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 from 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.

Interview with Daniel Chen from IGM Biosciences

Q: Checkpoint inhibitors, particularly with PD-L1/PD-1 targeting agents, have benefited a broad range of patients with cancer. How will we improve on this?

A: It’s true that PD-L1/PD-1 inhibitors have led to durable responses in a subset of patients, and survival benefit in many of the patients treated- either as monotherapy or combination.

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Call from PMWC 2019 Silicon Valley Program Committee – We Must Accelerate and Deliver on the Promise of Precision Medicine

Precision medicine advancements are real as demonstrated by the high volume of molecular, “precise” drugs on the market, which are based on extensive molecular and translational understanding of the specific drug targets.

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#AI Play in Patient Diagnosis? How Can We Prepare the Next Generation to Make Sense of Enormous Amounts of Health-related Data?

What role should artificial intelligence play in patient diagnosis? How can we best prepare the next generation to make sense of enormous amounts of health-related data? These were just a few of the questions explored at the 15th Precision Medicine World Conference held at Duke University September 24-25, 2018.

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Interview with Daniella Beller, Manager, Maccabi Research Institute Biobank

Q: What makes the Maccabi Research Institute biobank unique?

A: To explain the uniqueness of the Maccabi Biobank (named “Tipa” in Hebrew which means “drop” or “just a little”), first you must know a little about Maccabi.

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Why We Need Public-Private Partnerships (PPP) To Foster Drug Discovery

Investments in pharma R&D has substantially increased over the last decades. Yet there appears to be no clear correlation to the number of newly approved drugs. This fact is accompanied by ever-increasing healthcare costs, fueled by an aging population and the parallel rise in the chronic disease burden.

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Precision Medicine: A Decade of Improving the Standard of Care

In January, PMWC will host its 2019 Silicon Valley event, the largest Precision Medicine conference in the world with over 2,500 attendees gathering at the Santa Clara Convention Center. We are humbled and honored to have reached this stage of growth and are looking forward to continuing our work with key stakeholders and decision makers across the industry to ever strengthen this forum for exchange of critical and timely topics, to move the field of precision medicine forward and to improve the Standard of Care.

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Interview with David Hong from Karius

Q: What need is Karius addressing?

A: Physicians often have difficulty pinpointing the exact pathogen that is causing disease. Conventional diagnostics like blood cultures or PCR can have poor sensitivity due to pretreatment with antibiotics, the breadth of potential pathogens present, and the requirement for invasive procedures to access deep-seated infections.

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Interview with Charles Jaffe, MD, PhD from HL7

Q: What need is HL7 addressing?

A: For more than three decades, HL7 has provided the platform to enable global health data interoperability. This is more important than ever, as the cost of healthcare has increased exponentially, and the complexity of clinical evidence has grown to an almost unmanageable state.

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Interview with Eden Haverfield from Invitae

Q: What need is Invitae addressing?

A: Our mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Invitae is uniquely positioned to answer some of life’s most serious and complex questions with the highest quality genetics and at an affordable price.

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Call by Ralph Snyderman (Duke U.) for Big Changes to Get to the Next Level of Precision Medicine

Beyond next-generation gene sequencing and developing diagnostic tools and targeted therapies, theoverall approach to clinical care has to be re-envisioned to fulfill the promise of precision medicine. Care must move from sporadic treatment of episodic disease (a reactive mode) to predicting disease and then acting to prevent and mitigate it (a proactive mode).

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Interview with William Hearl From Immunomic Therapeutics, Inc.

Q: What need is Immunomic Therapeutics, Inc. addressing?

A: Immunomic Therapeutics’ nucleic acid vaccines have the potential to utilize the body’s natural biochemistry to develop a broad immune response, including antibody production, cytokine release and critical immunological memory.

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Interview with Ralph Snyderman from Duke University

Q: What are some of the critical contributions that academic institutions and medical centers are making to implement and accelerate precision medicine?

A: Over the past decade, the field of precision medicine has created technologies enabling far more personalized and effective health care delivery. Many of the most dramatic advances have come in the field of oncology but targeting care to the needs of the individual is rapidly achieving broader applications.

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Interview with Catherine Reinis Lucey from UCSF

Q: What research are you or your lab focusing on and why, and what problem(s) are you trying to solve?

A: My work involves designing, implementing and studying innovations in medical education that allow our medical schools to fulfill our social contract to improve the health of our communities and reduce the suffering of our patients.

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Interview with Gunnar Carlsson from Ayasdi

Q: What need is Ayasdi addressing?

A: Ayasdi is pioneering the application of artificial intelligence to value-based care by targeting two of the most complex problems in healthcare: population risk stratification and clinical variation management.

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Interview with Nikole Kimes from Siolta Therapeutics

Q: What need is Siolta Therapeutics addressing?

A: Chronic diseases, including inflammatory diseases such as asthma, now represent the leading cause of mortality and morbidity worldwide.

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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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