METHOD DEVELOPMENT, QUALIFICATION & VALIDATION
March 4-5, 2019
Marla Abodeely, PhD, Head, Bioassay/Immunoassay Method Development, Shire Pharmaceuticals
Marla Abodeely has been working in the Bioassay/Immunoassay field for over 12 years. During this time, she has worked with both small and large pharmaceutical companies in all stages of product development, from discovery to post-commercialization. Her primary focus has been protein therapeutics, including enzymes, GPCRs and antibodies. She is currently the Head of Bioassay/ Immunoassay (Potency and Process Residuals) Analytical Method Development at Shire Pharmaceuticals located in Lexington, MA. She received her B.S. in Biology at Columbia University in New York, NY with a focus in molecular genetics and earned her Ph.D. in the Biomedical Sciences at the University of California, San Francisco (UCSF) with a focus in biochemistry and cell biology.
Liching Cao, PhD, Director,Bioanalytical Operations, Sangamo Therapeutics, Inc.
Liching Cao is a Director of Bioanalytical Operations at Sangamo Therapeutics, focusing on bioanalytical assay development, validation and bioanalytical assay outsourcing in support of nonclinical and clinical studies across the company’s portfolios. At Sangamo, Liching is also responsible for interfacing with the clinical team, qualifying and overseeing external laboratories for assay set up and sample analysis. She has over 20 years of industry experience with 13 years focused on regulated nonclinical and clinical bioanalysis. Prior to joining Sangamo Therapeutics in 2016, she served as a bioanalysis supervisor managing the GLP laboratory at XOMA. Liching earned her BS in Biochemistry from University of Washington, Seattle.
Zhongying Chen, PhD, Senior Scientist, Analytical Bioassay Development, MedImmune
Zhongying Chen is currently a senior scientist in the analytical development group at MedImmune, the biologics unit of AstraZeneca. She is mainly working on the analytical method development and characterization of oncolytic virus and viral gene therapy products. Prior to that, she was the technical lead in the research and development of live attenuated influenza vaccines (LAIV) for more than 10 years. She has nearly 30 peer-reviewed publications and a number of key patents on LAIV development. She earned a Ph.D. degree in Molecular Biology and Biochemistry from Rutgers, the State University of New Jersey, USA.
Kuruppu Dharmasiri, PhD, Senior Scientist, Global Technical Operations, AstraZeneca Biologics
Kuruppu Dharmasiri is a senior scientist at the global technical operations group of AstraZeneca Biologics. Kuruppu received his Ph.D. in Analytical Chemistry from Michigan State University and completed postdoctoral training at the University of Nebraska. He has more than 20 years of experience in the areas of bioanalytical techniques, regulatory guidelines and biotechnology processes. His experience includes development and validation of analytical methods used in product release and stability programs, bio-therapeutics characterization, process characterization, supporting investigations to solve manufacturing issues and assessment of extractables and leachables in single use systems. Currently Kuruppu is leading analytical method transfer to global sites.
Deepika Gollapudi, Msc, Scientist, Analytical Development, VRC/Vaccine Production Program, National Institutes of Health
Dr Gollapudi obtained her MS in biotechnology from University of Houston and is currently working as a Scientist at vaccine production program/vaccine research center at NIAID/NIH. She has 8+ years of experience in analytical method development for various products including virus-like particles, fusion proteins, nanoparticles and monoclonal antibodies.
Gunasekaran Kannan, PhD, Senior Director, Biotherapeutics, Denali Therapeutics, Inc.
Dr. Guna Kannan has more than 15 years of experience in protein engineering and developing innovative technologies such as multi-specific antibodies. He currently holds Senior Director position at Denali Therapeutics and leads Biotherapeutic Discovery unit. Prior to joining Denali, he was Director of Antibody Engineering and CMC at Santen Inc. & Affinita Biotech and Principal Scientist and Protein Engineering and Optimization group head at Amgen. Guna has co-authored 60+ peer-reviewed research articles and patents on clinical molecules and novel technologies.
Holly London, PhD, Scientist II, QC, Biomarin Pharmaceuticals
Holly London is currently a Scientist at BioMarin Pharmaceutical, Inc in Quality Control Analytical Technologies. In her current role, she is responsible for method transfer, validation, and optimization. Prior to joining BioMarin, Holly worked in R&D at Affymax and MSAT in the diagnostics division at Novartis. She holds a B.S. in Chemistry from Santa Clara University and a Ph.D. in Organic Chemistry at the University of Wisconsin-Madison.
Niomi Peckham, Development Scientist III, Alexion Pharmaceuticals Inc.
Niomi began her career in biotechnology at IBI/Kodak in New Haven, CT. She obtained her B.S. from the University of Connecticut and Master’s degree from SUNY Stony Brook. After working for Enzo Diagnostics and Pfizer, she joined Alexion Pharmaceuticals in 2003 where she now manages the Late Stage Analytical Development group. She is responsible for development, validation and transfer of methods for pre-clinical through commercial stage products, with a focus on plate-based and electrophoretic methods.
