Archives for the month of: March, 2016

JDRF logo

Earlier this month we revealed that our fundraising efforts at the annual BIA Gala Dinner raised more than £30,000 for our charity of the year, JDRF, the type 1 diabetes charity. The money raised will go towards enabling future UK research into the disease. Here, Dr Clare McVicker, Director of Research Advocacy at JDRF, details some of the pioneering research currently being funded by the charity.

The BIA Gala Dinner was a fantastic event. The venue was spectacular and what an opportunity to network and meet lots of you. I was lucky enough to be there representing JDRF, the type 1 diabetes charity – BIA’s charity partner for 2016.

Thank you so much for supporting us through this event – together you raised over £30,000! These funds will go towards supporting JDRF’s research programme. Our portfolio covers research to cure, treat and prevent type 1 diabetes and its complications, but we don’t stop there. We’re making this life-changing research a reality for the people who need it. That’s why we ensure our impact is felt at every stage of the research pipeline, from funding world-class research, to lobbying for regulatory approval and reimbursement by health systems.

We are currently supporting over 450 projects in 18 countries worldwide, and since our founding in 1970, we have given over £1 billion to research. In the UK alone, we currently have £23 million committed to projects right across the country. The money you raised through the gala dinner will help us support this pioneering work.

Let me tell you about some of the flagship projects we’re working on.

JDRF_image

Ultimately our aim is to find the cure for type 1 diabetes. One way to do this is to replace the damaged insulin producing beta cells with cells grown outside the body, and protect them from the immune attack with a physical barrier.

JDRF funded researchers have been hitting headlines recently by developing new cell sources for transplantation. For example Professor Doug Melton at Harvard, and Professor Daniel Anderson at MIT worked together to place a new cell line of glucose-responsive insulin-producing cells in an innovative alginate hydrogel. They recently announced that these protected cells could deliver long-term glycaemic control in a mouse model of type 1 diabetes. We’ve also invested significantly in a partnership with Californian biotech company Viacyte to develop an innovative combination product involving a pancreatic islet cell source and macro-encapsulation device, which is now in phase 1 clinical trials.

Technology is already a vital tool in managing type 1 diabetes. JDRF supports a consortium of academic institutions and companies, all working to develop “Artificial Pancreas” systems to closely mimic the glucose regulating function of a healthy pancreas using existing insulin pump and glucose sensing devices. JDRF’s decade long investment in this area has created a whole range of opportunities for this technology to be developed into commercial products that can help families affected by type 1. We are proud to be partnering with many companies looking to bring this transformative technology to market.

There are so many other things to talk about from our pioneering work on glucose responsive insulins, a completely novel concept in insulin delivery, to innovative approaches to immunotherapy which will combat the autoimmune attack at the heart of type 1, but I’m out of space! The £30,000 that you raised helps enables us to pursue these opportunities, and many more besides. Thank you again for joining us in the pursuit of a world without type 1 diabetes.

And remember, if you are working in type 1 diabetes – or would like to do so – please get in touch so we can talk some more!

Oxford Dinner

A packed update for you this week following lots of activity in the lead up to the Easter break.

I was delighted to attend the launch of the new Advanced Therapy Manufacturing Taskforce of the Medicines Manufacturing Industry Partnership (MMIP) last week. Co-chaired by Minister for Life Sciences George Freeman and Ian McCubbin, GlaxoSmithKline, the new taskforce will be working to identify opportunities and actions to anchor advanced therapy manufacturing and the associated supply chain in the UK and to identify any gaps in the manufacturing landscape that need to be tackled.

Working together through the KTN, ABPI and the government’s Office of Life Science the taskforce is committed to delivering “a business plan” built on existing UK assets to articulate a clear vision for the growth of the sector and a simple but ambitious plan for the coming years with 3- 5 big asks with the associated risks. The taskforce has committed to complete its work this year.  It’s vital that the UK becomes not just a great laboratory for advanced therapies but a great place for them to be manufactured and commercialised. The MMIP taskforce will play a key role in ensuring that this leading sector of modern UK manufacturing continues to grow and produce these ground breaking therapies that will help to solve unmet patient needs both in the UK and its export markets.

