Archives for the month of: May, 2015

Following our CEO dinner in Hinxton last week, which featured guest speaker Dr David Roblin, COO and Director of Translation, this week’s sector video comes from the Francis Crick Institute.

On 1 April 2015, the Francis Crick Institute reached an important milestone as it moves towards opening in 2016. At this time researchers at the MRC’s National Institute for Medical Research and CRUK’s London Research Institute became part of the Francis Crick Institute. Watch the video to hear more.

We’ll be posting the highlights from our CEO dinner with Dr David Roblin on our blog soon – watch this space…

Do you have a video you would like the sector to see? Contact us.

At the State Opening of Parliament today, the Queen delivered a speech to set out the new Government’s legislative agenda for the parliamentary year ahead. Today’s Queen’s speech broadly stuck to the topics that have been discussed in the media over the last few days, including bills on devolution and the EU referendum (although notably, plans to scrap the Human Rights Act have been delayed until after the government has brought forward proposals for their British Bill of Rights).

A detailed briefing – including the Prime Minister’s speech, the Queen’s speech and background information on the bills and other provisions – is available here. The legislative announcements were fairly broad, but we’ve picked out the contents most likely to be relevant to the life sciences industry below.

  • Health – Although not in the form of a legislative bill, the speech mentioned that in England the Government will implement the NHS’s five year plan (NHS England Chief Executive Simon Steven’s Five Year Forward View, published last October). According to the detail in the briefing pack, the Government commits to increasing ‘investment into the NHS by £8 billion a year by 2020’, and transforming services to include ‘faster access to new drugs and treatments’. This will no doubt relate to the outcomes of Life Sciences Minister George Freeman’s Accelerated Access Review (if you’d like to get involved with the BIA’s input to the Review, get in touch).
  • Enterprise – The aims of the Enterprise Bill are to reduce regulatory burden on small businesses (building on prior efforts to cut red tape) and to ‘reward entrepreneurship, generate jobs and higher wages for all’. There’s also a somewhat ambiguous mention of ‘other measures to help strengthen the UK’s competitiveness and back businesses to create jobs’ – we’ll be watching this space.
  • Local and national devolution – On a local level, the Cities and Local Government Devolution Bill will introduce legislation to provide for the devolution of powers to cities and other regions. Putting into place the legislative framework necessary to deliver the Greater Manchester pilot and other future deals, this will help to build the government’s vision of the ‘Northern Powerhouse’ which was mentioned in the last Budget (see our Budget commentary for more detail on regional measures). The Bill will allow cities to bid for an elected mayor, and will devolve budgets and powers over planning, transport, policing and possibly health in order to boost local growth and raise UK productivity.
  • Unsurprisingly, devolution was a key theme in today’s speech and is the focus of four of the 25 new bills. In recognition that the UK ‘has changed, and that we need a union for the 21st century’, the Scotland Bill, the Wales Bill and the Northern Ireland Bill will aim to ensure ‘wherever you live in the United Kingdom, that you have a government that is on your side and representing your interests’. In the same vein, the Government will implement changes in the House of Commons to ensure decisions affecting England, or England and Wales, can only be taken with the consent of the majority of MPs representing constituencies in those areas (so-called ‘English votes for English laws’).
  • European Union Referendum Bill – Of course the speech also covered the Government’s commitment to ‘renegotiate the United Kingdom’s relationship with the European Union and pursue reform of the European Union for the benefit of all Member States’. The European Union Referendum Bill will legislate for an in-out referendum on British membership of the EU before the end of 2017. As set out in our UK Life Sciences Manifesto 2015-2020, the BIA maintains that the Government needs to set out a clear plan of the expected disruption to UK life science businesses, including how it would expect to handle the European Medicines Agency leaving London, how medicines would be approved and regulated, and the likely impact on investment.
  • Other: employment and transport – Skills and transport are also on the Government’s agenda, with other measures including a target to start three million more apprenticeships in the next five years and provisions to allow Government to build and operate the HS2 high speed rail link between London and the West Midlands.

Now that Parliament is officially re-open for business, MPs will debate the content of the speech over several days. In the coming weeks, as further departmental appointments will be made and select committees will begin to have Chairs assigned and members elected, BIA will continue to communicate developments of interest to the sector, and look forward to our annual Parliament Day with senior biotech representatives and policymakers on 25 June. For more information, contact us.

Chiswell_600300I hope you all enjoyed the bank holiday weekend and are back refreshed and ready for another week.

