2013 Archived Content
2013 Speaker Biographies
Palani Palaniappan, Ph.D., Vice President and Head, Biologics CMC, CMC Center, Millennium: The Takeda Oncology Company
Palani Palaniappan is head of Biomanufacturing Technology Laboratories and is responsible for biologics CMC activities within CMC Center in Takeda. Palani has been part of drug development teams for over 20 years and has played roles in the development and commercialization of several new medicines. He has a PhD in chemistry from Indian Institute of Technology Kanpur and has presented and published widely.
Evi B. Struble, Ph.D., Pharmacologist, Center for Biologics Evaluation and Research, US Food and Drug Administration
Dr. Struble is a Pharmacologist with the Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, CBER, FDA. She received her PhD in 2004 from Johns Hopkins University Biophysics Department, in the laboratory of Dr. Ed Lattman and completed post-doctoral training in the laboratory of Dr. John Marino, NIST. She also holds a MS in Chemistry and Toxicology from American University. Her laboratory experience includes structural characterization of protein preparations using x-ray crystallography and NMR.
While in CBER, Dr. Struble has established a research program focused in (a) the development of in vivo and in vitro models for evaluating safety and efficacy of antibody preparations during pregnancy, and (b) use of biophysical techniques to evaluate structure-function relationship of plasma derived proteins. She is a contributor to recently published research on Hepatitis C, SARS and vaccinia viruses, von Willenbrand Factor, serine proteases related to the coagulation cascade, and proteins involved in iron homeostasis, among others. Dr. Struble reviews animal studies to support marketing applications of Biologics, participates in conferences, public workshops and expert panels as a subject matter expert in issues of study design. She is a member of Society of Toxicology and Teratology Society.
Laurence A. Nafie, Ph.D., Distinguished Professor Emeritus, Department of Chemistry, Syracuse University
Laurence A. Nafie received his Ph.D. from the University of Oregon in 1973, studying resonance Raman scattering, and from 1973 to 1975 he was a postdoctoral associate at the University of Southern California, working on the discovery and confirmation of infrared vibrational circular dichroism (VCD). In 1975 he joined the Chemistry faculty at Syracuse University to establish a research program in VCD and Raman optical activity (ROA). In 1978, he was named an Alfred P. Sloan Foundation Fellow and was promoted to Professor in 1982. In 1978 he proposed and carried out the first measurements of Fourier transform VCD, now the basis of all commercial VCD instrumentation. He was appointed Chairman of the Chemistry Department in 1984 and served until 2000. In 1988 he measured the scattered circular polarization (SCP) form of ROA for the first time that is now used in the only commercially available ROA spectrometer. In 1989 he predicted theoretically a new form of ROA called dual circular polarization (DCP) ROA that was confirmed experimentally in his laboratory in 1991. In 1995 he became founding Editor of the journal Biospectroscopy, published by John Wiley & Sons and continued as Associate Editor of Biopolymers until 2010. In 1996, he co-founded with Dr. Rina Dukor the company BioTools, Inc. to market advanced vibrational spectroscopy instrumentation, including the ChiralIR VCD and ChiralRAMAN ROA spectrometers. In 1996 he published the theory of resonance ROA and its predictions were confirmed by its first observation in 1998. In 2000, he was named Distinguished Professor of Chemistry at Syracuse University. He was awarded the Coblentz Award (1981), the Bomem Michelson Award (2001), the William F. Meggers Award (2001) and the Distinguished Service Award of the Society of Applied Spectroscopy (2007). He served on the Governing Board of the Coblentz Society from 1984 to 1988 and was President from 1993 to 1995. In 2003, he served as President of the Society of Applied Spectroscopy, and in 2008 he became a Fellow of the Society of Applied Spectroscopy. In January 2010 he retired from full-time service at Syracuse University to become Distinguished Professor Emeritus and at the same time Editor-in-Chief of the Journal of Raman Spectroscopy published by John Wiley & Sons. In 2011 he published a comprehensive book on the fundamental theory, instrumentation, measurement, calculation and application of vibrational optical entitled Vibrational Optical Activity: Principles and Applications Wiley, Chichester (2011). In 2012 he was named the winner of the Pittsburgh Spectroscopy Award of the Spectroscopic Society of Pittsburgh, March, 2013. He has over 290 publications and several patents.
Steven Berkowitz, Ph.D., Principal Scientist, Analytical Development, Biogen Idec
Dr. Berkowitz received a B.S. degree in Biology from Fairleigh Dickinson University and a Ph.D. degree in Biochemistry from New York University. He then spent several years as a post-doctoral fellow at Yale University and the NIH. After his post-doctoral work Dr. Berkowitz held various positions at Celanese Research Company, J.T. Baker, and Lederle Laboratories before taking his present position at Biogen Idec.
Dr. Berkowitz’s technical areas of expertise are concentrated in the separation sciences and the physical sciences associated with the characterization of biopolymers and synthetic polymers. Much of Dr. Berkowitz’s work has centered on assessing the physico-chemical properties, micro-heterogeneity and aggregation properties of biopharmaceuticals using light scattering, analytical ultracentrifugation, chromatography, electrophoresis, and various forms of spectroscopy.
