but Kaplan and the Hodgkin's-disease tale is even more compelling—and wonderfully told in these pages. A budding Kaplan out there, one hopes, might read this book (or one of the others on this list) and be "called" to medicine. It's a great journey, and I'd do it all over again in a heartbeat.

939 Wal-Mart based McDonald's locations to get a makeover

In an effort to boost sales, McDonald's is looking to give their Wal-Mart based locations a facelift.

As part of McDonald's global reimaging program, all 939 Wal-Mart based locations will see expanded menus, including fruit smoothies and frappe coffee drinks, updated technology, and other improvements.  While these locations, which are primarily owned by franchisees, don't generate a large amount of profit for the corporation, they are hopeful that they will boost profits for the franchisees.  McDonald's is hoping that the profit boost will encourage most of these franchisees to renovate their other freestanding locations.

Click here to read more.

7 WordPress brands sites to admire

In preparing an assessment of web design and experience for one of our brand engagements, we took a look at features on some of these sites. All have been developed using WordPress, but there's nothing cookie-cutter or template-like about them.

What do you think?

fernwoodcoffee.com
simple can also be graphically pleasing with the right photography

healogix.com
pretty copy heavy, but looks modern. Needs more photos.

ehrtv.com
don’t get overwhelmed by all the video on this one; just consider the “sections”

weborchard.co.uk
simply, easy to read, no bells-and-whistle to slow people down

ericdies.com
it seems like everything is on one page – including the contact box

pixeltree.us
I like that the top tells the big picture; and the bottom offers you details

www.walktowashington.org
uses lots of features and tools. But you don’t need them all to start; just add later.

Seminar with researchers at UIC: Akt/PI 3-Kinase Signaling in Cell Death and Cell Survival

Last week, a colleague and I had the pleasure of attending a seminar for researchers at The University of Illinois at Chicago. The talk was given by Chandra Mohan, PhD of EMD Millipore Biosciences on the topic “Akt/PI 3-Kinase Signaling in Cell Death and Cell Survival.”

As Dr. Mohan said, “Akt (protein kinase B) has emerged as a critical enzyme in signal transduction pathways involved in cell proliferation, apoptosis, angiogenesis, and diabetes.”  The principal role of Akt is to facilitate growth factor-mediated cell survival and to block apoptotic cell death, he said.

“A number of oncogenes and tumor suppressor genes that function upstream of Akt influence cancer progression by regulating Akt. Akta is expressed to various degrees in breast cancer cell lines and is important in estrogen-stimulated growth. Treatment of multiple myeloma cell lines with the Akt inhibitor, 1L-6-Hydroxymethyl-chiro-inositol 2-(R)-2-O-methyl-3-O-octadecylcarbonate, results in reduced survival of both drug resistant and drug sensitive cells,” he presented.

“Akt plays a critical role in tumorigenesis, becoming activated when tumor suppressors such as p27 and PTEN lose their functions. Phosphorylation of p27 at Thr157 by Akt impairs its nuclear import. Cytoplasmic mislocalization of p27 has been strongly linked to loss of differentiation and poor outcome in breast cancer,” he said.  “Akt is also reported to physically associate with endogenous p21, a cell cycle inhibitor, and phosphorylate it at Thr145, causing its localization to the cytoplasm and subsequent degradation.”

Akt and p53 play opposing roles in signaling pathways that determine cell survival – and the interaction between these two molecules is becoming an important area of study.

In addition to the presentation, Dr. Mohan offered copies of his book, Signal Transduction: A Short Overview of its Role in Health and Disease.

Who are the researchers and why are they studying Signal Transduction?

1.    Diabetes and other metabolic disorders

• To elucidate the mechanism of binding and action of insulin and identify the causative factors in the development of diabetes. Also, identify the intracellular sites of insulin action.
• Product categories: hormones, protein kinases, protein phosphatases activators and inhibitors, cyclic AMP and GMP related products, calcium channel modulators

2.    Cancer

• To identify how and why certain cells respond abnormally to environmental signals and then design and develop new therapeutic measures to prevent and treat cancer in its earliest stage.
• Product categories: protein kinases, MAP kinase inhibitors, phosphatase inhibitors and activators, phorbol esters, nitric oxide related products, GTP-binding proteins, farnesyltransferase inhibitors, tyrosine kinase inhibitors, calmodulin related products

