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Bay Area Medical Device Lunch-n-Learn

 
When:
Tuesday, July 25 2017 - Tuesday, July 25 2017
11:30 AM - 1:30 PM

Add to Calendar America/Los_Angeles Bay Area Medical Device Lunch-n-Learn 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.  Biocom false MM/DD/YYYY

Where:
Ohlone College: Center for Health Sciences and Technology
39399 Cherry St., Room #NC2106
Newark, CA 94560
Registration Deadline:
Monday, July 24 2017
12:00 PM
Register


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. 

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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.

Agenda
11:30am to 12:00pm | Registration & Networking
12:00pm to 1:00pm | Minnie Baylor-Henry Presentation
1:00pm to 1:30pm | Networking


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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.

About The City of Fremont’s Office of Economic Development
The City of Fremont’s Office of Economic Development provides assistance to locate and grow businesses in Fremont, CA. They market the City as a quality place in which to live and do business, sponsor a variety of workshops to help Fremont business grow and work with state and regional organizations, along with existing Fremont firms with international ties, to strengthen Fremont’s position in the global economy.


About The Biomedical Manufacturing Network
The Biomedical Manufacturing Network is convened by a partnership of regional entities focused on building a biomedical manufacturing network for business assistance, technology transfer, education and training, and economic development.

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