Stream 3 - Speaker Bios

Speaker Bios

Rapid Methods to Assess Quality & Stability of Biologics
August 3-4, 2015

Paul Bigwarfe, Ph.D., Director, Analytical Sciences, 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.

Jianmei Kochling, Ph.D., Director, Quality Science and Analytical Technology, Genzyme, a Sanofi Company

Jianmei Kochling is a director of Quality Science and Analytical Technology of global industrial operations for biologics at Genzyme, a Sanofi company.  She is responsible for protein characterization supporting commercial stage manufacturing process improvement, introducing new technology platforms and developing analytical methods supporting product release and stability testing during analytical life cycle management, and cleaning validation for commercial production.  Prior to this position, Dr. Kochling was a director of Quality Control Technical Services for biologics.  Before joining the biologics division, she was a scientific associate director leading analytical development for a small molecule program (Cerdelga) from late Phase 2 to successfully global commercial launch at the Genzyme pharmaceutical division.  

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 at various positions with increasing responsibilities.  Jianmei Kochling received her PhD from Northeastern University, MS from Virginia Commonwealth University, and BS from Fudan University.

Michael Tovey, Ph.D., INSERM Director of Research, Laboratory of Biotechnology and applied Pharmacology, Ecole Normale Supérieure de Cachan, France

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

Shenjiang Yu, Ph.D., Associate Principal Scientist, Sterile Product and Method Development, MRL, Merck Co. & Inc.

Michelle Joubert, Staff Scientist, Genzyme, a Sanofi Company

Joël Richard, Ph.D., Senior Vice President Peptides, Technical Operations, Ipsen

Dr Joël Richard is currently Senior Vice President, Peptides in IPSEN (France). He is globally leading all the CMC development activities of both injectable and oral peptide-based products, including APIs and drug products, with major franchises in Oncology, Endocrinology and Neurology.  Dr Richard has more than 25 years of experience in chemistry and biopharmaceutical R&D, including several global senior positions in various Biotech and Pharma companies, such as:

-Vice President, Drug Product Development in Ipsen (France) (2008-2011),

-Director, Pharmaceutical Development in Serono and Merck Serono (Italy, Germany) (2005-2008)

-Vice President Research, and Europe R&D Director at Ethypharm (France) (2001-2004),

-COO at Mainelab (France), a drug delivery company he co-founded, which was specialized in developing solvent-free processes for protein delivery systems (1999-2001).

Since 1996, Dr Richard has focused his research activity on new formulation technologies and drug delivery systems (such as microspheres, nanoparticles, nanocapsules, chemically-modified proteins, supercritical fluid technology . . .), especially for injectable peptide and protein formulations.

Dr Richard has published 65 peer-reviewed scientific papers, 7 book chapters and 2 review editorials in various fields (colloids and interfaces, drug delivery, supercritical fluids, protein formulations, nanoparticles, sustained-release formulations . . .). He is the author of more than 100 international communications and 53 patent families.

Nataliya Afonina, Ph.D., President and Principle Consultant, AN Biologics Consulting LLC

Dr. Nataliya Afonina received her M.S. degree from the St. Petersburg State University, Department of Biology and her Ph.D. from Agro-Physical Research Institute, Russian Academy of Science, St. Petersburg, Russia with primary research focus on physical-chemical mechanisms of ion adsorption in electrical double layer. Since Jan 2015, Dr. Afonina is a President and Principle Consultant at AN Biologics Consulting LLC, which provides consultation in the area of biotechnology including protein aggregation, release and stability of biologics drug substance and drug product, non-compendial raw materials, method development, validation and transfer, and IND and BLA support. Prior to this, Dr. Afonina held Director (2009-2014) and Associate Director (2006-2009) positions within Biologics Analytical Development and Testing at Bristol-Myers Squibb Co. As well, she held several positions with increasing responsibilities in biopharmaceutical industry (commercial and research) at ImClone Systems Inc. (Eli Lilly & Co.), Bioprocess and Bioanalytical Research, MRL, Merck & Co., and McNeil CPC, Johnson & Johnson.

Reema Raghavendra, M.S., MBA, Scientist II, Global Protein Sciences, AbbVie, Inc.

Reema Raghavendra is a Scientist II at AbbVie Bioresearch Center in Worcester, MA. She is currently a member of the Global Protein Sciences group within the R&D wing of AbbVie. She is involved in the development and characterization of early stage antibody drug conjugates and multi-specific antibody therapies. Previously, Reema focused on analytical development and support of late pipeline and commercial projects within the Operations-Process Development group at AbbVie. During her tenure, she has had the opportunity to work on multiple in-house projects and other third party manufacturing projects using both established and innovative characterization techniques. . In the past, she has had the opportunity to work on collaborative projects with Harvard School of Public Health and across other Abbott and AbbVie sites and functions.

Reema holds an MBA from Isenberg School of Management at Umass and a Masters in Chemical Engineering from Wayne State University in MI. Her talk involves collaboration between AbbVie and Dr. Dean Ripple at NIST in the development and implementation of sub-visible protein-like standards for particle characterization by flow cytometry.