3.    Apoptosis, programmed cell death

• A failure of cancer cells to die. The interest in this field has been growing rapidly also in relation to Alzheimer’s disease where too many neurons die prematurely.
• Product categories: caspase inhibitors and substrates, proteasome inhibitors, inhibitors and inducers of apoptosis, reagents for cell cycling

4.   Hypertension and other cardiovascular disorders

• Design new treatments to reduce the incidence of hypertension, angina, and the risk of stroke and related complication
• Product categories: calcium channel modulators, nitric oxide related products, calcium probes, ionophores

5.   Osteoporosis and mineral metabolism

• To elucidate the mechanisms involved in bone growth and in increased mineral loss. Design and develop appropriate therapies for prevention of osteoporosis
• Product categories: growth factors, cytokines, calcium probes, second messengers, protein kinases

6.   Infection, trauma, and sepsis

• Design and develop new treatments to prevent and treat infection and sepsis. Help in the wound healing process.
• Product categories: cytokines, growth factors, protein kinases, calcium modulators, oxidative stress tools

7.   Neuroscience

• To identify the mechanisms involved in the development of Alzheimer's disease, neurochemical complications in muscular dystrophy, mental disorders, neuritis, and abnormalities in neuronal development, and design appropriate therapies.
• Product categories: regulators of calcium metabolism, neurotoxins, nitric oxide related products, protein kinases and related products, calmodulin and related products

Click here for more information about this research – along with a request form for the book. 

4 building blocks for a biosimilars strategy

Pharmaceutical Executive called biosimilars “this decade’s most disruptive technology.”

Biosimilars are the pharmaceutical industry’s segment that will finally seize momentum over the next few years, paced by the growing dominance of biologic drugs as top industry revenue producers and the scheduled launch of a few high profile biosimilars in 2014.

Here’s the basic forecast from Decision Resources data crunchers: by 2016, seven of the 10 top selling brands will be biologics, opening up new pathways in the biosimilars space, and resulting in biosimilars accounting for roughly a quarter of the total biologics market in 2019, or $14 billion annually. Another factor likely to accelerate prospects for biosimilars is that nearly all the revenue growth in biologics through 2019 will be driven by therapies already on the market.

Major healthcare companies are making biologic and biosimilar development a priority. Merck & Co., which recently merged with Schering-Plough, has made biosimilars the focus of MerckBioVentures, a division created in December 2008. Following the company's recent portfolio prioritization, Merck has five novel biologics and two biosimilar candidates in clinical development.

Moving forward, experts indicate that biotech firms will continue to face a challenging funding environment. Companies best poised for success are those that will increase financial and R&D efficiency and find creative models for funding and partnering.

To better position themselves against generic manufacturers, pharmaceutical and biotechnology companies are investing in their own biosimilar research. Expected to reach a market value of $10 billion by 2017, there is great interest in the development and manufacturing of these products. As a result, Novartis and Merck have established biosimilar development divisions. However, legislation regarding regulatory pathways and patent infringement could impact investment in this area.

The editors of Pharmaceutical Executive believe that what still makes it hard to assess prospects for biosimilars is the challenge of defining the terms of engagement. “The concept itself is open to interpretation, which leads to definitional problems,” they write. “In addition to biosimilars, which are essentially generic versions of branded off-patent biologics, there are biobetters, which are conceived to differ from the originator in formulation or delivery mode with the overall aim of obtaining an improved pharmacokinetic profile. This leads in turn to a lack of clarity in figuring where the real opportunities are and defining a strategy to exploit them.”

Here are four building blocks for a biosimilars strategy presented at a recent conference:

1. Biosimilars are a classic “disruptive technology” that will change the competitive landscape in unforeseen ways.
2. The biggest companies may be having second thoughts about entering the biosimilars space.
3. Pricing and market access remain unsettling questions for strategists.
4. Key policy issues must be resolved before the sector can truly obtain its market potential.

Click here to read the details of these four building blocks. 

And to help marketers study the landscape, a PharmaLive Special Report has been published entitled, “Biotech/Biopharma/Biosimilar Review and Outlook 2010.”  Click here to learn more.

Critical needs for patients – and business – met with orphan drug research

Industry experts estimate that orphan drugs bring in about $40 billion in annual sales. With drug companies facing devastating patent expirations and new drug opportunities drying up in existing markets, orphan drug development has become an enticing solution.

