Track 1: Developability & Candidate Selection
Speaker Bios

Russell Burge, Ph.D., Applications Scientist, Unchained Labs

Russell Burge earned a Ph.D. in molecular biology and biochemistry from The Scripps Research Institute in La Jolla, California. Russell received post-doctoral training at the University of Colorado, Boulder. Russell worked on the biophysical characterization of RNA and DNA aptamers relevant to the biopharmaceutical industry. Russell is an Applications Scientist at Unchained Labs where he designs and performs demonstrations of automated systems used in the research and development of pharmaceuticals.

Srinath Kasturirangan, Ph.D., Scientist I, Antibody Discovery & Protein Engineering, MedImmune

I have been working as a Scientist at Medimmune since November 2010. My primary responsibilities are supporting the ever growing Medimmune pipeline as well as technology development initiatives geared towards generation and characterization of novel bispecific antibody formats and antibody engineering for stability and half-life improvements. Prior to working at Medimmune, I got my PhD in Bioengineering at Arizona State University in the lab of Dr Mike Sierks working on antibody based therapeutics for Alzheimer's disease. My work involved targeting the misfolded beta amyloid oligomers using a novel biopanning protocol combining atomic force microscopy and phage display. I have several publications in peer reviewed journals and patents.

Hubert Kettenberger, Ph.D., Principal Scientist, Roche Pharma Research and Early Development (pRED)

Hubert Kettenberger holds a PhD in biochemistry from the University of Munich. After a PostDoc at the Max-Planck-Instutute for Biochemistry he joined the Large Molecule Research unit of Roche in Penzberg/Germany in the year 2006 and is now a Principal Scientist in the field of protein analytics. His areas of expertise include the biochemical and biophysical characterization of therapeutic proteins. Moreover, HK shaped strategies, in-vitro and in-silico methods for the assessment of new drug candidates (antibodies, bispecifics, next-generation biotherapeutics) for their “developability” aspects.

Pranay D. Khare, Ph.D., Consultant

Pranay D. Khare, Ph. D. has seventeen years of experience in biologic drug discovery and development including Phase I and II clinical trials in Immunotherapy and Gene therapy field. Currently Dr. Khare is working as independent consultant in the field of Cell Therapy, Gene Therapy, Immunotherapy and Tumor Targeting Strategies. Recently, Dr. Khare was the Director at Cancer Immunotherapy and Gene Therapy cGMP facility of Roger Williams Medical Center, Providence, RI; where his group was responsible for the genetic modification of T-cells with chimeric antigen receptor (CAR) for solid tumor clinical trials and bispecific antibody (BiAb) conjugated armed T-cells based clinical trials for solid tumors. Dr. Khare has expertise in novel biologic product discovery and development including their manufacturing in GMP and establish quality measures and procedures. Dr. Khare received several patents on his novel eukaryotic display technology that can identify the novel tumor specific polypeptides, receptors, ligands, biomarkers and antibodies at Mayo Clinic, Rochester, MN. Dr. Khare received his doctorate in T cell biology and pursed his scientific career in Cancer Immuno- and Gene Therapy field in different academia and industry. Throughout his career Dr. Khare has received research funding from the National Institute of Health (NIH), Susan G. Komen Breast Cancer Foundation, Leukemia Research Foundation, and other international funding agencies.

Torsten Kuiper, Dipl. Ing (FH), Prinicipal Scientist, Integrated Biologics Profiling, Novartis Pharma AG

Torsten Kuiper studied chemical engineering/biotechnology at the University of Applied Science in Emden (Germany) and received his degree as Graduated Engineer in 2001. Afterwards he worked nearly two years as Engineer in a commercial Biotechnology Manufacturing Unit of Roche in Penzberg (Germany). In 2002, he joined Novartis in Basel (Switzerland) as Scientist in Protein Analytics and headed later on the Affinity & Kinetics Expertise Lab of the Research Biologics Center. Since 2012 he has been heading the In-Vivo Fitness Assessment Lab within the Integrated Biologics Profiling unit. Torsten has more than 10 years of experience in the research and development of bio-therapeutics. His main expertise lies in the biochemical characterization of monoclonal antibodies and other therapeutic proteins as well as the development of new methods and strategies for developability assessment.

