Life Sciences Chronicle
Ogan Gurel MD
Thinking about Life Sciences

Waves now available on Kindle!

Inspired by Goethe's Faust and described as a cross between Michael Crichton and Umberto Eco, Waves weaves together action, drama, romance, and science in a global setting where the melding of good and evil results in shocking consequences. A technothriller, a psychological drama, a scientific dialogue: there's something in Waves for everyone and, yes, there's something of everyone in Waves.
 

Waves - The Trilogy

“An extraordinary book.”

“… powerfully imaginative …”

Waves - The Novel (Melody)

“Beautifully written!”

“Absolutely fascinating.”

Waves - The Novella (Harmony)

“[Waves] is provocative, engaging, and very believable … full of color and texture.”

“... a work of profound expression of human condition—love, suffering, joy, intrigue, frailty, jealousy, anger, evil, truth, hope, good, mystery—told with incredible knowledge, intellect, rigor, pace and humanity. Its scope and depth will allow every single reader to readily identify and explore herself/himself in this book.”

Waves - The Dialogue (Rhythm)

“... an intellectual tour de force—of literature, music, medicine, life sciences, languages—all woven together in triple architectural helix of Melody, Harmony and Rhythm, defining and elaborating secrets of life and the mystery of [the] human condition. It is not just a great fiction, but also a great science-in-fiction.”

“Waves is a completely hip page-turner, yet it is also a literary novel in the grand Western tradition. People from diverse backgrounds and educational levels should be able to connect with [Waves] from wherever they are—whether they're seeking a great escape, an exciting read, or a profound encounter with a novel of ideas."

“Rarely does a novel with such ambitious scope succeed. This one does.”

Excerpt from the Prologue


Faust is within all of us. Infinity beckons: whether it be infinite knowledge, everlasting love, limitless wealth, ageless beauty, eternal fame, infinite jest, and whatever else—known or unknown—that motivates.

Life however is finite.

Imagination and reality meet in mystery: between the infinite and the finite, this is our present, boundless struggle. In quest of the infinite, within us all is Tomas.


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Posted by Ogan Gurel MD MPhil at 8 February 2009, 12:02 AM | View Comments (1) | Add Comment

New Facebook Group for Waves!


There's a new Facebook group for Waves!  Join it by clicking here.  Or cut and paste the following link:

http://www.facebook.com/group.php?gid=45715403303

Lots of interesting photos, videos, and discussion topics.  Hope you can join!
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Posted by Ogan Gurel MD MPhil at 19 January 2009, 8:21 PM | Add Comment

Waves - a 21st century version of Faust with explorations in biopharma & biomedical technology

You can find Waves — a 21st century version of Faust in the spirit of Goethe, Mann, Bulgakov and Melville — on its own website or at the following links:

  • Table of Contents (This downloadable file is hyperlinked to individual chapters, movements & triplets. You can also directly click on the links within the Scribd window. This will make it easy to navigate around the novel)




  • Music referenced in the book (Music plays an important role in the book. This downloadable file is hyperlinked to nearly all the music in the book.


  • Videos (see Prologue and 'Trailer' below)

Comments (positive or negative) are very much appreciated. I am keen to have this book published so any suggestions and contacts along these lines are also welcome.

Prologue & Trailer on Video




Feel free to post here or email me Ogan Gurel at ogan@waves-the-book.com.


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Posted by Ogan Gurel MD MPhil at 7 January 2009, 12:00 AM | Add Comment

Global and Historical Perspectives on Invention & Innovation

On Marconi, Fermi and Columbus

Ogan Gurel, MD - 24 May 2008

gurel@post.harvard.edu

 

The distinction between invention and innovation[1] was discussed previously in a series of three articles published earlier:

Part I: Concepts of Innovation, Invention Should Now Be Regarded Differently

Part II: Invention Needs to Be Left Free; Innovation Must Be Managed

Part III: Innovation vs. Invention: Accelerating Development

Having spent the past few days in Rome, I’ve had the chance to reflect upon the rise and fall of empires, the invention/innovation concepts described in the above articles and the relation between these and the fate of nations. 

Reading today’s New York Times sober headlines (5/24/08) about teens unable to find a job (“Toughest Summer Job This Year Is Finding One”) and Wall Street bankers pondering their irrelevancy (“Wall Street Exodus: Fear, Panic and Anger”)[2], makes it seem a Prosecco sipping luxury to consider questions of invention vs. innovation.

It should be clear, however, that the central story of the rise and fall of nations – which certainly does impact us personally – more often than not invokes the ebb and flow of inventive people and innovative societies.  While prominent commentators (such as Thomas Friedman in “Imbalances of Power”)[3] depressingly note the triple storm of fiscal deficit, trade deficit and geopolitical deficit traumatizing America from one shining sea of vanishing strip mall jobs to the opposite shining sea of imploding investment houses, these deficits are but signs and symptoms of a deeper disconnect underlying civilizational decline.  Invention and innovation is the key to both understanding and solving such challenges.

I am writing at the tail end of the Pharma Finance 2008 conference organized here in Rome by the regional authorities – mainly Sviluppo (Development) Lazio, Filas S.p.A and the Italian Institute for Foreign Trade.  As with any business gathering, the 300 plus participants did the usual: sharing ideas and exchanging business cards.  However, this was no ordinary conference along the lines of the usual rituals of industry extravaganzas, investment bank deal-making retreats or government-sponsored foreign direct investment plays.  Pharma Finance 2008 was a very different affair.  This special conference – I will explain its uniqueness further below – combined with a very personal opportunity to contemplate the ruins of an ancient Roman aqueduct just outside my hotel window here in the historic Esquilino district taught me some important and timeless lessons.

Invention vs. Innovation

Invention and innovation are concepts that are often incorrectly conglomerated and confused.  Understanding the distinction will explain the unique importance of the Pharma Finance 2008 conference.

Invention refers to the discovery or creation of a new idea.  It is usually the work of an individual.  Invention is, by definition, outside of reality.  Inventions deviate far enough from reality so as to mark the inventor as being, let us say, a little crazy.  Insane genius is not an oxymoron.

Innovation refers to the combination of inventions and/or institution of processes around a core invention.  Innovation is typically the work of groups – not individuals – since a variety of capabilities and resources are required.  Innovation, by definition, takes invention into reality.  Innovation makes what would have been considered slightly crazy into what is routine.[4]

An innovative product; no invention

A salient example is the IBM Personal Computer (PC) of 1981 - named, as some may remember, Time Magazine’s “Man of the Year” in 1982.  The PC was devoid of invention yet it was most certainly one of the most revolutionary innovations of the 20th century.

The IBM engineers sent off to secluded Boca Raton to work their magic were specifically instructed not to invent anything new but simply to take off-the-shelf components and bring to market whatever it was to be within 18 months.[5]

American Ascendency

The PC exerts its influence not only prosaically on everyday lives but also shapes the geopolitics of our era from Iraq and beyond.  For example: we speak wistfully now of the extraordinary economic growth of the US in the late 1990’s.  The influential work of the Harvard economist Dale Jorgenson attributed much of that success to the “…acceleration of productivity growth, driven by information technology, [as] the most remarkable feature of the US growth resurgence.”  Innovation was the major driver of this - what the Dutch economist Luc Soete called the - “historically unique … pulling away of the leading technology country.”

This renewed US economic power – enabled by a remarkable spurt of desktop computing based innovation – has had profound implications since then.  With this power in hand, President Bush was able to write in the preamble to the well-known US National Security Strategy document of 2002:

“Today, the United States enjoys a position of unparalleled military strength and great economic and political influence.”

Powerful words indeed … made possible – quite literally – by a Word processor on a PC.  It is sobering to think how unaware the Bush strategy architects must have been of what is now a completely different economic situation marked by a triad of fiscal, trade and geopolitical deficits.

The Rise & Fall of the Roman Empire

The fall of the Roman Empire is perennially fascinating.  Edward Gibbon’s History of The Decline and Fall of the Roman Empire and his thesis that Rome fell because of a loss of “civic virtue” was more or less required reading for generations of 19th century English Eton and Harrow school boys prepping for their day in the sun as leaders of a British empire upon which the sun never sets … but eventually did.

There has been no shortage of theories to explain the fall of Rome. The still graceful half-ruin of my aqueduct neighbor beckons me to imagine less of the many insults dealt it - “death by a thousand cuts” – and more about the creativity that built it.[6]   This alternative explanatory perspective – looking at the rise rather than the fall – is substantiated by a simple appeal to the laws of thermodynamics – specifically the 2nd Law which mandates that in the absence of specific organizing forces, systems inexorably devolve into complete disorder.  Maximum entropy is the technical term for this state.

Take a sugar cube, for example.  There are only a few conditions of temperature and concentration that lead to the formation of homemade rock candy.  There are zillions of reasons, however – a veritable Avogadro’s number to be precise – for a sugar crystal to dissolve and disappear.  Since disorder is more probable than order, the factors driving an empire’s rise should more simply help to explain its demise.

Duodecim Tabulae and the jus Latii

Two unique “inventions” distinguished Rome from the multitude of other neighboring Latin villages during the 5th and 4th centuries BCE.  The first invention – established around 450 BCE - was the written codification of Roman law – specifically the Twelve Tables (Duodecim Tabulae); a far reaching “bill of rights” for that time.

This potent ability to depersonalize legal relationships, that is to say, to separate them from the particulars of ethnic or family ties enabled the second, even more significant, invention: the unique Roman institution of the Latin Right (jus Latii).  The Latin Right was a form of civic status in between that of full citizenship and non-citizenship (e.g. alien standing) which carried no legal rights.  The Latin Right allowed Rome, in contrast its neighboring states, to productively assimilate foreigners.  Likewise visitors of all origins flowed into a sleepy village which was rapidly transformed into a cosmopolitan city.  Rome became a powerful engine of innovation, tapping into individual inventions from all quarters of the known world, perfecting these and rapidly implementing them throughout the growing Republic. 

Ancient Rome: An Engine for Innovation

The ancient Romans were not known for being a particularly inventive people.  We may never know how much of the astounding variety of Roman innovation was natively developed or assimilated via foreign ferment.  It is safe to say though that for what was once a minor city-state to rapidly acquire the trappings and capabilities of empire could only have been possible through substantial cross-fertilization with other cultures combined with systematic technological improvement.  We know, for example, that the archetypical arch – which made possible the aqueduct still standing before me which, in turn, enabled the aqueous sustenance of large urban populations - was perfected from Etruscan influences.  Likewise, glassblowing came from Syria, a variety of inventions were most definitely imported from the ancient Greeks and even Roman numerals were adapted from Etruscan predecessors.  The Roman engineering corps (praefectus fabrum) was itself an innovation instituted to leverage advanced materials, water power and other inventions to build and sustain Roman military supremacy.

The stunning sophistication of Roman technology was highlighted by Prof. Hamlin Jennings of Northwestern University in a recent Nanotech Today interview “The Nanostructure of Portland Cement - New Approaches to Studying an Old Material.”  Jennings discussed the remarkable properties of the Pantheon – a nearly 2,000 year old domed structure still standing in Rome. In building the Pantheon and its dome, Pozzolana cement – a revolutionary invention in its own right - was applied in a unique layered fashion by which the upper sections of the dome were constructed from successively less dense concrete.  This innovation significantly reduced the Pantheon dome’s overall architectural stresses making possible its soaring grace.

