The CPI is a UK-based technology innovation centre and part of the UK’s High Value Manufacturing Catapult. Using applied knowledge in science and engineering and combining this with state-of-the-art facilities enables CPI clients to develop, prove, prototype and scale up the next generation of products and processes.
By utilising the proven assets and expertise of CPI, companies can take their products and processes to market faster, saving on investment and increasing market opportunity.
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Arecor CEO, Tom Saylor, discusses the company’s recent collaboration with the Centre for Process Innovation – the first industry partnership undertaken in association with the National Biologics Manufacturing Centre.
For the past 7 years Arecor has expanded its proprietary formulation platform to address the growing challenges of developing stable liquid formulations of proteins, peptides and vaccines. We have assisted our partners not only in progressing difficult to formulate products in development, but have provided competitive advantage through formulations offering benefits in patient use and convenience. Our approach has been to utilise approved excipients in non-conventional way that can be incorporated in standard manufacturing practices to ensure ease of implementation and regulatory consideration.
Working with 10 of the top 20 biopharma companies we have addressed many of the problems that limit product development of next generation biologics such as aggregation, viscosity and chemical instability. This work has led to licenses and broadly-based collaborations with companies such as Eli Lilly, Genzyme and GSK Bio. Our collaboration with the Centre for Process Innovation (CPI) potentially opens opportunities for extending the unique insights which provide the basis of Arecor’s industry leading formulation technology to the problems of interactions between drugs and containers such as vials and syringes.
Through the biotech network and former colleagues we became aware of CPI and the National Biologics Manufacturing Centre in the summer of 2013. Based upon our success in developing finished formulations, Arecor was seeking to partner with organisations with manufacturing expertise to demonstrate the value of Arecor’s technology to various stages of biologics production. The initiative appeared to be an excellent means to combine Arecor’s unique formulation technology with CPI’s manufacturing expertise and facilities to meet the needs of later stage manufacturing and packaging particularly for emerging enterprises that often only confront formulation problems late in development.
The difficulties associated with the interaction of drugs with containers can represent profound limitations on biologics development and marketing. According to the US Centre for Biologics Evaluation and Research, the majority of biopharmaceutical recalls are related to primary packaging. The collaboration between Arecor and CPI is addressing this problem.
On our own, Arecor would not have the expertise and resources to focus on these aspects of pharmaceutical development but the collaboration with CPI has opened new areas of opportunity to ensure that Arecor’s unique formulations address key challenges in manufacturing. The collaboration allows us to show that Arecor’s patented technologies and proprietary algorithms are applicable not only to developing stable formulations of the drug product, but ensuring that the formulation offers the maximum flexibility in pharmaceutical form and delivery.
One of the issues working within industry collaborations is the potential conflict of commercial objectives. Issues such as ownership of IP and exploitation rights can delay or destroy promising partnerships. However, in the current collaboration Arecor is delighted with the working relationship and synergy of interests between the partners.
We have received some very positive feedback off the back of our collaboration announcement, highlighting to us the significant interest in this area across the industry. We hope that the findings and results of our work together will help provide UK drug companies beneficial insights and strategies for future formulation and container selection processes.
Arecor and CPI are at the early stages of what promises to be an interesting and highly ground-breaking venture, which we hope will give insights into the causes of biopharmaceutical degradation caused by drug-container interactions. This is a very exciting time for Arecor, and we are delighted to be working alongside CPI to tackle an issue that is widely known across the industry, but until now poorly understood.
Following the release of their annual statistics last month, Lydia Christopher, Head of Industry Operations at the National Institute for Health Research (NIHR) Clinical Research Network, provides an overview of the Network and discusses their recent success.
The NIHR Clinical Research Network provides the infrastructure that allows high-quality clinical research to take place in the NHS, so that patients can benefit from new and better treatments. We help researchers to set up clinical studies quickly and effectively; support the life-sciences industry to deliver their research programmes; provide health professionals with research training; and work with patients to ensure their needs are at the very centre of all research activity.
As Head of Industry Operations, my role is to oversee the work we deliver for the life-sciences industry and last month we were delighted to announce record figures for commercial contract clinical research in the NHS in England during the 2013-14 year.
