In this roundtable discussion, we will review several business cases and outcomes, leading to key lessons learned regarding customer behavior. This knowledge will help you improve collaboration with your teams and drive more effective client relationships. The discussion is based on experience as a Project Management Institute-certified project management professional, a certified Lean Six-Sigma Green Belt, and 20+ years of clinical development and regulatory sciences experience working with pharma companies and contract research organizations.

The near-universally adopted method for document development, namely, the draftreview-revise process, is increasingly being questioned as best practice. As demands for shortening process timelines have continued to increase and software advances have made many interactions continuous, there appears to be a concurrent push for a more collaborative approach to authoring. Collaborative authoring can indeed speed the development of expert content in documents; however, it also poses new issues for authors, especially in the case of continuous collaborative authoring. Learn about the extent of this trend, variants in its implementation, impacts on authors, and techniques for managing collaborative authoring.

"Clinical Overviews are meant to be a critical assessment of the clinical data that support the marketing application for a drug product. This discussion will focus on how to fulfill the International Council for Harmonisation M4 guidance requirements and meet regulator’s current expectations. Learn practical tips for achieving a well-thought out and effective Clinical Overview. Each major section of the Clinical Overview will be broken down and evaluated; however, the product development rationale and the benefits/risks sections will be the main focus. "

The chemistry, manufacturing, and controls (CMC) information in an initial marketing application needs to be a balance between current manufacturing and testing practices, requirements in the various guidance documents, and the need for some flexibility in the lifecycle management of the marketed product. Learn about the CMC detail necessary in an initial marketing application balanced against the postapproval ramifications of including too much detail in certain aspects of the application.

Managing the challenges of patient engagement in the development of plain language summaries (PLS) will be discussed. Current challenges include how to identify and recruit patient reviewers, how to manage the engagement/review period, and what to do with the information provided. Synchrogenix has developed a solution to these challenges called the Podium PLS Review Platform. The platform, and some results from patient engagement work will be presented.