The following individuals have been invited to speak at the Chemometrics for the Pharmaceutical Scientist advanced training course hosted by the University of Maryland School of Pharmacy.
Christian Airiau, PhD
Christian Airiau currently works as a chemometrician in R&D Product Development at GlaxoSmithKline (GSK), where he is a manager in the data management and analysis group based in Philadelphia. He has more than 10 years of experience in the pharmaceutical industry with GSK, which he joined after receiving his doctoral degree in chemometrics from Bristol University (UK). His current areas of interest include the support of the "Quality by Design" framework implementation, as well as the development of multivariate modelling tools to improve and optimize GSK processes.
Katherine Bakeev, PhD
Director, Application Support Services
B&W Tek, Inc.
Dr. Katherine A. Bakeev is the director of analytical services and support for B&W Tek at their headquarters in Newark, Delaware. Dr. Bakeev is responsible for creating and growing B&W Tek's mobile molecular spectroscopy solution business.
Prior to joining B&W Tek in 2013, she was the chief scientist for CAMO Software Inc., applying her knowledge of spectroscopy and data analysis to solving diverse problems, supporting customers, consulting and teaching. She has many years of industrial experience in the electronics, chemical, and pharmaceutical industries. From 2005 to 2009, she worked in the Process Analytical Technology and Chemometrics group of GlaxoSmithKline in King of Prussia, Pennsylvania. Her work experience has included supporting customers in pharmaceutical and chemical industries as a product specialist for Foss NIRSystems and work in process analytical chemistry to enhance process understanding with specialty chemical manufacturer, International Specialty Products (ISP), and as a development engineer in the Department of Materials Science and Engineering at AMP Incorporated.
Dr. Bakeev earned her doctorate in polymer science and engineering from the University of Massachusetts in Amherst and has a master's degree in technology management from Stevens Institute of Technology, in addition to her bachelor's degree from Case Western Reserve University. She has written articles and given numerous presentations on the use of near-infrared spectroscopy (NIR) and PAT.
She is the editor of the book Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries, now in its second edition. She is the recipient of the 2007 Craver Award in Applied Vibrational Spectroscopy for her efforts in, and promotion of, near-infrared (NIR) spectroscopy and chemometrics. She has been a member of the Society of Applied Spectroscopy (SAS) since 1993, serving as the national secretary of the organization in 2010-2011. Dr. Bakeev is the past president of SAS. She has served on the publication and nominating committees, and serves on the editorial board of the journal Applied Spectroscopy. She is the past president of the Council for Near Infrared Spectroscopy (CNIRS), a has served as a member of the Chairman's Advisory Committee for the International Council for Near-Infrared Spectroscopy (ICNIRS), and a member of the ASTM committees E13 (Molecular Spectroscopy and Separation Science) and E55 (Manufacture of Pharmaceutical Products).
Keith Freel, PhD
Dr. Keith Freel is an applications specialist for Metrohm NIRSystems in Laurel, Md. His undergraduate and graduate work in both engineering and spectroscopy, combined with his time at MetrohmUSA, has seasoned him with more than a decade of experience in spectroscopy. In his role with Metrohm, he performs NIR feasibility studies, develops qualitative and quantitative models, leads NIR training courses, and supports Metrohm’s partners with their specific applications.
Stephen Hoag, PhD
Professor of Pharmaceutical Sciences
Director, Good Manufacturing Practice Facility
University of Maryland School of Pharmacy
Dr. Hoag is a professor of pharmaceutical sciences at the University of Maryland School of Pharmacy. He received his PhD in pharmaceutics from the University of Minnesota-Twin Cities, and his BS in biochemistry from the University of Wisconsin-Madison. Dr. Hoag has been a visiting professor at 3M Pharmaceuticals and Abbott Laboratories. His primary research interests include excipient functionality testing, QbD, tablet coating, coating polymers, tablet press instrumentation, tablet compaction modeling, and formulation design. His research has included studies in formulation of folic acid in multivitamin and mineral supplements, formulation of botanical products, controlled release formulation, polymer science, pigment stability in coating polymers and thermal analysis of polymers, powder flow, and formulation stability. In collaboration with the Center for Veterinary Medicine at the Food and Drug Administration, Hoag has studied the application of near infrared spectroscopy to the analysis of excipient identification, tablet quality, and production monitoring for process analytical technology (PAT) applications. Working with Larry Augsburger, PhD, he has edited a three volume set of books on tablet compaction. Hoag is a member of the National Institute of Pharmaceutical Technology and Education (NIPTE) Executive Committee and has been elected to the USP Counsel of Experts. He is an AAPS fellow and serves on the International Steering Committee for the Handbook of Pharmaceutical Excipients and the editorial board of the Journal of Pharmaceutical Development Technology.