Ravi Chari, Ph.D., Senior Scientist, Pharmaceutics, AbbVie Bioresearch Center
Dr. Chari is a Senior Scientist in the Preformulation Group at AbbVie Bioresearch Center in Worcester, MA. His primary work involves early discovery screening of biologics candidates for acceptable solubility, viscosity, and degradation profiles. He also supports later formulation development of API and Drug Product. His research interests include computer modeling of proteins to predict physicochemical properties.
Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
Tom Laue is the Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and professor of Material Sciences at the University of New Hampshire. He is the Director of both the Center to Advance Molecular Interaction Science and the Biomolecular Interaction Technologies Center.
He received his bachelor’s degree in Natural Sciences from the Johns Hopkins University in 1971 and his Ph.D. in Biophysics and Biochemistry from the University of Connecticut in 1981. His post-doctoral studies were conducted at the University of Oklahoma. Between 1969 and 1975, he worked as a technician in the deep space program of NASA.
He joined the University of New Hampshire in 1984 as an Assistant Professor, and teaches both undergraduate and graduate courses in biochemistry and biophysics. His research focuses on the development of instrumentation and methods that use the fundamental properties of mass and charge for examining macromolecular interactions. These instruments provide unique insights into these interactions, and have resulted in extensive collaborations with both academic and industrial labs. Tom has over 120 publications, serves on several editorial boards, and gives over one hundred lectures, seminars and workshops a year.
Philip N. Bryan, Ph.D., Institute for Bioscience and Biotechnology Research and Department of Bioengineering, University of Maryland
Philip Bryan obtained a Ph. D. with Donald Olins at the Biology Division of Oak Ridge National Laboratory where he used biochemical and biophysical approaches to characterize nucleosome structure. His postdoctoral work with Max Birnstiel at the University of Zurich and William Folk at the University of Michigan investigated the role of chromatin structure on the expression of developmentally regulated genes. From 1989 to the present he has applied of genetic, biochemical and biophysical methods to the study of protein folding and enzymology at the University of Maryland where he is a professor in the Institute for Bioscience and Biotechnology Research and the Department of Bioengineering. He founded Potomac Affinity Proteins, LLC in 2004 to translate fundamental principles of protein folding and enzymology into protein-based devices for protein purification, ultra-sensitive detection and therapeutics.
Tatiana Perevozchikova, Ph.D, Researcher, nSoft Consortium, University of Delaware/ National Institute of Standards and Technology
Tatiana Perevozchikova serves as a protein characterization expert in nSoft consortium, a government-led initiative for developing a cutting-edge methodology for production of soft materials. While at nSoft, she is specializing in establishing solid collaborations with leading pharmaceutical companies for studying the interfacial stability and solution properties of proteins at high concentrations.
Tatiana obtained her experience in working with protein aggregation while receiving her doctoral degree from the joint Oak Ridge National Lab – UT graduate program in Biophysics. There she studied amyloid aggregation formation and its implications in Huntington Disease using small angle neutron scattering (SANS) methods. Tatiana has a diverse background with degrees in Microbiology and Economics.
Lumelle A. Schneeweis, Ph.D., Senior Investigator, Protein Science & Structure, Bristol-Myers Squibb Company
Lumelle Schneeweis is a Senior Investigator at Bristol-Myers Squibb where she provides biophysical leadership and analysis for biologics discovery programs. She holds a Ph.D. in Biochemistry & Molecular Biophysics from the University of Pennsylvania. She has 13 years of experience studying the oligomeric state of proteins ranging from fusion proteins and antibodies to single domain biologics, PEG-conjugates, and multisubunit enzymes. Her work focuses on complementary methods for measuring the oligomeric state of proteins which spans both high content and high throughput methods.
Roxana E. Lacob, Ph.D., Research Assistant Professor, Department of Chemistry and Chemical Biology, BarnettInstitute, Northeastern University
Currently, as a Research Assistant Professor at Northeastern University Dr. Iacob’s major research interests are primarily focused on the application of mass spectrometric techniques to answering questions in structural biology.
The focus of Dr. Iacob’s research efforts are directed to understanding protein conformation and structure by hydrogen exchange mass spectrometry (HX MS). For the past 5 years Dr. Iacob’s gained extensive experience in HX MS having worked in Prof. John Engen’s lab, one of the pioneers in the field, studying the conformation and dynamics of several proteins of major medical interest such as Abltryrosine kinase, EGFR, HIV-neutralizing antibodies and interleukins. Additionally Dr. Iacob spent time improving the HX MS methodology and software in order to analyze large proteins and protein complexes in a more robust manner.
Nicolas Fawzi, Ph.D., Assistant Professor, Department of Molecular Pharmacology, Physiology and Biotechnology, Brown University
Nicolas Fawzi received undergraduate degrees in bioengineering and marketing at the University of Pennsylvania. He received a Ph.D. from the Joint Graduate Group in Bioengineering at the University of California, Berkeley and UCSF for his work with Teresa Head-Gordon on molecular simulation of protein aggregation, and completed postdoctoral training in the group of G. Marius Clore at the National Institutes of Health in biomolecular NMR spectroscopy of protein association and aggregation. Nicolas Fawzi joined the Faculty at Brown in the Department of Molecular Pharmacology, Physiology and Biotechnology in January 2013.
