APPG on Human Relevant Science

14 June 2023 | 17:30 | Minutes

Location: Committee Room 17, Main Committee Room Corridor, Palace of Westminster

Parliamentary Attendees	Martyn Day MP (Chair), Baroness Susan Hayman of Ullock, Tan Dhesi MP, Dr Paul-Enguerrand Fady (on behalf of Baroness Natalie Bennett)
Non-parliamentary Attendees	Isobel Martin (Animal Free Research UK), Darcie Wilson (Animal Free Research UK), Dr Gerry Kenna (Safer Medicines), Dr Lorna Ewart (Emulate), Chris Fegan (Catholic Concern for Animals)
Non-parliamentary Attendees Online	Professor Geoff Pilkington (Animal Free Research UK), Kerry Postlewhite (Animal Free Research UK), Kathy Archibald (Safer Medicines), Dr Malcolm Wilkinson (Kirkstall Ltd), Jessie Hellier (FRAME)
Apologies	Giles Watling Alex Sobel Sir Roger Gale Tommy Sheppard Alan Brown Deidre Brock Sir Greg Knight Laura Farris Caroline Lucas Liz Saville Roberts Grahame Morris Henry Smith Julian Sturdy Lisa Cameron Navendu Mishra Paul Blomfield Cat Smith Daniel Zeichner Anna Firth Jo Gideon Michael Fabricant Sir Ed Davey Sir Robert Buckland Allan Dorans John Baron Baroness Mallalieu Chris Loder Baroness Watkins of Tavistock Stephen Metcalfe Kerry McCarthy Marion Fellows Paula Barker Philippa Whitford Rachel Maclean Ronnie Cowan Sir Stephen Timms Tracey Crouch Wendy Chamberlain Caroline Nokes Ian Levy James Daly Mark Menzies Stuart Anderson Wayne David Emma Hardy Greg Clark John Redwood Thangam Debbonaire Baroness Kathryn Parminter Richard Fletcher-Vane Jonathan Reynolds Baroness Northover Kemi Badenoch Chris Green Baroness Finlay of Llandaff

 

1. Opening remarks

MD welcomed attendees and introduced GK and LE.

Dr Gerry Kenna Gerry is Pharmaceutical Director of Safer Medicine Trusts and a drug safety consultant. Gerry’s focus for the last decade has been on the development and implementation of novel, human biology-based drug and chemical safety assessment methods that can improve upon and replace data provided by animal studies. Previously, Gerry worked as a toxicologist in the pharmaceutical and agrochemical industries for 15 years, having led academic research teams that explored mechanisms underlying serious human adverse drug reactions for 19 years. He received B.Sc. and Ph.D. degrees in biochemistry from the Universities of Leeds and London and has authored or co-authored >110 peer reviewed scientific publications. Dr Lorna Ewart Lorna is Chief Scientific Officer at leading biotech company Emulate, where she provides strategic guidance and oversight of the scientific vision, leads partnerships with government agencies to achieve regulatory acceptance and collaborates with key customers to advance adoption of organ-on-a-chip technology as a positive disruptor to the drug discovery and development process. She has over 20 years’ experience in the pharmaceutical industry and gained her PhD at the William Harvey Research Institute, London. Lorna is a fellow of the Royal Society of Biology and British Pharmacological Society.

 

2. Introduction to subject

 

GK provided an introduction to the subject.

• Drug Induced Liver Injury (DILI) refers to damage to the liver caused by prescription drugs. Animals are routinely used to predict drug toxicity in humans. Problems in translating results from animal tests play a key role in the high rate of failure of promising drugs.
• There is an urgent need to increase the speed and accuracy with which new therapies can be translated from the lab to the clinic, bringing much-needed progress for patients.
• By providing results that are directly relevant to people, innovative, human-specific technologies have major potential to help get new medicines to market more safely and quickly. One of these exciting technologies is liver-on-a-chip.
• Whether human-focused testing could improve clinical translation was discussed at a seminar hosted by the Alliance for Human Relevant Science in April 2023. Proceedings of this meeting are being written and and will be shared with this APPG.
  • TD: This should be shared with the group so it can be sent to the relevant government departments to help drive through legislation.
• Current regulatory guidelines are not compatible with modern technologies such as liver-on-a-chip. Support at parliamentary level is needed to refresh the guidelines and re-direct funding streams.

