Formulation Development, Process Optimization, Validation and Regulatory Compliance
Day 1 | Day 2 | Download Development Brochure | Speaker Biographies
Michael Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut
Dr. Pikal is currently Professor and Distinguished Chair in Pharmaceutical Technology at the University of Connecticut. He received his Ph.D. in physical chemistry (1966) from Iowa State University and was a Postdoctoral Research Fellow with the Lawrence Livermore Laboratory(1966-1967). Prior to joining Lilly Research Laboratories in 1972, he was assistant professor of chemistry at the University of Tennessee (1967-1972). His current research activities include the solid state chemistry of pharmaceuticals, particularly the stability of amorphous materials, characterization of solids by calorimetry, and the science and technology of freeze drying with a focus on optimization of formulation and process for labile proteins. Dr. Pikal is a member of the ACS and AAPS. He was the recipient of the Ebert Prize (1977) and the PDA's "best paper of the year" award (1989). He received the Eli Lilly & Co. “Presidents Award" in 1996. Dr. Pikal was the Busse Lecturer (University of Wisconsin, 1983) and the Enz Lecturer (University of Kansas, 1998). Dr. Pikal is a Fellow of the AAPS, and received the AAPS Research Achievement Award in Pharmaceutical Technologies in 2001, and the Criofarma award in Freeze Drying in 2006. Dr. Pikal is the 2009 recipient of the AAPS Distinguished Scientist Award.
Michael Gross, Ph.D., Owner and Principal Consultant, Chimera Consulting North America
Michael Gross, Ph.D., RAC is the President of Chimera Consulting North America LLC, a consultancy specializing in quality, regulatory affairs and technical development strategy for drugs, biologics, medical devices and in particular drug delivery systems and combination products. He is a former FDA reviewer and inspector. He has worked in the medical products industry for over thirty years in senior quality and regulatory affairs roles for pharmaceutical and medical device manufacturers. He plays an influential role providing an industrial perspective on the regulation of combination products.
Sesha Neervannan, Ph.D., Vice President, Pharmaceutical Development, Allergan, Inc.
Dr. Sesha Neervannan is currently Vice President of Pharmaceutical Development at Allergan. In his current role, he oversees the CMC activities related to developing the drug product from Discovery to Commercialization that includes material characterization, formulation, process engineering, device & packaging engineering, analytical development, and drug delivery research and development efforts. Prior to joining Allergan, Sesha held senior positions at Bristol-Myers Squibb and Amgen, in both a functional and team leadership role. Sesha has several research publications and patents and is a well recognized invited speaker at several national and international conferences. He serves on the Scientific Advisory Board for CHDI, as well as on the Editorial Advisory Board for the journal, Expert Opinion on Drug Delivery. He received his Ph.D. in Pharmaceutical Chemistry at the University of Kansas.
Evgenyi Shalaev, Ph.D., FAAPS, Research Investigator, Allergan, Inc.
Evgenyi Y Shalaev, Ph.D.,
AAPS Fellow, is a Research Investigator in Allergan Inc. in Irvine, California, USA. He works in the Pharmaceutical Development Department, developing and applying physical chemical principles for characterization of small molecular weight drugs and proteins with a focus on drug delivery systems.
Dr. Shalaev held the Royal Society Fellowship in Pafra Biopreservation and the University of Cambridge, UK, post-doctoral research appointments at the University of Wisconsin-Madison and Cornell University, and worked at the Institute of Carbon (Russia), Institute of Molecular Biology (Russia), and Pfizer Inc. (USA), before taking his present position. Evgenyi Shalaev has been appointed as an adjunct professor in the Department of Pharmaceutics, University of Minnesota. His research interests include: amorphous and other disordered solids; phase transitions in aqueous systems during freezing and drying; chemical and physical stability of small molecules and biologicals. He has published over eighty peer-reviewed papers, book chapters, and patent applications.
Sean Cullen, Development Scientist, Technical Development, Genzyme Ireland Ltd in collaboration with University College Cork
After being awarded a B.Sc. (Biotechnology) from Dublin City University in 2007, Sean worked as a Process Technician in the Purification Department at Wyeth Biotech, Grange Castle. Sean then moved to Genzyme initially working as a Microbiologist for the Fill Finish manufacturing facility. Sean is currently a Development Scientist within the Fill Finish Technologies Department specialising in lyophilisation, thermal analysis and protein characterisation and will complete a M.Sc. by research in Biopharmaceuticals at University College Cork in the summer of 2013. Sean has 7 years industry experience.
Vamsi Mudhivarthi, Ph.D., Postdoctoral Fellow, Pharmaceutical Sciences, University of Connecticut
Vamsi K. Mudhivarthi, is a postdoctoral fellow at University of Connecticut, with Prof. Michael J. Pikal. He did his masters in Biochemistry at Andhra University, India. Later, he did his Doctorate in Chemistry at University of Connecticut with Prof. Challa V. Kumar, with a focus on stabilizing the proteins at protein-solid interface. Currently, he is involved in process development and protein stability aspects of freeze drying.
Mark Shon, MBA, Vice President, Technology Development, Technology Marketing, SP Scientific
Mark Shon is Vice President of Technology Development for SP Scientific. His career includes over 20 years managing businesses that primarily develop and manufacture equipment for Life Sciences research, development and production. Previous positions include: President, CEO Savant Instruments; President, CEO, E-C Apparatus; and Director of Business Development for Thermo Fisher Scientific. Mark holds graduate degrees in Molecular/Cellular Biology and Business.
