Catalent

Articles

Cell-based assays (CBAs) are key tools for evaluating the potency of new biologic drugs.
Catalent’s transcription-based bioassay simplifies and empowers the testing of new biologics.

Best Practices, Strategies & Use of Novel Biological Responses for Robust Cell-Based Potency Assays

Harmonizing technological innovation and a platform approach in biomanufacturing can reduce
time and cost barriers to produce stable, high-expressing antibody-based therapeutics

A Streamlined Platform Process to Accelerate Biotherapeutics from Gene to Clinic

By integrating QbD into the development process, organizations can achieve robust manufacturing processes, regulatory compliance, and commercial success.

Quality by Design (QbD) for Biologics: A CDMO's Perspective

Become equipped to navigate preclinical and clinical stages of development for oral lipid-based formulations.

https://www.pharmtech.com/pt_w/lipid-based-formulations

Lipid-based formulations are more than just a tool for enhancing solubility and bioavailability - they are essential to navigating the complexities of preclinical and clinical development. Join our expert-led panel to explore innovative formulation strategies, the diverse mechanisms of action, preclinical and clinical considerations, as well as encapsulation techniques, and more.

Understand the multifaceted role of lipid-based formulations in early-stage drug development, extending beyond solubility and bioavailability.

Navigate the preclinical to clinical considerations to optimize the development of lipid-based formulations.

Explore innovative encapsulation techniques and their impact on drug stability and release profiles.

Senior vice presidents (SVPs), VPs, and Directors

Chemistry, manufacturing, and control (CMC)


Professor of Pharmacy
University of Southern Denmark

René Holm, is a pharmaceutical expert who received his training and PhD from the University of Copenhagen in 1998 and 2002, respectively. He previously worked with Lundbeck. Since 2016, he has worked with Janssen. Dr Holm has worked in various fields, including physical chemistry, material science, and pharmaceutical development. He has co-authored more than 200 original articles and is currently a professor in pharmaceutical physical chemistry at the University of Southern Denmark.




Senior Manager, Pharmaceutical Development
Catalent Beinheim

Guillaume Enderlin is senior manager of pharmaceutical development at the Catalent Beinheim site (France). He has worked for 12 years in softgel R&D, from formulation to manufacturing development process, building expertise to cover the whole Rx pharmaceutical development process. Guillaume is a pharmacist (PharmD) and has a Master’s degree in pharmaceutical engineering.




Professor, Molecular Pharmaceutics
Uppsala University Sweden

Christel Bergström is a professor of molecular pharmaceutics at Uppsala University, and is an adjunct professor at Monash University. She leads a research group on drug delivery for challenging compounds and has published over 100 articles. Bergström directs The Swedish Drug Delivery Center and plays key roles in the Nordic POP initiative. In 2019, she founded Enphasys AB, focusing on animal-free drug absorption models.




Professor, Drug Delivery Disposition & Dynamics
University of Copenhagen & Monash Institute of Pharmaceutical Sciences

Prof. Benjamin Boyd is a colloid and physical chemist with a PhD from the University of Melbourne. With industry experience in explosives and pharmaceuticals, he holds an academic position at Monash University and recently received a Novo Nordisk Laureate Research Fellowship at the University of Copenhagen. His research focuses on lipids, lipid self-assembly, and pharmaceutical systems, including synchrotron-based characterization. Prof. Boyd is also the President of the Controlled Release Society.




Senior Director of Scientific Advisory
Catalent

Lisa Caralli is the senior director of scientific advisory at Catalent, overseeing small molecule and peptide scientific support for North America. She has over 30 years of industry experience in pharmaceutical research and development, with a focus on early-phase approaches to the chemistry manufacturing and control of small molecules and peptides. Lisa has held previous product development positions at Ionis Pharmaceuticals, Amylin Pharmaceuticals, and the Immune Response Corporation. She holds a BS in biochemistry from the University of California at Davis.

Webcasts

Webinar Date/Time: Wed, Oct 16, 2024 11:00 AM EDT


Oral Lipid-Based Formulations: Unlocking Value in Early-Stage Pharmaceutical Development

Learn about a comprehensive strategy to streamline development and derisk clinical studies.

https://www.pharmtech.com/pt_w/dedicated-scientific-partner


To ensure a successful phase 1 clinical study, it is crucial to carefully plan and lay the essential groundwork for achieving key milestones. These milestones include achieving adequate 

 drug exposure in glucagon-like peptide (GLP) dose-escalation studies and determining the appropriate clinical dose range and dose forms for phase 1. Achieving these milestones while resolving technical challenges is the key to increasing the likelihood of a clinical trial's success and progress beyond phase 1.


