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Speaker Bios 2Nd FDA/PQRI Conference on Advancing Product Quality

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Speaker Bios 2Nd FDA/PQRI Conference on Advancing Product Quality Speaker Bios 2nd FDA/PQRI Conference on Advancing Product Quality Professor Bertil Abrahamsson, Ph.D. Dr. Abrahamsson has a broad experience of industrial drug development from more than 25 years of work with Astra and AstraZeneca. During this period he has had various line and project management positions. Presently he is a Senior Principal Scientist with emphasis on biopharmaceutics., In this role he is leading biopharmaceutics research and product development support on a global basis. In addition, as one of the most senior scientists in AZ Pharmaceutical Development he is also a member of the local as well as the extended global leadership teams. Dr. Abrahamsson is an internationally recognised scientist and he has published more than 80 papers in the area of oral biopharmaceutics and drug delivery. He is presently an adjunct Professor in Biopharmaceutics at Uppsala University. He initiated and is currently leading a major european private public partnership project in oral biopharmaceutics area ( http://www.orbitoproject.eu). Ilgaz Akseli, Ph.D., MBA Dr. Akseli is a Senior Associate Director in the Pharmaceutical Development department in Boehringer-Ingelheim Pharmaceuticals, Ridgefield, CT. He is the head of the Formulation Material Profiling and Computational Modeling Labs. Two labs are in the global level and his team is guiding and supporting the formulation and process development for drug candidates in assigned therapeutic areas. Dr. Akseli earned his BSc degree in Mechanical Engineering with a focus on Design of Powder Compaction. He has two MSc degrees; one is in Materials Science and Engineering from University College London with a focus on Metal Powder Compaction and the other degree is in Business Management from London School of Economics with a focus on Lean Six Sigma implementations in the Pharmaceutical Industry. He earned his Ph.D. degree in Pharmaceutical Engineering from Clarkson University, USA. He did his Post-doctoral studies at Rutgers University in the Engineering Research Center (ERC) for Particulate Systems and Pharmaceuticals. He has authored of 36 refereed journal papers, 58 conference papers & presentations, 8 scientific magazine articles, 2 book chapters & 2 patents. Barbara M. Allen, Ph.D. Barbara Allen, Ph.D. is Head of Global Quality Systems for Eli Lilly and Company. Dr. Allen joined Eli Lilly and Company in 1991 in Ireland and has since held various assignments in API Manufacturing Technical Services, New Product Introduction, Quality Assurance, and Global Quality Systems, in Ireland and in the USA. In 2002, she began her current position in Global Quality Systems, where she is responsible for providing quality systems for Lilly and for ensuring that Quality Systems are integrated across the corporation. Dr. Allen was a member of ICH Q10 EWG (Expert Working Group) representing PhRMA and currently serves as a member of IFPMA RPTS & EFPIA Efficiency in Operations Committee. Gregory E. Amidon, Ph.D Dr. Amidon received his Bachelor of Science degree in Medicinal Chemistry (1974) and his Ph.D. in Pharmaceutical Chemistry (1979) from the University of Michigan at Ann Arbor, MI. He joined the University of Michigan, College of Pharmacy as Research Professor of Pharmaceutical Sciences after 28 years in the pharmaceutical industry. Prior to joining the University of Michigan in 2007, Dr. Amidon held research positions in pharmaceutical R&D for Pfizer, Pharmacia, Pharmacia & Upjohn, and The Upjohn Company. His current research interests include oral bioperformance assessment and in vivo predictive dissolution. He is also recognized for his expertise in the physical, chemical and mechanical property characterization of active pharmaceutical ingredients, excipients, and products as well as the development of scientific strategies for oral solid dosage form development. Dr. Amidon has served in a number of leadership roles in the American Association of Pharmaceutical Scientists (AAPS) as well as the United States Pharmacopeia (USP). Dr. Amidon is a member, Fellow, and 2015 President-Elect of AAPS. He is the recipient of the 2014 AAPS Research Achievement Award in Physical Pharmacy and Biopharmaceutics as well as the 1983 Ebert Prize from the American Pharmaceutical Association. He has served as a member and Chair of several USP Expert Committees over the past 25 years and currently serves on the USP Board of Trustees representing pharmaceutical sciences. Stefan Baier, Ph.D. Stefan Baier is a Senior Principal Scientist in the Measurement Sciences team, which is part of PepsiCo’s R&D Global Functions, Governance and Compliance. He leads global research projects around oral processing/material science analytics of reduced fat, sodium and sugar food and beverage products to increase consumer acceptability and implement reduction & nutrition strategies across PepsiCo. He received his engineer's degree (Dipl.