Archives for category: Policy

Following the outcome of the UK’s referendum on membership of the European Union, the BIA has worked closely with members and stakeholders to identify the threats and opportunities for biotech post-Brexit and to represent the sector.

Our BIA Brexit Briefing webinars will provide a monthly update on government policy, progress of working groups, and how these will potentially affect companies in life sciences – particularly with regards to innovation, financing, regulation and people.

Catch up on last week’s webinar below, delivered by Steve Bates OBE, Chief Executive Officer, BIA.

Visit our website for details on future Brexit webinars.

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

q-report-cover-oct-2016-to-jan-2017Our blog today, taken from our latest quarterly policy and regulatory affairs update, takes a look at clinical trials hot topics.

Revision of first-in-human clinical trials guideline

Following on from our comments in our last quarterly updates regarding the tragic incident which occurred during a Phase I clinical trial in France in January 2016, the BIA has kept a watching brief on the investigations and any implications for the conduct of first-in-human trials in the EU.

The European Medicines Agency (EMA), in cooperation with the European Commission and EU Member States, has proposed a revision of its guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products to further improve the safety of trial participants.

The EMA published the draft revised guideline for public consultation on 15 November. This follows an initial consultation in the summer on a concept paper that outlined the key areas of the current guideline (adopted in 2007) that need to be amended, taking into account the lessons learnt from the tragic incident, as well as the evolution of practices in the last 10 years.

While the 2007 guideline focused on the single-ascending-dose design used at that time, the practice for conducting first-in-human clinical trials has evolved towards a more integrated approach, with sponsors conducting several steps of clinical development within a single clinical trial protocol. For example, these trials may also include collection of data on food interaction, in different age groups as well as early proof of concept / proof of principle parts and bioequivalence of different formulations.

The BIA intends to respond to the consultation in collaboration with EuropaBio (the European Association for Bioindustries). If members wish to contribute to the consultation response please contact Christiane Abouzeid at cabouzeid@bioindustry.org.

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BIA attends EMA meeting on EU Clinical Trials portal and database

In November the BIA participated upon invitation in an EMA stakeholders meeting on the development of the EU clinical trials and Union database as part of the implementation of the EU Clinical Trials Regulation. Discussions focused on user management – a set of features and capabilities that manage user access to the clinical trials system functions according to their role, so the system will display the appropriate data and also the appropriate activities for them.

We will continue our ongoing dialogue with the Agency in order to address industry concerns and ensure that the clinical trials system is fit for purpose.

BIA responds to EMA consultation on clinical trial guideline

In December, the BIA inputted, together with EuropaBio, to a consultation by EMA on a draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials in connection with the implementation of the EU Clinical Trials Regulation. This guideline is of particular interest to members involved in clinical development of biological and biotechnology derived medicinal products in the EU.

Voluntary Harmonisation Procedure (VHP) for clinical trials – 1000th procedure

The Heads of Medicines Agencies’ Clinical Trials Facilitation Group has recently announced receipt of the 1000th application for the evaluation of a multinational clinical trial by the VHP procedure. Established in March 2009, the VHP is a useful tool for the initiation of the authorisation procedure for clinical trials in more than one EU member state by submitting a single application. It is worth noting the VHP served as a model for the new procedure in the EU Clinical Trials Regulation, which will come in to force in October 2018.

q-report-cover-oct-2016-to-jan-2017With the EU referendum, a new UK Government, and the US general election, 2016 has been busy but never dull for the BIA. This edition provides an update on the BIA’s influencing activity in the final quarter of the year, including continuing work on Brexit and the emerging Industrial Strategy, an action plan to anchor advanced therapy manufacturing in the UK, and a number of Parliamentary events. 

Download the report in full here and read on for a summary of some of the key topics covered in this edition. For a snapshot of our activity throughout 2016, check out our year in numbers.

Life Sciences, Brexit, and the Industrial Strategy

In the final quarter of 2016, the BIA continued to work to ensure the bioscience sector is at the heart of Government thinking in the lead-up to the triggering of Article 50 at the end of March. The UK-EU Life Sciences Transition Programme continued with key industry-Government meetings. At the Ministerial meeting on 23 November, a process for developing a new Life Sciences Industrial Strategy was established to complement the groups work on Brexit. The industry component of this work is being led by the Government’s Life Sciences Champion, Sir John Bell, with the BIA, ABPI, and Wellcome Trust, among others, represented on the steering group. The programme of work will involve a number of workshops to produce detailed ideas for consideration by a joint Government-industry board, which includes the BIA.