Republican Rome and the early phase of the Empire was built on innovation.  However, notwithstanding the proximal environmental forces that Jared Diamond and others ascribe to civilizational decline, it was the loss of creative forces and the shift to acquisitional conquest as a source of growth rather than material invention that led ultimately to the decline of Empire.  And so, with the dissipation of innovative energies, empires - as do all things – ultimately (and sometimes rapidly) succumb to their thermodynamic endpoint - entropic death.

All roads ultimately lead to disorder; entropy, in the end, rules.

Pharma Finance 2008 and Italian “Malessere”

Reflecting upon Pharma Finance 2008, I have come to realize that this conference was designed to address a very peculiar and important problem for the Italian life sciences community: namely the frustration in transforming the extraordinary inventiveness of the Italian scientific enterprise into productive and effective innovation.

Indeed, it could be said that this problem pertains to Italy more generally – not just the biotechnology sector.  Invention without innovation may be central to the deep “malessere,” or “malaise” felt by many Italians today.  This feeling was well described by Ian Fisher’s article last December in the New York Times “In a Funk, Italy Sings an Aria of Disappointment.”  His observations received mostly affirmative recognition here in Italy.  As Fisher writes:

“… these days, for all the outside adoration and all of its innate strengths, Italy seems not to love itself. The word here is “malessere,” or “malaise”; it implies a collective funk — economic, political and social — summed up in a recent poll: Italians, despite their claim to have mastered the art of living, say they are the least happy people in Western Europe.”

The article goes on further about the usual topics of economic hardship and political brittleness.  But these – like the traumas now afflicting America – are simply symptoms of a deeper problem.

Disappointment typically arises from a mismatch between reality and expectations.  Italians know they should be doing better but when their gains do not match their talents, these can be perceived as losses.  For Americans, “malessere” may soon arise from the increasing elusiveness of the American dream – and worse still its transmogrification into a nightmare of stranded SUVs languishing among suburban albatross McMansions abandoned with each mortgage readjustment.

Modern Italy: Inventive but not Innovative?

Since the Renaissance (which, by the way, was invented here – Florence to be exact), Italy has been an extraordinarily inventive nation; Italians are among the most original and creative people on this planet.  As is well appreciated, “Made in Italy” is a mark of quality and style.  More significantly “Invented in Italy” could well be the moniker for much of what we take for granted in our modern world.  Radio communication (Guglielmo Marconi), the atom bomb (Enrico Fermi), double-entry bookkeeping (Luca Pacioli), opera and many more remarkable yet now routine ideas were invented by Italians.

Indeed, Italians have not uncommonly been described by their fellow Europeans as being “slightly crazy” in deference to the very Italian ability to think just a bit differently than others.  The invention of a New World is what only an Italian such Christopher Columbus could do.

This uniquely Italian problem – invention without innovation – has two major consequences: economic stagnation and psychic disappointment.  It has also given rise to the significant emigration of inventive talent out of Italy.  There is a reason why Marconi, for example, went to England; Fermi went to the US[7] and Columbus reached America via Ferdinand and Isabella of Spain.

There is profound irony, then, in realizing that a Roman heritage marked by a high degree of innovation (with invention provided by foreign assimilation) being replaced by a modern Italy with its nearly limitless culture of invention (but not necessarily innovation).[8]

Pharma Finance 2008: Fostering Innovation Partnerships

Pharma Finance 2008 was arranged not necessarily to showcase Italian ingenuity and invention – of which there is plenty – but more to foster the partnerships and collaborations necessary for innovation.  Government sponsored business gatherings are often premised by: “look at our great stuff … now give us funding.” Here in Rome the goal was more imaginatively along the lines of “we have great ingenuity here … how can we work together to make it happen?”

The conference was also about opening up local entrepreneurs to the possibilities of partnership.  A senior conference organizer told me:

“Italians are very proud of their discoveries.  It is very personal for them and they hold their ideas quite close to their heart.  Such an attitude can make it difficult to form the necessary collaborations – for example giving up majority control to a venture capitalist – or other partnerships that are necessary for success.”

Another conference official summed it up pithily when he noted that:

“In Italy it is not impossible to have someone like a Michelangelo or even several Michelangelos.  But, how do you innovate around or commercialize something so precious? That is the challenge.”

Scrambler Therapy: An Example of Cross-Border Innovation

Prof. Giuseppe Marineo of the “Tor Vergata” University in Rome was frustrated.  Marineo had invented a new approach to treating visceral pain – the sort of intractable, deep neuropathic pain that arises, for example, from abdominal cancers.  His frustration stemmed from an inability to bring this revolutionary technology, which he called “scrambler therapy” to market.

“Scrambler therapy,” [9] instead of using conventional pharmacological pain-killers or interventional surgery such as neurolysis, uses externally applied electromagnetic signals to confuse endogenous pain pathways into transmitting a signal of “non-pain” rather than “pain” to the brain.  This represents a biophysical approach to treatment rather than a chemical (medical) or mechanical (surgical) one.

Having written before on bioelectromagnetic therapies “Bioelectromagnetic Therapies: Science Fiction or Reality?” the potential of such revolutionary approaches to medicine is not surprising.  Invention can be crazy but rarely is it insane.

Prof. Marineo’s frustration – “malessere” if you will – was not to last long.  During last year’s Pharma Finance 2007 conference the goal of bringing Italian invention to market was, in fact, amply realized.  At that time, Leonardo Zangani (of the Zangani Investor Community) introduced Prof. Marineo and his work to John Nano, Chairman of Competitive Technologies, Inc. (CTT.AMEX) – a technology holding company based in the US CTT took up the technique forming a partnership with GEOMC – a South Korean radio and television manufacturing company for the device’s fabrication.  The Hong Kong-based company Lee’s Pharmaceutical Holdings Ltd. was further enlisted to help with its Asian distribution.

The successful trans-national marriage of Prof. Marineo’s invention with industrial production and worldwide distribution embodied true innovation – a direct result of Pharma Finance 2007.  The hope is that Pharma Finance 2008 will do the same.

America: Land of Immigrants?

The United States is a nation of immigrants and like ancient Rome it has derived nearly all of its inventive creativity from new ideas and cultures outside its borders.  America, however, is now consumed by anti-immigration rhetoric and enforcement.  Consider a recent New York Times report “Italian’s Detention Illustrates Dangers Foreign Visitors Face” describing the travails of an Italian tourist Domenico Salerno – the son of a wealthy contractor – who was detained in a Virginia jail for more than 10 days.  He was locked up, as the New York Times describes it “without charges or legal recourse while Ms. Cooper [his American girlfriend], her parents and their well-connected neighbors tried everything to get him out.”  This criminalization of immigration – not the only such example – portends a tragic societal shift that may substantially accelerate America’s decline more than any combination of its fiscal, trade or geopolitical deficits. [10]

Mr. Salerno – apart from any real or perceived immigration violation – was not a criminal.  It is also unclear whether such draconian enforcement would prevent terrorism as it has been well documented that the 9/11 conspirators had no known criminal records and apparently complied with then-standing immigration requirements.  Ironically, it also should be noted that the ancient Roman Latin Right was not infrequently accorded to foreigners who were otherwise undesirables in their own lands.  Indeed, a grateful and energetic peoples helped drive the Roman innovation engine still impacting our lives today.

Immigration was also essential to America’s scientific and technological ascendency in the wake of World War II.  Legions of talented émigrés escaping war-torn Europe and specifically Nazi persecution were eagerly accepted by the US.  During the succeeding Cold War, the eventual US victory over the Soviet Union was not necessarily an obvious conclusion.  Without these formidable immigrant talents the outcome could very well have been different.

America and Invention

To be sure, invention and innovation cannot in separation drive economic growth and progress.  Invention and innovation work together.  Balancing these two is the essential – one may say existential – challenge which only the most successful societies resolve.

Among the two, invention is the more difficult to cultivate as it requires a culture of freedom, a respect for new ideas and an ability to tolerate a certain degree of “craziness.”  Innovation on the other hand can (and should be) managed and hence a process that may be actively developed. [11]

Clearly, Italy already has substantial innate inventiveness.  In this regard, then, Italy – despite its perceived failings – possesses a tremendous advantage over other nations.  In the absence of such indigenous creativity, it is extraordinarily difficult to create an inventive society as this is a function of deep-seated cultural mores[12]. Indeed, the only remedy to rapidly correct an invention deficit is to encourage selective immigration.

Education, of course, has always been regarded as a powerful and long-term mechanism for increasing a nation’s inventiveness. Education does have its limits.  Invention requires a certain ability to think unconventionally; overly proscriptive educational systems can certainly suppress individual inventiveness.  It should be noted that Leonardo da Vinci – an Italian and arguably history’s most inventive individual – had virtually no formal education; he was also known to have expressed a deep contempt for formalized learning.

Another problem for America is its high cost of education.  Students encumbered by oppressive loans have not the liberty, literally, to be inventive.  Education without freedom – true freedom – only serves to stifle invention.

Is the U.S. inventive enough?[13]

While Italy may be struggling with an innovation deficit, America may very well be facing an invention deficit.  Five factors come to mind:

  • Constraints on immigration (watch, for example the internet TV interview with Dr. Norbert Riedel – Chief Scientific Officer of Baxter International),
  • the regimentation of American education via the “No Child Left Behind” law,
  • a manufacturing sector increasingly crowded out by a service-based (and non-goods producing) economy that is fast approaching 80% of the US gross domestic product (GDP),
  • a foreshortened investment cycle driven by the necessary expectations of increasingly powerful private equity firms and hedge funds, and
  • the exaltation of mediocrity and ignorance[14] that spans resurgent American social and political movements that embrace the status quo rather than change.[15]

Each of these factors alone and certainly all in combination may make it increasingly difficult for America to invent new ideas.  The last point, while admittedly somewhat broad in scope, is particularly concerning.  The injection of political ideology into scientific discovery is bound to be fraught with unintended consequences.

For example, the Marxist-Leninist ideological rejection of cybernetics caused the Soviet Union – despite its tremendous sophistication in mathematics and engineering – to substantially lag behind the US in terms of advanced information technology and computer software capabilities.  Because of the relatively primitive state of Soviet software capabilities, President Reagan’s 1983 Strategic Defense Initiative proposal – the space-based anti-missile program colloquially called “Star Wars” – profoundly frightened the Soviet leadership.  They acutely realized that such an initiative relied heavily on strengths in artificial intelligence and other complex software technologies[16] that the Soviets, at least that time, could not match.[17]  By analogy, the ideologically driven prohibition against embryonic stem cell research here in the US[18] may very well result in similar unintended and insalubrious consequences.

It also becomes nearly impossible for inventive people to apply their talents, find work and survive.  In America, not matching a computer-driven resume scanning system or being inconveniently overly inventive to one’s employers can be a fate worse than having a felony conviction on one’s record.  Leonardo da Vinci would likely have been unemployed and homeless had he lived in America today.  This is unfortunate since the US, more than ever before, needs a modern-day da Vinci to provide creative solutions to its crippling addiction to foreign oil.

Innovation without Invention and is Consequences

Despite the growing invention deficit, innovation is actually quite strong here in the US.  In fact, one of Wall Street’s most recent innovations substantiates the profound problems that emerge from a system of innovation without invention.

Mortgage-backed securitization (MBS) was created – foisted, if you will, on a world eager for higher returns – as a means of expanding home ownership.  Not necessarily a bad thing but without the requisite supporting economic fundamentals this has become, above all, the essence of the current credit crisis.

