Archives: Agenda

• 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

• How to build a strong CRO onboarding plan that sets your study up for success
• Making your kickoff meeting count: aligning teams, timelines, and expectations
• Fast-tracking your study start-up — from project plan to site activation
• Anticipating and mitigating early risks to protect your study timelines

• Ensuring data accuracy: utilize eCOA to capture patient-reported outcomes in real-time, reducing errors and enhancing data reliability
• Streamlining patient enrollment: implement IRT to manage patient randomization and drug supply logistics, ensuring compliance and minimizing risks of bias
• Enhancing patient compliance: leverage eConsent to provide clear, accessible information to participants, ensuring informed consent and improving retention
• Strengthening data security: integrate robust encryption and authentication measures across eCOA, IRT, and eConsent platforms to protect sensitive data and maintain trial integrity
• Facilitating regulatory compliance: ensure all digital tools comply with regulatory standards (eg FDA, EMA) to streamline approval processes and enhance trial credibility

• Streamlining feasibility, site selection and qualification processes to minimize delays
• Leveraging technology to manage documents, workflows and communication
• Identifying common bottlenecks and strategies to overcome them proactively
• Aligning sponsor, CRO and site teams to ensure clarity from day one

Explore how artificial intelligence is revolutionizing the speed, quality, and consistency within clinical trials through innovative technologies and real-world applications. This presentation explores:

• Preparing your organization
• How to identify AI opportunities and associated value
• Real life examples of using AI to accelerate clinical trials

• DEI in rare diseases: how to ensure your trial participants represent the overall population in trials with limited patient numbers
• Navigating FDA regulations and devising a strategy for diversity and inclusion
• Building trust and relationships with communities who may not traditionally participate in clinical trials
• Working with advocacy groups to increase trial diversity and patient numbers

MODERATOR:

Robert Loll, Senior Vice President, Business Development and Strategic Planning, Praxis