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9 Essential Models to Predict the Future of Precision Medicine

As a quarter century follower of personalized medicine, the recent progress and pronouncements on precision medicine are greatly appreciated. Despite extraordinary complexities new ‘omics...

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Leveraging Blood-Based Biopsies

It is, without doubt, an exciting time to be an oncologist or a cancer researcher. As our understanding continues to grow of the underlying...

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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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Field Notes

Adding Value to Allele Data

In late winter at the Advances in Genome Biology and Technology (AGBT) scientific meeting in Marco Island, Fla., a coalition of 13 life science...

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Field Notes

A New Hope for Pancreatic Cancer

It’s a sad fact that most people diagnosed with pancreatic cancer feel their situation is hopeless. According to the National Cancer Institute, nearly 47,000...

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Precision Tools

Precision Medicine: The Importance of Correctly Matching the Tool to the Task

his year, on April 16th the Personalized Medicine World Conference (PMWC) made its debut in the UK. Attendee’s benefited from new insights behind the...

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Precision Tools

High Resolution: Bringing a Sharper Focus to Precision Medicine Through Design

With so much attention focused on new ways to collect, combine, and mine health data, it can be easy to overlook the critical need...

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Precision Tools

Paths to Precision Medicine: A Perspective

Cancer is a complex, heterogeneous disease, driven by multiple molecular pathways. There are hundreds of known oncogenes, which arise in myriad combinations, making every...

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20/20

Human Genome Pioneer Continues to Push the Envelope

Say what you will about J. Craig Venter – and opinions run the gamut from him being our generation’s greatest scientist to him also...

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Cognoscienti

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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Field Notes

Precise with Mice

A collaboration between the Jackson Laboratory (JAX) and six academic centers has garnered a five-year, $10 million grant from the National Institutes of Health...

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Field Notes

A Conversation with Werner Verbiest

Werner Verbiest has spent the better part of the last 25 years in roles focused on designing better diagnostics for a range of diseases....

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The Hub

Waves of Precision Roll Into the Bay

Some life sciences clusters grow as a natural combination of academia and a critical mass of successful trailblazing companies. Others are built by intention...

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Cognoscienti

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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Precision Tools

Methods Towards Clinical Actionability of Next Generation Sequencing

Precision Medicine necessitates continuously measuring the certainty with which the right patient receives the right treatment at the right time. Common clinical presentations are...

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Precision Tools

Electronic Health Systems: Golden Mine for Precision Medicine?

Precision medicine is an emerging field whose relevance is destined to grow at a pace, that at least in part, depends on the concomitant...

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Precision Tools

Blood-Based Companion Diagnostics

Since the seminal reports of the utility of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) in evaluating a cancer patient’s response to...

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Precision Tools

Epigenetic Therapies, Immune Therapies, and Anti-Angiogenic Therapies: The Triad of Oncology. Angiogenesis: Cause or effect?

Advances in technology have allowed medical providers to customize healthcare with medical decisions, practices, and therapeutics being tailored to the individual patient. Through the...

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Optimism and Purpose Drive Immune-Oncology Advances

It is, fair to say the field of immune-oncology is still in its infancy. But the concept of immune system activation as a means...

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20/20

Biotech Billionaire Dr. Patrick Soon-Shiong Brings Multidisciplinary Approach To Answering Biology’s Most Basic Questions.

When you hear Soon-Shiong elucidate his vision of the future of healthcare and the development of new therapeutics, the holistic approach he intends to...

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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 Tools

Pharmacovigilance and Data for Precision Medicine.

There is plenty of chatter surrounding ‘data driven discovery’ currently, yet do those authors, bloggers and conference speakers all talk of the same thing? Could...

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Precision Tools

Cancer genome sequence data combined with incidence statistics suggests large numbers of patients could benefit from off-label therapies.

Targeted molecular therapies offer the hope that they can be used in any disease that carries the specific molecular aberration being targeted. Combining data on...

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Cognoscienti

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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Precision Tools

Metabolomics, The Iceberg of Complexity and Clinical Utility

The genomic revolution continues to deliver research and clinical breakthroughs (CRISPR/Cas, WGS) that suggest greater precision and prediction is just ahead. And despite extraordinary complexities proteomics...

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Cognoscienti

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 Hub

Small in stature, Big in activity

It is well documented that within the historic walls of Cambridge University, Watson and Crick first made their discovery of the structure of DNA....

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Cognoscienti

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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Field Notes

Fine-tuning donor-patient organ matching

The International Genetics & Translational Research in Transplantation Network (iGENETRAiN) and commercial collaborator Affymetrix have together embarked on a genome-wide association study. The aim is to identify specific genetic variants that may...

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Finding the markers for a broken heart

PHOENIX – Research conducted at the Translational Genomics Institute (TGen) and the Barrow Neurological Institute has identified, for the first time, genes associated with stress-induced cardiomyopathy (SIC), a...

