Molecule to Medicine
Managing the transition from discovery to development
Event overview
The aim of the course is to provide attendees with an understanding of the chemical development aspects of transitioning a candidate molecule from discovery into early clinical trials. The topics that will be covered include:
- Where the development candidates come from and how we transition from research into development.
- How to assess a medicinal chemistry route and make it fit for purpose for stage appropriate scale-up.
- Understanding raw material supply and costing, including technology transfer and outsourcing.
- How to scale processes safely and the importance of heat transfer, mixing and how to anticipate what can go wrong before scaling up.
- Impurities, cGMP and solid form as a framework for regulatory compliance.
- The importance of data rich experimentation, new technologies and future developments in process development.
The course will be delivered over four LIVE afternoon sessions, via an online platform. Dates and timings are as follows;
Monday, December 8th | 3.00pm – 6.30pm GMT
Tuesday, December 9th | 3.00pm – 6.30pm GMT
Wednesday, December 10th | 3.00pm – 6.30pm GMT
Thursday, December 11th | 3.00pm – 6.30pm GMT
Course Outline
Section 1: Introduction
Section 2: Where do the development candidates come from?
Section 3: Scale Up of the Discovery Route
Section 4: Pre-Clinical Development
Section 5: Enabling Route Development
Section 6: cGMP and regulatory issues
Section 7: Impurities
Section 8: Genotoxic Impurities
Section 9: Solid form
Section 10: Technology transfer and outsourcing
Section 11: Complex synthetic medicines
Section 12: Preparing for Commercial Manufacturing
Key Learning Opportunities
- How drugs are discovered and preclinical candidates selected
- The requirements and challenges involved in transitioning from discovery into early clinical development
- How to assess a discovery chemistry route and adapt for early scale-up
- Gain an understanding of outsourcing strategy, tech transfer, impurities, solid form, and regulatory aspects of chemical development
- A basic introduction into chemical process safety, mixing and stage appropriate scale-up
- An introduction to data rich experimentation, new technologies and future developments in process development
Who Should Attend
- Discovery/medicinal chemists who want to know more about the chemical development aspects of transitioning a candidate molecule from discovery into early clinical trials
- MedChem Scale-up support teams
- Early-stage process development chemists and engineers
- Business development individuals or teams who want to understand more about the role of chemical development in drug discovery and development
- Academics/students who want to further their knowledge in process chemistry and drug development
What's Included
The course fee includes:
- Link to watch all five live sessions
- Electronic version of the course slides*
- Course certificate
For this course, there will be no recordings available and *the e-reader slides are NOT printable or downloadable (due to copyright).
If you would prefer a hard copy of the manual, there is the opportunity of purchasing a professionally printed copy during the booking process.
Other Information
Special Offers
1st delegate fee = Full price
2nd delegate fee = 5% off
3rd delegate fee = 10% off
4 or more delegate fees = 15% off
For more information on offers, do give us a call on +44 (0) 1892 956 222
Certificate of Attendance
Upon completion of the course, participants can request a Certificate of Attendance.
Brochure
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