Archives for the month of: April, 2015

BIOAs the countdown to BIO enters its final stages, it’s time to start finalising your plans for Phili. Need a helping hand? Our blog below explains some of the changes this year for the UK delegation, as well as details of what’s happening when, with who and how to get involved – your handy guide to getting the most out of BIO2015. 

In June the BIO International Convention is heading to the heart of the US biopharma industry. In close proximity to New York’s financial markets and Washington DC’s regulatory centre, the Philadelphia Metropolitan Area is home to more than 1,200 companies – ranging from the biopharma industry’s largest global companies to its fastest growing new ones. The region’s vast array of leading universities and research institutions fosters a collaborative environment. According to the Jones Lang LaSalle Life Sciences Cluster Report 2012, in the past 10 years alone the region has drawn nearly $4 billion in venture capital funding. The tri-state region of Pennsylvania, New Jersey and Delaware is home to 80% of the US pharmaceutical industry.

In just four days, BIO brings together 15,000 delegates from over 65 countries under one roof. Working out what to do and how to make the most of your time in Phili is often the biggest challenge. We hope the information below will help explain what’s different this year for the UK delegation, what’s happening when, with who and how to get involved.

The UK Pavilion

This year UKTI will be promoting the UK in a different way. You won’t see lots of UK companies exhibiting on the UK pavilion but instead this space will be used for informal meetings and a messaging service managed by UKTI. Find out more information here.

UK delegation dinners, drinks and breakfasts

One Nucleus are holding their executive dinner on the Sunday evening and networking breakfast on the Monday morning – for more information please contact Tony Jones. On the Monday afternoon, from 4-6pm, the UK, Aussies and Canadian delegations will come together once again for our BIO networking catch-up – for more information contact Karen Chandler-Smith, BIA. UKTI and AstraZeneca will be holding a drinks reception followed by dinner on the Tuesday evening – John Hoggard, UKTI is your contact for further info. There will also be a networking reception on the UK pavilion from 5-6.30pm on the Wednesday, please do pop along!

BIO Networking Receptions

The 2015 BIO International Convention hosts countless evening networking opportunities – from Monday’s Kickoff Concert (featuring Kool and the Gang!) to Wednesday’s Reading Terminal Reception and everything in between – you can’t find a better place to network with the industry’s most influential than at BIO. Details of all BIO receptions are available here.

Tri-State Regions Tours

Working together, the State of Pennsylvania, Select Greater Philadelphia, the City of Philadelphia, the State of Delaware and the State of New Jersey, are developing a schedule to showcase the tri-state region and larger life sciences community to the international delegates and visiting attendees. A range of tours are available on the Sunday, Monday and Friday of BIO week. Find out more here.

Getting to Philadelphia

If you’re yet to book your flight and hotel, don’t overlook the opportunity to take advantage of the services of Flight Centre Business Travel. Flight Centre are a One Nucleus Support Supplier and have exclusively negotiated significant discounts on flights and hotel rates in Philadelphia. Please click here to review the Flight Centre Business Travel offer.

BIA will be working with BioPartnerUK, UKTI, One Nucleus, MedCity and the London Mayor’s office to keep you updated on plans for BIO in the coming weeks and will be running a pre-BIO webinar on 5 June. You can register for the webinar here.

As always the BIA team are on hand to provide introductions and support to members companies.

We look forward to seeing you in Phili in June!

polls_BBC_600With one week remaining until the UK’s most uncertain General Election in decades, we take a look at the current political climate, what the potential outcomes might be and what they mean for the next Parliament. We’ve also compiled a handy table of seven parties’ manifesto commitments on the policy areas that matter most to the UK life sciences industry, including science and innovation, healthcare, finance and tax, and European membership.

If you’ve heard the pre-election commentary in the UK you won’t have failed to notice the overarching theme; the polling has been very close between the Conservatives and Labour with a very slight Conservative lead but, with neither party expected to win enough seats to command an overall majority, some form of minority or coalition government is expected. With the Liberal Democrats expected to win fewer seats compared to the 2010 election, a Lib Dem coalition with either of the main parties will still likely fall short of the 326 seats needed to form a Parliament. Which is why this year the General Election is far from a three horse race and the smaller parties – including the Scottish National Party (SNP), the Green Party, Plaid Cymru, and the UK Independence Party (UKIP) – have had more airtime.

