SlideShare a Scribd company logo
1 of 9
Download to read offline
strategy+business



ONLINE AUGUST 13, 2012




BY AVI KULKARNI AND NELIA PADILLA MCGREEVY
A Strategist’s Guide to
Personalized Medicine
Breakthroughs in pharmaceutical innovation are poised to
change the prevailing business model of the industry — with
dramatic, disruptive effects on healthcare costs and practice.
O
    A Strategist’s Guide to
    Personalized Medicine
    Breakthroughs in pharmaceutical innovation are poised to change
    the prevailing business model of the industry — with dramatic, disruptive
    effects on healthcare costs and practice.

    by Avi Kulkarni and Nelia Padilla McGreevy
1
www.strategy-business.com




              ne of the most innovative medications of recent     ly to benefit from chemotherapy. The results of this test
              years is Novartis’s imatinib, which is marketed     can help physicians avoid prescribing drugs with no
              as Gleevec. Introduced in 2001, it set a record     medical value; because those drugs often have severe
    for the fastest approval time by the U.S. Food and Drug       side effects, the test greatly benefits patients as well.
    Administration (FDA), and in 2011 had US$4.3 billion               The concept of personalized medicine is only 15
    in sales. Imatinib was the first of a new class of drugs      years old, and it does not have a perfect track record;
    that act by inhibiting a specific enzyme — in this case,      some of its medications have failed to get regulatory
    a receptor called tyrosine kinase — that is characteristic    approval or to be profitable in the marketplace. But
    of particular cancer cells. Because only certain cancers      where it has proven successful, it is creating for health-
    will respond to imatinib, it is prescribed only for           care businesses a fundamentally new value proposition.
    patients identified by specific diagnostic tests (for exam-   It represents a game-changing trend for healthcare
    ple, the Philadelphia chromosome abnormality test).           providers (hospitals and individual physicians); payors,
         Imatinib is an example of the products emerging          including Medicare and private insurance; and patients,
    from a new pharmaceutical field known as personalized         who can have a far more participative role in their own
    medicine (PMx): the tailoring of drugs and other treat-       care than they would without PMx. When physicians
    ments to specific populations, based on their genetic         and patients can draw upon a wealth of genetic and bio-
    profiles or other differentiating factors. (We use the        logical data, personalized therapy will become the
    abbreviation PMx to follow Rx for prescription medi-          norm, not the relatively rare occurrence it is today.
    cine and Dx for diagnostic tests.) The underlying tech-            The greatest impact of this new approach to indi-
    nology for PMx marries advances in diagnostic biotech,        vidualized diagnosis and treatment will probably be felt
    such as rapid gene sequencing, with a profound expan-         in the pharmaceutical industry. Leading pharmaceutical
    sion of scientists’ understanding of molecular disease        companies have long relied on innovation to expand the
    pathways. Another example is Genomic Health’s                 frontiers of better health — and to financially sustain
    Oncotype DX breast cancer test, introduced in 2004,           their businesses. But that capacity for launching new
    which uses an analysis of multiple genetic variations to      products is under severe strain today. Many pharmaceu-
    determine which cancers are likely to recur for a partic-     tical companies have recently seen their research and
    ular individual. It also indicates which patients are like-   development productivity erode. Biotech startups have
Avi Kulkarni                       Nelia Padilla McGreevy         Also contributing to this
                                                                  article was strategy+business
is a partner with Booz &           is a principal with Booz &     contributing editor
Company based in San               Company based in Boston. She   Lawrence M. Fisher.
Francisco and a member of          specializes in personalized
the firm’s global health           medicine and pharmaceutical
practice. His areas of expertise   regulations.
include personalized medicine,
life sciences R&D, and the
pharmaceutical and diagnos-
tics industries.




                                                                                                                                 2




                                                                                                                                 www.strategy-business.com
avi.kulkarni@booz.com              nelia.mcgreevy@booz.com




struggled to turn their scientific advances into viable            (1) the subtype of their HIV infection, (2) their body’s
drugs. Companies have resorted to alternatives such as             response to the infection, and (3) the stage of the over-
vaccines, preventive care, and geographical outreach for           all infection, they could prescribe the best tailored ther-
profits, but no pharma industry breakthrough has come              apy cocktail for each patient. This combination of
along recently to create a promising pipeline of new               prescribed diagnostics and pharmaceuticals has been a




Success and Disruption
products. PMx offers the potential for just that sort of           remarkable success story. It has improved quality of life
breakthrough.                                                      for patients and extended the average life expectancy of
      Thus, despite the disruptive nature of personalized          newly diagnosed HIV patients by 20 to 25 years.
medicine, the pharmaceutical industry is emerging as a                   HIV infects different patient groups in different
driving force in this field. The list of early PMx adopters        ways; for a patient diagnosed with it, a physician must
includes some industry giants: Roche, Pfizer, Novartis,            choose from more than 20 different antiviral agents in
and Lilly. The field is also populated with upstart com-           six unique drug classes. While undergoing antiretroviral
panies such as Genomic Health, XDx, and Prometheus                 therapy, patients are monitored with advanced diagnos-
Labs that offer specialized approaches to segmenting               tic blood tests every three to four months to assess the
disease, as well as the recognized pioneers in personal            severity of infection and confirm that the virus is being
genomics: 23andMe, deCODE Genetics, and DNA                        suppressed. Some of these tests can predict how indi-
Direct. In adopting PMx, they are all embracing a new              vidual patients will respond to specific therapies, thus
healthcare model that emphasizes segmentation of                   increasing their odds of survival. For instance, Selzentry,
patients, and decisions and practices tailored to individ-         an antiretroviral drug developed by Pfizer, works by
uals or small groups. Although this approach might                 binding to and thereby blocking the CCR5 receptor,
lead to smaller revenue pools for pharmaceutical pro-              which is found on the surface of certain human cells
ducers, PMx can actually improve their profits. A busi-            and is necessary for the entry of the virus into the host
ness model based on differentiated products can reduce             cell. But in some people, HIV can use other receptors
the system-wide costs and complications of one-size-               instead, which would render Selzentry ineffective.
fits-all medications, provide new opportunities for mar-           Therefore, before Selzentry can be prescribed, patients
keting, and establish new efficiencies in production and           are given an HIV tropism test called Trofile to deter-
distribution.                                                      mine whether the drug will be effective for them.
                                                                         Personalization of anti-HIV drugs benefits all con-
                                                                   stituents. Payors and governments maximize the value
As an example of the impact of personalized medicine,              of therapies on the market, squeezing the best effects
consider the evolution of treatment for human immun-               from the cheapest anti-HIV drugs. Physicians and clini-
odeficiency virus (HIV), the retrovirus that causes                cians, who have had to rethink their management of
AIDS, during the 1990s and 2000s. Physicians found                 HIV/AIDS treatment, have dramatically improved suc-
that by grouping patients into smaller subsets based on            cess rates. Patients are the ultimate beneficiary: An HIV-
A New Form of Pharma R&D



