Archives for the month of: August, 2013

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I’ll have officially been CEO for a year this week so I thought I’d use my update to reflect on my time here.

My aim has been to make the BIA legitimate, effective, progressive and sustainable and I’m proud to say that we’ve moved forward in all these areas over the last twelve months.

Legitimate

The legitimacy of any trade association derives from its ability to have in membership, engage with and draw in expertise from the sector that it represents. I’m delighted that we’ve seen a 25% increase in membership in the last year, helping us draft 22 considered responses to government consultations to keep our sector at the forefront of government thinking. The quality of and commitment of key industry figures both on our board, expert committees and at our events has helped ensure the BIA is the visible authoritative voice for the sector.

Effective

It’s because of this I believe that we’ve been able to be highly effective in delivering policy outcomes for our community. On matters from the somewhat technical Treasury issues of whether R&D tax credits should show above the line (delivered in last year’s Autumn Statement), to more straightforward arguments for the continuation of the Biomedical Catalyst (announced in this Summer’s Spending Review) the BIA has delivered tangible results for the sector. Not everything is a quick win. Policy debates can seem to move at a glacial pace sometimes, evidenced by our ongoing work to deliver clinical trial regulation at an EU level that ensures the UK is a competitive place to do clinical trials. These issues require perseverance to be effective so I’m proud that we are recognised for our expertise in this area and are organising the only EU event on voluntary harmonisation procedures.

Progressive

If trade associations don’t move with the times they run the danger of ossifying, especially in sectors undergoing change. This is one of the real attractions to me of this role. Biotech is changing. Pharma is changing. Health systems are changing. The scientific breakthrough of the genome is becoming useful for practical medical interventions. The IT revolution of big data and patient empowerment through social networking are reinventing the world we live in. Add in the aging population and the ongoing need for new therapies and I believe our sector is at the heart of what is changing fastest in our country in our lifetimes. Helping the sector navigate these changes is vital and in a small way I hope a number of new things we’ve introduced help in this direction. The inauguration of a new synbio committee to support that developing sector is a departure for the BIA that I hope puts us in a good place for the future. Similarly I hope offering more online opportunities to engage – via my monthly webinar or on our lively twitter feed and linked in groups – is in tune with the way busy modern executives engage. I also think working in partnership is the progressive way forward. Working together with One Nucleus, Bionow and BioPartner is what the sector wants us to do – and our joined up process to deliver a manifesto for the next parliament is a practical way to deliver what the sector needs for the future.

Sustainable

To do all this we need to be able to be around year on year with an attractive member offer, delivering member service. I am proud that we have the BIA on a stable and secure financial footing with an organisation right-sized to our income.  The BIA was established in an era when biotech businesses had different funding, ambitions and goals. We now have bigger pharma, fewer UK public biotechs, more virtual and more private biotech companies. The service sector in UK biotech services not just UK companies but the globe and is a vital part of our ecosystem and membership. This means the BIA has a broader membership with different needs and capacities, which we need to reflect in our offering and requests for 2014. What unites us all is a commitment that as a sector together we are stronger and can accomplish more.

I have enjoyed my first year tremendously and would like to thank the BIA team, Board and membership for making it a successful one. I think we’ve done a lot together, there is a lot more to do and I look forward to working with you in the coming year. I’m conscious of the need to continually improve and welcome input as to how we can achieve that so would be delighted to hear your thoughts or views on what we should do more (and less) of in future.

Best,

Steve

This week the BIA submitted inquiry suggestions to the Science and Technology Select Committee for their inquiry into Research and Development (R&D) funding for science and technology in the UK. Hana Janebdar, an Imperial College Biology student undertaking a Cogent placement at the BIA, outlines the submission. 

The BIA welcomed the opportunity to submit comments and emphasised the importance of government support for medical R&D in leveraging further private finance and encouraging collaborations that seek to translate research to development. Suggestions for inquiry topics proposed by the BIA were threefold: the Biomedical Catalyst, crowd funding and the UK public markets.

The Biomedical Catalyst (BMC)

The BIA suggested the Committee could assess whether a similar scheme to the BMC could be applied across other sectors. The BIA believes the BMC provides a blueprint for government support due to its impactful success in the biotech industry. Notable attributes of the BMC that were highlighted included its leveraging significant private capital, accelerating R&D and effectively joining together different public bodies. You can see the BIA’s report on the BMC here.

