Personalized Medicine Education and Advocacy

Thought leadership in personalized medicine


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FDA’s Approval of First NGS-Based IVD for NSCLC Raises New Question: Where Does This Leave LDTs?

Guest Blog
by Joydeep Goswami, President, Clinical Next-Generation Sequencing and Oncology, Thermo Fisher Scientific

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Joydeep Goswami

FDA’s recent decision to grant premarket approval of the first next-generation sequencing (NGS)-based companion diagnostic for non-small cell lung cancer (NSCLC) marks an important milestone in precision medicine. Patients and their oncologists now have access to an in vitro diagnostic (IVD) that can help expedite the selection of targeted therapies in days, a key advancement considering traditional testing methods can take several weeks for an answer — time that many NSCLC patients simply don’t have.

While this is great news for one segment of the more than 1.6 million estimated new cases of cancer that will be diagnosed in 2017,1 what options are available for the rest of the patients battling this disease and for which there is no approved IVD? There has been a lot of debate about laboratory-developed tests (LDTs) versus IVD testing, particularly as to whether to stop the use of LDTs or to regulate them. In the fast-moving field of oncology, where the power of understanding the disease and the selection of precision treatments are being improved rapidly by technologies like NGS, clinicians and oncologists want to be able to incorporate these latest advancements into their clinical diagnostic practices.

While IVD tests undoubtedly are the gold standard in terms of demonstrating clinical validity and utility, developing an IVD can take several years. Patients and doctors dealing with fast moving and fatal diseases like cancer do not have the luxury of waiting until an IVD test is developed and approved in order to have access to a viable test. On the other hand, LDTs allow clinicians and pathologists to validate a diagnostic much faster under the appropriate controls and quality guidelines from the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP).

Although LDTs do not meet the same gold standard achieved by FDA-approved IVD tests, they do provide patients and clinicians with a much-needed option and quicker access to the latest advances in science while an equivalent IVD test is being developed. LDTs thus speed the path and utilization of the latest biological discoveries and technological innovations for the benefit of patients. Banning them or over-regulating them could have a negative impact both on innovation and, more importantly, patient access.

But there may be a solution that would enable patients to reap the benefits provided by both testing approaches. In one scenario, FDA could mandate labs to switch from an LDT to an equivalent IVD once one is approved. Alternatively, considering the much more rigorous validation process that an IVD product has to undergo, the Centers for Medicare & Medicaid Services and FDA could work together to encourage their use by setting reimbursement levels for IVDs higher than those associated with LDTs. Such measures could more effectively balance patient safety concerns with the right to benefit from cutting-edge science immediately.

1. American Cancer Society. Cancer Facts & Figures. 2017. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2017.html. Accessed July 11, 2017.


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Breakthroughs: Insights From the Personalized Medicine & Diagnostics Track at the 2017 BIO International Convention

by David Davenport, Office Administrator, Personalized Medicine Coalition

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J. Craig Venter, Ph.D., Founder, President, CEO, J. Craig Venter Institute, delivers the opening keynote address at the BIO International Convention’s Personalized Medicine & Diagnostics Track last month.

“Health care today is reactive and costly … anything but personalized … but we are now entering a new era where health care is becoming proactive, preventive, highly personalized and most importantly predictive,” said J. Craig Venter, Ph.D., Founder, President, CEO, J. Craig Venter Institute, during his opening keynote at the Personalized Medicine and Diagnostics Track at the 2017 BIO International Convention in San Diego from June 21 – 22. The track, co-organized by PMC, brought together thought leaders to discuss breakthroughs in advancing personalized medicine. From those conversations several themes emerged:

Complex genetic data require a “knowledge network” to translate into personalized care.

During the session titled The Next Frontier: Navigating Clinical Adoption of Personalized Medicine, moderated by PMC Vice President for Science Policy Daryl Pritchard, Ph.D., panelists discussed how to accelerate the clinical adoption of innovative personalized therapies. Jennifer Levin Carter, M.D., Founder and Chief Medical Officer of N-of-One, a clinical diagnostic testing interpretation service company, explained that as data grows in complexity, there is a growing need for partnerships to efficiently analyze the data and develop effective targeted treatment plans. India Hook-Barnard, Ph.D., Director of Research Strategy, Associate Director of Precision Medicine, University of California, San Francisco (UCSF), agreed and discussed the need to build a “knowledge network” that can harness data and expertise to inform provider-patient decision-making.