3
www.strategy-business.com




    positive test used to be a short-term death sentence.        First, the prospects for innovation; second, the right
    Now HIV is considered a chronic, manageable disease,         value proposition; and third, the capabilities needed to
    with treatment costs that are considered acceptable and      deliver on that proposition.
    affordable even in sub-Saharan Africa.
         Pharmaceutical companies have also benefited
    greatly. The PMx approach to HIV/AIDS treatment, for         Back in the age of economies of scale, most drug com-
    example, has helped make Gilead Sciences Inc. the            panies’ business models depended on producing thera-
    world’s second largest biotech company, after Amgen          pies for the largest number of people with unmet
    Inc., with a market cap of $38 billion. The use of com-      medical needs: cimetidine (GlaxoSmithKline’s Tagamet)
    panion diagnostics allowed Gilead to improve the over-       for excess stomach acid, lovastatin (Merck’s Mevacor)
    all efficacy of its portfolio of drugs for HIV/AIDS,         for high cholesterol, and naproxen (Bayer’s Aleve) for
    cementing its lead in that market.                           aches and pains. Even biotech’s early successes, starting
         But of all the constituents, pharma companies face      in the 1970s, were conceived as mass-market products:
    the greatest disruption from personalized medicine. It       recombinant insulin (Lilly’s Humalog) for diabetes,
    forces them to adopt a new business model with a coun-       epoetin alfa (Amgen’s Epogen) for anemia, and etaner-
    terintuitive value proposition, requiring unfamiliar new     cept (Pfizer and Amgen’s Enbrel) for autoimmune dis-
    capabilities to make it work. For many pharma compa-         eases like rheumatoid arthritis and psoriasis. Each
    nies, PMx means changing established practices in all        represented a multibillion-dollar franchise sustained for
    aspects of the business — from the earliest stages of tar-   many years — and together, they reduced many causes
    get identification and drug discovery, through clinical      of early mortality, helping raise the average human life
    development, regulatory approval, commercial develop-        span.
    ment and operations, and marketing and sales.                      But an aging population also means that chronic
         PMx is only one of several strategies that pharma-      diseases — including immune-mediated diseases such
    ceutical companies will adopt in the next few years.         as cancer, metabolic diseases such as diabetes, and neu-
    Some will seek to retain the same business model even        rological diseases such as dementia — have become
    as their innovation pipeline dwindles. They will use         more prevalent. Unlike the acute killers of previous gen-
    their marketing capabilities to sell so-called branded       erations, these diseases tend to affect people in a rela-
    generics, off-patent versions of their own former block-     tively heterogeneous manner. Depending on their
    busters, accepting lower margins in return for high vol-     genetic makeup, people are susceptible to different dis-
    ume sales. Others will play the specialty pharmaceuticals    ease strains and may respond in different ways to the
    game, repurposing old drugs in new delivery systems for      same medication. For illnesses like these, the healthcare
    different diseases than those for which they were origi-     system can no longer afford a trial-and-error approach
    nally approved. This is a well-established low-risk model    to pharmaceutical research, in which physicians attack
    that investors understand.                                   diseases with one compound after another in hopes of
         But a number of pharmaceutical companies will           finding one whose benefits to the patient will outweigh
    adopt the personalized medicine paradigm. They recog-        its side effects.
    nize the competitive advantage that could accrue from a            With personalized medicine, segmentation begins
    segmented customer base with structures, processes, and      at the research stage. A PMx team seeks out patient pop-
    capabilities to match. They are just unsure about how to     ulations that can be identified using biomarkers. A bio-
    leap ahead into practice.                                    marker is a measurable substance in an organism — a
         That is why they need a plan for implementing per-      gene, protein, or other biological element — whose
    sonalized medicine. To be successful, they will need to      presence has been linked to a pathology, such as cancer
    take into account three elements of their current reality:   or autoimmune disease. A biomarker may also be a
types, such as tissues, bodily fluids,     management.        Biopharmaceutical
                                            and DNA/RNA and other proteins.            companies are accustomed to out-
                                            Map the patient’s journey from diag-       sourcing research, development,
                                            nosis to treatment, and use Dx tests       and clinical trials. But PMx is differ-
The experience of biopharmaceuti-           to develop efficient patient–disease       ent. It involves partnership capabili-
cals suggests that seven processes          stratification.                            ties that many companies do not
and practices are required for profi-         3. Cross-functional (Rx and Dx)          possess. A partnership for a com-
ciency in personalized medicine.            regulatory and clinical expertise.         panion diagnostic test, for example,
Together, these could become the            Drugs that are aimed at patient sub-       has regulatory, quality control, legal,
basis of a distinctive capability in this   sets and paired with companion             marketing,      and   sales   aspects,
field.                                      diagnostics make new demands of            involving both the test and the drug.
  1. Biomarker discovery and iden-          regulators, so applicants must come        It is critical to define in advance how
tification. The first step is to identify   prepared. Start by building optimal        much value the drug contributes
a biological trait that indicates the       indications — explanations of the          versus how much the enabling diag-        4
presence or progression of a dis-           diseases the drug is licensed to treat     nostic contributes, and to build a
ease. Next, develop a test that can         — and labels, which are the FDA-           win-win model for the Dx and Rx
detect the presence or quantity of          compliant texts that specify how the       participants.
these     biomarkers.      That     test    drug should be used. Introduce               6. Marketing. A pull-based strate-
becomes the diagnostic. Costs need          these materials early to key opinion       gy requires a knowledge-intensive
not be excessive because many rele-         leaders in the relevant field of medi-     effort aimed at key opinion leaders




                                                                                                                                 www.strategy-business.com
vant biomarkers have been discov-           cine.                                      and decision makers. You will also
The Essentials of




ered and classified by academic and           4. Pricing, reimbursement, and           need to reach out to national and
independent research labs and are           billing systems. Develop a sophisti-       regional payors.
PMx Practice




available in public databases. The art      cated knowledge of health econom-            7. Sales. Retrain your sales force
lies in establishing biomarkers’ clin-      ics modeling, and cultivate policy         to be conversant in complex science,
ical utility by separating the disease      experts. Base your projections on          including genomics, proteomics, and
signal from biochemical noise.              the idea that patients who gain no         bioinformatics. Revenues from each
  2. Assay development. Create in           benefit from a drug will not take it;      drug will be spread over fewer
vitro tests that scale beyond the lab-      this will cut costs throughout the         patients and total prescriptions, so
oratory setting to clinical or com-         healthcare system. The right drug to       each staff member will need to man-
mercial use. Develop assays on all          the right patient at the right time is a   age a larger number of products.
major technology platforms and              powerful value proposition.
across multiple analyte and sample            5. Partnership      selection    and



genetic variant that indicates an individual’s potential          ed levels of a protein marker called HER-2 in patients
response to a particular drug. Drugs are tailored to rela-        who responded. The FDA approved the medication for
tively small, well-defined patient groups, segmented by           only that group of people. Herceptin is now a drug with
these markers; the Dx enables the Rx.                             yearly sales of $6 billion.
     This type of pharmaceutical research first led to a               Since Herceptin, companies have used pharma-
marketable product in 1998, when the FDA approved                 cogenomic assays (tests based on genetic biomarkers) to
Herceptin — a breast cancer drug developed by                     resuscitate drugs that would have failed clinical trials, or
Genentech. Herceptin works in only about 25 percent               to manage the potential danger of side effects. Because
of breast cancer patients. Ordinarily a drug that did not         many cancers are prompted by mutations in the genet-
work for three-quarters of the patient population would           ic code, oncology has been the most fertile early ground
have failed to win regulatory approval. But researchers at        for these drugs. For example, Erbitux and Vectibix were
Dako AS, a diagnostics company based in Denmark,                  developed for colorectal cancer, but they work only in
devised an accompanying assay (an analysis of the pres-           people whose tumors have a mutation in the EGFR
ence of a substance or genetic indicator) showing elevat-         gene and a normal KRAS gene, and thus are prescribed
5
www.strategy-business.com


    only after positive responses to assays for those variants.     with global distribution and advertising, are too expen-
         Personalized medicine could be applied to a wide           sive and cumbersome for personalized therapies.
    range of chronic diseases. As knowledge of the human            Moreover, decisions about the use of personalized pre-
    genome expands, new and old drugs alike can be made             scription drugs are made by a relatively small number of
    more viable through genetic testing. Strattera (atomox-         sophisticated payors — hospitals, major providers, or
    etine), a drug used for attention-deficit hyperactivity         large payors — and not by general practitioners, who
    disorder, was linked to liver damage for patients with a        are disinclined to prescribe drugs that will not be reim-
    mutation in the CYP2D6 gene. It is now marketed with            bursed by Medicare or private insurance.
    a pharmacogenomic assay to rule out this population.                 As PMx 2.0 unfolds, popular demand will drive its
    Warfarin and Plavix, two blood thinners, can cause              growth. Because it takes into account each patient’s
    excessive bleeding among patients with particular genet-        unique pathophysiology; the biochemistry of the tumor,
    ic variations. Testing can show which patients should get       bacteria, or virus; and the individual’s ability to proper-
    other medicines.                                                ly react to and metabolize different drugs, it will repre-
         All this innovation still represents what might be         sent a step change in medical confidence and in
    called version 1.0 of personalized medicine: diagnostic         protection against side effects.
    tests applied only after a drug’s development to salvage             Already, the appeal of personalized medicine is
    or increase its value. Industry leaders now are moving          changing the way people spend their own money on
    toward another form of PMx innovation — call it ver-            healthcare. In 1996, for example, when Myriad
    sion 2.0 — in which new drugs are developed concur-             Genetics Inc. launched BRACAnalysis, a predictive test
    rently with companion diagnostics. Under this R&D               for hereditary breast and ovarian cancer, Medicare and
    model, researchers identify target patient subgroups in         private health insurance did not reimburse for it.




