InPharma Symposium 2023: Enabling drug products for oral administration: design and evaluation
The theme for the InPharma Symposium is Enabling drug products for oral administration: design and evaluation. There will be seven distinct sessions, as outlined below.
Enabling drug products for oral administration: design and evaluation
- 09:15 - 10:00
- Drug polymorphs and co-crystals in pharmaceutical development
- 10:00 - 10:45
- Lipid-based formulations in capsules: formulation design and characterization
- 10:45 - 11:15
- 11:15 - 12:00
- Getting oral formulations with cyclodextrins right– relevant characterization and biopharmaceutical considerations
- 12:00 - 12:45
- Possibilities and limitations in translating in vitro dissolution data to in vivo performance for a pediatric formulation using physiologically based biopharmaceutics modeling and virtual BE trials - an industry case study
- 12:45 - 14:00
- 14:00 - 14:45
- Absorption Modelling using the Simcyp ADAM Model: Enabling Formulations
- 14:45 - 15:15
- 15:15 - 16:00
- Factors affecting extrapolation of drug exposure from adults to pediatric populations after oral administration of pediatric aqueous suspensions: focus on dosing conditions
- 16:00 - 16:45
- Mechanistic prediction of the in vivo performance of low solubility drugs/incompletely absorbed drugs using GI-Sim
David TurnerSenior Principal Scientist at Certara (Simcyp Division)
David B. Turner PhD is a Senior Principal Scientist at Certara (Simcyp Division) having joined Simcyp in 2004. He is author or co-author on more than 40 peer-reviewed papers. His work at Simcyp has mainly focussed upon oral absorption modelling, for which he is the lead scientist, but also on physico-chemical aspects of PBPK modelling including tissue distribution and a variety of QSAR models. David was the PI for a recently completed FDA grant to develop modelling tools for handling supersaturating drug products and is currently co-PI on a second FDA grant focussed on BE of locally acting oral drugs. He has a Biochemistry BSc, a Computer Science MSc, and a PhD in Chemoinformatics and QSAR modelling all obtained at Sheffield University, UK. Prior to joining Simcyp he worked in a Computational Chemistry Group (Synt:em SA, Nîmes, France) focussed on high throughput in silico discovery and virtual screening projects.
Marina Statelova Senior scientist, Dissolution and Biopharmaceutics Group, Analytical Research and Development Department, Novartis Global Drug Development in Basel, SwitzerlandMarina StatelovaSenior scientist, Dissolution and Biopharmaceutics Group, Analytical Research and Development Department, Novartis Global Drug Development in Basel, Switzerland
Dissolution and Biopharmaceutics Group, Analytical Research and Development Department, Novartis Global Drug Development in Basel, Switzerland
Neil Parrott Neil Parrott, Distinguished Scientist in Modeling and Simulation, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Switzerland.Neil ParrottNeil Parrott, Distinguished Scientist in Modeling and Simulation, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Switzerland.
Neil Parrott works in the translational modelling and simulation group which is part of the Predictive Modeling and Data Analytics Chapter of Roche Pharma Research and Early Development in Basel, Switzerland. Neil specializes in physiologically based pharmacokinetic (PBPK) modeling and its application to Roche projects from early discovery to the market. Neil has a particular interest in the applications of PBPK modelling for first in human PK prediction, to guide formulation development, to guide studies in special populations such as children and to help manage drug-drug interactions by integrating data from advanced in vitro systems. He is involved in various research activities to develop better PBPK models and is active in cross-industry consortia such as the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ). Neil has published over 130 papers and has given numerous presentations at international conferences.
Rene HolmProfessor in pharmaceutical physical chemistry at the University of Southern Denmark
Dr. René Holm is a professor in pharmaceutical physical chemistry at the University of Southern Denmark. After receiving Master and PhD degree in pharmaceutics from the University of Copenhagen, Denmark, in 2002, he started his carrier in the pharmaceutical industry at H.Lundbeck in 2001 and changed to Janssen in 2016. Dr. Holm has worked within pharmaceutical development, formulations for non-clinical testing in drug discovery, physical chemistry and material science covering both small and large molecules. In 2021 Dr. Holm engaged into a carrier change and became a full professor. Dr. Holm is (co-) author of more than 220 original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation and physical pharmacy and book chapters and is co-inventor on 13 published patents.
Rolf HilfikerScientific Consultant and Advisor for Solvias AG
Rolf Hilfiker has been Scientific Consultant and Advisor for Solvias AG since he stepped back from operational responsibilities as Head of the Solid-State Department and CEO of Solvias Inc. in the USA in 2021.
Solvias is a scientific services company focused on leveraging expertise in various scientific disciplines to accelerate the drug discovery and development process. His department of some 20 people does contract research and development in the solid-state area, i.e. polymorphism studies, salt and co-crystal screening and selection, method development, crystallization optimization, etc.
Rolf started his industrial career at Ciba-Geigy and then became head of the Stability & Kinetics group at Novartis. In 1999 he participated in the management buyout to form Solvias AG. Under his guidance, Solvias became one of the leading solid-state service providers in the world. He has taught physical chemistry in New York and Basel, as well as numerous courses in solid-state development in Europe, Asia and the US. He is author of more than 60 scientific publications as well as numerous patents in various areas of physical chemistry and editor of “Polymorphism – In the Pharmaceutical Industry”, Wiley-VCH, 2006 and 2019.
Rolf holds a PhD in Physical Chemistry from Basel University and then did postdoctoral work at Stony Brook University (New York), whereafter he returned to Basel University as a research fellow. He holds a CAS in Corporate Management.
Sara CarletDirector at Advanced Drug Delivery in AstraZeneca Gothenburg
Sara Carlert, Director at Advanced Drug Delivery in AstraZeneca Gothenburg, has over 20 years of industrial experience in drug development. She started her journey as a formulator in pre-clinical phase, and completed her PhD in biopharmaceutics in 2012 focusing on intestinal drug precipitation. She has worked on projects in the entire range of the AstraZeneca small molecule portfolio from pre-LO to Phase 3. In 2021, she took on the role of team manager of the Small Molecule Preformulation team, leading other scientists to develop the medicines of the future with a strong focus on scientific excellence. Her core skill as a biopharmaceutics expert remains, and she continues to give biopharmaceutic input and lead the development of scientific strategies in the company. She has been involved in several external collaborations with a specific focus on precipitation and in silico absorption prediction models.
Vincent JanninHead of Applications Lab, Lonza Capsules & Health Ingredients
Dr. HDR Vincent Jannin is Head of Applications Lab. (R&D) at Lonza Capsules & Health Ingredients. He joined Lonza in January 2019. Previously, he held diverse positions up to Research Director – Pharmaceuticals at Gattefossé (1998-2018). He was also lecturer at Lyon University from 2003 to 2019 where he taught formulation sciences.
Vincent earned his Pharm.D. and Ph.D. from the University of Bourgogne, and received his HDR (Habilitation to Supervise Research) from the University of Lyon. Vincent has published 71 publications in peer-reviewed journals (h-index=38), 5 patent families, 5 book chapters, 77 meeting abstracts, and given 68 lectures as speaker on Drug Delivery Systems.