Method Development, Qualification & Validation
March 20-21, 2017

Elena Belitsky, Ph.D., Director, QC Clinical Operations, Biogen

Elena Belitsky received her B.Sc and Ph.D. degree in Biochemistry from Moscow State University, Moscow, Russia. She continued to work at Moscow State University, Biochemistry Department as a research scientist /assistant professor until she came to Boston, U.S.A. as a visiting scientist at Tufts University. In 2000 Elena Belitsky switched her career from academia to industry, and joined Biogen as a scientist in the Analytical Development Department, and then was transferred to Quality Control as a Head of Analytical Technology group supporting QC on Analytical methods testing troubleshooting, transfer, optimization, and validation for Biologics. Currently she is a Director of Quality Control Clinical Operations department.

Roger Bosse, Ph.D., Sales Development Team Lead, North-America, Life Sciences & Technology, PerkinElmer

Roger Bossé holds a Ph.D. in Pharmacology from the University of Sherbrooke (Quebec, Canada). He completed his Post Doctoral training in Neuroendocrinology in Marc Caron’s lab (Cell Biology, Duke University, NC). Dr. Bossé joined BioSignal in 1996 as the R&D Group Leader responsible for the development of the GPCR pipeline. Following the acquisition of BioSignal by Packard in 1998, he was promoted Associated Director R&D and his team developed the AlphaScreen product line. After the merger between PerkinElmer and Packard BioSciences in 2001, Dr. Bossé and his team initiated the development of the AlphaLISA platform. In 2006, he transitioned to new functions in Business and Sales development. Dr. Bossé co-organized the 13th SBS annual meeting in Montreal in 2007. He was elected on the SBS board of directors in 2008. He also created a new Special Interest Group (SIG) on Drug repositioning within SBS.

Fabio Camerini, MSc., Associate Researcher, Protein Chemistry, Merck Serono S.p.A.

Fabio Camerini has Master degree in Analytical Chemistry (2012) with a broad experience in analytical development. He has worked as external contractor at National Council of Research, Institute on Atmospheric Pollution Research for 6 months. Since 2012 he has worked in Merck KGaA in Analytical Development and Validation - Chromatography laboratory where he has developed analytical methods for CQAs monitoring in biotherapeutic products. His activities are mainly focused on the development, validation and characterization of chromatographic methods for Phase III products

Melissa Clague, Ph.D., Principal Research Scientist, Bioproduct Pharmaceutical R&D, Eli Lilly & Company

Melissa Clague is currently a Principal Research Scientist in Bioproduct Pharmaceutical Research and Development at Eli Lilly & Company. She joined Bioproduct Development in 2002, where she developed the analytical control strategy for a dozen bioproducts, including antibodies. She has been instrumental in developing the analytical tools, vendor relationships and business processes to advance the early-phase portfolio. Prior to working in Bioproduct Development, she worked at Lilly in Infectious Diseases Discovery Research, where she developed kinetically sound biochemical assays for high-throughput screening for several antimicrobial targets.

Claire Davies, PhD., Head of Bioanalytics, Sanofi

After obtaining her PhD from the University of London in 2001, Claire Davies performed her postdoctoral work at the William Harvey Research Institute (WHRI) at Bart’s and The London, Queen Mary's School of Medicine and Dentistry and Joslin Diabetes Center, Harvard Medical School, Boston. Over the last 14 years, Dr Davies has led analytical and CMC teams in product development and analytical method development and validation. Currently, Dr Davies leads Bioanalytics, a group responsible for developing methods and strategies to support process development, product characterization and release and stability testing for therapeutic proteins and gene therapy products in preclinical and clinical development.

