DAY ONE AGENDA

6:50 am Chair’s Opening Remarks

  • Sarah Hersey Vice President, Precision Medicine, Bristol Myers Squibb

Updates on Your Current Framework for Biomarker & CDx Development

7:00 am Criteria for Acceptance of Biomarkers in Drug Development: An FDA Perspective

  • Jeffrey Siegel Office Director, Office of Drug Evaluation Sciences, OND, CDER U.S. Food and Drug Administration

Synopsis

• Biomarkers for use in drug development programs may come to FDA through the qualification program for use in any relevant clinical development program or submitted directly to the review division for use in a particular drug development program
• There are multiple types of biomarkers that can be useful in drug development programs. For acceptance for regulatory decision-making, they need to demonstrate analytical validation and clinical validation
• The level of evidence required depends on the specific context of use (COU)
• Sometimes a stepwise approach to biomarker qualification can be useful, beginning with a COU that requires a lower level of evidence and then acquiring the data required for a higher-level biomarker, e.g., a surrogate endpoint

7:25 am Approval of Companion Diagnostics by the U.S. FDA: Exploring the Current Regulatory Environment & Important Hurdles to Overcome

  • Pamela Ebrahimi Deputy Branch Chief, Molecular Genetics Branch, CDRH, U.S. Food and Drug Administration

Synopsis

• Updates on biomarker-driven trial enrolment policy for regulatory compliant companion diagnostic development
• Exploring current approaches and challenges for companion diagnostic approval in the US
• How U.S. FDA members work together to help CDx development planning
• Outlook on the changing companion diagnostics environment and resulting questions and challenges emerging in-line with new technology application complexities

7:50 am The Digital Transformation of Pathology: Enabling Digital Pathology with a Platform Ecosystem

Synopsis

• An overview of Roche’s approach to digital diagnostics
• Why broad Digital Pathology adoption is at a tipping point
• How Roche is enabling digital pathology with an innovative platform ecosystem

8:20 am Reserved for:

8:50 am Reserved for:

9:20 am Panel Discussion: ED&I in Precision Medicine: Barriers to Accessibility & Global Technology Accessibility as Biomarker Technologies Become More Complex

  • Sarah Hersey Vice President, Precision Medicine, Bristol Myers Squibb
  • Shirin Khambata Ford Vice President, Head Companion Diagnostics, Global Companion Diagnostics, Global Oncology R&D, Daiichi Sankyo
  • Wenora Johnson Research & Patient Advocate,
  • Hilary Gee Goeckner Senior State and Local Campaigns Manager, Access to Care, American Cancer Society Cancer Action Network

Synopsis

• While we’re witnessing an exciting period for precision medicine technology innovation, as biomarker investigations become more complex and costly, are new barriers to global precision medicine interventions increasing?
• How can we be more aware of the benefits and challenges associated with growing technology complexity, to create broader awareness and implementation of biomarker strategies globally
• How can we ensure the equitable distribution and access to new technologies equipping physicians with insights to inform more targeted treatment approaches, within and beyond US borders?

9:50 am Structured Networking Break

Synopsis

An opportunity to network, discuss and collaborate with precision medicine leaders passionate about advancing patientcentric progress within the field

Biomarker Discovery & Translational Development

Fast-Tracking Promising Biomarker Development By Leveraging Collaborative Industry Resources

10:30 am Translation of Biomarkers from Discovery to Clinical Applications

  • Antonio Chambers Associate Director, Technical Diagnostic Testing Services, Eli Lilly and Company

Synopsis

• Recent biomarker development, translation to be used in clinical trials
• Approach for where to source samples, how to identify disease state
• How to ensure you have the right partners to help you be able to analytically and then clinically validate assay – (consortia, research and industry)

10:55 am Translating Preclinical Findings into Clinical Biomarker Assays to Support the Phase I/II Study of BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist®

  • Heather Cohen Director, Translational Sciences and Diagnostics, Bicycle Therapeutics

Synopsis

• Sharing a case study relating to the development of fit-for-purpose assays to monitor predictive and pharmacodynamic biomarkers in a Phase 1/2 cancer trial
• Addressing challenges and hurdles which create barriers to assay translatability to the clinic
• Pre-clinical validation studies to assess biomarker utility to advance downstream pipeline progression

11:20 am Reserved for:

