Grace De Santis

Doing now what patients need next. Infectious disease product development Built a new high performance interdisciplinary team (engineers, chemists, biochemists) and integrated within an existing broader structure. Developing and enhancing innovative product platforms to serve business, medical community and patient needs. Cartridge, sensors, assay, automation, automated visual inspection, critical to quality attribute development. Establish and led R&D technical exchange and peer review forums to enhance transparency and accelerate agile learning loops across R&D.

Team leadership (San Diego, CA & Oxford, UK). Cell biology analytical product development. Chemistry, Biology, Applications. System Integration. IP portfolio management. MTA & CDA. Prepared scientific job descriptions and ladders. Customer visits. Established Product Development framework and stage-gates. Reported to CEO. Led R&D team to synthesize new dye reagents and develop and launch 3 new super resolution imaging products (comprising assay, chips and analysis tools) within a year dSTORM Training Kit (UK) Cell Discovery Kit (UK) Extracellular Vesicle Profiler E2E system (US) w automation & analysis. ONI has a desktop integrated super-resolution imaging acquisition and analysis workflow.

R&D, Head of Clinical Product Innovation. Oncology, autoimmune disease and neoantigen / HLA profiling. Advance new integrated clinical product concepts via collaborations with leading Key Opinion Leaders and Partnerships with Biopharmaceutical Companies and illumina Lab Services Co-inventor on 4 Patent Families. Developed modular, multimodal assay strategy. Prepared pitches for board and senior executive presentations.

Technical Leadership, NGS, Preanalytics, Sample and Library Prep., Developed Molecular Diagnostics for Women's Health, Prenatal and Oncology applications. Developed automated high throughout factory scale NGS workflow for NonInvasive Prenatal Testing (NIPT) in CLIA lab. At SQNM helped develop and launch the first automated NIPT assay offering, MaterniT21. Evaluated contract manufacturing options for automation. Initiated oncology and reproductive health bio marker discovery collaboration with MD Anderson. Co-inventor on 2 Patent Families. https://ir.labcorp.com/news-releases/news-release-details/labcorp-announces-agreement-acquire-sequenom

Cardio-metabolic, hematology focused product development. Defined and delivered medical device/diagnostic system for point of care hospital use and home use. Technical and line management of R&D team for microfluidic cartridge and reagents. Led cross functional teams that included, regulatory, clinical, product management, R&D, and operations to develop and obtained regulatory clearances. Built and managed a leading team of biomedical engineers software developers and biochemists. Invented a new blood cell stabilization technology, that we used as a control material. Achieved two FDA 510k clearances and EU CE mark. Outlined technical assay to "monitor" new emerging drugs. Developed strategy and project plan for new instrument design with connectivity (HL7 for hospital and bluetooth for home use). Evaluated several technologies in support of M&A team. Evaluated contract manufactures for instrument. Conducted and published health-economics analysis in collaboration with leading physician KOL and Clinical Affairs team. https://www.massdevice.com/official-abbott-closes-5b-alere-buy/

Technology development, enzyme & protein assays, antibody and enzyme engineering, and creation of high throughput screens to enable discovery, and directed evolution Applied technology to diverse applications including bio-pharmaceuticals for inborn errors of metabolism, pharmaceutical synthesis, animal feed, transgenic crops, industrial processing and biofuels. Several patents, publications and commercial milestones achieved. Developed technologies and novel routes to key chiral pharmaceutical intermediates including for atorvastatin / Lipitor (R). Initiated B2B pharmaceutical collaboration with Biomarin and identified candidate PAL enzyme API for the treatment of PKU. A Biomarin PAL Palynziq(R) was approved by FDA in 2018, for pediatric PKU Started at Diversa Inc in a Scientist role, progressive increase in responsibility leading to Principal Scientist, and Associate Director roles. Technical lead on a series of strategic alliances and projects including with, DSM, Pfizer, BASF, Syngenta, Biomarin, Dow etc. Hired, developed and led a high performance technical R&D team. Unique position grounded in a technical leadership role, whilst concurrently managing and originating a couple strategic alliance/licensing relationships. (Recruited to Diversa Inc. by Vice President of R&D.) Company was about 200 people. The Diversa technology portfolio, was ultimately purchased by BP, DSM and BASF. Co-inventor on several composition of matter and method Patent Families. 3 BU Sold: BP ($98M 2010), DSM ($37M 2012) BASF ($62M, 2014) https://cen.acs.org/articles/91/i39/BASF-Acquires-Enzyme-Maker-Verenium.html https://www.dsm.com/corporate/news/news-archive/2012/04-12-dsm-acquires-food-enzymes-business-and-key-technology-from-verenium.html#

Elucidated mechanistic details and structure of DERA aldolase in complex with its substrate as well as developing enhanced variants of this carbon carbon bond forming enzyme (using both structure guided design and “directed evolution” to achieve biocatalysis of unnatural transformations. Publication in "Science" and other high impact journals. Enzyme variants and IP licensed to a biotech company for commercialization. Honed skills in protein engineering, molecular biology, enzymology, cell based screens and directed evolution. Canadian NSERC sponsored postdoctoral fellowship. Advisor Professor CH Wong.