 

3. Presentation from Dr Lorna Ewart (Emulate)

LE gave a presentation exploring the below:

• Regulation pertaining to animal testing was brought in in the UK in the 1930s following child fatalities due to anti-freeze used in the administration of cough medicine.
• Studies and analyses have shown that animals do not accurately predict drug toxicity in humans. Fortunately, 21^st century technology is now available that is a more reliable predictor of toxicity.
• Liver toxicity caused by prescription drugs can lead to death or liver transplantation in patients. Therefore, DILI remains a leading patient safety concern within the pharmaceutical industry. There is recognition that current workflows using conventional models are inadequate, emphasizing the need for an improved, human-relevant model to protect patient safety.
• Predicting toxicity is challenging due to a number of factors, including that toxicity is species and organ specific and drugs have an array of effects on humans.
• Current models are resulting in high R&D costs, failings of clinical trials and post-approval market withdrawals due to toxicity.
• Human relevant models such as Emulate’s liver-on-a-chip can now include dynamic blood flow and communication between organs to better replicate the human environment. Studies have shown that this liver-chip is a reliable predictor of DILI, out-performing conventional animal tests. The publication “Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology” outlining this has been accessed over 24,000 times, and currently has 17 citations.
  • TD: These types of publications need to be in the mainstream media to help constituents understand the issue.
  • LE: In America, large media outlets picked up the story, but this has not been the case in the UK.
  • GK: Often in the UK, scientists talk to each other and not the media.
  • BSH: A personal angle to stories is important to grab headlines.
  • Action: Strategize on increasing mainstream media engagement with human relevant technologies
• This technology must now move from hype to routine adoption. Legislative change and a regulatory framework, funding for new model development and qualification, and training and education for End Users and junior scientists is required.
• The FDA Modernization Act 2.0 changed the word “animal” to “non-clinical” which has resulted in the acceptance of non-animal tests in drug development.
  • Action: Develop a briefing on the FDA Modernization Act and circulate for use in policy development.
• During the COVID-19 pandemic, the Moderna vaccine was not tested on animals, which meant there were 66 days between the identification of the sequence to the vaccine’s administration.
  • PE: Pyrogenicity testing moved from rabbits, to horseshoe crabs, to biochemical systems. Illustrating precedents such as these can be powerful.
  • GK: Regulators are concerned with patient safety which means there is more caution at the regulatory level for pharmaceuticals. DILI is a good example of where animals are not useful but human relevant models are. It is a credible and more relevant example.
• Legislative change has occurred on the global stage in South Korea, the European Parliament, and the USA. Innovative funding approaches are also being championed in the USA, such as Maryland’s bill incentivising the use of animal model alternatives by asking facilities conducting animal testing to pay a contribution to alternative development. There is growing momentum seen at international research conventions. The UK must keep pace.
• More support is needed from funding bodies with training and education
  • IM: There is a bid being submitted to host the next World Congress in the UK. A letter of support from this APPG is recommended.
  • Action: Draft letter and circulate to MD for signature

 

4. Q&A session

• MD: What can this APPG do to support human relevant science?
  • LE: Raise awareness to the broader population, support training and education, and ensure investment from funders such as UKRI and MRC to enable models to be built
  • GK: Regulatory change is key like that seen in the USA and South Korea. It is also essential that the UK re-engages with Horizon Europe in a leading capacity.
• PE: It would be useful to know exactly what the FDA Modernization Act 2.0 outlined
  • GK: Legal professionals could be instructed by this APPG to analyse it
  • IM: One of the challenges in the UK is identifying where in the legislation such a wording change should occur. Our approach is governed by international regulatory guidance such as that set by the ICH.
• MD: In Parliament, this APPG can focus efforts on being successful in the ballot for Private Members Bills to raise awareness. A 10-minute rule bill could also be used.
  • Action: Encourage MPs to go into the ballot and explore 10 minute rule bill option.
• LE: It is important to stress the economic benefits of this science. It can help drive down inflation, drive investment towards life sciences, and reduce failure rate costs in the medical research industry.
• PE: It may be useful to explore collaboration with the Liver Trust and other organisations to source patient stories that can amplify the importance of this message

 

5. AOB

There was no other business.

 

6. Date for next meeting

This will be scheduled for September.

The meeting was closed by the Chair at 18:40

Actions

Circulate Minutes and Slides	IM , DW
Select date for the next meeting	IM, MD
Produce Executive Summary on the topic to share with all those who sent apologies, IM DW to circulate	GK, LE
Strategize on increasing mainstream media engagement with human relevant technologies to encourage public support.	IM, DW
Develop a briefing on the FDA Modernization Act and circulate to the APPG.	LE, IM
Draft letter supporting the UK’s bid to host World Congress and share with MD for signature	IM
Encourage MPs to go into the ballot and explore 10 minute rule bill option to raise awareness	IM, DW