FDA and Congress have further lured pharma companies to this niche sector with various incentives. The Orphan Drug Act of 1983 provides seven-year market exclusivity, tax breaks, and regulatory help for companies developing new drugs for orphan diseases. Since its introduction, more than 2,100 compounds have been submitted for orphan status in the United States and more than 350 have received designation. FDA is urging large drug makers, such as Roche and Johnson & Johnson, to determine if existing medicines may be able to help neglected disorders. Drugs with orphan drug designation are likely to receive fast-track status.

Despite the small patient pools they are being developed for, the most successful orphan drugs have more than recouped R&D investment for their developers. Merck's brain cancer drug Temodar was originally approved in 1998 for treating the orphan indication anaplastic astrocytoma, has since been approved for other brain cancer forms, and generated sales of more than $1 billion in 2009. Genzyme Corp., the leader in the orphan drug sector, realized $793 million in sales in 2009 with its Gaucher disease drug Cerezyme. Genzyme's success with Cerezyme and other rare disease treatments is likely the driver behind sanofi-aventis' attempted takeover of the company. More large companies are entering the orphan drug sector. Earlier this year, both GlaxoSmithKline and Pfizer Inc. opened research units dedicated to developing new biologics to treat rare diseases.

The most transformational devices to be developed in recent years are drug-eluting stents. These devices improved procedural quantities in two major cardiology markets. Another device success, Vitrasert, is an intraocular sustained delivery system for AIDS-related cytomegalovirus retinitis. This device has been very effective for this indication and, more importantly, has lead to commonplace use of intraocular drug delivery for other indications, including Lucentis for age-related macular degeneration.
     
A newly released PharmaLive report listed many developments in the orphan drug market, including partnerships, acquisitions, and investments that could be of interest to you.

Biopreneurs: The Molecular Millionaires

In today's video blog, I discuss the book BIOPRENEURS by Dr. Ryan Baidya.  You can learn more about it at http://www.biopreneur.org/download-e.htm

Survey says...clinicians still love pharma perks

Medical centers may ban them...
Med schools may rule against them...
Congress may investigate them...

...but pharma perks are still popular among clinicians.

This according to a new study published over the summer in JAMA. A survey of faculty and trainees in the The Mount Sinai School of Medicine consortium in the New York area found that attitudes toward industry and pharma items were generally positive.

In fact, 72.2 percent of participants found sponsored lunches appropriate. Notably, 74.6 percent found large gifts unacceptable.

As in previous surveys, most believed that OTHER physicians were more likely to be influenced by gifts and food from industry than they were.

4 traits of the "empowered" patient

HealthCentral partnered with Professor James Burroughs of the University of Virginia, who specializes in marketing and consumer psychology and behavior. Together, they designed a survey to identify traits and habits of a person who feels empowered to take a lead role in managing his or her health care.

Making treatment choices and selecting health care providers are high stakes decisions for people living with chronic conditions.  So, they were asked about:

• Relationships with doctors
• Treatment history
• Social habits 
• Need for cognition
• Self-confidence
• Media preferences

The survey found that people who take a direct role in managing their treatment plan have 4 traits that other more traditional patients lack:

1. Need for cognition drives the empowered patient
2. Education, income, source of health insurance had no effect
3. Empowered patients are leading the way online
4. This group is the most demanding but the most loyal

Click here to read more detailed findings and commentary.

HFEs for innovative drug delivery – collaboration with creative coprocessed excipient partner can mean faster time to market

Here at Stinson Brand Innovation, we’re always on the lookout for good example of partnerships that accelerate the development and commercialization process of new therapies.

One recent case was shared by Herman Mitchell in “Life Science Leader” (August 2010).  Mr. Mitchell is global director of marketing for Mallinckrodt Baker, a business unit of Covidien, a global provider of healthcare products.

We value the insights from Mr. Mitchell because he has more than 33 years of experience in the pharmaceutical industry, with commercial responsibility for performance chemistries supporting both pharmaceutical research and manufacturing worldwide.

Read what he has to say about speeding up time-to-market through collaboration.


“Whether generic or branded, in the high-stakes race to bring a therapeutic drug to market, manufacturers are engaged in two simultaneous challenges. The first is against the clock — a race to market approval; the second — to contain development and manufacturing costs.

