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8th Drug Formulation, Solubility & Bioavailability Summit -

8th Drug Formulation, Solubility & Bioavailability Summit
March 25 - 27, 2019
Boston, MA

The Modeling and Enabled Formulation Expertise You Need to Maximize Developability, Avoid Particle Formation, and Maintain Stability and Bioavailability

Faculty – 8th Drug Formulation, Solubility & Bioavailability Summit

Kang-Jye Chou
Scientist, GENENTECH

David Cipolla
Vice President, Research, INSMED

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David has more than 25 years of experience in the pharmaceutical industry with a focus on the development of formulation and drug delivery technologies to support pharmaceutical product development. David is currently the VP of Research at Insmed, Inc, where he is part of a team developing novel, targeted therapies to help serve the critical unmet needs of patients battling serious rare diseases. Prior to joining Insmed in 2018, David held positions of increasing responsibility at Aradigm (1996 to 2018) and Genentech, Inc. (1988 to 1996). David holds a chemical engineering degree from MIT (SB) and UC Davis (MS) and a pharmacy degree from the University of Sydney (PhD). David served as chair of IPAC-RS (2006-2008), chair of the ISAM Regulatory Affairs Working Group (2009-2010, 2017-2018) and ISAM Board Member (2011-2015).

Ann Daugherty
Senior Manager, Drug Delivery, GENENTECH

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Ann L. Daugherty, Ph.D. is a Senior Manager in Drug Delivery at Genentech where she works with promising internal and external delivery technologies for application to Genentech’s pipeline of protein drugs. A biopharmaceutical scientist with training and experience in pharmacokinetics and biocompatibility, her interests are in integrating all of the various aspects of drug delivery to provide an optimized product to patients. Over a 35 year tenure at Genentech she has researched alternative routes of administration for protein drugs, with a strong focus on ocular and CNS delivery of macromolecular therapeutics.

Eric Dinarello
Senior Scientific Associate, VERTEX PHARMACEUTICALS

Helen Hao Hou
Senior Scientist, Small Molecule Pharmaceutical Sciences, GENENTECH

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Dr. Helen Hou is currently a Senior Scientist in the Department of Small Molecule Pharmaceutical Sciences at Genentech Inc., where she is responsible for drug product development to allow fast-entry into human and the definition of market-image formulation/process. Prior to joining Genentech in 2015, Helen has worked at several pharma companies including Allergan, Abbvie, and Amgen. Helen received her Ph.D. in materials science and engineering from the University of Minnesota in 2006. Her primary research interests include 1) understanding the effect of excipients or manufacturing process on the quality and performance of amorphous solid dispersions, 2) designing in vitro models for the prediction of in vivo performance of supersaturating drug delivery systems.

Keith Horspool
Vice President, Pharmaceutics, BOEHRINGER INGELHEIM

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Keith Horspool is Vice President of Pharmaceutical Development at Boehringer Ingelheim, Ridgefield, CT. His department encompasses predevelopment support; physical pharmaceutics; formulation development; and process technology to support API selection, solid dosage form design and process development for technology transfer. The group has a strong interest in the evaluation and implementation of new technology — including advanced materials profiling, predictive methods for pharmaceutical development and drug delivery systems — to facilitate new products to patients.

Prior to joining BI, Dr. Horspool worked at Pfizer (UK and US) and AstraZeneca. He has more than 20 years of experience, during which he has managed pre-formulation, formulation development and materials science. He has a B.Sc. in pharmacy, and a Ph.D in pharmaceutical chemistry.

Hyungchul Kim

Wei Li
Postdoctoral Fellow, Laboratory for Drug Delivery, GEORGIA INSTITUTE OF TECHNOLOGY

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My name is Wei Li, and I am a postdoctoral fellow in Prof. Prausnitz’s research group at Georgia Institute of Technology where I have been since 2016. I received my B.S. and M.S. from Huazhong University of Science and Technology in China in 2009 and 2012 respectively and received my Ph.D. from City University of Hong Kong in 2015. My research interests are involved with the use of microneedle technology for transdermal drug delivery to improve human health.

