Toggle Mobile Navigation

Game-Changers for Expedited Drug Development at the Innovative Regulatory Pathways Summit

The Innovative Regulatory Pathways Summit, taking place January 29–30 in Arlington, VA, is the only regulatory affairs conference dedicated to global strategies for expediting drug development.

Download our brochure here to review the sessions dedicated to how breakthrough therapy designations fit into global development pipelines.

Receiving a breakthrough therapy designation has a huge impact on clinical development, which is why Joseph A. Sliman, M.D., MPHChief Medical Officer, at Synthetic Biologics, will discuss the implications of receiving a breakthrough therapy designation on clinical trial design for narrow populations.
A manufacturing plan that is harmonized with expedited clinical develop is essential for sponsors who seek breakthrough therapy designations, which is why Usha Ramesh, Ph.D., PMPExecutive Director, Regulatory Affairs, CMC, at Pharmacyclics, will share strategies to coordinate manufacturing readiness plans with accelerated drug development.
This conference will also feature presentations dedicated to Sakigake and EMA expedited programs. Review the full agenda here.
Innovative Regulatory Pathways Summit

Get Involved!

If you would like to learn more about presentation sponsorship or exhibition opportunities, contact David Finkel, Business Development Manager, at 917-242-3898, or dfinkel@exlevents.com.

For all other inquiries, contact Dario Cavaliere, Conference Production Director, at 917-258-5254 or dcavaliere@exlevents.com.
We look forward to meeting you in Arlington this January!

Breakthrough therapy designations and other expedited pathways encourage sponsors to increase communication and collaboration with the FDA, to enable efficient drug development. Accelerated drug development options are also available globally in ICH countries through programs like PRIME and Sakigake. Understanding how to best utilize these regulatory options is imperative to make an informed decision about the best ways to accelerate drug development.

ExL’s Innovative Regulatory Pathways Summit will bring together leading regulatory experts and thought leaders to discuss breakthrough therapy designations, accelerated approvals, and global regulatory strategies to expedite review/approval of drugs that have promise in treating serious or life-threatening conditions.

posted in ExL Events News

live chat software