In November, the BIA published a background discussion document called The place of bioscience in the UK’s Industrial Strategy to begin the conversation with members and policy makers on what our sector needs to continue to grow and succeed.

BIA fiscal wins in the Autumn Statement

With his first Autumn Statement, Chancellor Philip Hammond MP sought to show the UK is “open for business” and remains committed to being a science superpower post-Brexit.

An additional £4.7 billion was committed for research and innovation for this Parliament, which is expected to result in a “substantial increase in grant funding through Innovate UK”. The BIA welcomed this along with two new reviews on patient capital and improving the R&D tax incentive regime, which the BIA called for in its submission and discussed with the new Financial Secretary to the Treasury, Jane Ellison MP, ahead of the Autumn Statement. The BIA has upcoming meetings with the Treasury officials leading the reviews.

The Autumn Statement also confirmed the £100 million refill for the Biomedical Catalyst (BMC). We have produced an infographic showing how the BIA and its members have consistently campaigned since 2013 to keep this proven successful scheme funded to support early-stage bioscience.

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Advanced Therapies Manufacturing Action Plan published

Early in 2016 the Medicines Manufacturing Industry Partnership (MMIP), supported by BIA, ABPI and Innovate UK’s Knowledge Transfer Network (KTN), launched a joint industry-Government Taskforce to make the UK the go to destination for international investment in advanced therapies manufacturing. The Sector is expected to grow to be worth between $14-21 billion globally per year by 2025. The Taskforce is co-chaired by Ian McCubbin of GSK and Jo Johnson MP, with Mark Bustard of KTN leading the secretariat, and has representation from industry, academia, Government departments and associated bodies, including funders and regulators.

The resulting Action Plan, which outlines the key actions the UK can take to capture advanced therapies manufacturing investment, was launched to industry at the bioProcessUK conference on 23 November and simultaneously presented to Government at the Ministerial Industrial Strategy Group (MISG).

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Download Influencing and shaping our sector: BIA update October 2016 – January 2017 for details on the above topics and more. Including the Accelerated Access Review final report, the Advanced Therapies Manufacturing Action Plan and changes to the evaluation and funding of medicines appraised by NICE.

To learn more about BIA’s policy, public affairs and regulatory affairs work, see our previous quarterly policy updates, our consultation responses, or email Rachael with any questions.

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On 12 December, the All-Party Parliamentary Group for Life Sciences held its annual Winter Reception to celebrate the vitality of the UK life sciences sector and showcase some of the innovative technologies produced by British companies.

BIA members GE Healthcare, uMotif and Applikon exhibited alongside Roche, Woundcheck, Boston Scientific and Medtronic.

GE Healthcare gave MPs and other guests the opportunity to tour their advanced therapy manufacturing facilities using a virtual-reality headset. Chair of the Business, Energy and Industrial Strategy Select Committee, Iain Wright MP, was particularly impressed (pictured).

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Applikon brought along their MiniBio bioreactor, which can be used for a range of processes, including screening studies, media optimisation and cell culture. Applikon exhibited on behalf of the Medicines Manufacturing Industry Partnership, which recently published its Advanced Therapies Manufacturing Plan.

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uMotif demonstrated their software that use data to provide new insights for health services and all phases of clinical research, including real-world evidence.

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The APPG for Life Sciences, is a cross-party group of MPs and peers founded in 2015 by Kit Malthouse MP to raise awareness of the valuable contribution the life sciences sector provides to the health and wealth of the nation. The BIA supports the APPG in collaboration with ABPI, BIVDA and ABHI.

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Guests heard from the APPG’s vice-chair, Jo Churchill MP, the former Life Sciences Minister and now Chair of the Prime Minister’s Policy Board, George Freeman MP, and Michael Cumper from the heart patients’ organisation, the Somerville Foundation.