Taking the opportunity to engage with a different community, on Wednesday we travelled to Oxford to host a dinner (pictured above) bringing together CSOs and CMOs from within BIA membership. There were some great discussions over dinner around building upon our engagement here and over the coming weeks we’ll be proposing some news ways in which we connect this crucial network in our community in the future.

On Tuesday I appeared before the House of Commons Science and Technology Select Committee to give evidence on the impact of European regulation on UK life sciences, following the BIA response we submitted to the inquiry earlier this month. Throughout 2016 we’ve been working to ensure that the voice of the UK life sciences industry is heard loud and clear in the Brexit debate. BIA members have said they believe the industry will be stronger if we remain in Europe and we will continue to push this message over the coming months. If you’re interested in adding your voice to this issue, please get in touch, and you can find out more about our recent advocacy work in this area here.

Elsewhere on policy, there was movement on the Accelerated Access Review (AAR) as we gear up to the final report. Since the interim report was published last October, the AAR team has commissioned research on key questions to support this work. The findings have now been published and can be viewed here. I look forward to seeing the final report in the coming months.

Also on policy, we submitted a short response to the government’s review of the REF – the Research Excellence Framework that assesses the quality of university research and informs how funding is distributed. In line with members’ views, we recommended that the REF’s approach of assessing wide-ranging impacts (which included increased life expectancy and improved quality of life) is a positive step and should be continued. We also recommended that the weighting of impact relative to output (primarily publications) should be increased.

On antimicrobial resistance (AMR), Jim O’Neill’s review team published the latest in their series of reports, looking at the central role that infection prevention, control and surveillance need to play in combatting the rise of drug-resistant infections – you can read the report in full here. And it was fantastic to see BIA member Redx Pharma, whose pipeline includes programs that seek to address drug resistance, raise an additional £10 million last week following their listing on AIM a year ago.

Taking a different approach to fundraising, congratulations also to Axol Bioscience who, through crowdfunding site SyndicateRoom, have surpassed their £600,000 target to raise £1 million – a great result. It was also interesting to see BIA member Scancell revealed as SyndicateRoom’s first Public Market Placing, following their partnership with the London Stock Exchange announced earlier this month. The use of crowdfunding platforms has become an increasingly popular fundraising method within the biotech sector over the past year following Cell Therapy’s near £700,000 record in February 2015. Certainly an interesting space to watch.

A month ago I mentioned progress of the Access to Medical Treatments (Innovation) Bill, regarding the appropriate use of innovative approaches in medicine. The Bill has evolved since its original incarnation as the ‘Saatchi Bill’ to address concerns around patient protection and medical negligence, and it also now includes clauses to establish a national database recording the use and results of innovative and off-label medical treatments. To keep you up to date, last week the Bill passed its third reading in the House of Lords and received Royal Assent, meaning it has passed into legislation. How the new database will operate and how it fits alongside the present regulatory system, its impact on clinical trials and its impact on safety reporting are key issues of concern.

Finally, the Academy of Medical Sciences 2016 FORUM Annual Lecture takes place on 6 April. It promises to be another great evening with Dame Julie Moore, Chief Executive of University Hospitals Birmingham NHS Foundation Trust, presenting on ‘Breaking down the barriers between research and practice to improve productivity in the NHS’. BIA will be in attendance and if you’re interested in finding out more, further details are available here.

Best,

Steve

On Tuesday, BIA CEO Steve Bates appeared before the House of Commons Science and Technology Select Committee to give evidence on the impact of European regulation on UK life sciences, building on the BIA response we submitted to the inquiry earlier this month.

Watch the evidence session by clicking on the image below. You can find out more about the BIA’s position on the EU referendum and our recent advocacy work in this area here.

