Agenda May 19 2021
8:45 am - 10:45 am
EST
Pre-scheduled One-on-One Networking Meetings
10:45 am - 10:50 am
EST
Opening Remarks
10:50 am - 11:20 am
EST
Digital Innovation to Improve Oncology Clinical Trials and Remote Patient Care
Jorge Nieva, M.D. -
Associate Professor of Clinical Medicine,
Keck School of Medicine of USC
Rob Wilson - Research Business Director, MindMed
Performance status in oncology measures are important to assess and manage cancer patient enrollment and progress during treatment. In this session we will look at a potential improvement in those measures by considering a digital in clinic assessment combined with remote patient measurement tools including wearable sensors, epros, and televisits. Dr. Jorge Nieva from the USC Keck School of Medicine will join the program and talk about an innovative investigator sponsored trial that is planned to provide a real world example of digital innovation and remote patient care.
11:20 am - 12:00 pm
EST
Managing Oncology Trials in The Covid Era & Beyond
Amy Davis -
Senior Director, Clinical Development, Oncology,
Lilly Oncology
As the global pandemic continues to impact new and ongoing trials in Oncology, trial leaders, sponsors and administrators are looking for lessons on what others are doing to survive 2021 and trial integrity, as well as the remote patient experience. In this case study from one such example, attendees will gain insight into value added best practices across the trial spectrum including:
- remote study visits
- dispensing drugs via mail
- conducting surveys via telehealth
12:00 pm - 12:30 pm
EST
Networking and Refreshment Break: 1-1 Meetings and Speed Networking Rooms Open
12:30 pm - 1:00 pm
EST
Panel: Harnessing Digital Technologies to Drive RWE & Data
Gracie Lieberman -
Senior Director Regulatory Policy,
Genentech
Alok Tayi PhD - VP of Life Sciences, Egnyte
Health related information is increasingly being collected and stored digitally, with clinical trials as an increasing focal point in this new, digitalized landscape. Harnessing digital technologies create opportunities to drive valuable RWE generation and enriched data, increase efficiency, enhance trial planning, and maximize patient recruitment. How might sponsors best address challenges like data access, quality and creating/maintaining public trust in order to translate digital innovation into improved patient outcomes?
1:00 pm - 1:30 pm
EST
Panel: Overcoming Obstacles to Patient Adherence
Rose Gerber -
Director of Patient Advocacy and Education,
Community Oncology Alliance (COA)
Molly MacDonald - CEO/Founder, The Pink Fund
Allison Matthews - Service Designer, Innovation and Design, Mayo Clinic
The clinical trial rate of patient recruitment and retention is dismally low. Identify solutions to challenges ranging the full spectrum of planning, protocol design and execution. This session will also take into consideration problem solving for site access, education, socio-economic obstacles, and how to develop and enhance the overall patient experience.
1:30 pm - 1:45 pm
EST
Q&A Session
1:45 pm - 2:15 pm
EST
Fireside Chat: Opportunities in Decentralized Trials Design & Execution
Noolie Gregory -
Vice President, Decentralized Trial Operations,
Syneos Health
Julian Jenkins PhD - Group Vice President, Head of Development Operations and Project Management, Incyte Corporation
David Thompson - Senior Vice President, Real World Research, Syneos Health
Patrick Melvin - Vice President, Novel and Emerging Therapies, TA Lead, Hematology/Oncology, Syneos Health
The global pandemic radically accelerated changes in our industry, including the rapid uptake of decentralized clinical trials. Now that the dust is settling, it is important to better understand the many options and technologies available in our toolbox and to apply these in a thoughtful way in order to ensure trial success. This panel discussion will address key considerations for applying decentralized solutions for oncology including the long term follow-up aspects to meet the needs of multiple stakeholders, including sites, patients, regulators and payers.
Julian Jenkins PhD
Group Vice President, Head of Development Operations and Project ManagementIncyte Corporation
Patrick Melvin
Vice President, Novel and Emerging Therapies, TA Lead, Hematology/OncologySyneos Health
2:15 pm - 2:30 pm
EST
Q&A Session
2:30 pm - 3:00 pm
EST
Going Global: Working Across International Markets
Michel Azoulay MD -
Senior Medical Director Oncology,
Kyowa Kirin
Claudia Morato Guimaraes - Sr. Global Medical Affairs, Oncology, Eli Lilly
Laurie Smaldone MD - CMO/CSO, NDA Group
What are some of the differences between single-country and global clinical trials? Discuss what a framework for successful international oncology trials looks like, and identify the major challenges in international oncology trial collaboration.
