White Paper: Transitioning Your Product From Phase 1 To Phase 2 Clinical Studies: How A CDMO Can Help

Completing a Phase 1 clinical study is a major milestone for your development program and there are multiple considerations for the team depending on the drug product used in the study and the clinical outcome.

It is a common approach to adopt a Phase 1 appropriate formulation for the clinical study (e.g. Powder in Bottle, Solution / Suspension) to allow dose flexibility and accelerate the generation of early clinical data, however, this dosage form may not be suitable for Phase 2 clinical studies due to;

• Dosage form does not align with patient needs (e.g. reconstitution requirements)
• Storage or shelf-life of dosage form does not meet requirements of the study (e.g. refrigerated storage)

In most cases, a more conventional oral dosage form (tablet, capsule) is required for the Phase 2 clinical study to move towards the intended commercial format, however, maintaining unit dose flexibility as the development and clinical program progresses through the next stages is critical.

This guide explores how a partnership with a CDMO can help to define and implement the best pathways and key considerations including:

• Potential outcomes from a Phase 1 study
• Pharmacokinetic (PK) Profile
• Pharmacodynamic (PD) Effects
• Dose-Response Relationship
• Identifying the next steps in transitioning solid oral dosage forms to Phase 2.
• Process scale-up
• Formulation optimization
• Transition to formulated solid oral dosage form with equivalent in-vitro performance to Phase 1 formulation
• Dosage form development which includes addressing the formulation challenge
• Tablet development timeline