Sandra Mccurdy Email & Phone Number

Higganum, Connecticut, United States

Clinical Microbiology Consultant to the Pharmaceutical Industry

Morristown, New Jersey, United States

•Managed delafloxacin microbiology NDA writing activities including authorship of sections as well oversight of medical writing contractors leading to FDA approval of delafloxacin. •Author clinical microbiology FDA responses including pre-NDA meeting briefing books, SPA agreements and breakpoint response.•Manage clinical microbiology data for delafloxacin clinical trials including review of clinical trial protocols, eCRFs, lab management plans, and clinical microbiology manuals. Oversee microbiology data from central laboratory including ongoing review of data and auditing of central laboratory operations.•Work with medical affairs and commercial colleagues to devise pre and post launch clinical microbiology activities including surveillance, publications and microbiology training for commercial colleagues. •Manage AST development including disks, MIC gradient strips, TREK Sensititre panels and automated susceptibility testing systems including contracting, drug shipment and data analysis and review; leading to clearance of three susceptibility testing devices <45 days post-FDA approval of delafloxacin.•Manage delafloxacin global surveillance programs including US/EU and country specific surveillance programs including review of data and of resulting publications.• Author of delafloxacin AAC publication: http://aac.asm.org/content/early/2017/06/13/AAC.00772-17.long

Branford, Ct

•Author clinical microbiology sections of dalbavancin sNDA (5.3.5.4 and 2.7.2.4) including breakpoint section of NDA resulting in a revised breakpoint. •Manage clinical microbiology data for dalbavancin clinical trials including review of clinical trial protocols, eCRFs, lab management plans, and clinical microbiology manuals. Oversee microbiology data from central laboratory including ongoing review of data and auditing of central laboratory operations. •Manage dalbavancin reference laboratory activities and global surveillance programs. •Member of team that manages external microbiology studies supporting dalbavancin including scientific review of study proposals, contracting, procurement, drug shipment and review of final study reports and resulting publications.•Manage AST development including disks, MIC gradient strips, TREK Sensititre panels and automated susceptibility testing systems including contracting, drug shipment and data analysis and review.Manage dalbavancin Antimicrobial Susceptibility Testing (AST) activities and external vendor activities.•Manage microbiology reference laboratory (LSI); provide technical input as needed.•Manage dalbavancin fulfillment program. •Manage dalbavancin global surveillance programs including US/EU and country specific surveillance programs including review of data and of resulting publications. Work with Medical Affairs colleagues on new ways to visualize surveillance data. •Manage external clinical microbiology studies including review process. KOL management, legal, contracting, procurement, invoicing/payment, drug shipment,review of final reports and publications. • Author/co-author on two accepted dalbavancin clinical microbiology manuscripts.

Lexington, Massachusetts

•Manage writing and data analysis contractors for ceftolozane/tazobactam NDA (ZERBAXA).•Write and edit non-clinical pharmacology sections of ceftolozane/tazobactam NDA (2.6.2.4).•Review and edit internal and external study reports for ceftolozane/tazobactam and other programs; member of Investigator Initiated Research proposal review team.•Manage clinical microbiology data for ceftolozane/tazobactam ventilator associated pneumonia trial. •Review and provide input on clinical trial protocols, SAPs, eCRFS, lab management plans, clinical microbiology manuals. •Contributed to clinical microbiology sections of ceftolozane/tazobactam scientific platform,lexicon, core deck and MSL training modules.•Manage external research studies supporting ceftolozane/tazobactam clinical development including scientific review of study proposals, contracting, procurement, drug shipment and review of final study reports and resulting publications.•Manage AST development studies including contracting, drug shipment and data review.•Provide clinical microbiology support to discovery research project teams.•Member 2014 ECCMID booth committee. Worked with Parexel on booth design and Altered Image on Global Resistance iPad application for booth/eventual use by Medical Affairs fieldteams.•Member ceftolozane/tazobactam early access team.•Awarded 2013 Cube of the Year Award (Ceftolozane/Tazobactam NDA readiness team).

•Served as Clinical Microbiology liaison to Contract Research Organization (CRO) in China. Reviewed MIC data, identified errors, and made recommendations for data quality improvement.•Served as Clinical Microbiology liaison with JMI Laboratories (Liberty, IA) for MIC90 testing of lead compounds. Monitored MIC data and oversaw contract deliverables. •Independently set up collaboration with Diane Citron of Alden Research Laboratories to develop CLSI methodology for broth microdilution susceptibility testing for anaerobes. Oversaw all aspects of data generation including training of summer intern, organization of timelines, data interpretation and results. Data presented at 2011 ASM. •Developed protocols and provided data summaries for CLSI eight lab quality control studies and for new product formulations for Emerging Markets group. •Worked with Infectious Disease physician-collaborators to characterize linezolid resistance in clinical strains resulting in authorship on three abstracts for 2009 ICAAC conference.•Implemented ideas to improve efficiency of MIC testing process which included working with sample logistics and IT colleagues to improve efficiency of sample handling.•Presented posters at ICAAC, ECCMID and ASM. •First author on four abstracts and one paper, secondary author on nine papers and eleven abstracts.•Awarded numerous Individual Performance Awards.

•Managed primary screening and secondary cellular assays for a program that at its peak had five chemistry laboratories. Developed strong working relationships with chemistry resulting in enhanced the productivity of the agonist program. Program was awarded a 2006 Team Award. •Initiated transition in Immunology from 96 well based screening assays to 384 well based automated screening assays. •Formatted and refined Gene Blazer β-lactamase reporter assay to increase robustness, through-put and incorporate automation.•Developed secondary cellular and functional assays. •Developed expertise in drug screening processes including using automation.

•Managed secondary cellular assays for Janus Kinase 3 inhibitor program.•Provided cellular data package for the JAK3 kinase inhibitor for Science paper and for CAN data package including mixed lymphocyte reaction, IL-2 induced proliferation of human T-cell blasts, GM-CSF driven proliferation of HU03 cells and serum induced proliferation of human foreskin fibroblasts. •Developed automated tetanus toxoid ELISA assay to evaluate the effects of JAK3 inhibition on primate primary and secondary antibody response to tetanus toxoid antigen.•Developed expertise in immunological cellular assays such as IL-2 driven T-cell blast, human and murine mixed lymphocyte reaction and antigen specific lymphocyte proliferation.

•Conducted exploratory research on agents to treat osteoporosis and frailty.•Developed expertise in ex vivo assay development.•Developed expertise in organizing and executing murine animal studies and in characterizing transgenic animals.•Developed proficiency with basic molecular biology techniques such as PCR, RNA & DNA isolation, Northern & Southern blotting and PCR.

M.S., Medical Microbiology/Medical Technology

B.S., Medical Technology