Venerated and Vital: Using Lipid Based Delivery for Fast and Efficient Early Phase Development

Introduced to the pharmaceutical industry decades ago, lipid-based drug delivery systems are the most well-studied and widely utilized technology among all available bioavailability enhancement technologies.¹ Lipid-based drug delivery systems have delivered more than 60 unique drug molecules to market – and counting.²

With today’s increasingly complex new molecules emerging from R&D, optimizing bioavailability for early phase molecules is critical to their success. Not only do lipid-based drug delivery systems provide a reliable solution for poorly soluble molecules, they also allow for efficient and scalable dose formulation solutions which can accelerate progress to clinic and beyond, especially for orphan and breakthrough therapies. 

Learn how to apply lipid-based drug delivery systems to early phase molecules by joining academic and industry experts to develop a better understanding of new prediction models, novel lipid excipients, and lipid formulation screening tools with real-world case studies.  

Learning objectives:

• Understand the importance of and recent developments in lipid-based drug delivery systems
• Learn about novel lipid excipients, models, and screening tools for early phase development of lipid-based drug delivery systems
• Learn how to use mechanistic studies and modeling to predict the impact of lipids on oral absorption

References:

1: Review and analysis of FDA approved drugs using lipid-based formulations, DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2017

2: Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market, DRUG DEVELOPMENT AND DELIVERY, September 2016 Vol 16 No 7

Speakers

Nigel Langley, Director Technical Service and Scientific Affairs – BASF Pharma Solutions

Dr. Langley provides technical support to the pharmaceutical industry and helps solve drug development challenges with BASF’s platform solutions. Prior to joining BASF, Dr. Langley worked for Croda Inc. as Technical Director Health Care, responsible for product and application development for both dietary supplements and pharmaceutical excipients. He has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD in liquid crystals from the University of Hull, UK and an MBA from Leeds University, UK. Nigel has been a member of the Executive Committee at IPEC Americas since 2010 and is currently VC Users and Makers. He is also helping to lead the novel excipient initiative in collaboration with the IQ Pharma Consortium.

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Stephen Tindal, Director of Science & Technology, USA, Catalent

Stephen holds a Bachelor’s degree in Chemistry and Analytical Science from Loughborough University, UK. He has worked at Catalent for 30 years, holding positions in R&D responsible for formulation, process development and also for clinical and commercial operations. Stephen specializes in solving complex data analysis challenges such as low bioavailability and atypical analytical data (such as investigations for OOS Dissolution or related substances). Stephen is part of Catalent’s Science and Technology Team and is based at the Company Headquarters in Somerset, New Jersey.

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Rebecca L. Carrier, Professor & Associate Chair of Research, Chemical Engineering Department, Northeastern University

Rebecca Carrier earned a Bachelor’s Degree in Chemical Engineering from Rensselaer Polytechnic Institute (RPI) in 1995, and a Doctoral Degree in Chemical Engineering from Massachusetts Institute of Technology in 2000, where she worked in cardiac muscle tissue engineering. After completing her graduate studies, Dr. Carrier worked at Pfizer, Inc., as a Senior Research Scientist in oral controlled release drug delivery for three years. She joined the Northeastern University (NU) Chemical Engineering Department in 2003. The goal of Dr. Carrier’s research program is to relate material properties to biological response in drug delivery and regenerative medicine to enable technologies that benefit human health. To advance research efforts, Dr. Carrier has fostered collaboration and worked closely with multiple industrial partners including Pfizer, Merck, Boehringer Ingelheim, and Simulations Plus, Inc., a leader in development of pharmaceutical modeling software. Dr. Carrier received the National Science Foundation CAREER award in 2008 for mechanistic studies and modeling of lipid based drug delivery systems in the GI tract, the NU “Outstanding Teacher” and “Faculty Fellow” Awards in 2011 and 2014 for excellence in teaching and research leadership, and the Soren Buus Outstanding Research Award in 2017. She was invited to participate in the National Academy of Engineering Frontiers of Engineering (2016) and Frontiers of Engineering Education (2013) Symposia. She is currently the Member-At-Large for the Society for Biomaterials.

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