Unlocking the Future of Drug Development: How PBBM & Solid Form Screening Revolutionize Early-Phase Success
Thursday, 05 June 2025 | 16:00 CEST / 10:00 EDT
Rapid and cost-effective development of early-phase drug candidates is important in progressing molecules to first-in-human (FIH) trials. A common challenge is that many new chemical entities (NCEs) suffer from poor bioavailability because of their low aqueous solubility. For these molecules, it is critical to quickly screen for a lead enabled form, looking at both crystalline and amorphous alternatives, without adversely impacting pre-clinical and clinical study timelines and costs.
Physiologically based biopharmaceutics modeling (PBBM) software, such as the GastroPlus® platform from Simulations Plus, simulates the interplay of the physio-chemical, metabolism, and excretion properties of a molecule in conjunction with the target physiology and formulation attributes. When coupled with targeted strategic in vitro measurements, PBBM modeling can be used in the early stages of drug development to identify risks to absorption, and evaluate the ability of enabled forms and formulations to overcome these risks. Significant savings in time and effort are realized by eliminating the unnecessary in vitro and in vivo testing of suboptimal formulations. Furthermore, PBBM modeling informs and aids the design of preclinical and clinical studies with respect to dose, prandial state, drug-drug interactions (DDI), or gastric pH modification to maximize the likelihood of achieving desired PK profiles.
In this webinar, we will discuss the role of solid form screening and PBBM modeling to enable the accelerated timelines that are desirable in early-phase drug development. We will also share formulation maps for amorphous solid dispersions (ASDs) and the key criteria for salt screening that are used to select the optimal formulation in early-phase screening for enabled forms. Using a model drug case study, the optimized pathway to lead-enabled form selection using a combination of in vitro characterization techniques and in silico modeling tools will be highlighted.
Addressed Challenges
- In vitro dissolution methodology selection to guide API form/formulation selection during early stage development of a drug product.
- Formulation scientists must successfully balance the manufacturability, physical and chemical stability, as well as improved biorelevant solubility during the screening process of API co-crystals, salt and amorphous forms.
- How to use PBBM modelling in early-stage programs to predict relative absorption of enabled API forms and enable form selection.
What You Will Learn
- Learn how PBBM modelling can identify potential oral absorption risks for early drug candidates.
- Understand the importance of solid form screening and form selection in oral pharmaceutical development.
- Learn how PBBM modelling coupled with in vitro testing and solid form screening can guide early selection of drug form and formulation to achieve pre-clinical and clinical study goals (eg bioavailability enhancement) for a model compound.
Josh Marsh
BAE and PBBM Lead Scientist
Josh Marsh is a member of the Advanced Drug Delivery Technologies team at Lonza’s site in Bend, Oregon, USA. He started his career at the Bend site in 2016. Josh has focused on the design of amorphous solid dispersion formulations and informative dissolution testing with the goal of improving bioavailability. He is passionate about using PBBM modeling to further the understanding of in vivo drug absorption, and the design of better drug products for clients and patients. Josh earned his B.S. in Chemistry from Oregon State University.
Abhijeet Sinha
Manager, Solid Form Services
Abhijeet Sinha is the Manager of Solid Form Services at Lonza’s site in Bend, Oregon, USA, where he works on product development and internal R&D in preformulation, polymorph, salt and co-crystal screens. Abhijeet joined Lonza in 2020 from Kansas State University’s Chemistry Department, where he served as a Senior Scientist and Director of the university’s x-ray crystallography facility. Abhijeet’s expertise includes molecular modeling, in silico screening of active pharmaceutical ingredients (APIs) and polymorphs, particle engineering, industrial crystallization, organic and inorganic chemistry, and x-ray crystallography. He earned his B.Sc. and M.Sc. degrees in Chemistry at Delhi University, and received a Ph.D. in Inorganic Chemistry from Kansas State University. After graduation, Abhijeet completed two years of postdoctoral work at University College Cork, mapping the solid-form landscape of APIs for the pharmaceutical industry.
Contact us
- Mark Leach
- mark@pharmad-mand.com
S'inscrire sur vegasino ouvre la porte à un univers de jeux variés et d'opportunités passionnantes. Le processus de vérification du compte est simplifié tout en respectant les normes réglementaires. Les fonctionnalités d'auto-exclusion témoignent d'un engagement sincère envers le jeu responsable. Les animations visuelles lors des gains importants ajoutent une touche spectaculaire à l'expérience de jeu. En un mot, c'est un espace de jeu qui a tout pour plaire aux passionnés comme aux joueurs occasionnels.
Découvrir casino instant représente une opportunité unique pour les amateurs de sensations fortes et de jeux captivants. Le chat communautaire intégré permet aux joueurs de partager leurs impressions en temps réel pendant les parties. Le système de recherche intelligent suggère des jeux en fonction des préférences et de l'historique du joueur. La plateforme prend en charge plusieurs devises, facilitant l'accès aux joueurs internationaux. Avec chaque mise à jour, cette plateforme prouve qu'elle prend au sérieux les attentes de ses utilisateurs.
Pour une expérience de jeu sans compromis, bonus julius casino met à disposition des outils et des fonctionnalités de premier ordre. Les conditions des bonus sont rédigées de manière claire et concise pour éviter toute confusion. Les mises minimales particulièrement basses permettent aux joueurs prudents de profiter de l'expérience sans pression. Un mode nuit ergonomique est disponible pour les joueurs qui préfèrent des sessions tardives dans un confort visuel optimal. C'est le genre de plateforme que l'on recommande volontiers à son entourage.
Ce qui frappe en premier chez hermes-fr.com, c'est la variété impressionnante des jeux de casino accessibles en quelques clics. Chaque semaine, de nouveaux titres viennent enrichir une ludothèque déjà impressionnante. Les versions live des jeux classiques reproduisent fidèlement l'ambiance d'un casino terrestre. Les bonus sans condition de mise sont proposés ponctuellement, offrant une liberté totale aux joueurs. Avec un tel niveau de service, cette plateforme a de quoi satisfaire les joueurs les plus exigeants.