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University of Birmingham joins drug discovery collaboration with Evotec and Bristol Myers Squibb

Written by Louise Stanley on . Posted in Clinical trials, Experimental medicine.

BHP founder-member the University of Birmingham is part of a new industry collaboration launched to accelerate drug discovery projects by fast-tracking research from lab to patient.

Birmingham is one of four universities selected by drug development company Evotec SE and global pharmaceutical company Bristol Myers Squibb to be part of the newly formed beLAB1407.

Evotec, together with Bristol-Myers Squibb Company (NYSE: BMY) launched beLAB1407, a new $20m academic BRIDGE to identify and advance novel and breakthrough drug discovery opportunities across therapeutic areas from the UK’s top-tier academic institutions. Through a unique combination of Evotec’s drug discovery and development platforms and early-stage therapeutic concepts from the Universities of Nottingham, Birmingham, Edinburgh and Dundee, beLAB1407 offers a unique route to the advancement of first-in-class therapeutics and the creation of spinout companies.

Evotec’s BRIDGE (Biomedical Research, Innovation & Development Generation Efficiency) collaborations provide an integrated fund and award framework to validate exciting academic projects in collaborations with Pharma and biotech with the goal to form new companies. Since implementing the first academic BRIDGE ‘LAB282’ in Oxford in November 2016, Evotec has continued to evolve similar collaborations with a variety of academic, Pharma and venture capital partners across Europe and North America.

Researchers from the University of Birmingham’s Colleges of Life & Environmental Sciences, Engineering & Physical Sciences and Medical & Dental Sciences work across all areas of drug discovery from target identification to clinical trials, and will have the opportunity to apply for funding from this project.

David Coleman, Director of Enterprise & Innovation, University of Birmingham Enterprise, commented: “Over the last few years, the University of Birmingham has identified a significant pipeline of early stage life science discoveries. The support and investment provided by Evotec and Bristol Myers Squibb through beLAB1407 provides a great opportunity to validate and develop some of these into important therapies for the future, and we’re very excited to be working with them.”

Dr Werner Lanthaler, Chief Executive Officer of Evotec, said: “We are thrilled to launch beLAB1407 together with our partners at Bristol Myers Squibb with whom we’ve worked on a variety of projects over a period of many years. beLAB1407 provides researchers from the member institutions with a unique way to fast-track their projects, to validate them on our industrial-grade platform and have partnering options including company formations readily available to them.”

Dr Rupert Vessey, Executive Vice President and President, Research and Early Development at Bristol Myers Squibb commented: “This collaboration builds on our important connection to leading European universities. With beLAB1407, we are supporting UK-based universities that are exploring many interesting lines of scientific research and discovery. That research combined with Evotec’s proprietary data platforms has the potential to identify new and novel therapies for areas of unmet medical need.”

The name beLAB1407 alludes to the distance between Land’s End in the far southwest of Great Britain to its north-easternmost point near the village of John O’Groats in Scotland, which – if travelled by bike – adds up to 1,407 kilometres. To learn more about beLAB1407, visit www.belab1407.org.

New gene therapy innovation centre to turn scientific discoveries into life-changing treatments

Written by Louise Stanley on . Posted in Experimental medicine.

BHP founder-member the University of Birmingham is set to play a key role in a pioneering new gene therapy innovation centre which will advance scientific discoveries into promising treatment options for millions of patients with life-threatening diseases.

The Gene Therapy Innovation and Manufacturing Centre (GTIMC) will be led by the University of Sheffield in collaboration with the University of Birmingham, Cell & Gene Therapy Catapult, Centre of Process Innovation, University of Liverpool, and BHP’s Midlands-Wales Advanced Therapies Treatment Centre.

It is one of three pioneering hubs announced today in a new £18 million network funded by LifeArc and the Medical Research Council (MRC), with support from the Biotechnology and Biological Sciences Research Council.