Steve Commons STC

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SynpromicsThe explosion in the field of synthetic biology is causing ripples across the biotech industry. In today’s guest blog, David Venables and Michael Roberts of Synpromics, discuss the impact of synbio on another exciting area of biotech, gene therapy, by reducing the cost and increasing the scale and efficiency of viral vector manufacturing.

Synthetic biology is a relatively new discipline within the biotech industry, having leapt onto the scene only a decade ago, largely to address specific needs arising in the industrial biotechnology sector. There have been many definitions put forward over the years, but synthetic biology is broadly accepted as being the application of engineering principles to biological processes to improve and exploit them for commercial gain. A number of small start-ups are leading the field, and there is a strong entrepreneurial spirit akin to that seen in the IT sector. The vision is that all biological parts can be standardised and taken ‘off-the shelf’ to build complex biological systems that can be used to improve upon various industrial or, more recently, biomedical processes.

The synthetic biology landscape in Europe

The synthetic biology landscape in Europe, SynBioBeta

Synpromics is a synthetic biology company. We have IP and knowhow in the design of synthetic promoters – stretches of DNA just upstream of a gene that determine protein transcription/translation efficiency. Our synthetic promoters are designed to enable the controlled expression of genes under specific conditions: in a specific place or environment, or in response to a specific biological condition.

At the beginning of this year, we were delighted to announce a collaboration with the Cell and Gene Therapy Catapult, to remove a major barrier to the development of the cell and gene therapy industry by reducing the cost, and increasing the scale and efficiency of viral vector manufacturing. The collaboration will use our synthetic promoter design technology, and the Cell and Gene Therapy Catapult’s flexible manufacturing platform to create stable producer cell lines for the high titre and large scale manufacture of viral vectors. The work will be part funded by a £2m grant from Innovate UK.

Applications of synthetic biology

Applications of synthetic biology, SynBioBeta

Viral vectors are a crucial tool needed to modify patient’s cells to create a therapeutic effect. Established manufacturing platforms are limited by laborious processes, a lack of automation and low yields. This restricts the utility of viral vectors for the treatment of diseases where large amounts of virus would be needed, and has to date confined their use to local applications such as in the eye and to less prevalent indications, including orphan diseases.

This project will use synthetic biology to develop novel and controllable gene-expression promoters to drive the production of a much higher level of viral vector yield from new stable cell lines. This will allow the industry to produce vectors to much higher titres and with more efficiency, removing the current constraints associated with plasmid transfection of anchorage dependent cell lines.

For instance, these constraints particularly limit the manufacture of AAV-based viral vectors, where vector batches are currently produced from very low culture volumes (often only a few hundred litres). AAV is now the vector of choice in a number of clinical protocols as it mediates long-term gene expression, efficiently infects a number of different cell types and elicits a reduced immune response compared to previously used vectors. If AAV is to be widely adopted in the clinic then it is imperative that larger batches can be made in bioreactors to much greater scale (i.e. approaching tens of thousands of litres).

The project will run for three years, and will be focused on developing prototype cell lines to deliver industry relevant viral vectors, including Retrovirus, and Adeno Associated Virus. Synpromics will be responsible for the expression platform development with the Cell and Gene Therapy Catapult responsible for process industrialisation and control.

This will be the fifth major collaboration for Synpromics to apply our synthetic promoters in gene therapy. We believe Synpromics’ technology will provide a critically needed solution to high titre, industrial scale, vector manufacture, a critical barrier in the gene therapy industry. The result of this solution will be a major advance to the commercialisation of gene therapies in non-orphan drug indications.

Budget2016 pic_Newscast

Last Wednesday George Osborne delivered his latest Budget statement. As expected, the overall tone of the Budget continued that set at last July’s Budget and reinforced again in November at the Autumn Statement to evolve the UK to a higher wage, lower tax and lower welfare economy. For the main implications and announcements of relevance to the UK’s biosciences sector, do read our blog in full here.

It was positive to see the emphasis given to supporting British enterprise to support UK growth in the Budget statement. Reductions in the rates of Corporation Tax and Capital Gains Tax are both welcome and the move to extend Entrepreneurs Relief to longer term external investors responds to calls made by the BIA for the government to ensure reliefs effectively support high risk entrepreneurial companies that are the lifeblood of the UK’s life sciences sector.