The mortgage-backed securitization innovation (and its problems) was multi-fold: an appeal to global greed, the opacification of risk, the arbitrage of discrete credit ratings and again the leveraging of information technology capable of crunching voluminous masses of numbers regardless of whether they made any sense.  In this case, innovation occurred in the absence of invention.  True improvements in building design, safety features, energy efficiency or aesthetics did not underlie the increase in home prices.  As is well known, real estate price appreciation was sustained largely as a result of speculative froth (Bernanke’s “irrational exuberance” redux) enabled by complex (and “innovative”) financial reengineering.

Consider another innovation: the SUV where nothing new was created but rather market value (now crashing) was built around combining several “innovations”.  These include:

  • refashioning trucks as personal vehicles,
  • a sophisticated marketing pitch appealing to the emotional sense that “bigger is better,”
  • inexpensive gasoline enabled by artificially low crude oil prices during the late 1980’s,[19]
  • leveraging a suburban culture made possible by a lack of inventive approaches to high-speed rail, light rail or other transportation projects.[20]

As a final example, I can relate my recent experience as a judge for a business plan competition at a leading American business school.[21] Among the several excellent plans that were presented I saw nothing - again nothing - that was particularly inventive.  Proposing a new social networking site, or yet another “fast casual” restaurant concept or an e-mail data-mining capability does little, in my estimation, to create new economic value.  Unmanaged innovation can have rather surprising – and not so salutary – consequences.  More on this shortly.

Pharma Finance 2008: Building upon Invention

Pharma Finance 2008 highlighted some truly inventive approaches to important human problems.  Prof. Marineo presented yet another idea – Entropy Variation System Delta (Delta-S).  The Delta-S technology utilizes organized electromagnetic fields to deliver information to biological systems in order to create desired therapeutic results.  In this way a diseased tissue may be systematically coaxed by external influences to undergo a proper repair process much like the miracle of a developing fetus under the influence of growth factor gradients in tissues and calcium gradients within cells.[22]  Current applications of this revolutionary technology are being developed, for example, to treat liver cirrhosis.

Economic Growth and Anti-Entropy

Prof. Marineo’s “Delta-S: Entropy Variation System” was only one of several Italian inventions showcased here at Pharma Finance 2008.  The reason it is mentioned here, even more than its unusual creativity, is that it specifically relates to the main theme of this article which can be summed up in one phrase:

Value is created by invention converted into reality by innovation.

Modern US style capitalism is predicated on a very simple concept: the supremacy of free-markets.  But herein lays a profound logical and practical fallacy.[23]  The supply-and-demand clearing paradigm of free-markets is based, in practical terms, on the mathematics of market equilibrium.  At the same time the core principle of capitalist success is predicated on the expectation of continual growth which, by definition, implies an ongoing state of non-equilibrium.

Equilibrium – characterized by a state of maximum entropy – leads inexorably towards dissipation and disorder.  If and only if[24] valuable information enters into the growing system can successful enterprises be created and sustained.  This valuable information – the anti-entropy factor - is nothing other than invention. 

Non-equilibrium systems, such as life itself, are characterized by sustained growth and increasing degrees of order.  The success of a capitalist system, then, relies in fostering invention (via freedom) and enabling innovation (via management).  Freedom applies to invention; management applies to innovation.

The distinction between invention and innovation can now be seen to be a categorically essential difference.  Confusing the two and thus misappropriating freedom and management between these can lead to very undesirable consequences.  Excessive management of immigration or education stifles invention.  Unmitigated freedom of innovation leads to monstrosities such as mortgage backed securitization and SUVs.

This is why, in my estimation, Pharma Finance 2008 was such an exciting conference; indeed, an exciting concept speaking more generally.  The concept that Italy’s extraordinary ingenuity benefits from active management of its innovation.

Value is created by free invention converted into reality by managed innovation.

That, I believe, is what Pharma Finance 2008, here in Rome, was all about.  The Italians, evidently, are not so crazy after all.


[1] This distinction has also been discussed by several authors including Bill Buxton, Lewis Branscomb and Philip Auerswald, John Hagel and John Seely Brown, Larry Dignan, Michael Schrage and others who mostly discuss this topic in the context of information technologies.  The purpose of this article is to (1) apply some of these concepts to the life sciences and (2) present a global and historical perspective on the issue all in the context of the recent Pharma Finance 2008 conference.

[2] These are both articles from today’s New York Times (24 May  2008).

[3] Also from today’s New York Times (24 May 2008).

[4] The inventor Dr. Fred McBagonluri provided me with a witty and apt analogy:

A man arrived at the hospital, where his wife just had a baby. As he walked in, he noticed the pediatric nurse cleaning the baby. He walked past his wife without saying anything to her. He congratulates the nurse for cleaning the baby. His wife is mad and raging. Why? Because the baby was her invention and the nurse was simply the innovator. Invention is an uncleaned baby; innovation is when that baby is cleaned up enough to make money!

[5] The idea of taking off-the-shelf components and combining them also has tremendous potential for medical technologies.  See, for example, the articles Convergent Medical Technology: Part I - What is it?, Convergent Medical Technology: Part II - Why is it important? and Patent Reform Act of 2007: Innovation, Implications and the American Inventor.

[6] To be clear, the argument here refers more specifically to the rise of the Roman Republic – relative to the other Latin city-states in the area which it gradually assimilated – resulting in the conquest of Italy and subsequent consolidation of Latium thus creating the framework by which the later Roman Empire emerged.  These are the fundamental reasons for the Empire’s rise rather than the oft-quoted proximal reasons such as the political ambitions of Julius Caesar, the resulting civil wars and other military-political events.

[7] On December 2nd, 1942, Arthur Compton, director of the “Metallurgical Laboratory” at the University of Chicago telephoned James B. Conant, President of Harvard University with the news “The Italian Navigator has just landed in the New World.”  That cryptic message was meant to indicate that controlled and sustained nuclear fission – under the direction of Enrico Fermi – had been achieved.  This was a critical first step towards the development of the atomic bomb.

[8] These are generalizations and not meant, of course, to imply that innovation is absolutely non-existent in modern Italy.  The statement should to be interpreted in terms of a comparative analysis over time (e.g. modern Italy as compared to ancient Rome) and over societies (Italy as compared to other nations that might be considered to be more innovative).

[9] “Untreatable Pain Resulting from Abdominal Cancer: New Hope from Biophysics?” Journal of the Pancreas, 4(1): 1-10, 2003.  Click here for a video interview (in Italian) with Prof. Marineo and another video here (also in Italian) demonstrating an early version of the device.

[10] In reading today’s New York Times, another article “270 Illegal Immigrants Sent to Prison in Federal Push” stood out – more concerning than the teenage unemployment or I-banker redundancy reports noted above.  The article writes:

“In temporary courtrooms at a fairgrounds here [in Iowa], 270 illegal [mostly Guatemalan] immigrants were sentenced this week to five months in prison for working at a meatpacking plant with false documents.”

Juliet Stumpf – an immigration law professor at Lewis & Clark Law School – commented on the inauspicious action as being “… a startling intensification of the criminalization of immigration law.”

[11] As described further in the 2nd article (Part II: Invention Needs to Be Left Free; Innovation Must Be Managed) in the previously described three-part series.

[12] It is important to note that I am not at all referring to one people being more “intelligent” than another.  Inventiveness – while typically a result of individual work – results more from cultural attitudes than necessarily innate abilities.  One could say it is an epigenetic rather than genetic factor.

[13] See the work of the Task Force on the Future of American Innovation (http://www.futureofinnovation.org/) whose recommendations – namely to increase government research funding – while important but somewhat different from the one’s discussed in this article.

[14] See, for example, Susan Jacoby’s recent book The Age of American Unreason which was featured in a New York Times article “Dumb and Dumber: Are Americans Hostile to Knowledge?” commenting more generally the decline of American intellectual culture. See also another Op-Ed piece by Jacoby: “Best is the New Worst.”

[15] This statement should not be construed as a generalized indictment against conservatives.  David Brooks in his commentary “The Conservative Revival” writes convincingly about thoughtful conservative movements that are able to, and indeed, thrive under conditions of change.

[16] See: “Software Seen As Obstacle In Developing 'Star Wars'” which points out that the software requirements represent probably the critical component to the success of any such system.

[17] Russian software engineers have since – now unfettered by Marxist restrictions – proven themselves extremely capable so the Soviet weakness did not reflect some fatal lack of talent in this area.

[19] Low oil prices in the mid-to-late 1980’s (e.g. the 1986 crude oil price collapse) and then largely propagated through the 1990’s were driven by geopolitical considerations, namely as a primary means of burying (to use a phrase borrowed from Khrushchev) the Soviet Union.  In this regard, it is quite disturbing to see President Bush’s recent inability to convince the Saudis to increase their production as it speaks to a profound geopolitical weakness of the United States today.  This was - despite concerns about the rise of Japan in the 1980s – not the case twenty years ago.

[20] See Paul Krugman’s piece “Stranded in Suburbia.”  While Krugman emphasizes the development of fuel-efficient cars, he also points out (not at all the only one to comment as such) on the appalling lack of urban public transit options.

[21] Out of respect for the school and the participants this shall remain nameless.

[22] For a more direct (if somewhat abstruse) summary of Prof. Marineo’s idea:

“… the basic Delta-S system is composed of a sophisticated dedicated parallel architecture computer controlled by an expert system which has the task of constructing, instant by instant, the energy forms required in order to achieve a high selectivity vis-à-vis the desired biological target, to evaluate the safety parameters, by means of suitable electromagnetic fields in a feedback loop with the biological system being treated (self-guidance) in order to introduce the energy required with a suitable information content so as to achieve the desired biocompatibility within the process with which it is desired to interact.”

[23] It should be noted that the critique described here is not at all the same as the classical Marxist critique of capitalism which emphasizes the historically determined conflict between capitalist growth and social stability.  Nor is this critique the same as the Club of Rome concerns regarding sustainability and the “limits to growth.” The paradox noted in this article points out that successful capitalist enterprises are required to simultaneously straddle both equilibrium and non-equilibrium status.  This is obviously – from both a mathematical and practical sense – a highly problematic situation which, as is briefly argued here, can be resolved in a sustained manner only through the continual input of inventive ideas.

[24] The term “if and only if” is meant to be interpreted in its strict Boolean logic sense.

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Posted by Ogan Gurel MD MPhil at 12 November 2008, 11:24 PM | View Comments (1) | Add Comment

Where the Action’s at With Secrets of Everyday Life: Proteins or DNA?

There has been much excitement about the promise of molecular genetics and in particular the Human Genome Project in curing various diseases. Ever since the double-helical structure of DNA was published by James Watson and Francis Crick in 1953, DNA has been billed as the repository of the secrets of life.   Within DNA resides the genetic instructions driving life itself. Countless scientists and billions of dollars have been expended worldwide to crack that secret. Indeed, the code has been cracked and we now know – as announced in 2003 (a half century after the double helix was first revealed) – the complete sequence of a human genome.  For the midwestbusiness.com article click here.

 

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Posted by Ogan Gurel MD MPhil at 9 June 2008, 12:00 AM | Add Comment

Pharma Finance 2008 In Italy - Part Two Invention, Innovation Perspectives

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Posted by Ogan Gurel MD MPhil at 5 June 2008, 12:00 AM | View Comments (1) | Add Comment

Pharma Finance 2008 in Italy - Part One Invention, Innovation Perspectives

Part One of a series on Innovation For Part II click here.

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Posted by Ogan Gurel MD MPhil at 27 May 2008, 11:07 PM | Add Comment

The Persistent Socialized Risk Problem - Gas Tax, Health Care Insurance

The previous MedTech Futures column “Connection Between the Subprime Mess and the Uninsured: Socialized Risk” highlighted a relationship between the ongoing subprime mortgage crisis (now generalized the “credit crunch”) and the growing ranks of the health care uninsured.  For the Midwestbusiness.com article for this blog entry, click here.