Fredrik Sundberg, Global Director, Strategic Customer Relations, GE Healthcare Life Sciences
As Global Director Strategic Customer Relations, Fredrik is responsible for working with the pharmaceutical industry to improve current workflows with innovative bioanalytical solutions. He also advises on R&D projects and business development activities. Fredrik is author of several publications in the field of Drug Discovery and Biosimilar strategies. He is also member of an EMEA Pharmaceutical Industry Expert Panel, plus lectures and discusses regulatory issues with government officials and health authorities.
Keith Webber, Senior Scientist, Analytical Development, RegenxBio
Keith Webber obtained a Bachelor of Sciences degree in Chemistry at Mary Washington College, and has over 10 years experience with formulation and analytical method development for biopharmaceutical products at Human Genome Sciences and GlaxoSmithKline. Starting in 2016, he entered the field of gene therapy and continued method development for the analysis of gene therapy products.
Ying Xu, PhD, Scientist, Biologics Development, Sanofi
Ying Xu joined Sanofi in 2016 in the Analytical Development group. She is responsible for assay development and assay validation for both protein and gene therapeutics. Ying Xu hold a Ph.D in Analytical Chemistry from Duke University.
Jianchun Jason Zhang, PhD, Senior Principal Statistician, MedImmune
Jason received his Ph.D. in statistics from Purdue University in 2010 and since then worked for AstraZeneca. He provides statistical support for a wide range of areas including pre-clinical and clinical assays, analytical method, and process development, biosimilars, manufacturing control, and product complaints. He also has statistical expertise in adaptive clinical trial design, Bayesian statistics, statistical computation, and machine learning and AI. He has published over a dozen of articles, two book chapters and one monograph book. He was past recipient of ASA best non-clinical paper award and now serves as ASA best non-clinical paper award chair.
CHARACTERIZING AGGREGATES & IMPURITIES
MARCH 4-5, 2019
Zahir Akhunzada, PhD, DPST, Bristol Myers Squibb
Dr. Zahir Akhunzada is a PPD Consultant at Bristol-Myers Squibb Company. Prior to joining PPD, he worked for Schering-Plough/Merck, Sabinsa Corporation, KACST, King Saud University as Assistant Professor and as a Guest Investigator at the GI Research Institute of the VA Hospital, Newark, NJ. He earned his Doctorate degree in Chemistry from the H. E. J. Research Institute, Karachi, Pakistan. He did Post-Doc in Tubingen, Germany and gained research experience in Phamacognosy, at Leiden University, the Netherlands. He has several research publications and co- Authored a Textbook on, ”Stereoselective Synthesis in Organic Chemistry”, Springer Verlag New York, USA. He has a broad range of expertise in R&D, specializing in spectroscopy, organic synthesis, separation and wet analytical techniques. More recently, he has focused his expertise on characterizing biologics.
Bjorn Boll, PhD, Head of Particle Lab and HOS Analytics, Physical Chemical Analytics, Novartis AG
Dr. Boll studied in Göttingen and received his PhD from the University of Tübingen in Germany focusing on purification and characterization of proteins of antibiotic biosynthesis. He afterwards performed studies of the biological consequences of sub-visible particles at the Analytical Development Department at Roche in Basel, Switzerland. After joining Merrimack Pharmaceuticals in the Boston area and driving the physical-chemical characterization of early phase projects, Dr. Boll is now heading the particle lab and higher order structure analytics at Novartis in Basel, Switzerland.
Patricia Cash, PhD, MBA, Senior Consultant, Independent Biotechnology Consultant, LLC.
Dr. Patricia W. Cash, Ph.D. is a senior leader with over 25 years experience in all aspects of analytical development, specification setting, quality control testing and preparing and defending regulatory filings. She has served as senior director in the Analytical Biochemistry Department at MedImmune, where her group was responsible for developing and implementing analytical methods used for characterization, lot release, and in-process testing of all protein projects at various stages of development. She was also a director of analytical development at Sanofi Pasteur and worked as a scientist at BMS. She is currently an independent consultant, working with multiple biotechnology companies. She is an expert in visible particle identification and control, particularly in protein-based products (as confirmed by winning of the 2016 Fred Simon award for a paper on visible particle analysis).
Richard Cavicchi, PhD, Research Physicist, Biomolecular Measurement Division, Material Measurement Laboratory, NIST
Dr. Richard Cavicchi earned his Ph.D. in physics at Cornell University, was a post-doc at AT&T Bell Labs, and then joined the research staff at the National Institute of Standards & Technology in 1989. His work has covered a variety of electrical and optical measurements related to microfabricated sensors. Present research focuses on characterization of protein aggregates.
