Cell and gene therapies have the potential to be one of the most important advances in effectively treating and controlling disease. While the number of patients receiving cell and gene therapy is quite small compared to other therapeutics, many researchers and manufacturers have started investigating its effects on small populations. There is a lot to consider when creating a study in this area – from study design to regulatory hurdles.
Join us on September 17 for a workshop that will cover tips and tricks that may be critical to achieving long-term success in developing cell & gene therapy.
This workshop will cover:
· Product development
· Pre-clinical and toxicology considerations
· Manufacturing and CMC considerations
· Regulatory Framework and Interactions
*This program is a product of a collaboration between Johnson & Johnson Innovation – JLABS (JLABS) and the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
Snehal brings a confluence of early discovery, innovation and scientific expertise to her current role of Associate Director, gene therapy policy lead and North America regulatory liaison supporting cell and gene therapies, CAR-T and microbiome at Janssen. Beyond her role in regulatory affairs, she is founder and lead of a cross-sector gene therapy workstream, and serves on Janssen’s R&D gene therapy steering committee.
Ravi is a Scientific Director of Cell Technology department at Janssen R&D, where he is leading a process development team to develop and scale-up cell therapy, and viral vaccines based products. Previously at Janssen R&D, Ravi led a team to develop and implement industry’s first large-scale single-use bioreactor (1000L) and a single-use fluidized bed centrifuge technology for biopharmaceutical manufacturing.
Katherine is the Janssen Regulatory Head of Regenerative Medicine & Advanced Therapy (RMAT). In this role, she ensures global regulatory policy strategies contribute to and support development plans for RMAT products across several therapeutic areas and facilitates J&J enterprise wide efforts to enhance awareness and connectivity for the development of processes that enable assessing, partnering, and developing safe and effective advanced therapies globally.
Jessica is a Scientific Director in the Nonclinical Safety group within Janssen R&D, responsible for developing and executing the nonclinical safety strategy and providing toxicology expertise to Project Teams. Currently Jessica is supporting programs across multiple therapeutic areas including immuno-oncology agents, cell and gene therapies and microbiome based products along with managing a group of nonclinical safety leaders.
Johnson & Johnson Innovation – JLABS Notice
The views expressed during this event, including during any associated networking and/or individual meetings by anyone other than an employee of Johnson & Johnson Innovation LLC, its parent company or any affiliate companies (herein after referred to as “JJI”) are those of the speakers or experts alone, and such experts or speakers are solely responsible for the information and opinions expressed by them. By hosting this event, the presentations and any associated networking and/or individual meetings, JJI does not endorse the views of the speakers, experts or the attendees, and JJI makes no warranties, express or implied, as to the content, the views, advice or the information
