Addressing Toxicological and Biochemical Challenges for Drug Product Integrity
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Desmond G. Hunt, Ph.D., Senior Scientific Liaison, Department of Standards Development, United States Pharmacopoeia
Dr. Desmond G. Hunt is a Sr. Scientific Liaison in the Department of Standards Development (DSD) at the United States Pharmacopoeia. For the 2010-2015 revision cycle, he is responsible for assisting USP Expert Committees, Packaging, Storage and Distribution and Dosage Forms, in the development and revision of USP Standards. Dr. Hunt has over 15 years of research experience and prior to joining USP, in 2005, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA. Dr. Hunt has conducted a number of studies relating to the development and establishment of public standards for materials used for pharmaceutical packaging and has developed Pharmacopeial Education Courses on pharmaceutical packaging, the determination of particulate matter in parenterals and ophthalmic products and good storage and shipping practices. He is a member the Product Quality Research Institute Container-Closure and Extractable and Leachable Working Groups.
He obtained his Master of Science and Doctoral Degree from the University of Texas at Austin, USA.
Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corp.
Dennis Jenke Ph.D., MBA is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. His primary responsibilities include the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples. Foremost among these applications are the assessment of material-product interactions (specifically with respect to leachables/extractables) and the effect of such interactions on the safety and/or efficacy of pharmaceutical products. He has published extensively in the areas of analytical chemistry, environmental science and material/solution compatibility and serves as an expert reviewer for numerous pharmaceutical and analytical journals. Dr. Jenke is the author of the book entitled “Compatibility of Pharmaceutical Products and Contact Materials; Safety Considerations Associated with Extractables and Leachables”, the current Chair of the Extractables/Leachables Safety Information Exchange (ELSIE), a member of the USP’s Packaging, Storage and Distribution Expert Committee and the Chair of the PQRI Parenteral and Ophthalmic Drug Products (PODP) Extractables and Leachables Chemistry Working Group.
John Iannone, Program Manager &Technical Specialist, Toxikon Corporation
John Iannone is a Technical Lead and Program Manager at Toxikon Corporation. Since joining Toxikon in 2004, Mr. Iannone has assisted several drug and medical device developers with the development of product safety testing strategies. His areas of expertise include biocompatibility testing of combination devices, material characterization, and study design for custom microbiological and extractable/leachable studies. His responsibilities focus on providing technical support in client interface regarding unique testing requirements and facilitation of sound technical risk assessments of medical devices. Prior to joining Toxikon, Mr. Iannone received his Biomedical Engineering degree from Boston University, where he later became a research engineer in the College of Engineering.
Diane Paskiet, Ph.D., Director, Scientific Affairs, West Pharmaceutical Sciences
Ms. Paskiet has over twenty years of experiencein polymer analysis relating to product failures, deformualtion and migration studies. She has served as a project advisor in support of qualification studies associated with container closure systems for IND and NDA filings.Her current responsibilities include coordination of studies for technical supportand R&D.Previous to this role she was in chargeof site operations for West-Monarch Analytical Laboratories.
She is serving a five year term on the United States Pharmacopeia (USP) Packaging, Storage and Distribution Expert Committee and Chair of the PQRI Parenteral and Ophthalmic Drug Product (PODP) Leachables and ExtractablesWorking Group. She has authored national and international papers on the subject of leachables and extractables and is a faculty member of the PDA Training Institute.
Christopher Brynczka, Ph.D., Senior Toxicologist, Toxicology, Gradient Corp.
Dr. Christopher Brynczka is a toxicologist experienced in product safety assessment, medical device and pharmaceutical toxicology, and the evaluation of chemical effects on human health. Dr. Brynczka has expertise in the nonclinical development of medical devices and pharmaceuticals and has supported multiple programs toward market authorization. His particular areas of interest include risk assessment of medical device extractables and leachables, medical device and pharmaceutical nonclinical program design and implementation, and investigative toxicology. As a pharmaceutical Toxicologist, Dr. Brynczka managed multiple nonclinical programs spanning discovery through clinical Phase III. Prior to this he was a Study Director and Department Head at a global CRO, overseeing development projects in multiple therapeutic areas for biologics, small molecules and medical devices. Dr. Brynczka was a postdoctoral fellow at the Massachusetts General Hospital and Harvard Medical School, where he investigated genetic mutations producing acute myeloid leukemia.