Richard Huang, PhD, Senior Research Investigator, Pharmaceutical Candidate Optimization, R&D, Bristol-Myers Squibb
Richard received his PhD in Analytical Chemistry from Washington University in St. Louis under the direction of Prof. Michael L. Gross. His PhD work included developing strategies to characterize protein-ligand and protein-protein interactions and study protein structure by HDX-MS. Prior to joining BMS, Richard was National Research Council Postdoctoral Fellow at National Institute of Standards and Technology. He developed qualitative/quantitative methodologies in glycoprotein characterization and established the first automated HDX-MS system at NIST. He is currently a Senior Research Investigator at BMS focusing on mass spec-based stratigies for biotherapeutics characterization.
Yoen Joo Kim, MSc., Scientist II, Analytical Sciences, MedImmune
Yoen Joo Kim is analytical scientist with over eleven years of experience in particle and higher-order structure characterization of biopharmaceutical products at MedImmune. She is also an analytical lead for a late stage program. Prior to MedImmune, she worked as technical staff at the University of Texas at Austin on single molecule spectroscopy studies of HIV-Protein/ RNA/ DNA interactions to find the role of HIV Nucleocapsid protein. She also worked on the development of a non-invasive glucose sensor using near-IR absorption spectroscopic techniques at Samsung Advanced Institute of Technology after she graduated with a Master’s degree in Biochemistry from Seoul National University.
Maryam Mazaheri, MS, Assoc CMC Lead, Viela Bio
Maryam Mazaheri, received masters in biotech Enterprise from John Hopkins university and has more than 13 years of experience in pharmaceutical industry from pre-clinical to pre commercial. She was one of the primary members who designed, developed, standardized and validated visual inspection method in Medimmune. She has done an extensive amount of work in developing semi-quantitative method monitoring small inherent visible particles during product development. She is also coordinator and active member of the EBE visual inspection committee, working with members of 8 different pharmaceutical companies to assemble knowledge and provide guidance in regards to new emerging visual inspection challenges in biologics
Sheila Mugabe, Msc, Sr Development Associate, Macrogenics, Inc.
Sheila comes from MacroGenics Inc, a clinical-stage biopharma company working on discovery and development of antibody-based therapies where her leading role is to support last stage characterization using LC and MS technologies. Prior to Macrogenics, she was employed at Novavax Inc and Medimmune/Astra Zeneca. For the last 10 years she worked in the biopharma industry identifying post-translational modifications, glycan profiling, degradation pathways and determining structure-function relationships of therapeutic proteins. Sheila is a graduate of Master of Science in Analytical Chemistry from Makerere University, Kampala, Uganda.
Katelyn Smith, PhD, Senior Scientist, Pharmaceutical Sciences, Merck & Co., Inc.
Katelyn Smith is a Sr. Scientist in at Merck & Co., Inc. in West Point, PA. Since joining Merck in the Preformulation group, she has supported the biophysical characterization and formulation screening of peptide- and RNA-based drug products. Prior to Merck, Katelyn received a B.S. in Chemistry from The College of New Jersey and a Ph.D. in Chemistry from the University of Delaware where she investigated the assembly mechanism and molecular-level structure of fibril-forming peptides.
Yuanqi Tao, PhD, Investigator II, Integrated Biologics Profiling, Novartis Biologics, NIBR
I received my PhD degree in analytical chemistry, focusing on mass spectrometr characterization of peptides and proteins, from the University of California Riverside. Then I did a short internship at Genentech and later joined Bristol-Myers Squibb's analytical development group. I was working on method development and qualification and transfer of antibodies and therapeutic proteins at BMS, and was in charge of some projects as analytical CMC lead. In early 2018 I joined Novartis, working on developability assessment of therapeutic proteins. We use different analytical methods, including separation, mass spec as well as bio-physics techniques to assess the developability of biological drug candidates.
Telikepalli, PhD, Research Chemist, Biomolecular Measurement Division, NIST
Srivalli Telikepalli received her B.A. in chemistry at Cornell University in 2008 and Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 2014. Her thesis work was focused on understanding the formation of protein aggregates/particles as a function of different stresses and understanding the relationship between protein particle properties and their in-vitro immune responses. Upon completion of graduate school, she started working as a Research Chemist at the National Institute of Standards and Technology in the Biomolecular Measurements Division. Currently, her work focuses on developing protein-like particle standards, primarily subvisible and visible particle standards, as well as supporting the development of the monoclonal antibody reference material.
Susumu Uchiyama, PhD, Prof, Biotechnology, Osaka University
Susumu Uchiyama, Ph.D is a Professor of Department of Biotechnology, Graduate School of Engineering, Osaka University, Japan and currently is also a visiting Professor at ExCELLS, Japan. He is one of co-founder and CTO of a CRO company, U-medico corporation. His research topics are science-based engineering in the field of solution biophysics of protein and colloidal particles, especially by using various kinds of biophysical methods. His research interest includes energetic understanding of immune related proteins and also formulation development of therapeutic proteins and protein aggregation analysis. He has so far published more than 180 peer-reviewed papers.