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George Freeman MP told the reception “Our world-leading life science sector – which generates over £60 billion and over 220,000 jobs for the UK economy each year, and provides products which the NHS and UK patients rely on every day – is of critical importance to the country.”

View all photos from the event on our Flickr page.

As we head towards Christmas, we take a look at BIA’s year in numbers…

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To paraphrase Donald Rumsfeld – with Hillary Clinton’s defeat, her policy known unknowns can be discounted. With Donald Trump heading to the White House, we now face unknown unknowns.

Trump has defied expectations to be elected the 45th President of the United States of America. The result has caught markets off-guard, with indexes looking like a rollercoaster across the globe. However, with the threat of Clinton’s drug price regulation off the cards, there appears to be a silver lining for biotech stocks. Here we look at the potential impact of the US election on biotech in the UK and globally.

Biotech stocks rally on Trump win

Ahead of the election, a report by US analyst firm Leerink Partners said that $50 billion had been wiped from biotech stocks as markets predicted a Clinton win and a Democrat-controlled Congress. It concluded that biotech stocks could bounce back by 20% if Trump and the Republicans were successful.

As the UK market opened this morning, pharmaceutical shares rose in the FTSE 100 (which overall went down), with Shire, Hikma, GlaxoSmithkline and AstraZeneca all up between 2% and nearly 5%.

In the US, the iShares Nasdaq Biotechnology exchange-traded fund, which tracks biotech stocks like Gilead Sciences, Celgene and Biogen, rose 9% when the market opened. Pharma stocks also rallied – Pfizer up 10%, Merck 5% and Abbvie 7%.

Investors are clearly relieved. The Republicans have held onto both the Senate and the House of Representatives. As the Party has fiercely fought-off drug price controls in the past, this makes it very unlikely drug prices will see strong regulation. However, commentators are still divided on what the election result means for the industry. Trump’s health plans have centered on ripping up Obamacare “on day one”, whereas Clinton was set to expand the program. Adam Feuerstein, a columnist at TheStreet, says the worry could shift to reduced prescription drug volumes and lower sales if Obamacare is repealed.

Trump has also promised to remove the ban on importing medicines and to speed up the approval of generics, which will make the market more difficult for new medicines. This has been reported as a boon for generic manufacturers and could result in a more European-style healthcare market.

Wider Trump policy and its effect on the life sciences

While he has offered few details on policies for life sciences research, Trump said last year that he has heard “terrible” things about the US National Institutes of Health. In the run-up to the election and now after, US scientists in academia and industry have expressed concern that a Trump Presidency could result in less Government funding for biomedical research – potentially as a result of lowered taxes – and questions have been raised about his approach to evidence. He has repeatedly pushed the myth that vaccines cause autism. “I feel sick to my stomach,” a research director of a small biotech focused on autism therapies told BuzzFeed News about the prospect of a Trump administration.

Ben Carson, a heart-surgeon who dropped out of the Republican primary race and joined Trump’s campaign, has taken a more sensible approach to vaccines, and after being thanked in Trump’s victory speech could be a close adviser on health policy to the new President.

In his speech, Trump took a conciliatory tone. He promised to be a President for everyone. He said he would invest in infrastructure, double US economic growth and to put America first but “deal fairly with everyone, all nations and all people”. However, everyone agrees that his election signals a significant change to US foreign and domestic policy.

Trump supported Brexit and is said not to be a fan of the EU. He even had Nigel Farage campaigning alongside him. Some commentators have said this could mean a stronger “special relationship”. Trump is also against the Transatlantic Trade and Investment Partnership (TTIP) between the US and EU, which would exclude the UK if it went ahead after Brexit.

Trumps notorious stance on immigration — including a pledge to bar Muslims from entering the United States — will raise concerns that talented foreign scientists will be put off from working or studying at US institutions. And it is unlikely that Trump will appoint Supreme Court judges more positively minded towards intellectual property and research in life sciences, this may prove to be a competitive advantage for the UK sector.

Proposition 61 defeated

American drug companies have also avoided price regulation in California, where Proposition 61 was defeated in a vote that happened alongside the election. The legislation aimed to cap how much the state can spend on the prescription drugs it buys through programs like Medicaid or insurance plans for state employees. If it passed, it would have been a huge change to how drug pricing operates in the US that could trigger the introduction of similar legislation across the country.

