Carrie-Lynn Langlais Furr, PhD, RAC
Regulatory Affairs
Carrie's major accomplishments over ~15 years include regulatory and scientific input into multiple drug/biologic development programs leading to 7 FDA market approvals, 8 INDs, successful formal regulatory authority interactions and negotiations, 2 international Expanded Access programs, GMP facility oversight, detailed integrated development plans, and many other strategic, operational, and administrative activities in between. Development plans featured in non-dilutive funding applications have secured multi-millions of dollars to advance novel therapies to the clinic.
Carrie has worked collaboratively with over 30 pharma companies at various stages of development and for a broad range of indications. At the CRO Rho, she held leadership and operational roles in regulatory affairs, program management, and medical writing. As Sr Director of Operations, Carrie managed project resourcing and the performance of ~100 colleagues. She began her career as an Integrated Product Development Associate and advanced to Sr Regulatory Affairs Specialist at PPD. Before cofounding Bacteriophage & Drug Development Consultants, LLC (BDDC), she was VP Regulatory Affairs and Program Management for AmpliPhi Biosciences (now Armata Pharmaceuticals), a public, clinical-stage biotech developing novel phage therapies to treat bacterial infections, including AMR/MDR forms. Since launching BDDC, she’s consulted for foreign and domestic drug and biologic companies, became a scientific advisor for CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator; a global non-profit partnership; non-dilutive funding) and an editor of the peer-reviewed, scientific journal PHAGE Therapy, Applications, and Research. Carrie earned a PhD from Texas A&M University Dept Biochemistry and Biophysics elucidating the antibiotic mechanism of bacteriophages.