A Master Introduction to Developing Cell and Gene Therapies
Jun 
30
 | 
10:30am
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Nilesh Kumar

Partner, Novo Ventures

As Global Head of Johnson & Johnson Innovation, JLABS (JLABS), Melinda Richter fosters the Johnson & Johnson Family of Companies external R&D engine and supports the innovation community by creating capital-efficient commercialization models that give early stage companies a big company advantage.

9:30am–10:00am

Registration Opens, Networking & Introductions

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June 
05
, 
2020
 | 
7:00PM 
EDT
Date TBD

September 17, 2020

A Master Introduction to Developing Cell and Gene Therapies

[WEBINAR AVAILABLE ON-DEMAND]

A Master Introduction to Developing Cell and Gene Therapies
10:00AM
–
12:30PM 
EDT

7:00AM - 9:00 AM PST

3:00PM - 5:00 PM CEST

Overview

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


Source: https://www.cellandgene.com/doc/how-are-cell-and-gene-therapies-changing-drug-development-models-0001


*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.

Companies must have applied for a one-on-one meeting ahead of time and been approved. Applications are due June 11th, 2018.

Agenda

9:30am–10:00am

10:00AM Introduction by JLABS

10:30am–11:00am

10:05AM Presentations

11:00am–11:30am

10:45AM Q&A

9:30am–10:00am

10:55AM Break

9:30am–10:00am

11:00AM Presentations

9:30am–10:00am

11:40AM Q&A

9:30am–10:00am

12:00PM End of Broadcast

Speakers

Snehal Naik

Associate Director, Global Regulatory Affairs Janssen R&D

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 Bhatia

Scientific Director of Cell Technology

Janssen R&D

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 A. Tsokas

Regulatory Head of Regenerative Medicine & Advanced Therapy

Janssen R&D

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 Lynch

Scientific Director, Nonclinical Safety

Janssen R&D

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.

Event Partners

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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

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