Dong Geng, Ph.D., Principal Scientist, Biologics and Vaccine Bioanalytics, Merck

Have more than 18 years experiences in regulated bioanalysis. Have lead a few immunogenicity or bioanaltyical group at different companies such Johnson and Johnson, BMS, Imclone, Teva focusing on assay development and validation to support preclinical and clinical studies. Right now a principal scientist at Merck, and serve as technical lead to oversee the immunogenicity assay development and validation , as well as overall bioanalytical strategies for biologics

Tim Guo, Ph.D., Senior Scientist, Analytical Development, Novavax

Dr. Jingzhong (Tim) Guo is a Senior Scientist at Novavax. After receiving his Ph.D. degree in Physical Chemistry from Shandong University in China and postdoctoral training at York University in Canada, he started to focus his interests on method development and applications of mass spectrometry. He is the co-author of about 60 publications. In the past over ten years, he has been applying mass spectrometry for supporting development of small molecule drug products and vaccine products. His current interests is on applying mass spectrometry and other cutting-edge technologies for characterization of vaccine products including virus-like particles and protein nanoparticles, in particular on applying high resolution LC-MS approach for absolution quantitation of antigens and major host cell proteins in vaccine products.

Jim Jiang, Principal Scientist, Analytical Development, Pfizer Biopharmaceuticals

Dr. Jiang is an analytical scientist with more than 15 years of experience in protein and antibody-drug conjugates (ADCs) method development and qualification. He is also a subject matter expertise in CMC, stability program, and product/method specifications. Dr. Jiang’s contributions to ADC analytical development have led to two BLA submissions and multiple IND submissions for Pfizer in the past few years.

Kenneth Miller, Ph.D., Senior Scientist, Bioassay Development, MedImmune

Dr. Miller is a senior scientist in the Bioassay Development group at MedImmune. He is responsible for the development of lot release potency assays for clinical and commercial biotherapeutics. He is also responsible for the development of high-throughput functional assays to support process development and product characterization. He has specific experience with binding and cytotoxicity assays for ADCs and bioassays for immune-oncology (IO) candidate drugs. Dr. Miller has extensive experience in the use of label-free binding technologies for biotherapeutic characterization and currently serves as a member of the USP General Chapters Biological Analysis expert committee. Dr. Miller is also particularly interested in applying Quality by Design (QbD) approaches to analytical method development.

John E. Schiel, Ph.D., Research Chemist, Bioanalytical Chemistry, NIST

Dr. Schiel received his BS (2004) and Ph.D. (2009) in chemistry from the University of Nebraska-Lincoln, and is currently a research chemist in the NIST Biomolecular Measurement Division. He is leading the LC- and MS-based biomanufacturing research efforts at NIST; developing a suite of fundamental measurement science, standards, and reference data to enable more accurate and confident characterization of product quality attributes. Dr. Schiel is also the technical project coordinator for the therapeutic protein reference materials program, including the recombinant IgG1κ NIST monoclonal antibody Reference Material 8671. He is an author of over 20 publications, an editor of the ACS book series “State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization”, and recipient of numerous Awards, including the ACS Division of Analytical Chemistry Fellowship, Bioanalysis Young Investigator Award, and UNL Early Achiever Award.

Matthew Traylor, Ph.D., Senior Scientist, Analytical Development, Shire Pharmaceuticals

Matthew received his PhD in chemical engineering from the University of California, Berkeley in 2010 followed by a Fulbright fellowship at the University of Queensland in Australia. Matthew has worked at Shire for four years in Analytical Development and is head of the Research and Development Interface.

Steven Walfish, MS, MBA, Principal Science & Standards Liaison, Global Science & Standards Division, United States Pharmaceopeia

Mr. Walfish is Principal Science & Standards Liaison in the Global Science and Standards Division at United States Pharmacopeia (USP). Prior to this role Mr. Walfish was Principal Statistician at BD in Franklin Lakes, NJ. Previously, Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Mr. Walfish brings over 25 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. He is also an editorial board member for BioPharm International, and a regular contributor to the magazine. Mr. Walfish is a senior member of ASQ, a certified quality engineer and past chair of the Biomedical Division (2006-07). Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

Candi Warner, Field Application Scientist, Unchained Labs

Candi Warner is a Field Applications Scientist at Unchained Labs. She is responsible for teaching scientists how to use the Unchained Labs analytical instruments to improve their biologics stability workflows. She received a Master’s degree in Biotechnology from Johns Hopkins University. She spent eight years doing protein and antibody development, stability optimization, and analytical work in the biodefense sector before beginning a career as a Field Applications Scientist in biotechnology instrumentation.

