Archives: Agenda

• Outline critical factors biotech investors evaluate before committing their resources, offering actionable insights to help startups stand out in a competitive market.
• Steps for biotech founders to differentiate, IP strategy and to attract funding
• Avoiding missteps in budgeting and resource allocation together with prioritization and careful planning.
• Storytelling about key milestones achieved aligned with operational activities with feasible exit strategy?
• Does the biotech investor bring strategic expertise beyond capital needs?
• Does the biotech have the appropriate team and expertise to execute?

• Optimizing study-start up for improved timelines and site performance
• Integrating patient input into protocol design and the impact of patient motivation assessments
• Case studies: patient-informed protocol design for successful outcomes

This presentation delves into dynamics of enrollment challenges and underscores the significance of fostering strong site relationships in rare diseases, which often prove instrumental in driving successful outcomes. Beginning with a compelling case study, we navigate key drivers influencing sponsor decision-making processes, creating innovative strategies that positively impact the study. Emphasizing the paramount importance of timelines, we discuss how sponsor decisions are strategically molded to align with project deadlines. Through the lens of the “one team, one approach” philosophy, we highlight collaborative strategies that surmounted our enrollment hurdles effectively. Key takeaways offer actionable insights for stakeholders navigating the complex terrain of rare disease research, paving the way for enhanced enrollment outcomes.

• 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

• Biopharma’s role in supporting patients with their disease once no longer study participants
• Working with advocacy groups on long term patient engagement
• Where and how can trial sponsors step in to provide long term support for rare disease patients?
• Bridging the scientific advice gap for patients with rare diseases

• 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

• Patient reimbursement: how to relieve financial pressures on patients participating in trials
• Where are the main hurdles patients face and how can these be removed?
• Addressing low levels of health literacy in the patient population: how to improve communication
• Engaging patients and advocacy groups early on in the clinical trial design process

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.