With 24 years of industry experience across research and development, operations, formulation development, quality control, product quality, control strategy development, CMC leadership, and multiple clinical and commercial international regulatory filings, BioCell Therapeutics was born.  With a passion for leveraging data-driven science, solid CMC development, and appropriate risk taking by balancing quality, compliance, and technical considerations, we focus on bringing novel therapeutics to patients.

Dr. Nolan Polson is a Senior level Product Quality and Chemistry Manufacturing and Controls (CMC) Leader with deep expertise in drug development and commercialization across biologics, antibody drug conjugates (ADCs), cell and gene therapy, and small molecule modalities. Known for being a highly technical leader driving product quality strategy to support product definition, development, validation, regulatory filing, and launch to deliver clinical and commercial products to patients. Adept at providing strong leadership across global quality, product and analytical development, quality control, new product introduction and technology transfer, control strategy definition, GMP validation and manufacturing, and regulatory CMC framework and filing strategy. Passionate about planning and executing strategic CMC development and commercialization activities per business needs to enable the organization to achieve success and bring critical products to patients worldwide.

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What is our Mission Statement?

Our mission is to provide unparalleled strategic guidance and technical expertise in CMC and Product Quality, facilitating the successful development, commercialization, and regulatory approval of innovative biopharmaceuticals and cell therapies.

What CMC Development Serivces do we offer?

Crafting comprehensive Chemistry, Manufacturing, and Controls (CMC) strategies tailored to each client's unique drug development, supply chain, control strategy, and commercialization needs. Providing expertise in technology transfer, comparability studies, and ensuring seamless transitions from development to commercial manufacturing. Assisting in the preparation and critical review of regulatory filings, responding to health authorities, and navigating inspections from regulatory agencies worldwide.

What Product Quality Services do we offer?

Implementing robust Product Quality systems, ensuring compliance with regulatory requirements and optimizing quality control and assurance processes to support clinical and commercial development. Conducting specialized training programs and workshops to enhance internal teams' understanding of CMC and Product Quality principles.

What is our competitive advantage?

Dr. Nolan Polson brings a wealth of experience from leadership roles in renowned pharmaceutical companies, having played integral roles in support of clinical development and commercialization of multiple biologics, cell therapy, and small molecule drugs across global jurisdictions. His experience across the entire drug development lifecycle from pre-clinical, clinical, pivotal, and commercial enabling studies and regulatory filings to enable commercialization and launch of novel therapeutics.