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Part II: Clinical Strategies

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Contributors

  • Daniel Baltrukonis, MA, MBA

    Daniel Baltrukonis, MA, MBA, is Director and Biologics Group Lead in the Clinical Assay Group within the Department of Clinical Pharmacology at Pfizer in Groton, Connecticut. He currently leads a team responsible for clinical large molecule PK, immunogenicity, and select biomarker analytics across a diverse biotherapeutic portfolio spanning biosimilars, ADCs, bispecifics, ERTS, CAR-Ts, antisense drugs, nanoparticles, and gene therapies. This analytical support spans all stages of clinical development, all therapeutic areas, method development and validation, sample analysis, reporting and submission. Daniel has 21 years of industry experience at Pfizer with 14 years focused on regulated clinical and nonclinical bioanalysis. He earned his MA in Biology from Brown University and his MBA from Rensselaer Polytechnic Institute.

  • Jim McNally, Ph.D.

    Jim McNally, Ph.D. is Chief Scientific Officer for BioAgilytix, a premier large molecule CRO. Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he led a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.

  • Johanna Mora, Ph.D.

    Dr. Mora is currently a Director in the Non-clinical Disposition and Bioanalysis Department at Bristol-Myers Squibb (BMS). She received a Bachelor of Science degree in Chemistry from the University of Costa Rica in 1999 and a Ph.D. in Analytical Chemistry from the University of Kansas in 2004. At BMS she has oversight of the PK and immunogenicity strategy for programs in cardiovascular, immunoscience and fibrosis. She is a mentor to her team, is an author of over 18 scientific publications and has served in several cross functional teams within BMS. She is an active member of AAPS, has served in the Emerging Technology Focus group and is Past Chair of the Therapeutic Product Immunogenicity Community. Johanna has also held active roles within Applied Pharmaceutical Analysis Regulated Bioanalysis Committee.

  • Michael Partridge, Ph.D.

    Michael received his Ph.D. from Sydney University (CSIRO) developing immunoassays to screen for genetic variants in plants. He moved to the US for a post doc at Columbia University where he investigated integrin-mediated cell signaling and motility. He went on to study tumorigenesis and eventually develop immunoassays to detect biomarkers of radiation exposure. Michael left academia to work at Regeneron where he led a group of scientists developing and validating large molecule PK, ADA, NAb and biomarker immunoassays for nonclinical and clinical studies. He is currently the bioanalytical strategic lead for multiple therapeutic areas, interacting directly with clinical teams including physicians, clinical pharmacology and regulatory departments.

  • Jennifer Zemo, Ph.D.

    Jennifer has over 13 years of experience in the pharmaceutical industry, including over 9 years at BioAgilytix. Before joining the BAL team, Jennifer worked for Grifols (NC, USA) and completed her postdoctoral fellowship at NIEHS (NC, USA). She has over a decade of experience working on development, validation and sample analysis of immunogenicity and PK assays. She has extensive experience developing assays for complex molecules in a variety of matrices. At BioAgilytix, Jennifer manages a large team responsible for developing and validating PK, biomarker, ADA, and cLB NAb assays on multiple platforms, including MSD, ELISA, and Gyros. She earned her B.S. degree in Chemistry from Washington College (MD, USA) and her Ph.D. in Biological Chemistry from the University of North Carolina (NC, USA).

May 25, 2022
Wed 10:00 AM EDT

Duration 3H 0M

This live web event has ended.

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