“A manufacturer will invest years and millions of dollars to optimize a formulation and process. In the case of oral solid dosage forms, the manufacturer needs to perfect the finalized drug for safety, efficacy, and desired tablet properties. With respect to tabletability and cost per unit dose, the final formulation and manufacturing process are equally important to the development of the final drug. The drug manufacturer must formulate using a suitable, cost-effective process. This all adds up to speed to market. The speed and efficiency with which a drug maker formulates, develops a scalable manufacturing process, and gains regulatory approval is key to succeeding in today’s economic climate.

“For drug manufacturers who are tasking their organizations to improve time to market while reducing development and manufacturing costs, there are now innovative and cost-effective options available to streamline formulation development and manufacturing processes. By collaborating with experts in the supply chain, such as excipient manufacturers who have developed a wide range of solutions to meet formulation challenges, drug makers have greater access to novel coprocessed excipients and innovative drug delivery systems. These coprocessed, or high-functionality excipients (HFEs), are engineered particles which interact at a subparticle level to provide enhanced functionality and tableting performance that may, for example, enable direct compression of difficult-to-formulate active pharmaceutical ingredients (APIs). This allows the drug maker to focus resources on its core competencies rather than on inventing new processes.

“These collaborations between excipient suppliers, contract service suppliers, and the pharmaceutical firm’s research and development specialists have proven their effectiveness in developing solutions that maximize speed to market while enabling the regulatory compliance sometimes associated with the use of HFEs and new technology in general.

“Many marketed therapeutics have formulations that incorporate HFEs, in which a single excipient fulfills two or more functions (e.g. as a binder, filler, and disintegrant). Using HFEs can improve content uniformity and in many cases will allow manufacturers to eliminate time-consuming processes like wet granulation. Manufacturers can take advantage of well-established techniques and procedures for creating simplified formulations with challenging APIs. Additionally, HFEs can significantly reduce development time and costs by enabling products to get into clinical trials sooner and out to market faster.

“Leveraging their own R&D resources, capabilities, and spending, some leading-edge pharmaceutical manufacturers are cultivating innovative approaches to product development and manufacturing. Working in partnership with excipient suppliers and formulation specialists, drug manufacturers have created new platforms that utilize HFEs in their formulations. Best of all, HFEs with a well-defined design space help drug manufacturers implement quality by design (QbD) initiatives to develop robust, scalable formulations and manufacturing processes, again reducing time to market.

“HFEs, in addition to increasing speed to market, provide benefits to the drug manufacturer for years after the product launch. HFEs can produce significant gains in productivity, due to simplified processes, and higher throughput with fewer tablets rejected. In addition, reductions in cycle times and inventory turnover increases can also be achieved. These are all advantages that can improve a manufacturer’s bottom line from the day the product is launched until far into the future.”

Personalized Medicine: 3 key developments in this innovation trend

The $232 billion personalized medicine market in the U.S. is projected to grow 11% annually over the next several years. Advancements in science and diagnostic technology are required to reach this standard of care. In addition, health agencies need to establish clear regulatory frameworks for this complicated field, insurers must allow for adequate reimbursement, and medical providers will need to adopt new methods and procedures.

Once the groundwork is laid, the benefits will be many, including reduced costs of healthcare by eliminating ineffective treatments, faster approvals due to predictable safety and efficacy, lower rates of adverse reactions, earlier detection and prevention.

Personalized medicine will help developers and marketers identify patient populations most likely to respond to their medications.

A newly released PharmaLive report listed many developments in the personalized medicine trend, including these:

1. Strategic alliances, such as the sanofi-aventis alliance with Scripps Genomic Medicine, are being formed with academic and private research institutions as well as small biotech companies as major pharma companies increasingly look for alternative ways to strengthen their pipelines.
2. Roche's Herceptin, Novartis' Gleevec, Agendia's MammaPrint, and Genomic Health Inc.'s Oncotype Dx are all examples of early success stories in personalized medicine.
3. According to FDA, MammaPrint was the first approved product that profiles genetic activity. The genetic test determines the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer.

At Stinson Brand Innovation, we’re identifying companies involved in personalized medicine research.  If you have a drug or technology in development, we can work with you to address the challenges and capitalize on the opportunities.