Archives: Agenda

• Technology and innovation for addressing health literacy and how information is presented to patients
• Integrating health literacy principles into all phases of clinical research
• How low health literacy can

• Defining the full lifecycle of clinical and regulatory documents
• Identifying practical actions authors can take to facilitate compliance with electronic regulatory submission requirements
• Describing how technology tools are used to ensure efficient workflows and regulatory compliance

• Top tips for working with and supporting naïve physicians in order to ensure their success
• The importance of new study sites as a way of meeting FDA diversity requirements
• Lessons learned for the future: what should you consider when working with naïve doctors?

Carrie Lewis, Executive Director, Clinical Program
Optimization, Endo
Suzy Montanye, Site Relationship Manager, Endo

• 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:
Judyth Zahora, Senior Director, Clinical QA and Process Improvement, Zentalis Pharmaceuticals

PANELLISTS:
Rosanne Petros, Associate Director, Clinical Research, Merck Research Laboratories
Bryan Clayton, Clinical Systems Consultant, Alnylam Pharmaceuticals
Paresh Patel, Head of Global Clinical Intelligence, Otsuka

• What sites really want and need, and why they don’t understand sponsors
• What sponsors really want and need, and why they don’t understand sites
• Areas of common ground
• How sites and sponsors can reconcile and work together to find success

• Discover how integrating health equity & SDoH data improves patient representation and accessibility in clinical trials
• Learn how H1 supports sponsors in designing inclusive, patient-centric trials to meet diversity action plan requirements and feasibility benchmarks
• Explore real-world applications of inclusive research strategies that have successfully expanded patient diversity and engagement

• Is decentralization of clinical trials still relevant in 2025?
• Incorporating remote monitoring tools such as wearables into clinical trials
• An overview of new tools and solutions available on the market
• The growth of GenAI: when will this become widely used in clinical research?
• Balancing new techno

MODERATOR:
Rich Polgar, Managing Director, Danforth Advisors

PANELLISTS:
Ashlyn Jose, Director, Clinical Operations, Kyowa Kirin, Inc
Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health
Kristen Olszyk, Vice President, Clinical Operations, Neuraptive Therapeutics
Stefanie Kuhner, Head of Clinical Technology, Innovation and Patient Recruitment, Bristol Myers
Squibb

As the clinical research industry pushes toward innovative solutions to increase inclusivity and access, it’s time to look beyond traditional site-based trial models and digital platforms. Expanding access isn’t just about technology-centered solutions – it’s about rethinking where and how trials happen. This session explores how community-based research models, including mobile research sites, mobile clinicians, and flexible visit options, are redefining what it means to bring research to patients. This session will explore how building trust and presence in local communities leads to better enrollment, stronger retention, and more representation data.