Events and Networking

Expand Your Network at One of Biocom’s 150+ Annual Events

Breakfast with Biocom: 2017 Regulatory Reflections

When:

Thu Jan 25 15:00:00 GMT 2018 - Thu Jan 25 17:00:00 GMT 2018

Where:

The Alexandria
10996 Torreyana Road
San Diego, CA 92121

Register

Sponsor: 
User-added image


2017 Regulatory Reflections
How the Industry was Altered & Whats in Store for 2018

Moderator:
Lisa Haile

Partner at DLA Piper 

Panelists:
Joe Lamendola, Ph.D.

Former VP, US Regulatory Affairs at BMS
Current, SVP BioPharma Practice at YourEncore

Minnie Baylor-Henry, J.D.
Former Board Member & Worldwide VP, Regulatory Affairs, Medical Devices at Johnson & Johnson
Current, Head of MDD Practice at YourEncore


2017 ushered in a period of unique opportunities and challenges for FDA.  In addition to the new targets put in place through the User Fee goals for both pharmaceuticals and medical devices, FDA was presented  new goals through the enactment of 21st Century Cures.  Shortly after the active implementation of 21st Century Cures, the Center for Drug Evaluation & Research (CDER) and the Center for Device Evaluation & Research (CDRH) , along with the rest of the agency, welcomed Dr. Scott Gottlieb.  Dr. Gottlieb returned to FDA with the unique  advantage of having served at the agency during Dr. Mark McClellan's administration.  Dr. Gottlieb was therefore able to "hit the ground running." He indicated that the implementation of the Cures Act would be integrated into the broader agency efforts.  To this end, the Commissioner led the development of a work plan that lays out extensive implementation targets.  Within CDER, the new Oncology Center of Excellence was created; minimal risk clinical investigations was examined; a framework for regenerative medicine was created; and patient focused drug development was addressed.  In the medical devices area, there was a serious focus on digital health, as well as the creation of a breakthrough devices program.  Innovation has become the focal point for medical devices that continuously imagine a world that connects payers, patients and providers in a new way.

2018 promises to bring even more exciting changes.  The question of drug pricing and the role of generics will be a priority.  Within devices, the continued focus on pragmatic ways to evaluate the reasonable regulation of digital health devices is a priority.  The patient will continue to be at the center of most decisions, thus, allowing for greater consideration of real world evidence.  These innovative solutions will include countermeasures and cybersecurity devices that will tackle the ever increasing threats.


About the Series: Breakfast with Biocom
Formerly the Biocom Breakfast Meeting, Breakfast with Biocom has been a flagship tradition within the San Diego life sciences community for over 20 years. 100+ attendees, including Biocom Board Members, life science executives, leading scientists, innovators and thought leaders among the industry, gather each quarter with their sights set on business development and learning opportunities. Whether you are seeking a mentor, want to learn more about the industry you work in, or if you simply want to connect with old friends and colleagues, this is your ideal forum. These events are great for folks new to the industry and seasoned pros alike, and is intended to help foster the growth of the life sciences community.   
 
This event series, Breakfast with Biocom, focuses on one hour of pure networking, followed by a robust program that delivers thought provoking content and addresses issues that are relevant to the growth and well-being of the life science sector, including economic trends, financing, technology, education and workforce issues. We attract high-caliber, world-class speakers from across the nation. As we continue our growth along the coast of California, we will continue to expand these efforts to Orange County, Los Angeles, and the Bay Area. Register today and don’t miss out on the perfect opportunity to connect, learn and grow in this industry.
 
This series is open to any Biocom members, as well as any industry company that is not yet a member of Biocom. These events are only closed to non-member service provider companies.

Price of Admission

Member

Today's Price: 45.0

Important Dates

Amount

Registration Before

Registration Before

Registration Before

Refund after Wed Jan 24 00:00:00 GMT 2018

45.0

Refund after

Refund after

Non-Member

Today's Price: 85.0

Important Dates

Amount

Registration Before

Registration Before

Registration Before

Refund after Wed Jan 24 00:00:00 GMT 2018

85.0

Refund after

Refund after

Early Bird-Member

Today's Price: 35.0

Important Dates

Amount

Registration Before

Registration Before

Registration Before

Refund after Wed Jan 24 00:00:00 GMT 2018

35.0

Refund after

Refund after

Early Bird-Non-Member

Today's Price: 75.0

Important Dates

Amount

Registration Before

Registration Before

Registration Before

Refund after Wed Jan 24 00:00:00 GMT 2018

75.0

Refund after

Refund after

 

Register