It was disappointing not to see more on innovation policy in last week’s announcements. We understand more is to follow from the forthcoming National Innovation Plan and the BIA will continue to work with government on behalf of its members to ensure innovation policy takes the central position it deserves as a driver for the 21st century UK economy.

You can access the full documentation associated with Budget 2016 here.

Elsewhere last week, I was delighted to be able to announce the final figure raised for our charity of the year JDRF, the type 1 diabetes charity, at January’s Gala Dinner. In total over £30,000 was raised through the silent auction and donations throughout the night. It is fantastic to see that our members have really shown their support to such a worthy cause. Type 1 diabetes affects thousands of people in the UK and many of our members are actively involved in medical research to develop new treatments to support those living with type 1. You can read more about the partnership in this guest blog from Clare McVicker, Director of Research Advocacy at JDRF in the UK.

In another development for the sector, announced last Wednesday, UK-listed BIA members Vectura and Skyepharma announced their plans to merge. The creation of this new company is a great addition to the biotech ecosystem, building the UK’s offering of midsized companies – an essential component on our track to creating the world’s third global biotech cluster. Congratulations to both teams.

Also on policy, the Europe debate continues to move and, following our written submission, I will be giving evidence tomorrow as part of the House of Commons Science and Technology Committee inquiry into the impact of EU regulation on UK life sciences. Updates to follow next week.

For those of you preparing to head to Stockholm at the beginning of April for BIO-Europe Spring, do sign up to our webinar taking place tomorrow. I’ll be joining forces with Harriet Fear, Mike Barrett and Lucy Robertshaw to give you an outline of the main networking events, the UK delegation activities, sessions/keynotes and details on some of the main activities happening throughout the three days so you can plan your time effectively.

Finally, one for companies looking to scale up – ELITE are looking for the next cohort of companies to join at the end of April 2016. Delivered by London Stock Exchange in partnership with Imperial College Business School, ELITE enhances the growth prospects of member companies through a unique package of education, business support and access to investors. More information is available from this factsheet if of interest.

Newscast will be back next Tuesday following the bank holiday, so until then, enjoy the Easter break.

Best,

Steve

Today’s video showcase comes from BIA member, GlaxoSmithKline (GSK).

GSK’s vaccines business is one of the largest in the world, developing, producing and distributing over 1.9 million vaccines every day to people across more than 150 countries.

Find out more in the video below.

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

Budget2016 pic

Today’s Budget Statement fell at an unwelcome time for the Chancellor. Between global economic headwinds and turmoil closer to home within the Conservative party as the UK heads towards the poll boxes on Europe in June, the pressure was on for the Chancellor to deliver a solid performance.

As expected, the overall tone of the Budget continued that set at last July’s Budget and reinforced again in November at the Autumn Statement to evolve the UK to a higher wage, lower tax and lower welfare economy.

This was a Budget with few giveaways, unsurprising given that the Chancellor today revised down the UK’s growth forecast over the course of the next Parliament. As a consequence of this he also announced that a further £3.5 billion of savings from public spending in 2019/20 would have to be found, though there was no detail today on how that would be achieved.

Read on for the key announcements of relevance to the UK’s bioscience sector.

You can access the full documentation associated with Budget 2016 here.

Tax, business and enterprise

The Chancellor was keen to emphasise the government’s commitment to the “enterprise and innovation by British businesses which will deliver growth and opportunity for the next generation”.