Crowdfunding

How the government could effectively harness the funding potential of crowdfunding, a growing sector, was another line of investigation suggested by the BIA. In particular, the BIA recommended looking into setting up a form of regulated crowdfunding based on the French Fonds Commun de Placement dans I’Innovation (FCPI) scheme, in the shape of the BIA’s proposed Citizen’s Innovation Funds. The submission underlined the success of the FCPI in raising over €6 billion as well as its potential contribution to the sense of venture philanthropy as seen in the United States.

The UK public markets

The BIA suggested the committee could also assess the state of UK public market accessibility for innovative sectors like that of bioscience. The BIA stressed the difficulty of growing a bioscience company and the need for better accessibility to the public markets to fund further R&D and growth.

The BIA hopes these comments are taken into account and looks forward to hearing further news from the Committee.

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After a successful BIA-led campaign with the sector the Biomedical Catalyst (BMC) is continuing with the fourth round currently open for applications. The BMC continues to have a significant positive impact on the sector and it is important for life science companies across the country to engage with the process. That is why we are putting on a series of events around the country – ‘How to be successful in the Biomedical Catalyst‘ – starting in Oxford on 10 September and then in Nottingham on 17 September.

I would urge all those with an interest in applying to the BMC to come along. We will have people in attendance who have already been through the application process successfully and who will be able to share some of their ‘top tips’ to give you the best possible chance to succeed. It is important the sector continues to share best practice amongst ourselves to ensure the continued success of the scheme in accelerating important medical research. These events are completely free of charge to attend so please do register and come along to network with your peers on this important issue. The BMC has shown us that taking the time to learn from your peers can make all the difference to your application.

Sticking with the funding theme, Angels4LifeSciences has its next meeting on 9 October. The final list of presenting companies are being drawn up but there are still a handful of potential open slots for interested companies to pitch to investors. Emerging companies or life science opportunities that require angel-appropriate levels of funding in both the near and long term should get involved with this opportunity. Angels4LifeSciences is an important vehicle to put investors and entrepreneurs together and anyone interested should drop me a line.

Finally, if you think your business deserves to be recognised as one of the very best, you might want to consider entering the Queen’s Awards for Enterprise. These awards are bestowed each year by the Queen in recognition of the winner’s outstanding achievements in three categories – innovation, international trade and sustainable development. There is also an award for individuals – the Queen’s Award for Enterprise promotion. Entries or nominations are totally free with the closing date on 30 September. The UK boasts many innovative life science companies to match any other sector and it would be fantastic to have one of our own win an award like this so please do consider it and feel free to contact with the BIA if you would like to know more.

Best
Steve

Beatriz San Martin

Dr Beatriz San Martín

Last week the BIA submitted comments to the UK Intellectual Property Office on case C-364/13, the International Stem Cell Corporation (ISC) preliminary reference to the Court of Justice of the European Union (CJEU) requesting clarification of what is meant by the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, commonly referred to as the Biotech Directive. In particular, whether artificially stimulated ova that are incapable of developing into viable human beings should nevertheless be classified as human embryos. Dr Beatriz San Martín, Partner at Field Fisher Waterhouse LLP and member of our Intellectual Property Advisory Committee (IPAC), outlines the background to the case and the BIA’s position on this issue.

ISC applied to the UK Intellectual Property Office (UK IPO) for two patents comprising a new method for activating an oocyte in the absence of sperm through parthenogenesis (the initiation of embryonic cell development without fertilisation) using a variety of chemical and electrical techniques. Such ova contain only pluripotent cells and cannot develop to full term due to the absence of paternal chromosomes, typically only reaching the blastocyst stage (about five days after activation).

The UK IPO refused ISC’s patent applications on the grounds that the inventions disclosed in the patent applications were excluded from patentability as Article 6(2)(c) of the Biotech Directive specifically excludes from patentability ‘uses of human embryos for industrial and commercial purposes’. This was based on the CJEU’s previous decision in the Brüstle case where, the Court concluded (emphasis added):

That classification [of a ‘human embryo’] must also apply to … a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis. Although those organisms have not, strictly speaking, been the object of fertilisation, due to the effect of the technique used to obtain them they are, as is apparent from the written observations presented to the Court, capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.’

ISC appealed the decision to the High Court arguing that the only sensible way of interpreting Brüstle was to question what is meant by ‘capable of commencing the process of development of a human being’. According to ISC, clarification is needed on whether an organism must:

(a)   be capable of commencing the process of development which leads to a human being; or

(b)   be capable of commencing the process of development even if that process is incapable of leading to a human being.

ISC’s position is that the test adopted by the CJEU was directed at the first alternative because a parthenote is not totipotent and, whilst it can commence the process of development, it can never actually lead to a viable human being, therefore it should not fall within the patent exclusion for a ‘human embryo’. The High Court ruled in April this year that the issue was not ‘acte clair’ and referred the matter to the CJEU for determination.

