Free white paper: Strategic lead optimisation and selection for biotech teams

Accelerate your journey from discovery to first-in-human with a smarter, CMC-led approach to lead optimisation and selection.

Lead optimisation is where promising science either becomes a viable medicine or stalls. Complex modalities, tighter investor expectations and increasing regulatory scrutiny mean that traditional, “CMC-late” approaches are no longer enough.

This free white paper from 3Biotech shows you how to embed Chemistry, Manufacturing and Controls (CMC) thinking into your lead optimisation and selection strategy so you can move the right candidates forward with confidence.

Download the Guide

This guide is designed for teams working on small molecules and biologics, including:

• Founders and CEOs of early-stage biotechs who need a credible, investor-ready CMC plan.

• R&D and discovery leaders responsible for lead optimisation and portfolio decisions.

• CMC, technical development and process leads who want to be involved earlier in candidate selection.

• Translational and preclinical scientists planning the path from target validation to IND/IMPD.

If you’re preparing for Series A/B funding, partnering discussions or first-in-human trials, this paper will help you de-risk your programme and justify your decisions.

Why Download this White Paper?

Avoid costly late-stage surprises

Discover the three most common CMC pitfalls (late stability issues, unscalable synthesis routes and incomplete analytical packages) and how to prevent them during lead optimisation, not at the point of clinical supply.

Shorten time to IND or IMPD

See how early, parallel CMC development can compress timelines by up to 18 months by running formulation, analytical and process activities together instead of sequentially.

Make better, data-driven lead selection decisions

Learn how to link your Target Product Profile (TPP) to CQAs and developability criteria, so your final lead balances efficacy, safety and manufacturability, not just biology.

Build investor and regulator confidence

Understand how a robust, documented CMC strategy signals technical and organisational maturity to investors, while meeting evolving expectations from regulators such as EMA and FDA.

About 3Biotech

3Biotech is a specialist consultancy dedicated to accelerating drug development through expert CMC support and services, across small molecules, biologics and complex delivery systems. Services span risk assessment, lead optimisation and selection, CMC strategy, vendor and CDMO management, clinical batch oversight and regulatory submission support.

Our team acts as an extension of your organisation, providing the structure, expertise and bandwidth you need to move from promising science to first-in-human studies with confidence.