Publishing the business tax roadmap alongside the Budget, key announcements include:

  • Further to previous announcements that corporation tax would be cut to 19% in 2017 and then to 18% by 2020, today the government announced that corporation tax would be reduced to 17% in 2020.
  • The higher rate of Capital Gains Tax (CGT) for most assets will be cut from 28% to 20%. The basic rate of CGT will be cut from 18% to 10%. There will be an 8% surcharge for gains on residential property and carried interest for fund managers. The government hope that this will mean that CGT provides an incentive to invest in companies instead of other investments such as buy-to-let property.
  • Entrepreneurs’ relief will be extended to longer term external investors in unlisted companies. This will provide a 10% rate for external investors holding shares in unlisted companies for at least three years. It will apply to newly issued shares purchased on or after 17 March 2016, provided they are held for a minimum of three years from 6 April 2016, and will be subject to a separate £10 million lifetime limit on eligible gains. The government hopes that this will provide a further incentive for longer term investment into unlisted companies, helping them to access the finance they need to grow and create jobs. The BIA called for the government to look again at how Entrepreneurs Relief could be improved. This is a welcome announcement and it will be interesting to see what behaviour it drives in practice and how “external investors” are defined in legislation.
  • The government confirmed that it will introduce legislation to reform the Patent Box in Finance Bill 2016, so that this is consistent with the nexus approach agreed at international discussions, which links benefits to the level of R&D investment undertaken. These new rules will need to take effect by 1 July 2016 and the Finance Bill will be published on 24 March 2016.
  • There are also changes on loss relief. For losses incurred on or after 1 April 2017, companies will be able to use carried forward losses against profits from other income streams or from other companies within a group.
  • The government have committed to improving business interaction with HMRC. Today the government stated that it will introduce a dedicated phone line for businesses and self-employed individuals, announce plans by the end of 2016 to provide mid-sized businesses with access to a named adviser and pilot the delivery of targeted support to high-growth businesses through joint-working between HMRC and Regional Growth Hubs.

Science, health and innovation

There was not much mention of science or health today, however that is not surprisingly given the focus of the Comprehensive Spending Review and the details that continue to emerge from those announcements. It was disappointing to see a lack of mention of innovation today though we understand that focus will follow through the Department for Business, Innovation and Skills (BIS)’s National Innovation Plan. Further details are expected shortly and the BIA continue to engage with BIS on this issue. Watch this space.

There were however some announcements across the UK to note including:

  • Quadrum Institute: a £50 million contribution to a new world-leading centre for food and health research at the Norwich Research Park.
  • Compound Semiconductor Catapult: an investment of up to £50 million up to 2020/21 to establish a new Compound Semiconductor Applications Catapult in Wales.
  • The use of LIBOR funds to support children’s hospital charities in Manchester, Southampton, Sheffield and Birmingham.

Devolution

Unsurprisingly the issue of devolution was central to many of the Chancellor’s announcements today, including news on developments in the East of England.

The Chancellor gave mention to a new “single powerful East Anglia combined authority” in his speech and the detailed Budget documentation confirmed a mayoral devolution deal with East Anglia, covering Norfolk, Suffolk, Cambridgeshire and Peterborough, giving the local area new powers over transport, planning, skills, a £900 million investment fund over 30 years to grow the local economy, and access to £175 million ringfenced funding to deliver new homes. However, as the agreement documentation sets out, not all Councils and Local Enterprise Partnerships across these regions have to date signed up to the deal.

The Chancellor also mentioned the new £1 billion pound city deal for the Cardiff region, a new West of England mayoral authority, a new deal for Greater Lincolnshire and further infrastructure investments in the Northern Powerhouse.

Skills and Apprenticeships

The previously announced Apprenticeships Levy was again referenced today, confirming that further details on the operating model will be published in April and draft funding rates will be published in June.

Also announced today:

  • For the first time, direct government support will be available to adults wishing to study at any qualification level, from basic skills right the way up to PhD. During this Parliament, loans will be introduced for level 3 to level 6 training in further education, part-time second degrees in STEM, and postgraduate taught master’s courses.
  • From 2018-19, loans of up to £25,000 will be available to any English student without a Research Council living allowance who can win a place for doctoral study at a UK university. They will be added to any outstanding master’s loan and repaid on the same terms, but with the intention of setting a repayment rate of 9% for doctoral loans and a combined 9% repayment rate if people take out a doctoral and master’s loan. The government will launch a technical consultation on the detail in due course. Those who take out only a master’s loan will still repay at 6%, as announced at Autumn Statement 2015. The government will also extend the eligibility of master’s loans to include three-year part-time courses with no full-time equivalent.

