Erik Read Email & Phone Number

Cambridge, Cambridgeshire, GB

Cambridge, Cambridgeshire, GB

Cambridge, Cambridgeshire, GB

Silver Spring, MD, US

• Designed and managed as co-project lead Critical Path Initiative-funded research to create Process Analytical Technology (PAT) and Quality by Design (QbD) strategies for mammalian cell culture, downstream processing.
• Generated, executed and analyzed Plackett-Burman design of experiments (DoE) to assess antibody-producing bioreactor and demonstrate linkage to variations in downstream processing. Improved process robustness and bulk.
• Co-designed and implemented formulation development DoEs that resulted in dramatically decreased antibody aggregate formation and enhanced bulk drug substance stability.
• Cultivated multi-sector stakeholder partnerships across academia (Johns Hopkins University, University of Massachusetts - Lowell), industry (Janssen, Prosensus), and government (NIST and other FDA divisions) for.
• Spear-headed design of chimeric antibody expressing CHO cell line and negotiated with CMOs (Lonza, DNA2.0) for pricing, development timeline, and deliverables.
• Evaluated cutting-edge strategies for advanced analytical protein characterization (Sartorius/Umetrix, Optim, Octet, MALS, nIR, FBRM) and secured ~$2 million funding for equipment purchase, installation, training and.

Silver Spring, MD, US

• Reviewed new drug products submitted to the FDA for approval from pre-IND to post-BLA stages including 6 original submission INDs and 3 BLAs, 1 drug-device combination product and 1 Drug Master File.
• Evaluated and made recommendations on meeting packages and eCTD submissions for 4 antibody biosimilar biological product development programs.
• Authored primary responses and information requests, and conveyed regulatory guidance to pharmaceutical company representatives during drug product development through direct face-to-face meetings.
• Presented emerging regulatory review issues and contributed to the development of policies at internal FDA meetings for antibody product submissions, biosimilars, and the assessment of QbD containing applications.
• Implemented 21st century review policies to complete review assignments well in advance of statutory and internal quality review deadlines.

Silver Spring, MD, US

• Developed a bulk drug substance production process that incorporated bench-scale mammalian cell culture bioreactors, engineered in-line fluid autosampling and integrated datastreams for on-line HPLC-based PAT.
• Improved cell culture media formulation to increase antibody productivity 15% by the design and execution of a metabolomics collaboration with academia (UMBC), industry (Eli Lily) and foreign contract organization.
• Engineered a real-time, on-line system to determine protein quality attributes in bioreactors by inventing an in-line column switching valve that enabled development of 2D-HPLC methods for process fluids.
• Ensured antibody quality for collaborative research projects by implementation of control and recordkeeping principles from FDA Guidance for Industry: CGMP for Phase 1 Investigational Drug.
• Designed and created an institutional database of antibody glycosylation from BLAs for statistical analysis of assay validation, specifications, and other regulatory trends.
• Researched and published a two part review that surveyed the current PAT literature (Read et al. 2010) to focus the development of new PAT techniques for potential application in the laboratory.

Bethesda, MD, US

• Awarded 5-years of merit-based funding from National Academies of Sciences to study mechanisms of RNA transcription control during elongation and terminationPlanned and created experiments utilizing classical genetics.
• Incorporated cutting-edge molecular genetic techniques (transposon mutagenesis, recombineering) to identify and modify transcriptome regions regulated after RNA transcription initiation but during elongation.
• Sequenced, assembled and annotated entire genomic sequence of opportunistic pathogen Bacteroides fragilis bacteriophage B40-8.
• Developed and taught FAES post-graduate course BIOT 102 Introduction to Genetics that covered the central dogma of molecular biology to genomics to biotechnology of GMOs applications of genetically modified organisms.

JP

• Awarded merit-based funding from the Japan Society for the Promotion of Science to train the faculty in molecular genetic techniques for gene ablation.
• Characterized multiple strains with ablated outer membrane proteins for effects upon antibiotic susceptibility and liposome swelling assays to demonstrate transmembrane pore formation and role in barrier function.
• Investigated the physiological role of small energy-transducing transmembrane proteins of the dental pathogen Porphyromonas gingivalis.

Washington, DC, US

• Employed phenotypic and molecular techniques to identify clinical isolates from polymicrobial infections and complex biological (gastrointestinal) samples with a special emphasis in difficult to cultivate anaerobic.
• Pioneered the use of molecular biology techniques in the clinical laboratory to rapidly detect and identify isolates Bacteroides, Clostridium and Campylobacter.
• Employed state-of-the-art reverse genetics, and sequence analysis software to identify the role of membrane proteins in non-beta-lactamase mediated antibiotic resistance mechanisms.

Doctor Of Philosophy (Ph.D.), Microbiology

Master'S Degree, Microbiology

Bachelor'S Degree, Microbiology