Registration Details
In collaboration with the British Toxicology Society and the Health and Safety Executive’s Chemicals Regulation Division, the NC3Rs is hosting a two-day virtual workshop on 23-24 February 2022. The workshop will be chaired by Professor John Colbourne, University of Birmingham and Professor Alan Boobis, Imperial College London.
New approach methodologies (NAMs) have great promise in providing useful information for chemical hazard and risk assessment. In the last decade, significant investment has been made in developing new tools that can reduce reliance on animals and improve decision-making in chemical safety assessments, including computational models, read-across and grouping approaches, microphysiological systems and ‘omics’ technologies. However, there is often a lack of confidence in applying these methods within a regulatory setting, and uptake for hazard identification and characterisation of complex endpoints requires further development. A focus on methods that provide a better understanding of mechanisms behind adverse effects (i.e. AOPs – adverse outcome pathways), and that incorporate exposure science will support a move away from traditional tests in animals and potentially provide more relevant safety assessments.
The workshop aims to raise awareness of currently available NAMs and explore how regulatory application and acceptance of these tools can be accelerated by overcoming the most significant barriers to their implementation.
Key objectives are to:
- Showcase how NAMs are currently being used to enable and improve decision-making for chemical safety assessment.
- Determine the barriers and scientific gaps that if addressed could accelerate the development and application of NAMs for regulatory assessments.
- Explore new ways to speed up the validation and standardisation process of NAMs.
- Identify short, medium and long-term objectives to ensure a smooth transition from traditional toxicology to integrated testing approaches.
The meeting is relevant for academic, regulatory and industry scientists with an interest in the development and application of NAMs.
Register now via Zoom
NC3Rs event policy
The draft agenda for the workshop is below:
Day 1
| Time | Agenda Item |
|---|---|
| 13.00 -13.05 |
Welcome and introductions Professor John Colbourne, University of Birmingham (Chair) |
|
Session 1 |
A vision for NAMs in safety testing |
|
13.05 -13.30 |
A vision for regulatory application of NAMs – personal reflections Professor Alan Boobis, Imperial College London |
|
13.30 -13.55 |
New opportunities for NAM development and what can be achieved by Precision Toxicology Professor John Colbourne, University of Birmingham |
|
13.55 –14.05 |
Panel discussion |
|
Session 2 |
OECD test method developments – current status of NAMs and lessons learnt |
|
14.05 –14.30 |
Overview of recently adopted NAM OECD guidelines and future workplan Dr Anne Gourmelon, OECD |
|
14.30 –14.55 |
Validation and standardisation of latest NAMs Dr Nicole Kleinstreuer, NICEATM |
|
14.55 –15.10 |
Panel discussion |
|
15.10 –15.25 |
Coffee break |
|
Session 3 |
Recent research developments in NAMs – Part I What is possible; what are the limitations; what are the hurdles; what are the potential applications and case-studies |
|
15.25 –15.50 |
Increasing confidence in chemical grouping using omics-derived molecular data Professor Mark Viant, Michabo Health Science Ltd |
|
15.50 –16.15 |
Integrating in vitro bioactivity data, computational modelling and exposure science in animal-free cosmetic safety assessments Dr Maria Baltazar, Unilever |
|
16.15 –16.40 |
Using (Q)SAR models as part of a weight of evidence, to reduce reliance on animal testing and support regulatory assessments Dr Adrian Fowkes, Lhasa Ltd |
|
16.40 –16.55 |
Panel discussion |
|
16.55 –17.00 |
Re-cap and close of day 1 |
Day 2
| Time | Agenda Item |
|---|---|
|
13.00 -13.05 |
Welcome to Day 2 Alan Boobis, Imperial College London (Chair) |
|
Session 4 |
Recent research developments in NAMs – Part II What is possible; what are the limitations; what are the hurdles; what are the potential applications and case-studies |
|
13.05 –13.30 |
Microphysiological systems – what is possible and what are the limitations? Dr Jason Ekert, GSK |
|
13.30 –13.55 |
Importance of AOPs in NGRA – the case study of cardiotoxicity Dr Luigi Margiotta-Casaluci, Kings College London |
|
13.55 –14.20 |
Novel in vivo mechanistic toxicology approaches to inform regulatory testing Dr Francisco Inesta-Vaquera, University of Dundee |
|
14.20 –14.30 |
Panel discussion |
|
14.30 –14.40 |
Coffee break |
|
Session 5 |
NAMs and regulatory needs What regulators need and how NAMs can be applied in a regulatory context – what are the opportunities and how to overcome the challenges/barriers? |
|
14.40 –14.55 |
Barriers to and opportunities for the increased use of NAMs in the regulation of agrochemicals and biocides Dr Susy Brescia, HSE CRD |
|
14.55 –15.10 |
Non-animal methods and new approach methodologies in UK REACH registration Dr Helen McGarry, HSE CRD |
|
15.10 –15.25 |
The use of NAMs in regulatory assessments of cosmetics safety Professor Qasim Chaudhry, University of Chester |
|
15.25 –15.40 |
Current and future role of NAMs in regulatory assessments of food Dr David Gott, FSA |
|
15.40 –15.55 |
Acceptance of NAMs in the regulation of pharmaceuticals – what are the challenges and how they can be overcome Dr David Jones, Independent |
|
15.55 –16.10 |
Panel discussion |
|
Session 6 |
Discussion Specific questions to be addressed by all speakers and selected panellists |
|
16.10 –16.45 |
Questions and interactive discussion |
|
16.45 –17.00 |
Re-cap, take-home messages and outlook |