The following individuals have been invited to speak at the Tablet & Capsules Hands-On Short Course hosted by the University of Maryland School of Pharmacy.
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.
Larry Augsburger, PhD
Professor Emeritus
University of Maryland School of Pharmacy
Before joining the University of Maryland faculty in 1969, Dr. Augsburger was a senior research scientist for Johnson & Johnson Services, Inc. of New Brunswick, NJ. During his time at the School, he served as the Shangraw Chair of Industrial Pharmacy and Pharmaceutics, chair of the Department of Pharmaceutics, and director of pharmaceutics graduate programs. A leader in original research that has enabled the modernization of some key US Food and Drug Administration (FDA) policies, Dr. Augsburger's achievements include directing University of Maryland-FDA collaborative research programs that supported the development of the critically important FDA guidances on scale-up and post-approval changes (SUPAC) for drugs in the market, through which he and his team showed that certain formulation and process changes in drug preparations, such as tablets and capsules, result in significant differences in how a drug is absorbed and becomes available to the human body in order to exert its therapeutic effect, while others do not. He also established the Drug Development Facility in the School, which later became UPM Pharmaceuticals, Inc., a University-affiliated for-profit firm for developing drugs and manufacturing clinical supplies founded in 1997. Though retired, Augsburger continues to write, consult, and observe the drug development industry.
Andrew Birkmire
Process Development Manager
GEA Process Engineering, Inc.
Andrew Birkmire is the pharmaceutical process development manager for GEA Process Engineering, Inc., the world leader in continuous powder processing. Birkmire's background includes extensive experience in coating, drying, and granulation technologies, with a focus on continuous manufacturing processes. He is currently in charge of the GEA Process Development Center in Columbia, Md.
Brian Carlin, PhD
Director, Open Innovation
FMC Corporation
Brian Carlin was the 2012 recipient of the IPEC Foundation Award for Industry Research Achievement in Excipient Technology. He is director of open innovation (Pharma) at FMC Health & Nutrition. He was previously the global manager of pharmaceutical R&D, and has been with FMC for 18 years. He chairs the IPEC Quality by Design and Excipient Composition Committees, and also serves on the USP Excipient Committee. Prior to joining FMC, he worked at SmithKline Beecham & Richardson Vicks in new product development for sixteen years. He obtained his doctorate in interfacial rheology from the School of Pharmacy, University of London, and an honours degree in pharmacy from the University of Aston in Birmingham. He serves on the distance learning MSc course in QbD at Demontfort University, UK, where he is an honorary visiting professor. He has been a leading advocate for innovative scientific approaches to excipients and pharmaceutics in pursuit of the QbD vision of the 21st century cGMP initiative.
Simon Cashmore
Business Development Manager
Bosch North America
Simon studied industrial pharmaceutical science with applied chemistry at Liverpool John Moores University, England. Following the completion of his studies, he worked as a process scientist at Bosch-Manesty focusing on the development of tablet coating technology and compression. Later, he moved to Bosch-Hüttlin, again as a process scientist, but focusing on providing process support and optimization for fluid bed and high-shear systems. Simon’s current role as business development manager for North America includes providing technical support for customers in compression, tablet coating, pellet coating, and high shear/fluid bed granulation systems.
Alva Godfrey
Granulation Process Engineer
LCI Corporation
Alva Godfrey has been involved with low pressure extrusion and spheronization since joining LCI Corporation in 2017. Her responsibilities include evaluation of potential applications, providing technical training presentations, scale-up from laboratory to production, system commissioning, and technical support. She holds a BS in chemical engineering from Clemson University.