Dennis R. Livesay, Ph.D., Professor, Bioinformatics and Genomics, University of North Carolina at Charlotte

Dr. Livesay is a Professor of Bioinformatics and Genomics at the University of North Carolina at Charlotte. He received his PhD in Physical Chemistry from the University of Illinois in 2000, and joined the chemistry faculty at California State Polytechnic University at Pomona immediately thereafter. He moved to his current position in 2006. Dr. Livesay’s research interests are in the area of protein sequence/structure/function relationships. Specifically, he is focused on understanding how sensitive physical properties are to evolutionary events. He has coauthored over 50 peer-reviewed research papers, and is the editor of a volume in the popular Methods in Molecular Biology book series on protein dynamics. Dr. Livesay is on the editorial board of seven journals, including PLOS Computational Biology, BMC Bioinformatics, and Current Protein and Peptide Science.

Laura McIntosh, Ph.D., Vice President, Translational Research, Caprion Biosciences Inc.

Laura is VP, Translational Research at Caprion and is responsible for the scientific management of all proteomics collaborations. Before joining Caprion, Laura was GM of Osprey Pharmaceuticals, where she oversaw the development of therapeutic proteins. Prior experience includes positions at Advanced Research Technologies and Argose, developing novel optical and fluorescence technologies. Laura earned a Ph.D. in Cell Biology from the University of Manitoba, followed by a post-doctoral fellowship at the NRC.

Martin Pabst, Ph.D., Head of Bioconjugation and Analytical Chemistry, PolyTherics (Abzena)

Martin Pabst studied Chemistry at the University of Vienna, Austria and received a PhD in the field of bioanalytics at the University of Natural Resources and Life Sciences, Vienna, Austria. After a Post Doc and lecturer position at ETH Zurich, Switzerland he joined PolyTherics in 2014 as a team leader. Martin Pabst is currently Head of Bioconjugation and Analytical Chemistry and has established an analytical group performing characterisation of monoclonal antibodies and antibody drug conjugates.

Chetan N. Patel, Ph.D., Senior Research Scientist, Biotherapeutics Discovery & Research, Eli Lilly and Company

Dr. Patel received his Ph.D. in Chemistry from the University of North Carolina at Chapel Hill where he studied protein-protein interactions that mediate programmed cell death. He completed postdoctoral training in Biology at Stanford University where he characterized the mechanism of aggregation-induce proteasome impairment. Following his academic training, Dr. Patel joined Eli Lilly in 2009 and has focused on the optimization of diverse biotherapeutic platforms using developability assessment and rational protein engineering strategies.

Sylvain Raimondi, Ph.D., Head of Analytics Unit, Bioprocess R&D, Novimmune SA

Sylvain Raimondi has 15 years of experience in the field of analytical biotechnology, holding a Master’s degree in molecular chemistry from the University of Grenoble, France. Currently, he is leading the Analytics Unit in the Bioprocess R&D department at Novimmune SA (Geneva, Switzerland). His unit focuses on analytical development and validation for therapeutic monoclonal and bispecific antibodies and conducts drug substance (DS) and drug product (DP) long term stability, formulation and investigational studies as well as undertakes Process Characterization Studies for DS and DP Process Validation. He is also responsible for technical oversight of external CRO/CMOs for analytical activities. Prior to joining Novimmune in 2005, Sylvain worked in the Immunology Department at Covance, a Swiss-based CRO. From 2001 to 2005, he was in charge of the chemical synthesis of peptides and small proteins used in in vitro models in the Synthesis Department at GeneProt (Switzerland). Prior to GeneProt, Sylvain worked on therapeutic and vaccine approaches at Virbac (France).

Daniel Seeliger, Ph.D., Research Scientist, Discovery Research, Boehringer-Ingelheim

Daniel Seeliger studied Chemistry at the University of Ulm, Germany, and in 2008 obtained a PhD in Computational Biophysics from the Max-Plank-Institute for Biophysical Chemistry in Göttingen, Germany. After three more years as PostDoc in academia he joined the Computational Chemistry Group of Boehringer Ingelheim in 2010 where he established the computational support for biologics projects and also works on small-molecule drug discovery projects.

Meiri Shida, Ph.D., Researcher, Discovery Research, Chugai Pharmaceuticals Co., Ltd.

She joined Chugai Pharmaceutical as a Protein Analyst in 2008 where she evaluated the binding activity, physicochemical property and microheterogeneity of samples in the drug discovery phase, and she now addresses improvements to the evaluation system for manufacturability to accelerate the development of high-quality antibody drugs.