Salvador Ventura, PhD, Director, Institute of Biotechnology and Biomedicine, Autonomous University of Barcelona
Salvador Ventura Full Prof. at the Dep. of Biochemistry and Molecular Biology and Director at the Institute of Biotechnology and Biomedicine, Autonomous University of Barcelona (UAB). He has authored more than 170 peer-reviewed research and review papers, apart from several book chapters and patents. He got his Ph. D. in Biology at the UAB in 1998 and worked as postdoctoral fellow (1999-2002) at EMBL-Heidelberg. He has been researcher at Harvard Medical School (USA) and Karolinska Institutet (Sweden) among other centres. His research interests are protein folding, misfolding and aggregation, with an special focus on their role in conformational diseases.
Christopher Yu, PhD, Principal Scientist, Protein Analytical Chemistry, Genentech, Inc.
Christopher Yu is a Principal Scientist and Senior Group Leader in Protein Analytical Chemistry department at Genentech, with 20 years of biopharma industry experience. His expertise is in the application of mass spectrometry in structural analysis of protein therapeutics including monoclonal antibodies, characterization of product variants, degradation products, and process impurities. He has broad knowledge in analytical development in CMC setting, and a recognized expert in the advancement of state-of-the-art mass spectrometry technologies.
Hai Yue, PhD, Senior Scientist, Analytical Development, Juno Therapeutics
Dr. Yue currently is a Senior Scientist in Analytical Development at Juno Therapeutics, A Celgene Company. Prior to joining Juno, he worked at Amgen Inc. as a Scientist in Process Development for 4 years. Dr. Yue holds a Ph.D in Biochemistry from Washington University in St. Louis.
ADVANCES IN CHARACTERIZATION METHODS & APPROACHES
March 5-6, 2019
Michael Butler, PhD, CSO, Cell Technology, National Institute of Bioprocessing Research & Training (NIBRT)
Michael Butler is the Chief Scientific Officer at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific 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. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.
Mary Joan Castillo, PhD, Lead Metabolic Analytical Scientist, Bioanalytical Research, Synlogic Inc.
Mary Castillo is currently the Lead Metabolic Analytical Scientist at Synlogic. Mary grew up in the Philippines where she obtained her undergraduate degree in chemistry from the University of the Philippines. She started her industry career developing bioanalytical methods for drug research trials that asses the bioavailability and bioequivalence of generic formulations. She pursued graduate studies in the US and obtained her PhD from University of Connecticut in 2015 where her work was focused on novel tools for mass spectrometry-based protein biomarker validation.
Kevin Cook, PhD, Sr. Scientist, PKDM, Amgen Inc.
Kevin is a senior scientist in PKDM at Amgen, focusing on bioanalysis and stability of pre-clinical large molecule therapeutics. Prior to Amgen he got his Ph.D. in Immunology from the University of Rochester and did a post-doctoral fellowship at the Universtiy of North Carolina-Chapel Hill.
Christian Graf, PhD, Scientist, Technical R&D, Tech Dev Biosimilars, Novartis Pharma AG
Christian Graf has over 15 years of experience in protein analytics and biological mass spectrometry. He is a chemist from training and holds a Ph.D. in biochemistry from University of Heidelberg/Germany where he worked on protein folding and conformational changes of chaperones using mass spectrometric methods such as HDX-MS. In 2009, he joined Novartis Pharma AG in Basel, Switzerland, as a Senior Scientist for protein characterization in the Biologics Analytical Research & Development organization, mainly responsible for the early and late-phase MS characterization of therapeutic antibodies. He had then several roles as Lab head and Principal Scientist in the Integrated Biologics Profiling unit within the Novartis Biologics Technical Development & Manufacturing organization in Basel, supporting early characterization and developability assessment of numerous innovative biologics pipeline projects. In 2017, he joined the Novartis Technical R&D-Technical Development Biosimilars team in Oberhaching near Munich/Germany where he is Functional Lead and Scientist for analytical characterization and development of biosimilars and clinical NBE candidates.
Michael L. Gross, PhD, Professor, Chemistry, Immunology and Medicine, Washington University in St. Louis
Michael L Gross is a professor at Washington University in St Louis. His research goals are to develop methods for characterizing proteins, their structures, affinities, aggregation, folding, and misfolding. The strategies that his group develops are termed protein footprinting (HDX, FPOP), native protein MS, affinity measurements, and platforms for amyloid proteins, all enabled by high performance mass spectrometry (MS). He is the principal investigator of an NIH P41 Research Resource at Washington University where he develops methods and enjoys collaborations that test their measurement tools. He has been an independent academic investigator for 50 y during which time he educated over 100 PhD and postdoctoral students and published > 620 articles and book chapters with his students.
Danielle Hamler, Principal Research Associate, Sanofi
Danielle Hamler joined Genzyme (now Sanofi Genzyme) in 2006. For the past 12.5 years she has held roles in both Quality Control and BioProcess Analytics. During this time Danielle has worked on several method transfers and the development of analytical methods. She has also provided support for a range of chromatographic and plate based assays. Danielle has also been involved with the management of product activity and many ‘ways of working’ initiatives.
