Faster to Clinic with Lower Risk: Smarter Early Decisions in Oral Drug Development

Developability and Pharmacokinetic Insights

Early formulation decisions can shape the speed, cost, and success of oral small molecule development. This session explores how molecule developability assessment, enabling formulations, and PBPK modelling can help teams reduce risk and make stronger decisions from discovery to Phase 1.

Three Takeaways

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

Speakers

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

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, Associate Director, DMPK Advisory Services, Catalent.

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.