Wei Xu, Ph.D., Principal Scientist, Analytical Method Development, Merck & Co. Inc.

Dr. Wei Xu is a principal scientist in analytical method development at Merck Research Laboratories. He is an expert in characterization of therapeutic proteins using analytical methods based on mass spectrometry, UPLC and CE. Dr. Xu has 10+ years’ experience in characterization of mAbs and other proteins while working in Merck and legacy Schering-Plough. Prior to that, he worked on the characterization of cannabinoid receptor 1 (CB1 receptor). Dr. Xu received his Ph.D in pharmaceutical Sciences and MS in Statistics from the University of Connecticut.

Advances in Characterization Methods & Approaches
March 21-22, 2017

Joomi Ahn, Ph.D., Scientist II, Analytical Sciences, MedImmune

Joomi Ahn is a scientist II in MedImmune, Gaithersburg, MD. She received her Ph.D. in Chemistry and Chemical Biology from Northeastern University. Her research interests are the studies on higher order structure utilizing mass spectrometry, particularly in Hydrogen Deuterium Exchange. She has more than 15 years of industrial experience in analytical/protein characterization and published peer-reviewed papers and an US application patent.

Alain Beck, Ph.D., Senior Director, Analytical Chemistry, NBEs, Center d’Immunology Pierre Fabre.com

Alain Beck is Senior Director of Analytical Chemistry at the Center of Immunology Pierre Fabre and associated editor of mAbs. He contributed to the R&D of clinical stages anticancer mAbs (dalotuzumab licensed to Merck, ABT-700 licensed to AbbVie and h515H7) and vaccines (RSV, ELA/P40). He has published 170 papers and reports on mAbs, biosimilars, biobetters, ADCs, bsAbs, Fc-fusion structures/functions relationships and developability. He has contributed to 230 scientific meetings (WADC, PEGS, EAC, IBC, IMSC, ASMS, HPLC) as chairperson, invited speaker, panelist, moderator, advisor, and organizer as well as to meetings with regulatory agencies (ANSM, EMA, EDQM, FDA, PEI, WHO).

Verna Frasca, Product Marketing Manager, Sales and Marketing, Malvern Instruments

Verna Frasca received her Ph.D. in Biological Chemistry from the University of Michigan, and did post-doctoral training at NY State Department of Health (Albany) and Univ of Texas SW Medical Center (Dallas). Dr. Frasca joined MicroCal in 2001, and is currently the Product Marketing Manager. Dr. Frasca has extensive experience in protein expression, protein purification, enzymology, biophysical characterization, and molecular biology.

Sagit Hindi, Ph.D., Principal Scientist, Eli Lilly

Dr. Hindi is a Principal Scientist at Eli Lilly NY heading the bioanalytical sciences group. She joined Eli Lilly in 2007, after receiving her PhD in Organic Chemistry, and she is currently leading the bioanalytical and biophysical characterization of antibodies, bispecific antibodies, and ADCs in support of oncology research and development. Her expertise includes mass spectrometry, chromatography, electrophoresis, light scattering, and calorimetric techniques for protein characterization.

Amy King, Ph.D., Senior Scientist, BioMedicine Design, Pfizer

Amy King joined Pfizer’s biophysics group in 2009 and is experience in early-stage stability, formulation development, and manufacturability assessments of antibodies, Fc-fusions, bispecifics, and antibody drug conjugates.

Joseph Liu, Ph.D., Principal Research Scientist, Formulation, Eli Lilly & Company

Dr. Joseph Liu is a Principal Research Scientist in Formulation Development; BR&D_NJ of Eli Lilly & Co. Dr. Liu has more than fourteen years of formulation experience in the Biotechnology/Pharmaceutical industry. Prior to joining Formulation Development of Eli Lilly and Company, Dr. Liu was a Biochemist at Enzon Pharmaceuticals, NJ. Dr. Liu received his doctoral degree in Biochemistry/Molecular Biology and postdoctoral research training in Pharmacology at University of Minnesota. Dr. Liu is a member of several scientific societies, including American Association for the Advancement of Science (AAAS), Association of Pharmaceutical Scientist (AAPS) and American Chemical Society (ACS).

