Dharmesh Desai Email & Phone Number

• Over 15 years of experience in pharmacokinetic (PK/PD) and immunogenicity (ADA/NAb) preclinical and clinical method development, method validation and method transfer on multiple platforms and in multiple different modalities (e.g., receptor fusion proteins, therapeutic MAbs, pegylated proteins, endogenous replacement enzymes/proteins, antibody-drug conjugates, gene therapy products). Experience with CMC aspects of gene and cell-based therapy products (CAR T cell, attenuated Listeria monocytogenes). Well versed in bioanalytical and CMC regulatory guidances (including FDA, EMA, ANVISA and MHLW) and best practice white papers.• Over 25 years of immunology research and development experience with a concentration in cellular immunology and autoimmunity. Detailed knowledge and experience with standard molecular, biochemical and cellular immunological techniques. Specialized experience in developing and optimizing agent antigenicity and immunological response mechanisms of host species.• Strong written and verbal communication skills demonstrated by numerous manuscripts in peer-reviewed journals, presentations at scientific meetings and progress reports at internal meetings. Authoring responsibilities have included response letters to regulatory authorities, IND and BLA sections, bioanalytical and clinical study reports, method validation plans/reports and method/process SOPs. Selected as external peer reviewer for professional journals and meeting abstracts.• Supervisory experience related to hiring, training and guiding professional development of both direct and matrixed indirect reports.

Listed skills include Cell Based Assays, Glp, Immunology, Life Sciences, and 31 others.