Archives for the month of: October, 2013

John Burt and David Gauke MP at PolyTherics

Last week we held three excellent events that highlighted the work we do with both regulators and politicians.

Our workshop on the Voluntary Harmonisation Procedure for multinational clinical trials in Europe brought together senior experts from regulatory agencies and industry, contract research organisations, academic institutions, clinical trial units and medical research charities to share their experience with the Voluntary Harmonisation Procedure (VHP), which delivers significant benefits for the conduct of multinational clinical trials in Europe. The workshop was particularly timely given the recent changes to VHP and we were delighted that Dr Hartmut Krafft, Chair CTFG/VHP-Coordinator, and Head, Section Clinical Trials at the Paul Ehrlich Institute, gave the keynote presentation on VHP (available here). He provided an overview of the key facts and main features of the new version of the VHP guidance (version 3.1) and experience with the VHP over the last 5 years.

On the same day, 25 senior sector stakeholders with an interest in rare diseases joined our roundtable discussion in the House of Commons. The meeting, chaired by Andrew Miller MP, Chair of the Science and Technology Select Committee, had a particular focus on the new arrangements for evaluating and commissioning Highly Specialised Technologies (HSTs) across England and the devolved administrations following changes to the structure. Joining Mr Miller were the Rt Hon Stephen Dorrell, Chair of the Health Select Committee, Iain Wright MP, Shadow Business Minister, and Lord Turnberg who were able to share their expertise, views and pose a number of interesting policy questions to the attendees.

Parliament Day is our flagship advocacy event of the year. It helps us to represent the sector’s top policy needs to senior policymakers across Westminster and Whitehall and setting up our policy-driven activity for the year ahead. Next year, Parliament Day is on 30 January. If you are interested in more details please contact Zoe Freeman. Following on from engagement at this year’s Parliament Day, David Gauke, Exchequer Secretary to the Treasury, visited BIA member company PolyTherics at the London BioScience Innovation Centre. The Minister was interested to know about the availability of skilled biotech workers and the importance of retaining intellectual property in the UK, in addition to the more regular financial issues of R+D tax credits and corporation tax.

Our charity partner for 2013 is the Cystic Fibrosis Trust. In November our Public Affairs and Communications Executive, Zoe Freeman, will be tackling the “Survival of the Fittest” 10k assault course to help raise money for the CF Trust. You can support them via Zoe’s Just Giving page.

This week, the BIA is leading, alongside UKTI, a trade mission for 12 UK companies to the AusBiotech 2013 conference in Brisbane and to meet a number of other Australian companies in Melbourne. Next week we will, alongside BioPartner UK, be leading a UK delegation to BIO Europe including the Mayor Of London’s Deputy Mayor for Business, Kit Malthouse. As well as helping companies make new links and gain business we’re also using our twitter feed to provide a snapshot of what’s going on if you’re not there.

I look forward to seeing many of you in Vienna next week

Best
Steve

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25 senior stakeholders with an interest in rare diseases met yesterday morning for an informative and interesting BIA-led and organised roundtable discussion in the House of Commons, chaired by Andrew Miller MP, Chair of the Science and Technology Select Committee.

Joining Andrew Miller were the Rt Hon Stephen Dorrell, Chair of the Health Select Committee, Iain Wright MP, Shadow Business Minister, and Lord Turnberg who were able to share their expertise, views and pose a number of interesting policy questions to the attendees.

The meeting was called to discuss “rare diseases, complex issues” with a particular focus on the new arrangements for evaluating and commissioning Highly Specialised Technologies (HSTs) across England and the devolved administrations following changes to the structure.

The depth and quality of discussion, and the wide range of issues covered, was certainly helped by having all the key stakeholders present including representatives from the HST teams in NICE and NHS England together with industry, patient groups and other policymakers.

A wide range of important issues were discussed. Some of the key points touched upon included:

  • A shared and agreed belief that NICE should adopt best practice from AGNSS (the body which formerly evaluated HSTs) to ensure, amongst other issues, that patients are adequately communicated with and engaged. Joining together the service delivery element of the HST programme (dealt with by NHS England) and the evaluation (handled by NICE) is an important factor
  • A belief that patients need to be suitably empowered to engage with the process and make their voice heard. This is particularly important in rare diseases where we have small, often identifiable, patient populations. Accurately reflecting patient need and patient choice needs constant attention and refining
  • The research and development of orphan and ultra-orphan products has a number of unique factors and characteristics that need to be taken into account. Recouping of significant expenditure can only be achieved over a small patient population, manufacturing processes are complex and often need to be entirely bespoke, and there is often a paucity of disease data and knowledge
  • There is a continuum of diseases affecting differing patient population sizes – not just HSTs and more general conditions. Rare diseases offer a window into the world of the challenges that will be faced as more personalised medicines are approved targeting specific subsets of wider populations.
John Burt and David Gauke MP at PolyTherics

Dr John Burt and David Gauke MP at PolyTherics

Following on from engagement at the BIA Parliament Day earlier this year, David Gauke, Exchequer Secretary to the Treasury, visited BIA member company PolyTherics at the London BioScience Innovation Centre yesterday. PolyTherics Chief Executive Officer (CEO) John Burt summarised the company’s history and escorted the Minister on a tour of the labs.

