Meet Our 2017 BEBPA Board of Directors and Observers

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.

Board Members

Bassam Hallis

Bassam Hallis, Ph.D, Head of Preclinical Development, PHE

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.

LOCATION:
Salisbury, UK

TELEPHONE:
+44 (0) 1980 612310

EMAIL ADDRESS:
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Hans Joachim

Hans Joachim Wallny, Ph.D, Novartis

Dr. Hans-Joachim Wallny is a Technical project leader at the departement „TRD Biologics“, Novartis Pharma AG Switzerland. He was leading the technical team who recently 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 bio­pharmaceuticals during early development. Prior 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 departement, 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) after receiving his Ph.D. degree in Biochemistry/Immunology from the University of Tübingen, Germany. Dr. Wallny received a diploma in biochemistry from the University of Tübingen, Germany in 1989.

LOCATION:
Novartis Pharma AG

TELEPHONE:
+41 61 324 7383

EMAIL ADDRESS:
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Laureen Little

Laureen Little, Ph.D., Principal Consultant, Quality Services and President (BEBPA)

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.

LOCATION:
Seattle, WA

TELEPHONE:
951-659-1957

EMAIL ADDRESS:
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Jane Robinson

 C. Jane Robinson, Ph.D., Consultant

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.

LOCATION:
United Kingdom

TELEPHONE:
n/a

EMAIL ADDRESS:
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 Denise Krawitz, Ph.D., Principal Consultant, CMC Paradigms LLC

Denise Krawitz, Principal Consultant at CMC Paradigms LLC, is based out of the San Francisco Bay Area.  With over 15 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.

LOCATION:
South San Francisco, CA

TELEPHONE:
n/a

EMAIL ADDRESS:
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Board Member Emeritus

Stan Deming

Stan Deming, Ph.D, Statistical Designs

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.

LOCATION:
El Paso, TX

TELEPHONE:
281-841-3992

EMAIL ADDRESS:
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Observers

Cori Schrader

Cori Schrader, Meeting Organizer, BEBPA

Cori graduated from the University of California, Davis with Bachelor of Arts degrees in Political Science and History.  She has over a decade of experience in corporate event planning, both in the US and throughout Europe. Cori holds a certificate of Meeting and Event Planning from California State University, Sacramento and is a member of Meeting Professionals International and the Independent Meeting Professionals of Sacramento.

LOCATION:
Citrus Heights, CA

TELEPHONE:
916-747-6205

EMAIL ADDRESS:
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Patricia Koutz

LOCATION:
San Diego, CA

TELEPHONE:
n/a

EMAIL ADDRESS:
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Retired Board Member

Martin Vanderlaan

Martin Vanderlaan, Ph.D, Former Director of Analytical Operations, Genentech

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.

LOCATION:
San Francisco, CA

TELEPHONE:
n/a

EMAIL ADDRESS:
n/a

Tech Specialist

Dennis Schrader

Dennis Schrader

Dennis has more than 25 years’ experience in the customer service industry. He also has 25 years of event planning and marketing experience. Dennis is also the owner and operator of Dennis Schrader Photography. With a background in photography and graphic editing, anything is possible.

LOCATION:
Citrus Heights, CA

TELEPHONE:
916-747-2475

EMAIL ADDRESS:
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