Tingwan Sun, Ph.D., Scientist, Protein Analytics, Adimab

Tingwan Sun earned his Ph.D. in Cell Regulation from University of Texas Southwestern Medical Center (UT Southwestern) at Dallas, Texas in 2008. His graduate study focuses on pre-adiocyte cell differentiation. He continued his Postdoc training on Protein Phosphatase in cell cycle regulation in Department of Pharmacology at UT Southwestern. In 2012, he joined Adimab as a Scientist in Protein Analytics. His work focus on characterization of antibodies and antigens. Also he is working on development of high-throughput methods to detect self and cross interactions of antibodies to evaluate the developablity of antibodies.

Amy Tam, MSc., Senior Scientist, Global Biotherapeutic Technologies, Pfizer, Inc.

  • Undergraduate and graduate study at NYU
  • Worked in industrial over 15 years
  • Research area consisted of protein purification and characterizations

Johnson Varghese, Ph.D., Head, Analytical Development, Shire

Johnson Varghese has over 21 years of experience in recombinant protein product development. Prior to joining Shire, as Head of Analytical Development in 2012, Johnson held positions of increasing responsibility at MedImmune, Amgen, and Abbott laboratories. His technical expertise is primarily in physicochemical methods development, assay qualification, and protein and carbohydrate characterization. Johnson has lead various analytical organizations focused on either early or late stage development. He holds a PhD in Analytical Chemistry from King’s College London and undergraduate degrees in chemical sciences from universities of East Anglia and Glasgow in the U.K.

Liangyi Zhang, Ph.D., Senior Scientist, Analytical Development, AbbVie Biotherapeutics, Inc.

Dr. Liangyi Zhang is a Senior Scientist in the Department of Process Sciences at Abbvie Biotherapeutics, Inc. He received his Ph.D. degree in analytical chemistry from Indiana University. His current research interest focuses on developing innovative chromatographic and mass spectrometric methods for characterization of therapeutic proteins.

Track 2: Advances in Characterization Methods & Approaches
Speaker Bios

Greg Adams, Ph.D., Director, Analytical Development, FUJIFILM Diosynth Biotechnologies

Dr. Adams has 20+ years of experience in analytical development, specializing in the mass spectrometric characterization of protein based biopharmaceuticals. He received his doctorate from the University of Adelaide. His experience includes postdoctoral research at the University of California, Bioreliance and the last 17 years at FUJIFILM Diosynth Biotechnolgies where he currently leads the Analytical Development department.

Oleg Borisov, Ph.D., Director, Analytical Development, Novavax

Dr. Oleg V. Borisov earned a B.S. degree in Chemistry at Moscow State University (1992), and received his Ph.D. in Chemistry from Wayne State University (1997), after which he completed his post-doctoral studies at Lawrence Berkeley National Laboratories and Pacific Northwest National Laboratories. His background includes experience with analytical methods for characterization of biotherapeutic proteins and vaccine products, with emphasis on liquid chromatography and mass spectrometry methods. Dr. Borisov held positions at Genentech and Amgen with responsibilities that included protein characterization, testing improvement, leading innovation and CMC strategy teams. He is currently a Director at Novavax, Inc., developing methods and strategies for analysis and characterization of recombinant vaccines, based on nano- and virus-like particle technologies. His credits include several student awards, a book chapter, and over 25 scientific publications.

Roger Bosse, Strategic Product Development, Human Health, PerkinElmer

Dr. Bosse hold a Ph.D in Pharmacology, and Doctoral training in Neuroendocrinology from Duke University. Dr. Bosse joined BioSignal in 1996, as the R & D Group Leader. After BioSignal was acquired by Packard in 1998, he was promoted Associate Director R & D. Dr. Bosse and team initiated the development of the AlphaLISA platform after the merger of PerkinElmer and Packard BioSciences in 2001. In 2006, he transitioned to Business and Sales Development.

Michael Butler, Ph.D., Scientific Director of MabNet, Distinguished Professor, Department of Microbiology, University of Manitoba

Michael Butler is a Distinguished Professor of Animal Cell Technology at the University of Manitoba, Canada. His previous appointments include Associate Dean of Scientific Research at Manitoba and Principal Lecturer in Biotechnology at Manchester Metropolitan University. He has also been a Visiting Scientist at MIT (USA), Animal Virus Institue (Pirbright, UK) and the Universities of Oxford and Rio de Janeiro. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). His research work and teaching focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines. He is particularly interested in the bioprocess conditions that can be used to control the biochemical structure of glycoproteins. He has always collaborated closely with industry and is a past recipient of the Canadian national Synergy Award for University-Industry innovation. He is presently director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development.