The BBC’s coalition builder game illustrates how this numbers game could play out and just how challenging it may be to form suitable partnerships, with many of the parties fundamentally opposed on certain issues. Rather than a formal coalition between parties, another possibility is a ‘confidence and supply’ arrangement; essentially Party B agrees to support Party A in the event of a vote of no confidence against Party A’s Government and, in return, Party A agrees a deal with Party B that gives them some desired policy outcomes. For example, the SNP might back a Labour Government with a vote of confidence in return for greater devolution of powers to Scotland.

While the polls continue to attempt to predict the outcome, only two things are widely agreed upon: a) nothing is certain in this election, and b) it will be in the days and weeks following May 7th that the most impactful decisions will be made. Post-election agreements are likely to focus on producing a detailed plan for government before agreeing any deals. A second General Election would be called if a motion of no confidence is passed against the new Government and an alternative one cannot be formed. (Also see the BBC’s Q&A on ‘what happens if no-one wins‘).

Timeline

  • 7 May – General Election
  • 8 May – Results known. Coalition talks underway, could last two weeks or more
  • 18 May – Elected MPs return to Parliament (regardless of whether a Government is formed yet)
  • 27 May – State opening of Parliament. The Queen’s speech sets out top-line legislation for the first year of the Government (if a legitimate Government has been formed)
  • May, June – Cabinet appointed, Ministers appointed to departments, Select Committee Chairs elected, Select Committee members appointed
  • June 25 – The BIA’s Parliament Day, a key day of sector advocacy with a new cast of policymakers in Westminster and Whitehall

What should life sciences industry members care about in General Election 2015?

Our sector is fortunate that MPs of all political colours ostensibly recognise and support the need for medical R&D, the value of science and technological innovation, and the benefits these bring for the UK’s population and economy. However, some parties’ commitments on these issues are more solid than others, and positions also diverge much more on other issues that affect the ability of companies to thrive in the UK (such as EU membership, skilled immigration and transport infrastructure). Take a look at our party policy summary table to see how the parties’ positions compare on issues affecting BIA members.

Also see the Campaign for Science and Engineering (CaSE) excellent briefing on science policy in the party manifestos for more explanation of the parties’ positions.

BIA activity and engagement post-General Election

As a trade association for innovative companies in the UK’s life sciences sector, the BIA acts as a united and influential voice to policymakers. See our latest quarterly update for a snapshot of recent BIA policy, regulatory and public affairs activity. In our UK Life Sciences Manifesto 2015-2020 we set out policy recommendations towards securing the UK’s position as a global hub and as the best location for innovative research and commercialisation, including a competitive fiscal environment and support for the life sciences and important technologies like regenerative medicine and synthetic biology.

On 25 June we’ll be holding our key annual day of lobbying, BIA Parliament Day, at a later date than usual so that we can engage with the new incoming political cast. Aimed squarely at CEOs and senior level representatives primarily from our corporate (R&D and manufacturing) member companies, one of the issues we’ll be covering on the day is Life Sciences Minister George Freeman’s Accelerated Access Review (of Innovative Medicines and Medtech). This review has cross-party backing, so that whoever is in power after May should consider seriously the findings of this ‘root and branch’ review of the whole UK medical innovation pathway from pre-clinical research to uptake in the NHS. Contact us to register interest or for more information.

This General Election will see a number of proven allies of the sector leaving Parliament, so in the coming weeks we’ll also be working to strengthen our relationships with those remaining and to identify any new stakeholders with interests in science, innovation and business.

Stay tuned for the BIA’s post-election analysis as and when news emerges. As ever, we’d be keen to hear your thoughts – you can contact our policy team here.