Craig McKelvey
Specialty Dosage Formulation Group Lead, MERCK

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As part of his graduate work at the University of Delaware, Craig studied inorganic and organic templating of self-assembling microstructured colloids and the characterization of the resulting silica-based and polymeric architectures. Craig’s first experience with drug delivery was as a brewer at Dogfish Head Brewery in Delaware. In 2001, Craig joined the Pharmaceutical Sciences Department responsible for the design of new pharmaceutical products at Merck and Co., Inc. In 2003, Craig co-founded and led cross-functional teams chartered with establishing Merck’s capability to effectively orally deliver water-insoluble drugs which had become a key unmet need at Merck. These technology development efforts would continue to grow until a global solubilization center of excellence was established in 2008 which Craig led until 2014. As part of this center of excellence, Craig was responsible for charting the strategic course and implementation activities to enable reduction to practice across more than 20 development products which included the technical objectives of ca. 30 scientists, ultimately more than $6M in annual external partnerships, and creation of an integrated line of sight for the technologies from discovery applications to commercial launch. These solubilization technologies have enabled the successful commercialization of three drug products. Today, Craig leads the specialty dosage formulation group responsible for the design and development of long-acting implants, respiratory products, and other complex drug-device combination products. The potential to positively impact human health and to help others grow and develop to maximize their impact on human health through the design of new pharmaceutical products remain the primary motivations in Craig’s career.

Eric Munson
Professor and Head, Department of Industrial and Physical Pharmacy, PURDUE UNIVERSITY

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Eric Munson is currently the Dane O. Kildsig Chair and Head of the Department of Industrial and Physical Pharmacy at Purdue University. He received his B.A. degree from Augustana College in Sioux Falls, South Dakota, in 1987. After studying one year in Munich, Germany, on a Fulbright Fellowship, he received his Ph.D. in 1993 from Texas A&M University, and was a postdoctoral fellow at the University of California, Berkeley in 1994. He was in the Chemistry Department at the University of Minnesota before moving in 2001 to the Pharmaceutical Chemistry Department at the University of Kansas, to the Pharmaceutical Sciences Department at the University of Kentucky in 2010, where he was the Patrick DeLuca Endowed Professor in Pharmaceutical Technology. In 2018 he moved to Purdue University to become the Dane O. Kildsig Chair and Head of the Industrial and Physical Pharmacy Department. His research program is focused on the characterization of pharmaceutical solids using a variety of analytical techniques, with an emphasis on solid-state NMR spectroscopy. Dr. Munson is a co-inventor on three patents and has published more than 100 research, review, and book chapters. He is also the site director for the Center for Pharmaceutical Development, an NSF Industry-University Cooperative Research Center.

Rashmi Nair
Formulation Scientist, DR. REDDY’S

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Rashmi Nair is Senior Scientist (Pharmaceutical Product Development) at Dr. Reddy’s Laboratories Ltd., India. She is a qualified pharmaceutical professional with supplementary roles of Lead Technical Associate to business and is certified in intellectual property/patents. In the last decade of her work at Custom Pharmaceutical Services (CPS) division of Dr. Reddy’s, she and her team have worked with various innovator companies from the USA, Europe and Asia Pacific for the development of proprietary technologies and have specialized in bioavailability enhancement techniques for new chemical entities and repurposed drugs in clinical studies. The focus of her work, as reflected in her international papers and presentations, has been to highlight the importance of simplified innovation and integrated development between chemistry, preformulation, formulation and manufacturing teams. Her presentation for the 6th Drug Formulation, Solubility & Bioavailability conference focuses on distinct development needs at various stages of a clinical phase molecule.

Katharine Odneal
Senior Formulation Scientist, Research and Development, NESHER

Dhaval Patel
Senior Research Investigator, BRISTOL-MYERS SQUIBB

Robert Prud'homme
Professor, Chemical and Biological Engineering, PRINCETON UNIVERSITY

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I am a professor in the Department of Chemical and Biological Engineering, and founding director of the Engineering Biology Program at Princeton University. I received my BS at Stanford University and my Ph.D. from the University of Wisconsin at Madison under Professor Bob Bird in l978. I have served on the executive committees of the American Institute of Chemical Engineers Materials Science Division and the U.S. Society of Rheology. Currently, I am the past President of the U.S. Society of Rheology. I have served as the chair of the Technical Advisory Board for Material Science Research for Dow Chemical Company, which directed Dow’s materials research programs, I was on BASF’s nanotechnology advisory committee, and I served on the Board of Directors of Rheometric Scientific Inc., which was the leading manufacturer of rheological instrumentation. My awards include the NSF Presidential Young Investigator Award, Princeton School of Engineering and Applied Science Outstanding Teaching Award, the Sydney Ross Lectureship at RPI, the Bird,Stewart and Lightfoot Lecturer at the University of Wisconsin, and the Midland Macromolecular Institute Visiting Professor in Midland Michigan, and the Dinesh Shah lecturer at the University of Florida. I have been the organizer and Chair of the Gordon Conference on Ion Containing Polymers, and the Society of Petroleum Engineers Forum on Stimulation Fluid Rheology, in addition to organizing numerous sessions at AIChE, ACS, and SOR meetings. I directed the Princeton-University of Minnesota-Iowa State NSF NIRT Center on nanoparticle formation. My research interests include rheology and self-assembly of complex fluids. Systems of interest are biopolymer solutions and gels, surfactant mesophases, and polymer/surfactant mixtures. The goals of the studies are to understand how weak molecular-level interactions can be used to tune macroscopic bulk properties and phase behavior. Application of the work is directed at nanoparticle formation for the drug delivery, controlled release, targeting, and imaging.

