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Virtual Event

May 06, 2020 10:00 AM - May 07, 2020 4:45 PM

(Eastern Standard Time)

Fort Washington, PA 19034

Medical Affairs and Scientific Communications Forum

Breakthrough Designation and Expedited Approvals

Session Chair(s)

Lisa  Ambrosini Vadola, PhD, MA

Lisa Ambrosini Vadola, PhD, MA

Manager, Medical Writing

Whitsell Innovations, Inc., United States

FDA offers several expedited approval programs to facilitate rapid and effective review of New Drug Applications for therapies treating serious medical conditions that represent an unmet need. Introduced in 2013, Breakthrough Therapy Designation (BTD) is the most recent addition to FDA’s expedited approval pathways and has since been highly sought after by sponsors for therapies across a variety of serious conditions. In this session, we will present an overview of BTD and other expedited approval pathways and you will learn best practices for crafting successful applications for these designations.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Define FDA’s expedited approval pathways and their application
  • Recognize the requirements in a BTD application
  • Employ medical writing best practices in the drafting of a BTD application

Speaker(s)

Lima  Chutkan, PhD, RAC

Speaker

Lima Chutkan, PhD, RAC

Alnylam Pharmaceuticals, United States

Associate Director, Medical Writing

Karen  Moretti, MS, MSc, RAC

Speaker

Karen Moretti, MS, MSc, RAC

Pfizer, United States

Oncology Therapeutic Area Lead, Medical Writing Submissions

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