    A New Business Model
    advance and design drugs for these specific populations.        Nonetheless, many patients paid the $3,000 cost out of
         PMx 2.0 has been held back, somewhat, by cost.             pocket. So many of them forwarded the receipts to their
    The first human genome sequence cost $3 billion and             insurers and argued on behalf of the test that
    took many years to completely map. But now the costs            BRACAnalysis is now commonly reimbursed.
    are shrinking and the effectiveness is growing at an                 People have shown a willingness to pay for many
    exponential pace. Several companies offer personal              other personalized forms of healthcare as well.
    genome sequencing for a few thousand dollars or less;           Hundreds of thousands of people have opted for a sys-
    within 10 years, it is reasonable to expect that sequenc-       tem known as “concierge medicine.” They pay $59 a
    ing a personal genome will take an hour and cost per-           month, or more, for 24/7 access to a physician’s advice
    haps $300, or less than an MRI. It is not too much of a         and counsel, without other types of insurance included.
    reach to postulate cell phone–sized analytical devices          Thousands of others flock to alternative medicine,
    able to test for 500 biomarkers that cross the body’s           despite the lack of clinical evidence. At least in part,
    more than 50 organs in a single drop of blood.                  patients are attracted by the perception that alternative
         As it becomes more prevalent, the pairing of diag-         medicines are tailored to individual attributes. (For
    nosis and therapy will yield big gains in R&D produc-           example, some popular medical self-care books propose
    tivity. The patient subgroups that stand to benefit from        different regimes of food and herbal remedies based on
    a drug will be identified in advance of clinical trials. This   blood type.)
    could lead to a meaningful improvement in the average                Personalized medicine will change the way individ-
    response rate for drugs, which is currently 50 percent          uals learn about their health. It will lead to more
    across all categories and just 22 percent in oncology.          involvement of patients in managing their therapy, and
    That improvement, in cancer alone, would more than              better tracking of patient activity during and after treat-
    compensate for the cost of diagnostic technology.               ment. Today, any newly diagnosed cancer or autoim-
                                                                    mune disease patient can consult countless online
                                                                    forums devoted to his or her disease. The information
    The rise of personalized medicine provides pharma               there runs the gamut from accurate and helpful to well-
    companies and healthcare providers with a value propo-          meaning but inadequate to utterly fallacious.
    sition different from the one they’re accustomed to. The        Genentech discovered early on with Herceptin that
    standard pharmaceutical mass-marketing approaches,              innovative, proactive educational materials are essential
6




                                                                                                                            www.strategy-business.com
to successful PMx. Similarly, Gilead, the world leader in     traditional competencies such as those of medicinal
HIV/AIDS drugs, has a long tradition of working with          chemistry, molecular biology, and high throughput
AIDS activists — including some who massed angrily in         screening; they augment them.
front of its headquarters in the 1990s — to enlist them             The capabilities that distinguish a company in per-
in spreading information about the drugs and the vary-        sonalized medicine are not just tools, of course; they
ing effects of each drug on different individuals.            represent combinations of processes, technologies,
      To realize the business potential in personalized       knowledge, skills, and organization that have been
medicine, pharma companies will need to emphasize             developed over time. Nor can they be thought of in iso-
diagnostics — which, historically, has been a very dif-       lation. Distinctive capabilities are always cross-function-
ferent business from pharmaceuticals, with far lower          al. For example, a pharmaceutical company may decide
profit margins, making it unattractive to drug compa-         to develop its prowess in a particular type of medical




                                                                      • Build a mind-set in which personalization is not
nies in the past. Most pharma companies do not have           practice, such as oncology, immune system disorders, or




                                                              an option but a necessity — even in the face of the
the requisite Dx identification, development, or com-         mental illness. This will necessarily bring together pro-
mercialization capabilities to play effectively in this       fessionals in genetic research (for biomarker discovery
space, and will have to build, buy, or borrow them.           and development), patient outreach, finance (for devel-
      Fortunately for the companies, version 1.0 of per-      opment of pricing and economic models for stratified
sonalized medicine has already raised the value of diag-      patient populations), and sales and marketing (for




                                                                    • Retain flexibility. Place a premium on portfolio
nostic tests. In the past, they typically sold for $300 or    working with clinics). These are not separate processes
less. Today, some tests, such as Oncotype DX, produced        and systems; personalized medicine requires synchro-
by Genomic Health, are priced at about $4,000. This           nized adjustments in every part of the value chain from




The Capabilities System of Personalized Medicine
test is expensive because it is based on years of propri-     discovery to development to commercialization to life-
etary genetic research and multiple large-scale clinical      cycle management.
trials to confirm its predictive capability. Even so, it is         After 20-odd years of business process reengineer-
seen as affordable; without it, chemotherapy is far more      ing, most pharma company managers understand how




                                                                  • Build PMx capabilities into the existing capabilities
expensive and toxic.                                          to make structural changes, though they are often blasé




                                                              system. In an era of constrained spending and a vital
      Several leading pharma companies are beginning to       or cynical about the ultimate benefits. Personalized
build or buy the capabilities required to fulfill the goals   medicine could also require changing hearts and minds
of the patient-centric model. For example, Novartis           because it affects the character of an enterprise.
acquired Genoptix for $470 million in 2011 — a deal           Although individual companies will develop new capa-
that demonstrated, to many in the industry, that the          bilities in their own way, all successful PMx initiatives
largest companies were interested in PMx. In August           will need to include these imperatives:
2012, GlaxoSmithKline paid $3.6 billion to acquire
Human Genome Sciences, one of the earliest companies
to mine the genome in search of innovative drugs.             inevitable failures that occur with new drug candidates.
      As the bidding for diagnostics assets accelerates,      Assume that all molecules in the pipeline will be tailored
some target companies are likely to be overvalued, and        to specific patient populations; non-tailoring will
some acquirer companies may overpay. But sitting on           become the exception.
the sidelines is not a viable option. Payors and physi-
cians are increasingly unwilling to support drugs with        management skills, determining as early as possible
only a fractional response rate. Moreover, the PMx            which molecules to advance from research to develop-
promise to raise R&D productivity while improving             ment, and when to drop a hitherto promising candidate
patient outcomes is simply too compelling to ignore.          for which the PMx case is weak. Similarly, remain tech-
                                                              nologically agnostic; don’t commit to only one biotech-
                                                              nology research platform.
One way to think of PMx capabilities is as a set of new
instruments that will provide new insights into disease
and treatment. But just as ultrasounds and CT scans           need for R&D efficiency, essential PMx capabilities
have not displaced stethoscopes and thermometers in           must be identified and integrated into the existing value
the physician’s bag, the tools of PMx do not supplant         chain. Build the kind of organizational discipline that
• Access new capabilities through partnerships —




7
         • Build a sales force with new capabilities. Sales




    Managing a Disruptive Innovation
www.strategy-business.com




                                                                   to act is now. +
    eschews drug candidates with a potentially large market        gest that PMx could be disruptive in a way that the
    but lower probability of success. Favor smaller-market         healthcare industry cannot long ignore. “The advent of
    drugs that are more likely to succeed. With this               precision medicine,” write the authors, “heralds prod-
    approach, you may reap many benefits, such as faster           uct-line fragmentation in pharmaceuticals. Volumes per
    clinical trial enrollment, faster achievement of goals,        therapeutic compound will drop significantly, as the
    lower clinical costs, and greater likelihood of success.       number of therapeutic compounds expands.
                                                                   Blockbuster drugs will become rare. This will necessitate
    for example, for diagnostics development and commer-           a reshaping of the business model of today’s major phar-
    cialization. Ensure access to world-class diagnostics          maceuticals companies because — to borrow words
    without significant capital outlays by collaborating with      from oil exploration, in the future there will be fewer
    assay developers and other companies. Understand that          big gushers to cover the costs of drilling a lot of dry
    these are truly strategic partnerships that share fully in     holes.”
    the creation of value; they are not the routine outsourc-           An ongoing theme in Christensen’s work is that the




