The release of ICH E6 R3 (draft) has been a long time in its gestation, starting with the GCP Renovation document more then six years ago (January 2017). The overall direction has always been clear with a move to Quality by Design and enhanced risk-based approaches, but there are many more enhancements to this guidance that demand full review and implementation. This presentation will take you step-wise through the following topics: the main changes in principles, investigators, sponsors, and appendices plus a new section on data governance as well as detailed areas of oversight.

The acquisition scenario is not a rare event for small/biotech companies, but investing in outsourcing management is. Good outsourcing can increase asset value and be pivotal to a successful acquisition process. Early outsourcing strategy definition, a diligent selection process, practical contracting, and thorough, pragmatic vendor governance are not only essentials to overall clinical trial management, but they can also prepare the ground for a mutually successful, possibly pain-free acquisition.

Understanding challenges associated with changes in outsourcing strategy, vendor selection in digital era, and change management in accordance with current regulatory requirements will allow for the timely and successful completion of the projects, while minimizing exposure to the risks of stakeholders, such as participating sites. Key factors to consider when developing protocols and techniques to minimize complexity, adequately select vendors, mitigate risks and ensure trial success, will be discussed, particularly the impact these decisions have on sites, and therefore, patients.

In large pharmaceutical companies, the opportunities for advancement may be limited due to the availability of leadership positions, corporate siloing, and competition. In addition, exposure to the drug development process may be limited by function. Small biotech may offer an opportunity to use large pharma drug development and functional experience to gain further knowledge and expertise across functional areas leading to enhanced development and leadership opportunities. There is risk and a transition period when taking this leap. This presentation will focus on the differences between the work experience at a large pharma vs a small biotech, what to expect during the transition, and how to plan for success. Topics will include infrastructure, choosing a CRO, relationships, technology, culture, recruitment, hiring for success, and training and development of team members.

Clinical study success depends on three “C” or core elements: communication, collaboration, and cooperation from all participating individuals. When it comes to working on rare diseases, the chances of outsourcing to a CRO or vendor with prior experience in that particular indication are often nonexistent or quite limited. This presentation will focus on how Rezolute took a more direct, hands-on approach to executing a rare pediatric pivotal Phase 3 Global Program. How we removed divisions in vendor communication lines and instead led or joined the lines which helped facilitate site and vendor relationships, ultimately delivering faster outcomes and creating stronger and more cohesive study teams.

Running trials nimbly—utilizing in-house talent and managing a trial without a CRO. How to evaluate if this is the right model for you and look at the pros and cons for your team/organization. Which vendors and consultants will you need and which resources can be used from the company? Which processes and plans will need to be developed and which lessons learned?

Discover strategies for diverse clinical trial participation by developing inclusive protocol designs, applying data-driven site identification, and proactively customizing outreach and support for diverse populations. Attendees will learn strategies for determining trial-specific benchmarks and measuring success to enhance their ability to contribute to equitable and representative clinical trials.

This presentation on "Collaborative Partnerships" provides a glimpse into the exploration of collaborative partnership as a strategic avenue for operationalizing Diversity, Equity, and Inclusion (DEI) initiatives within organizations and even our healthcare system. The focus is on forging inclusive alliances that contribute to the effective implementation and integration of DEI efforts. We can approach this from case studies, best practices, and practical insights, which this presentation seeks to shed light on the transformative potential of collaborative partnerships in creating a more diverse, equitable and inclusive organizational culture and environment. This brief presentation will attempt to delve into key considerations, challenges, and success factors in establishing and nurturing these alliances, emphasizing the role of outsourcing and external partnerships in advancing DEI goals. Ultimately the goal is to provide a fair understanding of how organizations, such as sponsors, CROs, and clinical trial research centers can leverage collaborative partnerships as a powerful tool for operationalizing DEI initiatives and fostering sustainable positive change as we work together to better the lives of all citizens, regardless of race, religion, or ethnicity.