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.
• 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.
• 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.

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.

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