Chandan Thomas, Ph.D.

Product Quality Assessor (CMC) for CDER Biological Products • Assess and make regulatory recommendations CMC/product quality for therapeutic biologics pre-market and post-market submissions (CDER BLA-biologic/biosimilar), including pre-IND (type B and type C Meetings), IND, BLA, sBLA, and PMCs • CMC /product quality Assessor of a variety of biologic/biosimilar submissions of Aflibercept (Eylea and Zaltrap), filgrastim, peg-filgrastim, insulin glargine, tislelizumab, patritumab, adalimumab, etc. • CMC/ product quality Assessor for FDA's Emerging Technology Team’s (ETT)/CDER's Emerging Technology Program (ETP). Assessed continuous manufacturing process that consisted of upstream (cell culture) and downstream processes (purification, periodic processing, batch processing). • Assessed pre-IND and IND submission and meeting packages for a variety of biologics and biosimilars, including but not limited to monoclonal antibody, antibody-drug conjugates, bispecific antibody, enzymes, products manufactured in mammalian and bacterial expression systems; continuous manufacturing IND submissions • Pre-license inspection (PLIs) for BLAs, including biosimilar products

• Policy Lead/author for the Compliance Program for Preapproval Inspections (7356.832) • Co-Policy Lead for Guidance for Industry: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency; Questions and Answers • Policy Lead -CDER/ OPQ CMC working group for 505b2 NDAs, complex ANDA • Working Group/Team member for CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative • Co-Policy lead for CDER’s Proposed guidance for Distributed Manufacturing and Point of Care Manufacturing of Drugs

• Evaluate potential compliance and enforcement actions based on the review of evidence based on establishment inspections taking into account compliance policy and public health risks, recommend and initiate appropriate enforcement actions • Review and evaluate non-compliant firms’ remedial actions with the aim of achieving sustainable quality • Co-Chair for Stability and Beyond Use Date Working Group for Compounding Quality Center of Excellence (CQCOE) in Office of Compounding Quality and Compliance in the Office of Compliance • Experience with a variety of Compliance Actions • Injunction/Consent Decrees • Warning Letters • Regulatory Meetings • Untitled Letters • Response Letters

• Office of Lifecyle Drug Product (OLDP), Chemistry, manufacturing, and controls (CMC) review/assessment as CMC Team Lead and Expert Senior Reviewer of drug substances (API) and generic sterile and non-sterile drug products. • Primary and Secondary assessment of ANDAs • Make regulatory approval decision of ANDAs as OPQ Application Technical Lead (ATL) and responsibilities and duties equivalent to acting Quality Assessment Lead (QAL) • Expertise in the Pre-ANDA program for complex generics-ANDAs. Product Specific Guidances (PSGs) from a CMC/OPQ perspective • Subject matter expert (SME) for: • Product Quality for Generic Injectable Drug Products • Product Quality for Generic Ophthalmic Drug Products • Actively contributed as a part of policy making working groups at OPQ/FDA towards the development of several FDA Guidances for Industry, Complex Drug Product Specific Guidances, MAPPs, and USP monographs and chapters pertaining to sterile and non-sterile drug products. • Received multiple Awards and Recognized multiple times for excellence at FDA, CDER and OPQ

Ph.D. thesis in the development and characterization of pulmonary vaccination for Hepatitis B, titled “Respirable Particulate Carriers for Pulmonary Delivery of Hepatitis B Vaccine”. PLGA based aerosol formulation development of small and large molecular weight drugs, proteins and vaccine antigens. Worked with molecules like HBsAg, FVIII, Low molecular weight heparin, PGE1, insulin.

Part of successful first MHRA (formerly UK MCA) and US FDA approval quality team at Plant-1, Verna, Goa, India

Training/internship at German Remedies Limited, India a division of Zydus Cadilla. Trained in Quality Control, Assurance and Production/Manufacturing department of solid dosage and injectable dosage forms.