Keep calm and biotech on

As we have demonstrated since the EU Referendum result earlier this year, the strong fundamentals of our sector in the UK remain unchanged. The American election was never going to change that. Just this week Syncona revealed their part in a new £1 billion listed fund that will be a real boost for UK life sciences in the coming years, and today saw the official opening of the Francis Crick Institute in London. These are all positive developments for the UK ecosystem that will maintain and strengthen our position as the third global life sciences cluster.

q3-2016-updateSince our last update in July there have been a number of major developments in life sciences policy and in politics more widely. In this edition we have provided a key section focusing on Theresa May’s Government, Industrial Strategy and Brexit, and we also celebrate the Chancellor’s commitment to re-fill the Biomedical Catalyst scheme – a very welcome result after years of advocacy by BIA and our members!

Download the report in full here, and read on for a summary of the key topics covered in this edition.

The May Government, industrial strategy and Brexit – The last few months have seen significant change in the political landscape following the outcome of the EU Referendum. We now have a new Prime Minister, new Government, new Whitehall department and a new policy focus. Our latest update examines the work of the UK EU Life Sciences Transition Programme including next steps, BIA engagement with the newly re-structured Government, the renewed focus on industrial strategy and how it links to Brexit, and medicines regulation in the context of the UK leaving the EU.

Commitment to refill the Biomedical Catalyst – The Government has committed to fund the Biomedical Catalyst for the rest of this Parliament following a long-fought campaign by the BIA. The Chancellor, Philip Hammond MP, used his speech at the Conservative Party conference on 3 October to formally announce the £100 million investment in life science companies. The Government said in a statement that the BMC will provide grant support to ensure that “emerging disruptive healthcare technologies in disease prevention, earlier diagnosis and tailored treatments are delivered to market”. The programme will offer funding in 2017, 2018, 2019 and 2020 to support varying stages of technical and commercial development from feasibility studies through to proof of concept and early clinical trials.

Party conference insights – The BIA had a presence at four political party conferences this year. We hosted private roundtable meetings with the Conservatives and Labour and attended the Liberal Democrats and Scottish National Party conferences. The focus of the roundtable meetings was on maintaining the UK’s world-leading position in the life sciences after Brexit. As in previous years, the BIA partnered with the AMRC, BIVDA and ABPI to deliver the events and invited a range of stakeholders from academia, the NHS and our memberships to meet with MPs and policy makers. Our update also covers the key announcements from the conferences for the life science sector.

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UN report on global access to medicines and landmark declaration on AMR – The United Nations (UN) published a report on access to medicines written by a high-level panel of experts. The International Council of Biotech Associations, of which BIA is a member, published a response to the report which you can read in full in our update. It was also announced at the United Nations General Assembly that 193 countries had signed a landmark declaration agreeing to combat antimicrobial resistance as a matter of priority.

PRIME scheme six months on – The BIA has played an active role in influencing the development of PRIME, representing the views of member companies. As of 6 October 2016, 64 applications to the EMA’s PRIME scheme had been received. We have seen high levels of interest in PRIME from BIA member companies and we are pleased that a number of our members’ products have been accepted onto it.

Adaptive pathways: where are we today? – On 3 August the EMA published a final report on the experience gained during its pilot project on adaptive pathways. The EMA received 62 applications with oncology accounting for a third of the total submissions; 18 were selected for in-depth face-to-face meetings with the participation of other stakeholders. At the end of the pilot, six applications had progressed to parallel regulatory HTA scientific advice and one to scientific advice with EMA. The EMA will now explore the adaptive pathways approach further in the context of parallel scientific advice with HTA bodies – more details in our update.

Download Influencing and shaping our sector: BIA update July – October 2016 for details on the above topics and more.

lobbyingTo learn more about BIA’s policy, public affairs and regulatory affairs work, see our previous quarterly policy updates, our consultation responses, or email Martin with any questions.

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The Government is introducing legislation to give new powers to the Secretary of State for Health to control prices of unbranded medicines sold by companies that are in the voluntary Pharmaceutical Price Regulation Scheme (PPRS). It will also allow them to gather more cost data from companies in the supply chain supplying the NHS. The Medical Supplies (Costs) Bill is being scrutinised by MPs who have requested written evidence on its potential impact.

