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Thinking about Life Sciences: Personalized Medicine and Technology Co...

Thinking about Life Sciences

Monday, April 16, 2007

Personalized Medicine and Technology Convergence: Decisive Trends

It’s been one year since the debut of MedTech Futures on and it has been a pleasure and a
privilege to have the opportunity to share ideas with through this forum. As this column enters its second
year, I wanted to take an opportunity to briefly summarize some of the perspectives over the past year and
also discuss a topic of great timeliness and importance – namely personalized medicine.
Medical Technology and Pharmaceuticals
The title of this column seems to indicate that medical devices and associated technologies would be the
natural topic of discussion. Indeed, over the past year I’ve written about spine surgery, the medical design
excellence awards, diagnostics, drug-eluting stents on four occasions (I, II, III,IV), cosmetic implantables,
bioelectromagnetic therapies, artificial hearts, and orthopedic technologies. I’ve also written several
columns on biopharma such as the future of cancer care, Epogen and pre-dialysis patients, Vioxx, drug
safety, the BIO2006 conference here in Chicago, among other articles.
For a medical technology column, that’s a fair bit of “electronic newsprint” being dedicated to
pharmaceuticals. One of the most important recurring themes of MedTech Futures has been the
convergence of medical technologies. In the article on medical design excellence awards, for example, I
highlighted how devices that incorporate software or electronic connectivity to enhance their safety and
usefulness earned high marks in that competition. In commenting on the GE Healthcare acquisition of
Abbott Diagnostics, I proposed that prognosis is actually more important than diagnosis and that those
companies that can provide IT platforms that integrate complex clinical information with their diagnostic
tests would be at an advantage. In another article on partnerships in biotech and medtech, I commented
on the importance of combining technologies to achieve innovation advantage.
Technology convergence
In the inaugural article in this series I pointed out how technology convergence was a growing theme
among orthopedic technologies. In fact, in the reader survey associated with that column, over 74% of
you said that “medical technology convergence is an exploding sector that’s critical today and to the
future” as compared to about 18.5% who said that it was “hype that doesn’t mean much in today’s
society.” Just over 7% had “never heard of it.” Because over 80% of you feel that medical technology
convergence is a significant phenomenon or have never heard of it, that’s certainly a compelling reason to
devote “electronic newsprint” to the topic. Hopefully over the past year I’ve answered that call to some
Personalized Medicine
Personalized medicine. Everyone talks about it. Some call it the future of medicine; some say it is here
now. Being, at times, a contrarian, I’m going to tell you it’s been around for thousands of years. The
practice of surgery (which was done in all of the ancient civilizations from China to Egypt) has always
been personalized. While an abdominal or scalp incision has a fairly generic codification, once that
surgeon makes that fateful cut, the operation becomes unique to that patient. Every medical student
learns from the first days of anatomy about anomalous hepatic arteries, that an appendix can even be

