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

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

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

Event Overview:

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 in vivo 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.

Key learning Objectives:

• 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.

Who Should Attend:

• C-suite
• Research and development (R&D)
• Product development
• Chemistry, manufacturing, and controls (CMC)
• Consultants
• Scientists
• Incubators

Speakers:

Lisa Caralli
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.

Jesus Rosales
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.

Hibreniguiss Terefe, PhD
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.

Guillaume Enderlin, PharmD
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.

Matt Ling, PhD
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.

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