Transitioning an Oral Solid Dosage from Phase 1 to Phase 2 studies: Formulation challenges and strategies

Development timelines, formulation optimisation strategies and CDMO selection for transitioning oral solid dosage forms from Phase 1 to Phase 2.
Date
February 26th 2025
Time
3pm (GMT) / 10am (ET)
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About This Webinar.

Successfully transitioning oral solid dosage (OSD) forms from Phase 1 to Phase 2 clinical studies requires a comprehensive understanding of the challenges and strategies involved.

This webinar offers comprehensive insights into overcoming formulation hurdles and effectively preparing for the transition to Phase 2 clinical studies. Designed to address the critical challenges associated with oral solid dosage (OSD) development, it provides a thorough understanding of the strategies needed to advance drug products successfully through the clinical pipeline.

 

Dr. Ian Lafferty will explore practical approaches and proven techniques for refining formulations, managing Phase 1 outcomes, and optimizing development timelines. Real-world examples bring clarity to these complex processes, enabling you to navigate common obstacles with confidence.

 

Whether you’re refining an OSD formulation or preparing for regulatory milestones, this webinar highlights the key factors influencing clinical success. Gain actionable solutions to streamline your development process, minimize risks, and ensure your drug product is poised for progression into the next clinical phase.

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Built Around the
Challenges You Face.

Addressed Challenges
Navigating pharmacokinetic and pharmacodynamic outcomes from a Phase 1 clinical study and determining the right development response to the data. 
Addressing formulation challenges that arise from Phase 1 sub-optimal data without compromising clinical timelines or development programme integrity. 
Executing the steps required to transition from a phase-appropriate simple formulation to a conventional oral solid dosage form for Phase 2. 
WHAT YOU WILL LEARN
Understand the development timelines and strategic considerations for transitioning an OSD programme into a Phase 2 clinical study successfully. 
Learn proven formulation optimisation strategies for oral solid dosage forms that support progression through the clinical development pipeline. 
Understand what to look for when engaging a CDMO for Phase 1 to Phase 2 OSD transition, including capability, experience, and technical fit. 
Upperton webinar

Dr. Ian Lafferty

Chief Technical Officer, Upperton

Ian has 25 years’ technical, operational experience gained in early phase pharmaceutical development, encompassing the formulation design and development, process optimisation and manufacture of a wide range of dosage forms including oral solids, nasal drug delivery, inhaled powders, suspensions and injectables with a focus on challenging molecules, enabling technologies and high potent handling. Ian also has significant experience in facility design and management. Ian has previously held senior management and executive roles at a number of emerging and growing CDMOs, providing strategic and operational leadership to ensure excellence in all aspects of providing pharmaceutical services.

Meet the Speaker.

Free to attend.
Limited places.

February 26th 2025

3pm (GMT) / 10am (ET)

Reserve Your Seat

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