Paul Eder Email & Phone Number

Rockville, Maryland, United States

Washington, Dc

In Vitro Diagnostics (IVD) product development advisor to the Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services (HHS), guiding infectious-disease IVD product development.• Mentored 30 BARDA IVD molecular diagnostics programs, consulting on pathogen target identification, assay development, verification, and pre-clinical testing.• Supported eight FDA submissions for 510(k), BLA, EUA, and pre-EUA, on IVD projects in antimicrobial resistance, bacterial versus viral distinction, biothreat agents (anthrax, plague, melioidosis), emerging infectious diseases (Ebola, Zika), and pandemic influenza.• Advised the Director of BARDA on new assay technologies for advanced-stage molecular diagnostics for the Detection, Diagnostics and Devices Infrastructure portfolio.• Updated BARDA on all emerging molecular genetics technologies including third-generation sequencing, precision medicine, and advanced detection methods.• Contributed to Product Specific Requirements to guide government partners at FDA, CDC, NIAID, and DOD on proposed specifications for their viral and bacterial molecular diagnostics programs.• Maintained deep immersion and direct involvement in CARB-X programs for diagnostics and alternative therapeutics through EOI, Short-form, and Long-form reviews, as well as contract negotiations, Advisory Board, Milestone Review Board, and CST liaison.

Gaithersburg, Md

Concluded a successful clinical validation trial for a China State Food and Drug Administration registration of a global cervical-cancer screening test.• Oversaw five Research and Development functional groups including Assay Development, Biostatistics, Bio-Bank, Luminex Genotyping, and Laboratory Compliance, with five reporting managers and 25 total department reports.• Cleared multiple IVD products including sample collection medium, heater/shaker instrument, and immunoassay for HPV detection in samples self-collected by women in low-resource communities.• Transitioned process and production transfer from U. S. R&D facility to manufacturing facility in Shenzhen, China.• Led the assay development and integration teams on an automated virology screening system for a high-throughput pre-cancer diagnostic test.• Represented QIAGEN R&D as liaison and spokesperson for more than 50 technical presentations for Sales and Marketing to key national and international accounts.• Defended pre-submissions to FDA for an automated, high-throughput, screening molecular diagnostics assay and instrumentation system.

Gaithersburg, Md

• Launched successful external clinical studies, first in Rwanda, Haiti, India and China, then, eventually to Tanzania, Nigeria, Uganda, Nicaragua and Thailand.• Led a project team from feasibility research through product development, including verification and validation, up to clinical trials.• Played a key R&D role for Digene on the post-merger integration with QIAGEN.• Executed the logistics plan with the architect and contractors for the R&D laboratory and office expansion at the Gaithersburg facility.• Inaugurated and maintained leadership of a Bill and Melinda Gates Foundation project to develop a novel beads-binding immunoassay for developing countries.• Established collaborative partnerships with global key opinion leaders in cervical cancer screening and HPV testing.

Malvern, Pa

• Awarded an SBIR to advance small-molecule candidates as novel antimicrobial compounds that modulate essential RNA functions in Gram-negative and Gram-positive pathogens.• Invented new technologies to screen for novel regulatory elements in mammalian mRNA structures and sequences.

Postdoctoral Fellow, Biology

Senior Postdoctoral Scientist, Biochemistry

Ph.D., Biochemistry

Activities and Societies: Graduate Student Senate

B.S., Biochemistry