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found on the left-hand side of the abdomen and so on. Every patient is unique. Surgery – despite its oft
depicted aura of barbarism - is the epitome of personalized medicine. This fact is very important for the
development of modern personalized medicine which I will touch upon later in this column.
The Pharmacogenomic interpretation of personalized medicine
“Modern” personalized medicine has been largely defined in terms of pharmacogenomics which is the use
of a patient’s genotype or genetic information to select therapies that are particularly suited to that patient.
In fact, Illinois’ very own Barack Obama has sponsored a bill now in committee (S. 3822) entitled the
“Genomics and Personalized Medicine Act of 2006” You may very well see personalized medicine being
featured on presidential campaign ads. This bill provides for some very innovative measures including:
1. creating a Genomics and Personalized Medicine Interagency Working Group within the
Department of Health & Human Services,
2. a number of measures to encourage genomics and biobanking research,
3. enhancement of genomics workforce training and
4. an income tax credit for patients paying for genetic tests or the research related to that test.
The pharmacogenomic part of personalized medicine is indeed a very powerful and promising
phenomenon. To some extent it will continue to contribute to the “deconstruction of big pharma” whose
predominant business model based on blockbuster drugs is almost inimical to the personalization of
medicine. Many of the safety issues I have written about have developed because of the basic
incompatibility of the blockbuster model with the trend towards personalization (and consequently greater
safety) in medicine. With respect to Vioxx, for example, that drug got into trouble because its use was
being extended into areas such as colon cancer prophylaxis which required long-term, chronic use of the
drug. More applications, more patients and longer-term use are the very definition of blockbuster. As I
wrote in the Vioxx article, it is interesting to note that Merck is contesting (and mostly winning) each
claim. That’s because, technically speaking, the data only shows the adverse effects with long-term chronic
use of the drug. Generally speaking, that can only be documented for the colon cancer prevention trials
and not for the previously established indications. The erythropoietin (EPO) controversy represents yet
another example highlighting how an extended indication raises safety issues in yet another drug (in this
case erythropoietin for pre-dialysis renal patients).
It would seem, then, that one of the predictions of personalized medicine is the death of the blockbuster
model. Ironically, in an era of personalized medicine, one would think that drug companies would
successively decrease the range of indications and patient populations for their drugs. The blockbuster
model, however, demands the opposite. The two trends are incompatible and, quite frankly, the whole
drug industry model of the future is going to be determined by how this drama plays out.
So what is to be done? This is where technology convergence comes into play. You can read it for
yourself but Sen. Obama’s (S. 3822) bill actually mandates technology convergence between
pharmaceuticals and diagnostics. Basically, among the bill’s many provisions, it is stated that the FDA
“require the sponsor of a drug or biological product (e.g. a drug company) to (1) co develop a companion diagnostic
test, after filing an investigational new drug application or a new drug application to address significant safety
concerns of the drug or biological product [and] (2) to develop a companion diagnostic test if phase IV data
demonstrate significant safety or effectiveness concerns with use of the drug or biological product …”
Whether or not this bill passes, technology convergence between pharmaceuticals and diagnostics (also
termed theranostics) is here to stay. How drug companies will embrace that trend will unfold over the
coming year or two.
Medical technology and personalized medicine
I had indicated earlier that surgery represented the original paradigm of personalized medicine and I don’t
believe many would dispute that. In this regard, I consider “modern” personalized medicine as being

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more than just pharmacogenomics. Advances in electronics miniaturization, materials science and
minimally invasive techniques have made implanted devices more and more of a reality for millions of
patients. The “bionic human” is also a trend – well documented by a book by Dr. Frank Johnson “Health
Promotion for People with Implanted Prosthetic Devices” – that is here to stay. Implanted devices,
especially if they incorporate various intelligent algorithms, are also a powerful way to implement
personalized medicine. One of the award-worthy devices at the Medical Design Excellence Awards
(MDEA) was the Proprio Foot motor-powered prosthesis, by Ossur based in Reykjavik, Iceland. The
mechanics of the device are supplemented by a microprocessor driven software program that more
efficiently mimic different walking styles for the patient. From diabetic amputees to injured Iraq veterans,
this represents a significant advance. Other examples of devices that deliver personalized medicine
include various drug-delivery systems that optimize drug dosages according to patient-specific
parameters. This has been, for example, the holy grail of next-generation insulin infusion pumps which
continuously monitor blood glucose levels and deliver exactly the dose of insulin required.
Again, the personalized medicine of this sort implies technology convergence. Convergence between
devices and drugs and/or devices and computer software/hardware. Just as with the major
pharmaceutical companies, the device companies will also need to meet (perhaps less traumatically) the
challenges of technology convergence. The automobile industry did this when electronics (e.g. telematics)
became a larger part of automotive technology. Some companies did this well; others such as even highly
vaunted Mercedes-Benz encountered significant problems incorporating electronics into traditional
automotive technology.
Technology convergence, appealing as it sounds, is not easy. So, if I were to encapsulate an entire’s year’s
columns, I would say it would be this:
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.
Technology convergence was the topic of the very first column in this series and I would encourage you to
take a look at the reader survey on that page. An overwhelming majority of reader’s felt that this was an
important trend. This is only the beginning.
Ogan Gurel, MD MPhil

Convergent Medical Technology Personalized medicine Personalised Medicine pharmacogenomics practice of medicine technology convergence blog
Aesis Research Group Ogan Gurel MD

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