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20/20

Sequencing pioneer and serial entrepreneur Jonathan Rothberg continues his “wild ride”

Most 10 year old kids don’t grow up with the use a full chemistry lab in the basement and a copy of ‘Fortunes Formula’ to help...

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Field Notes

OME-ing in on precision wellness

Pathway Genomics’ OME personalized wellness app leverages Watson’s cognitive computing In early January at the Consumer Electronics Show in Las Vegas, Pathway Genomics announced the closed-alpha release of...

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CRISPR-Cas9: The bold, new, fast, inexpensive frontier of gene editing

If Helen of Troy possessed the face that launched a thousand ships, it is not a stretch to say that the publication in the summer...

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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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Field Notes

Glimpsing the future: New immune-based therapies for multiple myeloma.

Over the last year, the U.S. FDA approved a flurry of new drugs for use in multiple myeloma, a cancer that affects the bone...

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Precision Tools

The Computational Network Imaging Frontier: Relevance for Digital Biomarkers in Precision Oncology.

Cancer treatment is no doubt the greatest of the big challenges in the newborn field of Precision Medicine. As an effect of advances in imaging...

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Field Notes

The Mutual Benefits of Rare Disease Research and Precision Medicine

Precision medicine seems tailored to the study of rare diseases: at least 80 percent of them arise from genetic variations, and (though not always the case) show varying...

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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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Diagnosing Rare Disease

A few days after the world celebrated Rare Disease Day, an international effort to raise awareness of rare diseases, UK-based Congenica, a company that offers clinical interpretation of genome sequence...

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Field Notes

Clinical Conundrums

Early this year, backed by a 3-year, $1.5-million grant from the Sohn Conference Foundation, Columbia University Medical Center announced plans to provide genome sequencing to...

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Prostate Cancer’s Precision Promise

If you’re a man living in the US today, you have a 1 in 7 chance of being diagnosed with prostate cancer before you die....

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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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Cognoscienti

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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Field Notes

Liquid Biopsies Bleed Into Clinical Use

Technologies that can detect cancer in circulating blood have proliferated over the past few years, but proof of their prowess in the clinic has been...

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Field Notes

Companion Diagnostics – a Burgeoning Market

Since the first drug requiring a companion diagnostic test was approved by the U.S. Food and Drug Administration (FDA) in 1998, the global market for companion...

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Field Notes

The Race To Collect Genomes

In April, the precision medicine field got what researchers hope is a shot of adrenaline with the announcement by AstraZeneca that it will sequence the genomes...

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20/20

Glimcher Brings Bold, Unflinching Style to New Role as Head of Dana-Farber

Glimcher has a trail of impressive accolades that span her career as a prominent immunologist and leader. As dean of Weill Cornell Medicine, she led the recruitment...

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The Rise of the Consortium: A Game Changing Approach to Dementia Research.

Cancer research is overflowing with examples of fresh approaches accelerating meaningful, patient-centered results, but it should not be the isolated example. Many other areas of research...

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Field Notes

Ruminations on the Precision Medicine Leaders Summit: The Gordian Knot Connectivity of Stakeholders

The Inaugural Precision Medicine Leaders Summit (PMLS) was held in San Diego, California, on August 10-12th 2016 (www.precisionmedicineleaderssummit.com.) Currently there is a frenzied cacophony...

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Field Notes

The Current Developments Being Made in Cancer Immunotherapy

At the recent Precision Medicine Leaders Summit, the current developments being made in Cancer Immunotherapy were discussed on one of the many roundtables organised...

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Cognoscienti

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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20/20

At the Gates Foundation, Desmond-Hellmann Brings the Power of Precision Medicine to Public Health

As CEO of one of the world’s largest and most influential philanthropies, Susan Desmond- Hellmann, MD, MPH, directs an impressive portfolio: The Bill &...

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Precision Tools

The Dawning of Stem Cells in Precision Medicine.

Stem cell research has been around since the 1860’s . Fast forward a hundred years to the 1960’s with the advent of the bone...

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The Multi-Omics Revolution

Currently, genomics studies contribute the vast majority of precision medicine- based data. As of August 2016, over 2,500 genome wide association studies (GWAS) have...

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Field Notes

Taking Proteomics to Heart

Coronary heart disease (CHD) is enormously widespread, affecting some 6% of US the population and killing 370,000 people annually and portending a heart attack,...

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Cognoscienti

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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Field Notes

Blood Donors Seen as Saviors for Precision Medicine

In early October, with a bandage on her arm after donating a pint of type O negative blood, Erin Elliott earned her “gallon pin”...

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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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Precision and Accuracy in Medicine: the Case of “Ovarian” Cancer

While researching our new books on women’s and men’s cancers, we made a rather startling discovery: what everyone refers to as ovarian cancer doesn’t...

