25 years experience in scientific research, mainly in the area of vaccine research and development. Sue leads the Clinical Evaluation Team in the Vaccine Development & Evaluation Centre, a group of experts in the design, development and validation of binding and functional assays used to support vaccines at all stages of the vaccine life cycle. The group currently support numerous regulated clinical studies from early phase through to Phase 4. Our research interests are centred around supporting vaccine development for pathogens with pandemic potential.

Dr. Siân Estdale is the Head of Scientific Affairs, Central Laboratories at Labcorp.

Catherine Pritchett serves as the Vice President of Operations for BEBPA, where she focuses on the smooth functioning of each department within the organization. She takes great care in overseeing conference operations to ensure attendee satisfaction and the highest quality of services.

Catherine holds a degree in Fine Arts and English from the University of Washington. She joined BEBPA in 2017 and made significant contributions to the growth and organization of the database. In 2018, she took on the role of Head of Marketing, Databases, and Social Media. In 2020, Catherine initiated BEBPA’s internship program, which has helped numerous young individuals secure full-time positions with reputable companies straight out of college. In 2023, Catherine became the Vice President of Operations for BEBPA. She is enthusiastic about continuing and expanding the internship program, fostering charitable endeavors, organizing informative webinars, and facilitating small meetings for white paper development.

With 20 years of experience in the pharma/biotech industry, Anton Stetsenko is a consultant in CMC potency method development, validation, and troubleshooting. He specializes in in vitro enzyme activity, cell-based assays, immunoassays, and animal models. Anton has worked at Abbott Laboratories, Fresenius Kabi (formerly APP Pharmaceuticals), Dynavax Technologies, Orchard Therapeutics, ADC Therapeutics, 4D Molecular Therapeutics, and Orca Bio, where he was responsible for all aspects of the potency method lifecycle including comparability studies, method transfer, personnel training, data tracking and trending, customization of data analysis, preparation of regulatory submissions, reference standards, and qualification of critical reagents. This journey allowed him to learn about CMC potency aspects specific to different biopharmaceutical products such as small molecules, biosimilars, vaccines, antibody-drug conjugates, gene and cell therapies. He holds a Doctor of Medicine degree with an emphasis on clinical biochemistry from the Russian National Research Medical University and an MBA in General Business from Lake Forest Graduate School of Management.

Dr. Kevin Van Cott earned his B.S. in Chemical Engineering from Purdue University, and his Ph.D. in Chemical Engineering at Virginia Tech.

Kevin has been working with private companies since 2007 to characterize their proteins by LC-MS/MS and other methods. He has worked with over 40 companies and many more products, helping them characterize post-translational modifications and identify and quantify HCPs. In his first official HCP project, he was tasked with detecting and identifying immunogenic HCPs that had shut down a Phase III trial. Van Cott’s lab then worked with the process engineers who were revising the purification process to confirm those HCPs were getting removed, and the product was approved by the FDA. Since then, he has analyzed HCPs in recombinant enzymes, monoclonals, vaccines, oncolytic virus products, and highly engineered chimeric proteins that have been produced in bacterial, yeast, and mammalian expression systems. His specialty is developing fast, efficient, and sensitive workflows that could generate results quickly so that process engineers could make informed decisions about the next steps to take for their purification process.

He is currently an Associate Professor in the Department of Chemical & Biomolecular Engineering, College of Engineering at the University of Nebraska-Lincoln and works with startup companies that need help using LC-MS/MS methods to solve their development problems. From 2020-2024, Dr. Van Cott was a member of an Expert Panel within the United States Pharmacopeia that drafted the USP General Chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry. Kevin has been active in BEBPA HCP conferences since 2015 as a speaker and workshop leader, leading and facilitating several workshops on the use of LC-MS/MS in HCP analysis. He joined the BEBPA HCP Scientific Committee Member in 2018 and has been the chair since 2023; in 2024 he joined the BEBPA Board of Directors.