Jeffrey Glenn, Ph.D., Associate Director, Analytical Development, Bristol-Myers Squibb

Jeffrey Glenn received his BA in Biochemistry from Northwestern University and PhD in Biochemistry from Oregon Graduate Institute. After a post-doctoral fellowship at the University of Rochester on the biochemistry of Alzheimer’s disease Jeff started his career in business at DuPont Medical Products developing research-focused immunoassay kits. For the last 20 years he has worked for the pharmaceutical industry leading groups involved with the development of bioassays and immunoassays, and the testing of process development and clinical samples. He has held varying responsibilities at RW Johnson Pharmaceutical Research Institute, Human Genome Sciences, Curagen Corporation, Centocor R&D, and Bristol-Myers Squibb Company, where he is now Associate Director in the Analytical Development Bioassay Center of Excellence. During his career Jeff has worked on the development of assays for over 20 protein drugs.

Michael Gross, Ph.D., Professor of Chemistry, Washington University in St. Louis

Michael Gross is professor of Chemistry, Medicine, and Immunology at Washington University in St Louis. He has worked in mass spectrometry for 48 years, emphasizing instrumentation, ion chemistry, environmental applications, and recently the biophysics applications of MS. His laboratory has extended methods in HD exchange, developed FPOP, implemented ion mobility and native spray for large proteins and protein complexes, and utilized protein crosslinking. These methods, in combination, provide a particularly effective approach for characterizing proteins. He is the coauthor of over 550 scientific articles and book chapters.

Jeffrey W. Hudgens, Ph.D., Research Chemist, Biomolecular Measurement Division, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology

Dr. Hudgens conducts research that improves and validates hydrogen-deuterium exchange mass spectrometry as a method for evaluating similarity among an innovator drug, its subsequent production lots, and its competing biosimilars. Dr. Hudgens received his BS in Chemistry from Miami University (Ohio) and his PhD from the University of Illinois at Urbana. He was awarded a National Research Council Postdoctoral Associateship at the Naval Research Laboratory, where he conducted research for another seven years as a staff scientist. In 1984 he moved to the National Bureau of Standards (now NIST). His 130 publications and two patents span many topics including biochemistry, optical spectroscopy, mass spectrometry, thermochemistry, and nanoparticles. Dr. Hudgens is a Fellow of the American Physical Society.

Igor A. Kaltashov, Ph.D., Professor and Graduate Program Director, Department of Chemistry, University of Massachusetts-Amherst

Igor A. Kaltashov received his undergraduate degree at Moscow Institute of Physics and Technology in 1989 and a Ph.D. degree from the University of Maryland Baltimore County in 1996, where he worked on applications of mass spectrometry to problems in biochemistry under the guidance of Prof. Catherine Fenselau. Following two years as a post-doctoral fellow at Johns Hopkins Medical School (with Prof. Robert J. Cotter), he became a Director of the newly created Mass Spectrometry Center at the University of Massachusetts-Amherst in 1997. He was appointed an Assistant Professor in Chemistry at UMass-Amherst in 2000 and promoted to Associate Professor with tenure in 2006, and to Full Professor in 2011. His research program is focused on developing mass spectrometry-based experimental techniques to study structure, conformation, dynamics and interactions of biopolymers. The group actively collaborates with several biopharmaceutical companies, including Biogen IDEC, Pfizer, Alexion and Shire. Prof. Kaltashov co-authored over a hundred papers and book chapters, and a monograph “Mass spectrometry in biophysics: Conformation and dynamics of Biomolecules,” whose second edition was published in 2012.

Richard Ludwig, Ph.D., Principal Scientist, Molecular Analytics and Development, Bristol-Myers Squibb

Dr. Ludwig has 10+ years of industrial experience within the biopharmaceutical industry focusing on issues of protein characterization.

Anastasiya Manuilov, M.Sc., Senior Scientist, Analytical R&D, Pfizer, Inc.

Anastasiya Manuilov is a Pfizer member of the Analytical Research and Development (ARD) group located in Andover, Massachusetts. She has been with Pfizer / Wyeth for over 10 years, and has received her M.S. degree from the University of Massachusetts, Amherst. Anastasiya is responsible for developing analytical methodologies and strategies needed to progress biotherapeutic products through the pipeline. This includes method development and qualification, in-process, formulation and stability support and biochemical characterization of early- and late-stage PharmSci products. In addition, Anastasiya is a member of ARD's Technology Development committee, and on behalf of Project Progression Line 3 (PPL3) group advances continuous improvement projects and innovative, state-of-the-art technologies.

