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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.