In this session at AACR 2024, BLOODPAC panelists will discuss the ways we are currently conceptualizing cancer risk in the setting of current cancer screening guidelines and how a shift in thinking and terminology may be warranted with the introduction of new single and multi-cancer early detection technologies. Panelists include:

• Elizabeth (Betsy) O’Donnell, MD, DipABLM (Director of Early Detection and Prevention of Malignant Conditions, Dana-Farber Cancer Institute)

• Bree Mitchell, PhD (Senior Director, Translational Medicine and Research, Natera)

• Jeff Allen, PhD (President and CEO, Friends of Cancer Research)

• Lauren Leiman, MBA (Executive Director, BLOODPAC)

• Christina Clarke Dur, PhD MPH (VP Epidemiology, Distinguished Scientist, GRAIL)

• Victoria Raymond, MS (Sr. Director, Medical Affairs, Guardant Health)

• Wendy Rubinstein, PhD (Senior Scientific Officer, Division of Cancer Prevention, National Cancer Institute)

In this panel discussion at the 2024 Precision Medicine Tri-Conference, BLOODPAC members working in the cancer early detection space will explore the challenges and best practices for clinical validation of MCED assays.

Panelists:

Kathyrn Lang, Senior Vice President, Real-World Data and Analytics, Freenome

J. Carl Barrett, PhD, Professor, University of North Carolina

Alexey Aleshin, MD, General Manager, Oncology and Early Cancer Detection; CMO, Natera, Inc.

In this talk at the 2024 Precision Medicine Tri-Conference, BLOODPAC Executive Director Lauren C. Leiman will provide an overview of the Blood Profiling Atlas in Cancer (BLOODPAC)’s soon-to-be-published lexicon of key terms in MCED and single-cancer early detection, created through collaborative discussion involving major assay developers, pharmaceutical companies, academic institutions, and not-for-profits working in the cancer early detection space.

In this discussion at the 2024 Liquid Biopsy for Precision Oncology Summit, panelists from MEI Pharma, Johnson& Johnson, BLOODPAC, and University of Michigan will address the following topics:

• How is the potential and utilization of liquid biopsies for new indications benefiting patients from diverse backgrounds?

• Why are certain populations underrepresented in studies harnessing liquid biopsy?

• What is being done to overcome the historical disparities in liquid biopsy trials?

• How can the ED&I challenges be overcome by global and cross-sector collaboration for liquid biopsy research?

In this talk at the 2024 Liquid Biopsy for Precision Oncology Summit, BLOODPAC’s Executive Director Lauren C. Leiman will discuss the consortium’s work in:

• Investigating the use of liquid biopsy for diagnosis and determining disease severity

• Discussing recent collaborations and new guidelines for standardizations to set a regulatory precedent

• Furthering global implementation of frameworks and standards

• Evolving to support the community with emerging trends and technologies in liquid biopsy

In this talk at the Festival of Genomics and Biodata, BLOODPAC’s Executive Director Lauren C. Leiman will speak on BLOODPAC's work in creating liquid biopsy analytical validation protocols through collaboration between key stakeholders, including assay developers, biopharmaceutical companies, academic institutions, not-for-profits, and regulatory agencies. She will also describe the importance of frameworks and standards, including industry-specific lexicons, to drive clinical utility studies for emerging liquid biopsy applications such as MRD and MCED and touch on BLOODPAC's progress in defining best practices for clinical validation for MRD and MCED assays.

In this talk at the International Society of Liquid Biopsy annual meeting, BLOODPAC's Executive Director Lauren C. Leiman will discuss the organization's major achievements from the past 5 years, including:

• The publication of our Minimal Technical Elements for liquid biopsy data collection and submission to repositories

• Our Generic Protocols for analytical validation of ctDNA-based assays

• Progress in defining the pathways to implementation of liquid biopsy for cancer early detection and screening

• Our Global Regulatory group's progress in facilitating international regulatory standards for diagnostic testing with liquid biopsy

In this panel discussion, BLOODPAC members Angela Silvestro (Director, Companion Diagnostics, GSK) and Dan Stetson (Principal Scientist, AstraZeneca) will discuss:

• Current standards and frameworks in development for MCED and MRD testing

• Awareness, education and access coordination initiatives for MCED and MRD testing

• The importance of standardizing terms in emerging areas of liquid biopsy use for stakeholders who use or interpret these tests

• How standardizing early detection strategies impact the mitigation of the morbidities resulting from rare and currently unscreened cancers

• Key next steps in advancing implementation of MCED and MRD tests

In this event at the Festival of Genomics and Biodata, BLOODPAC members will discuss current progress and clinical advances in liquid biopsy for early cancer detection, and current challenges and opportunities in multi-cancer early detection testing and MRD testing/patient monitoring. Panelists include Jonathan Beer (Senior Director of Diagnostic Sciences, Bristol Meyers Squibb), Lauren Leiman (Executive Director, BLOODPAC), and Carl Barrett (VP Translational Sciences--Oncology, AztraZeneca).