Zhiqi Hao, PhD, Scientist, Protein Analytical Chemistry, Genentech
Dr. Zhiqi Hao received her Ph.D. degree on biochemistry at Cornell University, Ithaca, NY. After ten-year’s of working at Thermo Fisher Scientific on the application of mass spectrometry technology to proteomics and protein characterization, Zhiqi joined Genentech in 2014. Her current focus is on the analytical development for early and late stage ADC projects.
Xiaoying Jin, PhD, Senior Principal Scientist, Sanofi
Xiaoying Jin has been working in Genzyme/Sanofi for 18 years after she obtained Ph. D. from University of Michigan. She has extensive experience in protein characterization of recombinant glycoproteins, antibodies and adeno-associated virus vectors to support development. Her group is responsible for protein characterization in the comparability studies, structure and function relationship studies, reference standard qualification, and forced degradation studies for CMC filings. Currently she is also leading a gene therapy program as an analytical team leader responsible for establishing analytical paradigm, method development/qualification and release/stability testing.
John F Kellie, PhD, Associate GSK Fellow and Investigator, Bioanalysis, Immunogenicity and Biomarkers, GSK
Dr. John Kellie is currently an Associate GSK Fellow in the Bioanalysis, Immunogenicity, and Biomarkers group at GlaxoSmithKline. John received his B.S. in Biochemistry from Indiana University and his Ph.D. in Chemistry from Northwestern studying under Dr. Neil Kelleher. He was a Post-Doctoral Scientist at Eli Lilly and Company where he developed methods for intact protein quantitation of a Parkinson’s Disease biomarker from human brain tissue. At GSK, John utilizes mass spectrometry for development of novel bioanalytical methods for biotherapeutic & protein quantitation from pre-clinical and clinical samples.
Marina Kirkitadze, PhD, MBA, Head, Process Support & PAT, Sanofi Pasteur Canada
Marina Kirkitadze, Ph.D, MBA has 17 year experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Process Support & PAT, Analytical Sciences, Sanofi Pasteur. Marina's main focus is characterization of vaccine components, specifically, protein conformation and stability in solution and in adjuvanted form, analysis of raw materials, and particle sizing technologies. Her contributions went towards CMC section in eBLA application for Adacel, new manufacturing facility submission, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 34 manuscripts.
Seth Madren, PhD, Scientist I, Analytical Development, Biogen
Seth Madren is a Scientist I in the Analytical Development department at Biogen. He received a PhD in Analytical Chemistry from Indiana University where he focused on the fabrication and use of microfluidic devices. After graduate school he began working at Biogen, where he has worked for the past 4 years. At Biogen Seth supports both commercial and early phase programs. His activities include method development, troubleshooting, detailed characterization of protein therapeutics, and the evaluation of novel analytical methods.
Thomas Powers, PhD, Senior Scientist, Analytical R&D, Pfizer
Thomas Powers is a senior scientist at Pfizer, working in the Analytical Research and Development group at the Chesterfield, MO location. Thomas obtained his BS in chemistry and BA in economics at Furman University in Greenville, SC. He then attended the Medical University of South Carolina in Charleston, SC, where he completed his Ph.D. under the guidance of Dr. Richard Drake. Thomas joined Pfizer in 2015 and works in the Mass Spectrometry and Biophysical Characterization (MSBC) group, which is responsible for heightened product characterization and bioprocess support. Since joining Pfizer, he has developed a wide range of experiences working with multiple modalities, including mAbs, recombinant proteins, and ADCs. Currently, Thomas supports the gene therapy programs within Pfizer, specifically adeno-associated virus and adenovirus and is heavily involved in the implementation of multi-attribute monitoring by mass spectrometry.
Kathrin Schaeker-Theobald, PhD, Senior Scientist, NBE Formulation Sciences, Abbvie Deutschland GmbH & Co. KG
Kathrin Schaeker-Theobald is a certified biologist and received her PhD in Cell Biology from Heidelberg University, Germany. Following her PhD, Kathrin was a postdoc for diabetes research at Sanofi. In 2015, Kathrin joined AbbVie as a Senior Scientist in the NBE High Throughput & Advanced Formulation Sciences Department. The group employs a high-throughput approach to develop liquid formulations for biologics.