We had a great couple of days in Cambridge last week with our CEO dinner at Hinxton and the latest BIA breakfast at the Babraham Research Campus. Our guest speaker for the dinner, Dr David Roblin, COO and Director of Translation, Francis Crick Institute updated us on the Crick’s mission to create a world-class discovery institute extremely open to translation. In a little under 24 months they hope to have 1500 staff including 1250 scientists at their new state-of-the-art facility near King Cross Station in London. The BIA will be working closely with David and the Crick team over the next few months and will keep members updated on their progress and news.

The following morning, we headed over to the Babraham Research Campus for the third in our series of investor-ready events in 2015. Kymab’s David Chiswell kicked off the morning discussions, following their recent announcement of a US$90 million fundraise. Jane Dancer, COO F-Star, followed with an interesting presentation on the advantages of the company’s flexible modular structure – creating the two asset-centric vehicles F-star Alpha and F-star Beta. We also heard from Autifony’s Barbara Domayne-Hayman, who discussed the transformational effect of the Biomedical Catalyst for prospering start-up companies. Serial biotech entrepreneur Andy Richards concluded the presentations, providing an overview of the current economic market. It was interesting to hear his thoughts on the shift in the biotech ecosystem, as more start up companies look to scale up, and the challenges of doing so. Some lively discussion brought the morning to a close, with comments around the current need for more bright young talent to move into the small pool of seasoned CEOs – something we recently covered as part of the vision the BIA launched at the end of April.

Many thanks to all who came along to both events – we’ll be writing up the highlights on the BIA blog in the coming weeks, so keep an eye out.

On the topic of bright young talent, congratulations to Heptares Therapeutics’ Dr Steve Andrews, a Principal Scientist in its Medicinal Chemistry group, who has been awarded the prestigious EFMC Prize for a Young Medicinal Chemist in Industry. The prize, awarded annually by The European Federation for Medicinal Chemistry (EFMC), acknowledges and recognises an outstanding young medicinal chemist (<10 years after PhD) working in industry within Europe. A great showcase of UK talent.

Some good news last week as figures published by London & Partners, the Mayor’s promotional company for the capital, showed that a record number of leading international companies are investing in the London life sciences sector. The number of life sciences jobs in London tripled in the 2014-2015 financial year from the previous year, with eight foreign companies creating a total of 101 new jobs in the sector. It’s fantastic to see this international investment enriching the ecosystem both in London and also, more widely, the UK life sciences sector.

If you’re heading to the BIO Convention in a couple of weeks, please do register for our pre-BIO webinar ‘Making the most of your time in Philadelphia’ here. We also have two networking events in June – our Annual Lecture with Sir William Castell, Chairman, Wellcome Trust on 4 June and our Summer networking Reception on the Thames on 25 June – a busy month ahead! Please do join us.

For those who missed it, last Monday BBC One aired the latest Panorama, ‘Antibiotic Apocalypse’ featuring interviews with Dame Sally Davies and Jim O’Neill. You can catch up on iPlayer here.

This week will see the Queen’s speech take place on Wednesday. As always, we’ll be monitoring the content and will endeavour to keep you updated on anything of relevance to the sector. I’ll also provide a top-level summary of the highlights in next week’s Newscast CEO update – which, in a change from our usual schedule, will take place on Tuesday next week.

Best,

Steve

Innovate UK, the UK’s innovation agency, has a new chief executive for the first time in 7 years. Dr Ruth McKernan CBE joined the organisation on 1 May, and will lead Innovate UK for at least the next five years.

In today’s video, she talks to Michelle May about her background, her motivations and her vision for the organisation.

Read the BIS press release here.

Do you have a video you would like the sector to see? Contact us.

Angela KukulaIn March this year, the BIA submitted our response to Dame Anne Dowling’s review of business-university collaborations, highlighting the increasingly collaborative nature of the UK’s life sciences sector. In today’s blog, Dr Angela Kukula, Director of Enterprise at The Institute of Cancer Research (ICR), London, discusses the importance of the relationship between academia and industry to the success of the Institute.

How academic institutions can work more effectively with industry is an age old question that has been the subject of many reviews without finding a perfect solution. Another of these reviews, the Government-commissioned Dowling Review, launched in January this year with the aim of ‘helping researchers to understand better the interests of industry’.

It’s of course always worthwhile to try to understand how we could do things better – but we shouldn’t lose sight of the fact there are many researchers who already have a good understanding of how to work with industry and many organisations already forging successful links. Here, at The Institute of Cancer Research (ICR), London, our success depends on close industry collaboration. Our mission is to make the discoveries that defeat cancer, and in many cases working with industry is the fastest and most efficient way to take our discoveries to patients. Working with companies gives our research projects greater access to resources, research tools and complementary skills and gives industry access to our world leading research.

