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Bioassay Scientific Committee

Spencer Alford
Spencer Alford

VP, Biologics R&D, KALA BIO, Inc

California, USA

Bio coming soon.

Kristin Clement
Kristin Clement
Kristin Clement, Ph.D.

CEO, Bio-Val Consulting

North Carolina, USA

Dr. Kristin Clement received her Doctor of Philosophy in Cell and Molecular Biology in 2002 at the University of Cincinnati, where she focused on identifying the ligand bound by human macrophages to eradicate the pathogenic, spore-forming fungus, Histoplasma capsulatum. She then served as a study director at Battelle Memorial Institute from 2002 – 2013 where she developed and validated numerous in vitro assays in support of GLP studies testing medical countermeasures for biowarfare defense. In 2013 Kristin established Bio-Val Consulting, where she has assisted numerous clients with various facets of assay development, qualification, and validation. In 2019 Kristin joined Aruvant Sciences where she is the Director of Analytical Development. Aruvant Sciences, a part of the Roivant family of companies, is a clinical-stage biopharmaceutical company committed to developing and commercializing transformative gene therapies for rare diseases.

Ulrike Herbrand
Ulrike Herbrand, Ph.D.

Scientific Director Global in vitro Bioassays, Charles River Laboratories

Germany

Ulrike Herbrand joined Charles River Laboratories in 2007. She is Scientific Director Global in vitro Bioassays and Head of the Bioassay Research & Development team at Charles River Laboratories’ site in Erkrath, Germany. She gained a PhD in biological sciences during her time at the Max-Planck-Institute for Molecular Physiology in Dortmund (Germany) and worked five years at post-doctoral positions at medical research centers in the field of cancer research. She is an expert in mechanism of action-reflecting bioassays for protein therapeutics and ATMPs.

Alexander Knorre
Alexander Knorre, Ph.D.

Managing Director, Eurofins BioPharma Product Testing Munich GmbH

Germany

Dr. Alexander Knorre is Managing Director at Eurofins BioPharma Product Testing Munich GmbH and has more than 20 years of experience in the Biotech/Pharmaceutical industry. He is Senior Scientific Director Biologics and Bioassay for the European part of the global Eurofins BioPharma Product Testing network. Currently, he oversees five biologics groups in Munich providing QC GMP services and assay development services for bioassays, impurity assays, protein analytical assays, ATMP assays and microbiology methods to a global client base.

He received his Ph.D. in Cell and Molecular Biology at the University of Freiburg (Germany) in 2001 and joined Eurofins as bioassay expert in 2003 after 2 years as post doc at the Gene Center of the University of Munich (LMU).

Pierre Lebrun
Pierre Lebrun

Director, Principal Consultant, Cencora Pharmalex

Brussels, Belgium

Bio coming soon.

Mike Merges
Mike Merges

Vice President, Process Development and Site Head, Autolus Therapeutics

England, United Kingdom

Bio coming soon.

Nancy Niemuth
Nancy Niemuth, M.S.

Statistical Consultant, Act Two Consulting

Ohio, USA

Nancy Niemuth is a statistical consultant specializing in nonclinical research. Previously, she was the Technical Director for Biostatistics at Battelle, where she provided statistical support to the Biomedical Research Center. Ms. Niemuth is an expert in the use of animal models and related bioassays for medical countermeasures developed and licensed under the FDA Animal Rule. Ms. Niemuth has co-authored more than 40 peer-reviewed scientific publications and her work has supported presentations at national and international meetings. She offers an introductory course in biostatistics for bioassays through Fastrain Courses. Ms. Niemuth joined the BEBPA Scientific Committee in 2019 and leads the Statistical Interest Group.

Jane Robinson
C. Jane Robinson
C. Jane Robinson, Ph.D.

Consultant

United Kingdom

Dr. C. Jane Robinson is a consultant in biopharmaceutical development, specializing in in-vitro bioassays and reference standards. Previously, she worked for 25 years at the National Institute for Biological Standards and Control (NIBSC), UK, where she established a laboratory for the testing and standardization of polypeptide growth factors of therapeutic and diagnostic potential. Dr. Robinson has advised regulatory authorities and other organizations on bioassay design and analysis, led collaborative projects to develop World Health Organization international standards and participated in the European Directorate for the Quality of Medicines and Healthcare (EDQM) testing of Centrally Approved Products. Dr. Robinson has lectured and provided training for regulatory, professional, academic and commercial organizations. She received her Ph.D. degree in chemistry from the Katholieke Universiteit te Leuven, Belgium in 1982.

Michael Sadick
Mike Sadick
Mike Sadick, Ph.D.

Senior Director of CMC Analytical Development, Imugene

North Carolina, USA

Dr. Sadick is the Senior Director of CMC Analytical Development at Imugene. Previously, he was Principal Scientist at Catalent Biological Analytical Services, in Morrisville, NC., where he coordinated and oversaw Bioassay, ELISA and Molecular Biology projects. He managed the Bioassay/Relative Potency team, for 10 years, at Catalent Biologics in Kansas City, MO (formerly Aptuit, Inc). Prior to that, Mike worked for 6 years at Eli Lilly and Co. as a Research Advisor leading the Bioassay Groups, Molecular Biology and Virology in support of Phase I-III projects, as well as providing guidance for commercial bioassay testing. Before his tenure at Eli Lilly, Dr. Sadick ran bioassay groups for 10 years at Genentech in South San Francisco. Dr. Sadick has an extensive background in cellular biology, cellular immunology and receptor signaling, molecular biology and biochemistry. He received his MS and Ph.D. in immunology from University of Washington in Seattle, and his BA in biology from Johns Hopkins, in Baltimore.

Paula Urquhart
Paula Urquhart
Senior Assay Development Scientist, Labcorp England, United Kingdom Bio coming soon.

2026 US Bioassay Conference

March 23-25, 2026
College Park, Maryland
Hybrid Conference

Journal Club

April 23, 2026
Virtual Gathering

2026 Host Cell Protein Conference

May 27-29, 2026
Boulder, Colorado
Hybrid Conference

2026 Biomarker Assay Conference

June 23-24, 2026
Virtual Conference

2026 European Bioassay Conference

23-25 September 2026
Seville, Spain
Hybrid Conference

2026 Asia Bioassay Conference

November 2026
Incheon, South Korea
Hybrid Conference