11:50 am Reserved for:

Clinical Biomarker Development
Track Chair:

  • Zhen Su Chief Executive Officer, Marengo Therapeutics

Managing Increasing Complexity Within the Next Promising Wave of Biomarker Development

10:30 am Biomarker Strategies to Identify Patients With Resistance to Current Immunotherapies

Synopsis

• Review the current understanding on what determines resistance to immunotherapies
• Summary of available biomarker strategies
• Show cases/examples on how to detect resistance mechanisms in patients (such as Tregs, MDSCs, CAFs)
• Impact on current oncology clinical trial endpoints

10:55 am Novel Biomarker Strategy for Next Wave IO Therapeutics

  • Zhen Su Chief Executive Officer, Marengo Therapeutics

Synopsis

• Innovative development strategies to facilitate clinical investigation of novel IO therapeutics
• Clinical validation and integration of multiple predictive biomarkers within tumor cells and the TME
• Development of multifactorial synergistic predictive biomarkers to identify immunotherapy efficacy

11:20 am Reserved for:

11:50 am Panel Discussion Reserved for:

CDx Development
Track Chair:

  • Lakshman Ramamurthy Head of Global Regulatory Affairs, Precision Medicine & Digital Health, GlaxoSmithKline

Exploring The Scope of Today’s Drug-Dx CoDevelopment

10:30 am Clinical Interchangeability of PD-L1 IHC Assays for the Treatment of 1L NSCLC with Cemiplimab

  • Brian Baker Senior Director, Regulatory Affairs (CDx), Regeneron
  • Javier Perez Director, Precision Medicine, Companion Diagnostics, Regeneron

Synopsis

• Bridging study demonstrating high level of concordance and equivalent association of clinical efficacy with Cemiplimab in the PD-L1 >50% population
• Regulatory strategy supporting clinical validation/registration of a follow-on PD-L1 CDx

10:55 am Regulatory Considerations of Companion Diagnostic Development for Targeted Cancer Therapeutics

Synopsis

• Companion diagnostic strategy is vital to the development of targeted cancer therapeutics to identify appropriate patients and to increase the probability of regulatory success.
• There are multiple, appropriate strategies to develop and validate a CDx, each with their own regulatory considerations.
• Technological feasibility and regulatory capabilities should be considered when selecting CDx partner

11:20 am Reserved for:

11:30 am Reserved for:

12:20 pm Networking Lunch & 1-2-1 Meetings

Synopsis

Pre-Scheduled Meetings with Your Current & Future CB & CDx Partners:
Networking with market leaders pioneering exciting advances in the biomarker-driven drug development space

Tech Scouting in Exhibition Hall:
Meet a diverse array of industry solution providers to find out what new innovative solutions could create positive progress for your pipeline

Fast-Tracking Promising Biomarker Development By Leveraging Collaborative Industry Resources

1:20 pm Proactively Revisiting Patient Stratification: Post-Clinical Trial Translational Biomarker Discovery

  • Melinda Day Associate Director, Translational Clinical Development, Kronos Bio

Synopsis

• Applying RWE insights to design future patient stratification strategies for clinical programs
• Clinical-driven insights for determining the correct way to utilize information identifying biomarker rich patients
• Robust scientific evidence generation using an innovative approach and leveraging industry partnership for downstream biomarker validation enabling better pipeline progression decision making

1:45 pm Panel Discussion Reserved for:

2:15 pm Development of a Comprehensive Biomarker Strategy for the Latent TGFβ1 Inhibitor SRK-181 Phase 1 Clinical Trial, DRAGON

Synopsis

• Pre-clinical validation studies to assess biomarker utility
• Addressing challenges and hurdles which create barriers to assay translatability to the clinic
• Discuss early clinical biomarker data including imagebased analysis

2:40 pm NEW! TECH SLAM: New Exploratory Biomarker Technology

Synopsis

• Hear latest exploratory biomarker investigation and discovery solution advancements in a succession of quick demonstrations
• Get acquainted with the newest innovations to remain up to speed with latest progress and technologies, as well as make comparisons for assisting your nextgeneration biomarker technology selection

Defining Patient Populations

1:20 pm Digital Transformation in Biomarker and CDx Development and the Critical Role for the Application of Digital Pathology & AI in Multi-Omics Platforms in Clinical Development

