Amanda Simmons Email and Phone Number

Establishing pharma service partnerships with stealth startup/midsize/large pharma for drug development, clinical and commercial manufacturing support. Our Patheon CDMO leverages all services offered by Thermo Fisher Scientific. Collaborations typically include Drug Product, PPD, Fisher Clinical and Bioservice groups, which allows for an end-to-end comprehensive custom or platform solution for therapeutics. Our portfolio supports:* Pre-Clinical Development* Cell Line and Process Development* Analytical Development and Process Validation* Phase I, II, III Clinical Batch Supply* Cell Banking* Tech Transfer and Validation* Commercial Manufacturing* Drug Product Fill/Finish* Storage/Distribution* Regulatory Affairs Consultation and IND/INDP/BLA Dossier Services

R&D External Project Lead within R&D Operations. Point of contact for outsourcing service requests. Responsible for R&D contract development, external company quality management, KPI and business metrics, onboarding, project scoping and monitoring, business and CRO management, contract negotiation, project budgeting, procurement, resourcing and finance management for NPI and discrete studies within Genetic Testing Solutions and Global Health Equity Departments.• Experience with customer and external partner workflow troubleshooting with in-development and on-market instrumentation and qPCR kits.• Held several demo presentations for Thermo Fisher and external partners on sample prep and qPCR instrumentation.• Negotiated sample prep instrumentation sales with external partners for RUO and IVD projects.• Extensive knowledge of PCP for RUO/IVD product development in addition to project management methods and oversight.• Leadership experience includes stakeholder presentations and discussions, effective communication of project status andescalations, successful organization and management of inter/intra company collaborations and project teams.

qPCR R&D and Analytical Validation testing for numerous successful product development kits leading to RUO, 510K, IVD/R filings. Contributions include assisting in development of the original TaqPath COVID-19 EUA kit as well as other COVID and viral kit projects.Wet-lab applications include ISO 13485 compliance and amplicon/BSL2 proficiency with various sample prep and qPCR Thermo Fisher Scientific and third-party instrumentation; Interpretive software and instrument prototype testing.Technical writing of qPCR test plan, protocol and report development in accordance with FDA filing and WHO project submission requirements, addressing standardized (WHO, FDA, CDC, and CLSI) guidelines for application in Europe, the US, and developing countries.

• White paper and protocol execution on predicate qPCR instruments and the QS7 Pro• Assisted with software qPCR development by providing feedback on prototype instrumentation and algorithm applications.• Collaborated on assay design and performance and novel clinical testing for products designed for the IVD market.• Knowledge of FDA IVD and RUO product development and validation testing.• Experience in DOE, JMP data mining, predictive modeling, executing and interpreting protocol results. Product Commercialization Process Training and application.

Management of Radiation Oncology based FDA regulated cooperative, industry and investigator-initiated cancer studies.(Department of Defense, Bristol-Myers Squibb, Novartis; Gilead Sciences Inc., GlaxoSmithKline, Galera Therapeutics, Inc., AMGEN).• Quality and site visit oversight• Biological sample collection and lab processing of surgical, whole blood, and urine samples for biomarker and cancer targets.• Evaluation of PERP p53/p63 staining to indicate recurrence in head and neck cancer patients.• Aldehyde dehydrogenase 3A1 activation analysis in salivary stem cell samples to examine radiation-induced xerostomia• Proficiency in HIPPA, IRB and FDA regulation requirements.• CLIA and academic wet-lab experience• Grant writing, contract negotiation, trial marketing, project financial planning, and audit management.• Feasibility assessment of department studies including workload distribution, standard procedure efficacy, and supervision.Data entry, mining and analysis of clinical data resulting in several publications and presentations.