8:00 am Check-In & Light Breakfast

8:50 am Chair’s Opening Remarks

  • Flora Berisha Global Head - Diagnostics Partnering & Development, Precision Medicine, Johnson & Johnson Services, Inc

Successfully Navigating the Shifts in Companion Diagnostics Regulation to Maximize Stakeholders Influence & Patient Access

9:00 am Evaluating the Impact of Global Regulatory Bottlenecks on Patient Access to Companion Diagnostics

  • Lindsay Darling Director, CDx Portfolio Management and Operations, Regeneron Pharmaceuticals Inc


  • How has the IVDR framework influenced the global regulatory landscape?
  • Exploring strategies for diagnostics companies to manage and thrive amidst diverse regulatory requirements across different regions
  • Overcoming critical difficulties with regulatory protocols to streamline patient access to safer, more effacacious drugs

9:20 am Placeholder for Quest Diagnostics

9:50 am Panel Discussion: Shaping the Future of Laboratory Developed Tests During Significant Regulatory Shifts
Moderated by Veranex


  • How will the reclassification of high-risk LDT’s accelerate innovation and accessibility in the development of clinical biomarkers and companion diagnostics?
  • Exploring the impact of the new regulatory pathway conditions on the safety and efficacy of LDT’s
  • How will different healthcare sectors respond to shifting regulations?
  • How will the new LDT rule impact drug developers & IVD manufacturers?

10:20 am Placeholder for Agilent

10:50 am Morning Networking Break

Leveraging the Latest Innovations in Precision Oncology & Companion Diagnostics to Deliver Effective & Targeted Therapies to Patients Faster

11:20 am Harnessing ctDNA to Unveil Early Signs of Drug Response in Cancer Drug Development

  • Jonathan Beer Senior Director Diagnostic Sciences, Bristol Myers Squibb


  • Exploring the developments required for ctDNA to replace traditional tumor biopsies for monitoring treatment response and drug resistance in preclinical trials
  • How can ctDNA be leveraged to identify promising drug candidates early in translational development, informing go/no-go decisions for new therapies?
  • Considering the potential for ctDNA-guided patient stratification in translational studies, what are the ethical considerations and regulatory hurdles that need to be addressed?

11:40 am Confidence in Navigating Challenges to Biomarker Development & CDx Milestones

  • Varun Pattani Senior Director - Diagnostic Development, Foundation Medicine


  • How established, approved testing platforms can expand your biomarker population and accelerate timelines to CDx approval
  • Learn how to validate innovative new biomarkers, such as HRDsig, MTAP loss, and detection of clonal hematopoiesis (CH) for inclusion in your clinical trials
  • Review emerging CDx opportunities RNA, heme malignancies, and real-world data

12:10 pm Unlocking Unprecedented Insights with Urinal Biomarker Discovery for Revolutionary Patient Treatment

  • David Weingeist Scientific Director, Oncology Precision Medicine & Diagnostics, Johnson & Johnson Services, Inc


  • Urine-based genomic analysis has the potential to become a standard liquid biopsy approach in early bladder cancer
  • Urine enables convenient and reliable, non-invasive patient screening, addressing certain challenges of tissue and plasma-based testing
  • The highly sensitive method detects a broad spectrum of genomic alterations, enhancing its clinical utility beyond treatment selection

12:30 pm Placeholder for Guardant

1:00 pm Lunch & Networking Break

The Future of Artificial Intelligence in Precision Medicine: Advancing Breakthroughs for Reliable Clinical Development & Companion Diagnostics

2:00 pm Unleashing the Power of Digital Pathology & AI to Accelerate Drug Development Across All Therapeutic Areas


  • How can biopharma leverage AI and digital pathology to drive improvements along the continuum of drug R&D (target selection, MoA, PD, Endpoint analysis, Combination Strategies, Selection and Stratification)?
  • What role do foundation models play in accelerating AI models development and expanding diagnostic capabilities?
  • Highlighting the potential of AI and digital pathology in non-oncology areas

2:20 pm Placeholder for Roche

2:50 pm Harnessing Meta-Analysis & Multi-Modality Data to Build Robust CDx Development Beyond Disease Indication


  • Illustrating the importance of metanalysis in identifying reliable biomarkers
  • Demonstrating the integration of various data types, including genomic and transcriptomic data, to develop robust CDx models
  • Exploring the capacity of AI/ML to move beyond disease indication

3:10 pm Placeholder for Tempus

3:40 pm Afternoon Networking Break

Expanding the Boundaries of Precision Medicine: Accelerating Companion Diagnostic Development in Non-Oncology Indications for Unmet Clinical Need

4:10 pm Placeholder for Biotechne

4:40 pm Bridging the Gap for Clinical Biomarkers Between Oncology & Non-Oncology Therapeutic Areas to Expedite Personalized Treatment

  • Kara O’Brien Executive Director - Global Precision Diagnostics - Market & Ecosystem Shaping, Novartis AG


  • What insights can be leveraged from the extensive experience with precision approaches in oncology as biopharmaceutical companies explore new therapeutic domains?
  • How have recent advancements in genomic sequencing and bioinformatics contributed to new discoveries in diverse therapeutic areas?
  • Unlocking the limitless potential of CDx in new areas: an evaluation of the promise of precision medicine

5:00 pm Advancing Precision Medicine Globally: From Gene Therapy to HLA CDx Commercialization

  • Mark J Roberts Senior Director - Head of Precision Medicine Science & Strategy, LabCorp


  • Lessons from the first cell based CDx FDA approval in gene therapy
  • Understand the dynamics of 3-way and 2-way partnerships models between pharma, IVD companies, and Labcorp with real world examples
  • Strategic Considerations for Global Commercialization: from early development to trials, regulatory oversight, and post-commercialization support

5:30 pm Bringing the First Precision Medicine to Treat CNS Diseases using Innovative Biomarker Discovery Platforms

  • Wen Luo Chief Executive Officer & Chief Scientific Officer, Denovo Biopharma LLC


  • Investigating the challenges of identifying and validating pharmacogenomic biomarkers for CNS drugs, such as placebo effects, model gaps, and diagnostic heterogeneity
  • Leveraging a novel biomarker, DGM4, discovered through genome-wide screening of blood samples from a prior failed clinical study with liafensine, to predict treatment efficacy in TRD patients
  • Launching a global phase 2b study utilizing the DGM4 biomarker to enrich potential responders to liafensine, achieving significant success and paving the way for precision medicine in CNS disorders

5:50 pm Chair’s Closing Remarks & End of Conference Day One

  • Flora Berisha Global Head - Diagnostics Partnering & Development, Precision Medicine, Johnson & Johnson Services, Inc

6:00 pm Evening Thought Leadership Engager Hosted by Agilent


Register your interest to attend this learning and networking session with experts from Agilent and biopharma. Further details to be revealed!