The Clinical Trials Summit (formerly called the CRO/CMO Summit) will take place using a robust web-based platform that includes both live and on demand features. This annual event hosts biotechnology, pharmaceutical, medical device and diagnostic companies from the Mid-Atlantic region and includes a Keynote Opening Speaker, and two panels to discuss topics of importance to individuals planning or managing clinical trials. All attendees also have opportunities interact on the platform.
Virtual Event
Date: Friday November 20, 2020
Time: 8:30 AM - 12:00 PM
Who Should Attend:
· Individuals interested in becoming involved in a strategic partnership with a CRO or CMO in the next 12 to 18 months
· Biotech, pharma, medical device or diagnostic companies planning a clinical trial
· Individuals who have secured a CRO and CMO and the relationship has not been successful
AGENDA (Subject to Change):
8:30 AM: Welcome: Chris Molineaux, LSPA welcomes Executive Champion from West Pharmaceutical Services, Cindy Reiss-Clark, SVP Market Units and Commercial Solutions
8:45 AM - 9:15 AM: Opening Keynote: Understanding Vaccines and the landscape of COVID-19 Clinical Trials
*Keynote Speaker, Paul Duprex, PhD, Director, Center for Vaccine Research, Professor of Microbiology and Molecular Genetics, University of Pittsburgh
9:15 AM - 9:30 AM: Break, Networking available on Zoom
9:30 AM: Panel Discussion: Hot Legal Topics for Clinical Trials Today
- Clinical Trial-Related Injuries
- Updates to common rule/informed consent
- Broad consent for future research using blood and other biospecimens obtained in clinical trials: Don’t miss out on this opportunity
- Subject injury language in clinical trial agreements: How to avoid violating the Medicare Secondary Payer Act
- Section 111 reporting obligations in clinical trials: Civil money penalties are coming
- Clinical Trial Support and the Anti-kickback Statute
- How to get comparator drug for clinical trials when competitors won’t cooperate
- Implications of upcoming changes to the Sunshine Act reporting requirements
*Confirmed Speakers: Judy O'Grady, Partner and Ronni Fuchs, Partner, Troutman Pepper
10:15 AM - 10:30 AM - Break, Networking available on Zoom
10:30 AM - 11:30 AM: Panel Discussion: Strategy for Planning and Executing Clinical Trials – Looking Forward and Ensuring Business Continuity
- Managing disruption – shifting the size, duration and number of endpoints
- Protocol considerations: design and implementation for smaller and niche populations
- COVID-19 influence on patients, on-going studies, sites, visits.
- Data collection considerations for decentralized or partially-decentralized studies.
*Confirmed panelists: Takashi Asahi, Corporate Officer, Division Head of Project Management at CMIC Group; Fran DeGrazio, Chief Scientific Officer, West Pharmaceutical Services; JeanMarie Markham, CEO, Clinlogix and Earl Sands, MD, SVP and Senior Medical Officer, Parexel; Kristine Koontz, Head US Clinical Operations, GSK
11:30 AM – 12:00 PM: Post Event Networking for all Attendees, on Zoom
