DAY TWO AGENDA

7:20 am Chair’s Opening Remarks

  • Sid Mathur Regulatory Affairs Executive Director, Companion Diagnostics, Merck

Establishing a Footprint in Competitive Global Markets

7:30 am Creating Clarity on IVDR: Advancing our Understanding of the EMA Consultation Procedure for CDx Devices

Synopsis

• Bringing the global precision medicine community up to speed with the latest developments for CDx consultations under IVDR
• Creating awareness of the requirements for the summary of safety and performance and instructions for use under IVDR and learnings from initial EMA consultations
• Commercial implications and practical implementation of IVDR from the eyes of IVD manufacturers and Notified Bodies

7:55 am Reserved for:

8:25 am Reserved for:

8:55 am Reserved for:

9:20 am Comparison & Contrast of CDx in APAC – Route to Success

  • Dun Liang Director, Regulatory Affairs, CDx, Loxo Oncology at Lilly

Synopsis

• Critical regulatory updates in APAC & specifically China for precision drug developers to factor to in to biomarker & diagnosticenabled drug development program design in 2022/3
• Navigating and assessing the regulatory landscape in APAC & specifically China to define the compliments new drug and diagnostics will bring to this competitive landscape
• Using current guidance to inform and reveal efficiencies in portfolio planning in line with regulatory and compliance expectations

9:45 pm Morning Networking Break

Synopsis

An opportunity to network, discuss and collaborate with like-minded leaders accross the continuum of biomarker-driven & diagnostic enabled drug development

Biomarker Discovery & Translational Development

Track Chair:

Tools & Techniques Driving Efficiencies in Biomarker Discovery

10:20 am Panel Discussion: Tissue is the Issue

  • John Yi Director, Translational Medicine, G1 Therapeutics
  • Qing Li Head of Clinical Biomarker & CDx Strategy, H3 Biomedicine

Synopsis

• Logistics & tools to gain the most information from scarce samples
• How can we limit the challenges associated with sample storage?
• What tools and approaches are being used today to maximize biomarker information gained from scarce samples?
• Combining both logistical and scientific expertise and considerations to maximize output in discovery settings
• Is AI biomarker technology really the answer to extracting the most amount of data from biological samples?

11:20 am Reserved for:

11:50 am Reserved for:

Clinical Biomarker & Assay Development

Track Chair:

  • Victoria Rimkunas Senior Director, Head of Translational Medicine, Repare Therapeutics

Gaining a Strategic Advantage Through the Implementation of Latest Patient Stratification Approaches

10:20 am Achieving the Potential of Liquid Biopsy Application in Trials

  • Meijuan Li Vice President, Head of Biostatistics, Oncology Group, Eisai

Synopsis

• How can we implement ctDNA testing in trials in terms of surrogate endpoint monitoring?
• Creating a clear path forward for regulatory
• How can we preserve data and sample QC in the current pandemic-impacted landscape, whilst leveraging bloodbased tests to stratify patients in trials?

10:45 am Reserved for:

11:15 am Reserved for:

11:25 am Reserved for:

11:35 am Reserved for:

11:45 am Utilizing ctDNA Dynamics to Guide Early Drug Development

  • Victoria Rimkunas Senior Director, Head of Translational Medicine, Repare Therapeutics
  • Meijuan Li Vice President, Head of Biostatistics, Oncology Group, Eisai

Synopsis

• Considerations and limitations when using ctDNA to detect genomic alterations in DDR genes
• Early ctDNA dynamics to assess drug activity in early phase clinical trials
• How early clinical trial results showing an interesting biological link between ctDNA levels & drug activity create questions for understanding tumor pathophysiology

Commercialization in the CDx Industry

Track Chair

  • Susanne Rhoades Senior Director, Diagnostic Development, Loxo Oncology at Lilly

Creating & Maintaining Strong Market Access & Reimbursement Strategies

10:20 am Policy Opportunities to Improve Patient Access to Comprehensive Biomarker Testing

  • Hilary Gee Goeckner Senior State and Local Campaigns Manager, Access to Care, American Cancer Society Cancer Action Network

