Smarter Early Decisions: De-Risking the Path from Candidate to Clinic

The session is particularly relevant for companies developing small molecules and peptide-based therapeutics facing developability and bioavailability challenges. It is designed for teams working in early-stage and translational development who need to make informed decisions from candidate selection through to Phase 1 across therapeutic areas such as oncology, CNS, inflammation, and metabolic diseases.

Early development decisions can determine whether a promising molecule successfully reaches the clinic – or faces costly delays, reformulation challenges, or clinical failure later in development.

This session will explore how early developability assessment, enabling formulation strategies, and PBPK modelling can support smarter decision-making across the transition from discovery to Phase 1, supported by selected case examples and real development scenarios

Three Takeaways

• Learn how developability assessment can identify drug development risks before they affect timelines, cost, or clinical success.
• Understand how Developability Classification System (DCS), solubility enhancement and formulation strategy support faster, more informed Phase 1 readiness.
• Discover how PBPK modelling and integrated in silico/in vivo data can guide candidate selection, bioavailability assessment and formulation decisions.

Speakers

• Stephen Tindal is the Director of Science and Technology at Catalent. His work is largely focused on preclinical to phase 1 development and is based on assessing preclinical data to help define any challenges to dosage form development. Tindal has more than 36 years’ experience at Catalent, where he has held roles of increasing responsibility and has demonstrated expertise in root cause investigation, technology innovation and supporting business development. He holds a bachelor’s degree in Chemistry and Analytical Science from Loughborough University, Loughborough, U.K.
• Jan Neelissen, PhD, serves as the associate director of DMPK advisory services. He has over 25 years of pharmaceutical industry experience in the field of DMPK. In his current role, he advises drug innovators in developing new therapeutics and designing tailored formulation, delivery, and manufacturing solutions. Neelissen is a trained biologist and holds a doctorate in pharmaceutical sciences from Leiden University.

Agenda

11:45-12:00 Registration & Lunch

12:00-12:20 Using PBPK Modelling to Guide Early Development Decisions

Jan Neelissen, Associate Director, DMPK Advisory Services, Catalent

12:20-12:40 Rational Drug Product Development Using Molecule Developability Insights

Stephen Tindal, Senior Director, Scientific Advisory, Oral Small Molecules, Europe, Catalent

12:40-13:00 Q&A

13.00 Discussions with coffee

About Catalent

Catalent about itself: Catalent Inc. is a leading global contract development and manufacturing organisation (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.