Molecule to Medicine

Managing the transition from discovery to development

Date: 26 February - 27 February 2024

Location: Nice, France

Tutors: Dr John Studley

The aim of this course is to provide attendees with a good basis to work from when involved in taking development candidates to the first in human trials with a view also on some longer-term requirements.  The course content will therefore focus on the necessary early phases of chemical development as  would typically be required to support production of up to about 2kg using laboratory-based 20L equipment and pilot plant equipment. The course will  introduce and discuss the following:

> Requirements in order to move from small (<1g) supplies to the first 100g or so for preclinical work
> Further scaling to 1-2kgs non-cGMP
> Requirements to make material for use in clinical trial – an introduction to cGMP coupled with the scaling issues
> An overview of the requirements to move processes to fixed vessels, assuming cGMP is required – what operations can readily be transferred and those that should ideally be developed out
> The importance of physical form selection, understanding and control
> Impurities and their control, with specific discussion on genotoxic impurities and developing the specification for the API as it moves from preclinical  batch preparation to cGMP batches for clinical trials.

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Course Outline

Session 1:
Introduction to typical pharmaceutical development activities and timeframes for toxicological studies. Explore the interface between discovery chemistry and development- what can we learn from each other? Key interactions between medicinal chemists and process chemists. Discuss how rapidly we can we move a molecule into phase 1, the planning required to expedite the process and staying on top of compound supply.  Communication, working with other
disciplines and managing expectations.  How to plan for the unexpected. Contingency planning and redundancy in material supply.

Session 2:
Making the first 100g non-GMP batch for GLP toxicological studies; discussion of topics such as setting the specification, the use of chromatography,  accessing starting materials, identifying how much development to do.

Session 3:
Non-GMP vs GMP preparation. A brief introduction to GMPs and how they impact on the initial chemistry scaling exercise.

Session 4:
Physical version and form, spending time on the importance of salt selection, especially in the early phases of development with form/polymorph considerations also being discussed. There will be a brief introduction of polymorphism and which aspects of physical form should ideally be established at the early phase of development.

Session 5:
Process safety and raw materials supply issues and how these might impact on the chosen route.

Session 6:
Review of the day and questions.

Session 7:
Scaling into fixed vessels with discussions about those operations that transfer well and those which typically do not.

Session 8:
Technology transfer and a discussion of the issues and suggestions to mitigate against them.

Session 9:
A presentation about genotxoic impurities – what are they, what are the suggested control levels, how well do chemists identify them?

Session 10:
A presentation about impurities, including their identification, isolation/ preparation and control with discussions about setting specifications.

Session 11:
The final session of the course will review the two days and follow-up on any questions.

Case Studies and Problem sessions will also be included and audience participation is encouraged throughout the course.


Key Learning Opportunities

  • How long does it take to get from milligrams to 1-2kgs suitable for human clinical trials?
  • What are the main hurdles?
  • What can be left out and what must be included?
  • What are the key and strategic Project managers and those
    involved in technical outsourcing

Who Should Attend

  • Project managers and those involved in technical outsourcing
  • Project leaders and bench chemists involved in preparation of material
  • New starters to the area
  • Medicinal Chemistry support teams involved in making the first batches for toxicological evaluation

What's Included

The course fee includes:

  • comprehensive course manual
  • coffee/tea refreshments breaks throughout each day
  • buffet lunch each day
  • course dinner on the first evening
  • course certificate


I am not a chemist, however, the course was very informative and it allowed me to see the big picture from discovery stage to pilot plant.

Genentech Delegate

Molecule to medicine

Very good overview of the whole CMC process with excellent examples of what should/should not be done

Molecule to Medicine

I definitely enjoyed and learned a lot about the content presented. It was very detailed and technical and the lecturers were passionate about the topics presented

Molecule to Medicine

I wish i took this 10years ago, it would have saved me a lot of trouble learning much of this through painful trial and error experiences.

Molecule to Medicine

Overall, I thought the course was run exceptionally well. Even though there was a lot of material to cover I thought both instructors were knowledgeable in their respective sections and presented the material well.

Molecule to Medicine

The lecturers were knowledgeable and engaging with the audience. I greatly appreciated the time that they spent teaching this course. I learned a lot from this experience


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Molecule to Medicine

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Molecule to Medicine

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