Medicon Valley Alliance Boost Seminar – Optimizing Oral Bioavailability and Translating Formulation Advances for Clinical Success
Join MVA and Catalent at this Boost Seminar focusing on optimizing oral bioavailability and translating formulation advances for clinical success.
Oral solid dosage forms remain a preferred option for many pharmaceutical drug developers. However, their successful development and manufacture still present several unique challenges and opportunities. This event brings together pharmaceutical experts to discuss such challenges and offer solutions for improving bioavailability, applying different pharmaceutical technologies for dosage form designs, optimizing manufacturing, and accelerating progression to the clinic and on to market success. Experts will offer insights into enabling formulation technologies including lipid based formulation and solid dispersion, and share approaches to transitioning from preclinical toxicology to a viable formulation in the clinics in an accelerated pathway.
Date: Tuesday 29th August, 2023
Time: 12.00 – 16.30 CEST
Venue: Hubnordic, Kay Fiskers Plads 10, 2300 København – Auditorium
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Program
12:00 |
Networking, registration & lunch |
12:40 |
Welcome Note & Introduction
Anette Steenberg, CEO, Medicon Valley Alliance
Magnus Franzmann, Account Director, Clinical Development & Supply, Catalent Pharma Solutions
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13:00 |
Leveraging PBPK Modeling as a Support Tool for Oral Drug Development
Jan Neelissen, Associate Director, DMPK Advisory Services, Catalent Pharma Solutions
- How is PBPK modeling used to understand the molecule’s physiochemical properties, formulation parameters and absorption?
- Can PBPK models be used to select formulation technology?
- How to bridge learnings from preclinical PK studies to the clinic?
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13:30 |
Designs and Considerations of Lipid-based Formulations
Anette Müllertz, Professor, University of Copenhagen
- Discuss how self-emulsifying drug delivery systems (SEDDS, SMEDDS and SNEDDS) impart their solubility-enabling benefits
- Explain how the understanding of LBF performance has evolved in the field (e.g., how particle size is no longer predictive of absorption potential but lipid digestion products is).
- Innovative way to combine LBF and other enhancing technologies to increase supersaturation, physical stability, and absorption of a poorly water-soluble drug.
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14:00 |
Coffee Break |
14:30 |
Planning the Development Path into cGMP Manufacturing
Bengt Hedin, Senior Consultant Pharmaceutical Development, SDS Life Science
- How to conduct risk analysis to identify CMC gap?
- How to lay out the development path into GMP manufacturing that meets the client’s needs?
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15:00 |
Optimizing Drug Performance Using Bioavailability Enhancing Technologies
Stephen Tindal, Director, Science & Technology, Catalent Pharma Solutions
- How to better understand the links between drug physicochemical properties and successful lipid-based formulation/ amorphous solid dispersion approaches?
- Discussion on (a) formulation strategies to provide better outcomes in preclinical formulations & enable high-dose animal toxicology; (b) logistics of delivering, using, and testing preclinical formulations.
- Rational selection of enabling formulation technologies to improve oral bioavailability.
- How to transition from preclinical to a clinically viable formulation for patients?
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15:30 |
Closing Remarks & Questions
Magnus Franzmann, Account Director, Clinical Development & Supply, Catalent Pharma Solutions |
15:40 |
Mingle, networking, drinks, and light refreshments |
16:30 |
End of Boost Seminar |
Speakers
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Anette Steenberg, CEO at Medicon Valley Alliance
Anette became the CEO of Medicon Valley Alliance in November 2021. She has had an extensive career in the Ministry of Foreign Affairs of Denmark and has also worked with the combination of life science, investment promotion and regional development in Greater Copenhagen as investment director at Copenhagen Capacity.
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Magnus Franzmann, Account Director, Clinical Development and Supply, Nordics, Catalent Pharma Solutions
Magnus Franzmann has more than 10 years experience from the Pharma Industry from positions at Scantox, Thermo Fisher, Novo Nordisk, Merck Millipore & GE HealthCare. Magnus Franzmann is a biochemist by training and have a PhD in Biotechnology from Aalborg University.
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Jan Neelissen, Associate Director, DMPK Advisory Services at Catalent Pharma Solutions
Jan Neelissen has 20 years of industry experience in the field of DMPK, of which 17 years at AstraZeneca holding positions as Associate Principle Scientist delivering 7 clinical drug candidates, Associate Director in vitro DMPK, and Associate Director Modeling and Simulation. Dr. Neelissen is a biologist by training and received his doctoral degree from the University of Leiden, Netherlands. |
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Anette Müllertz, Professor at University of Copenhagen
Anette Müllertz is professor in oral drug delivery and industrial relations at the University of Copenhagen, Denmark (UCPH) and head of Bioneer:FARMA, a business unit of Bioneer A/S, which is a research-based, non-for-profit service provider within the area of biomedicine and pharmaceutical development. She is heading the Physiological Pharmaceutics Research Group at UCPH, focusing on developing oral lipid-based drug delivery systems and predictive biopharmaceutics tools. She has >250 publications in international, peer-reviewed journals (h-index: 67, 13815 citations, (Google Scholar 9/5-23). She is / has been supervising 12 post docs, 53 PhD students and numerous master students, primarily at the University of Copenhagen, but also at other universities. She is/has been involved in multiple national and international research consortia, e.g. the EU sponsored Innovative Medicines Initiative Consortium Oral Biopharmaceutics Tools and Horizon 2020 MSCA training network COLOTAN.She is a Fellow at the American Association of Pharmaceutical Scientists (AAPS) and recipient of the AAPS Lipid Based Drug Delivery Award (2005). She has been involved in the transition of two AAPS Focus Groups into Communities; Lipid-based Drug Delivery (Chair 2010-12; Steering Committee 2006-now) and QbD and Product Performance (Chair 2013-15; Steering committee 2009-2017). She is editor of Journal of Drug Delivery Science and Technology (IF2023: 5.062). |
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Bengt Hedin, Senior Consultant Pharmaceutical Development at SDS Life Science
Bengt joined SDS Life Science in 2022 as senior consultant within the Drug Development department. With more than 20 years of experience from the life science industry, Bengt has a solid understanding of drug development with special focus on medicines for children. Bengt’s expertise is within formulation development, but he has worked with formulation and process development and small-scale manufacture of most dosage forms from early phase, during registration and life cycle management post authorization.In Bengt’s previous positions as project leader and formulation scientist he has worked in various teams and settings both within drug development and cross-functionally. Bengt has also worked towards EMA and FDA and other regulatory authorities globally during clinical trial applications and market authorizations, as well as an expert within EDQM and the Swedish Medical Product Agency.Previous employments include Senior Scientist within Pharmaceutical development at APL, Project leader at APL and Formulation Scientist at Recipharm. Bengt’s educational background is Chemical Engineering at Dalarna University and Master of Science in Pharmacy at Uppsala University.
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Stephen Tindal, Director, Science & Technology at Catalent Pharma Solutions
Stephen Tindal plays an important role within the company’s research and development team by providing advice to clients in Europe and Asia-Pacific on the early phase drug development and delivery technologies to progress their small molecule programs. His work is largely focused on preclinical to phase 1 development and is based on the assessment of preclinical data to help define any challenges to dosage form development. Tindal has more than 30 years’ experience at Catalent where he has held roles of increasing responsibility, and has demonstrated expertise in root cause investigation, technology innovation and in supporting business development. He holds a bachelor’s in chemistry and analytical science from Loughborough University, Loughborough, U.K. |
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