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Posted by Ogan Gurel MD MPhil at 12 May 2008, 11:09 PM | Add Comment

The connection between the subprime mess and the healthcare uninsured: Socialized Risk

Ben Stein – the noted New York Times columnist cum Economist wrote an interesting piece “Wall Street, Run Amok” this weekend which at the time of this writing has become the “most popular” among business articles being e-mailed. In this Web 2.0 era, most popular either means there is something valuable and substantive or that it is enormously entertaining or crazy. Ben Stein has – in the past - satisfied both criteria and I’ll leave to you to decide between the two in this respect. Originally published in Midwestbusiness.com http://www.midwestbusiness.com/news/viewnews.asp?newsletterID=19129 << MORE >>
Posted by Ogan Gurel MD MPhil at 28 April 2008, 1:37 AM | View Comments (2) | Add Comment

The 4P’s of marketing for drug and device companies

Today’s New York Times has an article by Gina Kolata on the increasing cost of drug co-payments incurred by patients – even those with good health insurance. Here in Midwestbusiness.com, this column has made considerable note of the unsustainable marketing “arms race” that contributes significantly to the cost of drugs. Originally published in Midwestbusiness.com http://www.midwestbusiness.com/news/viewnews.asp?newsletterID=19091 << MORE >>
Posted by Ogan Gurel MD MPhil at 14 April 2008, 1:38 AM | Add Comment

A Proposal for Healthcare Cost Containment

A Proposal for Healthcare Cost Containment


 
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Posted by Ogan Gurel MD MPhil at 10 April 2008, 4:41 AM | Add Comment

Counterdetailing: A Cure for A Pharmaceutical Addiction?

In a little known but very significant development, a Senate Special Committee on Aging held a hearing last Wednesday to hear from industry experts on pharmaceutical marketing tactics and entertain “counterdetailing” proposals. Originally published in Midwestbusiness.com http://www.midwestbusiness.com/news/viewnews.asp?newsletterID=19002 << MORE >>
Posted by Ogan Gurel MD MPhil at 17 March 2008, 1:34 AM | Add Comment

Innovations Galore Spawning From 2008 Medical Design Excellence Awards (MDEA)

I’m here now in Los Angeles serving as a judge in the 2008 Medical Design Excellence Awards (MDEA), which is a premier competition for medical products, devices and technologies. I also published a column on 2007’s competition. Originally published in Midwestbusiness.com: http://www.midwestbusiness.com/news/viewnews.asp?newsletterID=18783 We actually haven’t finished our deliberations yet, and even if we had, I wouldn’t be able to tell you about the winners. Originally published on Midwestbusiness.com http://www.midwestbusiness.com/news/viewnews.asp?newsletterID=18851 << MORE >>
Posted by Ogan Gurel MD MPhil at 18 February 2008, 1:40 AM | Add Comment

The Logic of American Healthcare

On primary election day here in Illinois, it would be of interest to discuss healthcare reform – an issue that goes head-to-head with the Economy and Iraq as the number one issue facing voters this political season. One sentiment that appears to unite nearly all the candidates is the claim that our healthcare system is “broken.” Everybody has a healthcare reform package with the hope – among the Democrats in particular – to solve the huge problem of covering the nation’s 46 million uninsured. Originally published in Midwestbusiness.com http://www.midwestbusiness.com/news/viewnews.asp?newsletterID=18783 << MORE >>
Posted by Ogan Gurel MD MPhil at 5 February 2008, 1:42 AM | Add Comment

Innovation vs. Invention - Part III: Accelerating Development

This is the last part of a three-part series on innovation. The first part “Concepts of Innovation, Invention Should Now Be Regarded Differently” explored three basic points: 1. Innovation is different from invention 2. Innovation is the realization of invention 3. Innovation often results from a combination of inventions Originally published in Midwestbusiness.com: http://www.midwestbusiness.com/news/viewnews.asp?newsletterID=18697 << MORE >>
Posted by Ogan Gurel MD MPhil at 21 January 2008, 1:48 AM | Add Comment

Convergent Medical Technology: Part II - Why is it important?

This is the second article in a three-part series on convergent medical technologies (CMT).  The first article from last week discussed the definition of CMT – namely what CMT is.  This second part in the series will discuss one of Bach’s two-part inventions as background to reasons why CMT is gaining in importance.

Also found on the Zangani Investor Community and the Redington Life Sciences newsletter.

 

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Posted by Ogan Gurel MD MPhil at 17 November 2007, 11:05 PM | View Comments (5) | Add Comment

Advances in the Management of Cerebral Aneurysm Disease: InTimeTV interview with Dr. Bernard Bendok of Northwestern Univeristy

The archived InTimeTV video for the Insights in Medicine interview with Dr. Bernard Bendok (Assistant Professor of Neurological Surgery and Radiology at the Northwestern University Feinberg School of Medicine) is now available.  We had a wide-ranging discussion of the basics of cerebral aneurysm disease and clinical management basics for general practitioners, ER physicians and others.  For the full video clip, see: Advances in the Management of Cerebral Aneurysm Disease.

 

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Posted by Ogan Gurel MD MPhil at 2 October 2007, 2:32 PM | View Comments (1) | Add Comment

On Innovation Part II: Fostering Innovation

In this second part of a three-part series on innovation, we discuss the key elements involved in fostering innovation.  The previous installment of this series explored three basic points:

1.       Innovation is different from invention

2.       Innovation is the realization of invention

3.       Innovation often results from a combination of inventions

Because innovation involves the integration of multiple inventions and interdisciplinary combinations the factors involved in fostering innovation are quite different and in some ways almost opposite those that stimulate invention.

 

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Posted by Ogan Gurel MD MPhil at 2 October 2007, 2:18 PM | View Comments (1) | Add Comment | Trackbacks

Integrating Physical Health Care for Individuals with Serious Mental Illness: InTimeTV interview with Dr. Peter Weiden of the University of Illinois - Chicago

The archived InTimeTV video for the Insights in Medicine interview with Dr. Peter Weiden (Professor of Psychiatry and Director, Psychotic Disorders Program at the University of Illinois - Chicago) is now available.  The interview was an excellent overview of the importance of and challenges in managing medical illness in patients with severe mental illness.  For the full video clip click Integrating Physical Health Care for Individuals with Serious Mental Illness.

 

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Posted by Ogan Gurel MD MPhil at 29 September 2007, 8:42 PM | View Comments (1) | Add Comment

Expanding Health Coverage to the Uninsured: How to Pay for it - the Health Impact Tax

This proposal for a health impact tax (akin to a carbon tax) as a funding mechanism for expanding health coverage to the uninsured was originally proposed this past March in the article “Is Gov. Blagojevich’s new plan to cover the uninsured in Illinois a good or bad idea?”  The basic premise builds upon the following concepts:

·         Government covers the aged (Medicare) or poor (Medicaid) and to some extent children (SCHIP).

·         Business typically covers the working population

·         Of course, many of the uninsured are among the working public and the consensus is that somehow business should cover the cost of the uninsured

·         Proposals for a gross-receipts tax (such as recently done in Illinois) have failed in this regard

·         Instead, it is proposed that a health impact tax (apportioned to different businesses according to a general estimate of the overall impact – positive or negative - of their operations on the health of the population)

·         This tax would be similar to a carbon tax that is assessed on the basis of a businesses projected environmental impact

·         This proposal would apportion responsibility for coverage of the uninsured fairly

·         The program would be nationally based in order to enable freedom of movement and administered by the federal government as an extension of the Federal Employees' Health Benefits Program (FEHBP)

Read on for more and feel free to comment.

 

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Posted by Ogan Gurel MD MPhil at 20 September 2007, 11:23 AM | Add Comment | Trackbacks

On Innovation, Fostering Innovation and Accelerating Development: New Webcast

A brief video webcast on innovation, how to foster innovation and accelerate development.  The presentation was originally given at a Departmental Bioengineering seminar at the University of Illinois – Chicago on September 14th, 2007.

 

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Posted by Ogan Gurel MD MPhil at 18 September 2007, 10:07 AM | Add Comment

Which Countries and Cities are Considered Most Innovative? Find Out Here ...

What are the most innovative countries and cities?  Find out more here and feel free to submit your thoughts …

 

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Posted by Ogan Gurel MD MPhil at 17 September 2007, 7:42 PM | View Comments (2) | Add Comment | Trackbacks

On Innovation Part I: Innovation is Not the Same as Invention

Innovation is not the same as Invention.  Previously appeared in Midwestbusiness.com as Concepts of Innovation, Invention Should Now Be Regarded Differently. 

Previously appeared in Midwestbusiness.com as Concepts of Innovation, Invention Should Now Be Regarded Differently and on the Wisconsin Technology Network as Innovation vs. invention: Knowing the difference makes a difference.

Read on for more …

 

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Posted by Ogan Gurel MD MPhil at 17 September 2007, 3:53 PM | View Comments (3) | Add Comment

Women's Heart Health: InTimeTV interview with Dr. Annabelle Volgman, Director of the Rush Heart Center for Women

The archived InTimeTV video for the Insights in Medicine interview with Dr. Annabelle Volgman (Director of the Rush Heart Center for Women)  is now available.  We had a wide-ranging discussion on women’s heart health.  For the full video clip click Women’s Heart Health.

 

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Posted by Ogan Gurel MD MPhil at 17 September 2007, 9:22 AM | View Comments (6) | Add Comment

Nuts and Bolts of Innovation: InTimeTV talk show panel with Jonas Moses, PhD and Ogan Gurel, MD

The archived InTimeTV video for the On The Edge interview with Jonas Moses and myself is now available.  We had a wide-ranging discussion on innovation.  For the full video clip click Innovation and How to Foster it.

 

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Posted by Ogan Gurel MD MPhil at 17 September 2007, 9:10 AM | Add Comment

A Pharmaceutical Addiction

The New York Times reported earlier this week on an interesting phenomenon in the medical and pharmaceutical world – namely online advertising by pharmaceutical companies.  Milt Freudenheim’s article “A Medical Publisher’s Unusual Prescription: Online Ads” describes how the “medical publishing world [is meeting] the Internet.”  There are yet even more interesting implications to this trend.

 

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Posted by Ogan Gurel MD MPhil at 11 September 2007, 1:13 PM | View Comments (16) | Add Comment | Trackbacks

Medical Diplomacy: A Brief Outline

The New York Times reported today a very interesting initiative in the area of medical diplomacy.  Celia Dugger’s article “Ex-Senator to Lead Global Drive on Children’s Health” describes the ongoing efforts of former Senator Bill Frist to help the international charity Save the Children “make the preventable deaths of millions of children in the developing world an issue for Americans.”  

Actually medical diplomacy is not mentioned in the article explicitly but Sen. Frist’s work truly fits the bill.  There’s not much on the web, however, on medical diplomacy (in fact, if you Google “Medical Diplomacy” this blog actually comes up 9th!).  

Hence, the first part of this commentary provides an outline, a taxonomy of medical diplomacy.  The second part to follow provides some additional thoughts on Sen. Frist’s project as set within the broader context of medical diplomacy.