Europe

Finally the Chancellor took the opportunity of his Budget Statement to quote the Office of Budget Responsibility on the potential impact of the UK leaving the EU, referencing their comments that “a vote to leave in the forthcoming referendum could usher in an extended period of uncertainty regarding the precise terms of the UK’s future relationship with the EU. This could have negative implications for activity via business and consumer confidence and might result in greater volatility in financial and other asset markets”.

Glythera-42Antibody Drug Conjugates (ADCs) are monoclonal antibodies attached to biologically active drugs, often developed for use in the treatment of cancer. In today’s blog, Dave Simpson, Glythera CEO, discusses the rapidly growing pipeline of ADCs and the ever increasing demand for manufacturing capacity.

During the past decade the ADC pipeline has grown significantly from only eight distinct ADCs in clinical development in 2008 to over 60 in 2016. Whilst early targets were primarily focused towards the treatment of haematological disorders, the generation of newer ultra-potent toxins and, more recently, improved tumour penetration through alternative scaffolds has accelerated the growth in ADC discovery programmes, especially for the treatment of more difficult to treat solid tumours. This expanding pipeline has been mirrored by an increasing number of majors with an ADC focus as well as need for capability to manufacture.

ADCs are, by their very nature, complex entities, combining antibodies (whole or fragments) with potent toxins via conjugation chemistries and appropriate linkers. Even with the anticipated US $1 billion sales generated by the two currently approved ADCs Adcetris® and Kadcyla® and the rapid expansion of the field, relatively few innovators have elected to manufacture ADCs in-house with over 70% outsourcing their manufacturing to contract manufacturing organisations (CMOs).

Manufacturing houses require both biological capability and high containment cytotoxic facilities designed to handle compounds which have a very low Occupational Exposure Limits (OEL) – whilst maintaining aseptic and GMP compliance.

Glythera-371

Over the last 5 years, the CMO market has shifted dramatically from the manufacturing of blockbusters to specialist care drugs. Given the complexity of ADCs, there is a real prospect for manufacturing-oriented companies to offer specialised services through the provision of innovative solutions to current manufacturing challenges – and this, in turn, demands a highly skilled work force.

On top of the challenges of manufacturing drug substance for a selected antibody, plus a range of linker/payload chemistries, manufacturers face difficulties in generating homogeneous ADC and fill/ finish for the subsequent combination. Significant investment has been made by established CMOs and specialised services providers have emerged to support manufacturing by way of partnered supply chains or “one stop shops”.

With global revenues for contract manufacturing services estimated to reach US $60 million by 2018 – and ADC manufacturing anticipated to represent US $1 billion within the next decade – significant investments have been outlaid for facility expansion and to access broader services through mergers and acquisitions by established CMOs including Lonza, Piramal, Carbogen-Amics and Catalent.

Others have preferred to streamline their manufacturing process whilst broadening their potential client base and their manufacturing repertoire through supply chain partnerships. For example, FUJIFILM Diosynth Biotechnologies and Baxter BioPharma Solutions have signed up with Piramal and SAFC® respectively.

We have also seen the emergence of specialist service providers who support development and, perhaps more critically, provide a cost effective, compliant supply chain for early stage clinical trial material. In the UK Abzena, (formed through the combination of Polytherics and Antitope, and the subsequent acquisition of Pacific GMP and TCRS) has positioned itself as supporting a “bench to bedside” approach to ADCs including cell line development, ADC development and subsequent GMP manufacturing.

Glythera-445Thus, the development of ‘problem solving’ manufacturing platforms has underpinned the opportunity for companies to support ADC development and manufacturing. ADC Biotechnology was founded on proprietary technology which focussed on reducing ADC aggregation during manufacturing, therefore improving product safety profiles whilst accelerating ADC development programme timelines. The Company has recently announced significant investment to allow for the expansion of its facilities and capabilities, including GMP manufacturing of this important – and complicated – product class.