Gene therapy is a promising treatment option for more than 7,000 rare diseases that currently have no cure. It aims to treat these conditions, by engineering another gene to replace, silence or manipulate the faulty one.

The UK has a world-class genetics research base – however, to date, academics have found it difficult to get access to the clinical materials, facilities and expertise required to progress gene therapy research into clinical trials.

Professor Mimoun Azzouz, Director of the GTIMC and Chair of Translational Neuroscience at the University of Sheffield, said: “The Gene Therapy Innovation and Manufacturing Centre will tackle major challenges in gene therapy development for some of the most devastating diseases.

“Gene therapies are pioneering medical advances that have the potential to offer much needed, novel, effective treatments for many rare and incurable diseases that cannot be treated by conventional drug compounds.

“Sheffield has emerged as one of the leading players in the cell and gene therapy and this national network of partners, facilities and training programmes will allow us to keep pace with translational discoveries for new and potentially life changing treatments. This is a momentous milestone for revolutionary medical advances.”

Professor Dame Pam Shaw, Director of the NIHR Sheffield Biomedical Research Centre and co-applicant on the GTIMC application said: “This exciting development and partnership will speed up the pull through of new gene therapies into early phase clinical trials and offer hope to patients with neurological and other rare diseases that can be addressed in this way.

“The support given to this initiative will greatly accelerate the translational potential of genetic therapies in the UK and bring benefits in key areas of unmet medical need.”

Professor Philip Newsome, Director of Research and Knowledge Transfer at the University of Birmingham’s College of Medical and Dental Sciences, said: “We are delighted to be part of this pioneering new gene therapy innovation centre, providing our leading expertise to play a pivotal role in its potentially life-changing work.

“By smoothing the transition between small-scale supply for early clinical trials through to larger-scale manufacture for patient trials, and beyond, the centre will be able to advance scientific discoveries into promising treatment options for millions of patients with life-threatening diseases.”

The state-of-the-art centre will bring together academic institutions, NHS trusts, non-profit and industry partners across the north of England, Midlands and Wales enabling academic-led clinical trials of novel gene therapies.

The GTIMC will deliver essential translational and regulatory support alongside extensive training and skills programmes to enable upskilling and address shortage of skills in Good Manufacturing Practice manufacturing.

The facility will utilise highly efficient processes to manufacture clinical grade adeno-associated viruses and provide all the necessary quality assurance, regulatory certification and governance for human trials at Advanced Therapies Treatment Centres and NHS trusts within the GTIMC and the national network.

The three national hubs, located at the University of Sheffield, Kings College London, and NHS Blood and Transplant in Bristol will operate as a coordinated network, sharing technical skills and resources to enable innovative gene therapy research.

Dr Melanie Lee, CEO of LifeArc, said: “Recent innovations in gene therapies hold enormous potential for treating conditions such as rare diseases, but often promising ideas – particularly in academia – are not making it through to patients. Through our collaboration, we aim to meet the need for researchers to have access to the essential facilities and translational advice to progress promising research.”

The GTIMC will manufacture commonly used vectors including both lentivirus and adeno-associated virus that are needed for genetic therapy trials, while positioning the UK for significant bioprocessing innovation work with the potential to radically increase yields and reduce productivity barriers in future years. The hub network will also design and share commercially ready platforms, using common cell-lines, plasmids and reagents to reduce costs, facilitate simplified licensing agreements and streamline regulatory reviews.

Professor Fiona Watt, MRC’s Executive Chair, said: “The new network of Innovation Hubs for gene therapies will build on the UK’s great strengths in this area, providing targeted investment in vital infrastructure to accelerate academic research programmes down the path to patient benefit, supporting the delivery of a new wave of genetic medicines.”

Birmingham’s brain tumour centre awarded Tessa Jowell Centre of Excellence status

Written by Louise Stanley on . Posted in Cancer outcomes, Clinical trials, Experimental medicine.