IAS logo PNGIn order for the UK life science industry to grow and thrive, it must continue to engage the next generation of scientists. In today’s blog, Antony Poveda from outreach programme I’m a Scientist, Get me out of here! explains more about the project and how you can get involved, inspiring the biotech scientists of the future.

Explain your research in one sentence. Can you manage it? If you’ve ever been asked by your grandparents, cousins, or other family members over Christmas dinner ‘What is it you’re doing again?’ you may know it’s not as easy as it sounds. Over time, you may have even constructed a ready-made soundbite for these joyous social occasions. Now, instead of the politely interested relative you barely see, imagine your audience is a curious 13-year old school student and give it another try. If you can do it this time, you’re ready to inspire the next generation of biotech scientists by taking part in I’m a Scientist, Get me out of here!

It is widely acknowledged that we need to encourage today’s school students to consider choosing careers in our growing biotechnology sector. In order to achieve this, we need to have science outreach that more accurately reflects the range of careers available to scientists after studying. It’s important to show what life as a scientist is actually like, in all its possibilities – industry and academia. Think back to when you were 13 years old: did anyone make you aware of the biotechnology role that you’re currently in? Thanks to the Internet, you have the opportunity to be that person for school students across the UK.

I’m a Scientist is an online science outreach activity – an X-Factor style competition for scientists, where students are the judges. Five scientists each set up a profile on our website, have live online text-based chats and answer questions from school students all over the UK. Following the chats, students vote for their favourite scientist, with the winner receiving £500 to spend on public engagement and science outreach. It’s a simple format that changes the way students view science and scientists for the better. As one school student recently described it: ‘#bestsciencelessonever!

It’s crucial that today’s students have access to more role models working in bioscience companies across the industry. Taking part in I’m a Scientist is an accessible and enjoyable way to achieve this. By engaging with hundreds of bright, inquisitive school students all over the country, you can have a real, positive impact on their attitudes towards careers in biotech.

The benefits to researchers who take part are many. It’s a unique, fun way of taking your first steps in science outreach and developing communication skills. You can gain a fresh perspective on your research, connect with new networks, discover what young people think about science and the role of scientists, and remember why you fell in love with science in the first place. As Jo Sadler of GlaxoSmithKline, winner of the most recent I’m a Scientist in March, puts it “The questions really made me stop and think about what I’m doing and why I’m doing it – and most of all about how other people think about scientists and what we do”.

Accessibility is the strength of the competition. Everything in I’m a Scientist happens on the web, so you can take part without leaving your desk. Every event is a mix of themed zones (focusing on a specific topic, eg Hormones Zone, Health Zone) and general science zones (involving scientists from a variety of fields), so there is room for every kind of biotech scientist!

For the application all you need is that one sentence summary you came up with at the start of this blog, so get into the mindset of a school student and think: what would be interesting and understandable for that audience? If nothing else, you now have a new line ready for your next festive inquisition.

To find out more visit imascientist.org.uk/scientists, or email Antony on the I’m a Scientist team at antony@gallomanor.com.

You can apply now at imascientist.org.uk/scientist-apply.

Synbiobeta, London, 2015Last week was a busy one for the sector with a number of key events taking place, including SynBioBeta, the Anglonordic Life Science conference and the ABPI’s annual conference.

On Wednesday and Thursday, the SynBioBeta conference – pictured above – returned to London for the third year (see #SBBUK15 for a taste of the conversation), hosted by Imperial College’s SynbiCITE centre. Over 300 delegates attended from academia and industry, including many BIA members – from not only our Synthetic Biology Advisory Committee (Touchlight Genetics, Synpromics, Synthace, Ingenza, Chain Biotechnology and Biosyntha), but also the wider membership including AIM-listed Horizon Discovery. It’s great to see the growing recognition that companies don’t necessarily need to identify their activity as ‘synbio’ for this field to be relevant. The reality is that the majority of companies in biotech R&D and manufacturing can benefit from techniques that are covered in this forum, including massive scale up of affordable DNA synthesis, targeted gene or genome editing, synthetic promoters, intelligent modelling – everything at the interface of engineering, biology and data. Of course investment, entrepreneurship and the Lean LaunchPad were hot topics too.

