BioCell Therapeutics LLC is a specialized consulting firm that offers comprehensive expertise in the field of CMC (Chemistry, Manufacturing, and Controls) drug development, regulatory filing, commercialization, and Product Quality for the biopharmaceutical and cell therapy industries. Our founder and principal consultant, Dr. Nolan Polson, is a seasoned professional with a proven track record in leading successful CMC and Product Quality teams at top-tier pharmaceutical companies such as Amgen, Janssen, Bristol Myers Squibb, Celgene, GSK, and Juno Therapeutics.

Board Member and advisor to Survivors Alliance for Growth and Employment (SAGE), a non-profit organization that provides employment, mentorship, and job training in a Christ-centered environment for women who are survivors of human trafficking and sexual trauma.

Leading global end to end Product Quality initiatives across all drug modalities to help commercialize vital medicines for patients.

Leads team of specialized Quality technical staff that provides leadership, quality, and technical oversight on cross-functional teams including process development, drug product development, analytical sciences, quality assurance, quality control, manufacturing, regulatory affairs, and global operations in support of commercialization efforts for CAR-T Cell Therapies (liso-cel (JCAR017), ide-cel (bb2121), orva-cel (JCARH125) and other clinical assets).Developed a pragmatic product quality and compliance framework in support of advancing early cell therapy products through the clinical development phase.Key responsibilities include keys: Product Quality Lead program, as an end-to-end accountability for product quality across entire Cell Therapy Development Organization product portfolio, Method Lifecycle Management (including Method Validation and Transfer, Method Technical Support), Stability (cell bank, plasmids, vector, DP intermediates, DP), QC Operations in support of viral vector product release, and oversight of contract testing laboratories.

Director / CMC Leader within the Large Molecule Portfolio Management group within Process Development & Manufacturing Sciences (PDMS) at Janssen Research and Development. Drives overall operations strategy in support of the Clinical Development Team through early / late phase commercialization efforts including GLP / GMP manufacturing of drug substance and drug product manufacturing in support of Tox , Phase 1, Phase 2, and Phase 3 clinical studies. Current portfolio supports cardiovascular and oncology targets.

Director within global Product Quality Management group supporting commercialization efforts of large molecule bio-therapeutics.

Global Product Quality Leader for numerous of Amgen's commercial and clinical products (i.e. Kepivance (palifermin); Kineret (anakinra), Nplate (romiplostim), AMG 386 (cancer therapy). Oversight of technical product quality issues for both drug substance and drug product manufacturing processes. Lead Product Quality Team to discusss cross-functional product quality issues, data trending, compliants, technical issues, analytical methodologies, regulatory filing activities in support of commercialization activities, new product launches, and ongoing commercial support post licensure. Serve as the single voice of Quality on a Global Operations Team. Contribute to regulatory filings and participate in regulatory inspections. Author of Annual Product Reviews for commercial products.

Thermo Biostar, Medical Diagnostic Company, (Louisville, CO) - subsidiary of Thermo Electron Corporation (formerly called Biostar). Managed QC and Formulations staff to support routine manufacturing. 2000 - 2002: New assay development scientist in Research and Development2002-2005: QC/Formulations Manager. Represent manufacturing during new product transfers and introductions from Research and Development during commercialization activities. Served as technical expert to support manufacturing operations and aid in investigations.