Our latest figures have shown recruitment of more than 25,000 patients to commercial contract studies, this is a 26% increase on last year and means nearly 96,000 patients have participated in commercial contract studies over the last six years. The Network supported the delivery of to 533 unique commercial contract studies – the highest number since records began. On top of this, 86% of Trusts recruited patients onto our Portfolio of commercial contract studies. These figures are all substantial increases on previous years and reflect the hard work and dedicating focus on supporting the Life Sciences Industry.
Further to these fantastic figures, improved study set-up and strong delivery has meant the median number of days to achieve NHS Permission for commercial contract studies at all study sites is now just 26 calendar days. Over the last four years the Network has also more than tripled the number of commercial contract studies delivered to 100% time and target.
The NHS can confidently say it is internationally competitive in terms of speed of study set-up and because of the processes we have in place, in 2013/14 alone, the Network recruited 35 first global patients – a tremendous achievement.
Overall our work contributes to an excellent journey for the life-sciences industry – the speed to which companies can now set-up and deliver studies with Network support in the NHS is remarkable.
How we support the life-sciences industry
The Network acts as a gateway for companies wishing to undertake commercial contract research in the NHS, we are the research delivery arm of the NHS and aid the life-sciences industry through three key areas of support which are provided free of charge:
- Feasibility – Whether you have an idea for a study or have a draft final protocol, we can help you identify potential study sites and targets. Our coverage spans over 30 clinical specialties and hundreds of investigators. Our site identification and intelligence services are backed by the latest evidence based NHS clinical research performance and capacity information.
- Set-up – We are constantly working to improve the set-up and delivery of clinical research studies in the NHS. Our tools have been developed in collaboration with the clinical research community to efficiently support your study set-up. These include a suite of Commercial Study Costing templates and Model Clinical Agreements.
- Management – The service we offer means you can maintain study profile and aids consistent delivery across multiple sites – making it easier for you to manage a study across numerous locations. Our resource is available throughout England and ensures NHS staff have the skills and supporting infrastructure to conduct and deliver the highest quality research.
In order to be here for you, we have a dedicated central Industry Information Centre available to provide information and advice to help commercial life-sciences companies to use the Network service effectively.
We are here to help bring these impressive results to your study and invite you to start your journey with us today by contacting our support team:
An action packed week at Westminster saw an extensive reshuffle amongst Conservative ministers, with David Willetts leaving the Government and George Freeman joining it as Minister for Life sciences – you can read more of my thoughts on the reshuffle in my blog post.
It was great to see that Greg Clark’s first action as David Willetts’ replacement as Minister for Universities and Science was to announce a “war cabinet” of all the research councils and the Wellcome Trust to tackle antimicrobial resistance (AMR). The Medical Research Council (MRC) will lead this unprecedented cross-council initiative to tackle AMR, known as the Antimicrobial Resistance Funders Forum.
Meanwhile, the MRC along with the Biotechnology and Biological Sciences Research Council (BBSRC) are consulting on existing and emerging research skills and capabilities that are ‘vulnerable’ and may require further support – if you want to feed in your views by 5 September, the survey is here.
But perhaps the most strategic news in our sector is that the Boards of Abbvie and Shire reached agreement on the terms of a recommended combination on Friday. The deal between two BIA members, which valued Shire at £32 billion pounds, is significant for a number of reasons. Firstly, investors in Shire – a UK biotech stock – have done well and made money. This should be a cause for celebration for all life science companies seeking to engage the London markets in investing in our sector, and a story we need to tell for years to come. Secondly, a new global biopharmaceutical company with UK innovation at its heart – in the form of Humira, a drug developed in the UK – will now be domiciled here, providing an opportunity for significant UK engagement. We as a UK community have an opportunity to show them the ongoing excellence in innovation and encourage them to invest further in our ecosystem. Thirdly, the deal is also likely to ensure the issue of tax inversion remains high profile in Washington DC, and recent noises by the US Federal Government about their concerns mean this is a policy debate we are following closely. However I still don’t believe we will see significant movement on it in the USA under this President or Congress.
