Small Molecules Bites & Insights
Unlocking Solutions to Early Phase Drug Development Challenges
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Date:
Tuesday, 10 September 2024
Time:
9:30am - 12:30pm
Location:
Macclesfield SK10 4TG
United Kingdom
- Gain valuable knowledge from experts in the field
- Learn actionable methods to streamline your development process
- Connect with peers over a complimentary lunch, expanding your professional network
Don't miss out on this chance to advance your understanding and enhance your approach to early phase drug development. Register now to secure your spot and take the first step towards overcoming your development hurdles.
Learn more about our expert sessions
Christof Aellig
Principal Chemist, R&D
Lonza Small Molecules
Early-Phase Process Development and Manufacturing in Continuous-Flow
The route of synthesis complexity of small molecule APIs is increasing, leading to longer syntheses that challenge timely clinical readiness. In order to shorten early phase development and manufacturing timelines the use of continuous flow is a valid option to reduce time to market significantly.
In this presentation, we will discuss why the use of continuous flow in many cases leads to shorter development timelines and more efficient and sustainable production processes. We will share insights on the positive impact of this technology on CAPEX and production costs using Lonza’s highly flexible, modular production concept.
Learn more about our expert speaker
After receiving his M.Sc. in Chemical- and Bioengineering from ETH Zurich (Switzerland, 2009), Christof Aellig obtained a Ph.D. under the supervision of Prof. Dr. Ive Hermans. His thesis focused on selective aerobic alcohol oxidations mediated by nitric acid. After a post-doc with Prof. Dr. Ive Hermans and Prof. Dr. Javier Pérez-Ramírez at ETH Zurich, Christof Aellig joined Lonza AG Visp in 2015.
At Lonza Visp his work focuses on electrochemistry and microreactor technology for the continuous manufacturing of pharmaceutical compounds. In this position, he is taking over several roles as project leader, process chemist and technical project manager for different tech transfer projects to small- and midscale productions.
Casey Jager
Associate Director Technical Sales
Lonza Small Molecules
Amorphous Solid Dispersions for Bioavailability Enhancement: Leveraging in silico Assessment and Material-sparing Development for Rapid Progression to First-in-human Supplies
A significant majority of new chemical entities (NCEs) in pharmaceutical pipelines have poor aqueous solubility, thereby limiting oral bioavailability and hindering their progression as therapies for patients. Creating amorphous solid dispersions (ASDs) can often be a successful method to improve bioperformance through increased solubility. As NCEs become ever more insoluble, in tandem with the need for speed to clinic, it is imperative to select the most appropriate solid form at an early stage.
Lonza considers the unique physicochemical properties of each NCE, along with the desired target product profile (TPP), to guide selection of the solid form and formulation that will set the right trajectory for success in clinic. With over two decades of experience in ASDs and continued advancements made by our in-house R&D, Lonza uses in vitro tools coupled with physiologically based pharmacokinetic (PBPK) modeling to understand potential barriers to absorption. We then use material-sparing and model-based approaches to advance the development of ASD drug product intermediates and final dosage forms. Utilizing a risk assessment and phase-appropriate approach enables us to develop formulations for first-in-human studies. Our dedicated early phase clinical manufacturing facility enables fast-to-clinic supplies through a combination of ASD expertise, equipment parity with development, and early-phase appropriate GMP procedures.
Learn more about our expert speaker
Casey Jager currently works in Technical Sales at the Lonza site in Bend, OR, USA where he leverages his comprehensive knowledge to support customers with their projects, focusing on Bioavailability Enhancement and Inhaled solutions. Acting as a technical consultant, Casey engages in detailed discussions to identify problem statements, develop innovative strategies, and define programs that guide compounds successfully through the development process to commercialization.
With a Master’s degree in Chemistry from the University of Oregon, Casey has built a 22-year career characterized by deep expertise in various technical roles starting at Bend Research, until the site was acquired by Lonza. His extensive experience spans numerous aspects of the pharmaceutical development process. Starting as a lab bench chemist, Casey honed his technical skills in the laboratory. Over the years, he transitioned into increasingly complex roles. Casey’s expertise covers the entire spectrum from pre-clinical to commercialization, ensuring that compounds are effectively and efficiently brought to market.