Which of course, is the main reason industry wants to partner with us – to share the benefits of our research excellence. Businesses want to work with the best academic minds in their fields. This is a particular strength for the ICR – we came first overall in the Times Higher Education league table for university research quality compiled from the Research Excellence Framework. We were the leading higher education institution in the UK for the impact for our research on society and topped the table for biological sciences. We are also the world’s most successful academic organisation at cancer drug discovery – discovering 17 preclinical drug candidates since 2005, seven of which have progressed into clinical trials.

But research excellence is not the whole story, so we have had to adapt over the years to become more effective at working with industry. We have succeeded in this, for example over the last three years we have increased our number of industry contracts by 50% and increased their value by 200%. Though our main driver in these collaborations is to ensure our research reaches cancer patients, the ICR also continues to be the most successful higher education intuition in the country at earning invention income from its research – money which we use to fund more of our leading-edge research.

Our success is a result of our flexible and pragmatic approach to working with industry. We believe that all parties involved in collaborative research must communicate frequently in order build mutual respect, understanding and trust, and both parties must have the flexibility to accommodate the unexpected, find solutions to the inevitable problems that will occur and compromise where necessary. Movement of people between the academic and commercial sectors can also play an important role in promoting cultural understanding. Many of our academics have spent time working in industry.

There are also external factors that are essential to support these relationships. Funding from the Higher Education Innovation Fund (HEIF) has been a critical factor for our success. This has enabled us to build a team of professional business development managers who are able to cement the interactions with industry required to take our research into commercial development. In the 2013 Witty Review, Sir Andrew Witty recommended that the Government should increase HEIF funding to £250 million per year. We strongly support this recommendation and also believe that funding streams, such as HEIF, need to be flexible enough to support a range of activities.

UK science funding is also an important external factor. The gradual decline in the UK’s science spending risks slowing scientific progress, and the widening gap between UK investment in research and development and that of our competitor countries is a cause for concern.

Over the years many different initiatives have been set up to try to encourage collaborative working between industry and academia, with varying degrees of success. I can think of at least 17 different funding schemes all trying to address this same issue. These schemes often change before we know they are effective, and a changing landscape with many different initiatives can be hard for academic institutions and businesses alike to navigate. What we really need is secure long term government funding schemes to support research and development in the UK.

With a new Government in parliament, with new decisions to make on research spending and the allocation to HEIF, and the Dowling review collecting evidence, this is an interesting time for academia-industry collaborations. But whatever the future holds, we will continue to work closely with our industry partners – because cancer patients are depending on it.

The industrial biotechnology sector in the UK is growing. Estimates suggest that the potential size of the UK market could reach between £4 billion to £12 billion by 2025. Modelled on the Biomedical Catalyst, round four of the Industrial Biotechnology Catalyst will open later this week, with an additional £34 million funding available from Innovate UK, the Biotechnology and Biological Sciences Research Council (BBSRC) and the Engineering and Physical Sciences Research Council (EPSRC). Earlier this year, BIA member Green Biologics Ltd were awarded an early stage feasibility study grant as part of the competition – read their story below.

Green Biologics Ltd’s (GBL) January 2015 announcement of the successful completion of a fundraising round of $42 million came hard on the heels of the announcement that we had closed on the purchase of our first commercial plant – a Minnesota ethanol plant that will be retrofitted for the production of n-butanol.

Our process is based on an old technology. Solventogenic clostridial strains have been used since the early 1900s, initially for acetone production during the First World War, and then for making n-butanol. GBL has transformed and optimised these processes and generated new strains for the 21st century, enabling us to once again exploit this Acetone Butanol Ethanol (ABE) fermentation pathway. Our goal is to make renewable n-biobutanol sustainably but also cost-competitively with existing petrochemical manufacturing processes. However this is just the beginning for GBL. Solventogenic clostridia are robust industrial workhorses and with the increasing availability of tools for genetic manipulation, coupled with the rapidly developing field of synthetic biology, they are a promising platform for manufacturing a variety of high-value chemicals. It is with an eye toward this future metabolic expansion that we have been awarded funding through an Innovate UK Industrial Biotechnology Catalyst early stage feasibility study grant. Starting in April 2015 we will seek to demonstrate our proprietary genome engineering tools through the construction of a number of recombinant strains, each designed to demonstrate a new capability; feedstock utilisation, feedstock conversion or new metabolic product synthesis.