Ewa Marszal, Ph.D., CMC Reviewer, Hematology Research and Review, Center for Biologics Evaluation and Research, US FDA

Ewa Marszal is a CMC reviewer in the Division of Hematology Research and Review, Center for Biologics Evaluation and Research, US FDA. She earned her M.S. in Chemistry from Warsaw University of Technology, Poland and Ph.D. in Biochemistry from Utah State University, UT, USA. EM serves as an FDA liaison to the United States Pharmacopeia (USP) and has been a member of several USP expert panels. EM also participated in the development of WHO protein standards. The areas of her interest include protein folding and misfolding, protein aggregation in biological products and in human disease, product safety and evaluation of new analytical methods.

Joe Shambaugh, Ph.D., Senior Scientific Account Manager, Expressionist, Genedata

Joe Shambaugh has over 20 years experience in biological research and data analysis, including 15 years implementing enterprise information systems for life science research organizations. At Genedata, he has focused on computational solutions for data rich research environments to address complex biological questions. Joe is currently involved in defining the computational requirements to automate, streamline and accelerate Mass Spectrometry data analysis for the research and development of biotherapeutics.

Gayathri Vasudevan, Ph.D., Principal Scientist Group Leader, Analytical and Formulations Development, FUJIFILM Diosynth Biotechnologies

Dr. Vasudevan is an Associate Principal Scientist in Analytical and Formulations development in the Research & Development group at FUJIFILM Diosynth Biotechnologies, Inc. Her work includes complex recombinant proteins, enzymes, ADCs, etc. She earned her BS in Biochemistry/Microbiology from Bombay University, India and her MS & Ph. D. in Chemistry/Biochemistry from University of Massachusetts, Lowell, following which she held research and teaching positions at University of Massachusetts, Lowell and Wellesley College for over 10 years.

David Weis, Ph.D., Associate Professor, Chemistry and Pharmaceutical Chemistry, University of Kansas

David Weis is an Associate Professor in the Departments of Chemistry and Pharmaceutical Chemistry at the University of Kansas. His lab focuses on applications of hydrogen exchange mass spectrometry to protein-protein and protein-solvent interactions and the development of new data analysis methods.

Sam Wu, Ph.D., Principal Scientist, Biologics Research, Janssen R&D

Sam Wu has more than 15 years of experience in protein engineering and biotechnology. During the past years at Janssen (formally Centocor R&D), my research interest is to explore structure-functional relationship of antibody and antigen. I have led a technology development team to establish the early-stage developability assessment for therapeutic antibodies. Sam also developed comprehensive approaches for epitope mapping of neutralizing antibodies to understand the mechanism of actions and apply in therapeutic discovery.

Chongfeng Xu, Ph.D., Scientist II, Analytical Development, Biogen

Chongfeng Xu has PhD in Analytical Chemistry from Fudan University. Later he joined NYU Medical Center as postdoctoral researcher working on mass spectrometric analysis of proteins. He has been in Biogen since 2009. His expertise includes development of analytical methods, and characterization of protein therapeutics using separation methods and mass spectrometry. He has published 30+ peer reviewed papers in scientific journals.

Linda Yi, Ph.D., Scientist II, Analytical Development, Biogen

Linda Yi currently works at analytical development department of Biogen. She has over 10 years’ experience in analytical method development, method qualification and validation for therapeutic proteins, including monoclonal antibodies, bispecific antibody, fusion protein, peptide, protein vaccine. She is also proficient with protein characterization by liquid chromatography, LC-MS, electrophoresis.

