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.
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 Statistician at Merck Sharp & Dohme. Prior to joining Merck Sharp & Dohme in 2019, he was working at Pharmalex (formerly Arlenda) as a Statistical Consultant. 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 at the U.S. Pharmacopeia.
2020 PRESENTATION TITLE:
Design of Multiple Types of Experiments for Potency Assays
Wednesday, 23 September 2020, 14:45 CEST
Day 3: Lifecycle: Early Development to Post Commercial Session
See full abstract HERE.
Dr. Alexander Berger has been employed at Boehringer Ingelheim since 2015, as head of laboratory for potency assays. His tasks are to develop, qualify, validate, and transfer different potency assays like cell-based potency assays and binding ELISAs.
Prior to this role, Alexander has held a position as study director for microbiological release testing and study director for bioassays in the biotechnological industry. Alexander has experience in analytical development and quality control of new biological entities. He holds a PhD degree in Molecular Biotechnology from the University Hohenheim and studied at the Technical University Munich, where he gained first experience with antibody characterization, cell-based potency assays and binding ELISAs.
2020 CO-PRESENTATION TITLE:
Insight in Unspecific T-Cell Activation by CD3-Homodimers via Cell-Based Characterization
Monday, 21 September 2020, 17:15 CEST
Day 1: Handling Product References and Performing In-Depth Product Characterization Session
See full abstract HERE.
Dr. Matthias Kania has been employed at Boehringer Ingelheim since 2011, previously as head of analytical development for Boehringer Ingelheim´s contract manufacturing business. Matthias is currently heading the Potency Assay Skill Center within Development Biologics and is accountable for the development of different potency assays like cell-based potency assays, binding ELISAs and different Biacore methods, including qualification, validation, and transfer.
Prior to his current role, Matthias has held positions as scientist, Lab Head and CMC- Project Leader in the biopharmaceutical industry. Matthias has many years of experience in analytical development, quality control, and CMC development of new biological entities. Matthias holds a PhD degree in Cell Biology from the Technical University Munich, where he gained first experiences with antibody generation & characterization.
2020 CO-PRESENTATION TITLE:
Insight in Unspecific T-Cell Activation by CD3-Homodimers via Cell-Based Characterization
Monday, 21 September 2020, 17:15 CEST
Day 1: Handling Product References and Performing In-Depth Product Characterization Session
See full abstract HERE.
Mr. Steven Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee. Prior to this role Mr. Walfish was Principal Statistician at Becton Dickinson in Franklin Lakes, NJ responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish has held roles at GE Healthcare, Human Genome Sciences and Chiron. Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries.
Steven brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.
Steven holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
2020 PRESENTATION TITLE:
USP Updates: Bioassay Chapters and Assay Lifecycle Update for <1220>
Wednesday, 23 September 2020, 16:30 CEST
Day 3: Lifecycle: Early Development to Post Commercial Session
See full abstract HERE.
Dr. Stanley N. Deming is President of Statistical Designs, El Paso, TX, through which he consults and offers short courses in the areas of experimental design, optimization, and the statistical analysis of laboratory data, with emphasis on bioassays. Dr. Deming received his B.A. degree in chemistry from Carleton College, Northfield, MN, and his M.S. and Ph.D. degrees in analytical chemistry from Purdue University, West Lafayette, IN. He has been on the chemistry department faculties of Emory University (1970-1974) and the University of Houston (1974-2001) where he is Professor Emeritus. Over his academic career, he was the major research advisor for 16 Ph.D. students and 19 M.S. students. Since 1975 he has taught (with Stephen L. Morgan) over 600 short courses.
Dr. Deming has been the author or co-author of approximately 100 papers and three books, including Experimental Design: A Chemometric Approach (Elsevier), Sequential Simplex Optimization: A Technique for Improving Quality and Productivity in Research, Development, and Manufacturing (CRC Press), and The 4PL: A Guide to the Use of the Four-Parameter Logistic Model in Bioassay (lulucom). He has served on the editorial boards of the Journal of Chemometrics (1987-2003), Critical Reviews in Analytical Chemistry (1996-2002), and Chemometrics and Intelligent Laboratory Systems (1987-1993). His web site is http://www.statisticaldesigns.com.
2020 PRESENTATION TITLE:
Outliers in Bioassay 2: The Effects of a Single Blunder in Down-The-Plate Dilution
Thursday, 24 September 2020, 15:30 CEST
Day 4: Outliers: Their Significance and How to Deal with Them in a Regulated Environment Session
See full abstract HERE.
Dr. Michael Sadick is Senior Director of Analytical at Precision BioSciences. 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.
2020 PRESENTATION TITLE:
Outliers in Bioassay 1: The Effects of a Blunder in Top-Well-Transfers
Thursday, 24 September 2020, 14:45 CEST
Day 4: Outliers: Their Significance and How to Deal with Them in a Regulated Environment Session
See full abstract HERE.