Joshua S Sharp, PhD, Asst Professor, Pharmacology, Biomolecular Sciences, University of Mississippi
Joshua S. Sharp is an Assistant Professor of Pharmacology in the Department of BioMolecular Sciences at the University of Mississippi School of Pharmacy. Dr. Sharp received his Ph.D. in 2003 from a joint program between Oak Ridge National Laboratory and the University of Tennessee under the direction of Dr. Robert Hettich in the Organic and Biological Mass Spectrometry Group, developing the first benchtop chemistry for hydroxyl radical protein footprinting as well as the first use of hydroxyl radical protein footprinting for constraining structural modeling. Following his postdoctoral research under Dr. Kenneth Tomer (NIEHS), Dr. Sharp accepted a research faculty position in the Complex Carbohydrate Research Center of the University of Georgia in 2007. In 2015 he joined the Department of BioMolecular Sciences at the University of Mississippi in the Department of BioMolecular Sciences, where he recently received the 2017-2018 New Investigator Research Award. Dr. Sharp is also Chief Technology Officer of GenNext Technologies, Inc., a small business commercializing new benchtop HRPF technology for protein higher order structure analysis. Dr. Sharp has published widely in the field of biomolecular mass spectrometry, both as one of the early pioneers in the use of hydroxyl radical-protein chemistry to measure protein topography, as well as in developing new technology for the sequencing of sulfated glycosaminoglycan oligosaccharides. Dr. Sharp’s work has been funded by the National Science Foundation, as well as by multiple grants from the National Institutes of Health.
Chris Spahr, Senior Scientist, Discovery Attribute Sciences, Amgen, Inc.
Chris Spahr joined Amgen shortly after graduation from UCSB in 1994 (B.S., Pharmacology) and is currently in the Discovery Attribute Sciences department. His primary focus is protein analytics using mass spectrometry and other related techniques. Other expertise includes PTM analysis (especially N- and O-linked glycosylation), de novo sequencing, and nano-LC-MS/MS. He has published over 30 papers in peer-reviewed journals.
Zenobia F. Taraporewala, PhD, CMC (Product) Reviewer, Gene Therapies Branch, Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, CBER, FDA
Zenobia is a Product/CMC Reviewer in the Gene Therapies Branch at the Office of Tissues and Advanced Therapies (OTAT/CBER/FDA). She is responsible for regulatory review of preIND, IND and BLA submissions for gene therapy products. She has participated in several inter and intra-agency working groups/meetings focused on the development of cell and gene therapy products, and related guidance documents and standards. Zenobia received a BS (Microbiology) from University of Bombay (Mumbai), a MS (Microbiology) from M.S. University, Baroda, and a Ph.D (Molecular and Cell Biology) from the University of Maryland. She received her post-doctoral training in the Laboratory of Infectious Disease (Rotavirus Molecular Biology Unit) at NIAID/NIH, and continued in the same laboratory as a staff scientist until joining FDA in 2008. She is trained as a molecular virologist with expertise in viral replication, genomics, and reverse genetics, and structure-function analysis of viral nonstructural proteins. She is the recipient of the Fellows Award for Research Excellence (NIH), Norman Salzman Memorial Honorary Award (NIH) and the Public Health Service Award (CBER/FDA).
Stacey Traviglia, PhD, Associate Director, QC Analytical Technology, Biogen
Stacey Traviglia has a PhD in Chemistry from the University of California at Davis and has worked in the biotechnology industry for 17 years in areas of new technology research and development, downstream process development, manufacturing sciences, and analytical technology. Currently, Stacey Traviglia is an Associate Director of Analytical Technology in Quality Control at Biogen and her team is responsible for analytical method validation, transfer, troubleshooting, method optimization as well as the development and implementation of new technologies for advanced process control (APC), process analytical technology (PAT), and Quality Control (QC) release testing.
Shunhai Wang, PhD, Staff Scientist, Analytical Chemistry, Regeneron
Shunhai Wang received his Ph.D. in Analytical Chemistry from the University of Massachusetts Amherst (2013), after which he joined Regeneron Pharmaceuticals Inc. in Tarrytown NY. Currently, he is a staff scientist in the Analytical Chemistry Group, where he focuses on developing mass spectrometry-based experimental techniques for in-depth characterization of therapeutic mAb candidates, in order to support various activities during drug development and regulatory filings.
Bruce Yu, PhD, Professor, Pharmaceutical Sciences, University of Maryland School of Pharmacy
Bruce Yu is Professor of Pharmaceutical Sciences and Director of the Bio- and Nano-Technology Center at the University of Maryland School of Pharmacy. His research interests include imaging agents, biomaterials, and noninvasive chemical analysis. His current research focus is biomanufacturing and biopharmaceutical quality control. He received the 2004 Kimmel Scholar Award and the 2005 US Presidential Early Career Awards for Scientists and Engineers.
Zhaohui Sunny Zhou, PhD, Faculty Fellow, Barnett Institute of Chemical and Biological Analysis, Department of Chemistry & Chemical Biology, Northeastern University
Professor Zhou’s laboratory applies protein chemistry, analysis and engineering to biology and medicine. One program is “Hybrid Modality Engineering of Proteins”—a platform to introduce non-canonical chemical moieties and/or scaffolds into peptides and proteins to confer novel functions otherwise unavailable. The second is to devise chemo-enzymatic methodologies to characterize protein modifications, such as crosslinking, isoaspartic acid formation (asparagine deamidation) and methylations. In collaboration with biologists and clinicians alike, we also investigate their biological effects, and moreover, as critical attributes in protein pharmaceuticals.