Speaker to be Announced, Analytical Development, Biotech Products, Merck Serono
Jennifer S. Laurence, Ph.D., Associate Professor, Department of Pharmaceutical Chemistry, University of Kansas
Dr. Laurence is Associate Professor of Pharmaceutical Chemistry and member of the Bioengineering Research Center and NCI Cancer Center at the University of Kansas. She holds a PhD in Chemistry and received postdoctoral training in Structural Biology from Purdue University. She has 15 years of experience working with proteins, focusing on the analysis of their structure-function relationships, binding interactions, and physicochemical stability. Her research is supported by grants/awards from NIH, Coulter Foundation, PhRMA Foundation, and industry contracts. Since 2008 she has published over 20 papers and two book chapters, filed fifteen patents, and graduated four PhD and three MS students. In 2011, Dr. Laurence was awarded the Louise Byrd Graduate Educator Award for extraordinary devotion to graduate students and their education and for distinguished scholarship. She has received recognition as Mentor of the Year from the NIH IMSD program in 2006 and the American Association of Colleges of Pharmacy (AACP) Teacher of the Year in 2006.This past year; she developed a partnership with Nairobi University for participation in her department’s distance Master’s degree program. Dr. Laurence chairs the Education Subcommittee for the American Chemical Society’s Committee on Science and serves on the Vision 2025 Presidential Task Force, as well as the Editorial Advisory Board for the Journal of Pharmaceutical Sciences and Guest Editor for a 2012 special issue of Molecular Pharmaceutics on Advances in Biophysical and Bioanalytical Protein Characterization. She has served on NIH and NSF review panels covering grant applications related to biotechnologies, protein characterization, analytical tool development, and cancer detection. In Dec 2010, Dr. Laurence founded Echogen Inc. to commercialize her lab’s unique metal-peptide technology.
John P. Marino, Ph.D., Leader, Biomolecular Structure & Function Group, National Institute of Standards and Technology
Since 2008, Dr. Marino has been the leader of the NIST Macromolecular Structure & Function Group and Associate Director of the Institute for Bioscience and Biotechnology Research (IBBR), a joint research institute of the University of Maryland and NIST, in Rockville, Maryland. In 1997, Dr. Marino joined NIST as a Research Chemist and was appointed Adjunct Professor at the University of Maryland. Before coming to NIST, Dr. Marino graduated magna cum laude from Princeton University in 1989 and completed a Ph.D. in Chemistry from Yale University in 1995. He then worked for two years in the group of Prof. Christian Griesinger at the Goethe Universität in Frankfurt, Germany as an Alexander von Humboldt post-doctoral fellow. Dr. Marino’s research interests are focused on developing high-resolution Nuclear Magnetic Resonance (NMR) and other biophysical methods to advance precision measurement of biomolecular structure.
George Svitel, Ph.D., Senior Scientist, Process & Product Development, Amgen, Inc.
George Svitel is a senior scientist at Amgen in Process &Product Development, R&D, Thousand Oaks, California. George’s expertise is in analytical ultracentrifugation, light scattering and atomic force microscopy and applying these techniques in formulation development and characterization of protein aggregation and self-association. Before joining Amgen he worked at the National Institutes of Health, Bethesda, MD; Lund Technical University, Sweden; and United Nations Industrial Development Organization, Trieste, Italy. He received a PhD. in bioengineering from Technical University, Bratislava, Slovakia.
Christopher Mensch, Scientist, Vaccine Drug Product Development, Merck Research Laboratories
Christopher Mensch is a formulation scientist working for Merck out of West Point, Pennsylvania in the Vaccine Formulation Development group within Merck Research Laboratories. His research activities have encompassed the evaluation of formulation stability as it relates to freeze-thaw cycling, the screening of material and process compatibility for vaccines and biologics, evaluation of primary container and device selection, development of tungsten and silicone oil sensitivity screening methodologies, and the evaluation of the impact of extractables & leachables on drug substance and drug product stability.
Currently, he is leading a team focused on controlling and characterizing the agitation induced aggregation of drug product formulations. In addition to his role within formulation development and his leadership of an innovative team, Mr. Mensch also serves as a subject matter expert within his research group for several sizing methodologies including but not limited to NanoSight nano-particle tracking analysis and Micro-Flow Imaging.
Nausheen Rahman, Ph.D., Director, Bioprocess Research and Development, Sanofi Pasteur Limited
Nausheen is currently the Director of Formulation and Stability in Bioprocess Research and Development at sanofi pasteur where she is responsible for the process definition of the final vaccine candidate and management of the stability programs for new vaccine clinical candidates. Nausheen graduated with a B.Sc. in Chemical Engineering from Northeastern University followed by a Ph.D in Biomedical Science and drug delivery from Brown University. Soon after graduating she took on the role of development scientist in the formulation group at sanofi pasteur with responsibilities in the area of formulation and fill process design and stabilization of novel vaccine candidates. Her role within the group has evolved to span aspects of formulation development, process design and stability for new vaccine projects.