Mike Merges is the Executive Director and Global head of Analytical Sciences for Autolus Therapeutics and drives the analytical strategy for early- and late-stage clinical development programs. Mike was recently Director of Analytical Sciences and Technology at Emergent Biosolutions, where he oversaw the technical transfer and validation of analytical methods supporting manufacturing of a broad range of biologics. Mike has over 30 years of experience in analytical method development and validation with a background in cell biology, immunology and virology. He joined Emergent from Catalent where he was Director of Strategic Growth for Catalent Biologics managing the accelerated growth of Catalent’s Biologics Analytical Services spanning business development, technology innovations and technical advisory to Catalent’s Biologics manufacturing network. Prior to working at Catalent, Mike was Associate Director of Bioservices at Lonza. Mike performed vaccine research at the University of Maryland’s Institute of Human Virology, the National Cancer Institute and The Johns Hopkins University. Mike received his MS in Immunology from Hood College and his BS in Microbiology from The Pennsylvania State University.
2020 PRESENTATION TITLE:
Outliers in Bioassay 3: The Effects of a Consistent Blunder in Down-The-Plate Dilution
Thursday, 24 September 2020, 16:30 CEST
Day 4: Outliers: Their Significance and How to Deal with Them in a Regulated Environment Session
See full abstract HERE.
Dr. Laureen Little has been a bioassay consultant for over 25 years. During this time, she worked with small and large pharmaceutical companies in all stages of development, as well as supporting authorized products. She has worked with protein products, including antibodies, enzymes, carbohydrate-based products, and many other types. Laureen also has a vast experience with biopharmaceuticals including vaccines, viruses, cell-based products and combination products. She is the founder & President of BEBPA, Principal Consultant at Quality Services and was the original producer of the three largest and most popular bioassay conferences held in Europe and the USA.
2020 PRESENTATION TITLE:
Data Integrity and Potency Bioassays
Thursday, 24 September 2020, 17:15 CEST
Day 4: Outliers: Their Significance and How to Deal with Them in a Regulated Environment Session
See full abstract HERE.
Enrico Mazzarella holds a Master’s degree in Medical Biotechnologies from University “Federico II” of Naples. Currently, he is attending the final year of his Ph.D. in Technology and Science for Human Health at University of Palermo in collaboration with Merck KGaA, where he has been employed as Associate Researcher since 2016. Previously, he worked in the quality control area in support of manufacturing process at Alfa Intes, a company dedicated to the development and commercialization of ophthalmic drug products.
Before switching to pharmaceutical field, he worked for several years at Italian National Research Council, investigating the role of the endocannabinoid system in skeletal muscle development and maintenance.
During these years, Enrico has been involved in many projects, from basic research to early/late clinical phases of several drug development programs. He has experience in development and validation of analytical methods for drug release, stability and product/process characterization.
2020 PRESENTATION TITLE:
Exploiting Structure-Activity Relationships for an In-Depth Characterization of Biotherapeutics
Monday, 21 September 2020, 16:30 CEST
Day 1: Handling Product References and Performing In-Depth Product Characterization Session
See full abstract HERE.
Dr. Jaana Vesterinen holds a Ph.D. and adjunct professorship in Biochemistry from the University of Helsinki. She acts as a Laboratory Section Head at the Finnish Medicines Agency. Her expertise lies in analytics of biological medicines. She chairs the European Pharmacopoeia Monoclonal Antibody Working Party and represents Finland in the EMA Biological Working Party.
2020 PRESENTATION TITLE:
Developing Horizontal Standards: Bioassays for TNF-Alpha Antagonists
Monday, 21 September 2020, 15:30 CEST
Day 1: Handling Product References and Performing In-Depth Product Characterization Session
See full abstract HERE.
Pierre Lebrun is Director Statistics at Pharmalex, which Belgium arm is dedicated to statistical expertise. During more than 14 years, Pierre specialized in quality-by-design aspects related to processes and assays, with a strong emphasis on the use of Bayesian statistics to improve knowledge during the process and assay validation stages. Pierre is also a recognized trainer in statistics for the pharmaceutical industry, including design of experiments, Bayesian statistics, statistical process control, and assay development and validation. Two years ago, Pierre joined the USP panel in charge of the development of the USP 1220 chapter about a holistic approach to assay validation using the concept of the analytical procedure lifecycle.
2020 PRESENTATION TITLE:
USP1220 for Analytical Lifecycle: its Application for Bioassay?
Wednesday, 23 September 2020, 17:15 CEST
Day 3: Lifecycle: Early Development to Post Commercial Session
See full abstract HERE.
Rens Braster started at Genmab as Scientist Functional Characterization and Bioassays in 2019. The core expertise of this team is the development of CMC bioassays for characterization and release of Genmab’s innovative antibody therapeutics for the treatment of cancer. Rens obtained his Ph.D. at the VU University Medical Center in Amsterdam studying the role of myeloid cells in solid tumors and the impact of antibody modification on tumor cell clearance by these myeloid cells. He continued this research as post-doctoral fellow, until he joined the start-up company LUMICKS as an Application Scientist developing assays for a novel platform to study cell avidity by collaborating with multiple renowned laboratories over the world.
