Explore the Agenda

7:00 am Breakfast Briefing Hosted By Versiti Clinical Trial Solutions

*Invitation only

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8:00 am Chair’s Opening Remarks

Senior Vice President, Clinical Measurement Sciences, EMD Serono, the Healthcare Business of Merck KGaA

Unlocking Precision Through Data at Scale with AI‑Driven Integration Across Omics, Imaging & Clinical Insight

8:10 am Accelerating Target Discovery & Precision Medicine Through AI-Enabled Integration of Human Genetics & Multimodal Data

Vice President & Global Head, Target, Diseases & Systems Biology, Sanofi
  • Building FAIR, AI-enabled disease data ecosystems to accelerate translational discovery and cross-domain decision making
  • Combining human genetics, multimodal biology, and AI to identify and prioritize causal therapeutic targets
  • Resolving disease endotypes through multimodal data integration to enable patient stratification and precision medicine

8:30 am Cancer Biology Through 5hmC Liquid Biopsy: From Early Detection to Drug Development

Vice President, Translational Research, ClearNote Health
  • 5hmC is an epigenetic mark enriched at active gene bodies, enhancers, and promoters transitioning to an active state. Analysis of 5hmC in cell-free DNA therefore provides a window into active disease biology directly from blood
  • Genome-wide 5hmC profiling with ClearNote Health’s Virtuoso epigenomic platform enables cancer detection, subtype classification, treatment response prediction, and longitudinal disease monitoring with a single, liquid biopsy-based assay
  • Clinical evidence across lung, prostate, colorectal, and pancreatic cancers supports applications spanning early detection and drug development, establishing 5hmC profiling by Virtuoso as a versatile epigenomic tool across the oncology pipeline

9:00 am Panel Discussion: Applying AI & Advanced Data Analytics to Transform Biomarker Discovery & Clinical Trial Strategy for Improved Precision Medicine Programs

Vice President & Global Head, Target, Diseases & Systems Biology, Sanofi
Global Head, Data & AI, Clinical Development, Novartis
Executive Director & Head, Integrative Sciences, Oncology Translational Medicine, GSK
  • Application of AI across the precision medicine value chain what are the most promising, low-hanging fruits and least promising? 
  • Where can foundation models help inform clinical biomarker and diagnostic strategies?  
  • Pharma opportunities for AI applications – partnerships, infrastructure and considerations? 

9:40 am The New Frontier of Precision Medicine – From Tumor Fingerprint to Dose: Integrating Data & NGS to Power Neoantigen Therapies

Chief Scientific Officer, Tempus
Chief Business Officer & General Manager, Individualized Neoantigen Therapies, Moderna
  • The paradigm of precision oncology is shifting from standard biomarker targeting to highly personalized, data-driven therapies
  • In this fireside chat, we will discuss how combining next-generation sequencing (NGS) and advanced therapeutic platforms is accelerating the development of neoantigen therapies and personalized medicines, and has the potential to transform cancer care

10:10 am Morning Break & Refreshments

10:50 am One-to-One Meetings & Structured Networking

Biomarker Discovery & Translation

Chaired by:

Vice President, Translational Sciences, Compass Therapeutics

Innovation in Liquid Biopsy to Improve Disease Monitoring & Response Prediction for Earlier, Informative Precision‑Therapy Decisions

11:20 am Building a Fit-for-Purpose TPD Biomarker: Kinesin Quantification in PBMCs from Discovery Through Clinical Development

Senior Manager, Business Development, Biodesix
  • Discovery proteomics identified KIF22 peptides that quantify target abundance directly in PBMCs, and degrader-treated cell models confirmed selective loss of signal, establishing a repeatable, minimally invasive measure of degradation
  • Blood collection, PBMC isolation, and sample handling variables were characterized to define the conditions under which KIF22 measurement holds, translating into handling requirements that clinical sites can execute reproducibly
  • A targeted PRM assay quantifies KIF22 with high sensitivity and reproducible performance across donor matrices, supporting fit-for-purpose validation and pharmacodynamic assessment in early-phase development

