Kim, you are the chair of Solid Tumor Oncology and Investigational Therapeutics and the Donald S. Kim distinguished chair for cancer research at the Levine Cancer Institute, Carolinas HealthCare System in Charlotte, NC.

Q: What are some of the activities of the Levine Cancer Institute to address the current needs for cancer care?

A: We have developed Levine Cancer Institute (LCI) to be an academic-community based hybrid model which serves patients across North and South Carolina. Our efforts are grounded in conducting novel early phase clinical research with a focus on translational genomic studies. Additionally, we have developed several programs unique to the region including a Supportive Oncology Program, a large comprehensive patient navigation program, as well as the first mobile lung CT screening unit in the United States. To facilitate our regional-based approach, we have developed our own clinical pathways (EAPathways) which serve as a vital resource to our providers.

What are today’s challenges of oncology care? What are some of the challenges of clinical research?

Q: How can we address those challenges to improve oncology treatments?

A: As the field of oncology is changing rapidly, we will be constantly challenged by numerous factors affecting delivery of care, clinical research and costs. I think what we can control most effectively is the delivery of up-to-date clinical medicine. This includes implementing changing biomarkers and therapies based on FDA approvals. Clinical research is about access for patients. This includes not only having a number of trials available, but also to reshape the way we write studies with regards to exclusion criteria. Many have numerous eligibility criteria that exclude patients that could potentially enroll otherwise, such as renal insufficiency, history of brain metastases, age or concurrent malignancies. I have been heavily involved in an effort to modernize eligibility criteria with ASCO and Friends of Cancer Research to revise and implement expended eligibility criteria for clinical trials.

There are a number of unmet clinical needs not addressed by current methods when it comes to proper therapy selection and disease management.

Q: How can these needs be addressed and how will and can precision medicine help?

A: The implementation of biomarker-based approaches to determine appropriate treatment has really propelled the field forward. This has allowed us to optimize therapy for efficacy and even reduce unnecessary toxicity.

Q: How will ctDNA applications help with disease management?

A: Tissue is still the gold standard. However, the feasibility and difficulty in obtaining adequate as well as serial samples have impeded progress. Blood-based evaluation, especially with ctDNA, will allow further evaluation of tumor status and response to therapy. This could eventually lead to less radiographic imaging and better assessment of disease status.

Q: What are some of the challenges of community-based practices and how can we overcome them?

A: I have had the privilege of spending over a decade at MD Anderson Cancer Center and over 5 years here at LCI. Both experiences have given me the perspective of challenges that exist on both sides, academic and community. We know that the majority of care is delivered on the front-lines in the community and that many patients prefer not to or have the opportunity to travel long distances for care. I believe it is imperative that we are able to deliver cutting-edge care and clinical trial opportunities for patients treated in the community-based setting. We are seeing more regional based care delivery systems which highlight collaborations between institutions.

The Levine Cancer Institute (LCI) has an active role in the TAPUR study, the first ever clinical trial conducted by ASCO.

Q: What is the significance of the TAPUR study?

A: TAPUR is the first ever study conducted by ASCO (PI Richard Schilsky). When I was the Chair of the ASCO Cancer Research Committee, Dr Schilsky brought forth this idea and I really liked it and supported it. LCI was one of the first institutions to open the study and we have placed a high priority in screening and enrolling patients. The trial is challenging as it requires centers to coordinate genomic testing, biomarker matching, as well molecular tumor board discussions. The trial fits very well with providers as it allows us to test targeted drugs in molecular subsets in patient who otherwise would not have access to these drugs. It is really one of the first studies that has coordinated relationships well between community-based centers, ASCO, industry, regulators and patient advocates.

Q: What is the goal of the study and what is LCI’s role in it?

A: We want to identify patients in whom these drugs can be effective based on the tumor profile. LCI is one of the lead sites on the study and have been committed since the study opened to support it. I serve as the chair of the trial steering committee and several other members of LCI serve on other committees for the study.

Q: Is there anything else you would like to add?

A: As the Precision Medicine field is changing rapidly, it is important to have forums for discussion among multiple stakeholders. As I represent Levine Cancer Institute, it is important for me to demonstrate what type of care delivery can be accomplished in an academic-community based hybrid model for our patients with cancer.

Interview with Gabriel Bien-Willner of Palmetto GBA

Q: What does your role entail as the director of the MolDX program at Palmetto GBA?

A: The job directing MolDX is multifaceted; first and foremost the MolDX program is responsible for assessing molecular diagnostic tests on the market and makes coverage and pricing determinations for such tests and technology. This is usually done through local coverage determination policies or technical assessments.

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Interview with Peter Marks of FDA

Q: The CBER’s Regenerative Medicine Advanced Therapy Designation program has been very successful, with about 100 requests for designation in the two years of its existence. Can you please tell us about the program and how it was put together?

A: The Regenerative Medicine Advanced Therapy (RMAT) Designation program came into being as part of the 21st Century Cures Act that was signed into law on December 13, 2016.

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Interview with Calum MacRae of Harvard Medical School

Q: What patient data do we need to better understand the underlying cause of disease and how to prevent it?

A: Medicine at present is highly underdetermined and data poor. To be precise, one must be comprehensive, so medicine (with our consent) will use not only what we currently conceive of as biomedical information, but also data from across our lives.

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Headlines from PMWC 2019 Silicon Valley

A big ‘Thank You’ to all of our presenters and attendees for celebrating 10 years of precision medicine progress with us! PMWC 2019 Silicon Valley was attended by 2000 participants from 35 countries, which included over 400 speakers in 5 parallel tracks!

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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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