It is a challenging task because the synthetic biology ‘standardised parts’ for clostridia are very much a work in progress. Codon optimising and synthesising a gene target is now the easy bit – a number of companies provide this service, and even with the AT rich clostridial genome this is a fairly standard service for us. But as we venture further down the route of inserting new pathways and functionality into the cells, the simplest of questions start to become problematic. How do we regulate gene expression? How do we build functional artificial operons? And how do we make sure non-endogenous proteins are correctly folded and reach their required destination? With our molecular biology strengths these are not insurmountable. Perhaps the key questions therefore are what effect will these new features have on the clostridial physiology? How will the cellular metabolic pathways be affected and what unexpected consequences are we going to encounter? At this stage these are very much unknowns.

GBL also needs to consider responsible innovation. It is important to us that we understand and respond to the risks and potential societal benefits resulting from our research. As our technology matures and work begins on our US butanol plant, we are actively engaged with the local community and this will no doubt be a learning process for us going forward.

Despite the challenges, we are looking forward to starting this project. The need for creative solutions to overcome hurdles is motivating and ultimately success will allow us to showcase the use of these versatile microbes as platform hosts for a whole range of industrial biotech processes. We are ready to reboot this old technology for the greening of the chemical industry in the 21st century.

Round 4 of the Industrial Biotechnology Catalyst opens on 21 May. A webinar briefing for the competition will take place on 28 May.

Full details of all current Innovate UK funding competitions can be found here. A range of funding opportunities are also regularly highlighted and updated on the BIA website – click here for details.

Breakfast Banner no logoLast week we reported back on the outcome of the election and what this means for the make-up of Parliament. This week we have seen the Prime Minister appoint his Cabinet and government Ministers. For our sector the key appointment to note is that George Freeman has been reappointed as the Minister for Life Sciences and Innovation sitting across the Department for Business and the Department of Health. This provides beneficial continuity and prominence for our sector in the new government and sets up the previously announced Accelerated Access Review as a key policy focus for the rest of 2015. The BIA is engaging with the Minister and his team on this at our Parliament Day on 25 June and we are keen to hear members’ views on this important issue.

However whilst there is much continuity from the make-up of the last government to the 2015 intake, there is also some change to note, much of it resulting from the appointment of Conservatives in posts previously held by Liberal Democrats:

  • At the Department for Business, Sajid Javid replaces Vince Cable as Business Secretary, having previously sat at Cabinet for the Department of Culture, Media and Sport and also bringing extensive Treasury experience to the brief.
  • Also at the Department for Business, Anna Soubry is appointed to a new role as Minister for Small Business and Jo Johnson, younger brother of Boris and former head of the No 10 policy unit, takes the Science and Universities Minister spot from Greg Clark, who has been promoted to Communities and Local Government Secretary.
  • Greg Clark seems to take the cities brief with him in his move from the Business to the Communities Department, with a newly appointed Minister for the Northern Powerhouse, James Wharton, reporting to Clark.
  • The Northern Powerhouse is an area that has been linked to another new appointment, Jim O’Neill as Commercial Secretary at the Treasury. O’Neill, who has currently been leading on the AMR review, will be appointed to the Lords as a Conservative Peer.
  • Other Peers being introduced to fill Ministerial posts include Francis Maude, the new Trade Minister; Davis Prior who joins the Department of Health as Minister for NHS Productivity (replacing Freddie Howe who moves to Defence) and Ros Altmann, the new Pensions Minister.

The BIA will begin engagement with this new political cast and is currently also further developing its position on two issues likely to dominate in the coming years – Europe and devolution – we’ll be further consulting you on your views on these issues – watch this space.

It’s been a busy week for Jim O’Neill. Alongside his appointment by David Cameron, the third report as part of his review into antimicrobial resistance was released on Thursday. Securing new drugs for future generations: the pipeline of antibiotics focuses on the need to boost the development of new antibiotic drugs, including a proposal for a global AMR Innovation Fund of around $2 billion to de-risk R&D and kick start basic research into new antibiotics. The BIA have ensured that Jim O’Neill will have a platform at the leading global industry BIO conference this summer, and it’s great to see that he sees this as “a starting point not an end point” to this important global debate. He will be able to present his ideas for a global AMR Innovation fund there and we look forward to being part of the discussion.

