All projects are different, but a number of parameters are consistent in addition to the guidelines/requirements from ICH, FDA, EMA. Selected characteristics of Small Molecule development projects will be discussed.
Highlighting topics concerning:
- Management of risk and investment
- Optimization and adaptation of MedChem procedures towards manufacturing
- Sustainability
- Introduction of green(-er) chemistry
- Cost of waste management
- Selection and sourcing of raw materials
- Risk balancing of time versus cost
- Delivery stages, hard and soft deadlines
- Staging of the overall development-costs
When should each activity be initiated?
How to manage this?
Date: Wednesday 17th of January 2024
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
Program
| 08:30 | Networking, registration, and light breakfast |
| 09:00 | Welcome David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 09:05 | Company Introduction, Raybow Peter Halkjær-Knudsen, CEO of Raybow Europe, Head of Mergers and Acquisitions, Jiuzhou Pharmaceuticals |
| 09:20 | Selection of CDMO for your Project – When, Who and How? How to secure a smooth and efficient transfer of a small molecule from Research to Market Peter Halkjær-Knudsen, CEO of Raybow Europe, Head of Mergers and Acquisitions, Jiuzhou Pharmaceuticals |
| 10:00 | Q&A session |
| 10:15 | Networking |
| 11:00 | End of Good Morning Meeting |
Speaker
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Peter Halkjær-Knudsen, CEO of Raybow Europe, Head of Mergers and Acquisitions, Jiuzhou Pharmaceuticals A veteran of over 25 years in discovery and development. Peter graduated as organic chemist from University of Copenhagen and has been working most of his career inside corporations in USA, Switzerland, Sweden and China. He brings a deep understanding of the chemical development taking place from a target compound is identified to the point of filing an NDA. Lately Peter has also been engaged in establishing solutions for secure sourcing and on-time manufacturing & delivery. |
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