Lonza

https://www.pharmtech.com/pt_w/gemcitabine

Respiratory drug delivery relies heavily on particle engineering to control delivery of pharmaceuticals to target tissues. Process selection becomes even more crucial when supporting novel formulation approaches to drug delivery to the lungs. The speakers Bryce Beverlin II (Quench Medical) and Maureen Kadleck (Lonza Small Molecules) will use the case study of an Excipient Enhanced Growth for gemcitabine as an inhaled lung cancer treatment to illustrate a pathway from feasibility studies through scale-up to commercialization. There will be an emphasis on process design choices using traditional particle engineering approaches, and the new process capabilities needed to achieve the desired target product profile.

Gain an understanding of the excipient enhanced growth platform

Find out more about spray drying scale-up and lifecycle

-Anyone interested in learning about the excipient enhanced growth platform or spray drying scale-up

For any questions please contact Jordan Ramesh: jramesh@mjhlifesciences.com


Product Development Engineer and Project Lead
Lonza

Maureen is part of the Inhalation Technology Product Development Team at Lonza and has spent her four years with the company focusing on late-stage clinical projects, readying them for registration and process validation. She has taken projects through successful scale up and risk assessment processes across multiple platforms, including spray drying, encapsulation, twin-screw extrusion and fluid bed coating. Most recently, she has been focused on inhalation formulation development for small molecules and biologics.

Prior to joining Lonza, Maureen spent seven years with the Dow Chemical Company, where she held manufacturing and improvement engineering roles supporting multistep synthesis and purification processes. During her time with the company, she supported multi-million dollar capital expansion projects, earned a Six Sigma Green Belt, and chaired the young engineers network at the site. Maureen earned a chemical engineering degree from Northwestern University.

Bryce Beverlin II, PhD, founded Quench Medical to solve crucial problems in respiratory drug delivery for treating lung diseases. As CEO of Quench Medical, he is driven by a passion to help patients with lung diseases by developing the next generation of highly performing inhaled treatments. Bryce is a physicist entrepreneur with 15 years of cross-functional R&D experience, postdoctoral commercialization training at the University of Minnesota's Medical Devices Center, biomedical engineering training, and a physics PhD from the University of Minnesota.

Webcasts

Tuesday, June 14th, 2022 at 7:30am PDT | 9:30am CDT | 10:30am EDT

Join Lonza and Quench Medical in a joint discussion about process engineering for the respiratory delivery of gemcitabine to treat lung cancer

Respiratory Delivery of Gemcitabine for the Treatment of Lung Cancer

https://www.pharmtech.com/pt_w/absorbable

Compounds that are poorly soluble in water are still prevalent in the pharmaceutical industry drug development pipeline. Enabling technologies such as lipid-based formulations (LBF) and amorphous solid dispersions (ASDs) can address these bioavailability limitations, enabling the creation of effective drug products. Capsule-based dosage forms are ideal in these circumstances. Depending on the type of capsule shell selected, they can be filled with a liquid LBF, they can ensure the long-term stability of ASDs, and even promote 

 prolonged drug absorption. Lonza Capsule Applications Services lab offers ways to address drug solubility limitations, develop innovative capsules to tailor drug delivery, and optimize encapsulation processes.

Find out about the classification, main attributes and the available encapsulation technologies for lipid-based formulations;

Learn the main attributes of amorphous solid dispersions, and how capsules can increase their efficiency;

Discover the new Lonza Capsule Applications Services lab that offers ways to address drug solubility limitations, and speed up formulation and encapsulation process development.

Scientist, Senior Scientist, Principal Scientist

Preformulation, Formulation, Engineering, Drug Delivery


Head of Capsule Applications Services
Lonza Capsules & Health Ingredients

Dr. Vincent Jannin is Head of Capsule Applications Services at Lonza CHI. Previously, he held diverse positions up to Research Director at Gattefossé and was lecturer at Lyon University.

Vincent earned his Pharm.D. and Ph.D. in Pharmaceutical Technology from the University of Bourgogne, and received his habilitation (HDR) from the University of Lyon. Vincent has published more than 140 peer-reviewed papers and given more than 60 lectures on Drug Delivery Systems.


Senior Fellow, Global R&D
Lonza Small Molecules


David Lyon serves as a Senior Fellow, Global R&D, at Lonza’s site in Bend, Oregon, USA, where he advises on internal and external collaborations for bioavailability enhancement technologies, modified release, and bioprocessing. David joined Bend Research as a Research Chemist in 1991. During his tenure at Bend Research, he held positions of increasing responsibility, leading numerous large-scale research programs and ultimately being named Senior Vice President, Research prior to the company’s acquisition by Capsugel and, subsequently, Lonza. His areas of expertise include extensive work with amorphous solid dispersions for bioavailability enhancement of active compounds with low aqueous solubility, as well as the development of modified release formulations and bioprocesses. David received his Bachelor of Science degree in Chemistry from Western Washington University and his Ph.D. in Inorganic Chemistry from the University of Oregon. Subsequently, he completed postdoctoral work at the California Institute of Technology.

Wednesday March 2, 2022 at 11am EST | 4pm GMT | 5pm CET
Compounds that are poorly soluble in water are still prevalent in the pharmaceutical industry drug development pipeline. Enabling technologies such as lipid-based formulations (LBF) and amorphous solid dispersions (ASDs) can address these bioavailability limitations, enabling the creation of effective drug products. 

Capsule formulations to improve delivery of poorly absorbable drugs

https://www.pharmtech.com/pt_w/solubility

Molecules with solubility challenges continue to dominate drug development pipelines, increasing the demand for formulation technologies that can solve these issues. Amorphous solid dispersions is one such technology that offers many benefits when addressing solubility challenges. Spray drying, in particular, allows for simple, scalable systems to be quickly developed, and ultimately provides drug products for clinical evaluation faster.

