The path to regulatory approval starts here
Bacteriophage & Drug Development Consultants
The path to regulatory approval starts here
What We Do
All About BDDC
All About BDDC
All About BDDC
Bacteriophage and Drug Development
Consultants, LLC, is a boutique consulting firm focused on providing bench top to bedside strategic planning and management services. We leverage cross-functional experience gained from over 25 years of combined experience in the pharmaceutical, biotech, and CRO industry, along with longstanding industry
Bacteriophage and Drug Development
Consultants, LLC, is a boutique consulting firm focused on providing bench top to bedside strategic planning and management services. We leverage cross-functional experience gained from over 25 years of combined experience in the pharmaceutical, biotech, and CRO industry, along with longstanding industry relationships, to drive emerging technologies to market approval and ultimately to the patients in need. Bacteriophage & Drug Development Consultants, LLC can help by providing support ranging from gap assessments and strategies to client representation in formal dialogue with Regulatory Authorities, globally.
Our Mission
All About BDDC
All About BDDC
There is a saying, "The early bird gets the worm." In the competitive landscape of biotechnology development "first to market" holds unique benefits as well as unique challenges. The omnipresent specters of Time, Budget, and Quality ultimately form the basis for how projects or programs move forward. How companies balance this triad of f
There is a saying, "The early bird gets the worm." In the competitive landscape of biotechnology development "first to market" holds unique benefits as well as unique challenges. The omnipresent specters of Time, Budget, and Quality ultimately form the basis for how projects or programs move forward. How companies balance this triad of factors comes down to how quickly and successfully a client can balance and adapt to each variable.
To operate in the most efficient manner, in all respects, and to maximize "turning data into dollars" you need a team that can provide the line-of-sight planning, actionable recommendations (a path), and subject matter expertise to empower your team with the ability to make informed decision and move your therapy towards approval in the safest, fastest, and most financially responsible manner possible. Bacteriophage & Drug Development Consultants can help provide gap support.
Our Expertise
All About BDDC
Our Expertise
Bacteriophage & Drug Development Consultants specialize in microbiome, live biopharmaceuticals, bacteriophage, lysin, and antibiotic therapy development and provide end-to-end global regulatory stagey services to pharmaceutical, biotech, CRO, and academic entities. We are the Bacteriophage and Regulatory Affairs consulting experts. See our services for more details.
Our services
How can BDDC provide value to your therapy development?
Who are we?
Carrie-Lynn Langlais Furr, PhD, RAC
Carrie Furr, PhD, RAC is Co-founder, CEO, & Consultant of Bacteriophage & Drug Development Consultants (BDDC), a boutique consulting firm providing bench top to bedside strategic planning and management services. With 25 years experience as a PhD-level phage scientist together with 16 years integrated product development expertise she is an invited chair and/or reviewer of funding applications, a CARB‑X Scientific Advisor, an editor of PHAGE Therapy, Applications, and Research journal, chair and/or speaker at 11 phage therapy conferences, and 7 scientific publications covering phage characterization and clinical case studies of phage therapy treatments, Dr. Furr is recognized internationally as a phage therapy subject matter expert.
As head of regulatory affairs and program management of AmpliPhi Biosciences (now Armata Pharmaceuticals), a public, clinical-stage phage therapy biotech, she was responsible for operationalizing two international investigational phage therapy compassionate use programs that treated > 20 patients with serious, life-threatening, multi‑drug resistant bacterial infections (NCT03395769, NCT03395743), obtaining the FDA’s agreement on the Expanded Access program strategy, Phase 2 development plans, and the futility of traditional toxicology studies, as well several INDs, including single-patient emergency use and corporate INDs for a variety of indications. Additionally, she authored and submitted the first investigator-initiated IND that was deemed safe to proceed by the FDA for intravenously administered investigational phage therapy. These regulatory accomplishments set precedent for the emerging field of phage therapy and the trend to treat individual patients to inform randomized, controlled, clinical development intended to substantiate market approval.
In her 10 years in the CRO industry (PPD, Rho), 7 FDA approvals (1 biologic-device, 6 drugs) were obtained, and > 15 INDs and CTAs were filed permitting clinical trials. She led & prepared Sponsors for formal agency meetings, obtained Orphan Designation for a gene therapy, provided expert consultation to > 30 companies, helped secure non-dilutive funding, and was Sr. Director of Operations at Rho.
She received a PhD from Texas A&M University, Dept. Biochemistry & Biophysics. Her doctoral research elucidated the lysis mechanism & kinetics of ssRNA phage Qβ. Dr. Furr has held Regulatory Affairs Certification (RAC) from Regulatory Affairs Professionals Society (RAPS) since 2009.
Richard Dean. Furr, MS
Mr. Richard D Furr, MS is Co-founder, COO, and Consultant of Bacteriophage & Drug Development Consultants (BDDC), a boutique consulting firm focused on providing bench top to bedside strategic planning and management services. Mr. Furr has over 10 years of cross-functional development experience (Pilot Mfg., Clinical Operations, QA, Medical Writing) and is focused on driving forward biometric, clinical, and regulatory deliverable from document development to project leadership implementation.
Mr. Furr holds a Master’s degree in Regulatory Affairs for Pharmaceutical, Biologics, and Medical Devices from Northeastern University, a BS in Biochemistry from Hampden-Sydney College, has held Regulatory Affairs Certification (RAC), and has scientific laboratory experience (academic and industry), pilot scale manufacturing process development, was a EMT-P; Clinical Research Associate; Quality Assurance Auditor; Medical Writer; and Biometrics Project Manager all within the CRO and pharmaceutical. He was (and remains) a mentor as an Assistant Dean of Students. Mr. Furr, having both supported and managed private and government centric projects, capitalizes on his global and ground-level experience within the drug and biotechnology development space. His leadership translates to point-in-time readiness to assess project risks and implement strategies across a broad spectrum of disciplines. Whether it is protocol development, CRF design, to clinical trial monitoring, regulatory submission, or vendor management Mr. Furr is adept at identifying, rendering, and managing project/program specific deliverables such as: Project Management Plans, timelines (Gantt), Target Product Profiles, Integrated Product Development Plans, authoring Clinical Study Report to NDA module, and clinical monitoring services.