Sujit K. Basu, Ph.D., Senior Director, Drug Product Development, Shire Human Genetic Therapies
Sujit Basu joined Shire in 2012 and currently serves as Senior Director, Pharmaceutical Development. Dr. Basu has more than eighteen years of industry experience in pharmaceutical R&D, project management and cGMP manufacturing and is an inventor or author of more than 50 issued patents and patent applications and peer-reviewed publications. Before joining Shire, Dr. Basu was Vice President, Formulation at Dicerna Pharmaceuticals, responsible for nucleic acid formulation and delivery. Prior to that, Dr. Basu was Sr. Director, Formulation and project team leader at Altus Pharmaceuticals, responsible for developing drug products utilizing protein crystallization and formulation technologies and CMC team leader and staff scientist at Alkermes, responsible for developing inhalation and injectable drug products. Before coming to the USA he was a pharmaceutical manufacturing manager at Sarabhai Enterprises in Baroda, India, responsible for developing and commercial manufacturing of oral and injectable drug products.
Dr. Basu holds a B.S. in Pharmaceutical Technology and a M.S. in Pharmaceutical Engineering from Jadavpur University in Kolkata, India, a Ph.D. in Pharmaceutical Sciences from the University of Southern California, Los Angeles, and a Certificate in Management from Harvard University.
Joël Richard, Ph.D., Vice President, Peptides, CMC & Engineering, Ipsen
Dr. Joël Richard is currently Vice President, Peptides in IPSEN. He is globally leading all the CMC development activities of both injectable peptide products and oral small molecules, including APIs and drug products, with major franchises in Oncology, Endocrinology and Neurology.
Dr Richard has a 25-year experience in industrial R&D, including several global senior Pharmaceutical Development positions in various Biotech and Pharma companies, including Ipsen, MerckSerono, Serono, Ethypharm and Mainelab.
Since 1996, Dr. Richard has focused his research activity on new formulation technologies and drug delivery systems for injectable protein and peptide formulations. Dr Richard has published 63 peer-reviewed scientific papers, 7 book chapters and 2 review editorials in various fields including protein formulations. He is the author of 95 international communications and 51 patent families.
Alina A. Alexeenko, Ph.D., Assistant Professor, School of Aeronautics and Astronautics, Purdue University
Alina Alexeenko is an Associate Professor at the School of Aeronautics and Astronautics at Purdue University. She received her Ph.D. in Aerospace Engineering in 2003 from the Pennsylvania State University. She was a WiSE Fellow at the University of Southern California in 2004-06. Her research interests are in computational and experimental rarefied gas dynamics with applications to high-altitude aerothermodynamics and gas flows in vacuum systems. She has co-authored over 100 journal and conference papers in these areas.
Yong Quan, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.
I am currently a Senior Research Investigator at Bristol-Myers Squibb Company. I have worked in the formulation department in Bristol-Myers Squibb for the past 10 years. I am involved in the formulation development during the early stage as well as manufacture technology transfer during the late stage of biologics pharmaceutical development. My research interests include mechanism understanding and model prediction of the chemical degradations of protein drugs during product shelf life and formulation approaches to mitigate the degradations. I received Ph. D degree in Biomedical Informatics from University of Medicine and Dentistry of New Jersey.
Willow DiLuzio, Ph.D., Associate Director, Pre-Formulation and Formulation, Cambridge Biologics CMC Group, a CMC Center Department, Millennium: The Takeda Oncology Company
Willow R. DiLuzio is currently the head of the Biologics Pre-Formulation and Formulation Group at Millennium: The Takeda Oncology Company in Cambridge, Massachusetts. She has over 12 years of experience in formulation development and drug product manufacturing and over her career she has developed liquid and lyophilized formulations for small molecules, peptides, and protein drugs in vials and pre-filled syringes. She has been with Millennium: The Takeda Oncology Company for over 7 years and she previously worked at DuPont Pharmaceutical for 5 years. She received a B.S. in Chemical Engineering from The University of Massachusetts at Amherst in 1995 and a Ph.D. in Engineering from Harvard University in 2005.
Bakul Bhatnagar, Ph.D., Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Bakul Bhatnagar is a Principal Scientist in BioTherapeutics Pharmaceutical Sciences at Pfizer located in Andover, MA. He obtained a Ph.D in Pharmaceutical Science from the University of Connecticut and performed post-doctoral work in the department of Pharmaceutics at the University of Minnesota. He is experienced in formulation and process development of freeze-dried therapeutics and in frozen- and solid-state characterization of pharmaceuticals.
Dushyant Varshney, Ph. D
Dushyant is currently a Senior Project Manager at Novartis, USA. He has previously worked at Bristol-Myers Squibb, Sanofi and Eli Lilly & Company. He has made significant contributions in product & process development (including lyophilization), quality-by-design, process analytical technologies, managing technology transfers and quality for biologics, vaccines & small molecules. Having earned his Ph.D. from the University of Iowa, Dr. Varshney has authored several peer-reviewed scientific publications, review articles & book chapters. Presented at several international conferences and chaired scientific workshops.
David A. Thomas, Principal Scientist, BioTx Pharm. Science, Pfizer, Inc.