The brain tumour centre at BHP founder-member University Hospitals Birmingham (UHB) has been recognised as a Tessa Jowell Centre of Excellence following rigorous expert-led assessments by the Tessa Jowell Brain Cancer Mission.

With more than 12,000 people diagnosed every year with a primary brain tumour in the UK[i], and 300 new patients seeking treatment at UHB, the award has been introduced to recognise hospitals for their excellence in patient care. It represents a step change in the neuro-oncology landscape across the UK.

UHB was measured on a range of criteria, including its excellent clinical practice and training opportunities; emphasis on patient quality of life; providing clinical trials and offering a high standard of research opportunities. Led by a committee of experts in the field and virtual site visits, the assessments were backed up by patient feedback about the care they received.

At least 88,000 British people are currently living with a brain tumour but over 5,000 people a year will lose their lives to it[ii]. The “Excellence” status provides reassurance about the availability of excellent care within the NHS and positive recognition for its staff at UHB who, despite the challenges of the Covid-19 pandemic, continue to go above and beyond for their patients. Due to the strain Covid-19 has placed on the NHS, UHB’s brain tumour centre now offers virtual clinics for patients.

Founded to design a new national strategy for brain tumours, the Tessa Jowell Brain Cancer Mission is committed to helping as many hospitals as possible achieve the “Excellence” status in the future. To achieve this, the mission is launching the Tessa Jowell Academy, a national platform allowing hospitals to share best-practice to improve their services, as well as one-year fellowships for doctors to further specialise in brain tumours.

Jess Mills, Co-Founder of the Tessa Jowell Brain Cancer Mission and Tessa’s daughter, said: “Mum’s mission throughout 50 years of her political life was to tackle systemic inequality. So, it was tragic whilst fitting, that her final campaign was a call to arms to create universal equality in access to excellence in cancer care throughout the NHS. It is with immeasurable pride that just 3 years later, the Tessa Jowell Brain Cancer Mission has begun the real-world translation of that vision into reality. 

“We are thrilled to have awarded University Hospitals Birmingham for its excellent ongoing work for patients and commitment to support other centres in reaching the same level of Excellence. Shockingly, the UK still has one of the worst cancer survival rates in Europe, but in time, the Tessa Jowell Centres will make the UK a global leader in the treatment and care of brain tumour patients. We have a long way to go until the cutting edge of science is delivered to every patient, but this is a huge and transformational first step.”

Colin Watts, Professor of Neurosurgery at BHP founder member the University of Birmingham and Honorary Consultant Neurosurgeon at UHB, said: “We are delighted that our model of patient-centred, consultant-led, research-orientated care for brain cancer patients has been recognised in this way. This award is a tribute to the whole multidisciplinary team who put patients at the centre of everything they do and take real pride in delivering best practice for everyone.

“It is a privilege to be to be  given this status from TJBCM partner organisations and we are very proud to affiliate ourselves with this recognition. We have worked hard as a team over the years to develop and improve patient care and will always strive to make a difference wherever possible. We will continue this process collaboratively by sharing and developing best practice within our service, externally and between other service providers for this cohort of patients.”

Cally Palmer, NHS England National Cancer Director, said: “This award is a fitting tribute to Tessa Jowell and her dedication to excellence in cancer care, as well as to all the NHS staff who have worked tirelessly throughout the pandemic to continue to provide life-saving cancer services, and it is great to see NHS hospitals across the country being recognised as centres of excellence. NHS services are open and ready to help those who need cancer care, and I encourage anyone who is experiencing any worrying symptoms to contact their GP immediately to improve chances of a successful recovery.”

