John Simms Email & Phone Number

Manassas, Va

• Manager and founding scientist of the Immunology Core laboratory directly supporting core business and external contract awards generating >$1M in revenues. Achieved full ISO compliant operation in less than 3 months from start up.• Responsible for process development / improvement and preparation of operational documentation (SOPs, WINs, forms). Performed batch record review and approval for release of final products (>100 annually). Worked closely with key stakeholders to coordinate resource management, value stream management and production scheduling.• Acted as Study Director for work contracted to the ATCC BioServices business unit. Responsibilities included pricing, scheduling, resource management, data analysis and preparation of final study reports. Served as point of contact for study sponsors.• Evaluation of new technologies: championed in house live content imaging and high content/confocal capabilities.• Conducted independent research as part of a multi-disciplinary team. Research activities included MOA, SAR and efficacy studies on a novel immunomodulatory peptide. Responsible for both in house experiments and monitoring of subcontracted studies (including site visits) from initiation through to receipt of final study reports . Co-inventor on issued US Patent directly related to this research program.• Established and nurtured relationships with scientific collaborators and subcontractors in both academia and industry.

Manassas, Va

• Valued member of new cross-functional unit conducting independent research in key disease areas to develop new biological products for use as research tools, diagnostics and novel biotherapeutics.• Directly responsible for the generation of novel hybridoma cell lines against "high impact" antigenic targets (including highly pathogenic H5 avian influenza) as new product lines.• Led preclinical development team responsible for efficacy testing, MOA, and in vivo PK/PD studies. Advanced in house tumor modelling and in vivo imaging capabilities.• Prepared departmental scope documents including charter, start-up and operational budget forecasts. Resource management including purchase of equipment, hiring and direct supervision of key personnel.

Valencia, Ca

Managed multi-disciplinary preclinical team comprised of 10 individuals to conduct immunotoxicology testing of an inhalable dry-powder insulin delivery system (AFREZZA)• Established and optimized various immunological assays: NK cell, B cell, anti drug antibody and quantitative flow cytometry utilizing single-platform technology.• Collaborated with pharmacology group to design and perform PK/PD and clearance studies following pulmonary and SQ delivery of Technosphere® formulated biotherapeutics (insulin and GLP-1).• Led surgical team responsible for conducting in vivo testing of intranodal (IN) DNA based cancer vaccines and proprietary biotherapeutic molecules and as part of a preclinical development program.• Collaborated with the oncology group to optimize immunization regimens, evaluate analogue peptides, and to perform solid tumor modelling for the cancer vaccine program.• Established various inflammatory disease models in house, conducted in vivo assessment of a novel anti-inflammatory biotherapeutic molecule for the treatment of asthma, Crohn’s disease, rheumatoid arthritis and multiple sclerosis.

Chatsworth, Ca

In January 2003 CTL ImmunoTherapies was merged with AlleCure Corporation and Pharmaceutical Discovery Corp. (PDC) to form MannKind Corporation.

Duarte, Ca

Phd, Virology And Immunology

B.Sc. (Hons), Microbiology