                                                                   Resources
    ing of a fungible function.                                    leading practitioners of an old order tend to be the vic-
                                                                   tims of disruption, not the initiators. But The
    teams will need to pair targeted therapies with sophisti-      Innovator’s Prescription proposes that today’s healthcare
    cated diagnostic tests. In addition, they will need to be      leaders can educate themselves and play a major role in
    well versed in biological and disease pathway intelli-         disrupting their own businesses, as IBM did when it
    gence, and well-informed about patient segment attrib-         introduced the personal computer. There may not be
    utes that can impede successful treatment.                     much time to make the shift; across many disease areas,
                                                                   PMx and novel diagnostics are already changing the
                                                                   practice of medicine, and already accepted as a new way
    Like all innovations, personalized medicine has been the       to play in the life sciences market. That is why person-
    focus of a great deal of hype, and it is worthwhile to take    alized medicine should be on the senior agenda of every
    a few steps back to put it in perspective. It may be over-     pharmaceutical company. Major new capabilities are
    sold at times — particularly in oncology, where it has         not built overnight, and mind-sets are slow to change.
    been heralded as the next “cure for cancer.” Because can-      Some leading companies are already moving, and so are
    cer is many different diseases, with many different mod-       major stakeholders like payors and providers. The time
    ulators and multiple mutations even within a single
    tumor site, personalized medicine cannot be that kind
    of cure. It will never be a panacea.
         But it also is not a placebo. Eric Topol, a cardiolo-
    gist and geneticist, and the current director of the
    Scripps Translational Science Institute in La Jolla, Calif.,
    paints an optimistic picture in his recent book, The
    Creative Destruction of Medicine: How the Digital
    Revolution Will Create Better Health Care (Basic Books,
    2012). He proposes the integration of basic PMx tools
    — such as biomarkers for specific pathways and special-        Marcus Ehrhardt, Robert Hutchens, and Susan Higgins, “Five Steps
                                                                   toward a Revitalized Pharmaceutical Supply Chain,” s+b, Spring 2012,
    ized diagnostic technologies — into everyday life.             www.strategy-business.com/article/00094: Companies embracing person-
    Perhaps biomarker-sensitive devices embedded in                alized medicine will need to build these operational capabilities.
    mobile phones could detect cancer cells circulating in
                                                                   Gil Irwin, Art Kleiner, and Joyjit Saha Choudhury, “When Disruptive
    the blood or warn people of an imminent heart attack.          Integration Comes to Health Care,” s+b, 03/01/10, www.strategy-
         Topol also says that many of these innovations must       business.com/article/00020: The Innovator’s Prescription coauthor Jason
                                                                   Hwang talks about the next wave of healthcare business models.
    overcome the medical community’s profound resistance
    to change. In The Innovator’s Prescription: A Disruptive       Alex Kandybin and Vessela Genova, “Big Pharma’s Uncertain Future,”
    Solution for Health Care (McGraw-Hill, 2009), Harvard          s+b, Spring 2012, www.strategy-business.com/article/00095: As the era of
                                                                   the blockbuster drug comes to an end, the industry must cope with new
    Business School professor Clayton M. Christensen and           unknowns.
    physicians Jerome H. Grossman and Jason Hwang sug-
strategy+business magazine
is published by Booz & Company Inc.
To subscribe, visit strategy-business.com
or call 1-855-869-4862.

For more information about Booz & Company,
visit booz.com



• strategy-business.com
• facebook.com/strategybusiness
• http://twitter.com/stratandbiz
101 Park Ave., 18th Floor, New York, NY 10178




Looking Booz & Company Inc.
© 2012 for Booz Allen Hamilton? It can be found at at www.boozallen.com

More Related Content

More from Strategy&, a member of the PwC network

More from Strategy&, a member of the PwC network (20)

The seven stages of strategic leadership
The seven stages of strategic leadershipThe seven stages of strategic leadership
The seven stages of strategic leadership
 
Organizational effectiveness goes digital
Organizational effectiveness goes digital  Organizational effectiveness goes digital
Organizational effectiveness goes digital
 
Winning with a data-driven strategy
Winning with a data-driven strategyWinning with a data-driven strategy
Winning with a data-driven strategy
 
Automating trust with new technologies
Automating trust with new technologiesAutomating trust with new technologies
Automating trust with new technologies
 
Facing up to the automotive innovation dilemma
Facing up to  the automotive  innovation dilemmaFacing up to  the automotive  innovation dilemma
Facing up to the automotive innovation dilemma
 
The Four X Factors of Exceptional Leaders
The Four X Factors of Exceptional LeadersThe Four X Factors of Exceptional Leaders
The Four X Factors of Exceptional Leaders
 
What is fair when it comes to AI bias?
What is fair when it comes to AI bias?What is fair when it comes to AI bias?
What is fair when it comes to AI bias?
 
Chinese cars go global
Chinese cars go globalChinese cars go global
Chinese cars go global
 
Power strategies
Power strategiesPower strategies
Power strategies
 
Tomorrow's Data Heros
Tomorrow's Data HerosTomorrow's Data Heros
Tomorrow's Data Heros
 
Is AI the Next Frontier for National Competitive Advantage?
Is AI the Next Frontier for National Competitive Advantage?Is AI the Next Frontier for National Competitive Advantage?
Is AI the Next Frontier for National Competitive Advantage?
 
Memo to the CEO: Is Your Chief Strategy Officer Set Up for Success?
Memo to the CEO: Is Your Chief Strategy Officer Set Up for Success?Memo to the CEO: Is Your Chief Strategy Officer Set Up for Success?
Memo to the CEO: Is Your Chief Strategy Officer Set Up for Success?
 
Memo to the CEO: Is Your Chief Strategy Officer Set Up for Success?
Memo to the CEO: Is Your Chief Strategy Officer Set Up for Success?Memo to the CEO: Is Your Chief Strategy Officer Set Up for Success?
Memo to the CEO: Is Your Chief Strategy Officer Set Up for Success?
 
HQ 2.0: The Next-Generation Corporate Center
HQ 2.0: The Next-Generation Corporate CenterHQ 2.0: The Next-Generation Corporate Center
HQ 2.0: The Next-Generation Corporate Center
 
Keeping Cool under Pressure
Keeping Cool under PressureKeeping Cool under Pressure
Keeping Cool under Pressure
 
The Flywheel Philosophy
The Flywheel PhilosophyThe Flywheel Philosophy
The Flywheel Philosophy
 
Leading a Bionic Transformation
Leading a Bionic TransformationLeading a Bionic Transformation
Leading a Bionic Transformation
 
Why Is It So Hard to Trust a Blockchain?
Why Is It So Hard to Trust a Blockchain?Why Is It So Hard to Trust a Blockchain?
Why Is It So Hard to Trust a Blockchain?
 
The Future of Artificial Intelligence Depends on Trust
The Future of Artificial Intelligence Depends on TrustThe Future of Artificial Intelligence Depends on Trust
The Future of Artificial Intelligence Depends on Trust
 
Approaching Diversity with the Brain in Mind
Approaching Diversity with the Brain in MindApproaching Diversity with the Brain in Mind
Approaching Diversity with the Brain in Mind
 

Recently uploaded

Call Girls Service Jaipur Grishma WhatsApp ❤8445551418 VIP Call Girls Jaipur
Call Girls Service Jaipur Grishma WhatsApp ❤8445551418 VIP Call Girls JaipurCall Girls Service Jaipur Grishma WhatsApp ❤8445551418 VIP Call Girls Jaipur
Call Girls Service Jaipur Grishma WhatsApp ❤8445551418 VIP Call Girls Jaipurparulsinha
 
Bangalore Call Girls Nelamangala Number 7001035870 Meetin With Bangalore Esc...
Bangalore Call Girls Nelamangala Number 7001035870  Meetin With Bangalore Esc...Bangalore Call Girls Nelamangala Number 7001035870  Meetin With Bangalore Esc...
Bangalore Call Girls Nelamangala Number 7001035870 Meetin With Bangalore Esc...narwatsonia7
 
Bangalore Call Girl Whatsapp Number 100% Complete Your Sexual Needs
Bangalore Call Girl Whatsapp Number 100% Complete Your Sexual NeedsBangalore Call Girl Whatsapp Number 100% Complete Your Sexual Needs
Bangalore Call Girl Whatsapp Number 100% Complete Your Sexual NeedsGfnyt
 
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...Neha Kaur
 
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Cuttack Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on DeliveryCall Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Deliverynehamumbai
 