Robert Ernst Mayer, Ph.D., Scientist, Characterization Group, Sandoz GmbH

Dr. Robert Mayer received his Ph.D. at the University of Innsbruck in the field of analytical chemistry in 2009, where he was mainly dealing with plants and plant extracts to determine their antibacterial activities. When joining Sandoz GmbH in 2009 as a laboratory head, he was mainly responsible for characterization of proteins and peptides with chromatographic and mass spectrometric tools within the analytical characterization group. In his new role as analytical scientist, Dr. Robert Mayer mainly deepened his project responsibilities in the coordination of analytical tasks for a biosimilar project.

Dominik Mertens, Ph.D., Scientific Account Manager, Genedata

Dominik Mertens studied Bioinformatics and Genome Research at the University of Bielefeld (Ge). He received his PhD I Bioinformatics at the University of Freiburg (Ge) and works for Genedata in Basel (CH) for more than 3 years. His work encompasses characterization of biotherapeutics by MS using intact mass, peptide mapping and host cell protein (HCP) data. Customer projects include the processing of MS data and statistical analysis of complex experimental designs.

Hans-Martin Mueller, Director, BioProcess Development, MSD Merck

Martin Mueller, Ph.D., Biotech Engineer, started his career at a Biotech startup in Berlin. Following this he joined a globally acting CRO headquartered in Basel, Switzerland (RCC, today: Harlan Labs). There he worked as a GLP study director for close to hundred clients from the agrochemical industry and from big pharma companies. With this experience he joined Schering-Plough’s biotech division and built-up the new Global GMP Labs. In 2012, Martin relocated to New Jersey, U.S., and accepted a position within Merck’s BioProcess Division responsible for development and commercialization of biological key products. Today, he manages a biotech team co-located in Europe and in the U.S.

Yan Wang, Ph.D., Scientist, Analytical Development, Biogen

I received my Ph.D degree in Biochemistry from Boston University School of Medicine. I am currently working in the department of Analytical Development, Biogen. As a scientist, my job focuses on LC-MS based protein characterization to support protein quality attribute analysis.

Jason Wood, Ph.D., Market Manager, Biopharmaceuticals, Bruker

With a Ph.D. in Bio-organic Chemistry (University of Buffalo), Dr. Wood spent a number of years in the pharmaceutical industry before becoming the Global Product Line Manager of Quadrupole Mass Spectrometry at Varian Inc. After Varian, he was Senior Product Manager of Bio IC at Dionex Corp, and successfully released the world's first capillary ion chromatography system. He is currently the Market Area Manager for Biopharmaceuticals at Bruker, managing the biotherapeutics space.

Baolin Zhang, Ph.D., Senior Investigator, Product Quality Reviewer, Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), US Food & Drug Administration (FDA)

Baolin Zhang is a Senior Investigator and a Product Quality Reviewer in the Office of Biotechnology Products of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA). Dr. Zhang has 15 years of FDA regulatory experience in product quality review (Chemistry, Manufacturing and Control) of therapeutic protein product applications under investigational new drug applications (INDs) and biologic license applications (BLAs). He also leads a research team conducting FDA mission-related research aimed at improving drug safety and efficacy. Dr. Zhang’s scientific expertise lies in the areas of protein biochemistry, cell death and cell survival regulation, targeted cancer therapy, cancer biomarkers, and analytical assessment of therapeutic protein products. He has published over 75 original studies in prestigious journals, and presented at numerous scientific and regulatory conferences on the development of therapeutic proteins and predictive cancer biomarkers. Dr. Zhang serves as an Editorial Board member and as an ad hoc reviewer to numerous scientific journals. He has supervised and mentored many research fellows and regulatory staff. Dr. Zhang earned his Ph.D. in chemistry from Peking University in China. He is a recipient of the FDA Scientific Achievement Award, the FDA/CDER Excellence in Mentoring Award, the FDA/CDER Excellence in Leadership Award, and the FDA/CDER Team Excellence Award.

Xiaoyang Zheng, Ph.D., Senior Scientist, Analytical Development, Sanofi US

Xiaoyang Zheng is currently a Senior Scientist in the Department of Analytical Development at Sanofi US. She received her Ph.D. at Northeastern University in 2007. She focuses on using analytical techniques to characterize glycoproteins, carbohydrates-conjugated proteins, antibodies, carbohydrates, and small molecule impurities to support new methods development, co-qualification, and co-validation. She is an Analytical Subteam Leader of two critical programs of Sanofi and supports product development and corresponding regulatory filings.