 

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Posted by Ogan Gurel MD MPhil at 7 September 2007, 9:19 PM | View Comments (2) | Add Comment

Emerging Clinical Technologies: Opportunities & Challenges for Hospitals: InTimeTV talk show interview

I was interviewed by Dr. Kristine Mighion on her Healthcare Executive internet talk show on InTimeTV.  We discussed emerging clinical technologies and their implications for hospitals, health systems and healthcare executives.  For the full video clip click on: Emerging Clinical Technologies: Opportunities & Challenges for Hospitals.

 

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Posted by Ogan Gurel MD MPhil at 1 September 2007, 10:24 PM | Add Comment

The Present and Future of Primary Care: InTimeTV talk show interview with Dr. C. Anderson Hedberg, former President of the American College of Physicians

The archived InTimeTV video for the Insights in Medicine interview with Dr. C. Anderson Hedberg (former President of the American College of Physicians) is now available.  We discussed quite a few topics on the present and future of primary care including the new medical home for primary care model – the Patient-Centered Primary Care Collaborative.  For the full video clip click The Present & Future of Primary Care Medicine.

 

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Posted by Ogan Gurel MD MPhil at 27 August 2007, 7:21 PM | Add Comment

Advances in Cardiovascular Disease: InTimeTV interview

I was interviewed by Dr. Ray Fisher on his Heart Health Update internet talk show on InTimeTV.  My fellow guest was the cardiac surgeon Dr. Jeffrey Silver and among other topics, we discussed the future of drug-eluting stents. surgical robotics and off-pump bypass surgery.  For the full video clip click on: Advances in Cardiovascular Disease.

 

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Posted by Ogan Gurel MD MPhil at 26 August 2007, 10:05 PM | Add Comment

Diabetes: Looking Past Blood Sugar ...

The most frequently emailed article for the New York Times this past week - an internet version of a Times “best seller” - has been Gina Kolata’s “Looking Past Blood Sugar to Survive With Diabetes.”  Given the high prevalence of diabetes that’s no surprise.  But the article’s thesis that dogmatic fixation on blood sugar levels may compromise other aspects of diabetes care has no doubt piqued much interest.  Here are some additional angles to consider …

Also published on the Zangani Investor Community.

 

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Posted by Ogan Gurel MD MPhil at 22 August 2007, 1:11 AM | View Comments (10) | Add Comment

FDA issues a "black box" warning for Avandia - A Balancing Act Between Safety and Choice

The Avandia controversy has been a whirlwind – even a circus at times - but the outcome continues inexorably in favor of drug safety as consistently suggested by this blog.  Last week, the FDA issued a “black box” warning for Avandia as well as other thiazolidinedione type drugs (such as the Takeda drug Actos).

Also posted on the Zangani Investor Community.

 

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Posted by Ogan Gurel MD MPhil at 21 August 2007, 9:56 PM | Add Comment | Trackbacks

The Deconstruction of Amgen

As some of you may be aware, Amgen announced last week an unprecedented set of layoffs numbering almost 2,600 employees. What's going on? Amgen may have been a victim of its own success as it has been the darling of biotechnology ever since it introduced recombinant erythropoietin back in 1988.

Originally published in Midwestbusiness.com as “The Deconstruction of Amgen: Company is Victim of Own Success” and also published in the Wisconsin Technology Network as “Lessons from the deconstruction of Amgen.”  Also syndicated on the Zangani Investor Community.

 

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Posted by Ogan Gurel MD MPhil at 21 August 2007, 7:01 PM | Add Comment

Is Healthcare too Personalized for Personalized Medicine?

Is healthcare too personalized for personalized medicine? 

Originally published in Midwestbusiness.com and also published in the Wisconsin Technology Network as “Thoughts on health IT, personal medicine & tech convergence” and the Zangani Investor Community. Referenced in ScienceRoll.

 

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Posted by Ogan Gurel MD MPhil at 6 August 2007, 9:28 PM | Add Comment | Trackbacks

More on The Life Sciences Accelerator: An Audio (.mp3) Podcast

The July 28th InTimeTV.com web video covered a number of topics including the opportunities and challenges in accelerating technologies from “bench-to-bedside.”  Play this podcast (4:41 minutes) which summarizes and discusses further the Life Sciences Accelerator concept. 

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Posted by Ogan Gurel MD MPhil at 3 August 2007, 7:53 AM | Add Comment

Drug Safety & FDA Reform : An Audio (.mp3) Podcast

The July 28th InTimeTV.com web video covered a number of topics including the opportunities and challenges in accelerating technologies from “bench-to-bedside.”  Play this podcast (16:21 minutes) which focuses drug (and device) safety and proposals for FDA Reform. 

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Posted by Ogan Gurel MD MPhil at 3 August 2007, 7:45 AM | Add Comment

Accelerating market entry for new technologies: An Audio (.mp3) Podcast

The July 28th InTimeTV.com web video covered a number of topics including the opportunities and challenges in accelerating technologies from “bench-to-bedside.”  Play this podcast (8:43 minutes) which focuses additional barriers (other than the innovation gap) to bringing emerging medical technologies to market.  Discusses market barriers including the lack of pricing, product and vendor transparency in the healthcare market as well as some opportunities around accelerating FDA approvals.

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Posted by Ogan Gurel MD MPhil at 3 August 2007, 7:33 AM | Add Comment

Introduction to the Life Sciences Accelerator: An Audio (.mp3) Podcast

The July 28th InTimeTV.com web video covered a number of topics including the opportunities and challenges in accelerating technologies from “bench-to-bedside.”  Play this podcast (14 minutes) which focuses on the incubators and the life sciences accelerator concept to accelerate medical technology development.  Also discusses the reasons why accelerating medical technology development is so important from both a patient-oriented and business/investor perspective.

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Posted by Ogan Gurel MD MPhil at 3 August 2007, 7:27 AM | Add Comment

Bridging the Innovation Gap: An Audio (.mp3) Podcast

The July 28th InTimeTV.com web video covered a number of topics including the opportunities and challenges in accelerating technologies from “bench-to-bedside.”  Play this podcast (6 minutes) which focuses on the “innovation gap” and management support for life sciences companies.

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Posted by Ogan Gurel MD MPhil at 3 August 2007, 7:14 AM | Add Comment

Medical Nanotechnology and more on Convergent Medical Technologies: An Audio (.mp3) Podcast

The July 21st InTimeTV.com web video covered a number of topics including medical nanotechnology and its relationship to convergent medical technologies.  Play this brief podcast (3 minutes) for more on these important topics.

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Posted by Ogan Gurel MD MPhil at 2 August 2007, 7:01 AM | Add Comment

Accelerating Medical Technology Innovation and the Life Sciences Accelerator: An Audio (.mp3) Podcast

The July 21st InTimeTV.com web video covered a number of topics including the challenges around innovation and bringing medical technologies more quickly to market (and to patients) as well as the ideas around a Life Sciences Accelerator and how this project may help to solve this problem.  Play this brief podcast (4:20 minutes) for more on these important topics.

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Posted by Ogan Gurel MD MPhil at 2 August 2007, 6:59 AM | Add Comment

Personalized medicine: An Audio (.mp3) Podcast

The July 21st InTimeTV.com web video covered a number of topics including personalized medicine.  Play this podcast (3:49 minutes) for a brief discussion of personalized medicine (and its relationship to convergent medical technologies).

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Posted by Ogan Gurel MD MPhil at 2 August 2007, 6:54 AM | View Comments (1) | Add Comment

Partnerships and the Chief Partnership Officer idea: An Audio (.mp3) Podcast

The July 21st InTimeTV.com web video covered a number of topics including the very current issue of drug (and device) safety and its implications for FDA reform. growing importance of partnerships and ideas around the role of a Chief Partnership Officer.  Play this brief podcast (6 minutes) for a discussion of these concepts.

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Posted by Ogan Gurel MD MPhil at 2 August 2007, 6:42 AM | Add Comment

Drug safety and FDA Reform: An Audio (.mp3) Podcast

The July 21st InTimeTV.com web video covered a number of topics including the very current issue of drug (and device) safety and its implications for FDA reform.  Play this brief podcast (7:08 minutes) for a discussion of these concepts.

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Posted by Ogan Gurel MD MPhil at 2 August 2007, 6:34 AM | Add Comment

Convergent Medical Technologies: An Audio (.mp3) Podcast

The July 21st InTimeTV.com web video covered a number of topics including the growing area of convergent medical technologies (CMT).  Play this brief podcast (6:21 minutes) to find out more about CMT – what it is and why it is important.

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Posted by Ogan Gurel MD MPhil at 2 August 2007, 6:32 AM | View Comments (1) | Add Comment

Definition of Biotechnology: An Audio (.mp3) Podcast

The July 21st InTimeTV.com web video covered a number of topics including biotechnology.  Play this brief podcast (1:42 minutes) for a definition of biotechnology.

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Posted by Ogan Gurel MD MPhil at 2 August 2007, 6:27 AM | Add Comment

Accelerating Medical Technology Innovation, Drug/Device Safety and FDA Reform: InTimeTV broadcast

You can find the second InTimeTV.com video interview “Conversations in Emerging Medical Technologies” on the web.  This program (which is an archived version of last Saturday’s live broadcast) focused this time on the challenges around medical technology innovation and accelerating such technologies faster to market.  In light of this, the 2nd half of the interview focused on various drug (and device) safety issues and their implications for FDA reform.

Click here for the video or visit the InTimeTV archives. 

 

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Posted by Ogan Gurel MD MPhil at 1 August 2007, 5:48 PM | View Comments (1) | Add Comment

FDA panel votes to retain Avandia on the market: DrugWonks celebrate; Prince Hal rails against Falstaff ...

An FDA panel voted 22 to 1 on Monday (7/30) to keep Avandia on the market; the vote on the heart attack risk was 20 to 3.  The position of this blog has not so much been to take sides but rather to highlight the debate as a springboard for discussing the wider issues of drug safety, FDA reform and the “deconstruction” of the pharmaceutical business model.  Read on also for some discussion on how DrugWonks.com could improve the value of its contributions to the debate and a little about Falstaff and Prince Hal.

Also referenced in TortsProf Blog.  In that brief posting, Bill Childs summarizes the point very concisely.  Derek Lowe in his blog In The Pipeline also provides a nice reference and summary.

 

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Posted by Ogan Gurel MD MPhil at 31 July 2007, 7:50 PM | View Comments (45) | Add Comment | Trackbacks

"Nothing but Momentum" ... Life Sciences on a roll in Illinois

Just over a month ago, I published in Midwestbusiness.com as well as on this blog “The Future is Bright For Life Sciences in State of Illinois.”  Thanks to the leadership of so many people, this projection is coming to fruition in many concrete ways.  The iBIO organization led by David Miller has been instrumental in this developing renaissance and I came across an open letter of his that highlights the energy and reality of this movement. 

 

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Posted by Ogan Gurel MD MPhil at 30 July 2007, 9:01 AM | Add Comment | Trackbacks

InTimeTV interview. Live on Saturday, July 28th at 12noon (Central Time): Innovation, Life Sciences Accelerator, Drug Safety, FDA reform and other topics

On Saturday (7/28) I will be interviewed on live web-TV with InTimeTV where I will be discussing medical innovation, the “innovation gap,” patent reform, how to accelerate life sciences development and related topics.  Time permitting we may also talk about drug safety and FDA reform which relate to innovation acceleration to the extent that we want to bring drugs (and devices) to patients quicker yet also safely.

Date: Saturday, July 28th

Time: 12 noon (U.S. Central time)

Where: Go to http://www.intimetv.com/ and click on the link titled: “Click here now for the current live show!”  

Hope you can have a chance to watch the interview!