The twelfth annual Anglonordic Life Science Conference took place on Thursday – merging the biotech and medtech offerings for the first time – with a record number of more than 300 decision makers attending from across the UK and Scandinavia. There were some great sessions and company presentations, including from BIA members Crescendo Biologics, BigDNA and Glide Pharmaceutical Technologies – see #anglonordic for a snapshot of what was covered on the day.

Former Prime Minister John Major was the after dinner speaker at the ABPI’s annual conference. He said he was unable to imagine any party would form an alliance with UKIP and was particularly strong on the impact to UK business of any break from the European Union – warning that “divorce with the EU would be final. There could be no reconciliation”.  The majority of the day had debated the affordability conundrum. I was particularly struck by Lisa Anson of AZ’s presentation on the scale of the challenge – showing just how slow access to NICE approved medicine remains for UK patients.

On that point the BIA has today inputted to NHS England’s consultation on specialised commissioning, where we have called for separate frameworks for the evaluation and commissioning of medicines and treatments for rare and very rare diseases whilst emphasising that NHS England must be clear in that its role is not one of assessment and evaluation. Please see our response and press release for more detail.

In other news, congratulations to all involved with the Science Industry Partnership (SIP) on its one year anniversary. Since its launch, the SIP has enabled over 2000 science sector employees to access apprenticeships and placements, as well as training and development – making great progress to ensure the UK life sciences sector has the talent it needs to flourish. For more information on the SIP, watch our previous ‘video of the week’ here and follow the links to our guest blogs from Cogent and Chair of the SIP board, Malcolm Skingle; and case studies from Fujifilm and Takeda on their SIP experience.

We finally saw the launch of the Woodford Patient Capital trust last week and, as predicted, it went off with a bang – raising a record £800 million and entering the FTSE 250 index. To coincide with the launch, our video this week features Neil discussing his view of the sector – watch it here.

On policy, the Royal Society has launched its annual pairing scheme – pairing 30 research scientists from industry and academia with UK parliamentary and civil servants. By spending time together in Westminster and the researcher’s company or university, participants can learn about each other’s work and gain a greater insight into how research findings can help inform policy making. This year will be particularly exciting with a Parliament full of new faces, so if you’re interested do get your application in – find out more on the website here or contact Rachael Mann.

I’m very much looking forward to seeing many of you at our first ever Committee Summit in Oxford on Wednesday. With over 170 due to attend, the summit is set to be an exciting meeting with updates from each committee and the BIA in general. We’ll be tweeting on the day using #committeesummit and look out for a round-up of the day in next week’s update. If you haven’t registered but would still like to attend please contact Cathy Smyth. On that note, the BIA’s Finance and Tax Advisory Committee have produced a useful briefing document on the variety of equity incentives companies can consider using to incentivise their work force. Check it out here.

For those heading out to BIO in Philadelphia this June we will be running our pre-event webinar and providing support for members attending. Also if you are exhibitor or attending with full partnering, there is still time to apply for a UKTI Trade Show Access grant. More information can be found here.

Finally a quick look at up-coming events. Our UK CEO and Investor Forum, the only UK-based event exclusively for senior bioscience management, is now open for registration and will be taking place on the 8/9 July in Weybridge. I look forward to seeing many of you there.

Best,

Steve

Earlier this week, Neil Woodford raised a record £800 million for his latest investment trust, the Woodford Patient Capital trust, which will invest in early stage businesses and scientific IP emerging from British universities – including biotechnology.

It’s launch on the London Stock Exchange on Tuesday was the largest of any UK-based listed fund, and it now sits within the FTSE 250 index – a great boost for the industry.

Today’s sector video features an interview with Neil Woodford, from the Telegraph, discussing the prospect of a biotech bubble – with thoughts on the US and the UK markets.