Qinwei Zhou, Ph.D., Vice President, BioAnalytical Science, Eli Lilly and Company

Dr. Qinwei Zhou has over 25 years of biotech and bioparm experience, with more than 18 years of industry executive management experience from many different biotech and pharmaceutical areas. Currently is Vice President of BioAnalytical Science at Eli Lilly and Company. Major contributions to IND, BLA submissions/approval (Erbitux, Cyramza) and other biologics, and discussions with FDA, EU, Health Canada and other regulatory agents. Graduated with M.S. and B.S. in Chemistry from Fudan University in China. Earned a Ph.D. and M.Phil. from City University of New York in US. Appointed as Research Assistant Professor of Microbiology & Immunology at New York Medical College for 4 years after obtained Ph.D.

Track 3: Comparability & Biosimilarity
Speaker Bios

Nila Das, Ph.D., Senior Research Investigator, R&D, Bristol-Myers Squibb

Nila Das is a Senior Research Investigator in the Research and Development at the New Brunswick R&D site of Bristol-Myers Squibb in New Jersey. Her research interests include therapeutic monoclonal antibodies, antibody-drug conjugates. Most recently she had led the development of parenteral products at Boehringer Ingelheim. She had obtained her Ph.D. in Industrial Pharmacy from St. John’s University in 2008.

Adam Fung, Ph.D., Principal Scientist, Analytical Development, Agensys, Inc.

I am a protein biochemistry/biophysics scientist with a Ph.D. from the University of Maryland. Thus far in my career at Seattle Genetics and Agensys, I have developed a strong background developing and implementing a diverse array of analytical techniques to characterize physiochemical and immunochemical properties of monoclonal antibodies and antibody-drug conjugates (ADCs), including ADCs conjugated at cysteines involved in interchain disulfides as well as site-specifically with auristatin, auristatin-like, and pyrrolobenzodiazepine dimer (PBD drug-linkers.

John P. Gabrielson, Ph.D., President, Elion Labs

John P. Gabrielson co-founded Elion Labs with the vision to set the world wide standard for characterization of biopharmaceuticals. Prior to Elion, John led a multi-disciplinary analytical organization at Amgen focused on developing and implementing biophysical and particle characterization methods for higher order structural characterization and comparability testing of all protein products from late-stage clinical development through commercialization and post-approval. He has developed a number of improvements to biophysical characterization methods, from which he has delivered invited presentations, been issued one patent, and written numerous articles and book chapters. John received his Ph.D. in Chemical Engineering from the University of Colorado. His research interests include protein higher order structure characterization, aggregation and particle formation mechanisms, and applications of statistical modeling and simulation to evaluate analytical method capability.

Robert Kutlik, MSc., Scientist, Biotherapeutics Analytical R&D, Pfizer, Inc.

Robert Kutlik joined Pfizer’s BioTherapeutics PharmSci ARD in 2011. At Pfizer Robert works within the Mass Spectrometery and Biophysical Characterization group. Robert earned his Bachelor and Masters degrees in chemistry from the University of Georgia in Athens, GA.

Jasper Lin, Ph.D., Technical Development Scientist, Late Stage Pharmaceutical Development, Genentech, a Member of the Roche Group

Jasper earned his B.S. from University of California in Berkeley and Ph.D. from University of Washington in Seattle in biophysical chemistry. After a post-doc at the Puget Sound Blood Center – Research, he joined Genentech in 2010 as a formulation scientist. While supporting numerous development projects, his research interests include higher order structure, protein-protein interactions and protein degradation.

James Prescott, Ph.D., Associate Director, Analytical Development, Momenta Pharmaceuticals

Jim Prescott is an Associate Director of Analytical Development at Momenta Pharmaceuticals. In this role Jim supports Momenta’s approved complex generic products Enoxaparin Sodium Injection and GlatopaTM, and also provides technical support to Momenta’s Novel Products and Biosimilars programs. Jim’s experience includes formulation development, development of targeted and controlled drug delivery platforms, and development of marketed nanoparticulate drug products. Jim received his Ph.D. in Physical Chemistry from the University of Massachusetts, Amherst.

