Archives: Agenda

• Milli Expanding Vaginal Dilator’s Regulatory Arc: Wellness to Rx to OTC
• Market told us robust clinical would support adoption—need to do fast and cheap
• Developing the study protocol and clinical operations POMPOM – Milli
• Recruitment strategies and metrics
• Remote data collection and compensation
• Baseline Data Abstract accepted by ISSWSH
• What we learned
• Future studies: lather-rinse-repeat

• Recognizing and preserving patient trust: how and why should their data be shared?
• How data sharing platforms can work for you and what are the pragmatic ways to achieving the benefits?
• Ensuring an ROI on your data: Key financial considerations of data curation
• Logistical and regulatory challenges hindering the progress of data sharing

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable lasts for 30 minutes, delegates can select up to 2 roundtables.

RT 1
Careful planning and effective communication to implement tailored patient recruitment strategies
Hosted by Bruce Morimoto, Vice President, Drug Development, Alto Neuroscience

RT 2
Opportunities for AI and Digital Health to improve clinical research
Hosted by:
Meghan McKenzie, Director of Health Equity and Clinical Research, Chief Diversity Office, Genentech Kade Shippy, Chief Diversity Office, PKade Shippyatient Inclusion and Health Equity, Genentech Audrey Funwie, Chief Diversity Office, Patient Inclusion and Health Equity, Genentech

RT 3
Navigating the regulation landscape and the different approaches trial stakeholders are taking to be compliant

Hosted by Gina Morton, Former Director of Contracts and Outsourcing, Calico and Genentech

RT4
MEDICAL DEVICE ROUNDTABLE: Overcoming barriers to scaling: funding, regulatory hurdles, and market entry strategies for startups

• 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?
• How do strategic alliances impact this decision?