Ahmed Ibrahim, PhD
Department of Pharmaceutical Sciences
University of Maryland School of Pharmacy
Moheb Nasr, PhD
Vice President, CMC Regulatory Strategy
RD Chief Regulatory Office
After 22 years at the FDA, Dr. Nasr joined GlaxoSmithKline (GSK) in September 2011 as vice president for global CMC strategy. Dr. Nasr is responsible for the development and execution of GSK CMC regulatory strategy. He is a member of GSK leadership and governance boards accountable for product development, manufacturing and supply, and regulatory oversight.
Prior to joining GSK, Dr. Nasr served as director of the Office of New Drug Quality Assessment (ONDQA), CDER, FDA. He established and led ONDQA for eight years. He represented the FDA at ICH and was instrumental in the development of QbD concept and several regulatory guidelines.
Dr. Nasr received his doctorate in chemistry at the University of Minnesota in Minneapolis. He is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS), the recipient of AAPS Regulatory Science Achievement Award, and the University of Wisconsin Pharmaceutical Analysis Excellence Award.
Gary Ritchie, MS
President, Council for Near Infrared Spectroscopy
Director, Scientific Affairs
Gary Ritchie is the director of scientific affairs for InfraTrac, Inc., located in Silver Spring, MD. Ritchie is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods, including near-infrared and multivariate analysis. Ritchie has 19 years of industry experience with increasing responsibility, five years of policy experience, and ongoing consulting experience in the pharmaceutical and biopharmaceutical industry. He was a scientific fellow for process analytical technology (PAT) with the United States Pharmacopeia (USP) and liaison to the General Chapters, Pharmaceutical Waters, and Statistics Expert Committees from 2003 to 2008. As a USP in-house expert on the FDA Process Analytical Technology and Quality by Design Initiative, he was responsible for more than 30 Pharmacopeial chapter revisions that incorporated and reflected the revisions by the FDA on the 21st century cGMP initiatives. He also led collaborations on several FDA, USP, and industry projects that resulted in several Pharmacopeial standards. Ritchie has more than 25 peer reviewed papers and book chapter contributions, numerous industry journal articles, and has been invited to deliver numerous conference and symposia presentations worldwide. He is the 2012-2014 president of the Council for Near-Infrared Spectroscopy. He holds a Master of Science and Bachelor of Arts degree in biology from the University of Bridgeport.
Chief Operating Officer
CAMO Software, Inc.
Brad Swarbrick is the chief operating officer of CAMO Software, based in the Woodbridge, NJ, office. Swarbrick has held previous roles in the company in the areas of business development and product management, successfully bringing a number of innovative software tools and solutions to market, both commercially and for customized key client projects.
Swarbrick has more than 20 years experience in the application of MVA and DoE methods in a wide range of industries. With many years experience in the application and design of Near Infrared (NIR) and Mid-Infrared (MIR) spectrometers for both at-line and in-line applications, Swarbrick is a recognized leader in the areas of process analytical technology (PAT) and quality by design (QbD), being a former member of the pioneering PAT group at Pfizer Global Pharmaceuticals.
With a key focus on sharing experiences with clients and helping them to achieve their quality and efficiency objectives, Swarbrick is actively pursuing the development of industrial solutions that allow the collection of meaningful data, understanding the relationships within and between process operations and ultimately designing control strategies that meet client needs.
Swarbrick holds a BSc in chemistry with honors in the area of chemometrics. He has held numerous positions in industry committees, including a director position in the International Society of Pharmaceutical Engineers (ISPE), and is the current pharmaceutical section editor of the Journal of Near Infrared Spectroscopy.