Gary Hollenbeck, PhD
Chief Scientific Officer, UPM Pharmaceuticals
Adjunct Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
Dr. Hollenbeck has been a member of UPM's senior management team since its inception in 1997, and assumed the position of chief scientific officer on January 1, 2006. He serves as a key scientific and technical advisor at UPM and personally directs focused research and development projects in the area of novel drug delivery platforms. Dr. Hollenbeck also currently oversees the technical services, manufacturing, and materials management groups at the Baltimore facility. Prior to assuming this full-time position at UPM, he was a professor of pharmaceutical sciences at the University of Maryland School of Pharmacy. He received his Bachelor of Science from Albany College of Pharmacy and his doctorate in Industrial and Physical Pharmacy from Purdue University. Hollenbeck was associate dean for academic programs at the School of Pharmacy from 1991 to 1996, and was one of the principal architects of the School's nationally recognized Doctor of Pharmacy program. During that period, he was also co-principal investigator on the UMB/FDA Collaborative Agreement; a joint education, research and computer database effort aimed at establishing a scientific basis for review of new and amended drug applications. In this capacity, he and his associates received a special recognition award for the SUPAC IR Training Program, from the Center for Drug Evaluation and Research, FDA, PHS, DHHS. Dr. Hollenbeck also served as a member of the Advisory Committee on Pharmaceutical Science in the Office of Pharmaceutical Science at the FDA, and, in 2003, received a DHHS, FDA Commissioner's Special Citation for his work with the Center for Veterinary Medicine. Dr. Hollenbeck is a member of the editorial advisory board for Pharmaceutical Technology and continues to serve as an adjunct professor of pharmaceutical sciences at the School of Pharmacy.
Lauren Petraglia
Technical Sales Specialist
LCI Corporation
Lauren Petraglia has been involved with low pressure extrusion and spheronization since joining LCI Corporation in 2011. Her responsibilities include evaluation of potential applications, providing technical training presentations, scale-up from laboratory to production, system commissioning, and technical support. Prior to LCI she worked for PTI, Inc. delivering specialized technical and sales training to pharmaceutical salesman across the country. Petraglia holds a B.S. in Biology from the Pennsylvania State University.
Carmen Popescu, PhD
Senior Project Coordinator
Roquette America, Inc.
Dr. Carmen Popescu is a senior project coordinator at Roquette America Inc., located in Geneva, Illinois. She came to the USA in 1999 as an associate professor at the University of Illinois at Chicago, Pharmaceutics Department, where she is still an adjunct associate professor. Later, she moved to the pharmaceutical industry, working at Morton Grove Pharmaceutical, Baxter, and DeCode Genetics. In her career, she focused on classic dosage forms (liquid, semi-solid, and solid dosage forms formulation) as well as drug delivery systems (microparticles, nanoparticles, liposomes, niozome, etc.) for small and large molecules. She has published more than 120 research papers, book chapters, and presentations. She is also an adjunct associate professor with the University of Tennessee and Roosevelt University. She is a reviewer for the International Journal of Pharmaceutics, Journal of Pharmaceutical Sciences, and European Journal of Pharmaceutics and Biopharmaceutics. She is an active member of AAPS (Excipients Focus group and AAPS Chicagoland Discussion Group) and CRS.
Debra Repko
Product Specialist, Spray Drying Segment
Buchi Corporation
Debra Repko is the product specialist for the spray drying segment at Buchi Corporation. She has been supporting spray drying and encapsulation for Buchi since 2006. Her background consists of organic synthesis, formulation development and materials characterization of polymers. She has previously worked for AT&T Bell labs, DuPont, and DSM.
Mark Rice
Field Service Engineer
Specialty Measurements, Inc.
Mark Rice is a field service engineer for Specialty Measurements, Inc. (SMI). He has been with SMI nearly 14 years. His responsibilities include tablet press instrumentation, commissioning, training, and calibration. Mark is also tasked with performing software validation services for "The Director" instrumentation systems as well as authoring and completing factory acceptance test documents and IQ/OQ protocols for Riva tablet presses. He has contributed to various posters and white papers that SMI has produced.
SMI offers The Director and Director Pro software instrumentation and tablet press control systems. SMI is the sole North American distributer for the Riva line of tablet presses and also offers Adamus HT tablet press punches and dies, tool polishing, and inspection machines, as well as a full line of tablet press spare parts.
