Events and Networking

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

Los Angeles Medical Device Lunch-n-Learn


Wed Jul 26 18:30:00 GMT 2017 - Wed Jul 26 20:00:00 GMT 2017


The Dr. Dianne G. Van Hook University Center
26455 Rockwell Canyon Road
Santa Clarita, 91355


Combination Products: Is It a Drug, or Is It a Device?
As more companies develop combination products, it is critical to understand the regulatory interface between biopharmaceuticals and medical devices/diagnostics when planning for product development and market entry.  Strategic plans can be greatly impacted by the lack of clarity regarding the primary mode of action.  Minnie Baylor-Henry will share insights as to how best to navigate the regulatory landscape of these combination products and prepare for a pathway to success.

Minnie V. Baylor-Henry is an Executive Partner and the Medical Devices & Diagnostics Practice Leader at YourEncore, a consulting firm providing expertise to the medical device, diagnostics and other industries. Prior to assuming her current role, Ms. Baylor-Henry was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business (2011-2015), which is one of the largest and most diverse medical devices businesses in the world. She was directly responsible for coordinating the regulatory strategy for the approval of a wide portfolio of products globally, ranging from contact lens to sterilization products.  
Before returning to J&J in January 2011, Ms. Baylor-Henry was a National Director for Regulatory & Capital Markets Consulting at Deloitte & Touche, with a successful practice that focused on regulatory life sciences.  From 1999-2008, she worked in many executive leadership roles at J&J in the Pharmaceutical and Consumer businesses, including serving as J&J’s Vice President for Medical & Regulatory Affairs for the over-the-counter drugs business that included iconic brands such as Tylenol and Motrin. 
Prior to joining J&J, Ms. Baylor-Henry worked for the US Food & Drug Administration (FDA) where she served in many roles, most notably, FDA’s National Health Fraud Coordinator and the Director of the Division of Drug Marketing, Advertising, and Communications.  
Ms. Baylor-Henry is recognized as a leader in the area of food & drug laws and regulations. She previously served as the Board Chair for the Food and Drug Law Institute (FDLI), as well as the President and Chair of the Board for the Drug Information Association (DIA), a 50 year old global organization with over 20,000 members. Currently, Ms. Baylor-Henry serves on the Board of Directors for The Partnership and the American Society of Health-System Pharmacists Foundation, as well as the Board of Visitors for Howard University’s College of Pharmacy. Ms. Baylor-Henry is a frequent speaker on food & drug law topics and has received numerous awards and recognitions in this area.
Ms. Baylor-Henry received her Pharmacy degree from Howard University’s College of Pharmacy and her law degree from Catholic University’s Columbus School of Law.

11:30 | Registration
11:30am to 12:00pm | Networking (Lunch Provided)  
12:00pm to 1:00pm | Minnie Baylor-Henry Presentation & Q&A
The Dr. Dianne G. Van Hook University Center - Room 301
26455 Rockwell Canyon Road
Santa Clarita, CA 91355

Parking Info:
The building is on the College of the Canyon’s Valencia Campus located off of University Center Drive (off of Rockwell Canyon). Parking is available in lot 14. We will send out parking passes upon confirmation of attendance.

About YourEncore
YourEncore is a leading provider of proven expertise, delivering flexible resourcing and consulting services to the medical devices & diagnostics, biopharma, and consumer goods industries. YourEncore mobilizes the wisdom and knowledge of highly experienced, immediately effective experts to help companies outthink, outpace, and outperform. YourEncore was named a "100 Most Brilliant Company" by Entrepreneur Magazine.

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Combination Products: Is It a Drug, or Is It a Device?

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