Comparability & Biosimilarity
March 23-24, 2017

Allison Derenne, Ph.D., Researcher, Structure and Function of Biological Membranes Laboratory, Universite libre de Bruxelles

Allison DERENNE holds a Bachelor and a Master in Bioengineering from the Université libre de Bruxelles (ULB). She also obtained a Ph.D. in Sciences from the Laboratory of Structure and Function of Biological Membranes of the ULB. During her thesis, she developed a method based on FTIR spectroscopy to classify anticancer agents according to their mode of action. Her research has been the subject of 10+ scientific articles (7 as first author) published in international journals. Since 2013, based on her acquired knowledge about the technology, she is working on designing innovative methods for the industry to analyze therapeutic proteins using FTIR spectroscopy. She is co-inventor of a patent filed in March 2015 at the European Patent Office, which relates to the innovative process measuring various key parameters of therapeutic proteins simultaneously that will be presented during the presentation. Allison has been nominated among the 2016 Under 35 Belgian Young Innovators by the Massachusetts Institute for Technology (MIT) and has participated in numerous international conferences, for which she twice received the price for best poster presentation.

John Kim, MSc., Associate Director, Analytical Sciences, Teva

Associate Director, Analytical Sciences in the Biologics CMC organization of Teva Pharmaceuticals. Previously, led the Analytical and Comparability strategy for the first biosimilar mAb (Remsima/Inflectra) to be approved in developed markets.

Robert Karlsson, Ph.D., Staff Scientist, GE HealthcareRobert Karlsson, Ph.D., Staff Scientist, GE Healthcare

Robert graduated from the Univ. of Stockholm in 1976. He began his career as an Analytical Chemist at Pharmacia, joining a project team to develop a SPR biosensor. Resulting in the launch of the first BiacoreTM system in 1990. He has published close to 40 papers describing Biacore applications. The first on the use of surface plasmon resonance for kinetic analysis in 1991 and recently on calibration free concentration analysis in 2016.

Sophia Levitskaya, Ph.D., Scientist, Analytical Sciences, MedImmune

Sophia Levitskaya, Ph.D. is the Analytical Development Scientist in the Department of Analytical Sciences at Medimmune-AstraZeneca. She is responsible for method development, qualification, technical transfer, and CMC analytical support. Her main field of interest is stability and aggregation of protein therapeutics. Dr. Levitskaya received her M.S. in Chemistry with specialization in Bioorganic Chemistry & Chemistry of Natural Compounds from the National University in Tashkent, Uzbekistan. She was trained on Protein Chemistry at the Institute of Protein Research, Pushchino-na-Oke, Russia. Her Ph.D. thesis and postdoctoral studies focused on biochemistry and immunogenicity of lectins and plant glycoproteins at the Institute of the Chemistry of Plant Substances in Tashkent, and continued at the School of Pharmacy, Julius Maximilian University, Würzburg, Germany. Prior to Medimmune, Dr. Levitskaya worked on carbohydrate based vaccines at NABI Biopharmaceuticals in Rockville, Maryland.

Urs Lewandrowski, Ph.D., Lab Head Characterization, Sandoz GmbH

Urs Lewandrowski studied biochemistry at the Ruhr-University Bochum before concluding a doctoral thesis at the University Wuerzburg, Germany, in 2007. His main studies were in the fields of proteomics and glycoproteomics focusing on nHPLC and mass spectrometric approaches. After joining Sandoz in 2012, he worked as labhead and project analyst for late stage biosimilar products (drug product). He joined the Sandoz biosimilar analytical characterization department in 2015 in the function as labhead.

Arturo Orjalo, Jr., Ph.D., Scientist, ADQC-Biological Technologies, Genentech, A Member of the Roche Group

Technical Development Scientist, 2015 – present
Genentech, A Member of the Roche Group, South San Francisco, CA
Scientist/Senior Scientist, 2011 – 2015
Biosearch Technologies, Petaluma, CA.
Postdoctoral Fellow
2006 - 2011 Buck Institute for Research on Aging, Novato, CA
Graduate Student, 1999 – 2005 UC San Diego, Division of Biological Sciences, La Jolla, CA .