Discussing how personalized medicine can be integrated into community health centers lacking large research budgets, Lynn Dressler, Dr.P.H., Director of Personalized Medicine and Pharmacogenomics at Mission Health Systems, a rural community health care delivery system in Asheville, North Carolina, discussed the need to better educate physicians and patients as well as the role that a knowledge network could play in providing easy and cost-effective access to diagnostic testing services.

Delivering personalized medicine requires innovative partnerships involving industry, IT companies, providers, payers and the government.

During It’s a Converging World: Innovative Partnerships and Precision Medicine, a panel moderated by Kristin Pothier, Global Head of Life Sciences Strategy, Ernst & Young, discussed the need for “open data” where improved patient care is the shared goal, and how public-private partnerships that address education, evidence development and access to care can help foster personalized medicine.

During a session titled Nevada as a New Model for Population Health Study, Nevada-based health system Renown Health outlined a study in which it partnered with genetic testing company 23andMe to examine whether free access to genetic testing changes participants’ practices in managing their own health and facilitates the utilization of personalized medicine.

In the era of personalized medicine, measuring and delivering value requires a paradigm shift from population-based to individual-based evidence.

Following a discussion on regulatory and reimbursement challenges moderated by Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates, during which panelists called for the simplification of payment structures to be more consistent, more efficient and more connected to the patient market, a panel moderated by Jennifer Snow, Director of Health Policy at Xcenda, discussed how value assessment frameworks must adapt to consider the value of personalized medicine. During The Whole Picture: Consideration of Personalized Medicine in Value Assessment Frameworks, panelist Mitch Higashi, Ph.D., Vice President, Health Economics and Outcomes Research, U.S., Bristol-Myers Squibb, called for patient-centered definitions of value and advocated for the inclusion of predictive biomarkers in all value frameworks. Donna Cryer, J.D., President, CEO, Global Liver Institute, added that the “patient must be the ultimate ‘arbiter of value’” and urged “transparency” in how value assessment frameworks are used.

Noting that different assessment frameworks have different goals, Roger Longman, CEO, Real Endpoints, called for more dynamic frameworks that allow different stakeholders to “use the same criteria but weigh them differently.” The panel concluded that to advance personalized medicine, value frameworks must be meaningful, practical and predictive for patients; reflect evolving evidence needs like real-world evidence; and consider breakthrough payment structures like bundled payments.

From Promise to Practice: The Way Forward for Personalized Medicine

During the concluding session, Creating a Universal Biomarker Program, moderated by Ian Wright, Owner, Strategic Innovations LLC, on behalf of Cedars-Sinai Precision Health, panelists discussed how to make patients the point of reference for their own care, as opposed to being compared to the “normal” range of population averages in treatment decisions using biomarkers. The speakers concluded that moving in that direction requires providers to establish baselines for each patient, along with tools and metrics to facilitate the approach.

In the words of Donna Cryer, “personalized medicine is the definition of value for a patient.” With the ability to detect diseases before they even express themselves, the promise of personalized medicine has never been greater.

However, changing the health care system to improve patient access to valuable personalized medicines requires innovation and collaboration. As PMC President Edward Abrahams, Ph.D., said during his opening remarks for the track, that change “doesn’t come easily,” but “breakthrough” discussions like these continue to move us forward.

The complete track agenda can be downloaded here.


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Analyzing Actionable: The Key Elements of Successful Clinical Interpretation in Oncology

Guest Blog
by Jennifer Levin Carter, M.D., M.P.H., Founder, Chief Medical Officer, N-of-One

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Jennifer Levin Carter, M.D., M.P.H.

The pace of scientific development is proceeding unlike any other time in the history of health care. New technologies, diagnostic tests and drugs are being introduced at record speed. However, to keep abreast of this unprecedented progress and to realize the value of personalized medicine, physicians must be empowered to efficiently and effectively utilize molecular testing to match patients with the most promising treatments.  This is not getting easier — physicians must have access to accurate, timely and cost-effective clinical interpretation to enable the delivery of data-driven therapeutic strategies to every patient.

