Dr Bassam Hallis. Bassam has over 25 years experience in scientific research including 15 years in regulated activities including vaccine evaluation, release/stability and clinical trial serology. He has extensive experience in assay development and validation including cell based and functional assays as well as technology transfer of early stage and validated tests.

Dr. Hans-Joachim Wallny is Executive Director Scientific and Strategic Excellence in Technical Projects and Portfolio Manager of Technical R&D, Novartis Pharma AG Switzerland.

Before his current assignment, he was Development Unit Head Biologics Project Management, leading a group of several Technical Project Leaders in specific indication areas (Cardiovascular, Respiratory) for the CMC development of Biologic drugs.

In 2007, Hans-Joachim became a Technical Project Leader to lead CMC teams for the development of Biologic drug candidates. Amongst several project assignments, he was leading the CMC team who achieved the approval of a monoclonal antibody (ILARIS) for the treatment of a rare autoinflammatory disease (CAPS) in US, EU and Switzerland.

Before this assignment, he was head of a Bioanalytics group, responsible for the development and validation of biological potency assays and high molecular impurity assays for bio¬pharmaceuticals during early development. Prior to this, he was head of the Bioassay group, which included the responsibility for routine performance of bioassays for marketed products.

One of his main scientific ambitions was to develop and implement modern, fast, and reliable bioassays using early cellular events as read-outs (e.g., reporter gene assays, KIRA assays, etc.). For this, he was honored with the title “Novartis Leading Scientist” in 2003.

Prior to joining Novartis in 1997, he was a Lab Head in the Biotechnology Department, Research and Development of Biotest Pharma GmbH, Germany, responsible for the development of bioanalytical methods and analytics for preclinical/clinical trials (1995-1997).

Dr. Wallny was previously a Scientist at the Basel Institute for Immunology, Switzerland (1992-1995). He received his Ph.D. degree in Biochemistry/Immunology from the University of Tübingen, Germany in 1989.

Dr. 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. Dr. Little 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.

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

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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.

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.

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. 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.

Stanley N. Deming, Ph.D. 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.

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.

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.

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.

Dr. 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. Dr. Little 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.

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.

Karen Bertani is a Certified Meeting Professional with over 30 years’ experience in managing professional events in the US and internationally. Karen’s three decades of passion, integrity, and dedication to organizational success have justifiably earned her the greatest respect among highest levels of biopharma industry and regulatory leaders around the world.

Her greatest career efforts (to date!) have been spent with CASSS, the non-profit scientific society that is globally recognized for its excellence among biopharma organizations. Over her 24 years with CASSS, Karen designed, implemented, and managed the key administrative systems required to produce meaningful industry-regulatory conferences, support valuable scientific publications, and sustain organizational solvency.

Karen has a proven talent for building and maintaining cross-functional relationships with internal and external stakeholders for the sole objective of producing exemplary scientific content. She has considerable expertise in working with international industry, government, and academic conference committees to generate timely, meaningful deliverables. She is also highly skilled in garnering financial support from relevant industry sponsors to provide a variety of means to encourage dialog, and freely share knowledge.

However, Karen does not believe a non-profit professional organization should be forced to grow solely for growth’s sake. Her perspective is that a small organization must be both credible and sustainable, with the ability to deliver the highest quality content in the best possible venues at the lowest cost to attendees. Growth, if any, should be dictated by the stakeholders themselves, and should be measured and meaningful.

Karen is delighted with the opportunity to work with BEBPA in continuing its mission as an international forum for the biopharmaceutical community.

Caitlin is one of BEBPA’s exhibitor liaisons. She creates the informational packets, keeps our exhibitors informed, organizes set-up during BEBPA conferences, and completes the virtual training for all exhibitors.

Caitlin, a second-year biomedical engineering student, began her work with BEBPA in 2020 in Database Entry. During this time, she discovered a love for the sciences and began the journey of pursuing her Bachelor of Science. Over the years, she has had an opportunity to grow into the Exhibitor Liaison role.

She also works within BEBPA’s marketing department as one of our social media managers.

Working with the rest of the marketing team, Ryann creates, schedules, and organizes BEBPA’s social media, other marketing pieces and miscellaneous design assets.

Ryann holds a degree in Fine Arts focusing in Visual Communication from Eastern Washington University. She joined the BEBPA team in 2023 and is looking forward to pushing the boundaries of BEBPA’s marketing capabilities.

Patricia Koutz is BEBPA’s In-Person Speaker Coordinator. She communicates with all in-person speakers at BEBPA hybrid conferences to ensure they are well informed and prepared for their presentations. She is also BEBPA’s Website Manager.

Patricia received her Bachelor’s degree in Biochemistry & Cell Biology from the University of California, San Diego. She has 20 years of experience in research labs, including early work on heterologous gene expression in the methylotrophic yeast Picha pastoris at SIBIA Neurosciences, and running high throughput sequencing labs and cloning at LSRL-Baxter Diagnostics & Chugai Biopharmaceuticals. She was Director of R&D at V&P Scientific for 9+ years and enjoyed working with her friends at Atlantic Lab Equipment as a Technical Sales Specialist for ~3 years. In 2008, Patricia joined the BEBPA Board of Directors until 2013, when she took over BEBPA’s database & website management. In 2019, she became BEBPA’s Conference Producer & Website Manager. In addition to BEPBA, Patricia has been the Marketing & Training Coordinator at FasTrain Courses since 2013.

Anastasia started at BEBPA as a Data Specialist and was offered to be trained into accounting. Growing within BEBPA project-by-project, currently, she is BEBPA’s AR/AP Manager. She has handled full-cycle GL accounting and financial analytics (under the guidance of the BEBPA board and third-party CPAs) for over 5 years. She works with non-profit and for-profit clients on business process improvement through the financial lens.

Anastasia received a B.A. in French (minor in Microbiology) from the University of Washington, where she developed her skills for managing both quantitative and qualitative data. She also graduated from the CORe program at Harvard Business School Online where she studied business analytics, economics for managers and financial accounting. She is currently working through Google’s Data Analytics certificate program.

Anastasia speaks French and Russian, and currently learning Portuguese. So come say hello to her at the next conference!