Dr. Lai-Goldman is the Chief Executive Officer and co-founder of GeneCentric Diagnostics, Inc., a molecular diagnostics company focused on developing and commercializing assays that enable oncologists and their patients to make informed, individualized, treatment decisions. She is also the managing partner of Personalized Science, LLC, a consulting company that is focused on innovative diagnostics for patients’ unmet clinical needs. Dr. Lai-Goldman currently serves on the board of directors of West Pharmaceutical Services, Inc., a provider of drug administration systems, and Qvella Corporation, a privately-held molecular diagnostics company. Read her full bio.

Interview with Myla Lai-Goldman of GeneCentric Therapeutics

Q1a: GeneCentric employs Drug Response Biomarkers developed via the Cancer Subtyping Platform (CSP). (a) What makes your approach of biomarker development unique?

A: By applying CSPTM technology, GeneCentric is developing universal drug response biomarkers to enable more effective and efficient drug development informed by high resolution, genomic-defined cancer subtypes. This approach is distinct from other strategies which seek to generate biomarkers by profiling responders to specific drugs. Instead, CSP-derived genomic profiles are designed to characterize tumor biology by combining gene expression data with disease-related molecular pathways and immune cell expression through advanced computational biology technologies.

Q1b: What specific need are you addressing with these biomarkers?

A: Today, new treatment approaches such as immunotherapy and molecularly targeted therapies have begun to change the landscape for cancer treatment. This has resulted in dramatic improvements in long term survival rates compared with conventional chemotherapy, but the benefit has only been realized in a subset of patients. We believe that by targeting biological subtypes, drug developers could increase clinical development success for new therapies while expanding indications for existing drugs and achieving better patient outcomes overall.

Q: What are the specifics behind the Cancer Subtyping Platform? How does the technology work?

A: CSPTM leverages enormous, publicly available gene expression datasets complemented by proprietary data and tools to develop discrete sets of key genes that define cancer subtypes. By reducing the multitude of genes associated with each cancer to discrete key gene sets, GeneCentric enables rapid development of tumor specific clinical assays. CSPTM assays are “platform agnostic”, capable of being deployed on established, commercial instruments.

GeneCentric’s ability to identify and reduce to practice a select set of genes that define cancer subtypes and predict drug response underlies the company’s core patents and proprietary position.

Q: How do you prioritize specific biomarker (universal cancer subtypes) development? How do you decide on what diseases/cancers to focus on next?

A: Our initial subtypes were developed in conjunction with our scientific founders, Chuck Perou and Neil Hayes, who are experts in lung and head and neck cancer. Our subsequent profilers, such as bladder cancer, were developed in response to interest from our pharmaceutical partners. We plan to announce additions to our completed profilers shortly, also added due to commercial opportunities.

Q: How is the Cancer Subtyping Platform used in the context of drug development?

A: GeneCentric’s CSPTM provide unique value at each phase of drug development. As a couple of examples, CSPTM can be investigated as a response biomarker on retrospective data sets, which can be particularly useful if there were unexpected findings in the study. As I noted before, CSPTM profilers were developed to be platform agnostic, and therefore, can be developed as companion diagnostics to be integrated into a prospective trial to support drug approval or expand market potential. Conversely, our CSPTM can be applied in the setting of prospective clinical studies, to enrich for patient responders by qualifying them not merely on the basis of a particular alteration or mutation, but rather on their particular subtype comprised of both tumor and immune biology features to better characterize the nature of an individual’s cancer as well as the likelihood of response to both the active agent being tested, as well as the comparator agent against which it is being evaluated. This approach can increase the likelihood of favorable response to the active agent as well as accelerate conduct of the study – contributing to overall program success.

Q: Can you provide an example of successful drug identification/prioritization using the CSP technology?

A: We’re looking forward to publishing some recent results using the CSPTM technology.

Q: When thinking about precision medicine, what are some of the recent breakthroughs that are propelling the field forward and how will they impact healthcare?

A: We’ve all been excited about the recent successes that patients have been realizing with the expanded use of immunotherapy for the treatment of many different types of cancer. This has been truly transformative for patients who previously had little hope.

As we develop more treatment options for cancer patients, the fundamental tenets of precision medicine become even more critical: finding the right drug for the right patient. Therefore, the ability to define the fundamental biology of each patient’s tumor, through the development of better biomarkers (and future companion diagnostics), becomes even more critical.

In addition to thinking about the science of precision medicine, it’s interesting to look at the strategic moves that significant healthcare companies are making. For example, Roche acquiring Foundation Medicine, Flatiron Health, and Ignyta; LabCorp acquiring Covance; CVS acquiring Aetna, all signal that companies are thinking about different ways to deliver healthcare in the future.

