Virginia Beakes-Read
Executive Director, Global Regulatory Policy and Intelligence, Global Regulatory Affairs
Tell us about yourself:
I was born in Germany to a military family, then grew up in many locations throughout the US. I later joined the military and continued to work and live in different places abroad and in the US. I enjoy traveling and meeting new people, exercising, and spending time with family and friends.
Tell us what a day is like in your field:
All days are different, but what they have in common is that something always changes. There are meetings, calls, and projects to work on, but then something happens that is unexpected. That’s always the fun part for me – I like the challenges related to dealing with the unexpected.
Tell us what you like about working at your company:
Our mission is human health care, and we live by that. We are required to spend time and work with patients every year to better understand the people we are serving. That truly motivates me and the terrific people I work with.
Tell us what you would change in the industry:
I’d like to see better communication between industry and regulators. So many of the issues we face could be resolved with a better understanding, and increased trust, between industry and regulators. We also need to improve our communication with the public and find better ways to share information and understanding about innovation and value.
Give us one best practice tip:
If you have a drug with abuse potential, do a good job with your abuse liability studies and then present the information in a complete manner in your NDA. Once the NDA has been submitted, be persistent in your attempts to communicate and engage with FDA about the CSS assessment, and then with the DEA when the HHS recommendation has been sent to that agency. Most importantly, look for opportunities to advocate for reform of the current system, with the goal of allowing patients prompt access to important newly approved therapeutic options.
When: Thursday, January 16 to Friday, January 17, 2014
Where: The Washington Plaza Hotel, Washington DC
To Learn More, Visit: www.americanconference.com/controlledsubstances