Event Details
Cell and Gene Therapy Regulatory Affairs Summit
The Ultimate Chance to Tackle Regulatory Challenges in the Cell and Gene Therapy Space!
With over 5,000 cell and gene therapies in pre-clinical and clinical development worldwide, regulatory clarity is crucial for developers striving for efficient and seamless approvals in their first regulatory submissions. Leading innovators are pioneering new approaches, like in vivo gene editing, rapidly pushing products from the clinic to commercialization. This rapidly evolving field is now on a mission to learn from case studies and glean insights from the forefront to optimize regulatory processes from pre-IND to approval.
Introducing the inaugural Cell and Gene Therapy Regulatory Affairs Summit in Washington D.C. This event will unite biopharma experts across non-clinical,
clinical, and CMC regulatory domains in the cell and gene therapy sector. This is a uniquely positioned platform for the community to crystallize regulations, learn from the experiences of trailblazers, and engage in conversations to unravel regulatory bottlenecks.
Full Agenda - https://ter.li/3ir9uh
Don't miss this opportunity to gain exclusive insights from industry giants such as Orchard Therapeutics, AstraZeneca, Century Therapeutics, Bristol Myers Squibb, Cytolmmune Therapeutics, Prime Medicine, Verve Therapeutics, and more, as they work collaboratively to tackle the regulatory challenges facing the cell and gene therapy community.
Book Online (group discounts of up to 20% off available) - https://ter.li/vp9h4t
URLs:
Website: https://go.evvnt.com/2504368-0?pid=10018
Tickets: https://go.evvnt.com/2504368-1?pid=10018
Brochure: https://go.evvnt.com/2504368-3?pid=10018
Prices:
Drug Developer Pricing | Conference + Workshop Day : USD 4197.00,
Drug Developer Pricing | Conference Only: USD 2999.00,
Start-Up and Academic Pricing | Conference + Workshop Day: USD 3597.00,
Start-Up and Academic Pricing | Conference Only: USD 2599.00,
Standard Pricing | Conference + Workshop Day: USD 5097.00,
Standard Pricing | Conference Only: USD 3699.00
Speakers: Annelise Brossel | Director, Regulatory Affairs and Quality Assurance | Vivet Therapeutics, Beth Mellen | Vice President, Regulatory Affairs and Quality | Voyager Therapeutics, Chris Sharpe | Vice President, Regulatory Affairs | Quell Therapeutics, David Uguen | Senior Vice President, Head of Regulatory Affairs | Orchard Therapeutics, Dayna LeSueur | Associate Director, Regulatory Affairs | Verve Therapeutics, Fubao Wang | Senior Vice President, Head of Regulatory Affairs | Prime Medicine, Jean-Philippe Combal | Chief Executive Officer | Vivet Therapeutics, Keith Wonnacott | Vice President, Regulatory Affairs | Lexeo Therapeutics, Mallory Scott | Associate Director, Regulatory, Chemistry, Manufacturing and Controls | Legend Biotech, Melody Dai | Vice President, Head of Regulatory Affairs and CMC | Novasenta, Monica Veldman | Director, Global Regulatory Policy | Alliance for Regenerative Medicine, Omer Butt | Vice President, Regulatory Affairs | CytoImmune Therapeutics, Sagi Nahum | Global Senior Director, Analytical Sciences CMC, Cell and Gene Therapy | Orgenesis, Sean Russell | Senior Vice President, Regulatory Affairs | Achilles Therapeutics, Seraphin Kuate | Director, CMC, CAR-T Cell Therapy | Bristol Myers Squibb, Shirley Bartido | Director, Global Regulatory Affairs and Cell Therapy Oncology | Takeda Pharmaceuticals, Stephanie Woodall | Vice President, Quality and Regulatory | Abata Therapeutics, Tim Taps | Senior Director, Head of Regulatory Affairs, Regulatory Strategy, and Operations | Century Therapeutics, Wade Atkins | Regulatory Affairs Specialist | National Institute of Health, Yao-Yao Zhu | Director, Global Regulatory Affairs | AstraZeneca
With over 5,000 cell and gene therapies in pre-clinical and clinical development worldwide, regulatory clarity is crucial for developers striving for efficient and seamless approvals in their first regulatory submissions. Leading innovators are pioneering new approaches, like in vivo gene editing, rapidly pushing products from the clinic to commercialization. This rapidly evolving field is now on a mission to learn from case studies and glean insights from the forefront to optimize regulatory processes from pre-IND to approval.
Introducing the inaugural Cell and Gene Therapy Regulatory Affairs Summit in Washington D.C. This event will unite biopharma experts across non-clinical,
clinical, and CMC regulatory domains in the cell and gene therapy sector. This is a uniquely positioned platform for the community to crystallize regulations, learn from the experiences of trailblazers, and engage in conversations to unravel regulatory bottlenecks.
Full Agenda - https://ter.li/3ir9uh
Don't miss this opportunity to gain exclusive insights from industry giants such as Orchard Therapeutics, AstraZeneca, Century Therapeutics, Bristol Myers Squibb, Cytolmmune Therapeutics, Prime Medicine, Verve Therapeutics, and more, as they work collaboratively to tackle the regulatory challenges facing the cell and gene therapy community.
