About our CMC Webinar on API Development:

This webinar covers the path from small molecule candidate selection to First-in-Human (FIH) clinical studies. Strategic API development can compress overall timelines. As drug candidates grow more complex and clinical entry timelines shrink, early planning for API quantity, quality and supply has never been more critical.

The webinar outlines best practices for building a reliable supply route. It covers how to optimize synthetic processes and choose the right regulatory starting materials for efficient GMP production. Solid form and material science are also addressed. This includes polymorph and salt screening, solid form selection and stability assessment. These factors directly affect downstream formulation and manufacturability. Attendees will also learn about phase-appropriate analytical strategy, specification setting and regulatory considerations. All of these are essential to delivering high-quality API for FIH studies.

Key highlights:

API material supply can be rate-limiting to downstream activities. Sourcing strategies in development campaigns should take that into account.
CMC investment, batch strategy and logistics are defined by decisions made early on around regulatory starting materials and paths to GMP production.
Selecting the right API solid form requires careful screening. This process uncovers the physical attributes that matter most, such as stability, solubility and particle size. Those attributes connect directly to how the drug substance is made and tested. They also drive key considerations for the final drug product.
Planning for impurity coverage helps to ensure analytical methods are appropriate. This sets phase-appropriate specifications reduces risk and supports drug substance testing and release.
Understanding the evolving regulatory landscape is crucial to guide expectations for non‑mutagenic impurities, PMIs, and nitrosamines. This ensures a strong, compliant data package for clinical progression.

Meet our Speakers

Speakers:

Aaron Dumas – Senior Director, Process Chemistry at Pharmaron

Aaron Dumas is Senior Director, Process Chemistry at Pharmaron UK. In that role, he leads a team of chemists performing small molecule API development and manufacture supporting early phase clinical supply. He is also a departmental SME for mutagenic impurity and nitrosamine risk assessment. Aaron has nearly 14 years’ experience as a process chemist, joining Pharmaron in 2017 after being at MSD for 5 years before that. He is an author or inventor on more than 20 publications and patents. He earned his PhD in Organic Chemistry at the University of Waterloo, Canada, then completed postdoctoral training at the ETH Zurich, Switzerland.

Brett Cooper – Senior Director, Analytical and Material Science at Pharmaron

Brett Cooper is Senior Director of Analytical Chemistry at Pharmaron UK. He is a senior scientific leader with more than 25 years of experience in analytical chemistry, preformulation, and pharmaceutical development. He currently leads multidisciplinary teams supporting Process Chemistry, GMP analytical development, ICH stability programs, structural elucidation, and materials science activities including salt and polymorph screening, crystallisation development, and broader preformulation assessments. Before moving into senior leadership at Pharmaron, Brett held roles of increasing responsibility at Merck, PAION, and AstraZeneca, covering analytical sciences, preformulation, CMC development, early product development, and formulation strategy. He also served as Honorary Secretary of the Joint Pharmaceutical Analysis Group (JPAG) and previously held committee roles within the Industrial Group of the British Crystallographic Association.

Moderated by:

Peter Shapland – Senior Director, Drug Substance Commercialisation at Pharmaron

Peter Shapland, PhD, is Senior Director of Drug Substance Commercialisation at Pharmaron UK, where he leads late phase and commercial API programmes for small molecule therapeutics. With more than two decades of experience in API process development and CMC delivery, he specialises in technical project leadership, control strategy definition, and complex technology transfers to manufacturing sites. Before joining Pharmaron, Peter spent over 20 years at GSK in roles spanning chemical development, formulation analysis, and scientific leadership. He has extensive experience engaging with global regulatory agencies, including the FDA, EMA, and PMDA, and has presented advanced control strategies supporting continuous manufacturing. Peter holds a PhD in organic chemistry from the University of Manchester, has authored 19 peer reviewed publications and two patents, and is recognised for his collaborative leadership and strong scientific expertise.