Oncology is leading the way in the personalized medicine revolution. The oncology pipeline has expanded by 63 percent over the past 11 years,and oncology drugs accounted for 50 percent of all personalized medicines approved in 2016.2 Approximately 80 percent of cancer drugs in the pipeline are first-in-class therapies, and 73 percent target a specific biomarker.3 With this wave of new treatment options, how do physicians match their patients to the best possible therapy?

Much of the advancement in oncology drug development is a result of the uptake of next-generation sequencing in the clinic, and there is growing recognition that other molecular tests, like those evaluating copy number, fusions and protein expression, are becoming important tools for predicting response to therapies. New predictive tests for evaluating the efficacy of immunotherapies are in the pipeline. As patients are treated with targeted therapies and immunotherapies, novel resistance mutations, such as the EGFR C797S mutation after treatment with Osimertinib for EGFR T790M positive non-small cell lung cancer, are beginning to appear. Liquid biopsy tests have become a powerful method for identifying these mutations, especially in the absence of accessible tumor for biopsy. The results from these tests, if correctly interpreted, can prevent treatment with therapies that are no longer working.

Although this explosion of complex molecular data is vital for the advancement of personalized medicine in oncology, it also represents a critical challenge for clinicians. PMC’s Health Care Working Group notes that “to be successful, providers must deliver information about the significance of test results in a way that saves time and resources and allows for expansion that can keep pace with the rate of scientific advancement.”4

Due to the growing complexity of the molecular data and available therapeutic options, patient-specific clinical interpretation is required for helping the physician utilize molecular testing to select a therapeutic strategy for each patient. Each patient’s molecular test results must be analyzed to assess the effect of the clinically relevant alterations and the combination of alterations in the context of each patient’s cancer sub-type to determine the link to relevant therapeutic strategies. This must include sophisticated clinical trial matching.5

The key capabilities for patient-specific clinical interpretation necessitate:

  1. Analysis of each patient’s molecular profile at the gene, variant and disease level, plus an assessment of the impact of the interactions between alterations on drug sensitivity, drug resistance and combination therapy. This requires oncology domain expertise for on-demand analysis to evaluate any type of cancer and assess novel mutations
  2. Up-to-date clinical trial matching to address the growing complexity of patients’ molecular data and clinical trial design
  3. Capabilities to update a patient’s analysis based on subsequent testing and evolution in the molecular profile
  4. Integration of multiple types of tests to create a coherent treatment strategy, including immunotherapy approaches
  5. Integration of relevant patient data into the clinical interpretation to further refine clinical trial matching
  6. Delivery of therapeutic strategies to the point of care at the time of decision-making through the electronic medical record to enable physician-patient discussion

We as an industry can seize upon the opportunity to personalize the care of every patient. Molecular testing can play an increasingly valuable role in the diagnosis and treatment of disease. But for each patient to effectively receive this type of care, physicians must be empowered with exceptional clinical interpretation.

1 IMS Institute for Healthcare Informatics. Global Oncology Trend Report: A Review of 2015 and Outlook to 2020. June 2016. http://www.imshealth.com/en/thought-leadership/ims-institute/reports/global-oncology-trend-report-a-review-of-2015-and-outlook-to-2020. Accessed June 3, 2016.
2 Personalized Medicine Coalition. Personalized Medicine at FDA: 2016 Progress Report. 2017. http://www.personalizedmedicinecoalition.org/Resources/Personalized_Medicine_at_FDA. Accessed February 5, 2017.
3 Pharmaceutical Research and Manufacturers of America. Medicines in Development for Cancer: From Hope to Cure. 2015. http://phrma.org/sites/default/files/pdf/oncology-report-2015.pdf. Accessed May 15, 2016.
4 Pritchard, DE, Moeckel, F, Villa, M, Housman, L, McCarty, C, McLeod, HL. Strategies for integrating personalized medicine into health care practice. Personalized Medicine. Vol. 14, No. 2, 2017. Available at http://www.futuremedicine.com/doi/abs/10.2217/pme-2016-0064.
5 Carter, JL. Empower physicians to deliver precision medicine: The role of clinical interpretation. Personalized Medicine Coalition. Education & Advocacy. 2015. Available at https://personalizedmedicine.blog/2015/11/17/empowering-physicians-to-deliver-precision-medicine-the-role-of-clinical-interpretation/.