 

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Posted by Ogan Gurel MD MPhil at 27 July 2007, 7:40 PM | View Comments (2) | Add Comment

FDA Report on Avandia: Implications and a "critique" of the critique

According to the New York Times, the FDA issued a formal report today on the Avandia controversy that appears to substantiate the safety concerns raised earlier and reportedly sharply criticizes the manufacturer on a number of points.  See the New York Times article “F.D.A. Review Criticizes Diabetes Drug and Maker” and some brief commentary on that article in this posting. 

 

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Posted by Ogan Gurel MD MPhil at 26 July 2007, 5:58 PM | View Comments (1) | Add Comment | Trackbacks

"Conversations in Biotechnology and other topics": InTimeTV interview

Just posted on the internet is an InTimeTV.com video interview “Conversations in Biotechnology” touching upon a wide range of topics including biotechnology, convergent medical technologies, medical devices, telemedicine, smart devices, drug/device safety, the chief partnership officer idea, FDA reform, personalized medicine, the life sciences accelerator, medical nanotechnology and other topics.

Click here for the video or visit the InTimeTV archives.  Also found on the Zangani Investor Community. 

 

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Posted by Ogan Gurel MD MPhil at 26 July 2007, 2:30 PM | Add Comment

Has the private equity boom peaked?

Yesterday afternoon’s blog post “Private equity boom (and bust?): Implications for the Life Sciences” was also published on Midwestbusiness.com at “Life Sciences Funding: Has the Private Equity Boom Peaked?”  As part of the Midwestbusiness.com article, an associated reader poll was posted which is still open for your vote.  Read on to see the results as of 2:33pm (CDT) today …

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Posted by Ogan Gurel MD MPhil at 24 July 2007, 2:37 PM | Add Comment | Trackbacks

You voted on the FDA. See the results here ...

A recent Midwestbusiness.com article “FDA: Tortoise, Hare or Something Else Entirely?” included a reader poll asking whether you thought the FDA should be:

□       a tortoise (slower and more deliberate in its approval),

□       a hare (faster with its approvals), or

□       something else entirely, or

□       fine as it is

Read on to see the results and to post your own comments here …

 

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Posted by Ogan Gurel MD MPhil at 24 July 2007, 8:38 AM | Add Comment

Private equity boom (and bust?): Implications for the Life Sciences

In April of this year, I wrote about the $29 billion KKR deal with First Data as a springboard for a discussion life sciences innovation, the relative shift of capital from early-stage (equity) deals to later-stage (debt-based) deals and pharmaceutical research pipelines in general.  There are rumors that the private equity boom may have peaked.  If so, what are the implications for the life sciences? 

Published also in Midwestbusiness.com “Life Sciences Funding: Has the Private Equity Boom Peaked?” where you’ll find a reader survey on the issue and the Wisconsin Technology Network “Private equity's ups and downs: What it means for the life sciences.”  Also published in the Redington Life Sciences newsletter.

David Hamilton over at VentureBeat wrote a follow-up blog entry which I would strongly recommend taking a look at.

 

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Posted by Ogan Gurel MD MPhil at 23 July 2007, 3:56 PM | View Comments (4) | Add Comment

Boston Scientific, Medtronic settle some defibrillator suits; is the device safety storm over?

Recent postings, including this morning’s “Avandia, the Drug Safety Debate and How to Get a Nobel Prize” have focused on drug safety but the same premises hold true for the device market as well.  Back in 2005 and continuing on through last, we saw some very prominent headlines around Guidant and its massive defibrillator recall.   The topic is still quite timely (despite being overshadowed by Vioxx and Avandia) since just last week it was reported that Boston Scientific settled about $195M of the lawsuits related to the issue as part of its acquisition of Guidant.  Medtronic likewise just settled several lawsuits related to its defibrillators.  Is the device safety storm over then?

 

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Posted by Ogan Gurel MD MPhil at 23 July 2007, 1:58 PM | View Comments (3) | Add Comment

Avandia, the Drug Safety Debate and How to Get a Nobel Prize

Drug (and device) safety has been a recurring theme for this blog.  The article “Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial” from last year highlighted why safety is a growing issue and anticipated even more controversy.  Indeed this has been the case.  Sunday’s New York Times article “Drug Safety Critic Hurls Darts From the Inside” comments on the personal and professional backdrop behind Dr. Steven Nissen’s questioning of Avandia, his “shaking up of the nation’s pharmaceutical industry” and the furor around drug safety.  The purpose of this posting is not to take sides but rather to explore some deeper issues that strike to the very core of medical science.

 

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Posted by Ogan Gurel MD MPhil at 22 July 2007, 5:17 PM | Add Comment

Patent Reform Act of 2007: Innovation, Implications and the American Inventor

Yesterday, the U.S. House Judiciary committee passed the The Patent Reform Act of 2007.  The patent reform controversy has been brewing for some time now and this blog has, indeed, commented on the issue especially because of its significant implications for convergent medical technologies.  This posting discuss the implications of the new law (which is now passed over to the Senate) and concludes with an illustrative recap from last night’s television episode of American Inventor on ABC.

Published on the Zangani Investor Community.  Also referenced on Topix.com and on the internet blogs Names@Work and Innovators Network.  The latter has a nice summary of the points in this posting:

Ogan Gurel has something to say about the IP stew: "This debate distills into making a choice between maintaining a monophonic, medieval system sustaining the single-patent/single-product paradigm as compared to a reformed system that accommodates the unlimited diversity inherent in a polyphonic, Renaissance system." Gurel points out [an] example of such diversity [in] J.B. Bach's two-part inventions [associating] “convergent technology innovation with the novel polyphonic, contrapuntal techniques that drove innovation in music" [that] live on as favorite classical music pieces to this day, centuries later. And no copyright in sight. Patent Reform Act of 2007: Innovation, Implications and the American Inventor handily explicates some of the finer points of the patent debate.

 

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Posted by Ogan Gurel MD MPhil at 19 July 2007, 11:39 PM | View Comments (2) | Add Comment

Bleeding stents ... Is the drug-eluting stent era over?

An article by Steve Syre in today’s Boston Globe – “Bleeding stent sales” noted the rather precipitous decline in drug-eluting stent sales during the past year.  J+J, for example, reported a drop of 41% in the second quarter of this year alone.  Two things: (1) this reversal of fortune was predicted last year in a series of articles in this blog and (2) this further validates the concept of drug-eluting stents as being a “transitional” technology.

 

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Posted by Ogan Gurel MD MPhil at 19 July 2007, 3:56 PM | View Comments (6) | Add Comment

Financial Incentives Can Drive New Pharmaceutical & Medical Technology Adoption: What are the Implications?

A New York Times article from this weekend highlights how some drugs – despite strong indications of efficacy – are not reaching patients.  Why is this the case?  And what are some of the implications?…

Also found on the JamesSpot blog and the Zangani Investor Community.

 

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Posted by Ogan Gurel MD MPhil at 16 July 2007, 7:46 AM | View Comments (3) | Add Comment

GE Healthcare acquisition of Abbott Diagnostics deal scrapped: Who could be the next buyer in line?

CNN and Medical Device Link have just announced that the $8 Billion Abbott Diagnostics – GE Healthcare deal has been scrapped.  After GE Healthcare who could be a potential buyer?  Read on and the answer may (or may not) surprise you …

Also published on the Zangani Investor Community, the Wisconsin Technology Network – “Crazy like a Google? With GE-Abbott deal scrapped, could Google be next buyer” and Midwestbusiness.com.

 

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Posted by Ogan Gurel MD MPhil at 13 July 2007, 8:27 AM | View Comments (1) | Add Comment

Biologue Chicago - Life Sciences at the Columbia Yacht Club

Yesterday evening was a historic moment for Chicago.  Luckily, of course, no great fire but instead we had a gathering of over 70 professionals involved in all aspects of the life sciences in Chicago gather together at the Columbia Yacht Club on the lake front.  The organization that put this gathering together is called Biologue Chicago and it further substantiates the previous posting that forecasts a renaissance for life sciences business here in the Chicago area.

Also published on the iBIO news room.

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Posted by Ogan Gurel MD MPhil at 12 July 2007, 2:37 PM | View Comments (3) | Add Comment

How Doctors Think: Implications for Life Science Business & Finance

While this blog concerns the Business and Investment side of the Life Sciences, you may have noticed that interweaved in many of the discussions are concepts concerning the actual practice of medicine.  These span issues such as the relationship between medicine and surgery, the relative importance of diagnostics, therapeutics or prognosis, paradigm shifts in surgical thinking and so forth.  Clinical medicine and specifically what takes place between doctors and patients certainly does impact on the wider issues of business and finance.

 

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Posted by Ogan Gurel MD MPhil at 11 July 2007, 1:40 PM | View Comments (1) | Add Comment

Convergent Medical Technology: Part I - What is it?

Convergent medical technologies (CMT) are a growing sector in the life sciences.  What is CMT?  It would certainly be helpful to take a moment to define this area.  After taking a stab at defining CMT here, the next two postings will discuss why CMT is gaining in importance and how it will impact medicine and healthcare in the future.

Also found at: Nanotech feeder, the Redington Life Sciences newsletter and referenced in the MDD&I blog BiomaterialsTalk.

 

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Posted by Ogan Gurel MD MPhil at 10 July 2007, 9:46 AM | View Comments (4) | Add Comment

Chief Partnership Officer: An Idea Whose Time Has Come?

In light of today’s hip resurfacing posting and its implications for corporate partnerships as well as last year’s posting on the importance of partnerships more generally, I wanted to share with you another idea – namely the concept of a Chief Partnership Officer.  Does your organization have a Chief Partnership Officer?  Post your comments here ...

 

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Posted by Ogan Gurel MD MPhil at 8 July 2007, 3:33 PM | View Comments (2) | Add Comment

The Many Surprising Implications of Hip Resurfacing Implants

Stryker just received FDA approval for their Cormet Hip Resurfacing System.   Nearly 300,000 patients receive hip replacement procedures each year in the U.S and potentially as many as 15% of these may receive a hip resurfacing procedure instead of the more invasive and more definitive hip replacement operation. A closer view of this approval and the accompanying press release substantiate several important trends previously covered in this blog and which are are certain to continue in the future. 

The posting can also be found at Midwestbusiness.com, the Zangani Investor Community and on the Gerson Lehrman Group (GLG News) site.  See also follow up commentary by Erik Swain – Editor-in-Chief of Medical Device & Diagnostic Industry on the Medical Device Link blog.

 

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Posted by Ogan Gurel MD MPhil at 8 July 2007, 2:04 PM | View Comments (2) | Add Comment

FDA Reform Redux: On Business Models, Regulatory Reform and Safety

Are you interested in reading about ideas two weeks before they appear in the Economist?  If so, you should be reading this blog.  Several points on FDA reform were highlighted in this blog’s June 12th posting “FDA: Tortoise, Hare or Something Else” of which similar thoughts appeared over two weeks later in the June 28th Economist article “Beyond the blockbuster” and its accompanying leader “From bench to bedside.” 

Essentially, there are two sides to the problem (and its solution): (1) business models need to change and (2) regulatory frameworks need to be reformed.

Also found on the Redington Life Sciences newsletter and the Zangani Investor Community.

 

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Posted by Ogan Gurel MD MPhil at 6 July 2007, 7:09 PM | View Comments (19) | Add Comment

Too Few Biotech Firms in Chicago?

The June 25th issue of Crain’s Chicago Business has an interesting Letter to the Editor written by Prof. William O’Neill of UIC.  In that note he laments the lack of any biotech companies making the Crain’s Fast Fifty list of Chicago’s fastest-growing companies.  Here are my comments.