Marjorie A. Shapiro, Ph.D., Chief, Laboratory of Molecular and Developmental Immunology, Division of Biotechnology Products Research and Review I, OBP/OPQ/CDER, FDA

Marjorie Shapiro received her Ph.D. in immunology from the University of Pennsylvania where she studied molecular mechanisms underlying antibody diversity. She joined the Division of Monoclonal Antibodies (DMA) in 1993 and is a currently a Lab Chief in the Office of Biotechnology Products. Her areas of technical expertise include antibody mechanism(s) of action, characterization of monoclonal antibodies and novel mAb constructs such as ADCs, antibody cocktails and bispecific antibodies, and biosimilar products.

Christopher Shaw, Scientist I, Manufacturing Sciences & Technology, MedImmune

Christopher works in the Manufacturing Sciences and Technology department’s Biophysical lab at AstraZeneca's Frederick Manufacturing Center. The primary focus areas of the MS&T group are to provide forensic analysis and product characterization in support of AstraZeneca Biologics late-stage and commercial products.

Valerie Tsang, Ph.D., Technical Development Program Lead, Biogen

Dr. Valerie Tsang is a Technical Development lead for clinical protein biologics programs at Biogen where she coordinates technical development activities and strategies to support CMC goals and Regulatory filings. Valerie has been with Biogen for over 12 years within Technical Development. Prior to joining Biogen, Valerie earned her Ph.D. in Bioengineering at UCSD and her B.S. in Chemical Engineering at Rice University.

David Weis, Ph.D., Associate Professor, Chemistry and Pharmaceutical Chemistry, University of Kansas

David Weis is an Associate Professor in the Departments of Chemistry and Pharmaceutical Chemistry at the University of Kansas. His lab focuses on applications of hydrogen exchange mass spectrometry to protein-protein and protein-solvent interactions and the development of new data analysis methods.

Jane Xiao, Ph.D., Director, Biophysical Characterization, Oncobiologics

Jane Xiao received her PhD in Chemistry from Mass Spectrometry Center University of Wales Swansea UK. After a post-doctoral fellowship at University of the West of England and Mount Sinai School of Medicine, Jane held positions at Johnson & Johnson and Merck. She is currently a director at Oncobiologics. For the last 15 years she has worked for the pharmaceutical industry leading analytical method development for protein characterization, biomarker development in early phase clinical trials for Clinical Pharmacology and Experimental Medicines, biosimilar development including similarity and comparability assessment, authoring and reviewing briefing book and filing documents submitted to regulatory agency in EMA and FDA.

Joanna Qing Zhou, Ph.D., Product Quality Team Leader, Division of Biotechnology Review and Research I (DBRR I), OBP, CDER, FDA

Dr. Qing Zhou is a product quality team leader in the Division of Biotechnology Review and Research I (DBRR I) in the Office of Biotechnology Products (OBP), CDER/FDA. Dr. Zhou joined the FDA in 2010 as an Interagency Oncology Taskforce (IOTF) fellow and became a full time CMC/product quality reviewer in the Division of Monoclonal Antibody (DMA) in 2012. Dr. Zhou has extensive research experience in the areas of tumor and transplantation immunology and immunotherapy. Currently, she performs and supervises the review of regulatory submissions at the FDA for a wide range of novel and biosimilar biotechnology products.

Process Analytics and Characterization
March 21-22, 2017

Sherif Badawy, Ph.D., Research Fellow, Drug Product Science and Technology, Bristol-Myers Squibb

Sherif Badawy, Ph.D., is a Research Fellow in the Drug product Science and Technology of the Bristol-Myers Squibb Company. He received his B.S. in Pharmacy and M.S. in Pharmaceutics from Cairo University, and his Ph.D. in Pharmaceutics from Duquesne University. He has more than 20 years of industrial experience in drug product development. His current responsibilities at Bristol-Myers Squibb include formulation and process development and scale-up of commercial oral solid and liquid dosage forms. His areas of research interest include high shear wet granulation, tablet compaction, stability of solid dosage forms and bioavailability enhancement of poorly water-soluble compounds. He authored 40 manuscripts and numerous abstracts and presentations in those areas.

