PDA Pacific Northwest Chapter: Process Validation and Regulatory Strategy for ATMPs

Lotte McNamara

Dr. McNamara is a pharmaceutical scientist with 30 years experience in the development and regulatory areas of the biopharmaceutical industry. During the past 20 years she has provided CMC technical and regulatory consulting services for numerous small and large companies with an emphasis on CMC issues for biological products including antibodies, biosimilars, antibody-drug conjugates, cell and gene therapy products, PEGylated proteins, and polypeptide-drug conjugates. She has provided CMC development and validation strategies to support regulatory submissions for clinical trials and pre- and post-approval marketing applications in Europe, US, Japan and ROW. She has supported strategy development for and attendance at FDA and EMA Agency meetings.

In addition, she has supported selection, management and auditing of contract manufacturing organizations including analytical method and process transfers, process scale-up, and analytical method and process validation for aseptically-processed liquid and lyophilized drug products. She has extensive technical expertise in biologics development using utilizing Quality-by-Design concepts, as appropriate, including QTTP, CQA, DoE and risk assessments, including manufacturing, formulation, analytical method development, method and process validation, characterization, lyophilization, and stability programs.

Darius Pillsbury

Darius Pillsbury is a Senior Consultant with ValSource who has extensive experience working with many organizations in developing and manufacturing cell and gene therapy (Advanced Therapy Medicinal Products), biopharmaceutical/ biotechnology, small molecule, and vaccine medicinal products. Darius focuses on developing, implementing, and managing phase-appropriate Quality Systems and Process Validation activities through all stages of the product lifecycle. He collaborates with many industry professional organizations and currently serves on the Parenteral Drug Association (PDA) Advanced Therapy Medicinal Products Advisory Board.