Q: What are the short-term challenges that GeneCentric is facing in the context of precision medicine?

A: Many of the fundamental issues facing precision medicine overall are also at play in the development of subtype profiler assays we are advancing with our academic and industry partners. From the technical perspective, the drive toward liquid biopsy for detection and characterization of cancers, as well as assessment of response, is an area of tremendous effort, investment and potential. Progress has not been as rapid as many hoped, and translating our assays to the setting of liquid biopsies is also one of our objectives. On the practical side, the appreciation of both the clinical and economic value of NGS and novel biomarkers is a cause being spearheaded by PMWC among others. Resetting the value proposition for biomarker development and use among payers and providers, in order to enable their more effective and efficient development would be a transformational change for both industry and diagnostic companies, with the greatest beneficiaries being patients and the clinicians who care for them.

Q: Is there anything else you would like to share with the PMWC audience?

A: I’d like to thank the PMWC for understanding the importance of bringing together such an esteemed audience and for expanding its activities into North Carolina.

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Interview with Kara Davis of Stanford

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.” What is your first-hand experience the impact that those new drugs had on patients?

A: These immune checkpoint inhibitors have been an incredible demonstration of the ability of the immune system to control and in some cases.

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Interview with Shannon J. McCall of Duke University

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: After several years of the promise of precision medicine and abundant clinical trial work, the recent FDA approval of solid-tumor-agnostic therapies dependent on molecular biomarkers has catapulted genomic/precision medicine into the standard-of-care for late stage cancer.

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Interview with Tao Chen of Paragon Genomics, Inc.

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: For whole genome sequencing to be a reliable clinical tool, it will largely depend on the cost of sequencing the genome and our ability to interpret the data.

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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. How soon, do you think, will we see what kind of accelerated growth?

A: I think the acceleration has already begun. Large sequencing projects such as NHLBI Trans-omics for Precision Medicine (TOPMed) and NIH All of Us are sequencing 150,000 and 1 million individuals, respectively.

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Interview with Emily Leproust of Twist Bioscience

Q: NGS is enhancing patient care through improved diagnostic sensitivity and more precise therapeutic targeting. Prominent examples include cystic fibrosis and cancer. What other clinical areas NGS will most likely to change the standard-of-care in the near future?

A: Preventative medicine – using genetic data to identify traits that have the potential to cause harm in the future.

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Interview with Michael Phelps of UCLA

Q: You invented the PET scanner that changed the lives of millions of patients with cancer, brain and heart diseases. What are the potential benefits to patients of combining PET with radio-ablation technologies?

A: PET provides imaging assays of the biology of disease in many diseases today.

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Interview with Daniela Ushizima of Lawrence Berkeley National Lab

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 really hope that human physicians will not be replaced by machines in the foreseeable future.

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Interview with Amy Compton-Phillips of Providence St. Joseph Health

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? What technological advancements are driving this change?

A: Genomic medicine is poised to move quickly from the research realm into integration with healthcare delivery, but there is always a time lapse between technology advances and what we do with those advances.

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Interview with James Taylor of Precision NanoSystems

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: Patients are already receiving treatment using novel gene and cell therapies.

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Interview with Julie Eggington of Center for Genomic Interpretation

Q: Together with Robert Burton you founded the Center for Genomic Interpretation (CGI), a non-profit organization. Can you tell us more about CGI and the mission behind it?

A: CGI’s mission is to drive quality in clinical genetics and genomics. CGI works primarily with laboratories, health insurance payers, clinicians, and patients/consumers.

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Interview with Deven McGraw of Ciitizen

Q: Patient healthcare data aggregation and analysis is seen as both the panacea for tremendous breakthroughs in precision medicine and as one of its biggest challenges. Are both true and how so?

A:Yes, both are true. Achieving breakthroughs in precision medicine will require a lot of data – and yet it is often difficult for researchers to amass all of the data needed to advance precision medicine discoveries.

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Genomic sequencing, the driver of modern genomic medicine has come a long way in a short time, and its potential to continue driving innovations in precision medicine is enormous. PMWC 2019 Silicon Valley Jan. 20-23 in the Santa Clara Convention Center will focus on topics that are in the headlines and on everyone’s minds, in NGS and in precision medicine.

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Johns Hopkins
University Of Michigan

The Precision Medicine World Conference (PMWC), in its 16th installment, will take place in the Santa Clara Convention Center (Silicon Valley) on January 20-23, 2019. 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.

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

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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