Jonathan Bones, Ph.D., Principal Investigator, National Institute for Bioprocessing Research & Training (NIBRT), University College Dublin

Jonathan is the Principal Investigator of the NIBRT Characterization and Comparability Laboratory. Jonathan received a PhD in Analytical Chemistry in 2007. Following this he undertook postdoctoral research with Prof. Pauline Rudd at NIBRT. In 2010 Jonathan moved to Northeastern University in Boston, working with Prof. Barry L. Karger at the Barnett Institute of Chemical and Biological Analysis. Jonathan returned to NIBRT in 2012 following receipt of funding from Science Foundation Ireland to form his own independent research group. His research is focused on the development and application of advanced LC-MS and CE-MS solutions to solve challenges associated with the characterization and comparability assessment of therapeutic proteins and manufacturing processes.

Richard Braatz, Ph.D., Edwin R. Gilliland Professor of Chemical Engineering, Massachusetts Institute of Technology

Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at the Massachusetts Institute of Technology (MIT) where he does research in systems and control technologies and their application to pharmaceutical and biologic drug manufacturing. He received an MS and PhD from the California Institute of Technology and was the Millennium Chair and Professor at the University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard University before moving to MIT where he leads the Quality-by-Design (QbD) and control systems activities in the Novartis-MIT Center for Continuous Manufacturing and in the development of the Integrated and Scalable Cyto-technology (InSCyT) Platform for Biopharmaceutical Manufacturing on Demand. He has consulted or collaborated with more than 20 companies including Novartis, Pfizer, Merck, Bristol-Myers Squibb, Biogen, and Abbott Laboratories. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the Technical Innovation Award from the International Society of Automation, IEEE Control Systems Society Transition to Practice Award, and the AIChE Excellence in Process Development Research Award.

Michael Butler, Ph.D., CSO, National Institute for Bioprocessing Research & Training (NIBRT)

Michael Butler is the Chief Scientific Officer (CSO) of the National Institute of Bioprocessing Research & Training (NIBRT) in Ireland and Distinguished Professor Emeritus of 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 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 the 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.

Trina Formolo, Ph.D., Research Chemist, Bioanalytical Sciences Division, Material Measurement Laboratory, National Institute of Standards and Technology (NIST)

Dr. Formolo received her BS in biology from the University of Dallas and her PhD in molecular medicine from the Institute for Biomedical Sciences at The George Washington University. As a research chemist in the Biomolecular Measurement Division within the Material Measurement Laboratory of the National Institute for Standards and Technology (NIST) she focuses on the development of reference materials, methods and data relevant to the biopharmaceutical industry. Her interests include the mass spectrometry characterization of biotherapeutic proteins. She recently completed the LC-UV-MS/MS peptide mapping characterization of a recombinant IgG1κ monoclonal antibody (NISTmAb RM 8671) which was recently released as a Reference Material.

Rajesh K. Gupta, Ph.D., Co-Owner & Principal Consultant, Biologics Quality & Regulatory Consultants, LLC, former Deputy Director and Lab Chief, Division of Biological Standards and Quality Control, CBER, FDA

Rajesh K. Gupta has a Ph.D. in microbiology and is the Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years’ experience in the development, production, testing and regulation of biologics, working at both the regulatory agencies and the industry. At FDA, CBER, he was a Deputy Director and the Lab Chief in the Division of Biological Standards and Quality Control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods. In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH), in the USA and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in sterility assurance for biological products, adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and has made numerous presentations at scientific and regulatory meetings.

Alistair Kippen, Ph.D., Vice President, Biologics Development, Ipsen

Stephan O. Krause, Ph.D., Director, QA Technical Support, AstraZeneca Biologics

Dr. Stephan O. Krause is AstraZenca's Director of QA Technology in clinical/commercial biologics operations. Prior to that, he was in MedImmune's Regulatory Science group (headquarters). Other previous roles include Director of QC and Manager of QA/QC Technical Services and compendial liaison at Bayer Biologics.

Stephan’s book on risk-based method validation strategies won the 2007 PDA Distinguished Author Award. Stephan is the primary author and task force leader of PDA TR 57 (2012). He is co-author of PDA TR 65 for Tech Transfer (2014), PCMO's task force leader for IMP Specification Setting (2015), and the Biosimilars Initiative co-leader. He is a member of PDA's Biotechnology Advisory Board, a TRI member lecturer, and a member/liaison to PDA's Education Advisory Board. Stephan was nominated to PDA' Board of Directors (2017-18). In recent years, he was invited multiple times by the FDA to present an industry perspective to the CMC reviewer teams at FDA's headquarters.