David is principal scientist in the Biotherapeutics Pharmaceutical Sciences group at Pfizer in St. Louis, MO. He has Extensive experience in drug product development for mAbs, conjugated proteins, vaccines, oligonucleotides, peptides and small molecule parenteral dosage forms. He is works on development of new technologies for drug substance Bioprocessing, development and validation of analytical methods for protein based and small molecule products. He also holds regulatory CMC experience in authoring IND’s, BLA’s and Query response for US, EU, Japan and ROW submissions. His career path includes American Critical Care, DuPont, Baxter, Northfield Labs, G.D. Searle, Pharmacia and Pfizer.
Mark Yang, Ph.D., Director, Fill Finish Development, Commercial Process Development, Genzyme, a Sanofi Company
Mark Yang is the Director for Fill Finish Development at Genzyme. After earned his PhD from the University of Georgiain 1997 and completed his postdoctoral research at NIH, Dr. Yang has since been working in protein drug delivery, protein formulation, and fill finish development in a number of companies, including Genzyme, Acceleron Pharma, and Baxter. Dr. Yang is the invited speaker for many national and international meetings. He has published over 20 research papers in peer-reviewed journals and is the (co)inventor of numerous patents.
Kishore Ravuri, Ph.D., Group Leader, Late-Stage Pharmaceutical and Processing Development, Biologics Europe, F. Hoffmann-La Roche Ltd.
Dr. Kishore Ravuri is currently a scientist and group leader at the Late Stage Pharmaceutical and Process Development group at Roche in Basel. He has a strong focus on formulation topics related to protein stability and excipient degradation as well as process development topics such as scale down models for process characterization. He joined Roche in 2008 and holds a PhD in organic chemistry.
Jianmei Kochling, Ph.D., Director, Quality Control Technical Services, Genzyme, a Sanofi Company
Jianmei Kochling is the Director of quality control technical services of biologics division at Genzyme Corporation, a Sanofi company. She is responsible for Genzyme biologics cleaning validation, protein characterization and methods development during analytical methods life cycle management. Prior to this position, Dr. Kochling was a scientific associate director of analytical development for small molecules at Genzyme. Dr. Kochling has 12 years of experience in analytical development supporting small molecule drug development from pre-IND to NDA and 5 years analytical research experience in protein and peptides analysis. Dr. Kochling is a steering committee member for both the AAPS APQ dissolution and stability focus groups. She also serves on the USP expert committee for enzyme use in dissolution.
She has worked at GSK, Waters Corporation, Praecis Pharmaceuticals, and Vertex Pharmaceuticals prior to joining Genzyme. Jianmei received her PhD from Northeastern University, MS from Virginia Commonwealth University, and BS from Fudan University
Malgorzata Norton, MS, Biologist, Office of Blood Research and Review, Center of Biologics Evaluation and Research, US Food and Drug Administration
Malgorzata Norton (formerly Mikolajczyk) is a Biologist in the Division of Hematology, Office of Blood Research and Review, CBER, FDA. She received her M.S. from the Louisiana State University, School of Veterinary Medicine, studying veterinary immunology and infectious disease. During her 13 years at CBER, Malgorzata has been a product reviewer and facilities inspector for polyclonal immune globulin (antibody) products. Her research and publications focus on the characterization of polyclonal antibodies and their ability to bind viral and bacterial proteins. As part of her research, she studies protein-protein interactions using surface plasmon resonance technology.
Vishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.
Dr. Nashine received his M.S. degree in Bio-process Technology from Mumbai University, followed by a Ph.D. in Medicinal Chemistry and Molecular Pharmacology from Purdue University, and post-doctoral studies in Protein Biochemistry at Pennsylvania State University. He also has several years of exposure in the areas of Fermentation Technology, Downstream Processing, and Molecular Biology. He is currently a Senior Research Investigator in the Drug Product Science & Technology department at Bristol-Myers Squibb with experience in early and late stages of product development.
Martin Lemmerer, Principal Scientist, Integrated Biologics Profiling, Novartis, Inc.
I have been working for Novartis for over six years. My current role is Principal Scientist in the Integrated Biologics Profiling Group. My field of expertise includes automation and biophysical characterization of proteins I have received my training from the University of Applied Sciences Weihenstephan, Germany.
Michael G. Tovey, Ph.D., INSERM Director, Research, Laboratory of Biotechnology and Applied Pharmacology, ENSCachan, Villejuif, France
Michael G. Tovey, Ph.D, is INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, EcoleNormaleSupérieure, Cachan, France, author of 250+ articles, member numerous scientific boards, Chair International Cytokines Standards Committee, Chair, Coral Gables Symposia, member ISICR Meetings Committee, European Adjuvant Advisory Committee, editor-in-chief Detection and Quantification of Antibodies to Biopharmaceuticals, Associate Editor, Journal of Interferon and Cytokine Research, and member of the editorial boards of numerous journals.
C. Nick Pace, Ph.D., Distinguished Professor, Department of Molecular and Cellular Biology, Texas A&M
Dr. Nick Pace obtained his Ph.D. at Duke University working with Dr. Charles Tanford; and his post doctoral studies were at Cornell University working with Dr. Gordon Hammes. He is a Distinguished Professor in the Molecular and Cellular Medicine Department in the Texas A&M Health Science Center. His research focuses on the structure, stability, and folding of proteins. He has made many important contributions in these areas. For example, the two most cited papers in the history of the journal Protein Science are from his group and the article “How to measure and predict the molar absorption coefficient of a protein” has been cited over 2000 times. Dr. Pace was awarded the Distinguished Achievement Awards for both Research and Teaching at Texas A&M University. He was also selected for the Senior Investigator Excellence in Research Award by the Texas A&M HSC, and the Sigma XI Distinguished Scientist Award.
Yatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India
Wayne F. Reed, Ph.D., Professor of Physics and Engineering Physics, Department of Physics, Tulane University
Wayne F. Reed is Professor of Physics and Founding Director of the Tulane Center for Polymer Reaction Monitoring and Characterization and Chief Scientific Officer of Advanced Polymer Monitoring Technologies, Inc.
Michael S. Marlow, Ph.D., Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.
Michael S. Marlow, Ph.D. has been with Regeneron Pharmaceuticals, Inc. in the department of Protein Biochemistry since 2010. Michael is responsible for the biochemical and biophysical characterization of IND-track biotherapeutics and has played a role in the research and development of Eylea®, one of the most successful biotherapeutic launches in recent history. Prior to joining Regeneron, Dr. Marlow worked at OSI Pharmaceuticals for 2 years, where he assembled and ran a gene-to-protein suite in support of small molecule discovery. In addition, he instituted a number of biophysical assays for confirming and ranking small molecule leads emerging from high throughput screens. Dr. Marlow received his Bachelor of Science from Rensselaer Polytechnic Institute, a Ph.D. in molecular biophysics from Vanderbilt University, and post-doctoral training at the University of Pennsylvania.
Richard Cavicchi, Ph.D., Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology
Dr. Richard Cavicchi earned his Ph.D. in physics at Cornell University, was a post-doc at AT&T Bell Labs for two years, and then joined the research staff at the National Institute of Standards & Technology in 1989. His work has covered a variety of microfabricated sensors, and research on measurement methods such as nanocalorimetry and nanosecond microphotography. Present research focuses on characterization of protein aggregates.
Marina Kirkitadze, Ph.D., MBA, Deputy Director, Head, Biophysics and Conformation Unit, Biochemistry Platform Analytical R&D North America, Sanofi Pasteur Ltd.
Marina Kirkitadze, Ph.D, MBA has 10+ years experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Biophysics and Conformation Unit at Biochemistry Platform, Analytical R&D North America. Marina's expertise is in the field of protein science and biophysics. Her main focus is characterization of monoclonal antibodies, protein and viral vaccines, specifically, conformation and stability in solution and in adjuvanted form, and analysis of particulates.
Patrick Flanagan, Senior Research Associate, BioFormulations Department, Genzyme Corporation, a Sanofi Company
Patrick Flanagan is a Senior Research Associate within the BioFormulations Departmentat Genzyme Corporation (a Sanofi company). Patrick has eight years of experience in Early Formulation Development. Prior to his work in protein Formulation, Patrick worked as a Biopolymer Quality Control Analyst. Patrick received his Bachelor’s degree in Biochemistry from Worcester Polytechnic Institute.
Robert Simler, Ph.D., Senior Scientist, Genzyme Corporation, a Sanofi Company
Robert Simler got his B.S. in Chemistry from Duke University and his Ph.D. in Chemistry from The Pennsylvania State University where he worked on the thermodynamics and kinetics of multimeric protein folding. He has been with Genzyme for nine years in the BioFormulations Development group. His work focuses on novel approaches to preformulation utilizing spectroscopy and other biophysical techniques as well as evaluating and implementing technology to quantify and characterize subvisible particles.
Praval Shah, Analytical Associate III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.
Praval Shah received a Master of Science Degree in Pharmaceutical Sciences from Northeastern University. He is an experienced analytical chemist with several years experience in the Biopharmaceutical industry. His research and development experience includes the analysis and characterization of maytansinoid antibody drug conjugates (ADCs). He has expertise in the characterization of ADCs using light obscuration and microflow imaging techniques and in the application of these techniques to support ADC formulation development and fill finish operations.
Jennifer F. Nemeth, Ph.D., Principal Scientist, Biologics Discovery Program Leader, Biologics Research, Janssen Research & Development, LLC
Dr. Nemeth obtained a B.S. in Chemistry from the University of Scranton in 1995 followed by a Ph.D. in Analytical Chemistry from EmoryUniversity in 1999. After graduation, she worked under Dr. Richard Caprioli at VanderbiltUniversity as a post-doctoral research follow focusing on applied bioanalytical mass spectrometry. Leaving academia in 2000, Dr. Nemeth entered the biopharmaceutical industry where she was employed as a bioanalytical mass spectrometrist at Genetics Institute (now WyethBioPharma). In 2004, Dr. Nemeth joined Centocor’s Discovery Research departmentto initiate and head a new mass spectrometry group focusing on the characterization of molecules from inception through pre-clinical. The principal role of the group is structural characterization of biopharmaceuticals, and the antigens and receptors used during drug development. In July 2012, Dr. Nemeth took on a newly created position withing the Biologic Research Department in Janssen R&D (formerly Centocor R&D) as a Biologics Discovery Program Leader. In this role, she is responsible for the therapeutic development of multiple programs between pre-portfolio and New Molecular Entity declaration. Her publications include detailed protein characterizations, as well as new methods for protein analysis using mass spectrometry.