However, technologies such as spray drying cannot be successful in isolation. Development programs must be constructed in a way to advance these challenging molecules rapidly to the next milestone whilst keeping an eye on the downstream process development and commercialization. By leveraging an integrated approach, drug developers can rapidly screen formulation technologies and dosage forms in as early as the preclinical stage, using biorelevant in-vitro screening tools and physiologically based in-silico models to flag developability problems. This approach is essential before quickly transitioning drug candidates into clinical studies to understand a molecule’s full potential, with the ultimate goal of getting treatments to patients faster.

Join CMC Consultant, Peter Timmins, Lonza’s Sr. Research Fellow, David Lyon, and Quotient Sciences’ CSO, Peter Scholes, as they outline how a variety of data-driven strategies and integrated program designs can simplify development processes and reduce costs. Using expert insight and case studies they will showcase how spray drying can solve solubility challenges, and demonstrate how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines.


The drug delivery challenges presented by poor solubility

A review of formulation and manufacturing technologies to improve solubilization

How pharmaceutical spray drying can overcome poor drug solubility

The benefits of integrating drug substance to drug product manufacturing

In vitro tools and in silico methods to select SDD formulations

Choosing the right formulation for preclinical studies and dosage forms for First-in-Human (FIH) studies

The benefits of integrating GMP manufacturing and clinical testing to drive development efficiency

Optimizing and validating SDD drug product performance based on clinical data

How Quotient and Lonza can work together to deliver an integrated program


Chief Scientific Officer
Quotient Sciences

Dr Peter Scholes is the Chief Scientific Officer at Quotient Sciences. Peter has over 25 years’ experience in the pharmaceutical industry. In his role at Quotient, he has been instrumental in identifying and implementing the innovative and flexible benefits of integrating pharmaceutical development and clinical testing in early research. He is responsible for Quotient’s scientific strategy, to identify new technologies, capabilities, and services to accelerate the development of medicines for patients. Peter has served as a committee member for the UK Controlled Release Society and APS Biopharmaceutics focus group and in 2013 set up a GastroPlus™ user group with industry colleagues as a discussion forum for PBPK modelling and simulation science. In 2010, Peter was named one of PharmaVOICE’s 100 most inspiring people in the life-sciences industry. He was appointed as an Honorary Professor in Pharmaceutical Sciences at Nottingham University in August 2015 and also serves as a trustee and board member for the Nottingham Festival of Science and Curiosity.


Senior Fellow, Global R&D
Lonza, Small molecules

David Lyon serves as a Senior Fellow, Global R&D, at Lonza’s site in Bend, Oregon, USA, where he advises on internal and external collaborations for bioavailability enhancement technologies, modified release, and bioprocessing. David joined Bend Research as a Research Chemist in 1991. During his tenure at Bend Research, he held positions of increasing responsibility, leading numerous large-scale research programs and ultimately being named Senior Vice President, Research prior to the company’s acquisition by Capsugel and, subsequently, Lonza. His areas of expertise include extensive work with amorphous solid dispersions for bioavailability enhancement of active compounds with low aqueous solubility, as well as the development of modified release formulations and bioprocesses. David received his Bachelor of Science degree in Chemistry from Western Washington University and his Ph.D. in Inorganic Chemistry from the University of Oregon. Subsequently, he completed postdoctoral work at the California Institute of Technology.

Peter Timmins is a drug product design and development consultant based in the North West of England with several decades of experience in the research-based pharmaceutical industry, where his most recent role was Executive Director, Drug Product Science and Technology with Bristol Myers Squibb. Additional to his current consulting activities, where he is supporting clients with compounds at all stages of development, he is also a Visiting Professor in the Department of Pharmacy at the University of Huddersfield, contributing to teaching and research, as well as an Honorary Professor in the School of Pharmacy at the University of Nottingham. Although experienced and knowledgeable in small molecule formulation across all dosage form types, Peter’s particular areas of expertise include the formulation of amorphous dispersion intended to provide bioavailability enhancement, and the design, characterization, and development of modified-release products. Peter has a Batchelor of Pharmacy degree and a PhD in natural products chemistry, both from the University of Bradford.

Wednesday, February 23rd 2022 at 11am EST | 5pm CET

On demand available after final airing until February 23, 2023.

Wednesday, February 23rd 2022 at 11am EST | 5pm CET | Molecules with solubility challenges continue to dominate drug development pipelines, increasing the demand for formulation technologies that can solve these issues.  Join CMC Consultant, Peter Timmins, Lonza’s Sr. Research Fellow, David Lyon, and Quotient Sciences’ CSO, Peter Scholes, as they outline how a variety of data-driven strategies and integrated program designs can simplify development processes and reduce costs. Using expert insight and case studies they will showcase how spray drying can solve solubility challenges, and demonstrate how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines.  



Improving Solubility and Accelerating Drug Development through Integrated Programs

What are some effective strategies for compressing development timelines and derisking the process along the way? The PharmTech-Lonza Tech Talks Series on Integrated Services includes a 12-minute discussion of integrated drug substance form selection and optimization to drug product with Michael Grass, PhD, head of solid form services at Lonza.

Videos

From Drug Substance to Drug Product: Integrated Solid Form Selection

In this 15-minute talk, David K. Lyon, PhD, Senior Fellow of Research, Lonza, discusses a flexible, integrated model supporting over 600 small molecule therapies.

Integrated Early Phase to Commercial Drug Substance to Drug Product

In this Lonza Tech Talks: Streamining Pharmaceutical Development and Manufacturing with Integrated Services series, Jason Riggs talks about particle engineering through micronization as developers move from the clinic and into development.

Lonza

Articles