Archives: Agenda

• Optimizing and de-risking trial design and feasibility: how data-driven modeling and simulation tools are helping sponsors design smarter, more efficient trials from the outset
• Enabling in-stream decision-making during execution: using real-time insights to adapt trial operations dynamically, improving quality, timelines, and decision confidence
• AI’s transformative impact on trial delivery: from reshaping how we plan and run trials to redefining roles and workflows, AI is set to re-engineer every stage of clinical development

• Exploring different funding avenues: how to structure fundraising initiatives
• Working in collaboration with academia: benefits and opportunities
• The importance of building networks and insights from investors in addition to capital
• Lessons learned: analyzing both successes and learnings for future biotech initiatives

GlobalData’s clinical trials data indicates that trials initiations in H1 2025 increased significantly over previous years. Public reporting of clinical trials make it easy to miss when and where the real growth is happening. In addition to surprising Wall Street, this has shaken up the competitive landscape and created major opportunities for CROs, CDMOs and Pharma Tech.

• What drove the surge
• Where the next wave is coming from
• How can early signals give you the edge
• Whether you run trials, manufacture at scale, or partner with life sciences companies, this is about being prepared.

• Big pharma is a battleship in a speedboat world. FSP outsourcing offers the agility to cut through traditional development timelines and chart a faster course to patients.
• In this presentation, Parexel will share how they partnered with Bristol Myers Squibb (BMS) to make a strategic shift, transitioning from a predominantly full-service outsourcing model to a functional service provider model. This involved redefining traditional roles, innovating tasks and responsibilities, and talent redeployment in support of pipeline priorities.
• The presenters will discuss the strategic considerations and benefits of this transition, demonstrating how through a collaborative partnership, they worked to enhance BMS’ clinical trial operations, creating resource efficiencies, increasing agility, and optimizing clinical operations across their global portfolio. This presentation will offer valuable insights for companies seeking to adapt their outsourcing strategies to meet the demands of today’s complex and rapidly changing drug development environment.

• Opportunities for incorporating AI into clinical research: where should the industry be focusing?
• Why has pharma been relatively slow to utilize AI in clinical research?
• Understanding limitations of GenAI: what do you need to be wary of?
• Real case studies on AI in the clinical trial industry: where has there been progress and success?
• What does the future hold for AI in clinical trials?

MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

• Harnessing Apple Watch technology: key features for detecting heart arrhythmias
• What the evidence says: insights from published cardiovascular studies
• From wrist to research: smart distribution models for clinical trial success
• Making it work: tackling operational and data management hurdles for clinical trial success

• What is realistic, what isn’t, and how can you stay ahead of the curve?
• How biotech and pharma differ when it comes to technology and innovation: as a biotech, where should your priorities lie?
• Staying ahead of competitors when funding and resources are limited for technology investment
• Leveraging agility and flexibility to adopt technology quickly
• Balancing innovation with risk management and scalable development

MODERATOR Jay Russak, Former Senior Director, Clinical Operations, Keros Therapeutics

• Uncovering the invisible: a 20-year analysis of medically underrepresented populations in clinical trials
• Benchmarking against the US census reveals structural gaps and needs
• Adopt a six-pillar architecture to embed equity from the ground up