Also announced at the end of last week was the acquisition of Prosonix, a previous recipient of Biomedical Catalyst funding, by LSE-listed Circassia – great news for both parties. Circassia’s announcement also included details of another acquisition, that of Swedish company Aerocrine, bolstering their offering in asthma and creating “a world-class allergy and asthma specialty pharma business” – a fantastic boost for the UK ecosystem.

It was also great to see in the headlines this morning, news of the “groundbreaking” results from a trial of a cystic fibrosis therapy developed by BIA member, Vertex Pharmaceuticals, which modifies the genetic defect that causes around half the cases of the disease. What’s fantastic to see is the development of Kalydeco from a treatment for a small population of patients, to now part of a combination treatment which could be effective in around 50% of cases.

In other BIA member news, I was delighted to hear that Dr Harren Jhoti of Astex Pharmaceuticals, and BIA Board member, was one of four leading industry experts elected to the Academy of Medical Sciences among this year’s cohort of new Fellows, alongside new Innovate UK CEO, Dr Ruth McKernan, Dr Menelas Pangalos of AstraZeneca and Immunocore’s Prof Bent Jakobsen – four great additions to the Academy Fellowship. Congratulations also to Dr Ian Wilding who was recognised with an honorary doctorate from Monash University.

On Thursday evening I was pleased to be able to attend the European finals of the OneStart Award – a fantastic showcase from the future pioneers of the biotech industry. Congratulations to London-based Keregen who walked home with the £100 000 grand prize, as well as a year’s free membership of the BIA. Check out our video of the week to find out more about the company.

In policy, the BIA has inputted to the latest Treasury consultation on EIS/SEIS scheme operation as part of a wider review of tax-advantaged investment schemes. In our response we welcome the implementation of changes we had previously called for, including differentiated treatment of ‘knowledge-intensive’ companies such as those operating in bioscience, in order to incentivise investment towards such high-risk innovative sectors such as ours.

The Stop Vivisection initiative finally had its public hearing at the European Parliament in Brussels last week, who now have until 3 June to decide their next move. After all the hype, the reality appears to have been a somewhat muted affair. Nature have written a comprehensive article on recent developments in the argument from across the continent, which you can access here. We’ll be keeping an eye out for any response over the next couple of weeks.

Earlier this month, the first in a series of medicines manufacturing workshops, delivered by the KTN in partnership with the Medicines Manufacturing Industry Partnership (MMIP), supported by the BIA and ABPI, took place in Liverpool. The KTN have now written up a blog from the event, which focussed on the development of supply chains for the future – take a look here.

Finally, six of the UK’s leading technology transfer offices (TTOs) – Imperial Innovations, ISIS Innovation, Cambridge Enterprise, UMIP, UCLB and Edinburgh Research and Innovation – have recently published a briefing paper explaining the role and achievements of TTOs, and answering some frequently asked questions. The paper, which can be downloaded here, is of particular interest following the publication of our vision for the life sciences sector in 2025 which highlights the need for improvement in technology transfer in the UK.

Look forward to seeing you in Cambridge for our dinner and breakfast at the end of the week, and I’ll report back on the highlights next Tuesday following the bank holiday.

Best,

Steve

Last night, London-based Keregen were crowned the 2015 winners of OneStart Europe, receiving the £100k grand prize – and even better, a year’s free membership of the BIA!

Keregen develops first-in-class medicines for the prevention and treatment of neurodegenerative disease and is currently focussed on disease modifiers for Parkinson’s. Watch Jemma Gatliff, co-founder and CEO of Keregen, give some background to the company in their semi-finalist video from earlier in the competition.

Find out more about OneStart from our previous video showcase here, and read our guest blog from 2013 OneStart winner, Puridify’s Oliver Hardick, here.

Do you have a video you would like the sector to see? Contact us.

PersonalizedMed_Graphic (2)The goal of precision medicine is to foster a new healthcare approach where patients receive a tailored system based on their individual disease. This takes medicine away from the broad spectrum blockbuster drug approach, towards designing a specific treatment regimen to patient’s unique characteristics. It is hoped that this approach will be more likely to be effective for patients and improve their treatment outcomes. Rebecca Cummings of Cancer Research UK and Hannah Murfet of Horizon Discovery examine the potential of personalised medicine and recent collaborations in this exciting area.

Clinical trials for new treatments are typically tested on large patient populations to assess safety and efficacy. Individual tissues from individual patients show different properties; therefore studying treatments in large populations may not show how or where a treatment could be most effective. Where there is no or limited response to treatment this has a profound impact on the patient and the whole healthcare process, from losing precious time to the funding spent on ineffective treatment. Notable successes for precision medicine are increasing on an exponential rate; this includes lung cancer, breast cancer, chronic myeloid leukaemia and colorectal cancer. Enabling new designs for trials to support this research is crucial.