Over the past decade, Professor Zhou has been actively collaborating and consulting with biotech and pharm companies on biotherapeutics, enzymes and protein chemistry. These collaborations have led to the elucidation of product and process-related modifications (many of which were previously unknown). He also developed and now teaches a new advanced course entitled “Chemistry and Design of Protein Pharmaceuticals,” as well as workshops on antibody-drug conjugates (ADC), and training courses for scientists from industry, academia, and regulatory agencies in the US, China, and APEC economies.
COMPARABILITY & ANALYTICAL SIMILARITY
March 7-8, 2019
Wasfi Al-Azzam, PhD, GSK Fellow, Investigator- Biopharm Analytical Sciences, Biopharm Product Development and Supply, Pharmaceuticals R&D, GSK
Dr. Wasfi Al-Azzam is a GSK Fellow at biopharm product development, GlaxoSmithKline. He received his undergraduate in Biology from Yarmouk University, IrbidJordan in 1996 and an MS degree in 1999 from the Middle East Technical University, AnkaraTurkey. In 2005, he joined Bayer Health Care in RTP-NC as a lead for formulation and delivery devices development. In 2009, Dr. Al-Azzam joined biopharm analytical sciences at GSK to establish biophysical characterization team. He worked on various early and late stage products, a few are in the market. He also hold CMC leader role for radiolabeled product development for PET imaging clinical studies. Dr. Al-Azzam is well established in the scientific community. He has few collaborations, serving few scientific organizations & international forum, published several peer reviewed articles, and 2 patents.
Robert Brinson, PhD, Research Chemist, Bimolecular Structure and Function Group, Institute for Bioscience and Biotechnology, NIST
Robert received his Ph.D. in chemistry from Wake Forest University in 2005 where he studied the photo-activation of caged biocides under the direction of Paul Jones. He then entered the field of structural biology as a NIH/NIST NRC postdoctoral fellow under John Marino (NIST) and Stuart Le Grice (NCI). Under their direction, Robert performed high resolution NMR studies on purine rich RNA/DNA hybrids derived from HIV-1 and Saccharomyces cerevisiae long-terminal repeat (LTR)-retrotransposon Ty3. Robert is currently a research chemist in the Biomolecular Structure and Function Group at the Institute for Bioscience and Biotechnology Research (IBBR), a joint research institute of the University of Maryland and NIST, in Rockville, Maryland. Robert applies biophysical measurements to define structure and dynamics of nucleic acids, proteins, and glycoproteins with a specific focus on monoclonal antibody therapeutics. In particular, Robert seeks to push the limits of NMR methodologies to define the critical quality attribute of higher order structure for protein drug substances.
John Gabrielson, PhD, VP, Analytical Sciences, Elion Labs, a division of KBI Biopharma
John Gabrielson is currently Vice President of Analytical Sciences at KBI Biopharma where he oversees the Elion Labs division in Louisville, Colorado. John joined KBI when Elion was acquired in early 2018. Prior to joining KBI, John co-founded Elion Labs in 2015, where he served as President and CEO and was accountable for defining Elion’s strategic direction and implementing its business plan. Prior to co-founding 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 biologics from late-stage clinical development through commercialization and post-approval. He has developed 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.
Jeff Hudgens, PhD, Research Chemist, IBBR Fellow, Institute for Bioscience and Biotechnology Research, Biomolecular Measurement Division, NIST
Dr. Jeffrey W. Hudgens conducts research on hydrogen-deuterium exchange mass spectrometry (HDX-MS) with the aim of improving its application in drug research, quality control, and biosimilarity determinations. He is a Fellow of the Institute for Bioscience and Biotechnology Research and an employee of National Institute of Standards and Technology. He is a Fellow of the American Physical Society.
Katja Kleinsteuber, PhD, Scientist II, Cellular Analytics, bluebird bio
Katja Kleinsteuber, PhD leads the CyTOF platform within the Cellular Analytics group at bluebird bio. Her research focuses on development of cell-based assays for hematopoietic stem/progenitor and CAR-T products. Dr. Kleinsteuber’s expertise includes T-cell immunology of infectious diseases and cancer, immune-monitoring and single cell analytics. Prior to joining bluebird bio, she worked as a Scientist at the Center for Immuno-Oncology at the Dana-Farber Cancer Institute in Boston, MA. Dr. Kleinsteuber received her PhD in 2012 from the University of Hamburg, Germany and completed a postdoctoral fellowship at the Ragon Institute of MGH, MIT and Harvard.
Yuanyuan Li, PhD, Senior Scientist, Analytical CMC, Mersana Therapeutics
Dr. Yuanyuan Li is currently employed with Mersana Therapeutics as a Senior Scientist in the CMC analytical team. Mersana is a clinical stage antibody drug conjugate (ADC) company developing proprietary technologies that create ADCs with improved efficacy, safety and tolerability. She obtained her PhD degree from Prof. Milton Lee’s lab at Brigham Young University (BYU), where her research work was focused on development of monolithic capillary columns for biomolecules analysis. After graduation from BYU, she had a post-doc position with Dr. Jack Henion working on innovative sampling technique and LC-MS/MS method development for biological samples from pre-clinical and clinical studies. Before joining Mersana in 2017, she was a process analytical scientist at the AbbVie North Chicago site.
