The latest Business updates from the science industry


Connecting Development Partners for Medtech Devices by Heather Hobbs


NHS consultancy Health Enterprise East (HEE) has launched online portal MEDTECH Connect as a key pillar of the MedTech NAVIGATOR programme, a scheme funded by the European Regional Development Fund (ERDF) and delivered by HEE to enhance knowledge-sharing between NHS practitioners and the medtech industry on a free to access basis.


Tapping into clinical expertise during a device’s early development phase is vital to ensure products will help to address specifi c needs; however companies might currently struggle to identify research active clinicians who might be best placed to offer these insights.


By the same token, primary and secondary care clinicians have the opportunity to engage with industry innovators to co-develop the latest medical advances, with support and guidance from HEE where required.


Dr Chris Warwick, Senior Consultant at HEE, said: “In our experience, the quickest and most effective way to get new technologies that truly meet patients’ needs to market is for NHS experts and the medtech industry to work more closely together from the outset. MedTech CONNECT allows for easy, tailored two-way access which we believe could yield far-reaching benefi ts for patients, in terms of swifter access to innovative technologies. By removing some of the bureaucracy that can hamper innovation, we are confi dent that MedTech CONNECT will accelerate medtech adoption in our health service and ultimately improve patient outcomes.”


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PMDA System enhances Approval Process


manufacturers, a process which has also been progressing ahead of the DMF submissions.


Albumedix Ltd, a world leader in recombinant human albumin (rHA) has submitted Drug Master Files (DMFs) for two of its products to the Pharmaceutical and Medical Device Agency (PMDA) in Japan.


The DMF system allows manufacturers, such as the Nottinghham- based company, to submit detailed confi dential manufacturing, chemistry and controls information of a product to the regulator, assuring its safety, effectiveness and is of an appropriate quality for customers to use in their fi nal products. The registered information is necessary for inclusion


in


pharmaceutical products in which Albumedix products are used. As a non-Japanese company, Albumedix are


also required to apply to be accredited by the regulator as approved foreign


Commenting on the DMF submissions in Japan, Albumedix Director of Global Regulatory Affairs Harriet Edwards says, “These submissions are a continuation of Albumedix strategy and ethos; we are dedicated to supporting our customers in all aspects of their product development and beyond when using our products in order to become the partner of choice for advanced therapies worldwide. We are extremely happy to add to the support we currently provide our customers in Japan and believe the submissions further confi rm our intent to fully serve the Japanese market. This is a market we have had a presence in for many years and which is currently expanding, especially due to the advance of cell and gene therapies in this territory. The submission of the DMFs in Japan allows Albumedix to provide an enhanced level of regulatory support to these customers as well as an increased assurance of our product safety and quality, particularly for those in clinical development and heading towards commercialisation.”


Albumedix has already full DMF´s submitted in United States, Canada, Australia, New Zealand and China.


applications for


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Cell and Gene Therapy Training Centre to Boost Skills Pipeline


Plans to build a new therapy integration laboratory at the Cell and Gene Therapy Catapult (CGT) facility in Stevenage will be part-funded by the Government’s Getting Building Fund. The new laboratory, announced by CGT and Hertfordshire Local Enterprise Partnership (LEP), will provide cell and gene therapy manufacturing training utilising both digital and established teaching platforms on equipment capable of large-scale manufacture. The laboratory supports the national drive for skills development and complements existing skills initiatives coordinated by CGT Catapult, including the Advanced Therapies Skills Training Network (ATSTN) and the Advanced Therapies Apprenticeship Community (ATAC).


Life Sciences Cluster offers Growth Potential


Biotech Engitix Therapeutics, developers of programmes in fi brosis and solid tumours has relocated its operations to WestWorks, White City Place (WCP) following announcements of high-profi le collaboration agreements with Takeda Pharmaceuticals and Morphic Therapeutic. The move to the 8,000ft2 facility of bespoke offi ce and laboratory space in WCP will enable further growth and partnership development along with potential networking benefi ts. Engitix is the latest life sciences company joining the campus, with a number of biotech and global pharma organisations already occupying space in the emerging hub, including GammaDelta Therapeutics, Autolus and Synthace, as well as Novartis.


Stephen Brindle, COO of Engitix said: “Our move and expansion into this new, inspiring hub in White City is a signifi cant milestone for Engitix. Here, we will have the ideal premises to accommodate further growth as we look to double in size in the coming years, driven by progess


with both our proprietary programmes and major partnerships. As it emerges as a new centre in the fi eld of life sciences, White City also gives us access to excellent facilities and networking opportunities for industry players.”


David Camp, CEO, Stanhope PLC, the developer and owner of WCP, stated: “We are delighted that Engitix have decided to relocate their head offi ce to the growing life sciences cluster at the WestWorks building in White City Place. The addition of Engitix Therapeutics helps further enhance White City Place’s status as the number one location of choice for innovative, forward thinking companies in the life sciences and biotech sector.”


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Hertfordshire LEP selected five key projects to receive a share of its £16.8 million allocation from Government’s Getting Building Fund, which aims to kick-start local economic recovery. The five projects are set to deliver over 1,500 high value jobs across high-tech sectors including film and TV; cell and gene therapies; advanced therapeutics; and smart construction.


The cell and gene therapy integration laboratory was awarded £3,055,880 which will enable the CGT Catapult to equip the laboratory with the latest digital technologies including augmented reality, high-throughput manufacturing platforms and advanced analytics for the industrial manufacture of cell and gene therapies.


Paul Witcombe, Head of Enterprise and Innovation, Hertfordshire LEP, said: “We are delighted to have secured further investment to support future advances in cell and gene therapies. Skills digitalisation is a key differentiator and is absolutely critical if the UK is to remain a global centre of excellence in this sector.”


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