Precision medicine is transforming treatment paradigms using complex biomarkers in the interpretation of clinical data. Biomarkers, such as TMB and GEP that can identify immune status of a tumor as well as the tumor’s microenvironment, may help optimize treatment decisions, individually or in combination. New technological innovations offer the capability to further develop this field. Potential considerations in approving an IVD for complex biomarkers will be discussed.

Cancers driven by genetic amplification are dominated by poor prognosis, and have been a problematic target for therapeutics to date; however, the recent elucidation of ecDNA as a mechanism for supporting high copy number cancers and for driving tumor heterogeneity has also provided insight on previous therapeutic failures and new avenues for potential treatment. Using multiple laboratory approaches, new ecDNA specific targets can be identified to precisely select patient groups that can benefit from new treatments.

With the growth in on-market targeted therapies & strong precision medicine oncology pipelines the importance of shaping the associated ecosystem is increasing in importance.

As precision medicine continues to evolve, so does the role of liquid biopsy.  At Guardant Health, we work with our pharma partners to provide value from biomarker discover, to companion diagnostic development through commercial launch.

Biomarker diagnostics play a critical role in guiding decision making and delivering precision medicine to patients. This session will describe successful co-development cases that illustrate different approaches for incorporating biomarkers into drug clinical trials, and highlight the opportunities and challenges of co-development strategies for complex biomarkers, low frequency molecular subsets, and tumor agnostic indications. In addition, the current regulatory framework for companion diagnostics will be discussed in the context of recent FDA proposals for broader labeling of companion diagnostics for oncology therapeutics.

Precision medicine uses approved CDx tests to select patients to receive the right drug, at the right dose, and at the right time. Addressing regulations for drug and companion diagnostics has challenges running the gamut, from global clinical trial enrollment, to co-approval, to post-market commitments.

Successful commercialization of Rx/Dx combinations requires alignment between pharma and Dx players in a number of key areas.  In this session, we will review a framework to organize market development, test execution dynamics, quality, market access, partnering best practices.  We will also discuss innovative Dx life-cycle management concepts. 

This presentation will share the Foundation Medicine perspective and case studies in oncology and other therapeutic areas.

With more personalized medicines being approved and available for patients with cancer, a wealth of knowledge and experience with developing targeted oncology therapies has accumulated in recent years. By delineating the development strategies that led to recent oncology therapeutic and diagnostic approvals, common patterns in study designs and development approaches can be identified. Building on these successful co-development examples, this presentation aims to discuss when and how to incorporate a biomarker strategy into a clinical trial to expedite drug development, and to consider best practices for co-development of a companion or complementary diagnostic.

Molecular diagnostic tests are being used with increasing frequency, especially in oncology. Opportunities and strategies to help guide clinical trials for drug-diagnostic co-development are necessary to align patient and regulatory needs in the era of breakthrough drugs and complex biomarkers.

This presentation will address real world data considerations and how RWD can be utilized for regulatory purposes.

Liquid biopsy represents a revolution in cancer care, precipitating seismic paradigm shifts: (1) from tissue- to liquid-diagnosis; (2) from single- to multi-gene panels; (3) from tumor-specific to tumor-agnostic diagnosis and treatment; and (4) from late-stage detection to screening. The acceptance (and consequential reimbursement) of liquid biopsy will depend upon these pivotal transitions in thought and technology.

The testing paradigm in precision oncology is growing increasingly complex, including multi-gene, multi-modality approaches. Add to this the considerations of clinical, policy, and funding stakeholders and geographic variability in test access, and routine companion diagnostic testing becomes a goal that often takes too long to reach. The talk outlines typical barriers encountered, and some key planning and mitigation approaches that biopharmaceutical and diagnostics companies can take to meet key commercial implementation challenges in precision medicine.

Access and reimbursement are key factors in a successful diagnostic product go-to-market strategy. For a companion diagnostic, the complexity increases based on the pharmaceutical partner(s)’ drug access timeline, regulatory considerations, and fast changing or opaque in-country diagnostic access framework. This session will outline some key considerations in building a roadmap for CDx access.