The Minister was interested to know about the availability of skilled biotech workers and the importance of retaining intellectual property in the UK, in addition to financial issues which were the topic of a short focused discussion. The Minister heard from John Burt, BIA CEO Steve Bates, Atopix Therapeutics chairman Tim Edwards and Biomoti CEO Davidson Ateh about how tax-related policies and schemes have affected companies in the biotech sector. The discussion covered the Enterprise Investment Scheme (EIS) and Venture Capital Trusts (VCTs), R&D tax credits, and the financial and reputational benefits of the Biomedical Catalyst.

There was a brief discussion around the Patent Box and the overall consensus was that although in some cases it is currently hard to plan for, the Patent Box does hold macroeconomic advantages in making the UK an attractive location for R&D, and time will tell whether it will benefit small biotech companies as well as big pharma. The BIA has produced a two-page document outlining key points to consider when planning for the Patent Box.

Scottish Centre for Regenerative Medicine

Scottish Centre for Regenerative Medicine

There were a couple of standout news stories from our sector last week.

Member company MedImmune has acquired London-based antibody-drug conjugate company Spirogen for $200m plus up to $240m in milestones. The acquisition is, I believe, the largest UK deal this year.

On Tuesday it was announced that Neil Woodford, one of the most significant fund managers for UK biotech, would be leaving Invesco Perpetual in April next year. My understanding is that the team at Invesco remain committed to a long-term investment approach and are supportive of innovative enterprises. After leaving Invesco, Neil will be establishing a new fund and I hope that he will continue to invest in companies dedicated to the development of early stage technology, and therefore provide an additional source of funds for listed companies.

Co-incidentally, Invesco is one of the main investors in a new £50 million fund established to support spin-out business from the University of Cambridge. The Cambridge Innovation Capital fund plans to invest on a long-term, decade or more horizon unlike conventional venture capital funds, across a number of sectors and at various stages of company development.

In order to help you decide if the UK’s Patent Box will benefit your company this tax year we have published a short, two page document, on key considerations you need to take into account to make your decisions. The document has been prepared by Colin Hailey, of Confluence Tax, with additional expert opinion from our Finance and Tax Advisory Committee.

Last week I had a great visit to Scotland. It was good to visit the BioQuarter in Edinburgh and the Scottish Centre for Regenerative Medicine, and have constructive discussions about our sector north of the border with the Scottish Lifesciences Association. I also met a good crowd in Stevenage on Wednesday evening at an event discussing crowdfunding for our industry.

I also met Chuka Umunna, Shadow Business Secretary, at an Industry Forum event last week. He reiterated that he sees life sciences as a priority sector for the UK economy and for Labour party policy. We will be engaging with them a lot more during the next 18 months in the run up to the election.

Finally, on Tuesday I’m looking forward to a workshop for members on the latest improvements to the Voluntary Harmonisation Procedure, which delivers significant benefits for the conduct of multinational clinical trials in Europe. We expecting 90 people for an impressive pan European event headlined by Dr Hartmut Krafft, who coordinated the revision of the VHP announced earlier this year.

Best
Steve

John Alty Formal photo_220_portraitOn 1 October 2013, the specialist Intellectual Property Court for England and Wales, the Patents County Court, was renamed the Intellectual Property Enterprise Court (IPEC) and given a new home, as a specialist listing within the Chancery Division of the High Court. Here John Alty, Chief Executive and Comptroller General of the Intellectual Property Office, outlines the implications of these changes for the bioindustry sector. 

The Court, which was originally introduced in 1990 as a court for lower value patent disputes, has undergone a dramatic transformation since 2010 and following a series of striking reforms is now a distinct forum for those businesses that are forced to take legal action to protect their patent, offering a lower cost, speedier option than the High Court.

The most important changes, for patent holders, are likely to be the introduction of a scale of recoverable costs capped at £50,000, a time limit of trial hearings of 1-2 days, and proactive case management.

The time limit on trials is significant as it not only means swifter judgements, but more importantly focuses the parties’ minds on examining the key evidence, reducing unnecessary testimony and document discovery. Before any hearing, at the case management conference, the judge himself is now able to state what evidence he would like to see at the trial, and what isn’t necessary. This process can dramatically reduce the cost of a trial, as well as its length, limiting the amount of legal work need to be carried out prior to and during the hearing.

This process has worked well in recent years, for example, in one case last summer the court was able to give a judgement in a patent trial in one day, and, as the Liversidge vs Owen Mumford Ltd case last year proved, the court is still capable of handling the complexity of a case from the bioindustry sector.