What does the Bill do?

The Bill closes a loophole that currently means the Government is unable to regulate the price of unbranded medicines supplied to the NHS by companies in the voluntary PPRS.

Currently, any medicine not covered by the scheme (e.g. an unbranded generic medicine) is exempt from price controls if it is produced by a manufacturer that is a member of the PPRS. The Bill will make it possible for the Secretary of State to control the prices of these medicines through repayments or reducing the price directly, as it can do for companies in the statutory system.

It also amends existing legislation so that all pricing control powers apply to medical supplies as well as medicines. Medial supplies are defined as “surgical, dental and optical materials and equipment.”

Finally, the legislation gives new powers to the Secretary of State to request data from any company involved in the supply chain of medicines being sold to the NHS. The Government says this is to inform reimbursement payments to pharmacies and GPs and to determine if the NHS is getting value for money.

The BIA understands that the data collection requirements are not intended to apply to companies involved in the R&D of medicines but will seek more concrete assurances. The precise details of what data and what type of companies this will apply to will be set out in secondary legislation Regulations once the bill is passed by Parliament. The BIA is representing our members at meetings to discuss the Bill at the Department of Health and will be monitoring its passage through Parliament.

Why was this Bill introduced?

The Times reported in June 2016 that certain pharmaceutical companies were buying the production rights of medicines that were out of patent and producing and marketing them as unbranded generics. As they were the sole supplier, these companies were able to substantially increase prices, apparently by over 1000% in some cases. This was reported as costing the NHS an extra £262 million a year. The Bill is intended to prevent this from happening in the future. The Competition and Markets Authority has also launched an investigation.

What next?

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The Bill had its first debate by MPs (2nd reading) on 24 October and was broadly supported by Labour and other parties. It will now be scrutinised in detail by a committee of MPs, who are requesting written evidence from the public and business. See the Parliament website for details on how to submit. You can also contact Martin at the BIA with your evidence to inform the BIA’s position.

The Bill is expected to receive Royal Assent in spring/summer 2017 subject to Parliamentary business. The Regulations will then also need to be produced, consulted on and Parliament given opportunity to object to them. It is therefore expected that changes will not be introduced until the 2017/18 financial year.

For more information you can read the Department of Health’s factsheet or a briefing produced by the House of Commons Library.

It was an action-packed conference season this year as each political party faced its own challenges and opportunities resulting from Brexit. The BIA attended four conferences to meet and influence policy makers at this critical time for our sector. Here we take a look back at the key speeches for life sciences, fringe events and private meetings that we attended.  

The Conservative Party

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There was recognition of the importance of the life sciences to the UK’s future in speeches and events across the Conservative Party conference.

In her keynote address, the new Prime Minister, Theresa May, hinted that the life sciences would feature prominently in the new industrial strategy, saying “we will identify the sectors of the economy – financial services, yes, but life sciences, tech, aerospace, car manufacturing, the creative industries and many others – that are of strategic importance to our economy, and do everything we can to encourage, develop and support them.”

May’s sentiments were echoed by the former Life Sciences Minister, George Freeman, in fringe events, as well as senior figures in the new Government. David Davis, the new Secretary of State for Exiting the European Union, said that the UK is “a science superpower. A world leader in research and the arts. A trailblazer in biotech, in digital, in pharmaceuticals.”

More good news for the life sciences was formally announced by Philip Hammond MP in his first conference speech as Chancellor. In a sign that the Government is listening to the evidence put forward by the BIA and our members, he acknowledged that the Biomedical Catalyst was a “Government intervention that works” and committed £100 million to continue the scheme.

BIA members were able to put forward more evidence to policy makers at a private roundtable meeting that we hosted, with discussion focussed on how we can maintain the UK’s world-leading position in the life sciences after Brexit. As in previous years, the BIA partnered with the AMRC, BIVDA and ABPI and invited our members along with a range of stakeholders from academia and the NHS to meet with MPs and policy makers. We were joined by five Conservative MPs: Kit Malthouse, Chair of the APPG for Life Sciences; John Glen, Parliamentary Private Secretary to the Chancellor; Maggie Throup; Jo Churchill; and David Rutley. All were keen to hear about the opportunities and challenges of Brexit faced by our sector, and to discuss how they and the Government can help, including ensuring medicines regulation is high-up on the Brexit negotiation agenda, increasing access to finance, and using the NHS to drive progress through better uptake of innovation.

