Lonza

This webinar focuses on dose-flexible manufacturing strategies and their role in drug development.

https://www.pharmtech.com/pt_w/flexible-dose-development


This webinar focuses on dose-flexible manufacturing strategies and their role in drug development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized early in development. This presentation will focus on technical strategies that can help anticipate appropriate timing for implementation and how to do so cost effectively while adhering to required timelines.

Learn about appropriateness for multiple doses or dose flexibility to enable optimal clinical strategies.

Find out how to select the best various drug delivery and manufacturing technologies to achieve the required dose flexibility.

Discover how risk assessment strategies can be put in place when determining the best technology option for a dose-flexible approach.

Pediatric, Oncology and patient-focused innovators


Head of Multiparticulate Product Development
Lonza

Jonathan Cape, is Head of Multiparticulate Product Development at Lonza, where he has worked for 13 years in roles ranging from R&D to chemist, to technology manager. Jon earned his PhD in Biochemistry from Washington State University and has held postdoctoral positions at Washington State University and Los Alamos National Laboratory. Jon currently manages Lonza's Multiparticulate Product Development team and is focused on developing impactful patient-centric drug products.




Product Development Engineer III
Lonza

Kaylee Eyerly is a Product Development Engineer at Lonza. She has six years of experience in the pharmaceutical industry. She holds a Honors BSc in Chemical Engineering from Oregon State University. She has experience in formulation, process development, and manufacturing in every clinical stage, with specific expertise in late-stage programs, primarily specializing in multiparticulates and spray layered dispersions.




Webcasts

Webinar Date/Time: Tue, Aug 27, 2024 | 11:00 AM EDT | 4:00 PM BST


Flexible-Dose Development Strategies for Today's Clinical Landscape

Articles

Case Study: Early Solid Form Screening

Leveraging Advanced Analytical Tools to De-risk Pharmaceutical Development

Bioavailability Enhancement Technologies

Accelerating Small Molecule Advancements: The Power of Collaboration Between CDMOs and Biotechs (June 2024)

This webinar highlights Lonza’s commercial capabilities for creating amorphous solid dispersions using spray drying and informs on using a risk-based approach to support process qualification. How can it reduce risk, minimize material use during development, and help create robust processes ready for scale up? Register and learn more!

https://www.pharmtech.com/pt_w/spray-dried-dispersions

This webinar presents the commercial capabilities of the Lonza Small Molecules network and highlights a risk-based approach to support process qualification for amorphous solid dispersions made by spray drying. The speakers will discuss how process design and qualification fit into the process validation strategy, including how small-scale experiments can minimize drug substance usage and reduce risk to the process qualification stage. Elements of product design will be covered, including how taking a risk-based approach can help create robust processes with built-in manufacturing flexibility. Case studies will be presented to demonstrate in-process hold times at full scale.

Understand the commercial capabilities of Lonza Small Molecules.

Identify key attributes of SDD formulations and learn how they are made.

Learn how small-scale experiments can inform process qualification to reduce risk and material usage.


Principal Investigator, Associate Director CMC
Lonza Small Molecules

Dory King has worked at Lonza since 2002 in various roles supporting product development and GMP operations. She is an expert in modified release technologies, including osmotic tablet formulation, and bioavailability enhancement, and has a keen interest in process development, control strategies, and scale-up. Dory has led product development activities across many stages of the product lifecycle, from initial formulation selection through commercial filing, collaborating with a wide variety of pharmaceutical clients—from small university-based groups to teams within large pharmaceutical companies. Dory received a Bachelor of Science degree in chemical engineering from Cornell University.




Director, MSAT
Lonza Small Molecules

Robert Hall is director of Manufacturing Science and Technology (MSAT) at Lonza Small Molecules in Bend, Oregon. He has held positions within product development and manufacturing during his 12 years with the site, advancing products across the drug product lifecycle. As director of MSAT, he is focused on late-stage process development and commercialization of new chemical entities across multiple technologies at the Bend GMP manufacturing facility. Robert holds degrees in chemical engineering (University of Texas) and biological engineering (Oregon State University).


Webinar Date/Time: Thu, Jun 20, 2024 11:00 AM EDT