Top Rated Bangalore Call Girls Mg Road ⟟ 8250192130 ⟟ Call Me For Genuine Sex...
Top Rated Bangalore Call Girls Mg Road ⟟ 8250192130 ⟟ Call Me For Genuine Sex...Top Rated Bangalore Call Girls Mg Road ⟟ 8250192130 ⟟ Call Me For Genuine Sex...
Top Rated Bangalore Call Girls Mg Road ⟟ 8250192130 ⟟ Call Me For Genuine Sex...narwatsonia7
 
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...Taniya Sharma
 
Call Girl Number in Vashi Mumbai📲 9833363713 💞 Full Night Enjoy
Call Girl Number in Vashi Mumbai📲 9833363713 💞 Full Night EnjoyCall Girl Number in Vashi Mumbai📲 9833363713 💞 Full Night Enjoy
Call Girl Number in Vashi Mumbai📲 9833363713 💞 Full Night Enjoybabeytanya
 
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...aartirawatdelhi
 
Call Girl Coimbatore Prisha☎️ 8250192130 Independent Escort Service Coimbatore
Call Girl Coimbatore Prisha☎️  8250192130 Independent Escort Service CoimbatoreCall Girl Coimbatore Prisha☎️  8250192130 Independent Escort Service Coimbatore
Call Girl Coimbatore Prisha☎️ 8250192130 Independent Escort Service Coimbatorenarwatsonia7
 
Chandrapur Call girls 8617370543 Provides all area service COD available
Chandrapur Call girls 8617370543 Provides all area service COD availableChandrapur Call girls 8617370543 Provides all area service COD available
Chandrapur Call girls 8617370543 Provides all area service COD availableDipal Arora
 
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore EscortsCall Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escortsvidya singh
 
Top Rated Bangalore Call Girls Richmond Circle ⟟ 8250192130 ⟟ Call Me For Gen...
Top Rated Bangalore Call Girls Richmond Circle ⟟ 8250192130 ⟟ Call Me For Gen...Top Rated Bangalore Call Girls Richmond Circle ⟟ 8250192130 ⟟ Call Me For Gen...
Top Rated Bangalore Call Girls Richmond Circle ⟟ 8250192130 ⟟ Call Me For Gen...narwatsonia7
 
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...narwatsonia7
 
High Profile Call Girls Coimbatore Saanvi☎️ 8250192130 Independent Escort Se...
High Profile Call Girls Coimbatore Saanvi☎️  8250192130 Independent Escort Se...High Profile Call Girls Coimbatore Saanvi☎️  8250192130 Independent Escort Se...
High Profile Call Girls Coimbatore Saanvi☎️ 8250192130 Independent Escort Se...narwatsonia7
 
(Rocky) Jaipur Call Girl - 9521753030 Escorts Service 50% Off with Cash ON De...
(Rocky) Jaipur Call Girl - 9521753030 Escorts Service 50% Off with Cash ON De...(Rocky) Jaipur Call Girl - 9521753030 Escorts Service 50% Off with Cash ON De...
(Rocky) Jaipur Call Girl - 9521753030 Escorts Service 50% Off with Cash ON De...indiancallgirl4rent
 
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...narwatsonia7
 
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...Call Girls in Nagpur High Profile
 
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 

Recently uploaded (20)

Call Girls Service Jaipur Grishma WhatsApp ❤8445551418 VIP Call Girls Jaipur
Call Girls Service Jaipur Grishma WhatsApp ❤8445551418 VIP Call Girls JaipurCall Girls Service Jaipur Grishma WhatsApp ❤8445551418 VIP Call Girls Jaipur
Call Girls Service Jaipur Grishma WhatsApp ❤8445551418 VIP Call Girls Jaipur
 
Bangalore Call Girls Nelamangala Number 7001035870 Meetin With Bangalore Esc...
Bangalore Call Girls Nelamangala Number 7001035870  Meetin With Bangalore Esc...Bangalore Call Girls Nelamangala Number 7001035870  Meetin With Bangalore Esc...
Bangalore Call Girls Nelamangala Number 7001035870 Meetin With Bangalore Esc...
 
Bangalore Call Girl Whatsapp Number 100% Complete Your Sexual Needs
Bangalore Call Girl Whatsapp Number 100% Complete Your Sexual NeedsBangalore Call Girl Whatsapp Number 100% Complete Your Sexual Needs
Bangalore Call Girl Whatsapp Number 100% Complete Your Sexual Needs
 
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
 
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Cuttack Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service Available
 
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on DeliveryCall Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
 
Top Rated Bangalore Call Girls Mg Road ⟟ 8250192130 ⟟ Call Me For Genuine Sex...
Top Rated Bangalore Call Girls Mg Road ⟟ 8250192130 ⟟ Call Me For Genuine Sex...Top Rated Bangalore Call Girls Mg Road ⟟ 8250192130 ⟟ Call Me For Genuine Sex...
Top Rated Bangalore Call Girls Mg Road ⟟ 8250192130 ⟟ Call Me For Genuine Sex...
 
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
 
Call Girl Number in Vashi Mumbai📲 9833363713 💞 Full Night Enjoy
Call Girl Number in Vashi Mumbai📲 9833363713 💞 Full Night EnjoyCall Girl Number in Vashi Mumbai📲 9833363713 💞 Full Night Enjoy
Call Girl Number in Vashi Mumbai📲 9833363713 💞 Full Night Enjoy
 
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...
 
Call Girl Coimbatore Prisha☎️ 8250192130 Independent Escort Service Coimbatore
Call Girl Coimbatore Prisha☎️  8250192130 Independent Escort Service CoimbatoreCall Girl Coimbatore Prisha☎️  8250192130 Independent Escort Service Coimbatore
Call Girl Coimbatore Prisha☎️ 8250192130 Independent Escort Service Coimbatore
 
Chandrapur Call girls 8617370543 Provides all area service COD available
Chandrapur Call girls 8617370543 Provides all area service COD availableChandrapur Call girls 8617370543 Provides all area service COD available
Chandrapur Call girls 8617370543 Provides all area service COD available
 
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore EscortsCall Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
 
Top Rated Bangalore Call Girls Richmond Circle ⟟ 8250192130 ⟟ Call Me For Gen...
Top Rated Bangalore Call Girls Richmond Circle ⟟ 8250192130 ⟟ Call Me For Gen...Top Rated Bangalore Call Girls Richmond Circle ⟟ 8250192130 ⟟ Call Me For Gen...
Top Rated Bangalore Call Girls Richmond Circle ⟟ 8250192130 ⟟ Call Me For Gen...
 
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
 
High Profile Call Girls Coimbatore Saanvi☎️ 8250192130 Independent Escort Se...
High Profile Call Girls Coimbatore Saanvi☎️  8250192130 Independent Escort Se...High Profile Call Girls Coimbatore Saanvi☎️  8250192130 Independent Escort Se...
High Profile Call Girls Coimbatore Saanvi☎️ 8250192130 Independent Escort Se...
 
(Rocky) Jaipur Call Girl - 9521753030 Escorts Service 50% Off with Cash ON De...
(Rocky) Jaipur Call Girl - 9521753030 Escorts Service 50% Off with Cash ON De...(Rocky) Jaipur Call Girl - 9521753030 Escorts Service 50% Off with Cash ON De...
(Rocky) Jaipur Call Girl - 9521753030 Escorts Service 50% Off with Cash ON De...
 
