WELCOME & INTRODUCTIONS

OPTIMIZING YOUR REGULATORY STRATEGY

Regulators are changing the landscape to drive faster more efficient drug development. This session will review strategies sponsors can take earlier in development to expedite development timelines, reduce cost, and make assets more attractive for partnering. 

Presenters:
Robert Kleiman, MD, Chief Medical Officer, ERT
Bruno Gagnon, Vice President, Development Operations, Eidos Therapeutics

BEST PRACTICE APPROACHES TO CLINICAL TRIAL DATA COLLECTION

With regulations tightening, budgets closely managed and funding requirements become more stringent than ever, it’s critical that your trial is positioned for success from day 1.  Despite even the best planning, issues are bound to arise.  Learn the pros and cons of various data collection, safety & efficacy, patient engagement and trial management approaches that will help you proactively mitigate risk, collect higher quality data and enable better-informed decisions throughout the clinical development process.  This session will directly address the benefits of capturing clinical data digitally.

BREAK

LEVERAGING TECHNOLOGY FOR FAST-TRACK EARLY PHASE & RARE DISEASE STUDIES

Global regulators enable sponsors to accelerate rare disease therapies with Fast-Track considerations, but don’t provide guidance on how to modify study designs to accommodate progressive disease states, rater changes, and other special considerations.  ERT experts will review current literature, highlight global regulations and ISPOR recommendations, and educate attendees on the parameters for using PRO/eCOA in fast track and rare disease studies.

IMPROVING COLLABORATION AND EFFICIENCIES

It takes a village to successfully execute a trial, with multiple vendors and partners involved in data collection and information management – and multiple opportunities for inefficiencies and errors along the way.  With so many players, data inputs and tracking systems in place, how can you truly optimize trial performance?  This presentation will share a real-world example of how sponsors and CROs are leveraging data, analytics and a cutting-edge CTMS to provide near real-time visibility into critical study trends, enable proactive operations, automate repetitive manual tasks across trials, and provide better visibility and collaboration across all trial stakeholders.

Presenters:

Helen Hall, Director, Biometrics, Accelovance

Christine Kanalis, Relationship Manager, ERT

GROUP DISCUSSION & WRAP UP

We’ll summarize key takeaways of the day, review implications for early stage firms and wrap up the day’s proceedings.

DEPARTURES/OPTIONAL LUNCH