Paul Bigwarfe, Jr., Ph.D., Director, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals, Inc.
Paul received his BS in chemistry from St. John Fisher College in upstate NY. He followed that with a PhD from the University at Buffalo, SUNY, in Bioanalytical Chemistry studying proteomic applications of mass spectrometry. After a brief stint working at his advisor’s start-up company, he joined the pharmaceutical industry characterizing small molecules in drug discovery at aaiPharma. He then moved to the drug product development area at Hospira, overseeing analytical development for injectables with increasing responsibility on both internal and CMO projects. Paul joined Regeneron in 2010, where he is responsible for developing and qualifying bioanalytical methods for QC, setting specifications for drug substance and drug product, leachable extractable evaluations, release and stability testing of early to late phase clinical drug candidates, as well as anything that can be construed as an “analytical” CMC issue.
Stacey Williams, Associate Scientist, Process Development, Amgen, Inc.
Stacey is associate scientist in Process Development, Amgen Inc. with over 15 years of industry experience working on small molecules and protein therapeutics.
Donna L. Luisi, Ph.D., Senior Principal Scientist, Pharmaceutical Research & Development, Pfizer, Inc.
Donna L. Luisi, Senior Principal Scientist at Pfizer, obtained her Ph.D. in Chemistry from Stony Brook University. Her graduate work focused on characterization of the transition and the unfolded states of the N-terminal domain of the ribosomal protein L9. Dr. Luisi was a Postdoctoral Fellow in the Molecular Biology and Biophysics Department at Yale University. Her postdoctoral work focused on tetratricopeptide repeats and their role in Down Syndrome. Since joining Pfizer (formally Wyeth) in 2001, Donna and her group have been working to optimize and develop formulations and dosage forms for peptides, antibodies, drug conjugates and vaccines for Phase I through commercial development utilizing biophysical techniques.
Thomas Pohl, Ph.D., Senior Scientist, Research & Development, SuppreMol GmbH
Dr. Thomas Pohl has studied Chemistry & Biochemistry at the University of Manchester, UK and Freiburg, Germany. In his current role, Thomas is responsible for process development and formulation of drug candidates at SuppreMol GmbH, a Biotech company located in Martinsried, Germany.
Danny Chou, Ph.D., Senior Research Scientist, Biologics Development, Gilead Sciences, Inc.
Prior to joining Gilead Sciences, Dr. Danny Chou was the Co-founder and CSO of NorthStar Bio, a CRO that was dedicated to the characterization of sub-visible protein aggregates. Prior to starting his company, Dr. Chou was the Director of Pharmaceutical Development at Integrity Bio, a CRO/CMO that specializes in formulation development and CGMP fill and finish of biopharmaceuticals. Before that, Dr. Chou was also a Bioprocess Analytical Scientist and Process Development Scientist at Genzyme Corporation and Amgen Corporation, respectively. He has technical experience in therapeutic protein formulation development as well as strategies for increasing protein solubility, stability and elucidation of protein aggregation/self-association and degradation mechanisms. His expertise is in the study of protein-protein and ligand-protein interactions using laser light scattering, isothermal titration calorimetry (ITC) as well as fluorescence spectroscopy. Protein formulation, fill & finish process development, analytical method development, technology transfer, and manufacturing support are a few of his specialties. Dr. Chou is one of the leading industry proponents for the development of analytical methods to characterize sub-visible particles, a critical quality attribute that is associated with immunogenicity in protein pharmaceuticals. He has published review articles on this topic in leading pharmaceutical journals and has been invited to speak at international biotechnology conferences. Dr. Chou received his PhD in Pharmaceutical Biotechnology at the University of Colorado at Denver and his PharmD and MBA from the University of Florida.
Jan Jezek, Ph.D., CSO, Development, Arecor Ltd.
Jan Jezek, the principal inventor of the core protein stabilisation technologies, is a biochemist with a strong background in physical chemistry. Currently responsible for R&D activities, platform development and technical IP support in the field of stabilisation of biologics. He played a crucial role in the development of stabilising technologies for commercially important proteins that allow preservation of protein structure and biological activity during sterilisation by gamma radiation and during long-term storage at ambient temperature. Lead successful grant funded projects with TSB funding. Previously, a Principal Scientist at Insense Limited, he was responsible for development of novel medical devices from concept to market. Dr. Jezek holds a joint Doctorate from the University of Bedfordshire and the University of Chemical technology, Prague. He is a member of the Scientific Advisory Board of the Centre of Excellence in Biopharmaceuticals (University of Manchester). He is also a committee member of the Formulation Science & Technology Group (FSTG) at the Royal Society of Chemistry.
Paul Dubin, Ph.D., Professor, Chemistry, University of Massachusetts, Amherst
Devendra (Davy) S. Kalonia, Ph.D., Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut
Devendra Kalonia is a Professor of Pharmaceutics in the School of Pharmacy and holds a joint appointment at the Institute of Material Sciences at the University of Connecticut. Various areas of his research interest include protein formulation, stability, characterization, unfolding, and interactions of proteins with excipients, protein aggregation, protein-protein interactions and protein rheology. He is a leader in the area of high concentration antibody solution rheology and formulation. He has active research collaborations with major biotech companies. He has presented invited talks at national and international meetings, and his work has been published in highly reputed journals. He has consulted with a large number of pharmaceutical and biotech companies.
