Meet Our BEBPA HCP 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.

Christina de Zafra, Ph.D.
  • Director in the Nonclinical Sciences, Seagen
  • San Francisco, California

Dr. Christina Zuch de Zafra received her PhD in Toxicology from the University of Rochester and conducted a post-doctoral research fellowship at the University of Colorado; her research utilized rodent models to study the impact of toxins (lead) or neurodegenerative disease (Parkinson’s disease) on dopaminergic pathways in the central nervous system. Christina has been a part of the nonclinical toxicology departments at Genentech and Amgen, supporting the development of multi-modality biotherapeutics (including mAbs, fusion proteins, ADCs, and oncolytic viruses), and is currently a Director in the Nonclinical Sciences department at Seagen (based in South San Francisco). She has specialized in oncology, and has experience in neuroscience-, ophthalmic- and infectious disease-focused drug development. Her other areas of focus include product quality risk assessments, nonclinical abuse liability assessment, and the 3Rs of ethical animal use. Christina is a member of the Society of Toxicology and is a Diplomate of the American Board of Toxicology. BEBPA HCP Scientific Committee Member since 2018.

Kevin Van Cott, Ph.D.
  • Associate Professor, University of Nebraska-Lincoln
  • Nebraska, USA

Dr. Kevin Van Cott earned his B.S. in Chemical Engineering from Purdue University, and his Ph.D. in Chemical Engineering at Virginia Tech. He is currently an Associate Professor in the Department of Chemical & Biomolecular Engineering, College of Engineering at the University of Nebraska-Lincoln. BEBPA HCP Scientific Committee Member since 2018.

Frieder Kröner, Ph.D.
  • Group Head Bioanalytics, Novartis
  • Basel, Switzerland

Dr. Frieder Kröner works on the analytical development and characterization of new biological entities as the Group Head Bioanalytics at Novartis, Switzerland. He is heading a laboratory which develops analytical methods for biological impurities and potency.

From 2013-2015, Dr. Kröner was working as a postdoctoral researcher at Novartis establishing the use of a CHO platform HCP assay and establishing other additional characterization methods, e.g. as 2-D DIGE and LC-MS for host cell proteins. From 2015 on, Dr. Kröner became a functional lead in the late-phase analytics department including the role as expert for HCP impurities.

Dr. Kröner holds a doctoral degree in bioengineering with a focus on protein analytics and downstream process development from the Karlsruhe Institute of Technology in Germany.
BEBPA HCP Scientific Committee Member since 2019.

Alexey Khrenov, Ph.D.
  • CMC reviewer, DPPT, OTAT, CBER/ FDA
  • Silver Spring, Maryland

Dr. Alexey Khrenov received his Ph.D. in Biochemistry from the Institute of Biochemical Physics of Russian Academy of Sciences in Moscow, Russia and is currently CMC reviewer in the Division of Plasma Protein Therapeutics (DPPT), in the Office of Tissues and Advanced Therapies (OTAT) in CBER/ FDA. His review responsibilities include review of CMC sections of marketing and investigational applications and supplements for plasma-derived and recombinant hemostatic products. Dr. Khrenov also participated in multiple pre-license and surveillance inspections of manufacturing facilities. Prior to joining the FDA Dr. Khrenov worked at the American Red Cross Holland Laboratory, United States Pharmacopeia and National Institutes of Health. He has been with the FDA since 2013. BEBPA HCP Scientific Committee Member since 2018.

Stefanie Wohlrab, Ph.D.
  • Senior Scientist, Roche
  • Penzberg, Germany

Dr. Stefanie Wohlrab is a senior scientist and group leader in the Analytical Development and Quality Control Department at Roche. Her group is responsible for method development and qualification for process related impurities in classical and novel biopharmaceuticals. From 2014-2016, Dr. Wohlrab was working as a postdoctoral researcher at Roche with focus on new approaches to characterize host cell proteins and on the development of high-throughput methods. She received her Ph.D. in biochemistry with a focus on protein analytics from the University of Bayreuth.
BEBPA HCP Scientific Committee Member since 2018.

Ying Zhang, Ph.D.
  • Director, Sarepta Therapeutics
  • Massachusetts, USA

Dr. Ying Zhang is currently a Director in the Analytical Development and Quality Control (ADQC) department at Sarepta Therapeutics, where she leads the AD team to support product characterization, process development, analytical method validation and transfer, as well as regulatory filings for all products within Sarepta’s portfolio. Ying has specialized in mass spectrometry-based characterization, especially HCP analysis. Ying was previously an employee of Pfizer. She received her Ph.D. in chemistry from Washington University in St. Louis. BEBPA HCP Scientific Committee Member since 2022.

Catherine Shoemaker-Ramsey, Ph.D.
  • Associate Director of Analytical Development, Biogen
  • Cambridge, Massachusetts

Dr. Catherine Shoemaker-Ramsey is an Associate Director of Analytical Development at Biogen. She leads a group responsible for development and qualification of potency and residual impurity assays, including host cell protein measurement, for protein biologics and gene therapy clinical programs. She received her PhD in Biochemistry and Molecular Genetics from the University of Virginia. BEBPA HCP Scientific Committee Member since 2022.

Fengqiang Wang, Ph.D.
  • Principal Scientist, Merck & Co.
  • Kenilworth, New Jersey

Dr. Fengqiang Wang is currently a Principal Scientist in Analytical Research & Development department of Merck Research Laboratories (MRL), Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada). He started at MSD in 2011 as a senior scientist working on the biochemical characterization of biologics and biosimilars using a variety of analytical tools. Then a major part of his work focused on the development of process specific or platform HCP ELISA methods and their antibody reagents qualification by 2D Western blot coverage assessment to support residual HCP drug substance release and in-process testing for biologics development. Other than ELISA method development, he also worked on orthogonal characterization of HCPs using 1D/2D SDS-PAGE, 2D-DIGE, and 1D/2D-LC-MS/MS to assess the impact of process change on HCP expression and clearance during biologics early and late phase development. His work has contributed to the successful development of commercialized biologics including Keytruda, Zinplava, and Ilumya. In recent years, he has expanded his role to also cover HCP control strategy in small molecules drugs synthesized with biocatalysts and in live virus vaccines. Fengqiang has presented at many national and international conferences including BEBPA HCP Annual Conference, Bioprocessing Summit HCP Conference, and AAPS PharmSci360 annual meeting. He is an active contributor to the BioPhorum HCP Workstream since 2014 and an Expert Panel member of USP HCP Standard 2020-2025 Cycle. BEBPA HCP Scientific Committee Member since 2023.