september, 2015

17sep7:30 am11:00 amSpeed Filing of an NDA: Strategies and Challenges


Event Details

Introducing the Insight Series Inaugural breakfast meeting sponsored by BioBridges and CenterWatch focusing on the ‘Speed Filing of an NDA: Strategies and Challenges.’

The 3 ½ hour breakfast meeting provides an opportunity to network with fellow industry colleagues and hear from experts in each functional area involved in an NDA Filing—regulatory, clinical operations, biostatistics, and medical writing—on their experiences, strategies implemented, the challenges encountered and addressed, and key lessons learned.  Case studies will also be shared.

Breakfast Meeting Details:

  • Thursday, September 17, 2015
  • 7:30-8:00am – Breakfast and Networking
  • 8:00-10:30am – Presentations, Interactive Discussion, and Q&A
  • 10:30-11:00am – Closing Comments and Networking
  • Venue: Hotel Marlowe, Cambridge MA


  • Nicole D’Auteuil, SVP of Regulatory at Dyax Corporation
  • Ross Pettit, SVP Development Operations at Infinity Pharmaceuticals
  • Katherine Kacena, Principal Statistical Consultant at BioBridges
  • Jenny Thayer, Principal Medical Writing Consultant at BioBridges
Have questions about Speed Filing of an NDA: Strategies and Challenges?Contact BioBridges and CenterWatch


(Thursday) 7:30 am - 11:00 am


Hotel Marlowe

25 Edwin H. Land Blvd. Cambridge, MA 02141