The selection of enabling technologies during the early stage of product development involves several challenges, including limited API supply, the need for rapid turnaround, and limited development time. The selection of the right technology and partner is key to development of an efficient Phase I enabling drug product.
This 75-minute webinar will provide an overview of various strategies to optimize your drug candidates at early phase to expedite the pathway to market. Case studies of various enabling technologies will be provided in the field of drug delivery systems and to optimize the drug development strategy from molecule selection to clinical studies.
• Drug development challenges overview
• Management of drug development projects – towards market
The speaker will share his own experiences from coordination of product development & manufacturing of drug products to consistently supply of products for preclinical and clinical studies
• Early Technology Selection for Optimized Drug Development
We will go through the importance of selecting a drug delivery technology for both conventional and non-conventional (i.e. poorly soluble/permeable) drug candidates that lead to Phase I enabling formulations with a formulation for the market in mind. A dose form selection process will be discussed and case studies provided.
Presented by
Dr. Janet Hoogstraate,
Director Biovation Park, Acturum Life Science AB
Janet Hoogstraate obtained her PhD from Leiden University in the Netherlands in Biopharmaceutical Sciences and an executive MBA from Hult International Business School in London, UK. She is associate professor at the Department of Pharmaceutics at Uppsala University. During her research career she has worked at the University of Utah, University of Iowa and in various positions at AstraZeneca R&D. As the director of DMPK in AstraZeneca she headed a group of 63 scientists working in the entire value chain of pain and neurology drug development projects.
She is co-author of more than 45 papers and book chapters. Currently, Janet holds the position of director of Biovation Park at Acturum Life Science AB building a business and science park and incubator in Södertälje for life science companies and academic groups. She also hold various board positions such as chairman of the board of the Stockholm Brain Institute.
Christer Johansson,
CEO/Owner, BiQ Pharma and AQPS Academy of Quality in Pharm Science
Mr. Johansson has over 40 years' experience in the pharmaceutical industry and currently serves as the CEO/owner of BiQ Pharms and AQPS Academy of Quality in Pharm Science. Mr. Johansson also worked at Biotechvalley AB as the CEO and a senior consultant, quality director at Pfizer, Fresenius Kabi, Pharmacia, and the head of analytical laboratory at Astra. Mr. Johansson received his Master of Science in chemistry from KTH Royal Institute of Technologhy in 1980 and his MBA from Uppsala University in 2000.
Julien Meissonnier,
Director of R&D, Catalent Pharma Solutions
Julien Meissonnier serves as Director of R&D for Catalent Pharma Solutions. Mr. Meissonnier has 16 years of international experience in pharmaceutical development. At Catalent, he leads the European R&D organization providing technical and scientific leadership for the development of delivery systems for poorly soluble and permeable drugs that lead to approvable regulatory dossiers.
His responsibilities include early stage screening activities, developing products, scale-up and technology transfer, directing clinical supplies and supporting product launches. He additionally served as Board Director of Alsace BioValley innovation cluster. He received his Engineer Degree in Physico-Chemistry from the ENSI in Caen, France.