Susan Park, Ph.D., Senior QC Scientist, Global Biologics QC, Genentech, a member of the Roche Group

I am currently responsible for reference standards for commercial biological products at Genentech. I have experience in areas of Quality Control, Analytical Development for late-stage and commercial biotech products, comparability, method transfer and process validation support, through my current role and previous positions at Novartis Diagnostics, Tercica and MedImmune.

Íñigo Rodríguez-Mendieta, Ph.D.,  Manager Biophysical Group,  SGS Life Science Services

Iñigo joined SGS in January 2012 in the UK as an expert in Biophysical Analysis to support the provision of biopharmaceutical services in the SGS Life Science Services Division. He obtained his degree in Biochemistry at the University of the Basque Country (Spain) and his PhD at Leeds University (UK) developing ultrafast mixing technology for rapid kinetics of proteins using UV Resonance Raman spectroscopy. Following his doctorate studies, Iñigo joined a small CRO venture where he was in charge of the development of biophysical analysis services for the Biopharmaceutical Industry. After this, he returned to academia for a short period of time before becoming a freelancer consultant for the Biopharmaceutical Industry in the field of biophysics and pre-formulation. Iñigo has extensive experience in the characterisation of proteins in solution using biophysical techniques such as CD, FTIR, Raman, UV Raman, SVAUC, DLS, DSC and fluorescence spectroscopy among others. He actively applies his expertise in biophysics and biochemistry in the analytical services offered by SGS LSS. Inigo has recognized expertise within the Biopharmaceutical Industry in biophysical methods and its applications in Biotherapeutics Development. His scientific leadership in the field of biophysical analysis is proven by an uninterrupted professional dedication to the promotion and implementation of biophysical analysis within the Biopharmaceutical Industry.

Michael Tovey, Ph.D., INSERM Director of Research, Laboratory of Biotechnology & Applied Pharmacology, Ecole Normale Superleure de Cachan

Michael G. TOVEY, Ph.D, is INSERM Director of Research in the Laboratory of Biotechnology and Applied Pharmacology, CNRS UMR 8113 at the Ecole Normale Supérieure, Cachan, France. He is the author of more than 250 articles on interferon, cytokines, biotechnology, and immunogenicity. He is a member of numerous scientific boards and is French representative for the ICIS membership. He is chair of the International Cytokines Standards Committee, a member of the ICIS Meetings Committee, and a member of the European Adjuvant Advisory Committee. He is editor-in-chief of Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations, Associate Editor of Cytokine, Associate Editor of the Journal of Interferon and Cytokine Research, Associate Editor of The Scientific World Journal and a member of the Editorial Board of the Journal of Immunoassay & Immunochemistry. He is chair of Coral Gables

Desiree Tsao, Ph.D., Associate Director, Analytical Development, Momenta Pharmaceuticals

The author is an Associate Director in Analytical Development at Momenta Pharmaceuticals. Her group is responsible for method development and characterization/comparability tests for biologics in late stage development using NMR and biophysical techniques. Prior to working in the pharmaceutical industry, she received her PhD in Physical Chemistry from UC Davis, and was a post-doctoral fellow at the National Institutes of Health. She has co-authored over 25 peer-reviewed publications.

Xing Wang, Ph.D., President, R&D, Array Bridge, Inc.

Xing Wang, Ph.D. is President of Array Bridge Inc. Before establishing Array Bridge Inc., Xing worked at Pfizer for 14 years and was a Group Leader and Associate Research Fellow. His experience includes small molecule and protein therapeutics drug discovery and development, successful application of proteomics, genomics and bioinformatics to target identification and validation in the small molecule drug discovery, development of protein therapeutics, building platforms for the identification and characterization of process-related impurities such as host cell proteins (HCPs) and residual DNA (rDNA). Xing has more than 30 publications including many in biologics development. Xing’s current focus is the development of antibody arrays for therapeutic protein Higher Order Structure analysis and products in functional proteomics area for drug target identification and drug safety evaluation.

Simon Yeung, MSc., Research Associate II, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.

Simon Yeung is currently a Research Associate in the Protein Biochemistry division of the Preclinical Development department at Regeneron Pharmaceuticals, Inc. in Tarrytown, NY. His responsibilities include the development of protein characterization methods and application support of CMC regulatory filings, with an emphasis on calorimetric, electrophoretic, and light scattering techniques. Prior to his work at Regeneron, Simon worked as a graduate assistant in the lab of Dr. Donald Bryant and Dr. John Golbeck at Penn State University, where he earned a M.S. in the biochemistry, microbiology, & molecular biology program. He mainly studied iron-sulfur cluster proteins by characterizing their structure and functions with biophysical and biochemical techniques primarily using EPR and various optical techniques.