The BIA also met privately with Nicola Blackwood MP, the Health Minister with responsibility for NHS innovation and data, to discuss Brexit and the Accelerated Access Review, among other things.

The Labour Party

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Fresh from re-election, the Labour leader Jeremy Corbyn used his conference speech to say that his party would raise UK R&D spending to 3% of GDP and launch its own Industrial Strategy review. Elsewhere, Labour’s Shadow Minister for Higher Education, Gordon Marsden, said that the reorganisation of Innovate UK and the Research Councils should be put on hold in light of the challenges created by Brexit.

At the roundtable hosted by the BIA with our partners, ex-university researcher and current member of the Commons Science & Technology Committee, Dr Roberta Blackman-Woods, spoke with BIA members about the value of international collaboration, international employees and the ability to conduct Europe-wide clinical trials, particularly for rare diseases.

The Scottish National Party

Up in Glasgow, all minds were firmly fixed on the future of Scotland’s relationship with the EU and the rest of the UK. SNP leader Nicola Sturgeon once again promised to hold a second Scottish referendum if she believes the Brexit deal struck by the UK Government doesn’t work for Scotland.

Sturgeon highlighted the life sciences as an industry in which Scotland excels and we met with a number of SNP MPs and Members of the Scottish Parliament keen to discuss how the sector could be strengthened and protected, as set out in the Transition Programme report produced by the BIA and ABPI over the summer.

The Liberal Democrats

At the Liberal Democrat conference, their EU spokesperson Nick Clegg emphasised that industry sectors need to make clear to the Government what their particular challenges and complexities of Brexit will be. He is producing a collection of ‘Brexit Challenge’ papers to help communicate some of the issues.

 

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Today the BIA launched the next phase of its Celebrating UK Bioscience campaign. The aim of this campaign is to showcase the great work taking place in the sector – focusing on the potential human benefits of treatments that are currently in research and development – and to bring a greater understanding of the UK biotechnology sector to new audiences.

Biotechnology is technology based on biology, the science of life. Scientists in our sector work with living organisms to drive the development and manufacture of drug treatments, advanced therapies and diagnostic tests to support patients in the UK and beyond. The BIA is the trade association for innovative healthcare companies rooted in the UK’s bioscience base. The sector continues to evolve, investing in research and development activities, and translating research from the UK’s world leading science base into medicines to treat patients.

There is great depth and breadth in UK biotechnology: from a strong and emerging regenerative medicine and cell therapy sector, to specialist biomanufacturing companies developing therapies for cancer treatment, to personalised treatments and new antimicrobials. Advances in technologies such as synthetic biology are impacting upon the development of new types of therapeutics and new production methods. UK bioscience is not only changing lives, but saving them. It is vital that the sector continues to get the support it needs to keep this essential research and development going, now and in the future.

This campaign takes a look behind the scenes in the labs of some of our members to see what they are researching and developing and what the possible patient benefits these drugs and treatments could have in the future. The report is divided into five treatment areas: cancer, antimicrobial resistance, type one diabetes, dementia and Duchenne muscular dystrophy. Most people will be familiar with cancer and dementia, but this project wanted to look at less understood areas such as type one diabetes and antimicrobial resistance, as well as a rare disease, Duchenne muscular dystrophy, to demonstrate the breadth of scientific research and development taking place in our sector.

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A number of charities that took part in this project are directly funding research in BIA member companies. Collaborations between industry and medical research charities are increasingly recognised as a mutually beneficial relationship. This brings the patient perspective to companies and enables patients to access clinical trials or to stay informed about R&D, and even allows vital funds to be channelled into clinical research.

Alongside the report, there is a series of infographics and videos, which add further insight into each condition and what BIA members are doing to tackle them. You will hear first-hand from patients and their families who have shared their personal stories and what they hope UK biotech will be able to achieve. Go to www.bioindustry.org/newsandresources/celebrate to view and download all the resources.