About Me

I am a mother of three, a wife, and a scientist.

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I’ve spent my entire career developing assays for academic, contract research organizations, and pharmaceutical companies around the world.  My journey started in 1997 at the University of Cincinnati where I performed research in an infectious disease laboratory on a spore-forming pathogenic yeast (Histoplasma capsulatum). I was also teaching at Xavier University as adjunct faculty and was interested in becoming an associate professor when 9/11 happened, which changed the course of history and my professional trajectory. 

 

Upon graduating with my Ph.D. in Cell and Molecular Biology in 2002 I took a research scientist position at Battelle Memorial Institute in West Jefferson, OH helping to develop/technology transfer, qualify, and validate ligand binding and cell-based bioassays for pre-clinical and clinical studies. Over the course of 11 years, I led numerous GLP validations of assays used to support FDA filings for vaccines and therapeutics necessary to treat or prevent dangerous CDC Category A and B infectious diseases (anthrax, botulism, plague, smallpox, and viral hemorrhagic fever, etc.). I developed into a proficient assay scientist, a skilled leader, and diligent program administrator as evidenced by supervising up to 12 full time technicians on various analytical projects, managing multimillion-dollar government contract timelines, budgets, and deliverables, and providing guidance on program and regulatory issues.

 

Due to our growing family, in 2013 I left Battelle and established Bio-Val Consulting, LLC, my consulting company dedicated to helping companies navigate the complexities of assay development and validation.  Most companies neglect the “long game” of the assay life cycle and in a rush to check the box of validation meanwhile rushing past proper critical reagent management, biostatistical assay performance monitoring, and analyst training and proficiency testing. My goal as a consultant is to not only solve immediate problems, but to prevent new ones from occurring.  I have proudly worked with numerous institutions on assays to support drug product/substance characterization and release, and clinical testing of vaccine, monoclonal antibody, and cell and gene therapy products.

 

For the past 10 years as a freelance scientist and consultant, I have had the pleasure of working with institutions of all sizes and budgets. I’ve worked with small biotech startup companies with only a few employees (e.g., Countervail Corporation - developing products to prevent/treat nerve agent exposure and helping to patent and develop a point of care lateral flow test to detect nerve agent exposure) as well as large global companies too.  For three years I was immersed as a Director of Analytical Development at Aruvant Sciences in the groundbreaking work of cell and gene therapy developing cell-based potency assays for the release of lentiviral and adeno-associated viral vectors (LVV and AAV) for the treatment of ultra-rare genetic diseases.  I’ve also proudly worked with government agencies such as NIH/NIAID and NIH/NINDS on projects to support RSV and Covid-19 (Operation Warp Speed) and devastating diseases such as Duchenne’s Muscular Dystrophy.

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Finally, I am honored to be a member of the BEBPA (Biopharmaceutical Emerging Best Practices Association) scientific board. BEBPA is an organization dedicated to discussing current scientific issues encountered in the biopharmaceutical community.  BEBPA provides network of scientists and statisticians to whom I can turn to for peer support when issues arise to help solve practical real-world challenges.

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My passion is helping companies overcome analytical hurdles by meeting them where they are at and elevating them to where they need to be.