Seamus O’Connor, Ph.D., Senior Analytical Scientist, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals, Inc.
Seamus O’Connor is an analytical chemist, with experience in both the protein therapeutic and small molecule pharmaceutical industries. He currently leads the leachable extractable analytical efforts at Regeneron Pharmaceuticals, including drug product container closure evaluation as well as single use component risk assessments and testing. One goal of this program was to develop in house analytical methods used for leachable and extractable testing to improve the cost and turnaround times for obtaining data to support BLA filings. In addition to this, he has developed several novel methods for quantitation of impurities in biological drug substance materials, and continues to support the development of new analytical methods for innovative new drug candidates.
Ping Wang, Ph.D., MBA, Senior Manager, Pharmaceutical & Material Sciences, DPD, PDMS, Janssen Research & Development
Ping Wang is a Principal Scientist with Janssen R&D. He has been leading the leachable and extractable efforts of JRD for the past six years. His research interests and expertise include risk based material evaluation, E&L strategies and methodologies, biologics drug development, analytical technologies, and regulatory implications. He earned a PhD in pharmacy, and is a recipient of Regulatory Affairs Certificate (RAC).
Michael A. Ruberto, Ph.D., President, Material Needs Consulting, LLC
Dr. Michael Ruberto is the President of Material Needs Consulting, LLC which provides consulting services to manage the development and commercialization of medical devices and packaging, with a special emphasis on material selection, extractables and leachables, and supply chain management. He is an active member of various pharmaceutical working groups that have developed “best practices” for characterizing and evaluating the safety of container closure systems and packaging for several different drug dosage forms. Some of these teams include: • PQRI Orally Inhaled and Nasal Drug Product E&L Working Group • PQRI Parenteral and Ophthalmic Drug Product E&L Working Group • United States Pharmacopeia (USP) Packaging and Storage Expert Committee Dr. Ruberto was formerly the Head of Regulatory Services for North America at Ciba Specialty Chemicals where he was responsible for world wide notifications of new products, food contact notifications, and regulatory compliance of Ciba chemicals. He also designed leachable and extractable studies for the FDA approval of medical devices, packaging, and labels used on drug containers. Dr. Ruberto was previously the Director of Analytical Research, where he led a full service analytical laboratory that specialized in performing testing associated with the development and commercialization of new products including chemical characterization, migration studies, applications support, and technical service. Dr. Ruberto was employed by Ciba for fifteen years where he has performed numerous migration studies to support FDA and European Union indirect food contact notification for various additives, pigments, and polymers. He was part of a team commissioned to establish a Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP) program in Ciba’s Analytical Research Department and served as GLP Study Director for many product characterization and Base Set studies needed for global product registration of novel additives. Dr. Ruberto received a B.S. with thesis from Stevens Institute of Technology and a Ph.D. in Analytical Chemistry from Seton Hall University.
Gyorgy Vas, Ph.D., Research Fellow, Intertek Pharmaceutical Services
Dr. Gyorgy Vas has a M Sc in Analytical Chemistry and a Ph. D. in Mass Spectrometry. He had published 18 research papers that have been cited more than 800 times. Dr. Vas has several years of experience in E&L testing, pioneering and adopting solventless analytical sample preparation techniques. He is an expert for trace level analytical method development and method validation. He worked for Johnson & Johnson for 7 years and was recipient of Johnson & Johnson Outstanding Analytical Scientist Award and the Philip B. Hofmann Research Award.
Yasser Nashed-Samuel, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc
Yasser Nashed-Samuel, Ph.D., is currently a principal scientist at Amgen (Thousand Oaks, CA), Process and Product Development, R & D organization. Since joining Amgen in 2003, he established and led the leachables and extractables (L/E) effort. The L/E group engages in assessing product contact for manufacturing equipment, bulk containers, primary delivery containers and devices and incident investigations for both clinical and commercial products.
Pranhitha Reddy, Director, Cell Sciences, BioProcess and Analytical Sciences, Seattle Genetics
Pranhitha Reddy, PhD. Is Director in Process Science, Seattle Genetics with 20 years of experience in developing therapeutics for inflammation, oncology and metabolic diseases, from discovery research to commercial manufacturing processes. Her biotech experience extends to both small and large Biotech companies, and includes Immunex and Amgen.