 

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Posted by Ogan Gurel MD MPhil at 6 July 2007, 6:33 PM | View Comments (5) | Add Comment

New Blog Launch: Independent Life Sciences Business & Investment Blog Debuts on Independence Day

Today is the 4th of July and while the Life Sciences is truly a global industry, I’d like to debut this blog – the Life Sciences Business & Investment Daily – recognizing this Independence Day holiday. Today (actually yesterday to be precise) we launched this blog which has been designed to be a truly independent and integrative perspective on the business and investment side of the life sciences. 

The range of topics is very broad but some important themes include convergent medical technologies (a.k.a. combination medical products), personalized medicine, clinical trials, patient safety, new business models, innovation and emerging medical technologies in general. The convergent medical technologies (CMT) subject alone has a dozen (and growing number) of entries as this blog is intended, in particular, to be a leading information portal for CMT. 

It’s going to be exciting and your participation is warmly welcomed!

 

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Posted by Ogan Gurel MD MPhil at 4 July 2007, 8:28 AM | Add Comment

Zangani Audio Webcast: Technology convergence, Personalized Medicine and Patient Safety

Yesterday I was interviewed on the Zangani Investor Community and discussed among other topics patient safety, convergent medical technologies and personalized medicine. You can also listen to the webcast here.

Also posted on WallSt Radio and YouLoud.

 

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Posted by Ogan Gurel MD MPhil at 3 July 2007, 8:48 AM | View Comments (1) | Add Comment

Response to Zack

[This is a response to several postings on the Walk For Healthcare Wall. I have tried to hold myself back but Zack’s postings became, in my opinion, too egregious to ignore. Here is my reply]

I have followed this discussion carefully and have avoided commenting simply because the Walk For Healthcare is not about my opinions but about the “Voice of the People”—namely those whose stories appear, in my estimation, to be largely invisible to the politicians and lobbyists currently driving the healthcare reform debate in Washington.

I am dismayed, though not surprised, at Zack’s naïveté. But you are young and certainly lack medical knowledge. Your comment, “Except in the case of emergencies, we do not generally need health care to live, though it certainly makes the quality of life far better” is a case in point. And it is also clear to me that you have posted your thoughts without reading any of my dispatches from the field. You can find the first three days at these links:
I would hope that you would read these dispatches. In fact, given your exaltation of the brutality of existence, I would require you to read these dispatches before you post any more comments on this group. This group Wall is not a ‘soap box’ for your own personal opinions but rather a venue for people to discuss the Walk For Healthcare and the issues and stories that it specifically raises. Consonant with your exaltation of the individual and that personal responsibility and accountability are what counts, I could very well say, as a logical conclusion, that frankly your opinion does not matter. It only matters to you—not to anyone else.

I would like, however, to address some of your points and answer, in terms of your own personal interests (because that is what matters) why healthcare for all is in your own best interests. It will help make you wealthier than you are.

I can propose to you the potential situation where you are sitting on a plane and a gentleman with TB coughs on you. You get TB, you can’t work for several months. You become less wealthy.

I can suggest another scenario where perhaps your future wife is infertile unless she receives expensive fertility treatments. You will never have a child to pass on your superior genes. Your children will not be wealthy as you will have no children.

I can imagine another possible scenario where, out of frustration with your limited procreation, you engage in affairs and get an STD (you are young, after all). You receive the ‘kiss that lasts a lifetime … until death.” While you are supremely responsible and accountable, human beings like to have sex and I think it would be highly presumptious of you to never succumb to such sin. Many libertarian-oriented Republicans—Gov. Sanford comes to mind—have somehow fallen short of their principles. The STD you get is AIDS. You will likely have a limited life span (though lengthened through the miracles of expensive medicines) and you will be less wealthy, if not because some of your money goes to keep you alive, certainly because your accumulated wealth due to your fewer years on this earth will be less.

I repeat, “except in the case of emergencies, we do not generally need health care to live, though it certainly makes the quality of life far better,” is what you wrote. Healthcare is not about the occasional broken arm—although I have, in fact, garnered stories on my 25 mile-a-day walk about how a broken arm has driven people to bankruptcy. Healthcare is a public good, perhaps not in all circumstances, but certainly in many. And I could go on with even more economic benefits that come from a healthy population. It is a national catastrophe, a tragedy out here on my walk. Perhaps you may never see it, or imagine it, but you can, if you like, read it in my dispatches.

I suspect you are thoroughly irritated by now. You've likely noticed, that I've have started every sentence with “I” and you are thinking that I am totally self-centered, egotistical, uncaring, and selfish.

... Indeed.

Look into the mirror, my friend: that is how you sound. Healthcare is about 'us' not about 'me.' Every doctor—a good doctor that is—learns that early on in medical school. << MORE >>
Posted by Ogan Gurel MD MPhil at 3 July 2007, 8:15 AM | Add Comment

The Future is Bright For Life Sciences in State of Illinois

There is tremendous commitment and initiative around bringing more life sciences to the Illinois and the Chicago area more generally.  The mega BIO2006 conference kicked off the trend and all indications are for further rapid growth in startups, new initiatives, more resources and more talent flowing into the area.  For more info read on … You can also find the original posting at Midwestbusiness.com and also download the PDF here.

Also posted on iBIO.

 

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Posted by Ogan Gurel MD MPhil at 25 June 2007, 10:19 AM | Add Comment

FDA: Tortoise, Hare or Something Else

The drug pipeline needs to be accelerated. Should the FDA be a hare and speed up approval? Drugs need to be safer. Should the FDA be a tortoise and slow down approval? Read more here on how I think the FDA should be neither hare nor tortoise. You can also find the original posting at Midwestbusiness.com where you’ll also find a reader survey on the issue and can also download the PDF here.  The main take-away is summarized as follows:

Efficacy would be determined in the market as it is in the European, off-label, and nutraceutical world. Some may argue that we need a strong, efficacy-driven FDA. But remember that in 1962, communication among and between clinicians, scientists, and the broader market was much less open and transparent than it is now in today’s Google and YouTube era. It is unlikely that blatantly ineffective treatments will gain significant traction in such a market especially because academic peer review and market-driven judgments can be more efficiently transmitted to all providers. Truth-in-advertising laws would need to be upheld (and indeed enforced aggressively) and just as with off-label use, manufacturers would be prohibited from making any specific efficacy claims.

Also posted on the Wisconsin Technology Network (in two parts: Part I and Part II), Medical Daily (6/20/07), Medical Daily (6/13/07), mkeconnect.com and Stockhouse - Canada.

 

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Posted by Ogan Gurel MD MPhil at 12 June 2007, 12:47 PM | Add Comment

Call to Action: How to Accelerate Medical Technology in Illinois, Beyond

The Innovation Gap column highlighted what is likely the rate-limiting step in accelerating biopharma and medtech development.  This posting - originally published in Midwestbusiness.com outlines a new business model and, in particular, a life sciences accelerator concept that may help to bridge that gap and bring medical technologies more quickly from bench to bedside. The PDF of this posting can also be obtained here.

Also posted on: HealthLeaders, HealthLeaders IT and the Biotechnology Wire.

 

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Posted by Ogan Gurel MD MPhil at 30 May 2007, 3:02 AM | Add Comment

The ‘Innovation Gap’: Preventing Ideas From Untimely Deaths

The "innovation gap," which is a term originally coined by the former Undersecretary of Commerce Mary Good, is more than just a sad litany of promising ideas snuffed out and laid to rest. Instead, the innovation gap is the rate-limiting step along the arduous journey of bringing life-saving ideas from initial concept to actual patient benefit. While solving this problem would not necessarily prevent all ideas from suffering an untimely death, it would at least allow more of them to reach their full potential. This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

Also posted on Wisconsin Technology Network – “Who’s Minding the Innovation Gap?,” European Innovation Service (www.innovationservice.eu), the Biotechnology Wire and Consultaglobal by J. de Francisco.

 

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Posted by Ogan Gurel MD MPhil at 29 May 2007, 10:25 PM | View Comments (3) | Add Comment

The Diabetes Divide: Is Diabetes a Surgical or Medical Disease?

Diabetes has been classically regarded as a medical disease.  Looking more closely at the anatomy of the disease (with respect to insulin dependent diabetes) indicates that next-generation solutions to the growing diabetes problem may involve more of a surgical than medical approach.  This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

Also posted on: the Zangani Investor Community, WallSt Radio, and the Wisconsin Technology Network – “Barriers will not stop convergence of medical technologies”.

 

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Posted by Ogan Gurel MD MPhil at 14 May 2007, 10:16 PM | View Comments (1) | Add Comment

An Unfolding Tragedy: Balancing Act between Innovation and Access

The unfolding tragedy between Abbott Laboratories and Thailand over pricing and patent protection for the drug Kaletra has enormous implications for the pharmaceutical industry.  A broader view of the problem – particularly in the context of medical diplomacy – may be required for an optimal solution.  You can also read the original posting at Midwestbusiness.com here or download the PDF here. 

Also posted on DoctorSan.com (Thailand), Wisconsin Technology – “Abbott vs. Thailand has implications for innovation and access” and Google Finance,

 

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Posted by Ogan Gurel MD MPhil at 30 April 2007, 1:39 AM | Add Comment

Personalized Medicine and Technology Convergence: Decisive Trends

Personalized medicine and technology convergence have been decisive trends over the past year with profound implications for the life sciences industry.  For more info read on … You can also find the original posting at Midwestbusiness.com and can also download the PDF here.  To summarize the essential message over the past year:

Technology convergence is an important trend with both challenges and trends for the biopharma and medtech industries.  Technology convergence runs hand-in-hand with personalized medicine – a huge shift in the way medicine will be practiced which will transform clinicians, patients and business.

Also posted on the Wisconsin Technology Network - “Personalized medicine and technology convergence”, the Zangani Investor Community and Digg.com.

 

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Posted by Ogan Gurel MD MPhil at 16 April 2007, 10:01 AM | Add Comment

KKR Buys First Data: On Private Equity, Pipelines, Development

The rise of private equity has an impact on innovation financing and by implication on pharmaceutical pipelines. However the problems of sparse pharmaceutical drug discovery have less to do with lack of money or commitment but more to do with a fundamental gap in our understanding of how drugs work.  You can also find the original posting at Midwestbusiness.com and can also download the PDF here.

Also posted on the Wisconsin Technology Network – “Of private equity, research, and drug development.”

 

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Posted by Ogan Gurel MD MPhil at 2 April 2007, 7:50 AM | Add Comment

What Patients Want: A Story of Choice, Trials, Evidence-Based Medicine

Clinical trials are serious business. In addition to being big business, they also involve serious ethical issues and choices. Most of us are aware of the ethical principle of informed consent underlying all clinical trials. What is less obvious is that conducting a clinical trial carries with it the responsibility to obtain and share its results.. This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

Also published on the Wisconsin Technology Network and the Association of Clinical Research Organizations (ACRO) – “Patients Put High Value on Choice.”  The latter posting also had a very nice summary of the issue:

Does a treatment work safely or doesn't it? While clinical trials usually focus on answering that very question, patients are often most interested in learning about the full range of options available to them, as well as the outcome of any trials they participate in.  Reviewing both the medical literature and media response to the Spine Patient Outcomes Research Trial (SPORT), which was reported in the Journal of the American Medical Association in November 2006, Dr. Ogan Gurel contends that double-blind clinical trials can minimize the idea that medical decisions are often more gray than black-and-white, and that patients put a high value on their ability to make choices about the direction of their treatment.  Between 45 and 60 percent of the participants in the trial, which sought to measure the effectiveness of surgery versus non-surgical treatments in relieving back pain due to lumbar disk herniation, decided to change their course of treatment from surgery to waiting, or vice versa. "The starkly dichotomous nature of the treatments (e.g. surgery versus waiting) and the high number of crossovers clearly send a message that patient choice is absolutely critical and integral to the therapeutic process," Gurel says.