2020 PRESENTATION TITLE:
Case study: Bioassay Development: IND to CTA
Tuesday, 22 September 2020, 14:45 CEST
Day 2: Assay Development Session
See full abstract HERE.
Seth Foltz has been an employee at Eli Lilly and Company for 19 years, working in areas such as Lilly bulk operations, Elanco animal health, Lilly bulk operations technical excellence, laboratory of experiential medicine, and reference standards operations. He has experience developing, running, and transferring Immunogenicity, Biomarker, ELISA, and Cell-based assays in previous roles. In his current role, he is responsible for all corporate reference standard qualification, requalification, and implementation of corporate reference standards and is a technical subject matter expert for the establishment and use of ligand critical reagents.
2020 PRESENTATION TITLE:
Handling Product References for Potency Assays: A Review of the BEBPA White Paper
(Seth will be representing the BEBPA Expert Working Group)
Monday, 21 September 2020, 14:45 CEST
Day 1: Handling Product References and Performing In-Depth Product Characterization Session
See full abstract HERE.
Kate has worked at PsiOxus since 2014 as a scientist/senior scientist in the CMC group. Her role includes the development, qualification, tech transfer and use of various assays for the characterisation of oncolytic virus and cancer gene therapy products. Kate has developed several bioassays during this role, including virus infectivity assays, potency assays and ELISA expression assays and these have been used for product release, formulation development, process development and stability testing. She holds a PhD in Cell Biology from the University of Manchester and has also worked at Astrazeneca, Medimmune, and a wound healing biotech company, Renovo. At the latter company she was responsible for the development and validation of cell-based potency assays for the characterisation of recombinant protein products.
2020 PRESENTATION TITLE:
Cell Characterisation and Optimisation of Cell Handling Methods for the Development of Robust Bioassays
Tuesday, 22 September 2020, 16:30 CEST
Day 2: Assay Development Session
See full abstract HERE.
Mr. Patrick Heim has studied Pharmaceutical Technology (B. Sc.) and Biomedical Sciences (M. Sc.) at the University of Albstadt-Sigmaringen. Afterwards, he started to work for Hoffmann-La Roche Ltd. Basel in September 2013. In his role as Principal Associate, he conducted, developed and validated mass-spectrometric methods for the characterization of biotechnological products in the Phys-Chem section of the analytical department. In addition, he automated sample preparation workflows for various analytical methods with Hamilton Robotics. Since June 2017, he is working for the Bioassay section where he strongly contributed to the implementation of a global aligned automation strategy. As Subject Matter Expert in Basel, he was responsible for equipment qualification, automated method development and scripting. Furthermore, he holds the lead for operation and maintenance standard operating procedures within the global bioassay automation team.
2020 PRESENTATION TITLE:
Bioassay Automation: From Equipment Qualification to Automated Assay Validation
Wednesday, 23 September 2020, 15:30 CEST
Day 3: Bioassay Automation: From Equipment Qualification to Automated Assay Validation Session
See full abstract HERE.
Dr. Xu-Rong Jiang is currently a Senior Director of Quality and Technical of Development Quality Biologics and BioVentures at AstraZeneca. He has served as the Head of Quality for Centus Biotherapeutics Ltd, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics. From 2008, he was an Associate Director in Analytical Biotechnology at MedImmune, where he led the Bioassay Development Group for biologics analytical method development for IND filing, GMP testing, technology transfer and process development, and BLA. Prior to MedImmune, Dr. Jiang was a Principal Scientist in Process & Analytical Sciences at Amgen where his group was responsible for development, qualification, validation of potency assays for biologics development. Dr. Jiang was a Senior Scientist at Geron Corporation focusing on gene and cell therapy, high throughput screening, and regenerative medicine with embryonic stem cells. Dr. Jiang received his Ph.D. degree in molecular cell biology from University of London. He also had an M.D. in hematology from China Medical University. Dr. Jiang has served at various scientific and professional organizations and committees. He is an Associate Director for CASSS, an International Separation Science Society. He has been a member of Scientific Organizing Committee for CASSS Bioassays since 2011. Dr. Jiang has published more than 28 journal papers, one book chapter, and is an assignee of three U.S. patents. Dr. Jiang was the President and Chairman of the Board of Directors in the Chinese Biopharmaceutical Association-USA 2016-2017.
2020 PRESENTATION TITLE:
Biosimilar Development: Approaches for Analytical Biosimilarity
Tuesday, 22 September 2020, 17:15 CEST
Day 2: Assay Development Session
See full abstract HERE.
Darren has been a Group Leader in the Bioassay Center of Excellence at Bristol-Myers Squibb since 2017. Prior to joining BMS, Darren supported bioassay development at Eli Lilly and Company and has accumulated more than 10 years of experience in the development and validation of cell-based assays in support of both early and late stage biotherapeutics.
Prior to joining industry, Darren received his PhD from McGill University in Molecular Oncology in Montreal, Canada followed by post-doctoral studies at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
2020 PRESENTATION TITLE:
Designing Cells for Use in Cell-Based Potency Bioassays
Tuesday, 22 September 2020, 15:30 CEST
Day 2: Assay Development Session
See full abstract HERE.
