Bios Danae Christodoulou, US Food and Drug Administration [email protected] Danae Christodoulou is an Acting Branch Chief in the Office of New Drug Products/OPQ/CDER. Danae joined FDA in 1998 and served as primary reviewer in the Office of New Drugs, as a Chemistry, Manufacturing and Controls Lead and Acting Branch Chief since 2013. Danae has a background in Inorganic Chemistry and received her Ph.D. from the University of Michigan, Ann Arbor, MI. Prior to FDA, Danae worked at Johnson Matthey Inc. R&D Drug Discovery as a Senior Research Chemist and at the National Cancer Institute, in Frederick, MD. Danae served as the Chair for the EI Implementation Working Group at FDA. Marjorie Coppinger, Teva [email protected] Marjorie Coppinger is Head of Global Generic Research Quality (SOD/SSL) for Teva Pharmaceuticals. She received B.A in Chemistry from the University of Notre Dame, Maryland and has over 21 years of experience at Teva Pharmaceuticals in analytical research and development, technical services, manufacturing, quality control, compendial compliance and quality assurance. Currently Ms. Coppinger is Co- Chair of the NJPQCA Compendial Discussion Group and has represented both NJPQCA and GPhA on various USP planning meetings, stakeholder initiatives and project groups for the USP. Elisabeth Corbett, Bristol-Myers Squibb. [email protected] Elisabeth Corbett is an Associate Director, CMC, in Global Regulatory Sciences at Bristol-Myers Squib in Pennington, NJ. She joined Bristol-Myers Squibb as a process engineer in Process Chemistry R&D in 2001. In 2008, she relocated to San Antonio, Texas and served in Quality roles before returning to CMC Regulatory at BMS in 2012. In this role she has supported CMC lifecycle management of HIV and oncology products as well as of early development assets. Additionally, she is the regulatory lead for the implementation of ICH Q3D at BMS. She holds a B.S. in Chemical Engineering and Biology from Carnegie Mellon University and a M.B.A from New York University. 1 | Page Peter Colvin, Merck & Co., Inc. [email protected] Peter Colvin is an Associate Principal Scientist with the Manufacturing Division of Merck & Co., Inc. As part of Sterile & Liquids Commercialization, Peter specializes in the scale-up, tech transfer, process qualification, and launch of Merck’s sterile drug product pipeline. Peter has led drug product teams for both small and large molecules, including combination products. Peter started at Merck in 2003, and spent the first 5 years of his career in the sterile pilot plant leading drug product manufacture of clinical supplies. Prior to joining Merck, Peter earned a B.S. in Chemical Engingeering at Penn State University and an M.S. in Chemical Engineering Practice at M.I.T. David J. Fillar, Perrigo [email protected] David Fillar is a Quality Control Manager at the Allegan Site for the Perrigo Company. Current responsibilities at Perrigo include management of Lifecycle Analytical Services, Compendial Affairs, QC Informatics Support, Microbiology, and QC Purchased Materials. David has 25 years of experience in the Pharmaceutical Industry. Responsibilities have included Laboratory Systems, Process Validation, Environmental Monitoring, Quality Assurance, Supplier Quality Management, Operational Support, and New Products Project Management. David holds an MBA from Grand Valley State University and a Bachelor’s degree in Chemistry from Western Michigan University. Josh Foote, Perrigo [email protected] Josh Foote is a Senior Scientist in the Analytical Research and Development Department at Perrigo Company in Allegan, Michigan. Earlier in his career, he provided analytical support for a variety of drug product filings with a primary focus on small molecule organic impurities. In his current role his responsibilities include organic impurity method development for monograph products as well as evaluating new drug products for elemental impurity risks. He has helped establish an internal risk assessment and control strategy program for elemental impurities compliance and is a member of the Coalition for Rational Implementation of the Elemental Impurity Requirements. Josh received his Bachelor of Science degree in chemistry from Western Michigan University. 