Precision medicine tests, associated technologies, and early derived therapeutics are increasingly being adopted into clinical practice as evidence of their effectiveness grows. At the same time, many patients do not have access to precision medicine because most public and private health insurers do not yet offer coverage for genetic or genomic services unless certain clinical criteria and evidentiary standards are met. As a result, access to this next generation of promising and increasingly impactful clinical testing is often limited.

“Together, we must holistically look at the health care system and that includes social determinants of health, total lower costs, sustaining healthy populations, through focused efforts on primary and preventive care.”

Dr. Patrick Conway, President and CEO, Blue Cross and Blue Shield of North Carolina (BCBSNC) and presenter at PMWC 2018 Duke next month (full interview on PMWC blog)

Undeniably, we are still in the mode of demonstrating that routine genetic testing has value to the individual. Yet monitoring and rewarding success across larger populations as the healthcare industry moves deeper into risk-based reimbursements and pay-for-performance contracting is important and a must-have in order to generate the basis to keep advancing these genetic-based therapeutic approaches.

Strong evidence exists that accessibility to genetic testing should be a high priority for the industry based on demonstrated value of:

  • Next-generation sequencing for average-risk pregnancies to help accelerate the adoption and reimbursement of non-invasive prenatal testing
  • Genetic screening for all women above a certain age for gene mutations related to breast and ovarian cancer to increase life expectancy compared to traditional methods

Exciting news has taken center-stage with recent Centers for Medicare and Medicaid Services (CMS) announcements:

  • CMS is considering covering the cost of the newly, FDA-approved FoundationOne CDx NGS test – a 324 gene test – that can identify key biomarkers for certain cancers
  • CMS is covering diagnostic laboratory tests using NGS for patients with advanced cancer

….at present we seem to still be in the “evidence generation stage”!

However, there is definitely good reason to be hopeful that with CMS on board, albeit in a limited capacity, commercial payers may follow suit and start to explore more coverage options for precision medicine techniques.

As the precision medicine environment expands, developing financial models to account for the high initial costs of testing and treatment as well as dialing in the promise in savings through early detection and prevention of disease progression will be essential for creating a body of evidence to support the efficacy of precision therapies. With more data to guide payers, providers, and patients towards the most effective, lowest cost care plans, value-based care contracts around genetic testing and personalized therapies will likely become the path to controlling costs and ensuring better patient outcomes.

Cost clearly is one of the major hurdles of broad precision medicine adoption, an issue that must be addressed now, as drugs that are developed to target a person’s genetic or molecular characteristics are likely to be expensive and reimbursement for these targeted drugs are likely the biggest issue. At the same time, we need to continue the dialogue among all stakeholders as to how to capture the value and significant cost savings generated through early detection and treatment vs. later state interventions.

Improving Access to Precision Medicine requires…

  •  Encouraging the expansion of health insurance coverage of genetic and genomic testing, including diagnostic, predictive, and pre-symptomatic testing, as well as whole genome sequencing
  • Supporting the collection of evidence for the clinical utility and appropriate use of genetic and genomic tests
  • Improving access to genetic counselors and other relevant professionals, including strengthening related workforce education and training efforts to ensure availability

….and we need to do this while we are still facing some of these major challenges including:

  • How will the landscape of genetic testing be impacted or changed for the patient, payor, and molecular test provider?
  • How do we achieve a reimbursement process that is value-based versus cost-based?
  • How do we assess the value of precision medicine and molecular testing?
  • What is the economic impact of precision medicine on patients, payors, pharmaceutical industry, and providers?

Join PMWC 2018 Duke this September 24-25 to be directly involved in these critical discussions at a time where we’re setting the course for the next phase of precision medicine acceleration and implementation. We have an exciting session in store for you – the “Efforts to Accelerate Precision Medicine” that focuses on these topics, with speakers:

Patrick Conway
M.D., President & CEO,
Blue Cross and Blue Shield NC

Lauren Silvis
J.D., Chief of Staff
to the Commissioner, FDA

Brian Caveney
M.D., J.D., MPH,
Enterprise-wide CMO, LabCorp

Interview with Ken Bloom of Ambry Genetics

Q: Tell us more about your organization/company. What patient population are you serving and which services are you specializing in?

A: Ambry Genetics is a recognized leader in high quality complex genetic testing. We seek to find the genomic cause or contributors to rare diseases, abnormal phenotypes and hereditary disorders.