In this webinar, participants will learn about a comprehensive strategy to streamline development and derisk clinical studies. Experts will focus on the importance of physiologically based pharmacokinetic (PBPK) modeling, formulation, and technology expertise while sparing API and managing funding and timeline challenges. Case studies on navigating these challenges will be shared, providing attendees with insights into the issues that arise across a wide range of challenging molecules in nearly every project. Join this webinar to learn how Catalent’s approach to early-phase drug development, with an emphasis on an accelerated timeline and enhanced developability assessment, can speed up phase 1 readiness and beyond.

Explore strategies to speed up phase 1 readiness with minimal resources (time, API, funding).

Understand how preformulation and PBPK modeling can optimize small molecule developability assessment.

Discover streamlined strategies for transitioning from GLP dose escalation to successful phase 1 trials.

Learn how Catalent has helped small biopharma companies mitigate early-stage risks and enhance clinical success.

Chemistry, manufacturing, and controls (CMC)


Senior Director of Scientific Advisory
Catalent

Lisa Caralli is senior director of scientific advisory at Catalent, overseeing small molecule and peptide scientific support for North America. She has over 30 years of industry experience in pharmaceutical research and development, with a focus on early-phase approaches to the chemistry manufacturing and control of small molecules and peptides. Caralli has held previous product development positions at Ionis Pharmaceuticals, Amylin Pharmaceuticals, and the Immune Response Corporation and holds a BS in biochemistry from the University of California, Davis.




Principal Scientist, Product Development
Catalent

Jesus Rosales is a principal scientist at Catalent San Diego. Rosales serves as a product development lead, focusing on early clinical development of small molecules for oral delivery (preclinical to phase 2). With over 8 years of experience in the pharmaceutical industry, Rosales specializes in early-stage drug product development with a particular focus on spray drying formulation development.




Director, Research and Development
Catalent Somerset

Hibreniguiss Terefe, PhD, is the director of research and development at Catalent Pharma Solutions in Somerset, New Jersey. Prior to this role, he served as the vice president of research and development at ExxPharma Therapeutics for 14 years and as the head of the department of pharmacy at the University of Asmara, Eritrea, for 9 years. Dr Terefe is a research and development specialist with more than 25 years of experience in the pharmaceutical industry and academia. His broad expertise spans drug product development, commercial manufacturing, and proficiency in CMC. His core areas of specialization include solubility enhancement, modified release of solid oral dosage forms, drug delivery systems development, and twin-screw extrusion processes. He has extensive experience in product development of new chemical entities, covering preclinical to phase 3 clinical development stages, utilizing innovative drug delivery technology platforms, including abbreviated new drug applications and 505(b)(2), employing both conventional and specialized pharmaceutical manufacturing technologies. Dr Terefe is a coinventor of 3 approved and 2 pending patents, along with 2 provisional patents. He has published in scientific and professional journals and authored a book chapter. He holds a PhD in pharmaceutical chemistry and a pharmacy degree from Westfälische Wilhelms-Universität Münster, Germany. Additionally, he was a Fulbright Visiting Scholar at the University of California, Berkeley.




Senior Manager and Head, Product Development
Catalent Beinheim

Guillaume Enderlin, PharmD, is senior manager of pharmaceutical development at the Catalent Beinheim site in France. He has worked for 12 years in softgel R&D, from formulation to manufacturing process development to building expertise to now covering the whole prescription pharmaceutical development. Enderlin holds a PharmD and has a master’s degree in pharmaceutical engineering.




Director, Scientific Services
Catalent Nottingham

Matt Ling, PhD, has over 20 years’ experience in the pharmaceutical industry, much of it gained in big pharma, with roles in analytical, formulation development, advanced drug delivery, and project leadership spanning all phases of discovery and development. He has a PhD in organic chemistry from the University of Nottingham. Dr Ling has a keen interest in the application of drug delivery technologies to address the challenges of modern pharmaceutical agents with experience in approaches to enhancing the bioavailability of poorly soluble drugs, developing nanomedicine technologies, and developing products for pediatric administration. He is a member of the Site Leadership Team at Catalent Nottingham.




Webinar Date/Time: Tue, Sep 24, 2024 11:00 AM EDT


Boosting Phase 1 Success: A Dedicated Scientific Partner, Accelerated Timelines & Minimal API

Lipid-based formulations (LBFs) and softgels can offer numerous advantages in terms of clinical and commercial potential. Integrating formulation and manufacturing to enhance drug solubility and market speed can help unlock these benefits. Learn more about:	