  • Qing Li Head of Clinical Biomarker & CDx Strategy, H3 Biomedicine

Synopsis

• A path forward to a holistic & integrated platform to biomarker discovery and development in clinical development
• The road ahead & paradigm shift driven by digital transformation
• The critical role of pathology, how do we maximize the existing data and clinical information for patient selection

1:45 pm A Novel Breast Cancer Subtyping & Proliferation Gene Expression IVD Test

2:15 pm Tumoral DKK1 as a Predictor of Outcomes and Response to DKN-01

  • Jason Baum Vice President, Translational Medicine, Leap Therapeutics

Synopsis

• DKK1 is overexpressed in many cancers, often leading to worse outcomes by promoting cancer cell proliferation, metastasis and angiogenesis
• DKN-01 as a monotherapy and in combination has demonstrated compelling clinical data in multiple indications including gastroesophageal cancer, with enhanced responses seen in DKK1-high patients
• DKK1 CDx development to support the clinical development of DKN-01 is underway

2:40 pm Spliceosome Mutations as a Surrogate Biomarker for Emavusertib Treatment in MDS and AML

Synopsis

• Spliceosome mutations have previously been characterized as prognostic biomarkers in heme malignancies
• Specific splicesome mutations drive expression of the IRAK4-L isoform which is oncogenic
• Emavusertib is an IRAK4 inhibitor

Exploring The Scope of Today’s Drug-Dx Co-Development

1:20 pm Benefits & Risks: Evaluating CDx Investment Earlier in Trial Planning in Rare Disease

  • Silva Krause Senior Director, Clinical Biomarkers, Vertex Pharmaceuticals

Synopsis

• Exploring the overlap between early clinical translational work to define a robust early biomarker hypothesis
• Determining the need for patient selection, as well as companion diagnostic strategies, whilst overcoming challenges related to smaller amounts of data and samples to base CDx decision making
• Exploring the diagnostic test acceptance criteria and analytical performance to build a consensus around diagnostic testing with collaboration between testing labs, scientific leaders and patient advocacy groups

1:45 pm Reserved for:

2:15 pm Reserved for:

2:45 pm Panel Discussion: LDT Vs Companion Diagnostic: What Really Is the Status of Our Current Testing Landscape?

  • Sid Mathur Regulatory Affairs Executive Director, Companion Diagnostics, Merck
  • Lakshman Ramamurthy Head of Global Regulatory Affairs, Precision Medicine & Digital Health, GlaxoSmithKline
  • Deepti Aurora-Garg Executive Director, Companion Diagnostics | Vice President Companion Diagnostics, Merck | Prometheus Biosciences
  • Kaska Kowanetz Director, Global Regulatory Lead, Pfizer

Synopsis

• Providing a platform for precision medicine stakeholders to share their views on the use of LDT Vs CDx in drug development programs
• With a shift towards LDT usage being witnessed today, how do all see the testing landscape shifting and is this in line with their hopes for the industry
• Bringing together diverse viewpoints to address a front-of mind topic for all in the precision medicine industry

3:10 pm Afternoon Networking Break & 1:1 Meetings

Synopsis

Utilise this opportunity to converse with tech leaders & meet your discovery, translational, clinical, commercial, regulatory & market access peers you weren’t able to catch up with earlier!

Alignment in Biomarker Development in an Increasingly Complex Biological Landscape

3:40 pm Reserved for:

4:10 pm Reserved for:

4:40 pm Reserved for:

5:10 pm NEW! Interactive Workshop: Stakeholder Engagement in the Clinical Biomarker & CDx Development Industry

  • Lindsay Darling Associate Director, Companion Diagnostics Portfolio Management & Operations, Regeneron

Synopsis

As biomarker discovery and CDx development encounters greater complexities in-line with greater understanding of disease mechanism and progression, this session is designed to connect internal stakeholders on end-to-end CDx development and the connectivity between counterparts in the process. Discussing shared visions as well as where they diverge, this session will begin with a short introductory expertise panel and move into focussed roundtable sessions to address:
• Proposing a biomarker strategy for clinical integration
• Entering a CDx development agreement
• Operationally managing a portfolio of CDx products
• Clinical biomarker partner selection
• Stakeholder alignment on regulatory-informed biomarker development

6:10 pm Chair’s Closing Remarks & End of Day 1