Read More

Interview with Lee Pierce of Sirius Computer Solutions

Q: What is the state of big data and analytics in healthcare, and how to best use the reams of data available?

A: More than ever, Healthcare organizations are achieving measurable value through use of their data and analytics assets. There is more raw material available than ever to create value. This raw material is the data flowing from internal systems and applications and also from devices and systems external to healthcare organizations.

Read More

Interview with Anita Nelsen of PAREXEL

Q: There are various new, emerging technologies that bring us closer towards a cure for life-threatening disorders such as cancer, HIV, or Huntington’s disease. Prominent examples include the popular gene editing tool CRISPR or new and improved cell and gene therapies. By when can we expect these new technologies being part of routine clinical care?

A: Today’s emerging technologies are making the promise of individualized treatment a reality.

Read More

Interview with Ilan Kirsch of Adaptive Biotechnologies

Q: The Nobel Prize in Medicine was awarded recently to James Allison and Tasuku Honjo for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” What is your first-hand experience the impact that those new drugs had on patients?

A: For decades cancer was viewed as solely a cell-autonomous condition.

Read More

BMS buys Celgene | Lilly buys Loxo Oncology – Does this Signal a Return to Strong Deal-Making Activities in 2019?

Bristol-Myers Squibb’s blockbuster $74B deal to buy Celgene creates an oncology powerhouse amid industrywide excitement about the rapidly evolving science and explosive growth of the sector. The agreement could signal a return to deal-making for the pharmaceutical industry in the $133B global oncology therapeutics market.

Read More

Interview with Gini Deshpande of NuMedii

Q: What need is NuMedii addressing?

A: NuMedii, has been pioneering the use of Big Data, artificial intelligence (AI) and systems biology since 2010 to accelerate the discovery of precision therapies to address high unmet medical needs. Artificial Intelligence approaches are a natural fit to harness Big Data as they provide a framework to ‘train’ computers to recognize patterns and sift through vast amounts of new and existing genomic

Read More

Interview with Minnie Sarwal of UCSF

Q: Genomic medicine is entering more hospitals and bringing with it non-invasive technology that can be used to better target and treat diseases. What are some key milestones that contributed to this trend?

A: Completion of complete sequence data from the human genome project, and the advances in proteomic, microRNA and epigenetic assays added a layer of pathway biology to the understanding of human diseases.

Read More

Interview with Shidong Jia of Predicine

Q: Once sequencing has been validated as a clinical solution via trusted workflows, and coinciding with the technological developments driving costs lower, we can expect accelerated human genome profiling for clinical Dx. How soon, do you think, will we see accelerated growth and what can we expect?

A: We will see accelerated human genome profiling for clinical Dx in 2019 and the coming years as more biomarker-based cancer drugs are gaining approval.

Read More

Interview with Iya Khalil of GNS Healthcare

Q: Artificial intelligence (AI) techniques have sent vast waves across healthcare, even fueling an active discussion of whether AI doctors will eventually replace human physicians in the future. Do you believe that human physicians will be replaced by machines in the foreseeable future? What are your thoughts?

A: I think that there’s a lot of speculation and uncertainty around AI, but I don’t foresee a time when we won’t need physicians.

Read More

Interview with Ilya Michael Rachman of Immix Biopharma Inc.

Q: The Nobel Price in Medicine was awarded recently to James Allison and Tasuku for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” Besides CAR T-cell therapy what do you think next generation immunotherapies will look like to successfully combat cancer?

A: The next generation of immunotherapies will build on the insights discovered by immunologists like James Allison and Tasuku Honjo and extend them to modify the body’s response to tumors.

Read More

Join me to Kick off PMWC Silicon Valley in the Santa Clara Convention Center, Focusing on Every Element of Precision Medicine

My team worked in collaboration with Bill Dalton, Kim Blackwell, Atul Butte / India Hook Barnard, Nancy Davidson and Sharon Terry to create a program that touches every component of precision medicine while bringing together all of its key stakeholders. Leading participating institutions including Stanford Health Care, UCSF, Duke Health, Duke University, John Hopkins University, University of Michigan and more will share their learnings and experiences and their successes and challenges, as they make precision medicine the new standard of care for all.