With the continued expansion of the clinical pipeline, the expectation of further approvals and the market opportunity for manufacturing of ADCs, there is no doubt that the industry will continue to see further increase in supply chain partnerships and investment into the expansion of current CMOs including those based within the UK.

Glythera is focussed on the development of next-generation ADCs underpinned by its proprietary conjugation/novel toxin platforms. The company was spun out from Bath University in 2007 and relocated to Newcastle upon Tyne in 2012, through ongoing investment support from IP Group and the North East Technology Fund.

WIB_newscast

Last Tuesday we celebrated International Women’s Day in great company at our latest Women in Biotech (WIB) event, with some of our industry’s great female leaders. Our panellists shared their thoughts on their experiences and careers to date, exploring existing challenges and plans to improve workplace diversity. The importance of mentorship, a recurrent theme at many recent BIA events, was again echoed by both Brenda Reynolds, CEO, Calchan, and also Instinctif Partners’ Melanie Toyne-Sewell, who highlighted the support of Managing Partner, Sue Charles, in nurturing and developing their successful female-led team. From a European perspective, Nathalie Moll, Secretary General of EuropaBio, spoke about the different environment in cities across Europe. We have some great female talent in the UK biotech sector and it was fantastic to see so many of you last Tuesday. Our Women in Biotech network runs events through the year – our next gathering will take place on 15 June (more info here) and you can also join our WIB LinkedIn group to keep up to date.

On regulatory matters, the European Medicines Agency (EMA) launched its new PRIME (PRIority Medicines) scheme to strengthen support for the development of medicines that target unmet medical needs and earlier access to these medicines by patients. We welcome the EMA launch of PRIME as providing greater opportunities for UK life science companies to get their ground-breaking treatments to the patients that need them. We have seen a real interest from members eager to engage with the scheme. The BIA has played an active role in influencing the development of PRIME to represent the views of UK companies and this has been an excellent example of Europe wide collaboration to build a scheme that tackles unmet medical need.

Prime focuses on medicines that will provide benefits for patients that currently do not have any treatment options for their disease or that have major therapeutic advantages over the existing treatments. The scheme will also help to speed up the translation of new medicines by offering specific support to SMEs and the academic sector who will be able to apply at an earlier stage providing that they have compelling non-clinical data and tolerability data from initial clinical trials.

For more information on Prime and to find out how your organisation can apply, go to the EMA website. PRIME will be discussed in further detail at the BIA/MHRA joint regulatory conference on 4 May this year – go to the conference website to view the full programme and book your place.

A quick note of congratulations to BIA member GW Pharmaceuticals, who today announced positive phase 3 pivotal trial results in Dravet syndrome – a rare and severe form of epilepsy in children. Great news for a home-grown company and to see developments in an area for which there are no approved treatments in the US and a significant unmet need.

The big event this week will be the Budget, which takes place on Wednesday. As ever, the BIA will be monitoring its delivery closely on the day and will provide an overview of the implications for our sector in due course. For more immediate updates on the day, do follow our Twitter account @BIA_UK.

Finally, one to note for those of you involved in cell and gene therapies, registration is now open for the NICE Scientific Advice seminar “Exploring HTA evidence generation requirements for developers of Cell and Gene Therapies”. The seminar will be held on Thursday 28 April 2016 at the NICE offices in London.  More information can be found on the Scientific Advice webpage here.

Best,

Steve

BIA member Summit Therapeutics has released a video interview with Professor Mark Wilcox, Consultant Microbiologist & Head of Microbiology at the Leeds Teaching Hospitals NHS Trust, Professor of Medical Microbiology at the University of Leeds, and Public Health England’s Lead on C. difficile in England.

In the video, Professor Wilcox talks about the challenges in treating C. difficile infection and looks at the potential of the investigational antibiotic ridinilazole. Find out more by clicking on the video below.

SummitVideo

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