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 projects to gain regulatory acceptance of Colorcon’s products and components for various target markets.
He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University. His previous position at Colorcon was Director of Quality Assurance and Quality Control. He has been at Colorcon since 1977. He is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT).
Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee. He is now serving as the Vice Chair of Scientific and Regulatory Affairs where he is actively involved with the development of Regulatory, Safety, Excipient GMP and Supplier Qualification related guidelines to improve Excipient Acceptability, Safety and Global Supply Chain Security.
He has acted as an interface with many international regulatory agencies and pharmacopeias for the organization. He previously was the USP Liaison for IPEC-Americas and represented them as a member of the United States Pharmacopeial Convention. Mr. Schoneker previously coordinated International Harmonization efforts for the IPEC-Americas and participated in the development of IPEC’s Good Manufacturing Practices Guide and Auditing Guide for Bulk Pharmaceutical Excipients. He has also led IPEC’s efforts in developing guidelines for excipient qualification, significant change notification and the appropriate use of certificates of analysis. Additionally, Mr. Schoneker chairs a number of harmonization working groups on various excipients and has been chairing the Coalition for Rational Implementation of the Elemental Impurity Requirements since 2010.
Donna Seibert, Perrigo [email protected]
Donna S. Seibert, PhD is Sr. Manager in Analytical Research and Development in Consumer Healthcare at Perrigo Company, a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. Seibert has over 14 years of pharmaceutical R&D experience spanning branded, generic prescription, and generic OTC product lines. In her current role, Seibert’s responsibilities include new product development, raw material change management, cleaning method development and validation, as well as both organic and elemental impurity aspects of the USP monograph modernization initiative.
5 | Page
Seibert holds a BA in Chemistry from Transylvania University and a Ph.D. in Analytical Chemistry from Wayne State University.
Timothy Shelbourn, Eli Lilly and Company [email protected] Timothy Shelbourn is a Research Scientist in Pharmaceutical R&D at Eli Lilly and Company since 2003. Previously, he worked as a Research Scientist at Baxter Healthcare for 17 years. Timothy received his Bachelor’s degree in Agriculture from the University of Nebraska, Lincoln, his Master’s degree in Chemistry from Roosevelt University and a MBA degree from Webster University. Additionally, Timothy is a USP, General Chapters Expert Committee member (since 2005), IQ Consortium, ICH Q3D Implementation Working Group Co-Chair (since 2015) and an American Chemical Society, Atomic Spectroscopy Subject Matter Expert for SciMind web based education series on atomic spectroscopy (since 2014).
Bruno Spieldenner, European Directorate for the Quality of Medicines and Healthcare (EDQM) [email protected] Studied Physics and Chemistry at the University of Strasbourg and in 2006 he graduated a Master’s degree in analytical chemistry and spectroscopy from the University of Marseille, in France. After that he worked during 7 years as a laboratory engineer for a pharmaceutical company in Switzerland, where he was in charge of LC-MS/MS method development for both small and large molecules. There he got familiar with a broad set of analytical procedures used in quality control of medicinal products. Since 2013, he joined the European Pharmacopoeia department of the EDQM in Strasbourg, where he is involved in the modernisation of texts on general methods and the implementation of the ICH Q3D Guideline.
I-Chen Sun, Center for Drug Evaluation, Taiwan [email protected] Dr. Sun is currently Deputy Director, Division of Pharmaceutical Science, Center for Drug Evaluation, Taiwan and Adjunct Assistant Professor, National Defense Medical Center, Taiwan. Dr. Sun has 14+ years of CMC regulatory experience in charge of IND, NDA and DMF evaluation, as well as related consultation projects, as well as, 5+ years of principal investigator for Taiwan FDA founded projects and is the Chinese Taipei Representative for ICH Q3D & Q12 expert working group. Dr. Sun received her Bachelor’s degree in Pharmacy from China Medical University, Taiwan and her Ph.D. degree from the Department of Medicinal Chemistry and Natural Products, School of Pharmacy, University of North Carolina at Chapel Hill, U.S.A.
6 | Page
Katherine Ulman, Dow Performance Silicones [email protected] Katherine Ulman has been employed with Dow Corning Corporation, now a wholly owned subsidiary of The Dow Chemical Company, for more than 40 years. She is currently a global regulatory compliance manager for their Healthcare business, as well as an associate scientist. Ulman has held such positions as global technology coordinator and regulatory manager of the Dow Corning Healthcare Industries Materials Site. She has worked in the development and characterization of pharmaceutical excipient and medical device raw materials/components for nearly 30 years. Much of her earlier career was dedicated to the synthesis of novel silicone monomers and polymers/copolymers. Ulman has been a member of the ACS, AAPS, and CRS. She is currently an active member and vice chair of the Regulatory Committee for IPEC- Americas as well as a member of their executive committee. She has published and presented several papers in her field, developed and taught a college course in Organosilicone Polymer Chemistry and Technology through SDSM&T, and taught international courses on silicones for pharmaceutical/biomedical applications and medical adhesives through Technomic Publishing Co. Ulman earned her Bachelor of Science degree in chemistry from the South Dakota School of Mines and Technology in 1976.