NeilWoodford_vid

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

acmedsci_blogimageThe Academy of Medical Sciences has recently launched a call for input to inform its ‘Health of the public in 2040’ project, which aims to identify the main health challenges the UK population will face by 2040, and the opportunities to address them, to inform future strategies and recommendations for research. Here, David Bennett, Policy Officer at the Academy of Medical Sciences, outlines the importance of the project and how you can get involved.

25 years ago, the world was markedly different. We have since seen significant technological change, including the widespread adoption of the Internet, fundamentally transforming the way we communicate, work and learn. We have seen changes to our lifestyles: to diets, physical activity, and the consumption of alcohol and tobacco. We have seen changes to our cities and transport networks; to our health and education systems. We have seen political uncertainty, financial crisis, conflict, population growth, rising life expectancy and myriad other changes, each influencing, directly or indirectly, the health of the public.

Moving towards 2040, we will inevitably face many new challenges – be they technological, demographic, social, political, environmental or economic – which will impact the health and wellbeing of our growing, diverse and ageing population. It is therefore crucial that we have the appropriate evidence to inform decisions affecting the population’s health. What’s more, it is imperative that we have the means to support the generation of this evidence (in terms of partnerships, capacity and methods), and to ensure that it is effectively translated into policy and practice.

To address this, we at the Academy of Medical Sciences are undertaking an interdisciplinary working group project: ‘Health of the public in 2040’. The working group, chaired by Professor Dame Anne Johnson DBE FMedSci, intends to help secure future wellbeing by better understanding the factors which will affect the public’s health over the next 25 years. By exploring how these factors might be influenced to deliver desirable outcomes, and by identifying the uncertainties associated with these factors, the working group will make practical recommendations relating to future research requirements.

The final report of the project will be published in spring 2016, and will be aimed at policymakers, funders, researchers (including trainees), professional and regulatory bodies, public health service providers, and the public.

Coinciding with the launch of the project in November 2014, we held a one-day ‘aspirations and drivers of change’ workshop. The event brought together a diverse mix of people to explore desires for the population’s health, and the drivers of change which will shape it over the coming decades. A report of the event is available for download on our website.

To explore these ideas in greater depth, and to ensure that the project is informed by the views of the wider stakeholder community, we have recently launched a call for input. This is an opportunity for the working group to hear your views concerning the future health of the UK population. Your input will be instrumental in helping the working group develop tractable recommendations, ensuring that future generations have every opportunity to live healthy, fulfilling lives. We hope you are able to contribute to this exciting project, and look forward to hearing your thoughts.

If you’d like to find out more about the call for input, please visit the website or contact David Bennett.

Mark Corbett_Clinigen GAP

Early access has become an increasingly prominent issue within the global biotech sector – how to enable patient access to pioneering but investigational new treatments. In 2014, US biotech company Chimerix made international headlines following a social media campaign urging the company to provide Josh Hardy, a critically ill seven year old boy, with access to a potentially life-saving drug. One year on, Mark Corbett, SVP Clinigen Global Access Programs (GAP), explores the importance of early access education in response to a recent article in the Wall Street Journal from Kenneth Moch, former CEO of Chimerix. 

The Chimerix story

In a recent article in the Wall Street Journal Kenneth I. Moch called for new guidelines for access to experimental drugs in an attempt to create a more equitable approach to early access.

Following recent legislation changes in the US, including the FDA’s streamlined expanded access process and the increasing number of states passing new ‘Right to Try’ laws, Mr Moch is well aware of the pressure that pharma and biotech companies can face in deciding the right response to requests for access to drugs.

Moch is the former CEO of Chimerix, a small US biotech company which, over a matter of days, found itself at the centre of a social media frenzy which made the news around the world in 2014. The family of seven year old Josh Hardy from Virginia approached patient advocacy groups and used social media to pressure Chimerix to provide access to its experimental drug, brincidofovir; Josh’s last hope to fight a life-threatening infection.

Josh received the drug and is now about to celebrate his ninth birthday after unprecedented action from the FDA which enabled Chimerix to initiate a new Phase III clinical trial for which Josh was the first and, for a while, only patient. However, a month after brokering the trial, Moch was replaced as CEO by former CMO M. Michelle Berrey, and left the company.