John Linnan, North American Sales Manager, RedShiftBio
John Linnan, a sales and marketing executive with a strong background in the life sciences industry joined RedShiftBio in 2018 as North American Sales Manager. John’s career has spanned start-ups to industry leaders. As Global VP of Sales and Marketing, he helped transition Agencourt BioScience into a wholly-owned subsidiary of Beckman Coulter. He also developed and executed the commercialization strategy for QIAGEN Custom Solutions (formally Enzymatics) for enzyme manufacturing and OEM solutions targeting biotech drug & diagnostics development.
Jun Liu, PhD, VP, Product Development, Coherus
Dr. Jun Liu is currently an vice president in product development at Coherus Bioscience and prior to that he served as a executive director and senior director at Coherus Bioscience, and group leader, CMC team leader and principle scientist at Genentech. He received his Ph.D. degree in Biochemistry from the University of New Hampshire, and then performed postdoctoral research at Genentech. Dr. Liu has over 26 years of experiences in biotech industry. He has successfully involved in developing a number of novel protein therapeutics, combination products and biosimilar products. He has numerous scientific publications and patent application in fields of pharmaceutical development, analytical characterization and device development.
Sonia Taktak, PhD, Principal Scientist, Analytical R&D, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Sonia joined the Analytical R&D group at Pfizer, Inc. in 2017, as a Principal Scientist. In this role, she is responsible for the development of analytical methods and strategies needed to progress BioTherapeutic products in the pipeline, including method development and qualifications, analytical support for process development, formulation and stability, product characterization and comparability. Prior to Pfizer, Sonia was a Senior Scientist at ImmunoGen, Inc. where she led the CMC development effort of an early phase ADC product. Sonia holds a PhD in Chemistry from Tufts University and was a Harvard Medical School research fellow at the Massachusetts General Hospital.
Daniela Tomazela, PhD, Associate Principal Scientist, Biology-Discovery, Mass Spectrometry, Merck
PhD in Analytical Chemistry with extensive experience in qualitative and quantitative mass spectrometry (MS) techniques for biomolecule characterization: e.g, monoclonal antibodies, antibody-drug conjugates (ADCs), bispecific and multispecific antibodies, nanobodies and protein fusions. Joined Merck (Palo Alto – CA) in 2011 and currently leads the Protein Sciences Mass Spectrometry Analytical Group.
Xing Wang, PhD, President, 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 small molecule drug discovery, building platforms for the identification and characterization of bioprocess-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 biomarker discovery.
Yonghui Wang, PhD, Senior Scientist, Analytical Development, Janssen R&D LLC
Yonghui Wang is a senior scientist in the analytical development at Janssen R&D LLC. She has over 10 years of experience in biotherapeutic development. Her expertise are in protein characterization, method development and comparability. She obtained her PhD in analytical chemistry from Barnett Institute, Northeastern University.
Yemin Xu, PhD, Manager, CMC Regulatory Affairs, Regeneron Pharmaceuticals
Dr. Xu is Manager in CMC Regulatory Affairs Organization at Regeneron. His team is responsible for CMC related regulatory communication with Health Agencies, and internally support, manage and provide regulatory guidance to development team on various clinical and commercial projects. Prior to joining Regeneron, Dr. Xu was analytical team leader in Biologics Development Division at Bristol-Myers Squibb. Dr. Xu earned his Ph.D. from the University of Colorado-Boulder, where he worked for his thesis on protein formulation development in both aqueous and lyophilized products.
Jihong Yang, PhD, Principal Scientist, Bioanalytical Sciences, Genentech
Dr. Jihong Yang is a Principal Scientist in the Department of Bioanalytical Sciences at Genentech. She has over 15 years of experience in supporting biotherapeutic development. Dr. Yang has supported multiple biotherapeutic projects characterizing protein-protein interactions using various biophysical technologies. In addition, she leads a group that produces and characterizes critical reagents that enabled bioanalytical assays across the continuum of drug development. Data from her laboratory has supported many successful IND and BLA filings. Dr. Yang has authored/co-authored 25 articles in peer-reviewed journals and filed several patent applications. Dr. Yang received her Ph.D. in Chemistry from the University of Wisconsin-Madison and conducted her postdoctoral research in the Department of Protein Engineering at Genentech.
Kevin Zen, PhD, Senior Director, Biologics CMC, Manufacturing, AnaptysBio Inc.
Kevin Zen has 25 years of experience in developing biologics drugs for clinical and commercial. He is currently a senior director in analytical, formulation and drug product development, biologics CMC and manufacturing at AnaptysBio, Inc.