Denise Root
NIR Marketing Manager
Metrohm USA
Denise Root is the NIR marketing manager at Metrohm USA. Denise is a chemist with more than 20 years of near-infrared experience in the roles of applications scientist, product management, and marketing. She is a graduate of the University of Delaware and has co-authored many posters and papers related to NIR application to the laboratory and process environments in the pharmaceutical and chemical industries.
Myke Scoggins, PhD
Senior Director, CMC Development and Project Management
Syner-G BioPharma Group
Dr. Myke Scoggins earned his BS in microbiology from the University of Georgia and PhD in pharmaceutical sciences from Mercer University. He has 30+ years of experience in the pharmaceutical industry, including analytical chemistry, preformulation, formulation, process development and validation, scale-up, tech transfer, and manufacturing support. Prior to joining Syner-G BioPharma Group, Dr. Scoggins worked in other pharmaceutical development environments on various dosage forms and delivery systems including tablets, capsules, transdermals, and osmotic systems. He has worked at an analytical instrument manufacturer, a medical device company managing microbial and chemical testing, generic pharmaceutical companies, larger international companies, and at a research university (Georgia Institute of Technology). He has delivered numerous lectures on topics in the pharmaceutical sciences to graduate students, helped develop graduate courses in pharmaceutical sciences at local universities, and presented research findings at national and international meetings. Dr. Scoggins is currently a member of AAPS, and sits on the USP Expert Committee for General Chapters – Physical Analysis with memberships on the Powders and Particles Sub-committees and the Nanotechnology Joint Sub-committee. He currently serves as Senior Director of CMC Development and Project Management at Syner-G BioPharma Group helping guide clients through the CMC landscape from early development through commercialization.
Robert Sedlock
Director of Technical Training and Development
Natoli Engineering Company
Robert Sedlock is the Director of Technical Training and Development for Natoli Engineering Company. He has been serving the industry for over 18 years in the tablet compression arena. His early experience spans strain gauge force measurement technology and data acquisitions systems. Mr. Sedlock has many published technical papers in industry trade magazines and for American Association of Pharmaceutical Scientists. Areas of expertise include instrumentation systems, formulation optimization, compression studies and scale up. Mr. Sedlock is currently involved in many training seminars hosted by universities worldwide. His current responsibilities include tool / tablet designs, solid dosage troubleshooting and contract development work at the Natoli Institute of Industrial Pharmacy Research & Development located at Long Island University Arnold & Marie Schwartz College of Pharmacy and Health Sciences in Brooklyn, New York.
Timothy J. Smith, MS
Senior Process Development Scientist
Freund-Vector Corporation
Mr. Smith has been involved in the design and development of equipment and processes for the pharmaceutical, food, and confectionary industries for more than 30 years. Currently, he is serving as a senior process development scientist with Freund-Vector Corporation. Previously, he served as a research associate, application engineer, R&D engineer, and R&D project manager. Tim has given numerous presentations at seminars such as the University of Tennessee's tablet manufacturing short course, Colorcon, E&G, Evonik, FDA, Interphex, Lubrizol, TechSource, AAPS annual meetings, Freund-Vector's technical courses and numerous domestic/international customer facilities. He is the lead author of "Development, Scale-up, and Optimization of Process Parameters: Roller Compaction" (Chapter 31), in Developing Solid Oral Dosage Forms; edited by Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lirong Liu, and William R. Porter, 2008. Mr. Smith has a BS in chemical engineering and a MS in food science from Iowa State University.
Jack Torkildsen
Technical Service Specialist
Specialty Measurements, Inc.
Jack Torkildsen is a Technical Service Specialist for Specialty Measurements, Inc. (SMI). He has been with SMI since 2017. His responsibilities include tablet press instrumentation, controls & control panel wiring, commissioning, training, and calibration. Jack is also tasked with performing software validation services for "The Director" instrumentation systems, as well as completing factory acceptance test documents and IQ/OQ protocols for Riva tablet presses.
SMI offers The Director software instrumentation and tablet press control systems. SMI is the sole North American distributer for the Riva line of tablet presses and also offers Adamus HT tablet press punches and dies, tool polishing, and inspection machines, as well as a full line of tablet press spare parts.