Tessa Jowell Centres of Excellence:

      1. University Hospitals Birmingham
      2. Edinburgh Centre for Neuro-oncology
      3. King’s Health Partners of King’s College Hospital & Guy’s and St Thomas’s Hospitals in London
      4. Leeds teaching hospitals NHS Trust (Leeds General Infirmary and St James’s Hospital)
      5. Salford Royal Foundation Trust and The Christie (Manchester)
      6. Newcastle upon Tyne Hospitals NHS Foundation Trust
      7. Nottingham University Hospitals (NUH) NHS Trust
      8. St George’s University Hospital, Royal Marsden Hospital and Royal Surrey County Hospital
      9. University College London Hospitals NHS Foundation Trust

Over £700M is spent on cancer research in the UK every year, yet less than 2% of that is dedicated to brain tumours[iii]. The Mission will be supported by the All-Parliamentary Group on Brain Tumours chaired by Derek Thomas MP, to secure further support for NHS centres to enable more of them to achieve the “Excellence” status in the future. To kick-start additional monetary support, the Tessa Jowell Foundation, the charity set-up by Tessa’s family to lead the delivery of her legacy, has announced a fundraising appeal to raise £4M to enable the centres to excel after the network is launched.

[i] Cancer Research UK, https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/brain-other-cns-and-intracranial-tumours (Data: 2015-2017, UK)

[ii] Cancer Research UK, https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/brain-other-cns-and-intracranial-tumours#heading-Zero (Data: 2015–2017, UK). Accessed October 2020.

[iii] National Cancer Research Institute (NCRI) Cancer Research Database Data Package 2019

 

Birmingham secures National Training Centre for the Advanced Therapies Skills Training Network

Written by Louise Stanley on . Posted in Experimental medicine.

The National Horizons Centre, RoslinCT and the University of Birmingham have been selected to deliver high impact physical and digitally-delivered training courses as part of the growing ATSTN programme. The three centres bring with them complementing capabilities and a vast wealth of experience across GMP/GxP, manufacturing and bioprocessing, and their expertise within virtual reality training will prove instrumental for driving the successful development of cell and gene therapy as well as vaccine manufacturing staff across the UK, through the delivery of these industry-leading training courses.

The core aim of the Advanced Therapies Skills Training Network (ATSTN) is to develop National Training Centres to deliver specialist on-site courses, including innovative digital training utilising virtual reality, providing learners with the hands-on expertise and experience to succeed in the advanced therapies and vaccine manufacturing sector. The ATSTN programme also includes an Online Training Platform focused on upskilling existing staff within the industry and a Career Converter which measures an individual’s transferable skills from outside the sector and recommends applicable roles within advanced therapies and vaccine manufacturing.

Professor Phil Newsome at BHP founder-member the University of Birmingham and Professor Ivan Wall at Aston University said:
“We are excited that Birmingham will play a central role in delivering these much-needed skills for the UK’s advanced therapies sector. This will ensure the UK retains a world-leading position in the manufacture and delivery of advanced therapies. Moreover, it will further strengthen and leverage the rapidly-growing health and life science sector in Birmingham and the Midlands.”

Mayor of the West Midlands, Andy Street, commented: “Hosting an ATSTN National Training Centre in Birmingham is testament to the expertise we have developed in advanced therapies for the benefit of patients with complex conditions.  Developing  the skills to enable the therapies of the future, including new vaccines, to be delivered to patients is critical to our region and nation. And as well as leading on training, the University of Birmingham is proposing the development of new clean room facilities at Birmingham Health Innovation Campus, providing businesses with access to the critical infrastructure and expertise they need to develop, commercialise and manufacture at scale.

“To capitalise on this opportunity, extend Birmingham’s position as a leading player in advanced therapies, and deliver on the Government’s goal to be an international leader in the field, we will be seeking further support to help the delivery of innovation infrastructure in this Campus.”

Matthew Durdy, Chief Executive Officer at Cell and Gene Therapy Catapult commented: “The involvement of the National Horizons Centre, RoslinCT and the University of Birmingham is a major step in the effective development and rollout of impactful training courses which will enable the ATSTN to upskill and attract talent into the advanced therapies and vaccine manufacturing industry. It is also indicative on how the ATSTN is a truly collaborative initiative which continues to be developed in partnership with industry and academia, and the valued expertise from these three centres will provide users access to in-person training centres which complement each other and the wealth of online resources already provided on the ATSTN platform. I look forward to witnessing the great strides which will be made over the course of next year.”