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Pharmacogenomics: The Rx for Success

Guest Blog
by Konstantinos Lazaridis, M.D., Assistant Director, Mayo Clinic Center for Individualized Medicine

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Konstantinos Lazaridis, M.D.

Perhaps more so than other areas, the emerging field of preemptive pharmacogenomics holds enormous promise to immediately improve the medical care of our patients. Patients would save time, money and untold suffering if they proactively had DNA testing to match medications to their individual genetic profiles. It is also important to integrate those test results into the patient’s electronic health record so they are available at the moment physicians are prescribing therapies.

Pharmacogenomics testing is currently one of the most promising tools in personalized medicine because of the potential widespread impact. The RIGHT study, done at Mayo Clinic, indicates nearly all patients could benefit. The study found that 99.9 percent of participants studied had a genetic variant that impacted the way their bodies processed medications. Conditions that hold the most promise for pharmacogenomics include:

  • Pain and psychiatric treatment — identifying medications that balance effectiveness with side effects.
  • Transplants — immunosuppressants keep the body from rejecting a transplanted organ, but leave patients vulnerable to infection.
  • Patients with polypharmacy — taking several medications often means that a drug is not working. Pharmacogenomics testing can identify what drugs do not work and simplify medical therapy.

Finding the Most Effective Medication

It is likely not uncommon for patients with a chronic medical condition to be on a “therapeutic odyssey,” a term we’ve coined to describe the frustrations patients experience when they try medication after medication for years without getting any relief from the symptoms of their conditions. I further explain this phenomenon in Improving Therapeutic Odyssey: Preemptive Pharmacogenomics Utility in Patient Care, an editorial that appeared in the October 23, 2016 edition of The Journal of Clinical Pharmacology & Therapeutics.

Therapeutic odyssey represents a protracted journey in a patient’s quest to find effective therapy for a chronic disease, often leading to unsuccessful treatments, frequent visits to health care providers, poly-pharmacy, herbal or alternative medicine-based therapy options, and sometimes unwanted symptoms – or even adverse drug events. In fact, the Centers for Disease Control, in a study published in Journal of the American Medical Association (JAMA), reports one out of every 250 Americans visited the emergency room because of a harmful drug reaction in both 2013 and 2014. Now is the time for health care providers to proactively recommend pharmacogenomics testing for all patients and enter the results in the electronic health record in order to find the most effective medications.

Mayo Clinic has created 19 drug-gene rules that are embedded in the electronic health record, notifying prescribers when a genetic variation may have a harmful drug interaction. Those alerts in the electronic health record have prevented more than 10,000 drug reactions at Mayo Clinic since 2013.

Pharmacogenomics testing must become a standard practice in order to improve the safety and quality of care. Doctors, pharmacists, nurses and educators must all work together to adopt practices that make it possible for all patients to benefit from the individually tailored treatments that pharmacogenomics offers.

Dr. Lazaridis is the Everett J. and Jane M. Hauck Associate Director in Minnesota. He is also recognized as the William O. Lund, Jr., and Natalie C. Lund Director, Clinomics Program.


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Advancing the Promise of Personalized Medicine With Liquid Biopsies and Analysis of ctDNA

Guest Blog
by John Beeler, Ph.D., Vice President, Corporate and Business Development, Inivata

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John Beeler, Ph.D.

The promise of personalized medicine gained momentum with the publication of the human genome more than 13 years ago. Enthusiasm grew over the potential to decode the genetic basis of disease and enable efficient utilization of a new generation of genomically targeted therapies. Precision medicine, whereby genomic information is integrated into clinical decision-making, intended to realize a more personalized approach and treat the right patient with the right drug at the right time.

Despite clear examples of success illustrated by the development of molecular technologies to identify genomic alterations with high specificity and sensitivity and to guide the use of targeted therapies against altered genes, including EGFR, BRAF, ALK and others, there has been a growing chorus of skeptics who infer that application of these targeted therapies to a broader population harboring respective genomic alterations is nothing more than hype. According to these skeptics, one of the primary reasons that precision oncology medicine is an illusion is the lack of data from randomized clinical trials that support the use of genomically guided therapies in more tumor diverse populations. However, there are several factors that have contributed to the paucity of data supporting advances in precision oncology medicine, particularly in patients with advanced stage disease.