Diana van Riet-Nales, European Medicines Agency (EMA) [email protected]
Diana is a licensed pharmacist (1992, Utrecht University, NL) with a doctor degree in paediatric formulation development (2014, Utrecht University, NL), a master degree in epidemiology (2011, VU Amsterdam, NL) and a diploma A in marketing (1993, NIMA Dutch institute for marketing, communication and sales).
Diana is an experienced regulatory expert who is currently working as a senior assessor for the MEB. Over the last 20 years, she has hold different positions at other organisations as a community pharmacist, beginner, competent, advanced and principle chemical-pharmaceutical assessor, coordinator regulatory assessments & science, and head of the assessment department.
Diana has been a member of the CHMP QWP from 2000 and the QWP vice-chair (humans) from 2008-2014. She is a member of the QWP core team and currently representing the QWP in the IRN, the PDCO Formulation Working Group and the EMA Excipient team. From 2013-2016 she has also represented the QWP in the EDQM CEP Steering Committee; in which committee she is now acting as an individual expert. Diana has been rapporteur for several QWP guidelines including e.g. heavy metals, NIRS, ASMF procedure, paediatric formulations. Moreover, she has been the EU quality expert for both the ICH Q3D as well as the ICH M7 guideline at the start of both processes. However, when the work on both guidelines justified the participation of two quality experts, her participation in ICH Q3D was discontinued.
7 | Page
Diana has a special interest in international harmonisation, patient centric product development, training, and strategic business processes/management. As such, she is e.g. highly active in the annual QWP trainings and contributing to the EUNTC quality curriculum. Diana has written 17 Pubmed indexed publications and has given over 150 presentations on a wide variety of regulatory topics (including heavy metals) for international organisations such as AAPS, APIC, DIA, EAPS, EUPFI, Medicademy, PDA, TOPRA . Noteworthy: In 2013, Diana has given a presentation by invitation from the Russian authorities on “ICH standards as a guarantee of the quality of medicinal products”.
Siva Vaithiyalingam, Cipla [email protected]
Siva Vaithiyalingam currently serves as “Head of Regulatory Affairs” at Cipla LTD. His expertise includes Pharmaceutical Research, Product Development, ANDA Review, Generic and 505b2 strategies, Regulatory Initiatives, and Regulatory Affairs.
Previously, He served in organizations such as Teva Pharmaceuticals, Office of Generic Drugs at FDA and Barr Laboratories. He graduated from School of Pharmacy, Texas Tech University (2001) with a PhD in Pharmaceutical Sciences and MS degree in Pharmaceutics from Institute of Technology, BHU.
Phyllis Walsh, Merck & Co., Inc. [email protected] Ms. Walsh is an Associate Director, Regulatory Policy and Compendial Affairs for Merck. She has 35 years of experience at Merck/Schering-Plough Corporation in quality control, analytical development and compendial affairs. In her role in Regulatory Policy and Compendial Affairs she provides expertise and guidance in all aspects of the compendial issues to ensure compliance with the compendia. She handles correspondence with the compendia. She is a liaison between Merck and the compendia, and also provides guidance Merck sites on compendial requirements. Currently Ms. Walsh is the Chair of IPEC – Americas Compendial Review / Harmonization committee. She is a member of New Jersey Pharmaceutical Quality Control Association (NJPQCA) and served as chair of the NJPQCA Compendial Discussion Group for 14 years. She represented NJPQCA on USP Excipient Project Team, USP Process Improvement Project Team and the USP Biopharmaceutics Project Team which she served as chair. Also she was a member of the USP Advisory Group on Elemental Impurities. She is a member of Coalition on Elemental Impurities.
Glenn Williams, Rigaku Americas Corporation [email protected] Glenn is currently Manager of Analytical Services at Rigaku Americas Corporation located in The Woodlands, Texas. He received his Ph.D. in Physical Organic Chemistry from The State 8 | Page
University of New York at Buffalo where he focused on the studies of highly unstable carbocations and carbanions in aqueous solution. After graduating Glenn worked in the solid- state characterization of organic polymorphs and salts for 15 years in pharmaceutical industry at Pfizer, Apotex, and then GSK. He then joined Rigaku Americas Corporation in early 2013 and has worked with Wavelength Dispersive (WD) and Energy Dispersive (ED) X-Ray Fluorescence (XRF) systems in a variety of industries and universities across North America. For the last several years Glenn has worked, with his colleagues, to explore and validate the potential of XRF for use in the pharmaceutical industry. Additionally, he has recently joined as an XRF consultant with the IQ Consortium ICH Q3D Analytical Sub-group to demonstrate the capabilities of alternative techniques for elemental impurities.
Kahkashan Zaidi, United States Pharmacopeia (USP) [email protected]
Dr. Kahkashan Zaidi is a Principal Scientific Liaison in the General Chapters group of the Science Division at the United States Pharmacopeia. She is a liaison to the USP Expert Committee on Dosage Forms, Chemical Analysis, and Expert Committee on Physical Analysis. Kahkashan Joined USP in May 1999. Prior to that, she worked in the Pharmaceutical industry as a Research Scientist.
She has published articles and lectured internationally on topics related to impurities and USP and the standards development process.
She represented USP on the ICH–Q3D (Elemental Impurities) working group and is now a member of the ICH-Q3D Implementation working group. She is also the USP lead on this topic.
9 | Page