The media firestorm emphasised the complexity of the global early access space and the ethical questions and dilemmas that pharma and biotech companies now need to address, often as the ultimate decision makers in whether an experimental drug is made available.

Early access: Be prepared!

Although a US-centric incident, the Chimerix case is certainly not a one-off. There is increasing pressure from informed, mobilised patients and their physicians, partly as a result of more transparency of drug-development pipelines online. In the US, requests for expanded access made through the FDA increased by 92% in 2014, a trend that looks set to continue.

The Chimerix experience highlights the need for more education about the options available and the risks and benefits involved in the provision of early access both in the US and much further afield.

Preparedness is key as pressure mounts on corporate management to balance the pressing needs of an individual patient with the longer term potential benefits to a larger population. To have an early access strategy in place that considers and addresses the ethical considerations as well as the logistical needs is important, even if the answer ends up being not to provide access.

In addition, smaller companies developing a single drug or device often struggle most in finding the necessary resources to provide early access. Again, discussion and planning around this area is vital.

Moch has proposed an independent review board to help such companies to consider the associated costs, logistics and anticipated duration of an access program. These companies can also work with specialist providers like Clinigen Global Access Programs (GAP) that provide advice on the viability of a potential program.

In his article, Moch suggests that companies should publically state their policies on early access. Crucially, he believes that a company should also have the right to refuse if “it believes the greater good is served by this decision”. He also recommends that a regulatory framework is put in place to help companies address any unforeseen consequences from granting early access.

Mr Moch’s conclusion – that early access programs are no substitute for clinical trials but that ultimately these programs fulfil an important role for critically ill patients with no other treatment options available to them – is one that I very much agree with. The question is how best to strike that balance.

Having implemented over 120 global access programs for companies ranging from niche biotechs to top 10 pharma, I believe that it is critical to consider early access early, as a core component of the drug development and market access strategy. It is only by understanding the options available, discussing the relative benefits and risks and planning ahead, that corporate management can ensure a successful program. Therefore, educating the industry about ethical access to experimental drugs is essential.

To learn more about early access read the joint BIA and Clinigen GAP blog and post-event report ‘Early access in practice’ from November 2014.

Summer-Networking-Evening_banners_findoutmoreWith 17 days to go, the run up to General Election continues apace. Our sector video this week is from the British Science Association who have teamed up with journalist Susan Watts, former science editor of Newsnight, to question science spokespeople from each of the main political parties on the changes their policies would bring about if their party were to come to power. The Observer has also published an interesting article from Athene Donald of the University of Cambridge, which questions why science is so low on the agenda in the discourse leading up to the general election.

Following on from the Labour manifesto which I commented on last Monday, last week also saw the publication of the Conservative, Lib Dem, Green and UKIP manifestos and today the SNP have released theirs. Notable commitments so far have been:

