erika barboza prado lopes, msc, phd

Oakley, California 94561 adwt56@r.postjobfree.com 405-***-**** (cell) www.linkedin.com/in/erikabplopes

summary

Exceptional immunologist and R&D senior manager successful at designing and leading biomedical and biopharmaceutical research programs and clinical trials; and hiring, coaching, and directing eight staff. Innovative scientist who cost-effectively produces, troubleshoots, validates, and optimizes reagent and clinical and non-clinical assays for immune-related disease and oncology applications. Administers a $50M+ program budget, rolls out a portfolio strategy, and propels CRO performance. Partners with leadership, product development, and key external stakeholders (e.g., PIs, KOLs) to improve product time to market by reducing the development lifecycle and cost.

Expertise: Strategic Planning, Project Management, Cross-Functional Team Leadership, Risk Management, Process Improvement, Vendor Management, Data Analysis, GLP/GNP, Cell & Gene Therapy, Life Science.

experience

ASTELLAS PHARMA, SAN FRANCISCO, CA

Senior Manager, Clinical Development Immunology 2021 to Present

Develops, implements, troubleshoots, and optimizes cell-based, in vitro, and in vivo immunological assays for clinical trial testing of cell- and gene-based therapeutics (e.g., T-cell response) for rare muscle and congenital diseases (e.g., Pompe Disease) in concert with external stakeholders (e.g., KOLs, investigators, researchers).

Leads programs and cross-functional teams, designs studies and trials, creates study plans and timelines, and develops and administers a $31.5M budget, adhering to project timelines and budgets.

Negotiates vendor contracts; launches study activities (e.g., protocol development, budget forecasting, Core Team communications); collaborates with internal functional areas (e.g., R&D Operations, Regulatory Affairs, Quality); and drives quality and regulatory compliance as an Audit Team member.

Galvanizes and executes clinical trial and post-trial activities (e.g., document development, subject brochures, manuals, clinical regulatory interactions, reporting, publications).

Selects and monitors CRO performance and oversees CRO preparation and validation of five high throughput immunoassays for three programs, managing multiple immunology work streams.

Analyzes and interprets results from cellular, molecular, gene-based, immunological, and protein-based assays. Generates well-formulated recommendations for next steps.

Defines and completes risk assessment for subject adverse outcomes. Reviews the literature and makes protocol modifications for FDA submission.

Authors regulatory filings (IND, BLA) and clinical development documents. Responds to and presents to health authorities and regulatory agencies along with key external stakeholders.

Key Results

Produced and troubleshot Flow Cytometry and immunological assays.

Composed the FDA Clinical Hold Response for the FORTIS program, securing FDA Clinical Hold lift in 2023.

Wrote the FDA Clinical Hold Response for the ASPIRO program to be submitted April 2023.

BD BIOSCIENCE, SAN JOSE, CA

Manager, R&D Reagent and Assay Development 2019 to 2021

Manager, R&D Beads Development 2019 to 2021

Governed a $50M+ Flow Cytometry-based Companion Diagnostics (CDx) program in partnership with ONO Pharmaceutical Co. to produce gastric and lung oncology assays as the program manager and SME.

Hired, motivated, directed, and retained eight SME team members, giving staff the opportunity to work with external scientists. Aligned with leadership teams to promote career development by launching two HR programs.

Rolled out the business portfolio strategy, established SOPs and diagnostic programs, and participated in innovative reagent development to introduce new products and populate the product pipeline.

Conducting R&D, drove the cross-functional team to create reagents for CDx assay development and IVD reagents. Administered a five-year $30M budget and yielded and validated three reagents as the SME.

Coordinated with other functional areas (e.g., Regulatory Affairs, Quality) to support high throughput assay work.

Led the Clinical Discovery Research Reagents (CDRR) program. Launched the workflow and built unit-sized, pre-formulated, and optimized multicolor panels and beads that leverage automated BD Horizon™ Dri technology in concert with PIs, hospitals, and CROs; and RUO reagents. Brought in program work on time and on budget.

Authored and oversaw preparation of protocols, analyses, and technical reports.

Key Results

Employing data generated through collaborations with KOLs, minimal marketing investment, and no formal marketing campaigns, decreased the cost of reagent development and marketing for CDRR.

Worked with leadership and product development teams to diminish time to market by improving the development process and reducing the product development life cycle.

Partnered with an academic institution, KOLs, and CROs to enhance clinical tissue acquisition, lowering the cost for tissue samples, reagents, and assay production costs.

Originated three RUO multicolor panels, TBNK+CD20 Panel, Treg Panel, and Memory T-Cell Panel, for CDRR; and an IVD multicolor panel.

Implemented two IVD buffer reagents [(i.e., BD Horizon™ Dri Tissue, Tumor Dissociation Reagent (TTDR)].

Directed the R&D team for the US-IVD 510K Regulatory Tech filling

OKLAHOMA MEDICAL RESEARCH FOUNDATION (OMRF), OKLAHOMA CITY, OK

Associate Staff Scientist/Assistant Staff Scientist 2016 to 2019

Co-founded and managed the Mouse Cardiovascular Phenotyping Core service. Executed laboratory research for mouse metabolic and exercise testing.

Led and developed five staff, mentoring two staff into higher level positions.

Collaborated with scientists and students to plan and roll out research projects including: establishing protocols, analyzing samples, troubleshooting and validating assays, and interpreting data.

Published articles and presented at conferences.

Postdoctoral Fellow 2013 to 2016

Directed research projects, formulated in vivo and in vitro laboratory techniques, and analyzed data.

Led, coached, and mentored three staff.

Co-authored a NIH Small Grant Program (R03). Published articles and presented at conferences.

UNIVERSITY OF BARCELONA (UB), INSTITUTE FOR RESEARCH IN BIOMEDICINE, BARCELONA, SPAIN

Coordinator/Associate Professor, Immunology Department 2008 to 2013

Wrote the new Immunology Department curriculum for theoretical and laboratory classes as a Coordinator.

Trained, reviewed, and oversaw associate professor performance. Assigned them to teaching schedules and reported their research activities to the department chair.

Taught classes including laboratory sessions focused on immunology, held office hours, and communicated with graduate students as an Associate Professor.

education, certification & languages

Education:

Doctor of Philosophy degree in Biomedicine, University of Barcelona, Spain, 2013. Graduated cum laude. Student Grant, 2012; Fellowship, 2009-2013; Graduate Research Assistant, 2008-2013.

Master of Science degree in Immunology, University of Barcelona, Spain, 2009. Fellowship, 2008-2009.

Bachelor of Science degree in Biological Science, Federal University of Espirito Santo, Vitoria, Brazil, 2007. Research Assistant, 2005-2007.

Certification: Business Strategy, Harvard Business School Online, expected 2023. Flow Cytometry, University of Barcelona, 2010. Level B2 European Certificate in Spanish, 2008. Project, Business and Communication Management, Learning Biotech, 2012.

Languages: Portuguese, native speaker; Spanish, fluent; Catalan, French, and Italian, beginning.

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