One programme that is looking to assist with taking precision medicine to the standard of care in the UK is Cancer Research UK’s Stratified Medicine Programme 2 (SMP2). The programme aims to change the way we deliver innovative targeted therapies to late-stage lung cancer patients in the UK by using the specific genetic profile of each patient’s individual lung tumour. Through this research it is hoped that it will be possible to identify groups of patients who are more likely to benefit from a number of different targeted drugs.

SMP2 will take up to 2,000 non-small cell lung cancer patients through innovative Next Generation Sequencing (NGS) testing. NGS allows the patients genetic biomarkers to be determined and matched to a treatment regimen under the National Lung MATRIX trial (MATRIX). The trial is being led by Birmingham’s CRCTU and Prof Gary Middleton, and is a multiple biomarker/multi-drug trial (multiple drugs reviewed against multiple genetic markers). This co-ordinated approach aims to assist the UK in establishing the infrastructure for precision medicine and drive forward the understanding on the relationship between biomarker and treatment.

Precision medicine is having a profound impact on both healthcare and regulatory infrastructure. New concepts must be considered from the volume of data, to new biomarkers of unknown clinical significance, to challenges over accuracy and consistency. One notable challenge has been observations in proficiency testing studies of Next Generation Sequencing; this has shown that variation in biomarkers detection can depend on the workflow approach undertaken.

To ensure consistency of results in the SMP2, Cancer Research UK will use Horizon Discovery’s reference materials. These reference materials contain the cancer specific genetic biomarkers and can be screened by NGS to confirm agreement across instruments and laboratories and to show consistency. The value of these reference materials is that they are cell-line derived and thus provide a sustainable common reference point. The programme relies on a community effort to embed precision medicine into UK healthcare. Collaborations between Cancer Research UK and organisations such as Horizon Discovery are contributing to this success.

In a world of precision medicine, the cost of treatment will be reduced in the long term, by removing expensive and ineffective approaches to diagnosis and treatment. It is a really exciting time for the pharmaceutical and medical device fields. It’s time to make medicine personal.

On 11 June, the BIA and the Medicines and Healthcare Products Regulatory Agency (MHRA) will be joining forces to hold our established conference for the fifth year. As the event draws closer, we’ve highlighted what you can expect from the day below.

The fifth joint UK BioIndustry Association (BIA) and Medicines and Healthcare Products Regulatory Agency (MHRA) conference presents the opportunity to network with regulatory experts, while showcasing the collaborative approach between stakeholders to support innovation and facilitate clinical development and timely access to new treatments and vaccines.

This year the keynote presentation will be delivered by Professor Sir Michael Rawlins, newly appointed chair of the MHRA, who will discuss patient access to innovative therapies and technologies. With senior experts and leading speakers from the MHRA and National Institute for Biological Standards and Control (NIBSC), the life science industry, the Wellcome Trust, the Jenner Institute and patient organisations, the conference is the ideal place to hear the very latest thinking on topics including:

  • Patient involvement. During this session an insight into patient involvement in regulatory decision-making and drug development will be provided from patient, industry and regulatory perspectives. Guaranteed to spark discussion, the session will be followed by a panel discussion and Q&A.
  • NIBSC/ MHRA post-merger. Following their merger, both organisations are keen to showcase their collaborative approach in the research and development of medicines. Speakers from the NIBSC and MHRA will engage the audience in areas such as progress with advanced therapy medicinal products and recent regulatory developments in this area, and the role of NIBSC in the standardisation of biosimilars and development of assays for immunogenicity.
  • Accelerated regulatory approvals and processes. Taking the response against the Ebola virus disease as a case study, the afternoon session will focus on stakeholder collaboration to address public health emergency and find innovative solutions to facilitate clinical development and timely access to new vaccines and treatments. Following a key note presentation, ‘Ebola – Where are we today and where are we going?’, academic, industry and regulatory presentations will cover activities from bench science to clinical research. A panel discussion and Q&A will round off the afternoon, covering lessons learnt and how they might apply to other therapeutic areas.

If the above details have peaked your interest, you can find out more about the event – including full programme details and confirmed speakers – here.

The fifth joint BIA and MHRA conference, Pathway of Innovation from Research to Patients, will take place on Thursday 11th June at the Wellcome Trust, and is open to all members and non members. To register please click here.