Read More

Interview with Dominic Eisinger of Myriad RBM

Q: The Nobel Price in Medicine was awarded recently to James Allison and Tasuku for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” Besides CAR T-cell therapy what do you think next generation immunotherapies will look like to successfully combat cancer?

A: Next generation immunotherapies include CAR-Ts, TCRs, cancer vaccines, ADCs, bi-specific antibodies, and checkpoint inhibitors.

Read More

2018 Year in Review Milestones: Stakeholder Partnerships Carving Precision Medicine’s Future

2018 has clearly been a year when significant opportunities intersected with strong partnerships to yield advancements. In particular, the clinical advancements that were realized are a testimony to stakeholders working together to deliver on promises affecting major aspects of precision medicine. 2018 has clearly been a year when significant opportunities intersected with strong partnerships to yield advancements.

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Interview with Lisa Alderson of Genome Medical

Q: Tell us a little bit about Genome Medical. What market need is Genome Medical addressing and how?

A: Genome Medical is a telegenomics company that is bridging the gap between available, genetic expertise and the clinical application of genomics.

Read More

Interview with Nasir Bhanpuri of Virta Health

Q: What need is Virta Health addressing?

A: Virta Health delivers an evidence-based treatment to safely and sustainably reverse type 2 diabetes without the use of medications or surgery. In the U.S. alone, type 2 diabetes and prediabetes affects 115 million people, and the economic burden is well-over $300 billion and growing.

Read More
Johns Hopkins
University Of Michigan

The Precision Medicine World Conference (PMWC), in its 17th installment, will take place in the Santa Clara Convention Center (Silicon Valley) on January 21-24, 2020. The program will traverse innovative technologies, thriving initiatives, and clinical case studies that enable the translation of precision medicine into direct improvements in health care. Conference attendees will have an opportunity to learn first-hand about the latest developments and advancements in precision medicine and cutting-edge new strategies and solutions that are changing how patients are treated.

See 2019 Agenda highlights:

  • Five tracks will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
    • AI & Data Science Showcase
    • Clinical & Research Tools Showcase
    • Clinical Dx Showcase
    • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
    • Digital Health/Health and Wellness
    • Digital Phenotyping
    • Diversity in Precision Medicine
    • Drug Development (PPPs)
    • Early Days of Life Sequencing
    • Emerging Technologies in PM
    • Emerging Therapeutic Showcase
    • FDA Efforts to Accelerate PM
    • Gene Editing
    • Genomic Profiling Showcase
    • Immunotherapy Sessions & Showcase
    • Implementation into Health Care Delivery
    • Large Scale Bio-data Resources to Support Drug Development (PPPs)
    • Microbial Profiling Showcase
    • Microbiome
    • Neoantigens
    • Next-Gen. Workforce of PM
    • Non-Clinical Services Showcase
    • Pharmacogenomics
    • Point-of Care Dx Platform
    • Precision Public Health
    • Rare Disease Diagnosis
    • Resilience
    • Robust Clinical Decision Support Tools
    • Wellness and Aging Showcase

See 2019 Agenda highlights:

    • Five tracks will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
      • AI & Data Science Showcase
      • Clinical & Research Tools Showcase
      • Clinical Dx Showcase
      • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
      • Digital Health/Health and Wellness
      • Digital Phenotyping
      • Diversity in Precision Medicine
      • Drug Development (PPPs)
      • Early Days of Life Sequencing
      • Emerging Technologies in PM
      • Emerging Therapeutic Showcase
      • FDA Efforts to Accelerate PM
      • Gene Editing / CRISPR
      • Genomic Profiling Showcase
      • Immunotherapy Sessions & Showcase
      • Implementation into Health Care Delivery
      • Large Scale Bio-data Resources to Support Drug Development (PPPs)
      • Microbial Profiling Showcase
      • Microbiome
      • Neoantigens
      • Next-Gen. Workforce of PM
      • Non-Clinical Services Showcase
      • Pharmacogenomics
      • Point-of Care Dx Platform
      • Precision Public Health
      • Rare Disease Diagnosis
      • Resilience
      • Robust Clinical Decision Support Tools
      • Wellness and Aging Showcase
  • Luminary and Pioneer Awards, honoring individuals who contributed, and continue to contribute, to the field of Precision Medicine
  • 2000+ multidisciplinary attendees, from across the entire spectrum of healthcare, representing different types of companies, technologies, and medical centers with leadership roles in precision medicine
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