Dr. Bloom brings more than 30 years of clinical and business experience in pathology, oncology, telemedicine, and bioinformatics. His role at Ambry is to expand, strengthen and commercialize the full-suite of precision medicine capabilities offered within the pathology and genomics markets for Invicro and Ambry Genetics. Previously, Dr. Bloom was President and Head of Oncology & Immunotherapy for Human Longevity Inc., where his team developed and commercialized an industry leading cancer exome product and commercialized a technique for validating neoantigens predicted from sequencing. Read his full bio.

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. This is accomplished with a diverse team of expert professionals and a state of the art super-lab where testing is performed.

Q: What makes your healthcare/company service unique?

A: There are several factors that make us unique. We are a 20 year old genomic company with a long heritage of innovation. We launched the first genomic test for cystic fibrosis in 1999, the first test for Lynch syndrome in 2003, the first commercial next-generation sequencing assay in 2010 and the first CAP/CLIA exome test in 2011. We are seeking actionable answers for patients. While many labs offer NGS testing with a basic report, we are differentiated in several key areas:

  1. Confirmatory testing: Our NGS pipeline has been extensively optimized with over 20,000 samples in which all nonpolymorphic variants were Sanger sequenced. Our data published by Mu et al in the Journal of Molecular Diagnostics in 2016 highlights the importance of setting quality thresholds and confirming NGS findings with Sanger sequencing and other technologies, such as MPLA, microarrays, and PCR. Findings in complex genomic regions including A/T rich regions, G/C rich regions, homopolymer stretches and pseudogene regions, may be false positive results and should be confirmed by an orthogonal method.
  2. Our team of experts: Ambry has about 800 employees focused on delivering the highest quality results to patients because once you are our patient, you are our patient for life. We have experts in all facets of the testing process from running the most comprehensive and accurate genomic testing, to analyzing and interpreting the findings with best in class processes, to reporting the patient’s results in a comprehensive and understandable manner. Our team of genetic counselors is world-class and available to clarify any and all findings.
  3. Variant interpretation: Ambry is a leader in variant interpretation. Reviewing data from population databases, published data and our proprietary Ambry database of over 1 million test allows us to better classify variants into an actional category and minimize the number of variants classified as variants of unknown significance. Ambry’s translational genomic lab has demonstrated our ability to reclassify a specific type of variant known as splice variants. Prior to RNA studies in our translational genomics lab, 92% of splice variants are classified as variants of unknown significance, but after RNA studies performed in our lab only 8% remain as variants of unknown significance with the rest being resolved as likely benign or likely pathogenic.
  4. Detailed reporting: Ambry produces the highest quality reports with clear comprehensive results, interpretation and explanation.
Q: What is your role at and what excites you about your work?

A: I have recently joined Ambry Genetics as the Chief Medical Officer for Advanced Genomic and Pathology Services in a joint role with Invicro, a leading imaging CRO. Both companies were acquired by Konica Minolta in 2017 as it creates a precision medicine business. Konica was founded in 1873 and Minolta was founded in 1928. In August 2006, the company divested its original core businesses of film and camera transforming itself to remain a leading company in the 21rst century. Konica Minolta, through its research and development efforts, continues to be a leader in several core technologies including imaging, optics, nanofabrication and materials. With a customer base of over 2 million companies and sales in over 150 countries, we are well positioned with a global footprint and the ability for further expansion. Our R&D efforts have allowed us to leverage our core technologies to create a high sensitivity detection system for routine immunohistochemistry. The product based on phosphor-integrated dots or PIDs, are precisely manufactured nanoparticles, densely packed with a fluorescent dye surrounded by a protective capsule coated with 2500 streptavidin molecules. These PIDs can be used as a secondary detection system for routine immuohistochemistry allowing for extremely high sensitivity without the problems introduced by amplification. In addition to the high sensitivity obtained, the intensity of the fluorescent signal is directly related to the number of bound epitopes allowing for greater dynamic range and linearity making quantification possible. These PIDs can also be bound directly to antibodies against therapeutic antibodies and small molecules allowing for a more precise and localized determination of the pharmacokinetics and pharmacodistribution of these drugs. Combining Konica Minolta’s unique technologies with the core assets of Ambry Genetics and Invicro, gives us the ability to aid pharma and clinicians in identifying the key biomarkers that will enable precision medicine. We have a global footprint and key assets to aid in the evaluation of patients from whole organs to cells to proteins to genes as well as the infrastructure to organize that data and apply our proprietary image solutions and deep learning tools. I have been in academics and industry for over 30 years and have never seen an infrastructure as exciting as what we are creating at Konica Minolta.

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.

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.

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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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