11:50 am Definition of the Best Practices in Clinical Utility of Liquid Biopsy: Clinical Guideline, Technologies, Cost-Effectiveness, Reimbursement, a Unidirectional or Multidirectional Path

Head, Clinical Genomics, Clinical Measurements Sciences, EMD Serono, the Healthcare Business of Merck KGaA, Darmstadt, Germany
  • Decipher the tumor shedding mechanism
  • Precision medicine-driven cut-off strategy implmentation
  • Tired fit-for-purpose liquid biopsy solutions combined with real-world genomic data mining
  • 1ctDNA-guided treatment and consideration of cost-effectiveness thresholds

12:10 pm Accelerating Biomarker-Driven Therapy & Clinical-Trial Enrollment with Rapid Front-Line NGS

Associate Attending, Memorial Sloan Kettering Cancer Center (on behalf of Pillar Biosciences)
  • Learn how rapid front-line targeted NGS enables earlier detection of actionable biomarkers, supporting timely precision oncology treatment decisions and companion diagnostic strategies 
  • Discover best practices for developing, validating, and implementing a rapid targeted NGS assay that complements comprehensive genomic profiling while accelerating biomarker identification
  • Explore how rapid genomic insights can expedite biomarker-driven clinical trial enrollment, improve access to targeted therapies, and support pharmaceutical and diagnostic partners developing companion diagnostics
  • See how optimized workflows using the Illumina MiSeq™ i100 Series and Hamilton STARlet can reduce NGS turnaround times, helping bring biomarker-guided therapies and CDx solutions to patients faster

12:40 pm Session Reserved for Predicine

Vice President - Cdx & Biopharma Partnerships, Predicine

Presentation Details to be Announced

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12:50 pm Panel Discussion: Transforming Patient Enrolment & Monitoring Through Innovation in Liquid Biopsy Analytes, Detection Sensitivity & Data Interpretation

Associate Vice President, Companion Diagnostic Development, Merck
Head, Clinical Genomics, Clinical Measurements Sciences, EMD Serono, the Healthcare Business of Merck KGaA, Darmstadt, Germany
Senior Director, Clinical Biomarkers, Clinical Development, Eikon Therapeutics
Vice President, Translational Sciences, Compass Therapeutics
  • What are the most fit-for-purpose recent innovations in liquid biopsy biomarkers, and how can these be robustly validated and integrated into clinical trial designs?  
  • How can drug-diagnostic stakeholders build collaborative, scalable frameworks to advance liquid biopsy technologies, particularly in improving standardization, and harmonization? And who should contribute to this framework?
Clinical & CDx Development
Rx–Dx Commercialization & Adoption
Digital Pathology & Spatial Biomarkers
Multimodal & AI-Enabled Precision Medicine

1:10 pm Lunch Break & Networking

1:10 pm Lunch & Learn Hosted By Natera

*Invitation only

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1:40 pm One-to-One Meetings & Structured Networking

Biomarker Discovery & Translation

From Biomarker Discovery to Early Clinical Translation Advancing Precision Oncology Through Next-Generation Panels

2:10 pm Demoncratizing High-Sensitivity Cancer Detection

Chief Executive Officer, SentryDx
  • Bicycle PCR provides high sensitivity, high specificity and is cost-effective
  • Come learn the secret sauce of this simple and scalable trick
  • Looking for partnership opportunities

2:40 pm Advancing Precision Oncology: Developing Translational Biomarkers for a Novel Mitochondrial-Targeted Therapy

Chief Medical Officer, Bantam Pharmaceutical LLC
  • Therapeutic programs with novel targets and mechanisms of action present significant challenges when developing translational biomarkers to select patients and characterize treatment responses
  • BTM-3566 modulates mitochondrial dynamics as a unique therapeutic strategy for treating tumors resistant to standard of care and those tumors with aggressive genomic profiles
  • A summary of the scientific progression of this drug and the considerations for various biomarker strategies explored will be presented as well as current clinical study plans to develop a precision medicine product

3:00 pm Session to be Confirmed

Inquire about remaining partnership opportunities at sponsor@hansonwade.com

3:10 pm Panel Discussion: Navigating Biomarker Complexity as a Biotech to Build Smarter Precision Oncology Strategies that Maximize Clinical & Commercial Impact