  • Conservatives – support Britain’s modern industrial strategies such as the Life Sciences strategy, direct further resources towards the Eight Great Technologies, create more R&D hubs, hold an in-out referendum on membership of the EU by the end of 2017, spend at least an additional £8bn by 2020 over and above inflation to fund and support the NHS’s action plan, implement findings of the Innovative Medicines and Medical Technology (Accelerated Access) Review, take forward recommendations of the independent review into antibiotic resistance, foster research, innovation and jobs in the life science industry
  • Liberal Democrats – continue to develop the industrial strategy, remain a committed member of the EU so the UK can complete the Single Market, continue to allow high-skill immigration to support key sectors of the economy, aim to double innovation and research spending across the economy (supported by greater public funding on a longer timescale), more ‘Catapult’ innovation and technology centres, continue to ring fence the science budget and ensure that by 2020 both capital and revenue spending increase at least in line with inflation, reinstate post-study work visas for STEM graduates, expand the British Business Bank to tackle the shortage of equity capital and providing long-term capital for medium-sized businesses, deliver the £8bn England’s NHS leaders say is needed to keep it strong
  • Green Party – support an in-out referendum but remain committed to EU membership, allow foreign students to work for two years in the UK after graduation, immediately increase overall NHS budget by £12bn a year to overcome the current funding crisis, increase the overall NHS budget annually in real terms by 1.2 per cent to take account of the ageing population, stop the breeding of and use of genetically altered animals, cease Government funding for animal experimentation, support a moratorium on the use of genetically modified organisms (GMOs) in all agricultural systems
  • UKIP – an In/Out referendum on EU membership as soon as possible, seeking ‘continued access on free-trade terms to the EU’s single market’, an Australian-style points based immigration system, an additional £3bn a year into the NHS in England for frontline patient care, UK students taking approved degrees in STEM subjects exempt from tuition fee repayment
  • SNP – establish a new Ministerial led Innovation Forum, £1 million Innovation Challenge Fund to help address major societal and industrial challenges, support ambitious collaborations between universities, businesses and others to capitalise on Scotland’s world-class research including through a network of eight Innovation Centres, oppose a referendum on membership of the EU, seek reintroduction of the post study work visa, vote for an increase in NHS spending across the UK of £24 billion by 2020-21
  • (And for completeness) Labour – a new long-term funding policy framework for science and innovation, strengthening the UK’s relationship with the EU, the most competitive rate of Corporation Tax in the G7, a ‘sensible commissioning framework’ for the NHS

Also on policy, we’ve recently published the latest ‘Influencing and Shaping Our Sector’ update for Q1, covering our work and key achievements in policy and regulatory affairs from January to April – including the final Budget of this Parliament, the latest on access to medicines, and related developments at an EU level. You can download the full report here.

On Friday we submitted the BIA’s response to the Nurse Review of Research Councils. While we often focus on policy issues directly affecting industry, the research councils – particularly the Biotechnology and Biological Sciences Research Council (BBSRC), Medical Research Council (MRC) and Engineering and Physical Sciences Research Council (EPSRC) – are an essential component of the UK’s life sciences ecosystem. Our response highlighted their vital role and noted that a dramatic restructuring of the research councils could be a misstep, destabilising the current system, and therefore any proposed changes must be on a rigorous evidence basis.  We also commended the Biomedical Catalyst and called for its continuation, noted the potential of the Catapult Centres to boost translational work, and argued that industry input would be valuable in prioritising both academic and industrial strategy related funding.

It’s a busy week for events with both SynBioBeta, the ABPI’s annual conference and the Anglonordic Life Science Conference taking place in London. This is the third year SynBioBeta will be returning to London to showcase the best of synthetic biology. John Cumbers, founder of SynBioBeta, has written us a guest blog reflecting on the explosive growth of synbio since he launched the conference three years ago and gives some details on what to expect from this year’s offering – you can read the blog here. Follow @BIA_UK on Twitter for our live updates from the conference and #SBB15 for all the best bits. We’ll also be popping into the ABPI and the Anglonordic Life Science Conference on Thursday – again, check out our Twitter for any updates and follow @Anglonordic. More information and any highlights from these events in next week’s update.

If you’ve been considering applying for the EuropaBio SME Award I’d urge you to go ahead, as the application deadline has been extended to this Friday 24 April.

Best

Steve

In the midst of election fever, the British Science Association have teamed up with journalist Susan Watts, former science editor of Newsnight, to interview the science spokespeople from the main political parties in the run-up to the General Election on Thursday 7 May.

Science spokespeople from the major UK political parties were questioned on their policies and manifestos for the next Government if their party were to be elected. The questions are centered around the effect their policies will have on the public, and what difference they would see if a particular party were to come to power.

Watch the full series below.