The lack of tumor tissue available for molecular profiling is a primary barrier to more robust clinical data. Reasons for the lack of tissue necessary for broad molecular profiling include poor performance status, which precludes patients from being subjected to the invasive procedure necessary for obtaining a tissue specimen. On other occasions, it has been noted that tumors are inaccessible for a biopsy (e.g. bone metastases) and even when obtained, the limited amount of biopsy material can be insufficient for molecular profiling. According to published reports, approximately one-third of advanced stage cancer biopsies deliver tissue specimens that are either poor quality or have insufficient tumor material for a molecular analysis to be performed.

Tissue-based biopsies are further constrained by spatial and temporal limitations that may provide an inaccurate representation of the heterogeneous nature of the malignant growth, which results in the treatment of a patient based on an inaccurate molecular diagnosis. Finally, tissue biopsies are not conducive to serial sampling and are thus incapable of monitoring the molecular evolution when a tumor progresses. The failure to obtain a high-quality tissue specimen that accurately reflects the complete tumor biology may be a contributing factor to the lack of data supporting the realization of precision oncology medicine.

Fortunately, we now find ourselves at a potential inflection point, capable of positively impacting the field of personalized medicine. Recent advances in the application of “liquid biopsies” and the potential to harness molecular information in circulating cell-free tumor DNA (ctDNA) from the convenience of a simple blood draw offers a “game-changer.” Analysis of ctDNA represents a new generation of molecular applications that are capable of producing data that was previously unavailable, thereby helping to deliver on the full promise of providing health care that is both more precise and personal.

First identified more than 60 years ago by Mandal and Metais, advances in genomics and molecular methods now allow analysis of cell free DNA with unprecedented sensitivity and specificity to expand the range of opportunities for liquid biopsy applications that will impact the major aspects of a patient’s care. Analysis of ctDNA can identify genetic alterations that enable therapy selection, quantitatively monitor treatment progress, including disease recurrence via serial sampling, and detect new resistance mutations as they emerge. This liquid biopsy approach has the potential to revolutionize cancer care and improve and/or resolve many of the limitations inherent in current tissue-based standard treatment protocols for providing a broad molecular profile.

This is particularly relevant in non-small cell lung cancer (NSCLC), where a significant number of patients with advanced NSCLC are not receiving molecular testing for first-line therapy and even less are receiving a molecular profile at disease progression following first-line therapy. The opportunity to improve the availability of a molecular profile when one is not otherwise obtainable and provide valuable molecular information that impacts clinical decision-making offers to help deliver on the promise of personalized medicine.

In contrast to the current state of euphoria generated by the liquid biopsy approach and analysis of ctDNA, there is still significant work to be done to generate data illustrating the benefits of ctDNA. The data is necessary to address the limitations of current tissue-based testing, to drive adoption and utilization of this innovative approach, and to improve trust in the regulatory and reimbursement landscape. At Inivata we believe it is vital to get this aspect correct, most importantly for cancer patients, to fulfill the promise of personalized medicine.


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An Infrastructure for Innovation: How the 21st Century Cures Bill Established a More Favorable Landscape for Personalized Medicine in 2017

by Daryl Pritchard, Ph.D., Vice President, Science Policy

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Daryl Pritchard, Ph.D.

Barack Obama’s administration was clearly committed to the advancement of personalized medicine.  In addition to launching the Precision Medicine Initiative and the Cancer Moonshot effort, during his tenure President Obama regularly described personalized medicine as the future of health care.

“I want the country that eliminated polio and mapped the human genome to lead a new era of medicine, one that delivers the right treatment at the right time,” he said in his 2015 State of the Union Address.

The election of Donald Trump as the 45th President has led to a great deal of uncertainty on the future of personalized medicine and the fate of Obama’s signature personalized medicine programs.

Fortunately, Congress has confirmed its support for personalized medicine by passing the 21st Century Cures Act.  The law, designed to accelerate the pace of biomedical innovation, a goal that President-elect Trump has expressed interest in, provides continued momentum for personalized medicine. The House of Representatives voted 392 – 26 in favor of the legislation one week before the Senate passed the law 94 – 5. President Obama is expected to sign it.