Yimin Hua, Scientist II, Quality Science and Analytical Technology, Genzyme, a Sanofi Company

Yimin Hua is a Scientist II in Quality Science and Analytical Technology at Genzyme.  The focus of her efforts at Genzyme is to develop analytical methods for supporting process development and validation, as well as for QC releasing and stability testing using new technology platforms.  She received her Ph.D. in Analytical Chemistry from University of Arizona.

Amy Hilderbrand, Ph.D., Technical Development Scientist, Protein Analytical Chemistry, Genentech, Inc.

Amy Hilderbrand received her Ph.D. in analytical chemistry from Indiana University focusing on the use of ion mobility / mass spectrometry to separate and identify peptide sequence isomers.  After her Ph.D., she did a post doc at the University of Arizona and then worked at Thermo Scientific where she was a demonstration chemist for their Orbitrap mass spectrometer instrument line.  During her time at Thermo she used mass spectrometry to characterize oligonucleotides, peptides, proteins, small molecules and polymers.  She then moved to Roche, where she characterized protein targets for small molecules and small molecule impurities.  In 2012, she joined Genentech and is currently focused on the characterization of biotherapeutics at the interface between research and development.

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

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

Jan Stracke, Ph.D., Principal Scientist, Pharmaceutical Development & Supplies, ​PTD Biologics Europe, F. Hoffmann-La Roche Ltd.

Jan Stracke joined Roche in 2001 working on chemical modification and purification methods for protein therapeutics. Later, he took a position in Protein Analytics, specializing in the physico-chemical analysis, characterisation and stability assessment of therapeutic proteins. Recently, he joined Roche Early-Stage Pharmaceutical Development & Supplies in Basel as Principal Scientist, responsible for the formulation and pharmaceutical development of biotherapeutics. His main interests are the evaluation of chemical and physical degradation pathways and the elucidation of the structure-function relationships for the new therapeutic entities.

Richard K. Brown, Ph.D., President, AVIA Biosystems

Ranajoy Majumdar, Ph.D., Research Scientist, Biophysical Characterization, Biopharmaceutical Research and Development, Eli Lilly and Company

Ranajoy is a research scientist in the biopharmaceutical R&D department of Eli Lilly and Company. He is a member of the biophysical characterization group and leads characterization efforts for several molecules in internal CM&C teams. His research interests include high throughput structural characterization and application of biophysical techniques in formulation and process development of biomolecules. Prior to joining Lilly, Ranajoy obtained a Ph.D. in Pharmaceutical Chemistry from the University of Kansas.

Geetha Thiagarajan, Ph.D., Senior Scientist, Sterile Product and Analytical Development, Merck & Co.

After obtaining my Ph.D. in Biochemistry from India on the biophysical aspects of protein aggregation related to cataract of the eye lens, I continued to pursue my interest in protein unfolding and aggregation leading to disease. This included my studies of A aggregation in Alzheimer’s and Polyglutamine aggregation in Huntington’s disease with Prof Ronald Wetzeland collagen-based disorders with Prof Barbara Brodsky. I worked in the area of Human Genetics with Prof Robert Desnick at Mount Sinai School of Medicine, NY identifying Single Nucleotide Polymorphisms (SNPs) in receptor proteins which could impact the uptake of lysosomal proteins. I joined Merck in 2011 and have been associated with the Biophysical and Analytical Characterization group in the Sterile Product and Analytical Development Department.

Manvi Hasija, M.S., Formulation and Stability Scientist, BioProcess Research and Development, Sanofi Pasteur

Speaker Bios

Virus Detection, Clearance and Safety of Biologics
August 6-7, 2015

Barbara J. Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting LLC

Otmane Boussif, Ph.D., Director, Purification & Formulation Processes, Sanofi Pasteur

Dr. Otmane Boussif is currently Head of Downstream & Formulation R&D at Sanofi Pasteur, where he is in charge of managing the bioprocess development of suitable vaccine purification and formulation processes from the preclinical stage up to Technology Transfer to clinical and manufacturing sites. Otmane has over 20-year biotech experience spanning from drug delivery systems, gene therapy vectors, MAb-derived entities purification and formulation to adjuvanted combo vaccines development. This allowed him to develop a broad expertise in developing New Biological Entities.

Dr. Otmane Boussif held a Ph.D. in Bio-physicochemistry and master degree in Organic Chemistry and Biochemistry from University Louis Pasteur, Strasbourg, France. Throughout his career, he held several positions with increasing scientific and management responsibilities.

Horst Ruppach, Ph.D., Global Manager Viral Clearance and Global Coordinator Virology, Biologics Testing Solutions, Charles River Biopharmaceutical GmbH

Dr. Horst Ruppach joined Charles River Laboratories with the acquisition of NewLab BioQuality AG in 2008. He studied chemistry at the University of Cologne and the University of Marburg, Germany. He earned his PhD in Human Immunodeficiency Virus (HIV) research in the laboratories of Dr. Rübsamen-Waigmann at the George-Speyer-Haus in Frankfurt. From 1997 to 2005, he and Dr. Andreas Immelmann established Analysis Biomedizinische Test GmbH, an internationally company supplying services in the field of viral safety studies for the pharmaceutical industry. With the fusion of NewLab BioQuality AG and Analysis GmbH in 2005, he developed and managed the two virology departments providing virus safety testing and viral clearance studies for biologics. With the acquisition of NewLab by Charles he managed the expansion of the viral clearance department in Cologne and established the viral clearance site in King of Prussia, PA, USA.

