Program Overview:
Second to funding, navigating the regulatory process can be the most challenging aspect of running your start-up. This session will help you pinpoint the information you need to develop a regulatory roadmap, and then hit the ground running. You will learn what healthcare startups need to know about regulatory affairs and how to locate the information. This \’how to\’ workshop is geared towards pharmaceutical, biotech, and medical device start-ups.

Key topics will include:
– Common regulatory questions and challenges in early development
– Publicly available info
– Evaluating consultants
– Hiring your first Regulatory FTE

The workshop will feature Kathleen Gibbon, Director of Global Regulatory Affairs with Janssen Research & Development. Kathleen has over 20 years of industry experience and has held leadership positions at companies ranging from start-up biotechnology organizations to Fortune 500 healthcare corporations.

The \’How to… Workshop\’ series is dedicated to giving you the keys to a successful business, from creation to exit. As with all our events, the \’How to… Workshop\’ is interactive and informal so bring your questions with you!

Agenda:
11:30am | Registration, Networking and Lunch
12:00pm | Presentation
12:30pm | Q&A
1:00pm | Close

Speaker:
Kathleen H. Gibbon, Director, Global Regulatory Affairs, Janssen Research & Development, LLC
Kathleen Gibbon is a Director of Global Regulatory Affairs at Janssen Research & Development, (a division of Johnson & Johnson), a position she has held since 2008. She has over 20 years of industry experience – 16 of those in Regulatory Affairs. Kathleen has held leadership positions at companies ranging from start-up biotechnology organizations to Fortune 500 healthcare corporations. She has contributed to the development of investigational and marketed drugs, vaccines, and medical devices. Her particular expertise is in the early development of small molecule compounds. Kathleen obtained her Bachelor’s degree in Physiology from U.C. Berkeley.
Connect with Kathleen:

Fees:
$35 General Public
$20 Student/Academic
$45 Onsite

Location:
JLABS @LabCentral
700 Main St
Cambridge, MA 02139