In this talk at the 6th annual Advances in Circulating Tumor Cells meeting, BLOODPAC's Executive Director Lauren C. Leiman will discuss the organization's major achievements from the past several years, including:

• The publication of our Minimal Technical Elements for liquid biopsy data collection and submission to repositories

• BLOODPAC’s Generic Protocols for analytical validation of ctDNA-based assays

• Our progress in defining the pathways to implementation of liquid biopsy for cancer early detection and screening

• Our Global Regulatory group's progress in facilitating international regulatory standards for diagnostic testing with liquid biopsy

Stakeholder collaboration is critical for advancing the development and clinical implementation of multi-cancer early detection and screening. In this talk at the Next Generation Dx 2023 Conference, BLOODPAC’s Executive Director will discuss the efforts BLOODPAC has launched related to standards and framework development, education, and access coordination for MCED. The vision of BLOODPAC’s Screening and Early Detection Working Group includes:

(1) thinking creatively about how best to evaluate the impact of early detection strategies on morbidity and mortality resulting from rare and currently unscreened cancers

(2) engaging providers and patients in understanding and mitigating the barriers to implementation of blood-based cancer screening tests and provide recommendations for an equitable, resilient, and sustainable healthcare ecosystem that benefits people

(3) engaging and collaborating with regulatory agencies to generate postmarket evidence to support the safety and effectiveness of blood-based cancer screening tests in real-world use.

In this session, we will discuss progress to date on these initiatives, including our soon-to-be-published lexicon of standard terms for blood-based assays for the screening and early detection of cancer.

In this session at the Next Generation Dx 2023 Conference, BLOODPAC’s Executive Director will lead a discussion on the following topics:

• How BLOODPAC works collaboratively to develop and execute a strategic plan for MRD implementation

• BLOODPAC's progress in establishing an MRD lexicon, determining recommended data elements, and developing clinical protocols 

• The value of data curation and a data commons in accelerating research

• Next steps in moving towards clinical use of MRD

Panelists include Gregory Jones (Head of Precision Diagnostics, NeoGenomics) and Christina Lockwood (Associate Professor, University of Washington; Director, Genetics & Solid Tumors Laboratory; Medical Director, Brotman Baty Institute for Precision Medicine).

Molecular residual disease (MRD) testing is being increasingly utilized in the clinic to detect solid tumor cancer recurrence early and improve patient outcomes. With several assays now on the market and numerous ongoing trials investigating clinical utility, standardized protocols and frameworks for MRD assay validation are vital to ensure that these new tests work as intended and move efficiently through the regulatory approval process. In this webinar, hosted by BLOODPAC member organization Horizon Discovery, Lauren C. Leiman (Executive Director, BLOODPAC) will discuss:

• Progress to date in MRD testing for solid tumors

• Use cases of MRD testing along the cancer patient journey

• The importance of MRD assay analytical validation, including BLOODPAC’s work in creating validation protocols in collaboration with the FDA

• The importance of reference material/contrived materials for assay validation

• Multi-stakeholder collaborative efforts to build consensus on use of reference materials in validation

This AACR23 session will update the cancer research community on the FDA guidance and other various efforts from multiple stakeholders on the use of liquid biopsies in early-stage, solid tumor drug development. Jonathan Baden (Bristol Myers Squibb), co-chair of BLOODPAC's Analytical Validation working group, will be representing BLOODPAC on the panel.

BLOODPAC members representing drug and assay development will discuss the value of strategic collaborations to advance the implementation of MRD and its validation as an early endpoint in solid tumors. This panel will be part of the 2023 Molecular and Precision Medicine Tri-Con. Panelists include Angela Silvestro (Director, Companion Diagnostics, GSK), Asaf Zviran (Founder and CEO, C2i Genomics), Duane Hassane (VP, Tempus Labs), and Minetta C. Liu (CMO, Natera).

In this talk, BLOODPAC's Executive Director will discuss the organization's progress in:

(1) Educating the liquid biopsy community on evidence-based clinical utility and healthcare satisfaction

(2) Democratizing access to tests to improve patient outcomes

(3) Adopting liquid biopsy access approaches through the improvement of frameworks for access

(4) Evalutating the use of current regulation for adequate ctDNA access.