Pranhitha’s technical expertise is in designing protein therapeutics and developing cell culture processes to optimize yields and control product quality with peer reviewed publications and patents. She has organizational leadership in developing strategies, new technologies, and establishing best practice to address product safety and CMC Regulatory needs in bio-therapeutic development and manufacturing.
Melody Sauerborn, Ph.D., Senior Expert Immunogenicity, Bioanalysis, TNO Triskelion
Dr. Sauerborn spent most of her undergrad years in well-known institutes such as the Centers for Disease Control and Prevention in Atlanta to widen her knowledge in immunology. After acquiring her Masters in Science she joined the lab of Prof. Schellekens and Prof. Jiskoot, two experts in immunogenicity of protein drugs, to shed more light on the immunological aspects of antibody formation against aggregated protein therapeutics. After obtaining her PhD she started a spin-off, ADA InVivo BV, a biotech CRO in the field of drug safety. Currently she is a project leader, trainer and senior expert in immunogenicity at the bioanalysis and immunogenicity department at TNO Triskelion BV.
Prakash Manikwar, Ph.D., Scientist I, Formulation Sciences, MedImmune, Inc.
Dr. Prakash Manikwar is currently working as a scientist in the Formulation Science group at MedImmune. Prior to joining MedImmune in 2013, he worked as a post-doctoral researcher at Macromolecule and Vaccine Stabilization Laboratory, University of Kansasfor about 2.5 years. He has both led and coordinated various projects resulting in the successful characterization, stabilization and formulation of therapeutic protein drugs and vaccines. In addition, Dr. Manikwar has co-led an important research project to investigate the relationship between protein dynamics and stability.Dr. Manikwar earned his Ph.D. degree in Pharmaceutical Chemistry at the University of Kansas in 2010. His Ph.D. work focused on developing novel peptide-based drug conjugates as a potential treatment for multiple sclerosis. Dr. Manikwar has technical expertise in protein and vaccine formulation, protein-drug conjugation, analytical method development, and conducting long-term physical and chemical stability studies. He has extensive experience in preparing technical reports, co-authored 10 scientific publications and is a co-inventor on one U.S. patent.
Edward J. Smith, Ph.D., Principal, Packaging Science Resources LLC
Ed Smith is Principal at Packaging Science Resources LLC which provides consulting and training in the packaging of injectable drug products for the pharmaceutical, biotechnology, and medical device industries.
Ed is a member of the PDA and American Chemical Society. Within PDA, he leads the Packaging Science Interest Group, and served on the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG) where he co-authored PDA Technical Reports 39 & 46 on cold chain best practices. He is also a member of the PQRI Working Group on Parenteral & Ophthalmic Drug Products (Extractables/Leachables). He is a member of the faculty of the PDA Training and Research Institute. He is also a member of the ACS Consultants Network.
He has published many articles and chapters on pharmaceutical packaging and is a frequent speaker at industry meetings and courses related to extractables/leachables and cold chain.
Prior to forming his consulting practice, Ed was associated with Wyeth Pharmaceuticals where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products. He also served as a technical expert on parenteral packaging issues particularly with respect to the management of extractables and leachables. Before that, he was associated with Helvoet Pharma Inc. and West Pharmaceutical Services in various technical management positions. He holds a B.S. in Chemistry from Villanova University and received his M.S. & Ph.D. in Analytical Chemistry from Seton Hall University (So. Orange, NJ).
Dominick DeGrazio, Associate Scientist, Analytical Laboratory, West Pharmaceutical Sciences
Dominick recently graduated from Franklin and Marshall College in 2012 with a B.A in Biochemistry and a B.A in Neuroscience. During the summer of 2011 he was given a Clinical and Translational Science Award (CTSA)Internship at the University of Pennsylvania where he worked under the guidance of Dr. Xiaolu Yang to study the effects of glycolytic proteins on the metabolism of cancer cells. In his senior year of college, he collaborated with Dr. Robert Jinks and others to functionally characterize a recessive mutation in the HERC2 gene seen in people of the Amish and Mennonite communities. Their research culminated in a paper published in the Journal of Human Mutations.
Currently, Dominickworks as an Associate Scientist in the Analytical Laboratory at West Pharmaceutical Services in Exton, PA. He performs functional analyses for internal and external customers and employs various methodologies to quantitate extractables or leachables from packaging components.
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