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
 
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
 
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
 

A Strategist's Guide to Personalized Medicine

  • 1. strategy+business ONLINE AUGUST 13, 2012 BY AVI KULKARNI AND NELIA PADILLA MCGREEVY A Strategist’s Guide to Personalized Medicine Breakthroughs in pharmaceutical innovation are poised to change the prevailing business model of the industry — with dramatic, disruptive effects on healthcare costs and practice.
  • 2. O A Strategist’s Guide to Personalized Medicine Breakthroughs in pharmaceutical innovation are poised to change the prevailing business model of the industry — with dramatic, disruptive effects on healthcare costs and practice. by Avi Kulkarni and Nelia Padilla McGreevy 1 www.strategy-business.com ne of the most innovative medications of recent ly to benefit from chemotherapy. The results of this test years is Novartis’s imatinib, which is marketed can help physicians avoid prescribing drugs with no as Gleevec. Introduced in 2001, it set a record medical value; because those drugs often have severe for the fastest approval time by the U.S. Food and Drug side effects, the test greatly benefits patients as well. Administration (FDA), and in 2011 had US$4.3 billion The concept of personalized medicine is only 15 in sales. Imatinib was the first of a new class of drugs years old, and it does not have a perfect track record; that act by inhibiting a specific enzyme — in this case, some of its medications have failed to get regulatory a receptor called tyrosine kinase — that is characteristic approval or to be profitable in the marketplace. But of particular cancer cells. Because only certain cancers where it has proven successful, it is creating for health- will respond to imatinib, it is prescribed only for care businesses a fundamentally new value proposition. patients identified by specific diagnostic tests (for exam- It represents a game-changing trend for healthcare ple, the Philadelphia chromosome abnormality test). providers (hospitals and individual physicians); payors, Imatinib is an example of the products emerging including Medicare and private insurance; and patients, from a new pharmaceutical field known as personalized who can have a far more participative role in their own medicine (PMx): the tailoring of drugs and other treat- care than they would without PMx. When physicians ments to specific populations, based on their genetic and patients can draw upon a wealth of genetic and bio- profiles or other differentiating factors. (We use the logical data, personalized therapy will become the abbreviation PMx to follow Rx for prescription medi- norm, not the relatively rare occurrence it is today. cine and Dx for diagnostic tests.) The underlying tech- The greatest impact of this new approach to indi- nology for PMx marries advances in diagnostic biotech, vidualized diagnosis and treatment will probably be felt such as rapid gene sequencing, with a profound expan- in the pharmaceutical industry. Leading pharmaceutical sion of scientists’ understanding of molecular disease companies have long relied on innovation to expand the pathways. Another example is Genomic Health’s frontiers of better health — and to financially sustain Oncotype DX breast cancer test, introduced in 2004, their businesses. But that capacity for launching new which uses an analysis of multiple genetic variations to products is under severe strain today. Many pharmaceu- determine which cancers are likely to recur for a partic- tical companies have recently seen their research and ular individual. It also indicates which patients are like- development productivity erode. Biotech startups have
  • 3. Avi Kulkarni Nelia Padilla McGreevy Also contributing to this article was strategy+business is a partner with Booz & is a principal with Booz & contributing editor Company based in San Company based in Boston. She Lawrence M. Fisher. Francisco and a member of specializes in personalized the firm’s global health medicine and pharmaceutical practice. His areas of expertise regulations. include personalized medicine, life sciences R&D, and the pharmaceutical and diagnos- tics industries. 2 www.strategy-business.com avi.kulkarni@booz.com nelia.mcgreevy@booz.com struggled to turn their scientific advances into viable (1) the subtype of their HIV infection, (2) their body’s drugs. Companies have resorted to alternatives such as response to the infection, and (3) the stage of the over- vaccines, preventive care, and geographical outreach for all infection, they could prescribe the best tailored ther- profits, but no pharma industry breakthrough has come apy cocktail for each patient. This combination of along recently to create a promising pipeline of new prescribed diagnostics and pharmaceuticals has been a Success and Disruption products. PMx offers the potential for just that sort of remarkable success story. It has improved quality of life breakthrough. for patients and extended the average life expectancy of Thus, despite the disruptive nature of personalized newly diagnosed HIV patients by 20 to 25 years. medicine, the pharmaceutical industry is emerging as a HIV infects different patient groups in different driving force in this field. The list of early PMx adopters ways; for a patient diagnosed with it, a physician must includes some industry giants: Roche, Pfizer, Novartis, choose from more than 20 different antiviral agents in and Lilly. The field is also populated with upstart com- six unique drug classes. While undergoing antiretroviral panies such as Genomic Health, XDx, and Prometheus therapy, patients are monitored with advanced diagnos- Labs that offer specialized approaches to segmenting tic blood tests every three to four months to assess the disease, as well as the recognized pioneers in personal severity of infection and confirm that the virus is being genomics: 23andMe, deCODE Genetics, and DNA suppressed. Some of these tests can predict how indi- Direct. In adopting PMx, they are all embracing a new vidual patients will respond to specific therapies, thus healthcare model that emphasizes segmentation of increasing their odds of survival. For instance, Selzentry, patients, and decisions and practices tailored to individ- an antiretroviral drug developed by Pfizer, works by uals or small groups. Although this approach might binding to and thereby blocking the CCR5 receptor, lead to smaller revenue pools for pharmaceutical pro- which is found on the surface of certain human cells ducers, PMx can actually improve their profits. A busi- and is necessary for the entry of the virus into the host ness model based on differentiated products can reduce cell. But in some people, HIV can use other receptors the system-wide costs and complications of one-size- instead, which would render Selzentry ineffective. fits-all medications, provide new opportunities for mar- Therefore, before Selzentry can be prescribed, patients keting, and establish new efficiencies in production and are given an HIV tropism test called Trofile to deter- distribution. mine whether the drug will be effective for them. Personalization of anti-HIV drugs benefits all con- stituents. Payors and governments maximize the value As an example of the impact of personalized medicine, of therapies on the market, squeezing the best effects consider the evolution of treatment for human immun- from the cheapest anti-HIV drugs. Physicians and clini- odeficiency virus (HIV), the retrovirus that causes cians, who have had to rethink their management of AIDS, during the 1990s and 2000s. Physicians found HIV/AIDS treatment, have dramatically improved suc- that by grouping patients into smaller subsets based on cess rates. Patients are the ultimate beneficiary: An HIV-
  • 4. A New Form of Pharma R&D 3 www.strategy-business.com positive test used to be a short-term death sentence. First, the prospects for innovation; second, the right Now HIV is considered a chronic, manageable disease, value proposition; and third, the capabilities needed to with treatment costs that are considered acceptable and deliver on that proposition. affordable even in sub-Saharan Africa. Pharmaceutical companies have also benefited greatly. The PMx approach to HIV/AIDS treatment, for Back in the age of economies of scale, most drug com- example, has helped make Gilead Sciences Inc. the panies’ business models depended on producing thera- world’s second largest biotech company, after Amgen pies for the largest number of people with unmet Inc., with a market cap of $38 billion. The use of com- medical needs: cimetidine (GlaxoSmithKline’s Tagamet) panion diagnostics allowed Gilead to improve the over- for excess stomach acid, lovastatin (Merck’s Mevacor) all efficacy of its portfolio of drugs for HIV/AIDS, for high cholesterol, and naproxen (Bayer’s Aleve) for cementing its lead in that market. aches and pains. Even biotech’s early successes, starting But of all the constituents, pharma companies face in the 1970s, were conceived as mass-market products: the greatest disruption from personalized medicine. It recombinant insulin (Lilly’s Humalog) for diabetes, forces them to adopt a new business model with a coun- epoetin alfa (Amgen’s Epogen) for anemia, and etaner- terintuitive value proposition, requiring unfamiliar new cept (Pfizer and Amgen’s Enbrel) for autoimmune dis- capabilities to make it work. For many pharma compa- eases like rheumatoid arthritis and psoriasis. Each nies, PMx means changing established practices in all represented a multibillion-dollar franchise sustained for aspects of the business — from the earliest stages of tar- many years — and together, they reduced many causes get identification and drug discovery, through clinical of early mortality, helping raise the average human life development, regulatory approval, commercial develop- span. ment and operations, and marketing and sales. But an aging population also means that chronic PMx is only one of several strategies that pharma- diseases — including immune-mediated diseases such ceutical companies will adopt in the next few years. as cancer, metabolic diseases such as diabetes, and neu- Some will seek to retain the same business model even rological diseases such as dementia — have become as their innovation pipeline dwindles. They will use more prevalent. Unlike the acute killers of previous gen- their marketing capabilities to sell so-called branded erations, these diseases tend to affect people in a rela- generics, off-patent versions of their own former block- tively heterogeneous manner. Depending on their busters, accepting lower margins in return for high vol- genetic makeup, people are susceptible to different dis- ume sales. Others will play the specialty pharmaceuticals ease strains and may respond in different ways to the game, repurposing old drugs in new delivery systems for same medication. For illnesses like these, the healthcare different diseases than those for which they were origi- system can no longer afford a trial-and-error approach nally approved. This is a well-established low-risk model to pharmaceutical research, in which physicians attack that investors understand. diseases with one compound after another in hopes of But a number of pharmaceutical companies will finding one whose benefits to the patient will outweigh adopt the personalized medicine paradigm. They recog- its side effects. nize the competitive advantage that could accrue from a With personalized medicine, segmentation begins segmented customer base with structures, processes, and at the research stage. A PMx team seeks out patient pop- capabilities to match. They are just unsure about how to ulations that can be identified using biomarkers. A bio- leap ahead into practice. marker is a measurable substance in an organism — a That is why they need a plan for implementing per- gene, protein, or other biological element — whose sonalized medicine. To be successful, they will need to presence has been linked to a pathology, such as cancer take into account three elements of their current reality: or autoimmune disease. A biomarker may also be a
