Accelerating Pharmaceutical Development: From Early CMC to Regulatory Submission

API and Drug Product Development Strategies from Early stage up to Market

Developing a new drug is a complex journey, with many potential pitfalls across both API and drug product development – including injectable and oral solid dosage forms. Join us to learn how to avoid common challenges, accelerate development timelines, and strengthen your development strategy and successful market launch with expert insights from a science-driven CDMO.

Key Take Aways

• Proactive approach for an effective medicine development
• De-risking pharmaceutical development across the CMC lifecycle
• An integrated approach from drug substance to product to accelerate development timelines 

Agenda

08:30 – 09:00 | Welcome, registration, mingling with coffee and croissant 

09:00 – 09:10 | Discover Siegfried 

09:10 – 10:00 | Small Molecule Drug Substance: From lab to launch – Accelerating the timeline in pharmaceutical development 

10:00 – 10:30 | Spray Drying as a Bridging Technology: From Early Development to Final Drug Product Design 

10:45 – 11:15 | Early-stage drug product CMC: accelerating entry into PI and PII (Injectables and Oral Solid Dosage forms) 

11:15 – 11:35 | Late-stage drug product CMC: de-risking the path to submission 

11:35 – 11:40 | Academy Event Wrap-up (Jean-Paul Hermet and Lydie Allain) 

11:40 – 12:30 | Lunch and mingling

Meet the Experts

• Stefan Randl, Chief Scientific Officer, Siegfried AG (Switzerland)
• Markus Weigandt, Global Head R&D, Drug Product, Siegfried AG (Switzerland)
• Rui Costa Da Silva, Senior Spray Drying Expert, Siegfried Barbera Del Valles (Spain)

About Siegfried

Siegfried about themselves: Siegfried is a globally leading outsourcing partner, providing tailor-made services that seamlessly integrate into the value chain of our customers. We offer contract development and manufacturing of APIs and finished dosage forms.

Founded in 1873 in Zofingen, Switzerland, today we operate a global network of 13 sites on three continents. Our workforce of more than 3,800 highly skilled professionals is committed to take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide.