Virtual Summit Program

DAY ONE: THURSDAY JUNE 25, 2020

9:25 - 9:30 AM ET

Opening Remarks 

9:30 - 10:15 AM ET

Current Regulatory Update & Guidance on Managing New and Ongoing Clinical Trials in the Ongoing COVID-19 Pandemic and 2020

Hear an update from the FDA on the latest regulatory guidance, how the agency is taking the current climate into consideration for clinical trials impacted by the ongoing pandemic, and what study teams can do to prepare for the rest of the year. 10 minute Q&A to follow presentation. 45 Min
Diane Maloney, Associate Director, Policy, Center for Biologic Evaluation and Research (CBER), Food and Drug Administration (FDA)

10:30 - 11:15 AM ET

Global Regulatory Lessons From COVID19

Discuss contingency measures organizations have put into place during the pandemic and the long term impact on working and procedures. How are companies managing with the intelligence of and compliance with varying country-specific, unique COVID-19 requirements and what influence can the industry put on the Agencies to maintain the flexibility of executing clinical trials that has been allowed during the pandemic phase? Also examine measures being taken to adapt to the changing nature of inspections in a remote-audit world, including challenges and remediation measures for data privacy concerns. How will the 2020 pandemic shape the future of clinical trials? 45 Min

Heiner Gertzen, Head, GxP Inspection & Audit Readiness, Sanofi 
Moderator: Prof. Steffen Thirstrup,MD, PhD Fmr. Head of Division, Medicines Assessment and Clinical Trials,Danish Health and Medicines Authority; Director, NDA Regulatory Advisory Board  

11:30 AM - 12:15 PM ET

Patient Engagement Now and in the Post Pandemic Era 

Community Oncology centers provide clinical trials to cancer patients across the U.S Learn how COVID 19 is impacting patients and their oncologists on the front lines of community cancer care. How can organizations optimize patient identification and communication when in person communication is not feasible? Explore the pros and cons of clinical trial promotions during a pandemic and examine strategies for leveraging telehealth and remote monitoring solutions for clinical trial participants. 45 Min

Leslie Jebson, Executive Director of Clinical Business Operations, Texas A&M Health Science Center
Rose Gerber, Director of Patient Advocacy and Education, Community Oncology Alliance (COA)

12:30 - 2:30 PM ET

Scheduled Virtual Networking Meetings

DAY TWO: FRIDAY JUNE 26, 2020

10:00 - 10:45 AM ET

Moderated Chat: Navigating Outbreak-Related Challenges in Ongoing Clinical Trials

Discuss what it means to navigate the COVID-19 Pandemic, day to day operations, management, remote working and planning a return to “normalcy. Explore strategies for ongoing clinical trial management during and after outbreaks, site closures, and other obstacles in 2020 like preparing for a 2nd wave of COVID19. 45 Min

Jeff Douglas, Head of Clinical Operations, MyoKardia
Jennifer Healey, Head of Global Medical Operations, Sanofi
Moderator: Tim Hagerty, VP Development & Business Operations, Dantari 

11:00 - 11:45 AM ET

Moderated Chat: Accelerating the Drive to Digital, Virtual and Hybrid Clinical Trials

The impact of the current pandemic and COVID19 on clinical trials has acted as an accelerant to the shift towards partial or fully virtual trial designs. What best practices can be gleaned by early pioneers of this model, and how can existing and future trials streamline the transition? 30 Min

Craig Lipset, Fmr. Head of Clinical Innovation, Pfizer
Moderator: Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS

12:00 PM - 4:30PM ET

Scheduled Virtual Networking Meetings