The drug development landscape has witnessed a broadening of targets and indications, the emergence of promising new classes of therapeutics, but also an evolving regulatory framework. This symposium will present current and novel drug safety testing approaches and the underlying regulatory toxicology strategies. The sessions cover the full spectrum from early discovery to late stage investigations and across a wide range of portfolios but all focused on non-clinical drug safety testing. From de-risking panels to regulatory filing and from clinical hold lifting approaches to case studies, this symposium will engage dynamic yet pragmatic discussion on real-life drug safety testing challenges!
PRELIMINARY AGENDA
- 09:30 am – 10:00 am : Welcome coffee
- 11:05 am – 11:20 am : Break
- 12:00 pm – 01:15 pm : Lunch
- 02:35 pm – 02:50 pm : Break
- 04:00 pm – 05:30 pm : Cocktails
Please note that this complimentary event is by invitation only, and includes lunch, refreshment breaks and afternoon cocktails.
SELECTED SPEAKERS
Monika Chabicovsky, PhD, MC Toxicology Consulting GmbH :
»Toxicity and Safety Testing with CRISPR/Cas-Based Therapeutics »
Denis Roy, PhD, SciLucent, LLC :
»Nonclinical Regulatory Hurdles and Challenges in Developing Cell and Gene Therapies’‘
David J. Pepperl, PhD, Biologics Consulting :
»Challenges and Strategies in Nonclinical Evaluation of Novel Cancer Immunotherapies »
Guillaume Ravel, PharmD, PhD, Sanofi Pasteur :
»Nonclinical Safety Considerations for the Development of Anti-infectious Vaccines and Monoclonal antibodies »
HOTEL INFORMATION
DoubleTree Suites by Hilton Boston – Cambridge
Address: 400 Soldiers Field Rd, Boston, MA 02134, USA
Phone: +1 617-783-0090