Executive Director, Translational Biomarkers & Diagnostics, Immunone
Acting Chief Development Officer, Incendia Therapeutics
Director, Clinical Biomarkers, Agenus
Vice President, Translational Medicine & Research, Pyxis Oncology
  • When to integrate biomarker considerations into translational or early clinical development without overburdening trial design, patient recruitment, or organizational capacity?
  • What can biotech do to evaluate partnership models that foster innovation while ensuring operational feasibility, sustainable costs, and long-term scalability of CDx?
  • How to determine when a biomarker‑enabled strategy truly advances the program, balancing scientific risk, portfolio focus, and capital efficiency?
Clinical & CDx Development
Rx–Dx Commercialization & Adoption
Digital Pathology & Spatial Biomarkers
Multimodal & AI-Enabled Precision Medicine

3:40 pm Afternoon Break & Dedicated One-to-One Meetings

Driving Precision Medicine in Unmet Patient Populations with Biomarker Designs for Novel Assays & Small Cohort Studies

4:05 pm Chair’s Opening Afternoon Remarks

Senior Vice President, Global Head, Research Unit, & Neuroscience, Immunology & Billerica Campus Head, EMD Serono the Healthcare Business of Merck KGaA

4:10 pm Session Reserved for Personalis

Presentation Details to be Announced

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4:40 pm Rare New England’s Broad Role in Community & Policy

Board of Directors, Policy, Rare New England
Board of Directory, Secretary, Policy Co-Lead, Rare Disease Patient & Advocate, Rare New England
  • Rare New England’s (RNE) broad role in community and policy
  • Biomarker-testing from a patient/patient advocacy perspective: Describe the current status of biomarker testing coverage bills across New England and evaluate the impact of these policies on the rare disease community
  • What can be done in the future: Explain the role that clinicians and other healthcare professionals can play in facilitating access to care for rare disease patients

5:00 pm Panel Discussion: Beyond the Contract: Inside a Pharma–CDx Partnership

Staff Program Manager, Thermo Fisher Scientific Inc
Director - Diagnostic Partnering, Thermo Fisher Scientific Inc
Scientific Director, Johnson & Johnson Innovative Medicine
Director, Thermo Fisher Scientific Inc
Sr Manager Regulatory Affairs, Thermo Fisher Scientific Inc
  • A candid discussion on aligning strategy, regulatory requirements and execution across the CDx development lifecycle

5:30 pm Translational Pharmacology & Biomarker Strategy in Drug Discovery & Development

Senior Vice President, Pharmacology & Biomarkers, PTC Therapeutics
  • Approval of a drug requires a statistically significant improvement in an outcome measure. Outcome measures, reflecting how patients feels or function, can require many patients and long studies to reach statistical significance
  • Biomarkers, object measures of biological changes, can be used to select the dose and to provide evidence of disease modulation with fewer patients and in less time
  • Preclinical studies can be utilized to link a biomarker to subsequent outcome measures

5:50 pm Closing Remarks & End of Conference Day Two

Senior Vice President, Global Head, Research Unit, & Neuroscience, Immunology & Billerica Campus Head, EMD Serono the Healthcare Business of Merck KGaA

5:55 pm Patient Access Reception: Opening Remarks & Video Premiere

6:00 pm Patient Access Reception

An evening of networking and recognition dedicated to the partnerships, adoption initiatives and implementation successes advancing precision medicine worldwide for unmet patient need.

7:15 pm Hosted Reception Engager in Partnership with Personalis

Establishing a Robust Framework for Tumor Informed ctDNA Testing in Solid Tumors for Patient Selection, Stratification, & CDx Development

As ctDNA transitions from translational research to prospective, interventional clinical trials, biopharma companies face critical decisions in assay selection, sensitivity thresholds, and regulatory alignment. This session provides a practical roadmap for integrating ultra-sensitive, tumor-informed ctDNA platforms for solid tumors into clinical trial workflows for patient selection, response monitoring, and stratification. Join Personalis and leading biopharma partners for an interactive panel discussion on navigating the pathway from Clinical Trial Assays (CTA) to commercial Companion Diagnostics (CDx). 

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