SC1: Sub-Visible Particles, Aggregates and Impurities: Measurement, Characterization and Impact

Dean Ripple, Ph.D., Supervisory Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology

Dean received a Ph.D. from Cornell University in 1991. After a successful career at NIST developing methods and standards in thermometry, in 2010 he became Leader of the Bioprocess Measurements Group, which conducts research supporting biomanufacturing and health care. His own research focuses on new standards and methods for characterizing protein particulates. Dean has presented workshops on measurement issues to many industrial groups, ranging from petroleum producers to vaccination program coordinators. . He is an active member of the NCSLI Healthcare Metrology subcommittee, the ASTM committee on the Manufacture of Pharmaceutical Products, and expert panels of the US Pharmacopeia. In recognition of his contributions, he has received awards from the Department of Commerce, ASME, and ASTM committee E20 on Temperature Measurement.

Srivalli Telikepalli, Ph.D., Research Chemist, Biomolecular Measurement, National Institute of Standards and Technology

Srivalli Telikepalli received a B.A. degree in chemistry at Cornell University in 2008 and a Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 2014. Her thesis work was focused on understanding and characterizing protein aggregates and particles as a function of the many types of stresses that biopharmaceuticals are likely to encounter over their life span. In addition, she has had the opportunity to work on many collaborations with biotechnology/pharmaceutical companies. In one collaboration with Amgen, she worked on understanding the relationship between protein particle properties and in-vitro immune responses using human immune cells. Upon completion of graduate school, she started working as a Research Chemist at the National Institute of Standards and Technology (NIST) in the Biomolecular Measurement Division in Dean Ripple’s group. Currently, her work at NIST focuses on developing protein-like particle standards.

Maryam Mazaheri, M.S., PMP, CMC Project Manager, Pipeline Management, Medimmune

Maryam Mazaheri has been a stability coordinator and subject matter expert on visual inspection since 2006. She has done extensive work in developing Semi-quantitative method monitoring small inherent visible particles during product development and in clinic. She holds a B.S. in Cellular, Molecular biology and Genetics from University of Maryland and M.S. in Biotechnology from John Hopkins University. Currently she is a CMC Project Manager for MedImmune, a member of the AstraZeneca Group.

SC2: Glycobiology of Antibodies

T. Shantha Raju, Ph.D., Scientific Director, Biologics Research, Janssen Research & Development, LLC

Dr. T. Shantha Raju (Raju) is currently working as a Scientific Director at Janssen R&D of Janssen Pharmaceutical Companies of JNJ. Dr. Raju joined Centocor Inc in 2004 which became Janssen R&D in 2011. At Centocor Dr. Raju has worked as an Assistant Director and then as a Research Fellow. Prior to Centocor, Dr. Raju has spent more than 5 years at Genentech and little more than a year at Fibrogen. Dr. Raju’s research interest is to explore structure-function relationship of antibody glycosylation and glycoprotein therapeutics. Dr. Raju has more than 18 years of experience in the research and development of biotherapeutics including monoclonal antibodies and glycoproteins. Dr. Raju was involved in the development of leading cancer therapeutics such as Rituxan, Herceptin, Avastin and immunology therapeutics such as Remicade, Simponi, Stelara, Daratumumab etc. Dr. Raju has published more than 40 research articles, several reviews and book chapters. He is currently in the editorial board of mAbs, Analytical Biochemistry, BioProcess International and Drug Discovery and Development journals. Dr. Raju has been a member of ACS and Division of Carbohydrate for the last 25 years. He is also a member of ASBMB for the past 18 years.

SC3: New Analytical Approaches & Strategies for Comparability and Biosimilarity

Hans-Martin Mueller, Director, BioProcess Development, MSD Merck

Martin Mueller, Ph.D., Biotech Engineer, started his career at a Biotech startup in Berlin. Following this he joined a globally acting CRO headquartered in Basel, Switzerland (RCC, today: Harlan Labs). There he worked as a GLP study director for close to hundred clients from the agrochemical industry and from big pharma companies. With this experience he joined Schering-Plough’s biotech division and built-up the new Global GMP Labs. In 2012, Martin relocated to New Jersey, U.S., and accepted a position within Merck’s BioProcess Division responsible for development and commercialization of biological key products. Today, he manages a biotech team co-located in Europe and in the U.S.