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2020-01: Limited Population Pathway
Thursday, January 16, 2020, 5:30 PM - 8:00 PM EST
Category: Events

Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD)

 

Speaker:  Carrie-Lynn Langlais Furr

Co-Founder Bacteriophage & Drug Development Consultants, LLC

 

REGISTER

 

Thursday, January 16th

 6:30 - 7:30 Presentation

 

WEBEX ONLY!!

The webex information will be in your registration confirmation email 

This presentation will focus on the US Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).  The qualifying criteria, labeling requirements, and general considerations for a product to be approved under LPAD will be introduced and discussed.  Case studies of the 2 products that have been approved under LPAD will also be reviewed.

 

After earning a PhD in Biochemistry & Biophysics from Texas A&M University, Dr. Furr has gained 13 years of drug development experience in the CRO industry (10 years) and as VP Regulatory Affairs and Program Management for a publicly-traded biotech company developing bacteriophage therapies to treat bacterial infections, including antibiotic resistant forms (3 years).  At the beginning of her career she received intense, focused training in Integrated Product Development (PPD, Inc.) and specialized in regulatory affairs.  Since then, she has collaboratively worked with over 30 pharmaceutical companies wearing many hats.  Dr. Furr has made significant contributions to and/or lead the preparation and submission of 8 INDs, 7 FDA market approvals (1 biologic-device BLA approval and 6 NDA approvals), 2 international Expanded Access programs, several formal Regulatory Authority interactions and negotiations, and many other strategic and operational activities in between.  In June 2019, she co-founded Bacteriophage & Drug Development Consultants, LLC to help advance development of drugs and bacteriophage therapeutics.  Since launching BDDC, she has become a CARB-X Scientific Advisor and an Editor of the peer-reviewed journal PHAGE, Therapy, Applications, and Research.  Dr. Furr has held RAC from RAPS since 2009 and remains an active member to date.