Dr. Krawitz, Principal Consultant at CMC Paradigms LLC, is based out of the San Francisco Bay Area. With over 20 years of strategic and technical CMC development experience, Denise provides consulting expertise to large and small biotechnology companies to move products from late-stage research to commercialization efficiently. Denise’s skill set is the product of working directly as a bench scientist, group, leader, project team leader, and project manager. She has broad process development experience, with an emphasis in analytical development and impurity analysis.

Prior to becoming a consultant, Denise served multiple technical and team leadership roles at Genentech, BioMarin, and Ambrx. At Genentech, she was the subject matter expert for host cell protein (HCP) strategy and testing. Denise led all R&D related to HCP strategy, including development of HCP ELISAs, characterization of HCP ELISA reagents, CHO and E. coli proteomics, and implementation of orthogonal techniques to monitor HCPs. Additionally, Denise was responsible for setting the strategic direction for HCP management across the Genentech pipeline, including setting acceptance criteria, risk assessments, and authoring all regulatory documents. Denise has authored several peer-reviewed publications in the HCP field, and been invited to give presentations at multiple international conferences.

Denise received her Doctor of Philosophy in Molecular and Cell Biology from the University of California, Berkeley. Her focus was establishment of chromatin structures that modulate gene expression. Additionally, she received a Fulbright fellowship to study protein folding in Regensburg, Germany.

Martin Vanderlaan has recently retired after 20 years at Genentech, where he was Director of Analytical Operations. This centralized testing laboratory is unique in the Roche network of sites, and provides analytical testing using such diverse analytical methods as PCR, ICP-MS, HPLC-MS, CE, FTIR, and ELISAs. This laboratory has responsibility for all Genentech process-related impurity testing, such as host cell protein and DNA, and leached Protein A, and all media component testing, such as vitamins, amino acids, and trace metals. Martin’s particular areas of interest include the use of assay automation and robotics, data management in electronic lab notebooks, and host cell protein assays. Martin is a member of the US Pharmacopea Expert Group on host cell protein analysis, a member of the California Separation Science Society, and a member of AAAS and ACS.

Martin has held previous leadership positions at Genentech in departments with responsibility for protein analytical chemistry method development, potency testing, and protein PK assay development. Prior to coming to Genentech, Martin was Director of Immunochemistry at PerSeptive Biosystems, a start-up instrument company in the Boston area. In this capacity, he developed products using immunoaffinity HPLC, and describes himself as being “bilingual”, speaking both the jargons of chromatography and immunoassays and always looking for opportunities for synergism between these techniques. Prior to this, Martin ran one of the first hybridoma laboratories on the West Coast, at Lawrence Livermore National Laboratory. His mAbs for glycophorin blood typing (M/N blood groups) were the industry standard.

Academically, Martin has a BS in physics from the University of California at Santa Barbara, and a Ph.D. from New York University’s Institute of Environmental Medicine, where he specialized in Oncology. More recently, Martin completed an executive MBA at the University of San Francisco. Martin has more than 75 publications, 10 patents, and was editor of the ACS Symposium Series book Immunoassays for Trace Chemical Analysis: Monitoring Toxic Chemicals in Humans, Food, and the Environment.

Catherine Pritchett serves as the Vice President of Operations for BEBPA, where she focuses on the smooth functioning of each department within the organization. She takes great care in overseeing conference operations to ensure attendee satisfaction and the highest quality of services.

Catherine holds a degree in Fine Arts and English from the University of Washington. She joined BEBPA in 2017 and made significant contributions to the growth and organization of the database. In 2018, she took on the role of Head of Marketing, Databases, and Social Media. In 2020, Catherine initiated BEBPA’s internship program, which has helped numerous young individuals secure full-time positions with reputable companies straight out of college. In 2023, Catherine became the Vice President of Operations for BEBPA. She is enthusiastic about continuing and expanding the internship program, fostering charitable endeavors, organizing informative webinars, and facilitating small meetings for white paper development.