  • 5. types, such as tissues, bodily fluids, management. Biopharmaceutical and DNA/RNA and other proteins. companies are accustomed to out- Map the patient’s journey from diag- sourcing research, development, nosis to treatment, and use Dx tests and clinical trials. But PMx is differ- The experience of biopharmaceuti- to develop efficient patient–disease ent. It involves partnership capabili- cals suggests that seven processes stratification. ties that many companies do not and practices are required for profi- 3. Cross-functional (Rx and Dx) possess. A partnership for a com- ciency in personalized medicine. regulatory and clinical expertise. panion diagnostic test, for example, Together, these could become the Drugs that are aimed at patient sub- has regulatory, quality control, legal, basis of a distinctive capability in this sets and paired with companion marketing, and sales aspects, field. diagnostics make new demands of involving both the test and the drug. 1. Biomarker discovery and iden- regulators, so applicants must come It is critical to define in advance how tification. The first step is to identify prepared. Start by building optimal much value the drug contributes a biological trait that indicates the indications — explanations of the versus how much the enabling diag- 4 presence or progression of a dis- diseases the drug is licensed to treat nostic contributes, and to build a ease. Next, develop a test that can — and labels, which are the FDA- win-win model for the Dx and Rx detect the presence or quantity of compliant texts that specify how the participants. these biomarkers. That test drug should be used. Introduce 6. Marketing. A pull-based strate- becomes the diagnostic. Costs need these materials early to key opinion gy requires a knowledge-intensive not be excessive because many rele- leaders in the relevant field of medi- effort aimed at key opinion leaders www.strategy-business.com vant biomarkers have been discov- cine. and decision makers. You will also The Essentials of ered and classified by academic and 4. Pricing, reimbursement, and need to reach out to national and independent research labs and are billing systems. Develop a sophisti- regional payors. PMx Practice available in public databases. The art cated knowledge of health econom- 7. Sales. Retrain your sales force lies in establishing biomarkers’ clin- ics modeling, and cultivate policy to be conversant in complex science, ical utility by separating the disease experts. Base your projections on including genomics, proteomics, and signal from biochemical noise. the idea that patients who gain no bioinformatics. Revenues from each 2. Assay development. Create in benefit from a drug will not take it; drug will be spread over fewer vitro tests that scale beyond the lab- this will cut costs throughout the patients and total prescriptions, so oratory setting to clinical or com- healthcare system. The right drug to each staff member will need to man- mercial use. Develop assays on all the right patient at the right time is a age a larger number of products. major technology platforms and powerful value proposition. across multiple analyte and sample 5. Partnership selection and genetic variant that indicates an individual’s potential ed levels of a protein marker called HER-2 in patients response to a particular drug. Drugs are tailored to rela- who responded. The FDA approved the medication for tively small, well-defined patient groups, segmented by only that group of people. Herceptin is now a drug with these markers; the Dx enables the Rx. yearly sales of $6 billion. This type of pharmaceutical research first led to a Since Herceptin, companies have used pharma- marketable product in 1998, when the FDA approved cogenomic assays (tests based on genetic biomarkers) to Herceptin — a breast cancer drug developed by resuscitate drugs that would have failed clinical trials, or Genentech. Herceptin works in only about 25 percent to manage the potential danger of side effects. Because of breast cancer patients. Ordinarily a drug that did not many cancers are prompted by mutations in the genet- work for three-quarters of the patient population would ic code, oncology has been the most fertile early ground have failed to win regulatory approval. But researchers at for these drugs. For example, Erbitux and Vectibix were Dako AS, a diagnostics company based in Denmark, developed for colorectal cancer, but they work only in devised an accompanying assay (an analysis of the pres- people whose tumors have a mutation in the EGFR ence of a substance or genetic indicator) showing elevat- gene and a normal KRAS gene, and thus are prescribed
  • 6. 5 www.strategy-business.com only after positive responses to assays for those variants. with global distribution and advertising, are too expen- Personalized medicine could be applied to a wide sive and cumbersome for personalized therapies. range of chronic diseases. As knowledge of the human Moreover, decisions about the use of personalized pre- genome expands, new and old drugs alike can be made scription drugs are made by a relatively small number of more viable through genetic testing. Strattera (atomox- sophisticated payors — hospitals, major providers, or etine), a drug used for attention-deficit hyperactivity large payors — and not by general practitioners, who disorder, was linked to liver damage for patients with a are disinclined to prescribe drugs that will not be reim- mutation in the CYP2D6 gene. It is now marketed with bursed by Medicare or private insurance. a pharmacogenomic assay to rule out this population. As PMx 2.0 unfolds, popular demand will drive its Warfarin and Plavix, two blood thinners, can cause growth. Because it takes into account each patient’s excessive bleeding among patients with particular genet- unique pathophysiology; the biochemistry of the tumor, ic variations. Testing can show which patients should get bacteria, or virus; and the individual’s ability to proper- other medicines. ly react to and metabolize different drugs, it will repre- All this innovation still represents what might be sent a step change in medical confidence and in called version 1.0 of personalized medicine: diagnostic protection against side effects. tests applied only after a drug’s development to salvage Already, the appeal of personalized medicine is or increase its value. Industry leaders now are moving changing the way people spend their own money on toward another form of PMx innovation — call it ver- healthcare. In 1996, for example, when Myriad sion 2.0 — in which new drugs are developed concur- Genetics Inc. launched BRACAnalysis, a predictive test rently with companion diagnostics. Under this R&D for hereditary breast and ovarian cancer, Medicare and model, researchers identify target patient subgroups in private health insurance did not reimburse for it. A New Business Model advance and design drugs for these specific populations. Nonetheless, many patients paid the $3,000 cost out of PMx 2.0 has been held back, somewhat, by cost. pocket. So many of them forwarded the receipts to their The first human genome sequence cost $3 billion and insurers and argued on behalf of the test that took many years to completely map. But now the costs BRACAnalysis is now commonly reimbursed. are shrinking and the effectiveness is growing at an People have shown a willingness to pay for many exponential pace. Several companies offer personal other personalized forms of healthcare as well. genome sequencing for a few thousand dollars or less; Hundreds of thousands of people have opted for a sys- within 10 years, it is reasonable to expect that sequenc- tem known as “concierge medicine.” They pay $59 a ing a personal genome will take an hour and cost per- month, or more, for 24/7 access to a physician’s advice haps $300, or less than an MRI. It is not too much of a and counsel, without other types of insurance included. reach to postulate cell phone–sized analytical devices Thousands of others flock to alternative medicine, able to test for 500 biomarkers that cross the body’s despite the lack of clinical evidence. At least in part, more than 50 organs in a single drop of blood. patients are attracted by the perception that alternative As it becomes more prevalent, the pairing of diag- medicines are tailored to individual attributes. (For nosis and therapy will yield big gains in R&D produc- example, some popular medical self-care books propose tivity. The patient subgroups that stand to benefit from different regimes of food and herbal remedies based on a drug will be identified in advance of clinical trials. This blood type.) could lead to a meaningful improvement in the average Personalized medicine will change the way individ- response rate for drugs, which is currently 50 percent uals learn about their health. It will lead to more across all categories and just 22 percent in oncology. involvement of patients in managing their therapy, and That improvement, in cancer alone, would more than better tracking of patient activity during and after treat- compensate for the cost of diagnostic technology. ment. Today, any newly diagnosed cancer or autoim- mune disease patient can consult countless online forums devoted to his or her disease. The information The rise of personalized medicine provides pharma there runs the gamut from accurate and helpful to well- companies and healthcare providers with a value propo- meaning but inadequate to utterly fallacious. sition different from the one they’re accustomed to. The Genentech discovered early on with Herceptin that standard pharmaceutical mass-marketing approaches, innovative, proactive educational materials are essential
