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Live Webinar | Wednesday April 22, 8:30 pm IST | 11 am EST

Accelerating Timelines Through Integrated Drug Substance (DS) and Drug Product (DP) Development

Avoid late-stage surprises. Learn how parallel DS–DP development can recover 2–3 months of timeline and reduce CMC risk.

Register Now
Register Now

What you'll learn:

Traditional sequential development often locks in Drug Substance (DS) decisions long before Drug Product (DP) risks are understood. This leads to formulation failures, costly rework, and extended timelines.

In this webinar, you’ll discover how integrated DS–DP development enables faster, more predictable outcomes. Through a real-world case study, we’ll highlight how synchronized CMC workflows helped recover 2–3 months in development timelines while ensuring stronger product quality and regulatory readiness.

Key Topics Covered:

  • Hidden bottlenecks in traditional small-molecule development
  • Why DS specifications alone don’t guarantee DP success
  • Critical impact of solid-state form, particle attributes, and excipient compatibility
  • Aragen’s “Follow the Molecule” integrated DS–DP approach
  • Case study: Resolving dissolution variability, instability, and CU issues through cross-functional CMC integration
  • A 12-month integrated pathway from developability to regulatory submission
  • Particle engineering, formulation optimization, and QbD-aligned development strategies

Key Reasons To Attend:

  • Accelerate IND timelines by 2–3 months
  • Transform CMC risks into competitive advantages
  • Leverage end-to-end small-molecule capabilities under one roof

Your Speakers

Dr. Srinivasa Rao Madarapu
Dr. Srinivasa Rao Madarapu
Associate Vice President R&D, Chemical Development Solutions
in
Dr. Athappan Chidambaram
Dr. Athappan Chidambaram
Director R&D, Formulations Solutions
in
Sujatha Anand
Sujatha Anand
Project Manager D&M
in

Who Should Attend

  • CMC leads and program managers
  • Formulation and process development scientists
  • Early development, tech transfer, and regulatory teams
  • Biotech and pharma leaders driving small-molecule pipelines

Secure your spot today and learn how integrated DS–DP development accelerates your path to clinic.

Register Now

Frequently Asked Questions

Integrated DS–DP development is a synchronized approach where API development and formulation development progress in parallel rather than sequentially. This allows teams to evaluate solid-state properties, particle characteristics, and formulation compatibility early, reducing development risks and accelerating timelines.

Aragen’s “Follow the Molecule” approach connects discovery, drug substance development, drug product formulation, and manufacturing under one roof. This enables faster decision-making, better risk management, and streamlined progression from developability assessment to regulatory dossier preparation.

Participants will learn how an integrated DS–DP strategy helped resolve key formulation challenges, including dissolution variability, chemical instability, and content uniformity issues. The case study demonstrates how coordinated CMC execution enabled faster development timelines and improved product quality.

No problem! The session will be recorded so just fill out the form and we'll share the deck and recording afterwards via email.