Meet Our BEBPA Bioassay Scientific Committee Members

The genesis of BEBPA came from a number of scientists from various companies, institutes and regulatory agencies. As our discussions matured we realized that despite the various venues for meetings and publication, there was no place for new approaches and ideas about common problems to be openly discussed and vetted without firms worrying that their comments would be taken as corporate policy. Each individual expressed the belief that something should be done about this – and that if something were done by the industry as a whole, then the individual companies involved would benefit immensely.

BEBPA provides an international forum for the presentation and discussion of scientific issues and problems encountered in the biopharmaceutical community. The aim of this open discussion is to promote development of innovative approaches and solutions thus facilitating safer and faster biopharmaceutical product development.

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.

Sian Esdale
Siân Estdale, Ph.D.
  • Head of Scientific Affairs, Labcorp
  • United Kingdom

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

Michael Sadick
Mike Sadick, Ph.D.
  • Senior Director of CMC Analytical Development, Imugene
  • Durham, North Carolina

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.

Perceval Sondag, Ph.D.
  • Senior Director of Data Science, Novo Nordisk
  • Plainsboro, New Jersey

Dr. Percy Sondag holds a Bachelor’s Degree in Physical Therapy and Master’s Degree in Biostatistics from the Catholic University of Louvain-la-Neuve, and a Ph.D. in Biomedical Sciences from the University of Liege. He is a Senior Director of Data Science at Novo Nordisk. He previously worked at Merck and Pharmalex (formerly Arlenda) as a Statistician. He specializes in Bayesian modelling and statistics applied to bioassays and process manufacturing. Since 2017, he is also a member of the Bioassay Expert Panel and the Statistics Expert Committee at the U.S. Pharmacopeia.

Kristin Clement
Kristin Clement, Ph.D.
  • CEO, Bio-Val Consulting
  • Cornelius, North Carolina

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.

In addition to her role at Aruvant, Kristin is the Principal Consultant of Bio-Val Consulting (BVC) based in Charlotte, North Carolina Area. Kristin is committed to helping clients meet today’s demands for regulatory compliance with their bioanalytical needs. Her mission is to assist clients to condense drug development timelines and get products to market efficiently without compromising quality or budget.

Nancy Niemuth, M.S.
  • Statistical Consultant, Act Two Consulting
  • Columbus, Ohio

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.

Ulrike Herbrand, Ph.D.
  • Scientific Director Global in vitro Bioassays, Charles River Laboratories
  • Erkrath, 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.

Anton Stetsenko, M.D., M.B.A.
  • Director of Analytical Development, Orca Bio
  • Granite Bay, California

Anton Stetsenko is Director of Analytical Development at Orca Bio. He is responsible for bioassays supporting cell therapy programs. Anton has more than 15 years of pharma/biotech industry experience working at Abbott Laboratories, Fresenius Kabi (formerly APP Pharmaceuticals), Dynavax Technologies, Orchard Therapeutics, ADC Therapeutics, and 4D Molecular Therapeutics. Anton holds a Doctor of Medicine degree with an emphasis on clinical biochemistry from Russian National Research Medical University and an MBA in General Business from Lake Forest Graduate School of Management.

Alexander Knorre, Ph.D.
  • Head of Quality Control, Eurofins BioPharma Product Testing Munich GmbH
  • Munich, Germany

Dr. Alexander Knorre is Head of Quality Control 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 four biologics groups in Munich providing QC GMP services and assay development services for bioassays, impurity assays, protein analytical assays and ATMP assays 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).