The court’s scale of recoverable costs allows businesses to prepare financially for the potential cost of legal action, providing them certainty on how much they could have to pay if they lose the case. This is particularly important for smaller businesses, who can be dissuaded from protecting their patent in the courts by the prospect of potentially paying for the other side’s expensive legal team. Alongside the cap on costs the court also carries a cap on damages of £500,000.

There will always be some patent cases that remain too complicated for these simplified processes and the Patents High Court remains an important venue for a lot of patent cases. However, the existence of a proven, viable low cost alternative for many of the bioindustry’s disputes is something that the IPO is keen to promote.

If you would like to know more about IPEC, there is comprehensive user guidance (along with contact details) on the Intellectual Property Office and the Ministry of Justice websites.

Boris Johnson, Mayor of London, at the BIA UK Bioscience Forum

Boris Johnson, Mayor of London, at the BIA UK Bioscience Forum

Our UK Bioscience Forum last Thursday was a tremendous success. With more than 350 delegates for the forum joined by another 50 for our Autumn reception, the event is our second biggest of the year.

Our keynote speakers, Mayor of London, Boris Johnson, and BIO’s President and CEO, Jim Greenwood, were both excellent. Boris highlighted London’s history as a centre for science and discussed his belief that innovative industries such as ours are the key to future economic growth. Jim outlined the relationship between BIO and the BIA and spoke about the international nature of our sector. Jim said that the ongoing Transatlantic Trade and Investment Partnership (TTIP) negotiations present huge opportunities for the sector, in particular he highlighted the desire for mutual recognition of GMP between the US and EU. If you wish to get a flavour of the day, search for the hashtag #biaukbf on Twitter to review the tweets sent during the day.

The BIA launched two reports at the forum. The first is an update of our report on the Biomedical Catalyst which shows that UK biotech is flourishing thanks in significant part to the Biomedical Catalyst. The report highlights that over 100 business-led projects in the UK are now accelerating the translation of innovative scientific and medical research into therapies that can be used by patients and sold around the globe. Additionally, the report shows that to date over £120 million has been awarded thus far, over £80 million of which is to support innovative business-led research, and almost £70 million of additional project-specific private capital has been leveraged into the UK alongside grants.

The second report we have published jointly with EY on the State of the Nation for UK biotech. The report shows that on key indicators – pipeline, investment capital raised, environment to start a company and innovative funding – the UK is the strongest bioscience cluster in Europe. I will be discussing the findings from the report in my “Coffee with Steve Bates” webinar on Thursday 17 October.

Finally, we also held our AGM last Thursday and revealed the members appointed to our Board for three years from 1 January 2014. The successful candidates are Kevin Cox, Donna Hackett, Jane Osbourn, Stephen Taylor, Patrick Verheyen and Tim Watts. Additionally, John Brown and Ian Tomlinson have been re-appointed to the Board. I look forward to working with them.

Best
Steve

BIA at BHF_biotechweek_440_220Last week was European Biotech Week and we had a really fantastic week at the BIA, with plenty of good news to share. On Monday thanks to Europabio over 60 people from across Europe met with the European Medicines Agency (EMA)’s at their London headquarters, to understand the new routes available to SMEs to engage with regulators for innovative products.

On Wednesday I was pleased to speak at the opening ceremony of Fujifilm Diosynth Biotechnologies’ new state of the art disposable mammalian cell culture plant, which was opened by Royalty in Teeside, and that same evening EuropaBio announced the winner of their European Most Innovative Biotech SME Award 2013.

What a great result to have PsiOxus Therapeutics – a UK company and a BIA member – announced as the winner. I think this further highlights the UK’s position as the leading biotech cluster in Europe. Many congratulations to PsiOxus Therapeutics, who were recognised for their innovative approach in cancer therapy.

BIA at BHF_biotechweek_250_squarishFinally on Friday, the BIA joined up with the Babraham Institute and Papworth Hospital to promote bioscience R&D at the British Heart Foundation (BHF)’s Peterborough furniture and electrical store. With goody bags and balloons, talks from a BHF researcher and a clinician, plus live displays of CPR and educational props to illustrate healthy hearts and arteries, we ‘took the cause to the store’ to thank and highlight to BHF shoppers how their support and donations help to fund biotech research.

This week, on Thursday 10 October it’s our Bioscience Forum and evening Autumn Reception at the Royal College of Surgeons. We’ve got a great day lined up packed with sessions on the topics that matter to you – including intellectual property, manufacturing, finance and hot topics such as antimicrobial resistance – together with plenty of opportunity for networking. If you haven’t yet applied for one-to-one partnering – or even if you haven’t yet booked! – take this last chance to book now. With over 380 delegates, 65 speakers, 24 exhibition stands and of course keynote talks from Boris Johnson and Jim Greenwood, CEO of BIO, it’s sure to be an event you won’t want to miss.

Our AGM also takes place this Thursday, so don’t forget to vote now for the BIA Board elections, the ballot closes tomorrow.

I hope to see you on Thursday.

Best
Steve