Clinical Operations

Risk Based Quality Management/Central & Remote Monitoring Choosing The Most Effective Monitoring Strategy To Improve Participant and Site Compliance And Data Reliability -Michael Walega Head of Centralized Monitoring, Bristol Myers Squibb Diversity, Equity, and Inclusion in Patient Engagement/Decentralised Trials Outlining the strategies for supporting more robust engagement in communities hence improving clinical trial diversity -Karen Correa Vice President, Head Global Clinical Operations Takeda Emerging Biopharma Challenges And Opportunities In Early-Stage Biotech Funding Understand the strategies startupsneed to stand out from the competition -Paul Blake Chief Executive Officer Papyrus Therapeutics Inc Digital Measurements/ Clinical Data Promoting Diversity in Clinical Trials: organizational challenges and opportunities -Seun Makinde Associate Director Clinical Development, Shionogi Global Site Selection and Feasibility Study Identifying Your Sites by Examining Selection Criteria and Site Performance: What Selection Criteria May Inhibit Your Clinical Trial’s Success? -Adriana Comprelli Therapeutic Area Head, Clinical Operations Strategy Bristol Myers Squibb -Lorie Crowe Program Director, Global Trial Optimization Merck & Co Investment,Private Equity & Venture Capital EtPartnerships How Wall Street’s Roller Coaster Ride is Affecting the CRO/CDMO Ecosystem -Alex Zisson Managing Director, H.I.G. Capital

Risk Based Quality Management/Central & Remote Monitoring Exploring Important Trends in RBQM: A Comprehensive Overview -Rachel Geedy Associate Director RBQM Technology, IQVIA Diversity, Equity, and Inclusion in Patient Engagement/Decentralised Trials Increasing diversity in clinical trials requires redesigning our approach -Sarrah Val MPH Vice President of Global Sales, MD GROUP Emerging Biopharma Increasing diversity in clinical trials requires redesigning our approach Digital Measurements/ Clinical Data How advanced AI technologies such as Intelligent Document Review and generative AI, Chat GPT can help Pharma accelerate filings -Gary Shorter Head of Research and Development of AI into Products, IQVIA Global Site Selection and Feasibility Study Overcoming Inertia to Accelerate Study Start-Up -Aruna Adhikari Thapa Senior Director of Product Strategy and Product Management, IQVIA Clinical Technologies Investment, Private Equity & Venture Capital Partnerships

Risk Based Quality Management/Central & Remote Monitoring A Developed Risk-Based Quality Management Approach To Mitigate Potential Risks and Liabilities -Amy Neubauer Director, GCDM Operational Excellence, Alexion Pharmaceuticals Diversity, Equity, and Inclusion in Patient Engagement/Decentralised Trials How Can We Recognize And Eliminate Obstacles That Prevent Minority Involvement, Such As Historical Distrust, Accessibility Issues, And A Lack of Awareness -Jennifer Sheller AVP Clinical Operations, Merck & Co -Kelly Clark Head of US Partnerships and Global Site Development, Merck & Co Emerging Biopharma Clinical Development Perspective on: “What options are available to biopharma companies that face unique challenges due to their size and scale? -Amanda McEwen Vice President, Clinical Development, Salubris Biotherapeutics Digital Measurements/ Clinical Data How can state of the art data analytics transform clinical trials? What obstacles exist? -Sonia S. Cawley Global Head, Analytics Innovation, Boehringer Ingelheim Global Site Selection and Feasibility Study Robust and Actionable Site Responses: Improve the accuracy of feasibility survey responses by Establishing a precise method to collect and analyze relevant and actionable data -Laura Vessey Senior Director, Head of Early Development and Clinical Pharmacology, Janssen Investment, Private Equity & Venture Capital Partnerships Why are CRO M&A deals on the rise? How expanding full service capabilities, through a strategic M&A process brings global efficiencies to sponsors -Matthew Rosenberg Advisor, Guxi Capital

Risk Based Quality Management/Central & Remote Monitoring Enhancing Trial Knowledge And Driving Better Outcomes By Using RBQM And Deep Learning -Katherine Taylor Head Risk Evaluation and Adaptive Integrated Monitoring, Merck & Co Diversity, Equity, and Inclusion in Patient Engagement/Decentralised Trials Redesigning Clinical Trials: Patient Perspectives; Enhancing Inclusivity; Leveraging AI -Craig Granowitz Chief Medical Officer, Lexicon Pharmaceuticals -Tracy Newbold VP Clinical Operations, Lexicon Pharmaceuticals Emerging Biopharma What future developments and commercial realities businesses with concentrated pipelines or single assets are facing? -Christopher J. Schaber Chairman, President & Chief Executive Officer, Soligenx Digital Measurements/ Clinical Data Realizing Value and Impact to Clinical Development Programs from Data Derived from Digital Technologies In Clinical Trials -Gayle Wittenberg VP, Neuroscience Data Science and Digital Health, Janssen R&D -Srinivasan Vairavan Director, Data Science and Digital Health, Janssen R&D Global Site Selection and Feasibility Study What are the biggest feasibility errors that even the most experienced sponsors occasionally make and how can we have a hands on approach to avoid these mistakes? -Michele Sharr-Hyde Executive Director, Head Clinical Science, DaiichiSankyo Investment, Private Equity & Venture Capital Partnerships Why are the big Pharmas relying on partnerships and acquisitions to access new innovations and expand their pipelines? -Saikat Nandi Global Chief Business Officer, Oryzon Genomics SA