A Patient First Approach to Translational Safety.
From Nonclinical to Clinical
Following the success of last year’s Drug Safety Forum, ApconiX has organised Drug Safety Forum 2024, a free to attend, one day symposium on translational safety at the Wellcome Collection, 183 Euston Road, London, on the 17th of October 2024.
For this ambitious topic, we bring together a diverse array of industry toxicologists, patient safety/pharmacovigilance physicians and regulators to deliver a broad scope of critical and thought-provoking presentations. Speakers include friends and colleagues from AstraZeneca, Explic8, Lhasa, ImmunONE and ApconiX.
The safety of healthy volunteers and patients in clinical trials and, ultimately, our drug products, rely on a complex interplay between many disciplines and functions of which nonclinical drug safety is only one. We call this multidisciplinary construct “Translational Safety”. It only works well when the scientific input is complemented by adequate strategies, operational setups, effective communication, and leadership.
We usually hear about Translational Safety when one or more components of this value chain break. Dr Steffen Ernst will give some noteworthy examples in his opening keynote address.
This one-day meeting will bring together experts from key pharma safety functions and disciplines, from nonclinical, clinical and regulatory, to discuss current practices, examples and best practice. The day will run from 9am to 5pm with lunch and refreshments provided throughout the day. The meeting will be highly relevant for pharma and biotech industry, scientists, physicians, and regulators.
Invitations to register for the symposium will be sent out in May. We look forward to welcoming you to this event. If you are interested and would like more information or would like to attend please email drug.safety.forum@apconix.com.
One Day Symposium Programme
Wellcome Collection
183 Euston Road
London
UK
NW1 2BE
October 17th 2024
Click here to download the programme
(subject to change)
| Time | Title | Speaker |
| 9:00-9:45 | Arrival and Registration with coffee and pastries | |
| 9:45-10:00 |
Introduction |
Dr Richard Knight, ApconiX |
| Opening Keynote | ||
| 10:00-10:30 | Translational Safety [Medicine] by Examples | Dr Steffen Ernst, ApconiX |
| Morning Session | ||
| 10:30-11:00 | Translational Safety – from Strategy to Implementation | Dr Peter Schulz, Explic8 |
| 11:00-11:30 | Designing Preclinical Packages to Support Risk Assessment for Reproduction | Dr Jane Stewart, ApconiX |
| 11:30-12:00 | Nonclinical Prediction & Evaluation Strategies to Minimize Drug-induced Liver Injury | Dr Dominic Williams, AstraZeneca |
| 12:00-13:00 | Lunch Break | |
| Afternoon Session | ||
| 13:00-13:30 | Understanding Cereblon Neosubstrate Safety: a Key Approach for De-risking Targeted Protein Degraders | Dr James Sidaway |
| 13:30-14:00 | Making Decisions in the Face of Complex Data: a Carcinogenicity Assessment Case Study | Dr Adrian Fowkes, Lhasa Limited |
| 14:00-14:30 | Benefits of Early Screening for Detection of Seizure Liability: Utility of In Vitro Assays for Problem Solving and Decision Making | Dr Kimberly Rockley, ApconiX |
| 14:30-15:00 | Coffee/Tea | |
| 15:00-15:30 | Nonclinical Approaches Providing Improved Translational Safety for Inhaled Products | Professor Victoria Hutter |
| 15:30-16:00 | TBC | David Jones, ApconiX |
| 16:00 | Expert Q&A
Chair Dr Steffen Ernst |
Dr Jane Stewart
Dr Peter Schulz TBC |
| 16:30 | Close |