As the Brexit debate rumbles on, BIA took the opportunity last week to submit a comprehensive and factual overview paper to the Commons Science and Technology Committee’s inquiry on EU regulation of life sciences. Building on our position that UK life science businesses see the future of our sector in Europe and we are supportive of effective reform in Europe, this paper adds detail on the regulatory framework underpinning the biomedical life sciences industry, as well as wider business considerations. It recognises that there are other areas, such as with GMOs, where companies report significant obstacles in implementation of the regulatory regime. And in some cases, problems are due to implementation within the UK itself, as has been seen with gold-plating of the Clinical Trial Directive. Overall, we emphasise again that it’s vital the UK remains engaged in the EU and takes a leading role in shaping legislative and regulatory policy developments affecting the life sciences sector.
In other lobbying efforts, following our consultation input to the IPO, it was great to hear that a zero opt-out fee has been agreed for the Unified Patent Court (UPC). This means that those with existing European Patents will not have to pay not to use the system. For more information on the UPC you can read our member briefing, produced by the Intellectual Property Advisory Committee.
On regulatory matters, the European Medicines Agency (EMA) has published detailed guidance for biopharmaceutical companies on the requirements to comply with its policy on the publication of clinical data. Further details will be provided in the 2016 Q1 BIA update report and you can read more in their press release here.
Relating to the work of BIA’s Cell Therapy and Regenerative Medicine Advisory Committee, I’m pleased to note that BIA has signed a Memorandum of Understanding with FIRM, a charitable organisation that brings together virtually all the cell and gene therapy (and supply chain) companies in Japan. The MoU will help FIRM to become the formal industry association for cell and gene therapy in Japan, presents an opportunity to expand and strengthen the existing networks between UK and Japanese companies and regulators in this field.
It’s Manufacturing March on the BIA blog this month, and we’ve kicked it off by taking a look at the achievements of the Medicines Manufacturing Industry Partnership (MMIP) since its launch back in 2014. You can read the blog in full here or take a look at our new leaflet for more background to the partnership. The MMIP’s mission is to ensure that the UK is recognised by the global medicines industry as a world-class, advanced centre for medicines manufacturing. Part of this involves representing the voice of the sector and ensuring that it is aligned with the challenges and opportunities that the industry has identified. If you’re part of the medicines manufacturing sector, the newly launched MMIP LinkedIn group is a great opportunity to keep up to date with the work of MMIP, engage with it and share your thoughts – do take a look and join here.
In other news, the spotlight was on the UK’s immuno-oncology sector last week with a number of key announcements. Congratulations to BIA member Autolus, who secured an additional £40 million in a Series B financing round last week – raising £70 million in less than 18 months from inception – and to another BIA member, Horizon Discovery, who announced their new joint venture with Centauri Therapeutics. Both great pieces of news for the sector and a show of strength in the UK’s booming immuno-oncology industry.
On events this week, International Women’s Day takes place tomorrow and we’ll be celebrating at our latest Women in Biotech session, hearing from our panel of industry leaders including Flic Gabbay of TranScrip Partners, Sue Charles from Instinctif, Nathalie Moll of EuropaBio, Brenda Reynolds of Calchan and Denise Scots-Knight from Mereo Pharma. Our WIB events always provide some great discussions – keep an eye out for the highlights next week. We’ve also got two webinars lined up for you in March, focussing on platform technologies this Thursday and later in the month, one to help get you ready for BIO-Europe Spring. Do take a look and sign up.
Finally, Understanding Animal Research (UAR) are looking for brief case studies on the value and limitation of animal models in biomedical research. This information is urgently required in order to support the European Commission’s planning of a large scientific conference to be held in Brussels December 2016 as promised in their response to the Stop Vivisection European Citizens’ Initiative. The following themed sessions have been outlined in a provisional programme: validity of the animal model; models used in biomedical research; models used in regulatory testing; research funding and research reporting; and future prospects. Please contact us for more information if you have a case study to support any of the themes above. Contributions must be received by 15 March.