Birmingham maternity experts call for urgent action on pregnancy ‘drug drought’

Written by Louise Stanley on . Posted in Clinical trials, Experimental medicine, Maternal health.

Leaders in maternal healthcare from Birmingham Health Partners (BHP) have called for lifesaving research into pharmaceuticals for use during pregnancy, in a new report which highlights the challenges of pregnancy-related complications, pre-term birth and pre-existing conditions.

Globally, 2.7 million women and children die each year from causes related to pregnancy and childbirth – including one death every six minutes due to pre-eclampsia. As well as pregnancy-related health conditions which develop during pregnancy, expectant mothers may be diagnosed with infections such as COVID-19 or serious diseases including cancer, and many women enter pregnancy with pre-existing conditions like asthma, diabetes or depression. Despite this, only one new drug has been developed specifically for use in pregnancy in more than 30 years, and 73% of drugs used in pregnancy come with no safety information relating to their use by pregnant women.

Experts from BHP’s founding members the University of Birmingham and Birmingham Women’s and Children’s NHS Foundation Trust are today urging politicians, clinicians, academia, industry, patients and research funders to end this ‘drug drought’ through developing and testing new and existing medicines in pregnancy, and help achieve the UK Government’s aim to halve maternal and infant deaths by 2025. The report, ‘Safe and Effective Medicines for Use in Pregnancy: A Call to Action’ sets out how this crucial research can be managed to de-risk research, mitigate safety concerns and give confidence to women and their clinicians.

BHP’s Katie Morris, Professor of Obstetrics and Maternal Fetal Medicine, explained: “The COVID-19 pandemic and confusion surrounding the vaccine has brought into sharp focus the absence of pregnant women in most pharmaceutical trials. The lack of understanding of which drugs can be safely used in pregnancy combined with reluctance to develop new medicines for mothers-to-be adds up to a major global public health issue, but it’s one which could be reversed. With collaborative effort, we can stop excluding pregnant women and breastfeeding mothers from clinical research and give them access to the medicines they deserve.”

Peter Brocklehurst, Professor of Women’s Health at BHP, commented: “Pregnancy complications, including pre-term birth and pre-eclampsia have a huge impact on families and society as a whole. The consequences of preterm birth alone cost the UK economy almost £3bn annually and, while we have the ability to tackle these issues for mothers at home and abroad, we have barely begun. Many of the women and babies who die during pregnancy and birth could be saved, and 15 million babies could be spared the disability and mortality risks linked with being born too early, if we act now.”

Dr Sheuli Porkess, Medical Director at the Association of the British Pharmaceutical Industry, commented: “We completely agree on the need for action to address the needs of pregnant women and the lack of licensed medicines and treatments researched for use in pregnancy and breastfeeding.

“We have already started work, including on better representation of pregnant women in the design of and recruitment for clinical trials. We are pleased to have Maternal Health reflected in our Memorandum of Understanding with Birmingham Health Partners and to be working with our members, BHP, the MHRA, HRA and others on this important area.”

The report concludes that, through collaboration, research into medicines for pregnancy could be progressed at pace. By creating financial incentives for investment, building public-private partnerships, addressing regulatory gaps and hurdles and harnessing new technologies, the UK can directly impact the health, safety and wellbeing of pregnant women worldwide.

‘Safe and Effective Medicines for Use in Pregnancy: A Call to Action’ can be downloaded from https://www.birminghamhealthpartners.co.uk/wp-content/uploads/2021/01/21560-Policy-Commission-Maternal-Health-Report-AW-accessible.pdf. Its signatories – BHP Professors Katie Morris, Peter Brocklehurst, Arri Coomarasamy and Shakila Thangaratinam – will next establish a major policy commission to review evidence, opportunities and options for policy which will be integral to the formation of clear, multi-stakeholder recommendations to the UK Government.