Medicinal chemistry routes are designed for speed and diversity, but are often unsuitable for further scaleup to fulfil IND enabling studies and clinical trials. Many critical parameters including workup and isolation, salt and physical form selection, and even analytical development are frequently left too late, despite their direct impact on API quality, formulatability and security of supply. As a result, critical drug substance parameters are often locked before the downstream impacts are understood, creating hidden timeline creep. At scale, and under regulatory scrutiny, these issues quickly translate into costly delays that put first in human timelines at risk.
This webinar begins by introducing some of the main challenges when scaling up from a medicinal chemistry route for the first time, and the impact that they can have on timelines if not properly considered at the outset. The session will show how scientific expertise, combined with overlapping drug substance and formulation development, can identify risks earlier, reduce pauses, and prevent unnecessary rework.
We will explore a series of decision focused case studies, each examining a specific point where early development choices led to lost time downstream. Together, they illustrate some of the common pitfalls when scaling up from a medicinal chemistry route for the first time, how gaps in impurity understanding and regulatory strategy can trigger significant delays, and how early drug substance form decisions can directly constrain drug product development.
Attendees will leave with practical insights into common issues that arise when first scaling up from medchem. They will also gain clarity on the critical drug substance decisions that shape IND timelines, what data is truly needed early, and the right questions to ask before locking a route. We’ll close by showing how integrated teams enable better decisions—not just faster ones. Register now to learn how to identify risk earlier and keep your programme on track.
Key Learning Objectives
- Recognise common early‑development decisions that quietly delay IND and first‑in‑human timelines when programmes transition from medicinal chemistry to scale.
- Understand, through decision focused case studies, how impurity control, solid form behaviour, and drug substance choices influence GMP readiness, regulatory risk, and downstream drug product feasibility.
- Identify which drug substance decisions matter most early on, what data is truly needed at each stage, and how overlapping DS/DP development can reduce risk, rework, and recovery effort.
- Appreciate how CMC regulatory expectations shape development strategy—from impurity justification to submission readiness—and how earlier alignment supports smoother IND/IMPD filings.