Book Online (group discounts of up to 20% off available) - https://ter.li/vp9h4t
URLs:
Website: https://go.evvnt.com/2504368-0?pid=10018
Tickets: https://go.evvnt.com/2504368-1?pid=10018
Brochure: https://go.evvnt.com/2504368-3?pid=10018
Prices:
Drug Developer Pricing | Conference + Workshop Day : USD 4197.00,
Drug Developer Pricing | Conference Only: USD 2999.00,
Start-Up and Academic Pricing | Conference + Workshop Day: USD 3597.00,
Start-Up and Academic Pricing | Conference Only: USD 2599.00,
Standard Pricing | Conference + Workshop Day: USD 5097.00,
Standard Pricing | Conference Only: USD 3699.00
Speakers: Annelise Brossel | Director, Regulatory Affairs and Quality Assurance | Vivet Therapeutics, Beth Mellen | Vice President, Regulatory Affairs and Quality | Voyager Therapeutics, Chris Sharpe | Vice President, Regulatory Affairs | Quell Therapeutics, David Uguen | Senior Vice President, Head of Regulatory Affairs | Orchard Therapeutics, Dayna LeSueur | Associate Director, Regulatory Affairs | Verve Therapeutics, Fubao Wang | Senior Vice President, Head of Regulatory Affairs | Prime Medicine, Jean-Philippe Combal | Chief Executive Officer | Vivet Therapeutics, Keith Wonnacott | Vice President, Regulatory Affairs | Lexeo Therapeutics, Mallory Scott | Associate Director, Regulatory, Chemistry, Manufacturing and Controls | Legend Biotech, Melody Dai | Vice President, Head of Regulatory Affairs and CMC | Novasenta, Monica Veldman | Director, Global Regulatory Policy | Alliance for Regenerative Medicine, Omer Butt | Vice President, Regulatory Affairs | CytoImmune Therapeutics, Sagi Nahum | Global Senior Director, Analytical Sciences CMC, Cell and Gene Therapy | Orgenesis, Sean Russell | Senior Vice President, Regulatory Affairs | Achilles Therapeutics, Seraphin Kuate | Director, CMC, CAR-T Cell Therapy | Bristol Myers Squibb, Shirley Bartido | Director, Global Regulatory Affairs and Cell Therapy Oncology | Takeda Pharmaceuticals, Stephanie Woodall | Vice President, Quality and Regulatory | Abata Therapeutics, Tim Taps | Senior Director, Head of Regulatory Affairs, Regulatory Strategy, and Operations | Century Therapeutics, Wade Atkins | Regulatory Affairs Specialist | National Institute of Health, Yao-Yao Zhu | Director, Global Regulatory Affairs | AstraZeneca
Entry Fees
Free Registration
Categories
Event Frequency
One Time
Event Timings
(GMT-4:00) Eastern Time (US and Canada)
08:00 AM - 03:30 PM (Oct 28, Oct 29, Oct 30) (Public)
Speakers
Annelise Brossel
Director, Regulatory Affairs and Quality Assurance | Vivet Therapeutics
Beth Mellen
Vice President, Regulatory Affairs and Quality | Voyager Therapeutics
Chris Sharpe
Vice President, Regulatory Affairs | Quell Therapeutics
David Uguen
Senior Vice President, Head of Regulatory Affairs | Orchard Therapeutics
Organizer
Hanson Wade
4 Followers
Follow
Hanson Wade specialises in bringing people together through outstanding business conferences and year round community contact.
More Events By Hanson Wade
Tags
Comments on Cell and Gene Therapy Regulatory Affairs Summit
You must Login to write a comment.
Peoples Interested in Visit
0 Peoples Interested to Visit
Event Location
Washington Marriott Capitol Hill
175 L Street Northeast ,
Washington 20002, District of Columbia, United States
Washington 20002, District of Columbia, United States
Official Link :
Featured Event
Please Wait...
More Events By Organizer
20
Jul
2026
6th mRNA-Based Therapeutics Summit
Boston, United States
Free
Conferences
14
Jul
2026
4th Obesity and Weight Loss Drug Development 2026
Boston, United States
Free
Conferences
20
Jul
2026
5th Liquid Biopsy for Precision Oncology East Coast
Suffolk County, United States
Free
Conferences
22
Jul
2026
Advancing Electrical Prefabrication 2026
Dallas County, United States
Free
Conferences
28
Jul
2026
4th ADC Linker and Conjugation Summit
Boston, United States
Free
Conferences
21
Jul
2026
5th Targeted Radiopharmaceuticals Summit US On 21 Jul to ...
La Jolla, United States
Free
Conferences
Similar Events
04
Dec
2023
2nd GCP Inspection Readiness
Online
Free
Conferences
29
May
2024
4th Gene Therapy Patient Engagement Summit
Boston, United States
Free
Conferences
10
Sep
2024
5th GxP Cloud Compliance Summit
Boston, United States
Free
Conferences
07
Oct
2024
Reporting stage at Reuters Events: Sustainability USA
United States
Free
Conferences
07
May
2025
Reuters Events: The Future of Insurance Europe
Amsterdam, Netherlands
Free
Conferences
12
Jun
2025
Reuters Events: The Future of Insurance USA 2025
Chicago, United States
Free
Conferences