-Ing) from the Friedrich-Wilhelms University of Bonn, Germany in Food Technology and Engineering in 1999 and his Ph.D. in Food Science from the University of Massachusetts, Amherst, U.S.A. in 2003 in Food Colloids and Biopolymers. Before joining PepsiCo in 2010, he worked for Cargill, Inc. as a senior scientist from 2002-2008 and Frito-Lay North America (PepsiCo) from 2008-2010 as a project scientist for protein fortification of snack foods. Alfred Berchielli, M.S. Al Berchielli has been working in Drug Product Design group at Pfizer for the last twenty years and also worked in the Formulation group at Wyeth for 5 years. Al’s areas of expertise include development and scale-up of drug delivery systems (e.g., sustained release osmotic and matrix tablets). His research interests include IR/CR combinations, application of active ingredients in tablet coatings, controlled release functional coatings, and modeling of coating processes. Al received his M.S. in Industrial Pharmacy from the Arnold and Marie Schwartz School of Pharmacy at Long Island University, New York, and his B.S. in Chemistry from the State University of New York College at Cortland. Al has several published patents / papers in the area of sustained release and tablet coating process modeling. 2 | Page 2 nd FDA/PQRI Conference Bios Professor Ecevit Bilgili Dr. Ecevit Bilgili is an associate professor and associate chair of the Department of Chemical Engineering at New Jersey Institute of Technology (NJIT). After joining NJIT in Fall 2009, he established a Particle Engineering & Pharmaceutical Nanotechnology Laboratory, where his group conducts research in designing formulations and processes for high-value-added products like pharmaceuticals with enhanced functionalities. Prior to this academic position, Dr. Bilgili worked as Principal Development Engineer within R&D and Pharmaceutical Commercialization Technology Department at Merck & Co., Inc during 2004–2009. He holds a B.S. degree from Bogazici University in Istanbul, Turkey and Ph.D. from the Illinois Institute of Technology, Chicago. He worked as a post-doctoral research associate at the Particle Engineering Research Center, University of Florida. Dr. Bilgili is a well-recognized member of the Particle Technology Community. He served as an elected Executive Committee Member of the Particle Technology Forum of AIChE and as the Chair of AIChE Area3a: Particle Production and Characterization. He is currently the leader of Project A1: Particle Formation within the NSF ERC for Structured Organic Particulate Systems. He also serves as the 2015 Programming Co-Chair (2016 Chair) of Pharmaceutical Development to Manufacturing Area of AIChE. Dr. Bilgili has authored 56 peer-reviewed journal articles, 3 U.S. patents (one recently filed), 2 provisional patents, and several invention disclosures. He delivered 70+ national/international presentations and 20+ invited talks. He has served as a guest editor to Powder Technology Journal and referee to 18 engineering and pharmaceutics journals, as a chair/co-chair in 24 sessions of national/international conferences, and as a member of AIChE and ACS. He was one of the organizers of the Topical Conference titled Pharmaceutical Engineering for the 21st Century at the AIChE Annual Meeting in 2007. Dr. Bilgili is the recipient of the Best PhD Thesis in Particle Technology Award from AIChE, Who’s Who in Science and Engineering, and NJIT’s Excellence in Teaching Award among many others. His research is funded by NSF ERC and several major pharmaceutical companies. Ashley Boam, MSBE Ashley Boam currently serves as acting Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. This Office also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products. Prior to joining CDER, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University,
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