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Precision Medicine is a Value-of-Information Proposition – and Vice-Versa

In this inaugural issue of the Journal of Precision Medicine, we would like to draw attention to a decision-analytic concept that has grown prominent...

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Precision Medicine: Too Much Precision, Not Enough Medicine?

“Precision Medicine,” a new name for “molecular medicine,” has been the goal of medicine since the time of the Greeks. Medicine without scientific precision...

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Why Do Physicians Experience Genomics Education Gaps, and What Can We Do About It?

Of the many factors needed for the complete clinical uptake of personalized medicine and its use to improve health out comes, one of the...

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Precision & Accuracy: A Way Forward in Cancer Medicine

We have reached a point where in the last 30 years your chance of surviving cancer has increased from 1 in 4 to roughly...

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Personalized Health Care: Unlocking the Potential of Genomic and Precision Medicine

President Obama’s Precision Medicine Initiative has refocused national attention on the ability of genomics and other emerging technologies to provide a better understanding of...

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Are Payers Ready to Assess the Combined Value of Drugs with a Companion Diagnostic?

Targeted drugs that are tailored to biomarkers are most often developed or co-developed with a companion diagnostic to identify patients who are good responders....

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What’s in a Name? The Evolution of “P-Medicine”

The current paradigm of modern healthcare is a reactive response to patient symptoms, subsequent diagnosis and corresponding treatment of the specific disease(s). This approach...

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Precision Medicine in Infectious Diseases: Changing the treatment paradigm for bacterial infections to end the Antimicrobial Resistance Crisis.

Precision medicine is often associated with oncology where the ability to screen and select patients based on a particular mutation is critical for use and...

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Precision Diagnosis for Precision Medicine

The Precision Medicine Initiative and a “Moonshot to Cure Cancer” were announced by President Barack Obama in two consecutive State of the Union addresses in January...

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Personalized Medicine at FDA: 2015 Progress Report

The transformation of health care from one-size-fits-all, trial-and-error medicine to a targeted approach utilizing an individual patient’s molecular information continues to accelerate as the U.S. Food...

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The Complementary Iceberg Tips of Diabetes and Precision Medicine.

Diabetes is perceived as a “simple disease” and manifested in the form of inadequate blood glucose regulation. Paradoxically, it is now also recognized as a...

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Towards Targeted Therapeutics: The Pharmaceutical Industry and Personalized Medicine

“The pharmaceutical industry is deeply committed to delivering on the promise of personalized medicine.” Ian Read, Pfizer CEO, National Press Club, Washington, DC, May 14, 2015.

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IMAGINARY WORLDS: REPRODUCIBILITY AND MODELED CLAIMS IN PRECISION MEDICINE

Developing decision models to support comparative cost-effectiveness claims is now an accepted standard in submissions both to gatekeepers for single payer health systems as well as...

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The Silent Epidemic of Alzheimer’s Disease: Can Precision Medicine Provide Effective Drug Therapies?

Alzheimer’s disease is a complex, multi-faceted condition. Our understanding of the causal onset, diagnosis, progression, and treatment of the disease is limited and beset with...

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Barriers to Implementation of Precision Medicine for Cancer Treatment in the U.S. Healthcare System.

Cancer is a complex disease caused by a combination of genetic factors and environmental and life style influences. These manifest across a wide spectrum of...

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Biobanking for Personalized, Precision Medicine: an Annotated Bibliography

A biobank is an organization that acquires and stores human tissue and genetic data for future research use. Biobanks provide an opportunity for more efficient...

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Assessing Direct-to-Consumer and Consumer-Directed Products for Clinical Integration.

With more and more Direct-to-Consumer (DTC) and Consumer-Directed (CD) ‘Omics products hitting the US market, leading providers, physician groups and healthcare systems in the field...

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Call to Action: Breaking Down Barriers for Patient Participation in Oncology Clinical Trials

A cancer diagnosis is a life-changing event. For advanced cancer in particular, standard of care treatments have limited impact on long term patient survival. Precision Medicine...

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Precision Medicine as a New Paradigm in Drug Development

Over 2000 years ago, Hippocrates and the ancient Greeks believed that humors (bodily fluids) determined an individual’s behavior and disposition (On the Nature of...