  • 7. 6 www.strategy-business.com to successful PMx. Similarly, Gilead, the world leader in traditional competencies such as those of medicinal HIV/AIDS drugs, has a long tradition of working with chemistry, molecular biology, and high throughput AIDS activists — including some who massed angrily in screening; they augment them. front of its headquarters in the 1990s — to enlist them The capabilities that distinguish a company in per- in spreading information about the drugs and the vary- sonalized medicine are not just tools, of course; they ing effects of each drug on different individuals. represent combinations of processes, technologies, To realize the business potential in personalized knowledge, skills, and organization that have been medicine, pharma companies will need to emphasize developed over time. Nor can they be thought of in iso- diagnostics — which, historically, has been a very dif- lation. Distinctive capabilities are always cross-function- ferent business from pharmaceuticals, with far lower al. For example, a pharmaceutical company may decide profit margins, making it unattractive to drug compa- to develop its prowess in a particular type of medical • Build a mind-set in which personalization is not nies in the past. Most pharma companies do not have practice, such as oncology, immune system disorders, or an option but a necessity — even in the face of the the requisite Dx identification, development, or com- mental illness. This will necessarily bring together pro- mercialization capabilities to play effectively in this fessionals in genetic research (for biomarker discovery space, and will have to build, buy, or borrow them. and development), patient outreach, finance (for devel- Fortunately for the companies, version 1.0 of per- opment of pricing and economic models for stratified sonalized medicine has already raised the value of diag- patient populations), and sales and marketing (for • Retain flexibility. Place a premium on portfolio nostic tests. In the past, they typically sold for $300 or working with clinics). These are not separate processes less. Today, some tests, such as Oncotype DX, produced and systems; personalized medicine requires synchro- by Genomic Health, are priced at about $4,000. This nized adjustments in every part of the value chain from The Capabilities System of Personalized Medicine test is expensive because it is based on years of propri- discovery to development to commercialization to life- etary genetic research and multiple large-scale clinical cycle management. trials to confirm its predictive capability. Even so, it is After 20-odd years of business process reengineer- seen as affordable; without it, chemotherapy is far more ing, most pharma company managers understand how • Build PMx capabilities into the existing capabilities expensive and toxic. to make structural changes, though they are often blasé system. In an era of constrained spending and a vital Several leading pharma companies are beginning to or cynical about the ultimate benefits. Personalized build or buy the capabilities required to fulfill the goals medicine could also require changing hearts and minds of the patient-centric model. For example, Novartis because it affects the character of an enterprise. acquired Genoptix for $470 million in 2011 — a deal Although individual companies will develop new capa- that demonstrated, to many in the industry, that the bilities in their own way, all successful PMx initiatives largest companies were interested in PMx. In August will need to include these imperatives: 2012, GlaxoSmithKline paid $3.6 billion to acquire Human Genome Sciences, one of the earliest companies to mine the genome in search of innovative drugs. inevitable failures that occur with new drug candidates. As the bidding for diagnostics assets accelerates, Assume that all molecules in the pipeline will be tailored some target companies are likely to be overvalued, and to specific patient populations; non-tailoring will some acquirer companies may overpay. But sitting on become the exception. the sidelines is not a viable option. Payors and physi- cians are increasingly unwilling to support drugs with management skills, determining as early as possible only a fractional response rate. Moreover, the PMx which molecules to advance from research to develop- promise to raise R&D productivity while improving ment, and when to drop a hitherto promising candidate patient outcomes is simply too compelling to ignore. for which the PMx case is weak. Similarly, remain tech- nologically agnostic; don’t commit to only one biotech- nology research platform. One way to think of PMx capabilities is as a set of new instruments that will provide new insights into disease and treatment. But just as ultrasounds and CT scans need for R&D efficiency, essential PMx capabilities have not displaced stethoscopes and thermometers in must be identified and integrated into the existing value the physician’s bag, the tools of PMx do not supplant chain. Build the kind of organizational discipline that
  • 8. • Access new capabilities through partnerships — 7 • Build a sales force with new capabilities. Sales Managing a Disruptive Innovation www.strategy-business.com to act is now. + eschews drug candidates with a potentially large market gest that PMx could be disruptive in a way that the but lower probability of success. Favor smaller-market healthcare industry cannot long ignore. “The advent of drugs that are more likely to succeed. With this precision medicine,” write the authors, “heralds prod- approach, you may reap many benefits, such as faster uct-line fragmentation in pharmaceuticals. Volumes per clinical trial enrollment, faster achievement of goals, therapeutic compound will drop significantly, as the lower clinical costs, and greater likelihood of success. number of therapeutic compounds expands. Blockbuster drugs will become rare. This will necessitate for example, for diagnostics development and commer- a reshaping of the business model of today’s major phar- cialization. Ensure access to world-class diagnostics maceuticals companies because — to borrow words without significant capital outlays by collaborating with from oil exploration, in the future there will be fewer assay developers and other companies. Understand that big gushers to cover the costs of drilling a lot of dry these are truly strategic partnerships that share fully in holes.” the creation of value; they are not the routine outsourc- An ongoing theme in Christensen’s work is that the Resources ing of a fungible function. leading practitioners of an old order tend to be the vic- tims of disruption, not the initiators. But The teams will need to pair targeted therapies with sophisti- Innovator’s Prescription proposes that today’s healthcare cated diagnostic tests. In addition, they will need to be leaders can educate themselves and play a major role in well versed in biological and disease pathway intelli- disrupting their own businesses, as IBM did when it gence, and well-informed about patient segment attrib- introduced the personal computer. There may not be utes that can impede successful treatment. much time to make the shift; across many disease areas, PMx and novel diagnostics are already changing the practice of medicine, and already accepted as a new way Like all innovations, personalized medicine has been the to play in the life sciences market. That is why person- focus of a great deal of hype, and it is worthwhile to take alized medicine should be on the senior agenda of every a few steps back to put it in perspective. It may be over- pharmaceutical company. Major new capabilities are sold at times — particularly in oncology, where it has not built overnight, and mind-sets are slow to change. been heralded as the next “cure for cancer.” Because can- Some leading companies are already moving, and so are cer is many different diseases, with many different mod- major stakeholders like payors and providers. The time ulators and multiple mutations even within a single tumor site, personalized medicine cannot be that kind of cure. It will never be a panacea. But it also is not a placebo. Eric Topol, a cardiolo- gist and geneticist, and the current director of the Scripps Translational Science Institute in La Jolla, Calif., paints an optimistic picture in his recent book, The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care (Basic Books, 2012). He proposes the integration of basic PMx tools — such as biomarkers for specific pathways and special- Marcus Ehrhardt, Robert Hutchens, and Susan Higgins, “Five Steps toward a Revitalized Pharmaceutical Supply Chain,” s+b, Spring 2012, ized diagnostic technologies — into everyday life. www.strategy-business.com/article/00094: Companies embracing person- Perhaps biomarker-sensitive devices embedded in alized medicine will need to build these operational capabilities. mobile phones could detect cancer cells circulating in Gil Irwin, Art Kleiner, and Joyjit Saha Choudhury, “When Disruptive the blood or warn people of an imminent heart attack. Integration Comes to Health Care,” s+b, 03/01/10, www.strategy- Topol also says that many of these innovations must business.com/article/00020: The Innovator’s Prescription coauthor Jason Hwang talks about the next wave of healthcare business models. overcome the medical community’s profound resistance to change. In The Innovator’s Prescription: A Disruptive Alex Kandybin and Vessela Genova, “Big Pharma’s Uncertain Future,” Solution for Health Care (McGraw-Hill, 2009), Harvard s+b, Spring 2012, www.strategy-business.com/article/00095: As the era of the blockbuster drug comes to an end, the industry must cope with new Business School professor Clayton M. Christensen and unknowns. physicians Jerome H. Grossman and Jason Hwang sug-
  • 9. strategy+business magazine is published by Booz & Company Inc. To subscribe, visit strategy-business.com or call 1-855-869-4862. For more information about Booz & Company, visit booz.com • strategy-business.com • facebook.com/strategybusiness • http://twitter.com/stratandbiz 101 Park Ave., 18th Floor, New York, NY 10178 Looking Booz & Company Inc. © 2012 for Booz Allen Hamilton? It can be found at at www.boozallen.com