“The 21st Century Cures bill supports personalized medicine,” PMC President Edward Abrahams said. “The Precision Medicine Initiative, the Cancer Moonshot and speedier access to innovative therapies based on molecular pathways, in particular, will all contribute to a healthier nation.”

Among other things, the bill:

  • Authorized $4.8 billion in funding over 10 years for programs at the National Institutes of Health (NIH) that include the All of Us Research Program and the Cancer Moonshot Research Program, as well as $500 million for FDA to implement provisions to improve innovation
  • Required FDA to make the patient experience a more central part of the drug development process
  • Established a review pathway at FDA for biomarkers and other drug development tools
  • Included provisions related to FDA’s oversight of diagnostics, albeit without addressing the longstanding debate on the regulation of laboratory-developed tests
  • Modernized clinical trial design and evidence development as it relates to the consideration of real-world data and other topics
  • Required FDA to pilot one or more inter-center institute(s) to help develop and implement processes for coordination of activities in major disease areas between the drug, biologics and device centers
  • And enhanced the country’s capacity to deliver personalized medicine through improvements and incentives in health information technology.

The law is not perfect. Policymakers have pointed out, for example, that the amount of NIH funding is half of what was proposed in the 2015 version, and that the programs are authorized rather than appropriated, thereby not guaranteeing that they will be funded. Others object to using the Affordable Care Act’s prevention funds to pay for Cures provisions.  Furthermore, although proponents claim the law’s new measures will not weaken FDA’s regulatory oversight, some critics disagree, especially regarding regenerative medicine.

But despite these concerns, the 21st Century Cures Act has provided a more favorable setting for personalized medicine amid ongoing uncertainty under a new administration.

The Personalized Medicine Coalition applauds Congress for passing the legislation and delivering it to the President, who has indicated his strong support for its provisions.  By allocating resources for personalized medicine programs and encouraging biomedical innovation, the 21st Century Cures Act will help drive personalized medicine’s enormous potential for patients and the health system in a future that otherwise remains uncertain.


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A Chancellor’s Tale: Transforming Academic Medicine

Guest Blog
by Ralph Snyderman, M.D., James B. Duke Professor of Medicine, Chancellor Emeritus, Duke University

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Ralph Snyderman, M.D.

A Chancellor’s Tale:  Transforming Academic Medicine is a personal and intimate story of my 15-year journey as Duke University’s Chancellor for Health Affairs during a time of major upheaval in medicine. The story, I hope, will help demonstrate the importance of planning, leadership and organizational change to the advancement of the personalized medicine paradigm.

My experience as a scientist and a physician prior to assuming my role as chancellor did little to prepare me to deal with a highly complex and entrenched institution that, unbeknownst to itself, was in need of disruptive change. The story describes the path the institution and I took during my tenure as chancellor, during which time the Duke University Medical Center became known for innovations in medicine and the conception of personalized health care.

As CEO of the Duke University Health System, I saw that despite our delivering outstanding, state-of-the-art care, treatments were generally directed towards the reversal of episodes of late-stage disease.  By 2000, anticipating the power of genomics and associated advances in technology, my colleagues and I began to envision an entirely new approach to care.  Rather than being reactive to disease, health care could be proactive, predictive, preventive and personalized.  As health and disease are a consequence of one’s genetics and environmental exposures over time, the availability of technologies to quantify health risks, track disease progression and identify specific disease mechanisms could be a game-changer for how care is delivered.  Rather than starting with a disease manifestation and working back, clinicians could, in conjunction with their patient, anticipate disease risks and work to mitigate them and to treat them precisely when needed.  As a consequence of this thinking, my colleagues and I conceived of an entirely new approach to health care and in doing so, laid the foundation for personalized health care.

A Chancellor’s Tale tells the story of the major transformation of Duke’s academic enterprise along with the concepts that resulted in the creation of care delivery models for personalized, proactive, patient-driven care. The book describes the difficulties of making change in a complex academic institution including what worked, what went wrong and lessons learned.  My hope is that the personalized medicine community will find the stories interesting and my learning experiences useful.

The book is available for purchase at https://www.dukeupress.edu/a-chancellors-tale.

Special offer: Use coupon code E16SNYDR to save 30 percent on the hardcover edition when you order from dukeupress.edu.