In other news this week, the BIA published new materials on biological medicines, including biosimilar medicines, to enhance prescribers’ and other stakeholders’ understanding of these medicines and answer any frequently asked questions. Working with the ABPI we hope that they will assist healthcare professionals in particular to be aware of, and better understand the challenges of, the introduction of biosimilar medicines to the NHS. I’d welcome feedback on this. We’ve also been working on a concept paper on pharmacovigilance specific considerations for biological medicinal products and biosimilar medicinal products, which recommends that a biological-specific module of the EMA Guideline on good pharmacovigilance practices be developed.
On the blog this week, we’ve published a great piece writing up our Horizon 2020 breakfast on member experience of accessing European funding, which was held in the Commons earlier this month – its well worth a look.
Until next week
Earlier today, AstraZeneca revealed the proposed designs for their new £330 million Global R&D Centre and Corporate Headquarters, to be based at the Cambridge Biomedical Campus. For those who are interested, an animated video of the proposed building can be seen here.
Today’s member video features AstraZeneca and the Medical Research Council (MRC) discussing their recently announced collaboration, which will include the creation of a joint research facility at AstraZeneca’s new R&D centre in Cambridge.
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Last week, BIA members met with MPs for a roundtable breakfast to discuss European funding with a particular focus on Horizon 2020 (H2020), the European Commission’s successor to Framework Programme 7 (FP7). H2020 is the biggest EU Research and Innovation programme ever with nearly €80 billion of funding available over 2014-2020.
The event was hosted by Rt Hon Michael Moore MP, EU Business Adviser to the Deputy Prime Minister Nick Clegg and former Secretary of State for Scotland. Ann McKechin MP, member of the Business Select Committee and MP for Glasgow North, also took part in the discussion. They were joined by Dr Harren Jhoti of Astex who chaired the discussion, Professor Bryan Hanley from the KTN who advises companies on H2020, and 15 BIA member companies representing a range of companies both large and small with a range of experience in bidding for FP7 and H2020.
For Michael Moore MP the discussion was an opportunity to engage with business leaders on the issue of how UK companies interact with Europe, to inform a report to the Deputy PM on increasing the competitiveness of UK industry. He was keen to meet companies directly, find out what support businesses need and learn about challenges of funding for medical research translation.
Professor Bryan Hanley leads for the Knowledge Transfer Network (KTN) on life science aspects of H2020 and has helped several SMEs to navigate the application process. The KTN works closely with Technology Strategy Board (TSB), who have designated National Contact Points for H2020. Bryan outlined an overview H2020 and logistics of applying.
Compared to FP7, H2020 is more focused towards delivery and impact. There is also dedicated SME Instrument to direct funds to help existing SMEs to succeed, and via this route companies can apply as single entities rather than in a large consortium. However, there is a large volume of applications and attendees learned that the biotech success rate in the SME instrument is around just 2.5%. Some attendees compared this favourably to the likelihood of receiving venture capital funding however.
In H2020 as a whole there is a move away from large unwieldy consortia towards more effective consortia that will deliver impact, and Bryan noted that the Commission is looking to increase the proportion of awardees who are ‘strategic innovators’. The outline decision in H2020 is reached more quickly than in FP7, although the time taken to receive funds is still several months.
The company experience: lessons learned
Dr Hayley French, Commercial Director and General Counsel at Apitope, spoke from the company perspective of receiving FP7 funding earlier this year. Applying as a Belgian company, Apitope received €6 million to develop a therapeutic vaccine for Grave’s disease. Hayley recommended looking at H2020 as a whole rather than the SME instrument for a greater chance of success, and described the approach Apitope took. The company hired a specialist European consultant to assist in the compilation and subsequent management of their successful application and would advise other companies to do the same if possible.
A well-balanced and well-managed consortium is key. Hayley suggested planning the consortium early and having at least 3 members from different members states (minimum required by the Commission) but no more than 5, in order to be able to manage the group effectively. Hayley highlighted that the consortium should be well balanced in terms of geography and skills. Attendees agreed that good management includes ensuring that all the stakeholders understand the process, keeping in touch regularly and reiterating that it’s a business proposal and all members need to remain focused on the product. Hayley also advised treating the application like an exam – really focusing on the elements of the call and making sure it’s a good fit, and considering economic and social impacts.
