Debra Barngrover, PhD

Senior Consultant

Debra came to Biologics Consulting with over 25 years of experience in the biopharmaceutical industry. Prior to joining Biologics Consulting, she was Vice President, Technology, at Genzyme Corporation. During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in over 40 countries, and managed the Technology Development group responsible for development of more than 15 small molecule, protein and viral vector products, including seven commercial products. She provided managerial leadership to process development, analytical, formulation development, project management, manufacturing package and label engineering and risk management functions. She has authored and reviewed several CMC BLA submissions and participated in agency meetings and plant inspections. She was responsible for developing a Supply Chain Risk Management program, which monitored the risks and mitigation strategies for the commercial supply chains, many involving Contract Manufacturing Organizations around the world. Additionally, she has experience in designing packaging and logistics solutions for cold chain products to multiple markets. She has taught courses in regulatory strategy, mammalian cell culture, supply chain and recombinant protein development for RAPS, ISPE, ASME and other organizations. She holds a B.S. from Colorado State University and a Ph.D. degree in Biochemical Nutrition from Cornell University.

As a Senior Consultant in Regulatory / Manufacturing at Biologics Consulting with 4 years of experience, Debra utilizes her broad technical and project management expertise to assist clients in the following areas:

• Gap analysis for regulatory filings
• Preparing and reviewing CMC sections of regulatory filings (pre-INDs, INDs, BLAs, sBLAs)
• Protein, cell therapy and viral vector process development, technology transfer and scale-up
• Product development planning, program and alliance management
• Strategic capacity planning, make/buy decisions, CMO selection and management
• Temperature sensitive distribution strategy development and packaging design
• Biosimilar development
• Risk analysis, FMEA workshops and determination of process control strategies
• Preparing for facility inspections

Education

PhD, Nutritional Biochemistry, Cornell University, Ithaca, NY

BS, Colorado State University, Fort Collins, CO