Philippe Lam, Ph.D., Senior Engineer, Pharmaceutical Processing & Technology Development, Genentech, Inc.
Philippe Lam holds a BS in chemical engineering from Michigan Technological University and a Ph.D. in chemical engineering from Rensselaer Polytechnic Institute. After a brief stay in academics, teaching in the Department of Chemical Engineering at Virginia Commonwealth University, Philippe joined the Pharmaceutical Processing group at Genentech in 2000. At Genentech, Philippe’s responsibilities include general manufacturing support as well as studies of large scale freeze-thaw of biologics, freeze-drying process development, spray-drying, container closure development.
Satoshi Ohtake, Ph.D., Senior Principal Scientist, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Jeffrey Breit, Ph.D., Director, Pharmaceutical, Bend Research
Jeff Breit is a Director at Bend Research Inc., where he is responsible for inhalation drug delivery, biotherapeutic development, and formulation technologies. Dr. Breit earned his Ph.D. in pharmacology from the University of South Alabama, College of Medicine while working in the Center for Lung Biology. His doctoral work focused on identifying novel signaling pathways involved in pulmonary hypertension. Dr. Breit performed his postdoctoral work at Roche Pharmaceuticals in Palo Alto, California. Dr. Breit has been with Bend Research since 2007.
Arnab Ganguly, Ph.D. Candidate, School of Aeronautics and Astronautics, Purdue University
Arnab received a MS in the School of Aeronautics & Astronautics at Purdue University in 2010 with a focus on modeling low-pressure water-vapor flows applied to freeze-drying. His research emphasis is on understanding key mechanisms and control of low-pressure vapor and ice dynamics applied to vacuum freeze-drying. In 2012, he was awarded the Baxter Young Investigator award for his research during the MS and PhD work. Arnab is currently a research scientist at IMA Life, North America and is also working towards his dissertation for a PhD at Purdue.
T.N. Thompson, President, Millrock Technology, Inc.
Mr. Thompson is president of Millrock Technology, a manufacturer of high tech freeze dryers. Millrock Technology focuses on improving freeze drying equipment and control systems and has developed several recent patents for new technologies. Mr. Thompson was previously the President of FTS Systems.
Vikram Sadineni, Ph.D., Senior Research Investigator, Drug Product Science and Technology, Bristol-Myers Squibb Co.
Venkat R. Koganti, Ph.D., MBA, Associate Director, Formulation & Process Development, Celsion Corp.
Dr. Venkat Koganti is currently Associate Director of Formulation and Process Development at Celsion Corporation where is leads the product development of targeted nano drug delivery portfolio. Prior to this role he worked at Pfizer leading several liquid drug products at different stages of clinical development. He received his PhD. in Chemical Engineering from University of Kentucky.
Steven L. Nail, Ph.D., Senior Baxter Research Scientist, Pharmaceutical Research & Development, Baxter Healthcare Corp.
Steven L. Nail is currently a Senior Baxter Research Scientist with Baxter Pharmaceutical Solutions in Bloomington, IN where he is responsible for scientific and technical leadership for parenteral dosage forms. Prior to joining Baxter, he was a Research Fellow in the Pharmaceutical Sciences R&D organization of Eli Lilly & Company, Indianapolis, IN. His undergraduate training is in chemical engineering at Purdue University, and his Ph.D. is in pharmaceutics, also from Purdue. From 1975-1991 he worked for The Upjohn Company, Kalamazoo, MI in various capacities, all related to development and manufacture of parenteral products, with a special interest in the science and technology of freeze-drying. In 1991, he became Associate Professor in the School of Pharmacy at Purdue, and was promoted to Professor in 1999. His research interests at Purdue focused on the physical chemistry of freezing and freeze-drying, characterization of frozen systems and freeze-dried solids, stability of proteins as freeze-dried products, pharmaceutical thermal analysis, and pharmaceutical applications of supercritical fluid technology. His teaching responsibilities have included undergraduate pharmacy courses in parenteral pharmaceutical products and graduate courses in pharmaceutical processing. He is Chairman of the USP Committee of Experts in Parenteral Products, and was recently named a member of the Executive Committee of the Council of Experts at USP. He is a Fellow of the American Association of Pharmaceutical Scientists.
Robin Bogner, Ph.D., Associate Professor, School of Pharmacy, University of Connecticut
Dr. Bogner is Associate Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science and a UConn Teaching Fellow. She received her B.S. in Pharmacy from Rutgers University, M.S. from the University of Iowa, and Ph.D from Rutgers University after which she joined the faculty of the University of Connecticut. Dr. Bogner’s research interests are focused on solid dosage forms, both oral solids and parenteral lyophilized solids. Modeling the effect of variation on product quality and product performance is a recent area of interest. Dr. Bogner has served on a USP Expert Committee and various other leadership roles in AAPS and AACP. She is on the editorial boards of Pharmaceutical Research, Pharmaceutical Formulation and Quality, and Pharmaceutical Development and Technology where she is Editor for mini-reviews submitted to that journal.
Bakul Bhatnagar, Ph.D., Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Bakul Bhatnagar is a Principal Scientist in BioTherapeutics Pharmaceutical Sciences at Pfizer located in Andover, MA. He obtained a Ph.D in Pharmaceutical Science from the University of Connecticut and performed post-doctoral work in the department of Pharmaceutics at the University of Minnesota. He is experienced in formulation and process development of freeze-dried therapeutics and in frozen- and solid-state characterization of pharmaceuticals.
Wenjin Cao, Ph.D., Senior Scientist, Amgen, Inc.
Day 1 | Day 2 | Download Development Brochure | Speaker Biographies