This seminar provided an overview of a structured approach with parallel formulation feasibility assessment that is designed to reveal the most suitable pathway to enhance bioavailability and accelerate development. Speakers also discussed the latest developments in enabling technologies: Lipid Based Delivery Systems, Particle Size Engineering, Amorphous Systems, Solid State Optimization.
KEY LEARNING OBJECTIVES
During the early stages of drug development process (i.e. preclinical to Phase I), scientists are often faced with a set of challenges to deliver against the Target Product Profile, with the top three being bioavailability, stability, and delivery profile. A viable bioavailability enhancement toolkit already exists. However, to accelerate development and discharge risk at an early phase, it is essential to examine and rank multiple delivery options in parallel. This approach optimizes the performance of the drug candidates advanced through early preclinical and clinical studies.
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MEET THE EXPERTS
Cornell Stamoran, Ph.D.
Catalent Institute Board Member, Vice President, Strategy & Corporate Development, Catalent Pharma Solutions
Dr. Stamoran has spent nearly 25 years engaged with the healthcare industry, and has experienced the realities of patient adherence and outcomes enhancement from almost every stakeholder perspective: from direct engagement with retail and hospital pharmacists; medical professionals; specialty pharmacies and clinics; and pharmacy benefit managers and payers. He has directly participated in adherence and outcomes enhancement strategies for more than 150 drugs over the last 10 years.
Ralph Lipp, Ph.D.
Founding Advisory Board Member, Catalent Institute, President & CEO of Lipp Life Sciences, LLC
Dr. Ralph Lipp has more than 20 years of experience in the life sciences industries. Before founding Lipp Life Sciences LLC, where he advises clients on innovation-based value creation, he served as Vice President Pharmaceutical Sciences R&D at Eli Lilly and Company and Head Pharmaceutical Development at Schering AG. He holds a degree in Pharmacy from Johannes Gutenberg University (Germany) and obtained a Ph.D. in Medicinal Chemistry as well as a Habilitation for Pharmaceutical Technology from Free University Berlin (Germany). He graduated from INSEAD’s (France) International Executive Program and from Harvard Business School’s (USA) Advanced Management Program. Ralph’s scientific contributions comprise over 120 publications, including more than 20 patents, covering 5 marketed medicines.
David Bard Ph.D.
Principal, Advisory Services, Quintiles
Dr. Bard received his Ph.D. in mechanical engineer and is known for his exceptional skill in performing complex analyses and designing new products and processes. He also a MBA with strong experience helping senior business executives to develop and implement strategies for enhancing R&D and manufacturing for biopharmaceutical and industrial companies.