Ultimately Apitope found the large effort to be worth it for the reward, which was fundamental to move the product and the company forward. They learned a lot from FP7 which made the process for their current H2020 bid easier. While Hayley advised not to underestimate the time involved, she strongly recommended companies to go for H2020 as the scheme is good for business and good for collaboration.
Dr Mark Lees added that Magnus Life Sciences have considerable FP7 experience and have multilingual staff members who are truly connected throughout their consortia. They see strength in being part of multi-disciplinary and international groups and are looking beyond the funding to future collaborations.
Gordon Lundie described UCB’s innovative backing from the European Investment Bank (EIB) which is looking to fund more innovative projects on a partnership model. In a first-of-its-kind ‘at risk co-development funding’ deal, the EIB has reached a milestone agreement on a selection of UCB products across a spectrum of risk in their development stages. UCB has worked with the EIB to diversify the funding of these research projects, and if all the products are successful then the bank will get a good return. Attendees showed considerable interest in the model and Gordon said that, as the ability to share risk and the fast timeline were great benefits over more traditional funding options, he hopes there will be more such EIB funding in the sector. This innovative deal fills a funding gap for companies struggling to get on to the market. He advised that as SMEs are more risky, it might be worth considering approaching EIB with a basket of products, perhaps from a consortium of SMEs.
UK competitiveness and the EU
Reflecting on the prospect of referenda, attendees asked Mr Moore about the potential effects of an EU referendum on funding schemes such as H2020. Liberal Democrat MP Mr Moore and Labour MP Ms McKechin agreed that because the funding programme is up and running, decisions on European funding will remain professional, not political, and UK companies will not be disadvantaged. Ms McKechin also noted that the Business Select Committee has a watching brief and is aware that remaining in the EU is important for UK companies.
Although Mr Moore was not in a position to speculate on whether or not there will be an EU referendum, he recommended that it would be prudent anyway for companies to take that possibility into consideration when planning ahead by leaving some bandwidth and considering their positions.
Attendees agreed that UK innovation could be kick-started by accepting more risky ventures and that, far from thinking about whether or not to leave Europe, with our excellent universities and innovation the UK is in a position to lead Europe in healthcare and medical research.
As many of you will have spotted on the news yesterday, David Cameron held a major reshuffle of his government – one of the biggest in recent years. Whilst the headlines in the papers have mainly focused on the Foreign Office, with Philip Hammond being promoted to Foreign Secretary and William Hague leaving, the key moves which matter most to our sector involve the middle and junior ranks.
The top news for our sector is that George Freeman MP has been appointed as a junior minister (Parliamentary Under Secretary of State) at the Department of Business, Innovation and Skills (BIS) and the Department of Health (DH). This new appointment mirrors the re-organisation of the Office for Life Sciences (OLS) to sit across the two departments and I imagine George, as Minister for Life Sciences, will lead on this policy area. George has followed the life science agenda ever since his election to parliament and, as he likes to say, lost his hair raising VC in biotech, so he knows our sector well. This is a key appointment and means the sector has an informed and engaged advocate in the ministerial team. George also knows the BIA well and he has attended a number of our events, including the Early Access to Medicine Scheme event in April and our annual Parliament Day.
Sadly, after an excellent four years in the position, David Willetts MP has stepped down as Minister for Science and Universities. I paid tribute on behalf of the sector to his work, saying “David Willetts made his mark globally as a minister through championing the UK life sciences sector. He won the BIO International Leadership Award for his commitment to advancing UK biotechnology by delivering this government’s life science strategy, truly understanding what it takes to turn the UK’s fantastic science into the jobs, health and wealth the UK needs in the coming decades”.
Greg Clark MP has been named as the newly appointed Minister for Science and Universities. He has a strong understanding of cities, clusters and planning from his previous brief at the Cabinet Office and has HM Treasury experience. It is expected that Greg Clark and George Freeman will work together closely in their new roles.