Lilly Roy

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Lilly Roy is a pharmaceutical scientist with over 7 years of experience including polymorph screening, solid-state characterization, crystallization development, preformulation assessment, formulation design, and drug product manufacturing. Lilly currently works in the formulation department at Vertex Pharmaceuticals in Boston, MA. She completed her PhD in Pharmaceutical Sciences at the University of Michigan.

Aliasger Salem
Head, Division of Pharmaceutics and Translational Therapeutics, UNIVERSITY OF IOWA

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Dr. Aliasger Salem is the Bighley Chair and Professor of Pharmaceutical Sciences and head of the Division of Pharmaceutics and Translational Therapeutics at the University of Iowa College of Pharmacy. He was educated in applied chemistry at Aston University of Science and Technology, Birmingham, UK (BSc 1998). He received his Ph.D. in pharmacy at the University of Nottingham, UK in 2002. He then received postdoctoral training at Johns Hopkins School of Medicine until 2004. He is an elected fellow of the American Association for Pharmaceutical Scientists and an elected fellow of the American Institute for Medical and Biological Engineering.

Manuel Sanchez-Felix
Senior Fellow, Formulation, NOVARTIS

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Dr. Manuel Sanchez-Felix is a Senior Fellow with the Chemical and Pharmaceutical Profiling (CPP) group at the Novartis Institutes for BioMedical Research in Cambridge, MA. He is a scientific leader with over 20 years of experience in drug discovery and development where he co-invented products and contributed to the successful development and launch of various pharmaceutical products.

At Novartis, Dr. Sanchez-Felix leads a cross-functional group from Discovery and Development that is responsible for the evaluation and implementation of external Novel Delivery Technologies. His previous position at Novartis involved heading a group of scientists at the interface between Research and Development, establishing physicochemical and biopharmaceutical properties, and combining this information to initiate development strategy and formulation design. Prior to joining Novartis, Manuel was at Eli Lilly & Company for 20 years. His area of expertise includes Biopharmaceutics, drug delivery, and patient-centered formulation design. Areas of drug discovery were he has developed products include CNS, infectious diseases (specifically TB), oncology, bone regeneration, and diabetes.

Dr. Sanchez-Felix received his B.Sc. Honors degree and Ph.D. in Chemistry from the University of Surrey, UK. He is also an Adjunct Professor in the Department of Industrial and Physical Pharmacy at Purdue University (West Lafayette, IN) and a Fellow of the Royal Society of Chemistry. Recently, he has joined the Advisory Board for the Biomedical Program at Middlesex Community College and is a member of the Scientific Advisory Board member of an instrument company.

Jerome Schentag

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Dr. Jerome J Schentag is Emeritus Professor of Pharmacy at the University of Buffalo, NY; Prof Schentag has 30+ years of US and Global Clinical Trial expertise in Infectious Diseases, Critical Care, Sepsis and Metabolic Syndrome. He is also the inventor of SmartPill, a medical device for diagnosis of GI tract malfunction and the predicate device for the characterization of the ileal Brake. He is the Co-inventor of Brake™, the first oral mimetic of RYGB Bariatric surgery and its associated cure of Type 2 Diabetes and Metabolic syndrome. He is also deeply involved in Neural net mathematical modeling of disease progression, chiefly as the Co-inventor of FS-index, the best available means of describing the cardiovascular improvements that occur in patients whose metabolic diseases are cured or improved. He has authored or co-authored more than 350 publications and 15 patents.

In the course of this research and development, Dr. Schentag and colleagues have used the teachings of the SmartPill to Invent a practical means of oral absorption and intracellular delivery of peptides, proteins, and other macromolecules. This is the only known means of converting these otherwise injectable biologicals into a practical form for regular use. Prof. Schentag’s entrepreneurial experience comprises several private equity investments and exit transactions across a broad spectrum in healthcare.

Wei Xu
Director, Preformulation, MERCK

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Wei Xu is currently a director of Preformulation at Merck. She has over 20 years of drug development experience spanning from discovery support to late stage product development. She has led multiple cross-functional teams to advance new chemical entities and pursue product value enhancement opportunities. Her research interests include materials characterization, predictive dissolution, and novel formulation technologies for small molecules and peptides.

Tao Zhang
Principal Scientist, Drug Product Design, PFIZER

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