 

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Posted by Ogan Gurel MD MPhil at 19 March 2007, 10:42 PM | Add Comment

Is Gov. Blagojevich’s new plan to cover the uninsured in Illinois a good or bad idea?

This blog has mostly concerned itself with the business of health care. Today, the tables will be turned and we will discuss – albeit only briefly in this short space – the health care of business with specific reference to the recently proposed IllinoisCovered plan to address the problem of those without healthcare insurance in the state of Illinois.  The essence of the proposal is as follows:

For the purposes of funding universal health care, businesses should be taxed according to their respective health care burdens on society.

You can also find the original posting at Midwestbusiness.com where you’ll also find a reader survey on the issue; a PDF of the article can be downloaded here.

Also posted on the Wisconsin Technology Network – “Healthcare of business: Universal coverage plan includes new business taxes” and the Healthcare IT Transition Group.

 

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Posted by Ogan Gurel MD MPhil at 5 March 2007, 7:30 AM | Add Comment

Medical Design Excellence Awards Offer Decisive Glimpse Into Future of Health Care

I just returned as a juror from the 2007 Medical Design Excellence Awards (MDEA). I thought it would be of interest to see what caught the judge’s eyes and what it takes to be an MDEA winner. Such considerations have important implications for future trends in the medical device industry. You can also read the original posting at Midwestbusiness.com here or download the PDF here. 

Also posted on or referenced on DeviceLink, the Wisconsin Technology Network – “And the winners in medical design are …”, ThomasNet Industrial News Room, the Medical Daily and quoted in the Coloradoan.

 

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Posted by Ogan Gurel MD MPhil at 20 February 2007, 5:24 PM | Add Comment

What’s More Important in Medicine: Diagnostics, Therapeutics or Prognosis?

What is more important: diagnostics, therapeutics or prognosis? While all play a role in medicine, this column provides some thoughts on how past history has addressed this question and also how recent events (such as the GE acquisition of Abbott Diagnostics) shed light on this fundamental issue.  This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

Also posted on the Wisconsin Technology Network – “A prognosis for GE and Abbott Diagnostics,” LabSoftNews, and medicexchange.com,

 

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Posted by Ogan Gurel MD MPhil at 5 February 2007, 10:50 PM | Add Comment

Lance Armstrong and the Future of Cancer Care

The Future of Cancer Care will be defined by a number of technology trends including earlier detection and diagnosis, targeted therapies, personalized medicine and minimally invasive intervention. So what’s the connection to Lance Armstrong? Read on … You can also find the original posting at Midwestbusiness.com and may also download the PDF here.

Also posted on the Wisconsin Technology Network and Mesothelioma Aid.

 

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Posted by Ogan Gurel MD MPhil at 22 January 2007, 10:38 AM | Add Comment

Subtle But Powerful, Publication Bias Goes Beyond Financial Incentives

Many of you are aware of the phenomenon of "publication bias" in the scientific literature. This most commonly refers to the fact that "negative" results find their way into publication much less commonly than "positive" results. In our less-innocent modern age, there are additional forces influencing publication bias.  This posting discusses this phenomenon in the context of the current erythropoietin (EPO) controversy and was originally published at Midwestbusiness.com and a PDF may also be obtained here.

Also appeared on RenalWeb.

 

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Posted by Ogan Gurel MD MPhil at 9 January 2007, 9:22 PM | Add Comment

Biotech Med Tech Business Models: Investors, Patients Deserve Better

Gary Pisano of the Harvard Business School has commented on the need for new business models for the life sciences and biotech in particular.  Muhammad Yunus of the Grameen Bank recently won the Nobel Peace Prize for his innovative microcredit programs.  What's the connection?  This article - originally published in Midwestbusiness.com - explores that connection. The PDF can also be obtained here.

Also found on the Biotechnology Wire.

 

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Posted by Ogan Gurel MD MPhil at 11 December 2006, 2:38 AM | View Comments (1) | Add Comment

Drug-Eluting Stents, Part Two: Triple Storm Catching Industry Attention

Like the 19th Century “Great Game” among the European powers in Central Asia, the major players (Johnson & Johnson, Boston Scientific and Abbott Labs) in the drug-eluting stent (DES) field are honing their strategies to dominate the drug-eluting stent market.  Part One of the series set the stage and described the J+J strategy and this article (Part II) outlines the Abbott strategy and summarizes possible trends going forward.  This article was originally published at Midwestbusiness.com and a PDF may also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 28 November 2006, 4:26 AM | View Comments (2) | Add Comment

Drug-Eluting Stents, Part One: Triple Storm Catching Industry Attention

Safety issues around drug-eluting stents (relating primarily to long-term instent thrombosis issues) have cast the market into deep turmoil.  All the players are now jockeying for position and this article highlights the background behind these changes and the Johnson & Johnson strategy of incremental improvement and product differentiation in particular.  Part Two highlights the Abbott Labs strategy and some of the next likely trends.  This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 27 November 2006, 4:40 AM | Add Comment

So Far, Venture Capital Relatively Unsuccessful in Biopharma Market

Innovation is usually assumed to be more advanced at smaller companies.  While this statement certainly has validity, small size along does not ensure innovation and there are structural aspects of the current VC model (as applied to the life sciences) that may limit innovation.  New business models may be required to overcome the biopharma innovation bottleneck. This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 14 November 2006, 9:02 PM | Add Comment

Cosmetic Implantables: There’s More Beneath the Surface

On the surface cosmetic implantables show great promise.  Underneath the surface, however, there are considerable risks particularly in the context of a growing emphasis on patient safety.  However, combining the technology behind cosmetic implantables with other medical technologies to meet unmet medical needs may create even greater value at lower risk.  This posting was originally published in Midwestbusiness.com and a PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 31 October 2006, 3:19 AM | Add Comment

Bioelectromagnetic Therapies: Science Fiction or Reality?

Bioelectromagnetics – the interaction of non-ionizing radiation with biological systems – has been around as a therapeutic modality since the first cardiac pacemakers of the 1950s.  New applications are under development and this growing area is increasingly become less “hocus-pocus” and more reality.  You can also read the original posting at Midwestbusiness.com here or download the PDF here. 

Also found on the Therapeutic Neuromodulation Weblog, Wetware hacking, and the Bioelectromagnetics Newsletter (a publication of the Bioelectromagnetics Society).

 

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Posted by Ogan Gurel MD MPhil at 16 October 2006, 2:10 AM | View Comments (1) | Add Comment

FDA-Approved Artificial Heart From Abiomed a Whimper, Not a Bang

The just approved artificial heart from ABIOMED is a technology tour-de-force yet one with significant safety and cost concerns.  It would appear that the FDA and even the company itself are hedging their bets – hence as described further in the article this advance is more of a “whimper” than a “bang.”  This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 8 September 2006, 6:16 AM | Add Comment

The Devil’s in the Details: A Closer Look at Merck’s Vioxx Trials

Why has Merck decided to fight every Vioxx claim in the courts?  Why is safety becoming an ever more important issue?  Read on as the answers may surprise you … This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 7 August 2006, 10:02 PM | Add Comment

Drug-Eluting Stent Market: $5 Billion Turning on a Dime

The drug-eluting stent market has reached $5B from virtually nothing three years go.  During that short period of time, massive market share shifts have also occurred.  This posting (originally published at Midwestbusiness.com) explores these trends and the reasons behind such turmoil with further market shifts also being anticipated.  A PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 24 July 2006, 4:05 AM | Add Comment

A Time to Make Friends: More Partnerships in Biotech, Med Tech?

Partnerships are becoming more important in building value in biopharma and medical technology.  The increasing importance of convergent medical technologies (CMT) is driving this trend and near the end of the article there’ll be a summary on where pharmaceutical industry has been and where it is going.  You can also read the original posting at Midwestbusiness.com here or download the PDF here. 

 

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Posted by Ogan Gurel MD MPhil at 12 July 2006, 7:38 PM | View Comments (1) | Add Comment

The Future of Drug-Eluting Stents: A Big Issue or a Non-Issue?

Safety issues have become increasing important with drug-eluting stents.  What does the future hold?  You can also read the original posting (along with an accompanying reader survey) at Midwestbusiness.com here or download the PDF here. 

 

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Posted by Ogan Gurel MD MPhil at 26 June 2006, 7:14 PM | Add Comment

Intellectual Property: Does it Matter?

Intellectual property – particularly in terms of freedom-to-operate – has always been important for the biopharma and medtech industries.  However, the rapid development of technologies (and obsolescence of existing products that results) along with the growing importance of combination products place more of a premium on the ability to accelerate to market and the ability to form productive partnerships in building value for businesses.  Intellectual property is “not dead yet” but there are other factors that increasingly underlie value creation in the industry.  This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 13 June 2006, 6:47 AM | View Comments (7) | Add Comment

‘Medicare Part D’: What the Benefit Means For Medical Technology

The Medicare Modernization Act adds a third player – pharmaceutical companies – to the traditional reimbursement balance of power between hospitals and physicians.  This new dynamic will also impact medical device firms and some perspectives and forecasts are posted here.  The article was originally published at Midwestbusiness.com here or you can download the PDF here. 

 

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Posted by Ogan Gurel MD MPhil at 15 May 2006, 7:43 PM | Add Comment

Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial

Safety has always been important in medicine but its relative importance has waxed, waned and waxed again over time.  During the Age of Hippocrates – the birth of western medicine – safety was at a premium and in the modern era the remarkable efficacy of contemporary medicine and surgery has shifted the risk-benefit balance.  However, we are seeing a new emphasis on safety as typified by the Vioxx controversy and this posting (originally published at Midwestbusiness.com) explores that trend and the reasons behind it.  A PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 1 May 2006, 3:36 AM | View Comments (2) | Add Comment

Perspective Following BIO 2006: The Midwest as Innovation Central?

BIO 2006 just finished here in Chicago.  What does this mean for the life sciences in the Midwest and, in particular, what are the special strengths of this region.  I think that the Midwest can be a leading center for combination or convergent medical technologies.  The article was originally published at Midwestbusiness.com here or you can download the PDF here. 

 

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Posted by Ogan Gurel MD MPhil at 17 April 2006, 7:59 PM | View Comments (2) | Add Comment

Innovators Have Rights Too!

Innovation -- variously defined as "the ability to create and capture economic value from invention" -- often results from the combining of inventions. This has important implications for the evolving patent law debate around convergent technologies and may have a very profound impact on the development of convergent medical technologies (CMT).  This posting was originally published as a letter to the editor at the Wall Street Journal.

 

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Posted by Ogan Gurel MD MPhil at 17 April 2006, 11:14 AM | Add Comment

Tech Convergence a Key Theme at Orthopedics Conference in Chicago

A recent small-cap orthopedics conference highlighted a number of companies with one major theme being that of technology convergence or the rise of combination medical products.  This posting discusses a few specific examples substantiating the trend as well as implications for personalized medicine, regulatory reform, different sales & marketing models and changing reimbursement paradigms   This posting was originally published at Midwestbusiness.com and a PDF can also be obtained here.

 

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Posted by Ogan Gurel MD MPhil at 3 April 2006, 11:16 PM | Add Comment
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