CGTP Summit: Comparability Assessment Strategies for Cell & Gene Therapy Products
Comparability assessments are conducted to ensure that manufacturing changes do not adversely affect the product in terms of quality, safety, or efficacy. Demonstration of product comparability is generally based on a combination of analytical testing and biological assays at the product release and characterization levels, as well as at the process performance level, and can involve nonclinical and/or clinical data. The extent of a comparability assessment also depends on the phase of product development. The overarching principles for evaluating comparability of biological products are described in ICH Q5E and, while these principles are generally applicable to cell and gene therapies, there are unique challenges posed by this diverse and complex class of medicinal products. In this summit, we will discuss comparability strategies that address the unique challenges posed by cell and gene therapy products. Examples for viral vector-based gene therapies and cellular therapies will be presented.
The CGTP Summit will bring together industry, regulatory and academic professionals to discuss pertinent challenges in the cell and gene therapy field. This one-day meeting will have an open format with deep-dive discussions. The CGTP Summit will debut in 2023 as an extension to the Cell and Gene Therapy Symposium dedicated to the topic of comparability. The Summit will be offered in-person as well as live streamed to a virtual audience.
CGTP Summit Chair - Kathy Francissen
All presentations and exhibitions will be held at the Bethesda North Marriott Hotel & Conference Center in Rockville, MD, USA. Summit registration includes all sessions on June 26, 2023, continental breakfast, networking lunch, networking breaks and networking reception as well as access to the CGTP Summit Live Stream and access to the online schedule which features the final program, abstracts, and presenters' slides. In-person registration will close Monday, June 12, 2023.
Virtual registration includes a live streaming broadcast of all talks and panel discussions as well as access to the online schedule which features the final program, abstracts, and presenters' slides. Virtual registration will close Thursday, June 22, 2023.
Come for the Summit, Stay for the Symposium! Register for both at the same time and save 10% on registration fees!* Promo code = CGTP23_10SUMMIT
New to CASSS? First-time attendees are eligible to receive a 23% discount on registration.** Promo code = NewIn23
Contact Program Manager Randi Jacobs for more information on the available registration rate promotions.
*This promo is available for in-person registrations only. In order to qualify for this promotion, you must register for both the Symposium and Summit in one transaction. You will not be eligible
for the promotion if you register in separate transactions.
**This can be used for the Summit or Symposium.
CASSS is committed to protecting its attendees, participants, and staff members to the highest degree possible when attending our conferences. To ensure we provide a safe environment, CASSS strongly encourages COVID-19 vaccinations, and all other routine vaccinations to protect you from infectious diseases, serious illness, and hospitalization. CASSS will follow guidances established by the facility hosting the conference and/or local and state health authorities in which the conference is located.
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Rockville, MD, USA 20852
Telephone: (301) 822-9200
Website: Bethesda North Marriott Hotel & Conference Center
Join us at the Bethesda North Marriott Hotel & Conference Center in Rockville, MD, USA for CGTP Summit 2023! Conveniently situated across from the vibrant sights, sounds and tastes of Pike & Rose and steps away from the North Bethesda Metro Station, the Bethesda North Marriott Hotel & Conference Center offers a hotel that appeals to all. The hotel features sophisticated guest rooms, oversized flat-screen TV’s, spa-like bathrooms, and a modern fitness center.
A room block is reserved for summit delegates at the special group rate of $254 USD for a single or double room (plus 13% occupancy tax). The deadline to reserve your accommodations is Friday, June 9, 2023. The Bethesda North Marriott & Hotel Conference Center requires a credit card to guarantee your reservation. In the event of a cancellation, the hotel requires 72 hours’ notice to receive a full refund.
After Friday, June 9, 2023, reservations will be accepted on a space and rate availability basis. We recommend that attendees book their hotel accommodations well before the deadline to secure this rate.
NOTE: Check-in time is 4:00pm and check-out time is 12:00pm.
U.S. Federal Government Rates
A limited number of U.S. Federal Government rate rooms are available to book online on a first-come, first-serve basis.
NOTE: By staying at the host hotel, you help CASSS meet its contractual obligations and keep future registration fees reasonable. Please take this into consideration when making your accommodation decisions.
Past Event Videos
Cell and Gene Therapy: Sharing Knowledge Between Industry, Academia and Regulators
Cell & Gene Therapy Products 2022 Keynote: Peter Marks, CBER, FDA
Cell & Gene Therapy Products 2020 Keynote: Simon Frost - Action Potential: A Parent’s Perspective
Become Part of Our Community: Ken Miller Shares His CASSS Experience