2 | Page John Glennon, GlaxoSmithKline [email protected] John Glennon has 24 years experience in pharmaceutical analysis, focused primarily on analytical development and method transfer. This includes working at the GSK-sponsored Anti- Doping Science Laboratory during the London 2012 Olympic and Paralympic games. He is currently a member of the Product Quality and NPI Analytical group in GSK Global Manufacturing and Supply, and is based at the GSK manufacturing facility in Zebulon, NC. With a personal focus on Solid Oral Dose products, he is also a member of the group within GSK that sets global standards of workmanship for analytical testing. John has been working on the implementation of ICH Q3D within GSK for nearly four years. He is a member of an inter– industry consortium that is aiming to share data and align approaches to Q3D. John holds a B.Sc. in Chemistry from the University of Birmingham, UK, and an MS in analytical chemistry from North Carolina State University. Andre Hermans, Merck & Co., Inc. [email protected] Andre Hermans is a Principal Scientist in the Analytical Sciences Division at Merck and Co. in West Point, PA. He received is PhD from the University of North Carolina in Chapel Hill in Analytical Chemistry before joining Merck in 2007. During his time at Merck, Andre supports analytical method development and process development in the small molecule solid oral dosage area. In this function he co-authored several IND and NDA applications mainly for enabled formulations. Additionally, he is leading Merck’s efforts around in-vivo predictive technologies and dissolution innovations as well as the implementation of ICH Q3D for new filings and member of several industry-wide ICH Q3D working groups. Samina Hussain, Exova Health Sciences [email protected] As the Metals Group Leader at Exova, Ms. Hussain has over 19 years of extensive experience in testing hundreds of different matrices for metal content by ICP-MS and ICP-OES. Her expertise in preparing samples for analysis is the cornerstone of her knowledge and includes simple acid digestions, organic solvent sample preparations, and microwave techniques. Over the last several years she has been working with the pharmaceutical and dietary supplement industries on implementation of USP <232>, <233>, <2232>, and ICHQ3D and has performed many method validations. 3 | Page Alison Ingham, Health Canada [email protected] Alison Ingham obtained her B.Sc. (Chemistry and Biochemistry) at the University of the Witwatersrand in South Africa and her Ph.D. in Bioinorganic Chemistry from the University of Victoria, Canada. After graduation she lectured at the University of Ottawa, before joining Health Canada. During her tenure at Health Canada, Alison has been involved with assessing the certification process at the European Directorate for the Quality of Medicines, and was appointed an Assessor by EDQM in 2006. She was the Manager of Product Assessment in the Nutrient and Isolates Division at the Natural Health Products Directorate. Currently she is a Manager in the Bureau of Pharmaceutical Sciences of the Therapeutic Products Directorate of Health Canada where her responsibilities include assessment of generic drugs as well as guidance development. Joy E. Mason, Eli Lilly and Company [email protected] Joy Mason is a Quality Consultant in Compendial Affairs at Eli Lilly and Company, with 28 years of experience in pharmaceutical quality systems, microbiological testing, project management, change management, and six sigma initiatives. Joy received her Bachelor’s degree in Microbiology at Miami of Ohio, and her Master’s degree in Pharmaceutical Sciences at Butler University in Indiana. She received her six sigma black belt certification from Purdue University in Indiana in 2013. She has completed four six sigma initiatives to support laboratory operations. She has also coordinated the implementation of several large-scale Compendial changes for Lilly labs. Denise McClenathan, Procter & Gamble [email protected] Denise is currently Senior Scientist and Group Leader in Procter & Gamble’s Global Elemental Analysis Capability. She joined P&G as a Scientist in 2004 after receiving a B.A. in Chemistry from Saint Mary’s University of Minnesota and a Ph.D. in Analytical Chemistry from Indiana University. At IU, Denise researched plasma source time-of-flight mass spectrometry, studying with Professor Gary Hieftje. At P&G, she is responsible for strategies to address an array of complex elemental analysis problems, across all of P&G’s consumer products programs, from upstream innovation projects through marketed-product compliance needs. Denise is currently a member of the Technical and Analytical Challenges Team sponsored by IPEC and her research interests include instrumentation and methodologies for elemental analysis, spanning microwave digestion, ICP-OES, and ICP-MS, as well as validation strategies. Denise is the author of 16 publications and patents. 4 | Page David R. Schoneker, Colorcon [email protected] David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and market expansion