At the Treasury, David Gauke MP who has engaged on the Patent Box, R&D Tax Credits and has visited BIA members, has been promoted to Financial Secretary, while Priti Patel MP joins George Osborne’s Treasury team replacing David as Exchequer Secretary.
Another important move is that Lord Hill is to be the Prime Minister’s nomination for European Commissioner. We will watch to see if he gets a brief that encompasses competitiveness or other portfolios relevant to our sector.
For those of you who are interested, a more general brief on changes in the government is available from the BBC.
Award winning – I’m delighted to report that the BIA’s Bioscience Forum won the Trade Association Forum (TAF) Conference of the Year Award at the TAF Best Practice Awards last week. Thank you to Cathy and Karen for all their hard work and for you as members for making it the best trade association event in the UK last year.
It was great to see so many members in good form at Lingfield Park last week for our CEO and Investor Forum. I thought the exchange of views on topics including public markets, private funding, grants, government incentives, market access and collaborations, were high quality and very relevant. It was good to get the latest on initiatives which the BIA has supported, such as MedCity and the Francis Crick Institute (where David Roblin as the new COO will ensure an industry translational focus). It was also interesting to hear that the precise remit of the planned Precision Medicine Catapult is still being refined and that CPI are now planning a ‘Biologics factory of the future’ to go alongside the National Biologics Manufacturing Centre in Darlington.
The evening session on whether the UK biotech sector needs a vibrant public market in London brought about a dynamic discussion, with attendees noting that all public markets have their remits and that companies which are favoured by the London market – such as Circassia or Horizon on AIM – are not the same beasts as ones which can thrive and access finance on NASDAQ – like GW or Oxford Immunotec.
“What a bioscience CEO needs to know about market access today for success tomorrow”, chaired by Dr Nick Crabb, Programme Director of Scientific Affairs at the Centre for Health Technology Evaluation, NICE, was timely and insightful – especially as investors now consider market access planning on a par with regulatory plans. In order to continue investment in projects, big pharma or follow-on investors now expect a developed ‘value story’ at all stages.
I found the interactive session on leading and driving collaboration really helpful, chaired by Executive Coach Sarah Brummitt, with varied insights from tech firm Integrella, head-hunters Odgers Berndtson, global company GE Healthcare Life Sciences and the charity sector represented by the AMRC.
I left the Forum on Friday afternoon with a clear sense that the future is looking brighter – thanks to both the integrated series of financial and fiscal supports available from the UK government in their various guises, and the new-found interest in the sector from non-government sources, either privately funded or through the public markets. My thanks go to all who made the event such a success, but in particular to those members who gave freely of their time and expertise by chairing or participating in panels.
From a personal perspective it was great to see the importance of much of the policy work we have been engaged in over recent years that has come to fruition in the first half of this year. We look forward to hearing first-hand views on the Biomedical Catalyst, the new early access and adaptive licensing schemes, and the extension to R&D tax credits.
The Science Industry Partnership, launched last week, will offer SMEs vouchers for workforce development grants for training needs, which is a key win for BIA members. You can read a guest blog on the SIP today and we will provide more details in coming weeks.
Last week we had a good discussion on accessing European funding for our sector, hosted in the House of Commons by Rt Hon Michael Moore MP – stay tuned to our blog for more details of the discussion. Therefore I’m happy to highlight the launch of the European Public Private Partnerships (PPPs) in several areas, including the second Innovative Medicines Initiative PPP known as IMI 2. The first call for proposals for IMI 2 features two topics: Translational approaches to disease modifying therapy of Type 1 Diabetes Mellitus (T1DM) and Discovery and validation of novel endpoints in dry age-related macular degeneration and diabetic retinopathy. Take a look at our funding opportunities page for further information.
Also last week the global International Council of Biotechnology Associations was officially announced – the BIA are proud to be a founder member of this six continent organisation. The press release is available here.
I’m watching the Abbvie/Shire discussions with interest, as well as the Cabinet reshuffle speculation, and will update members as appropriate soon.