Kristin Krukenberg, Ph.D., Analytical Scientist, Process Development, Shire

I obtained my BS in Chemistry at Rice University. I obtained my PhD in Chemistry and Chemical Biology from the University of California, San Francisco, where I studied the structure of the chaperone protein Hsp90 using small angle X-ray scattering and other biochemical and biophysical techniques. After graduating from UCSF, I moved to the Department of Systems Biology at Harvard Medical School where I investigated the biochemical and cellular regulation of poly(ADP-ribose) polymerase 1 and its interactions with other proteins. Since July of 2015, I have been working as an Analytical Scientist at Shire leading method development and characterization activities for an early stage biologics program.

Bhumit A. Patel, Ph.D., Associate Principal Scientist, Bioprocess Development, Merck & Co, Inc.

Bhumit Patel graduated with his Bachelors in Biochemistry from Binghamton University. From there his graduate work at Cornell University focused on the expression and purification of heme proteins where he graduated with his PhD in Biochemistry, Molecular & Cell Biology. After doing a post doc at University of Pennsylvania & working at a small biotech company, he joined Pfizer in 2012. There he was part of the Analytical R&D team which characterized Antibody Drug Conjugates in addition to analytical method development for the bioprocess and formulation groups. At Merck, Bhumit is leading efforts to develop PAT technologies including MAM to characterize biologics and ultimately push the technology forward to manufacturing.

Ramila Peiris, Ph.D., Manager, Process Modelling and Process Analytical Technology, Sanofi Pasteur

Dr. Ramila Peiris received his PhD in Chemical Engineering from the University of Waterloo. His expertise includes mathematical modeling, process analytical technology and the control and optimization of biopharmaceutical manufacturing processes. He has authored several refereed journal publications and is the recipient of numerous awards for innovation and industrial performance. Ramila currently works as the Manager of Process Modeling and Process Analytical Technology at Sanofi Pasteur, Toronto, Canada.

Richard Rogers, Ph.D., Scientist 4, Just Biotherapeutics

Dr. Rogers got his Ph.D. from the Johns Hopkins University in 2003. In Mike Matunis’ lab he studied the effects of Sumo modification on transcription factors. As a post doc, Dr. Rogers joined John Aitchison’s lab at the Institute for Systems Biology. At the ISB, Dr. Rogers expanded his research on post translational modification by applying mass spectrometry to detect phosphoryatlation and other ubiquitin-like modifications in macrophages. In 2012, Dr. Rogers joined the Analytical Sciences group at Amgen. At Amgen, Dr. Rogers developed a mass spectrometry based multi-attribute method (MAM) for biotherapeutic characterization and release from QC. Dr. Rogers is currently working for Just Biotherapeutics in Seattle. At Just, Dr. Rogers is continuing his work on the MAM.

Ryan Swanson, Ph.D., Scientist II, Process Development Analytics, Bristol-Myers Squibb

Dwight Stoll, Ph.D., Associate Professor of Chemistry, Gustavus Adolphus College

Dwight Stoll is Associate Professor and Co-Chair of Chemistry at Gustavus Adolphus College in St. Peter, MN. He has authored or co-authored 47 peer-reviewed publications in separation science, and over 90 conference presentations. His primary research focus is on the development of two-dimensional liquid chromatography (2D-LC) for both targeted and untargeted analyses. Within this area he has made contributions on the topics of stationary phase characterization, new 2D-LC methodologies and instrumentation, and fundamental aspects including re-equilibration in gradient elution RP-LC and analyte focusing. He is the 2009 recipient of the John B. Phillips Award for contributions to multidimensional gas chromatography, the 2011 recipient of LCGC’s Emerging Leader in Chromatography Award, and the 2015 recipient of the American Chemical Society Division of Analytical Chemistry Award for Young Investigators in Separation Science.