Amanda Sheets Email & Phone Number

Collegeville, Pa, Us

Chapel Hill, Nc, Us

Brentford, Middlesex, Gb

In this role, I planned and oversaw scientific and operational aspects of clinical trials, managed external microbiology, animal efficacy and PK-PD studies, evaluated data, and contributed to scientific content of clinical program documents.• CRO MANAGEMENT: Liaised with vendors/CROs to request proposals to conduct clinical/microbiology studies; managed work orders/accruals, approved invoices.• CLINICAL SCIENCE: Developed clinical study protocols and SAPs; provided input/review of CRF design, data management plans and data sets; planned microbiology/efficacy analyses; reviewed TLF shells; identified and resolved data quality issues through review of clinical data listings and patient profiles, reviewed and approved final biostats deliverables, authored and reviewed CSRs.• CLINICAL MICROBIOLOGY: Planned antibiotic susceptibility testing (AST) strategies; oversaw central lab services including review of laboratory procedure manuals; monitored QC data trends.• CLINICAL OPERATIONS: Managed operational aspects of Phase 2/3 clinical trials; reviewed study plans, oversaw data management teams from study start up through final database lock and analysis, developed end of study timelines, oversaw database lock activities.• TRANSLATIONAL SCIENCE: Oversaw studies conducted to identify non-clinical PK-PD index targets for key target pathogens, and PK-PD target attainment analyses based on clinical data, supporting dose selection for delafloxacin CABP program.• REGULATORY: Authored and reviewed microbiology and clinical efficacy sections of regulatory submission documents: IB, Annual Safety reports, PSP/PIP, IND/NDA/MAA, briefing books.• DUE DILIGENCE: Reviewed data/documents of potential partners/assets from a microbiology perspective (as part of Cempra strategic review).• ABSTRACTS/MANUSCRIPTS: Strategic publication planning, drafting, execution, and review.

Chapel Hill, North Carolina, Us

In this role, I planned and oversaw scientific and operational aspects of clinical trials, managed external microbiology, animal efficacy and PK-PD studies, and contributed to scientific content of clinical program documents.• Solithromycin CABP Program: I wrote and reviewed microbiology sections of the solithromycin NDA/MAA and reviewed the proposed solithromycin label. As an AdCom preparation team member I reviewed our briefing document, prepared backup clinical trial and micro data slides, attended mock meeting presentations, and provided Q&A support at the 04Nov2016 meeting via the “war room.” • Fusidic Acid ABSSSI & BJI Programs: As a core program team member, I contributed to eCRF/database design, eCRF completion guidelines, data management plans (DMP), data transfer agreements (DTAs), and monitored data reconciliation activities for the Phase 2/3 trials. I developed antibiotic susceptibility test (AST) strategies, managed central lab services, including review of microbiology lab procedure manuals, and ensured collection of quality clinical microbiology data through ongoing review of blinded listings and profiles. I developed end-of-study timelines and unblinding plan, led the clinical/pathogen evaluability review process, and oversaw database lock. For the successfully completed ABSSSI trial, I approved the final TLF deliverables and authored the CSR.

Chapel Hill, North Carolina, Us

In this role, I managed the execution of external non-clinical/translational and microbiology studies, and provided subject matter expertise to the clinical and regulatory teams. I liaised with academic and contract laboratories to develop study protocols, monitored conduct of experiments, and reviewed study reports. I authored and reviewed basic science/microbiology sections of regulatory submission documents for the US, including solithromycin and fusidic acid IND summaries and annual safety reports.• Solithromycin Biodefense Program: I coordinated & co-authored a technical proposal for a government contract (BARDA); served as the project team lead for solithromycin biodefense program; managed the successful completion of NHP efficacy studies (cynomolgus macaque aerosol challenge models of anthrax and tularemia), bioanalytical method validation studies, and PopPK and dose humanization studies. I was responsible for communicating project updates and risks to senior management & the BARDA team.• Solithromycin CABP Program: I supported Clinical Development activities for the solithromycin CABP program by developing microbiology overview procedures/protocols for two Phase 3 clinical trials and by managing the specialty central lab services. I was responsible for ensuring quality of diagnostic microbiology data through ongoing review of blinded data listings, EDC/lab vendor data reconciliation, and final TLF review. I reviewed efficacy sections of the CSRs, prepared specialty microbiology subreports, and summarized QC results.• Fusidic Acid ABSSSI Program: I was the lead microbiologist for the fusidic acid development program starting in 2015. In this role, I managed international surveillance studies, contributed to the development of clinical protocols for Phase 2/3 trials (ABSSSI, BJI), planned efficacy and microbiology analyses (aligned with FDA guidance documents), reviewed SAPs, and designed TLF shells.

Chapel Hill, Nc, Us

Research Topic: Investigated the role of Bordetella fimbriae, filamentous hemagglutinin, and adenylate cyclase toxin in suppression of pulmonary inflammation, using genetically manipulated strains of B. bronchiseptica with a murine model of respiratory infection.

Durham, North Carolina, Us

Research Topic: Identification and characterization of the major adhesin expressed by the Haemophilus cryptic genospecies, a pathogen associated with obstetric and neonatal infections. We reported the novel finding that expansion and contraction of a variable peptide repeat region modulates the adhesive and aggregative activities of this protein, designated Cha. This work represents an important advance in understanding the functional organization of a unique trimeric autotransporter adhesin. The impact of peptide repeat variation on the activity of this protein likely enhances the adaptive capability of these bacteria and may represent a widespread mechanism among pathogenic microorganisms to generate cell-surface antigenic and/or functional diversity.

Phd, Molecular Genetics And Microbiology

Phd, Molecular Microbiology And Microbial Pathogenesis

Bs, Biochemistry & Molecular Biology