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

“Without animal research, medicine as we know it today wouldn’t exist.”  This is a line taken directly from the website of a campaigning group in favour of continued animal testing. In many respects they’re right; to date, research in animals has provided instrumental data in the development of many life-changing pharmaceutical and non-pharmaceutical chemicals, for understanding their impact on the environment, and for advancing our basic knowledge of human and animal health and disease. However, times are changing, and there is increasing recognition from the industry that animal models may no longer be sophisticated enough to meet the needs of drug development in the 21st century. But according to some groups who oppose animal research, this shouldn’t be a problem because there are “very obvious and more appropriate non-animal methods of research that could have been used instead”. So why aren’t pharmaceutical companies and the biotechnology sector adopting these non-animal approaches more readily? The truth is not as black and white as some of these groups may lead us to believe. Dr Anthony Holmes, Programme Manager – Technology Development at the NC3Rs, explores why.

There are considerable scientific, regulatory, practical and technological hurdles to overcome before non-animal approaches can be adopted. However, driven by the realisation that unless something changes, the pharmaceutical industry is at risk of entering an ice age, the sector is embracing these challenges. The drug development process is long and expensive. High attrition rates due to safety liabilities and lack of efficacy observed in the clinic, but which were not identified during preclinical development is a major contributor to the escalating costs and reduced productivity of the industry. Current preclinical testing paradigms rely predominantly on animal models, including rodents, dogs and non-human primates. However, the high rate of attrition has called in to question the utility of some of these models and demands for more predictive tools.

Companies have tried since the 1970s to address this by frontloading their discovery and development processes with in silico and in vitro approaches. The aim is to identify compounds with undesirable characteristics as early as possible and remove them from development before they enter regulatory animal testing and clinical trials – fail fast, fail cheap is the mantra. This has been successful in reducing attrition due to poor pharmacokinetics and bioavailability, but the simple two-dimensional single cell-type cultures (often using transformed cells) are not sufficient for reliably determining efficacy and safety in modern drug development.  Increasingly, the research community is saying ‘goodbye flat biology’ and embracing advances in tissue engineering and microfluidic technologies to represent the multicellularity of organs in vivo; creating potentially more physiologically relevant three-dimensional cell and tissue cultures for early screening.

It is outwith the scope of this article to provide detailed case studies of how these technologies are being applied, but two excellent recent reviews in Nature Reviews Drug Discovery and Advanced Drug Delivery Reviews, cover this in great detail.

It is still early days in terms of the wider application of these technologies, but they hold great potential and there is real interest from the pharmaceutical sector in their development. The Wyss Institute in Boston, USA is leading the way, but there is increasing activity in Europe and the UK to capitalise on the growing excitement. However, for the full potential of these technologies to be realised, three steps need to be taken:

  1. Companies need to engage collaboratively with the international regulatory agencies. Regulators are keen to support companies in applying these new in vitro approaches and shouldn’t be seen as a barrier to innovation. To maximise the benefit of guidance regulators can provide, industry needs to engage with them early, and regularly as data emerges and the technology grows, to demonstrate its utility and justify its use.
  2. Companies need to take a leap of faith. Industry is currently maintaining a watching brief as these technologies develop, but to affect a paradigm shift, greater willingness to adopt and validate these approaches for their specific needs, is required. This is starting to happen, and as the results of these studies emerge we will start to see more companies embracing these alternative approaches.
  3. Greater cross-sector collaboration. Academics can be naive of the challenges faced by industry, and industry is often unaware of the advances being made in the science base which could benefit their business. More effective collaboration between these communities will ensure that the technologies emerging from the science base can be translated for industry application.

Opportunities are emerging to support industry in meeting these steps. New guidance from the European Medicines Agency to support companies in applying non-animal models through a ‘safe harbour’ approach has recently been drafted, and examples exist where drugs have entered clinical trials without having to go through standard regulatory animal studies (see Megit S. Immunocore pioneers new safety studies. In MedNous. 2011;5:14–15). The UK Government, through Innovate UK (formerly the Technology Strategy Board) and the major research funding councils, is investing in non-animal technologies to transform business and improve product development across a range of bioscience industries. This new initiative provides funding to support companies in working collaboratively with other businesses and the public sector to advance the development and application of novel, more predictive technologies. Finally, open innovation initiatives like CRACK IT from the NC3Rs is connecting researchers across sectors in highlighting industry challenges and providing considerable funding to support research and development of the solutions and a route to market.