Synopsis

• Current barriers to patient access to comprehensive biomarker testing
• Policy solutions to expand equitable access to biomarker testing and biomarker-driven therapies
• Opportunities for patients, health care professionals and industry to support efforts to advance equitable access to biomarker testing through state policy change

10:45 am Reserved for:

11:15 am Reserved for:

11:45 am Biopharma’s Commercial Go-to-Market Strategy for CDx

  • Amy Gorman Director, Global Commercial Strategy, Precision Medicine, Janssen

Synopsis

• Pharma’s jump to Targeted treatments by leveraging Precision Medicine
• Alignment between internal/external stakeholders for synchronized Drug-Dx launch
• Raising testing awareness. No test – No treatment

12:10 pm Networking Lunch: Pre-Scheuled Meetings & Exhibitor Demos with the Biomarker Industry’s Leading Partners

Synopsis

Uncover novel technologies and strengthen relationships with experts to define your precision pipeline strategy in 2022 & beyond

Next Generation Biomarker Discovery

1:10 pm Novel Global Peptidome-Driven Strategies for Biomarker Discovery and Translation

  • Satya Saxena Director, Global Proteomics, Clinical Pharmacology and Translational Medicine, Neurology Business Group, Eisai

Synopsis

• Mass spectrometry based ultra-deep peptide profiling to accelerate novel biomarker discovery and translation to clinic
• Identification of peptide-level alterations for deep molecular characterization of disease subtypes
• Development of predictive biomarker signatures by combining unique disease stage or subtype-linked peptide profiles

1:35 pm Reserved for:

Earlier Intervention for Better Patient Outcomes

1:10 pm Applying Machine Learning in Patient Subgroup Identification and Predictive Gene Signature Development: A Case Study in a Late Phase Oncology Trial

  • Jie Cheng Senior Director, Statistical and Quantitative Sciences, Takeda Pharmaceutical Company

Synopsis

• The utility and application of ML for exploratory patient subgroup identification from clinical trial data
• Applying ML in parsimonious gene signature development
• Good practice guidelines for applying machine learning based predictive models

1:35 pm Reserved for:

Ensuring Access in Routine Practice

1:10 pm Working with Patients to Improve the understanding of Bio-Marker Testing and Access

Synopsis

• How can healthcare groups better work with patients and advocates to enable greater access to testing?
• Education, awareness, and resources needed to work towards coverage and improved testing uptake
• How emerging biomarker testing & analysis technology, including AI-based approaches, can result in patient benefits to help make more informed treatment choices
• Sharing patient perspectives on industry progress to accelerate the delivery of next-generation precision medicines and testing technology to market

1:35 pm Partnering in Practice: Co-Development with a CDx Partner Through the Eyes of a Biopharma

  • Minghao Song Director, Precision Medicine Lead, AstraZeneca

Synopsis

• Understand capabilities and needs in the process for a partner selection and considerations
• Maturity of the technology through the lens of CDx
• Climbing up regulatory mountains
• Readiness for the clinical trial and commercial launch
• Initiating partnership to develop a CDx important to pipeline progression
• Advise for smaller biotech firms with their first CDx venture

2:05 pm Afternoon Networking Break

Synopsis

Your final opportunity exchange business cards to takeaway meaningful and long-lasting connections beyond this year’s event – We look forward to hearing about your progress next year!

Collectively Progressing Precision Medicine

Track Chair:

Synopsis

Talk details shortly to be confirmed

2:35 pm Reserved for:

3:05 pm Reserved for:

3:35 pm Reserved for:

4:05 pm Panel Discussion: Therapy Agnostic Collaborations with Consortia to Address Challenges in Precision Medicine

Synopsis

• Collaboration with consortia to tease out regulatory challenges and democratize access to precision medicine in the community setting through the generation of robust and reliable data
• Pre-competitive industry data contributions to standardize biomarker technology usage to work towards more harmonized and standardized procedures
• How can consortia membership driving harmonization and the implementation of personalized medicine into healthcare systems

4:35 pm Chair’s Closing Remarks & Close of the 12th World Clinical Biomarkers & CDx Summit 2022