Dr. Horst Ruppach has 20 years of experience in the field of virology and is a proven expert for technical and regulatory aspects of virus safety testing and virus/prion clearances studies. He is currently responsible for the business development of Charles River’s viral clearance service worldwide.

William Daniels, MSc, Senior Scientist, Purification Process Development, Pfizer, Inc.

Senior Scientist with over 10 years of industry experience in purification process development of biologic therapeutics, working on both early and late stage programs.  Responsibilities have included leading academic and corporate collaborations that have focused on chromatography resin reuse challenges so as to better understand and resolve resin fouling situations.         

Paul W. Barone, Ph.D., Associate Director, Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB), MIT Center for Biomedical Innovation

Dr. Barone has been at the MIT Center for Biomedical Innovation since 2010. He currently is the Associate Director of two biopharmaceutical industry consortia housed at MIT: the Biomanufacturing Research Program (BioMAN) and the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB). He manages sponsored projects and activities for both BioMAN and CAACB with topics ranging from analysis of media treatment options to risk assessment and risk control for adventitious agent contamination.

Shilpa Ananthakrishnan, MSc, Scientist I, Process Sciences, Purification, AbbVie Bioresearch Center

I am a scientist working for AbbVie. Joined Abbot as a Graduate student from WPI in Worcester. I major in Biochemistry and have always been interested in the interactions of molecules with one another. Primary area of research for Master’s coursework was to identify the role of metal transferring ATPases in Mycobacterium tuberculosis infections. Used my expertise in Bioinformatics and Biotechnology, and applied it to my field of study in the work place. Working in the industry has taught me about drug substance manufacturing, Immunology, clinical trials and - but not restricted to - the workings of FDA and clinical filings.

Kathryn Martin Remington, Ph.D., Principal Scientist, Development Services, BioReliance

Kathryn Martin Remington joined BioReliance in 2010 as a Principal Scientist to assists clients in designing their viral clearance studies as well as provide technical expertise to support Clearance Services. She came to BioReliance from Catalent Pharma Solutions where she established and managed their viral clearance program for 7 years. Prior to that, Kathy was the Section Head of the Viral Validation group for Bayer Healthcare. During her 17 years in viral clearance, she authored a number of publications on the viral safety of biopharmaceuticals. She has also worked in research, studying drug resistant feline immunodeficiency viruses. Kathy earned her M.S. and Ph.D. in Microbiology from the University of Montana.

Deqiang Yu, Ph.D., Senior Scientist, Process Development, Bristol-Myers Squibb Co.

Dennis is a Sr. Scientist and Process Development Lead on mAb projects in Bristol-Myers Squib.  Prior to BMS, Dennis led a downstream PD group for viral vaccine development in Novartis Vaccines and Diagnostics.  Prior to that, he worked as a Sr. Scientist in PlantForm Corporation in Canada on mAb development from transgenic plant.  Dennis completed his PhD and Postdoctoral studies in Chemical Engineering at McMaster University, Canada.  Prior to PhD study, Dennis worked at Shenzhen Kexing Biotech in China with considerable experience in PD and manufacturing of recombinant protein drugs.

Siemon Ng, Ph.D., Scientist, Microbiology & Virology Platform, Department of Analytical Research & Development North America, Sanofi Pasteur

Dr. Siemon Ng, PhD. is a scientist at the Analytical Research and Development North America department at Sanofi Pasteur (Toronto, Ontario).  Dr. Ng completed his PhD. at Simon Fraser University (Vancouver, BC, Canada) as part of the Genome Canada project working on the Atlantic salmon genome.  Subsequently, he worked on mouse genomics at The Jackson Laboratory (Bar Harbor, Maine, USA).  In 2008, Dr. Ng moved to Toronto to join the team at the Ontario Institute for Cancer Research analyzing the genomic landscape of stem cells before joining Sanofi Pasteur in 2011.  Dr. Ng is currently involved in the development of various assays and the implementation of next-generation sequencing technologies within the Microbiology and Virology platform in the Analytical Research and Development North America department of Sanofi Pasteur.

Brenda Richards, Staff Scientist, Functional Genomics, Genzyme, a Sanofi Company

I have worked at Genzyme on multiple projects for over twenty years.  Key areas of focus have included developing DNA-based assays for diagnosing rare diseases and performing gene expression studies supporting various rare disease programs.  More recent work has included taking advantage of microarray and Next-generation sequencing (NGS) technologies which allow for expression analysis of the entire transcriptome.  I have also had the opportunity to work on a team employing NGS technology to identify a bioreactor contaminant and to establish detection limits for bacteria and viruses in spiking experiments.



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