Steven Shire, Ph.D., Staff Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.
Dr. Shire has over 30 years experience in the pharmaceutical biotechnology industry. He received his Ph.D. from Indiana University Chemistry Department and after Post Doctoral Training at the University of Connecticut began his career at Genentech as Research Scientist in the Department of Protein Chemistry. He was involved in the early work to isolate heterologous recombinant proteins expressed in bacterial systems. This work led to the granting of a patent and served as the basis for further product development of proteins expressed in bacterial systems. During his tenure in the Protein Chemistry Department he used numerous physicochemical techniques to characterize Genentech proteins at various stages of development. Shortly after the creation of the Pharmaceutical Research and Development Department at Genentech, he joined the department where he made numerous contributions to development of protein formulation and delivery. In addition, he set up one of the first analytical ultracentrifugation laboratories in the Biotechnology industry. Currently he is a Staff Scientist in the Late Stage Pharmaceutical Development Department at Genentech, and an adjunct faculty member of the USC School of Pharmacy and University of Connecticut School of Pharmaceutical Sciences. He has been responsible for directing research and development of formulations for a variety of recombinant human proteins including Pulmozyme® and Xolair®. Dr. Shire has served as the chair of the American Association of Pharmaceutical Scientists (AAPS) Biotechnology Section, and was elected as a Fellow of AAPS in 1998 and member at large to the AAPS Executive Council in 2001. He has published over 80 reviews and papers dealing with various aspects of formulation and pharmaceutical development of therapeutic proteins.
Dhananjay Jere, Ph.D., Group Leader, Early-Stage Pharmaceutical Development & GLP Supplies, Biologics Europe, F. Hoffmann-La Roche Ltd.
Dr. Dhananjay Jere is the group leader, Early-Stage Pharmaceutical Development, Hoffmann-La Roche, Switzerland. He focuses on research and development of ocular drug delivery and bispecific mabs, peptides and small molecule formulation development. He is also the project leader for multiple NBE/ NCE projects, and external technology evaluation.
Shuxia Zhou, Ph.D., Research Scientist, Drug product Development, Janssen Pharmaceuticals, Johnson & Johnson LLC
Dr. Shuxia Zhou obtained her M.S. and PhD in Pharmaceutical Chemistry from University of Kansas from Dr. Christian Schöneich group (Lawrence, KS, USA), M.S. in analytical chemistry from University of Mississippi (Oxford, MS, USA) and B.S. also in analytical chemistry from Fudan University, Shanghai, China. Dr. Zhou is a very experienced research scientist at Johnson and Johnson in leading multidisciplinary and international project teams for liquid/lyophilized formulation/process development and characterization for both small molecules and biologics from discovery to Phase III with Pfizer Inc. and Johnson & Johnson. She is proficient in formulation development and optimization of biologics and new chemical entity candidates, study design, degradation pathway characterization, process development, clinical trial support, process scale-up and addressing regulatory drug product inquiries. Dr. Zhou has published 15 peer-reviewed research and review articles on international circulated journals. She also presented her scientific findings in multiple international professional conferences.
Hui Yu Huang, Ph.D., Senior Scientist, Formulation Research, Novo Nordisk A/S
Hui Yu Huang got his Ph.D in pharmaceutics and controlled drug delivery from the University of Toronto in 2008. He worked as a Research Scientist majoring in immediate and sustained release small molecule drug formulation development in Teva Pharmaceutical Industries from 2008 to 2009. He started to working as a Senior Scientist majoring in protein/peptide drug formulation development in Novo Nordisk A/S from 2010. He has expertise in the preformulation and formulation development of both small molecule and protein drugs, as well as in nanoparticle technology for both small molecule and protein drug delivery. He has two patent applications on protein drug delivery.
Daniel Seeman, Researcher, Dubin Research Group, Department of Chemistry, University
Daniel is a senior graduate student in the lab of Prof. Paul L. Dubin at
UMass-Amherst. His research focuses on the study of model proteins as
well as relevant pharmaceuticals in high concentration formulations.
Electrostatically driven interprotein interactions are studied as a function of
solution pH and ionic strength in order to limit the extent of unwanted protein
self-association. The impact of electrostatics on association of native
proteins is assessed via various scattering techniques (DLS, SLS, etc).
His research couples experimental methods with quantitative electrostatic
modeling, and simulation.
Gabriella Leo, Ph.D., Associate Researcher, Structural and Biophysical Characterization Laboratory, Analytical Development Biotech Products, Merck Serono (Italy)
Gabriella Leo received a degree in chemistry with a specialization in Biochemistry by the University of Naples “Federico II”, (Italy). After a Master in “Experts in industrial biotechnology and innovation management in the field of biotechnology” provided by ATIBB BioTekNet, she holds a PhD in Biotechnology Science (Industrial and Molecular) from the University of Naples “Federico II”, (Italy). She joined Merck Serono in 2011 as a researcher in the Structural and Biophysical Characterization Lab (SBC) of the Protein Chemistry department of Merck Serono Italia. She has profound experience in protein characterization focusing mainly on Mass Spectrometry techniques.