CELL & GENE THERAPY WORLD CONGRESS 2023 EUROPE
"Realising the promises of next generation therapies"
Day 1 - Monday 3rd July 2023
- Complex challenges and key considerations for cell & gene therapy development
- Pre-clinical solutions to address scientific, regulatory, and commercial risks to accelerate development
- How to maximize the potential and simplify the transition from basic cell therapy research to clinical manufacturing and beyond
- Current trends and innovations to advance cell & gene therapies
Panelist:
Zhimei Du, MD/PhD, VP of Process Sciences, Atara Biotherapeutics
Wenliang Dong, Chief Operating Officer, ORCA Therapeutics
OVERVIEW, CURRENT LANDSCAPE & FUTURE TRENDS
- Complex challenges and key considerations for cell & gene therapy development
- Pre-clinical solutions to address scientific, regulatory, and commercial risks to accelerate
development - How to maximize the potential and simplify the transition from basic cell therapy research to clinical
manufacturing and beyond - Current trends and innovations to advance cell & gene therapies
PANELIST: Wenliang Dong, Chief Operating Officer, ORCA Therapeutics B.V.
- Setting the scene: comparison of rare disease/CGT and traditional pharma
- The importance of stakeholder engagement: perspectives across different functions
- Creating a CGT platform: stakeholder engagement as a tool to support not only the
development/commercialization of specific assets, but to build a sustainable platform
Marianthi Psaha, Global Head Cell & Gene Therapy, Santen Pharmaceutical
- Challenges and obstacles in bringing this highly complex therapies to market
- Stakeholder collaboration on the road towards a solution
- Lessons learned and applications for new entrants
- Strategies that can be taken to improve timely market access and access for patients
Doug Danison, Head of Commercial, Cell and Gene Therapy Unit, Bayer
- Standardized approaches being developed to address complexity of trial design and lack of
experience with CGT trials - Considerations to overcome constraints in manufacturing capacity
- Strategies and best practices in facilitating patient recruitment and retention in CGT clinical trials
Amir Hefni, Global Head, Cell & Gene Therapy, Novartis
Zhimei Du, VP, Process Sciences, Atara Biotherapeutics
- PDC*line is a new potent and scalable therapeutic cancer vaccines based on a proprietary allogeneic
cell line of Plasmacytoid Dendritic Cells - PDC*line is much more potent to prime and boost antitumor antigen, including neoantigens, specific
cytotoxic T-cells than conventional vaccines and improves the response to checkpoint inhibitors - The technology can be applied for any cancer
Eric Halioua, President & Chief Executive Officer, PDC*line Pharma
- Introduce the development of novel gene therapies
- Introduce pivotal non-clinical studies
- Discuss the relevant non-clinical considerations within the context of a case study of a novel gene
therapy
Mark Singh, Non-Clinical Manager, Cell and Gene Therapy Catapult
- Leveraging success of gene therapy pioneers to enable accelerated development
- Front-loading manufacturing investment to reduce clinical trial timelines
- Bloomsbury Genetic Therapies case study: building a de-risked portfolio for maximal clinical
translation and approvability
Adrien Lemoine, Co-Founder & CEO, Bloomsbury Genetic Therapies
- Present innovative approaches for flexible Cell Therapy facility design solutions.
- Provide an overview of the latest Cell Therapy manufacturing technologies.
- Outline the benefits of implementing robust methods of process closure in the manufacturing
operations. - Discuss sustainability factors associated with the design of modern manufacturing facilities.
- Outline how all these factors can increase speed to market while reducing the environmental footprint
of a facility.
Stephen Judd, Process SME – Biologics / Cell & Gene Therapy, DPS Group
Anthony Newcomb, Chief Operating Officer, VectorY
- Current GMP and general process validation concepts and practices that applies to CGT manufacturing
processes and analytical methods - Key challenges in analytical method validation and proposed solutions.
- Extensive regulatory requirements for a controlled validation
- Robust CMC package that creates a path toward commercialization
- Vigorous process validation strategy through the life cycle of these novel therapies