Archives: Agenda

• 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

• Understand the key points of recent FDA guidance aimed at enhancing diversity and equity in clinical trials
• Discuss how recent FDA guidance supports patient optionality in clinical trials, especially for underrepresented populations
• Identify actionable strategies for integrating FDA guidance into clinical trial designs to achieve diversity and innovation goals
• Explore the potential impact of FDA guidance on future clinical trials, with an emphasis on patient-centricity and inclusivity

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.

• Defining a start-up plan based on key study objectives
• Using a data driven approach for effective start-up planning, including data from regulatory intelligence, site intelligence, and KPIs to support start-up planning
• How effective start-up execution drives a successful trial

• 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

• Exposing the inefficiencies of current vendor qualification practices and challenging the industry to adopt a proven process innovation that will help sponsors onboard vendors more quickly leading to a real reduction in clinical trial start-up times
• Learn how embracing innovation, and adopting a risk-based data-driven approach to vendor management can help organizations strength their compliance practices in a heavily regulated industry
• Uncover the advantages of a centralized approach to vendor qualification that provides unique benefits to both sponsors and vendors across the globe

• Weighing up pros and cons of different outsourcing models: which is best for your trial?
• When is mixing and matching better than fully outsourcing or keeping trials fully in house?
• Developing an outsourcing strategy as a small to medium sized biotech with limited resources
• Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?