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A Clarion Call for Creating a Global Precision Medicine Network

Precision Medicine is a complex, multifaceted “novel” approach to the prevention, diagnosis and treatment of disease, predicated on the analysis of individual patient data....

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Early Drug Development in the Era of Precision Medicine

Circa the 5th century BC, Hippocrates established the basis for modern medicine, stating “It’s far more important to know what person the disease has...

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Saudi Human Genome Program – Towards Identification, Characterization and Prevention of Rare Diseases

Studying the genetic makeup of a population is a powerful tool for healthcare systems. For rare Mendelian diseases it offers the opportunity to identify...

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Truth, Friction and the Dream

I walked into my office a few minutes late and found Jacob with his cheek down on the table, his mother and aunt flanking...

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Establishing The Promise Of Next Generation Sequencing: The Minnesota Guidelines

Unless a coherent and believable evidence base is established it is doubtful that the promise of precision medicine utilizing next generation sequencing (NGS) will...

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Precision Medicine Also Means An Excellent Diagnosis

I was recently introduced to a beautiful lady, immaculately dressed and wearing a wig. She told me she had cancer and was is in...

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Ready for a Dose of Reality?

New laboratory and point-of-care tests are emerging to help physicians refine dosing of expensive and powerful biologics drugs, with the aim of bringing relief...

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Realizing the Value of Precision Medicine: Today

For eight years, a group of 200 healthcare experts from six different stakeholder groups set aside their competitive agendas to search for an answer...

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Differentiation of Precision Medicine-Advancing Care Through Pharmacogenomics at Mayo Clinic

Mayo Clinic is an integrated multi-specialty group medical practice. The individual components operate under the auspices of Mayo Foundation, the not-for-profit parent organization. The...

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Realizing the Potential of Precision Oncology

As we approach the 20th anniversary, in 2018, of the approval of Herceptin, the field of precision oncology has never been more exciting and...

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Pharmacogenomics: Making the case for Primum non nocere

As a practicing clinician and an educator, I consistently arrive at crossroads when I need to make therapeutic choices. This often is done in...

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The Complex Strategic Landscape for Precision Medicine: Cost, Convergence, Culture, Computing and Creative Destruction

I was encouraged on reading the first issue of this journal, and now subsequent issues, that it would not be yet another forum for...

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Emerging Models for Clinical Adoption of Personalized Medicine

Enthusiasm, publicity, promise … personalized/precision medicine has captured many people’s imaginations with its potential for transforming healthcare. But is every academic and community health...

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FDA and Precision Medicine 2017- An Interim Report from Washington

Change and uncertainty accompany any political transition, and as the new administration was taking shape back in the early part of the year, FDA-regulated...

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The Precision Medicine Initiative at Merck: State-of-the-Art Patient Selection

As a cornerstone of the Merck approach to the development of companion diagnostics (CDx), we have developed a CDx guide that is applied across...

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How to Align the Moving Parts in Personalized Medicine Reimbursement

Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge...

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The Diagnostics Year In Review – 2017

2017 was an important year for Diagnostics’ impact on healthcare – marked by multiple positive milestones. While many of these milestones were overdue, we...

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Are we at the Tipping Point for Precision Medicine IVD’s?

Medicine is full of examples of innovative and intuitively appealing ideas, some of which have really improved patients’ lives and some that just turned...

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Regulatory Applications of Real World Evidence

Real-World Evidence (RWE) holds out the promise of reducing time and costs of product approvals, identifying new uses for existing products, increasing our ability...

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Shifting Precision Medicine from Treating Cancer to Its Prevention: The HeritX Initiative

How a global collaborative effort and its Accelerated Roadmap to Prevention leverage BRCA gene mutations as the scientific gateway to cancer prevention

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Thirty Years On, Quo Vadis Cancer Companion Diagnostics?

The concept of companion diagnostics for cancer was introduced in 1998 with approval of trastuzumab (Herceptin®) together with the respective HER2 test for selecting...

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Breaking the Mold: FDA Pushes Towards Personal

In June, FierceBiotech reported that FDA would continue to “rethink targeted therapy regulation” to “speed development” in 2017. The agency certainly made good on...