This workshop will focus on the key considerations for research projects at the preclinical-to-clinical translation phase, a critical barrier when translating fundamental scientific discoveries to improvements in human health.

During this interactive workshop, participants will work in small, pre-defined cross-disciplinary teams incorporating a mix of chemists, clinicians and bioscientists. Your team will assess a fictional in-licensing opportunity, as though you were carrying-out a due diligence assignment for a pharma company and you will be asked to feedback on your insights, observations and recommendations at the end of the session.

The exercise will require your collective knowledge and understanding of the preclinical-to-clinical translation phase and how best to manage risk during this phase in order to provide a considered and well-justified view on whether or not to invest in the opportunity presented to you.

Although the case itself is fictional, the data and technical information you will be reviewing are based on genuine clinical development compounds. While the asset under discussion will be a small molecule therapeutic, the learning from the workshop as well as the cross-disciplinary networks established during the event will benefit researchers working in all fields of drug discovery and devices.

Learning Objectives

• Develop working knowledge of aligned disciplines and their contribution to drug discovery projects.
• Establish cross-disciplinary networks and learn from your peers about the key considerations to support drug discovery research activities at the preclinical-to-clinical translation phase, future projects and grant-writing.
• Build knowledge and understanding of the interface between biomedical research, drug discovery and early clinical development.

Who is this course for?

Participants should be academic or clinical researchers employed by a University in receipt of a Wellcome Institutional Translational Partnership Award, or working for an associated NHS Foundation Trust. This course is generally not suitable for PhD students (see FAQs below).

Participants can be involved in drug discovery projects across all modalities including small molecules, antibodies, peptides/proteins, nucleotide and cell-based therapies. We also welcome researchers working in other areas of translation such as devices and development of biomarkers.

Schedule

10:00: Welcome

• Briefing from David and Team formation.

10:20: Teamwork Session

• Teams join their assigned breakout rooms to work together on the exercise with mentorship provided by David.

12:30: Presentation Prep

• Teams given time to finalise their presentations.

13:00 onwards: Presentation Slots

• One by one, each Team presents their findings to David for a 10-minute presentation (all other Teams can take breaks here until their assigned presentation slot).

~ 14:15: Feedback

• Everybody returns to the main room for feedback from David.

No later than 15:00: Close

About the Trainer

David Fox has been the Wellcome-funded Expert in Residence, working with the Translational Research Team, at the University of Birmingham since 2019.

David has over 18 years of experience in the pharmaceutical industry along with expertise in STEM education and training. He joined Pfizer in 1993 as a medicinal chemist Team Leader and was Senior Director heading up the Chemistry Section for 11 years, working across various therapeutic areas including antivirals and cardiovascular. He brings vast experience in drug discovery from early conception to preclinical evaluation having been involved in the identification of eleven development candidates, from eight mechanistic classes, including four Phase II compounds.

David is a Fellow of the Royal Society of Chemistry, where he introduced a series of precompetitive workshops to help drive increased cross-sector collaboration in pharmaceutical research. At the University of Birmingham he delivers drug discovery teaching modules for the School of Chemistry and is supporting the Birmingham Drug Discovery Hub with his expertise in translation and drug development.

FAQs

What is Due Diligence?

• Due diligence is the process of deciding if a new technology, drug or idea makes sense from a risk-benefit perspective – it is an essential step on a translational research pathway. It primarily involves detailed technical evaluation alongside assessment of risks and consideration of risk mitigation options.

What if I cannot attend the whole event?

• Spaces on this course are extremely limited and so we ask that you only sign up if you are sure you can attend. It is essential that each team has representation from multiple disciplines - attendees are split into small groups by David in advance. It is therefore imperative that attendees are fully committed to attend the full event.
• We understand that some attendees, particularly our clinical colleagues, may have unavoidable commitments arise on the day. As long as you are able to attend the briefing and are able to contribute work to your team presentation, you can drop in and out during the teamwork and presentation sessions.

I am a PhD student - can I register?

• This course is generally not suitable for PhD students. However, your registration will be considered if you are already a clinician / clinical fellow doing a PhD, or if you are involved in a project of a highly commercial nature (e.g. approaching licencing or being put forward for ICURe or something similar).