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The Hub

Revolutionizing Healthcare in British Columbia with Precision Medicine

Among the breath-taking backdrop of the Canadian Coast Mountains, an ecosystem is emerging in the province of British Columbia. But rather than one borne...

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The Earliest Genetic Snapshot: Non- Invasive Prenatal Testing Is Coming of Age

Today, more than one in five pregnant women in the US gets her blood drawn when she’s about ten weeks pregnant, not to gauge...

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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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Metastatic Melanoma: A New Era of Treatments

Historically, the prognosis for metastatic melanoma has been poor. Patients with metastatic disease have a median survival of 6-9 months and less than 10%...

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Field Notes

A Personalized Twist For Oncolytic Vaccines

Prospects for using viruses to fight cancer got a huge boost in late 2015 when the US Food and Drug Administration granted its first-of-a-kind...

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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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PRECISION MEDICINE: The Center for Individualized Medicine, Mayo Clinic

In its 150-year history, the Mayo Clinic has stayed true to its patient-centered model of care. That same vision has guided the trajectory of...

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Setting the Stage – A Brief History of FDA Regulation of Precision Medicine, and a Glimpse to its Possible Future

Precision Medicine occupies a complex space – driven by science, dependent upon third parties for financial support, and bounded by vague and emerging laws...

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Field Notes

A Genomic Mandate

In 1989, a young man affected with hemochromatosis, a genetic disorder of iron metabolism, told this story: “I have been successfully treated with low...

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Cognoscienti

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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20/20

From chromosome ends to science advocacy

Elizabeth Blackburn, PhD, began her pioneering studies of the cap-like ends of chromosomes, called telomeres, some four decades ago. Then a molecular mystery, telomeres...

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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 first challenge of any population-scale research study is building a cohort of engaged participants.

The first challenge of any population-scale research study is building a cohort of engaged participants. But once that major feat is accomplished, there’s a...

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Dr. Stephen Kingsmore – a vision for transforming medicine with rapid genome sequencing

Dr. Stephen Kingsmore, MD, DSc, is the President and CEO of the Rady Pediatric Genomics and Systems Medicine Institute. Shawn Baker CSO of AllSeq...

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Innovative Methodologies to Drive Enrollment of Molecularly Defined Patient Populations for Diagnostic- Enabled Basket Studies

Today, the genomic profile of a patient’s tumor may be as important, if not more so, than the tissue of origin. Patients whose tumors...

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Antidepressant Pharmacogenetics

The focus of this year’s World Health Organisation (WHO) world health day on April 7th was major depression. The prominence given to depression reflected...

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Mission Possible: Moving Diagnostics to the Forefront of Precision Medicine

The Journal of Precision Medicine was founded in order to bridge the gap between the evolving technology in healthcare and the clinical needs of...

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Field Notes

Personalized Medicine at FDA: 2016 Progress Report

If new drug approvals are any indication, personalized medicine is progressing steadily despite ongoing challenges in regulation, reimbursement and clinical adoption. The Personalized Medicine...

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A new disease level precision medicine model; starting with melanoma

In just a few months, the PM Connective expects to complete a new model for melanoma that will offer clinical and financial benefits in...

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Field Notes

The Diagnostics Year in Review – 2016

A patient has nothing without an accurate and timely diagnosis. Diagnostics are the glue that holds the healthcare system together. An inaccurate, missed or...

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Field Notes

A Conversation with Stephen J. Ubl

Stephen Ubl is president and chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), which represents America’s leading biopharmaceutical research companies. Mr....

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PRECISION MEDICINE CENTER PROFILE: The Jackson Laboratory

The Jackson Laboratory (JAX) is living proof that translational genomic medicine is not the unique domain of academic hospitals. Founded in 1929 as a...

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Field Notes

Why diagnostic companies need to control their own market.

It has been nearly 20 years since what most consider to be the advent of Precision Medicine, when two targeted therapies (Herceptin and Gleevec)...

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Field Notes

California Paves the Way for State Efforts in Precision Medicine

It all started with a few lines in the California governor’s 2014 State of the State address: “Just as California has led the way...

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Field Notes

A Conversation with Norma Nowak.

Norma Nowak got hooked on the excitement and the promise of the Human Genome Project more than three decades ago and never looked back....

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Cognoscienti

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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Cognoscienti

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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20/20

Propelling Medicine into the Digital Age

Eric Topol, MD, is not your average gadget guy. As a renowned cardiologist, he has made hand-held medical devices and mobile technology an essential...

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Precision Tools

Understanding and Managing Stress: Perspectives from in vivo Quantum Biology

Stress is a type of reaction to a stimulus that disturbs our physical and mental equilibrium. Chronic stress is an escalating health problem that...