Comment

Capturing commercial value from stem cell research would be far easier under a narrower definition of what constitutes a ‘human embryo’ in terms of patentability. Nonetheless, the law has to strike a balance between encouraging the investment of those in biotechnology and the need to respect the principles safeguarding the integrity of the person. In considering the Biotech Directive and the potential for stem cell technologies to transform medicine, the High Court emphasised that excluding processes which are incapable of leading to a human being would not strike a balance at all and was ‘more akin to a total exclusion from patent protection of the fruits of stem cell research, to the detriment of European industry and public health’.

The BIA was assisted in its submission by two of its advisory committees: the Cell Therapy and Regenerative Medicine Advisory Committee (CTRMAC) and IPAC. A copy of the BIA submission can be found here, which concludes that unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, are not human embryos under the Biotech Directive.

Through its experts on the IPAC and CTRMAC committees the BIA will continue to monitor developments in this case; please contact Antonis Papasolomotos with comments. Whilst an Advocate General opinion has been common in the past, the CJEU is increasingly bypassing this step. There is also no guarantee that there will be an oral hearing, such that the next we hear of this case could be the ruling from the CJEU.

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Last week the BIA made it’s first public comment on the government’s proposals for a new statutory pricing scheme. As it stands, the government’s proposed pricing regime for branded medicines in the UK will put at risk future investment in the UK biotech base. The government’s pricing consultation is an opportunity of vital significant importance to the UK life science sector, which will set the attractiveness of the UK as a location for ongoing medical research and development and ultimately patient access to new treatments.

In our formal submission on the statutory pricing scheme consultation, the BIA makes four key observations:

  • A poor reimbursement framework undermines efforts in basic and translational research and development.
  • The government’s proposal is at odds with the positive actions and interventions taken forward under its Strategy for UK Life Sciences.
  • The proposals risk the UK ceasing to be an attractive global launch market for new treatments.
  • The life sciences sector is an ecosystem – where investment in research and development is linked to potential for reward for the resulting innovation.

On a different note, Vince Cable’s announcement that the Technology Strategy Board will establish a new Diagnostics for Stratified Medicine Catapult in 2015/16 is welcome. This new Catapult will help identify and provide the right care for individual patients, allowing businesses to develop new treatments and reducing the cost of healthcare. I encourage the sector to engage in the development of this new Catapult, which will complement the work of the Cell Therapy Catapult and the National Biologics Manufacturing Centre. The BIA is excited to play a full role in ensuring the Catapult succeeds in enabling UK life science businesses to deliver jobs and growth.

There is now more financial assistance than ever before available to eligible organisations who wish to join international trade missions to biotech events this autumn. As a Government Accredited Trade Organisation thwe are working closely with BioPartner UK and UK Trade and Investment (UKTI) to offer members the opportunity to join supported UK delegations to major biotech conferences around the globe. Upcoming discounted missions this September to November include to ‘BioPartnering Latin America 2013’ (Rio de Janeiro), ‘BioPharm America 2013’ and ‘Redefining Early Stage Investment’ (both in Boston), ‘AusBioTech 2013’ (Brisbane), ‘BIO-Europe 2013’ (Vienna), ‘SynBio Beta 2013’ (San Francisco) and ‘2013 BIO Convention in China’ (Beijing).

There were some interesting articles in the media on the sector last week. Andrew Jack’s Financial Times piece looking at the pharma sector’s refocusing on research notes a trend towards more personalised treatments. Matthew Herper at Forbes has looked at the costs of bringing drugs to market and his headline figure of $5 billion is staggering and unsustainable. Nuala Moran at BioWorld has examined the grants available to biotech companies in Europe and highlights the success of the Biomedical Catalyst.

Starting with this issue, we are now highlighting the policy and regulatory news updates through our blog. We think this is easier to view and will reach a wider audience than we have before.

Finally, there is just a week left until nominations for our Board close. Please contact Rowena Gardner for further information.

Best
Steve

BIA events autumn 2013

This autumn the BIA is running its busiest events, missions and meetings programme ever. There are over 35 opportunities for members to network, develop their business and make new contacts. These events cover a range of overseas missions, the BIA UK Bioscience Forum on 10 October and even more accessible events for smaller companies around the country focused on issues that most directly affect their business. A handy flyer is available to download and print. Looking forward to 2014, the BIA will be kicking off the new year with its signature BIA Gala Dinner at the Natural history museum on 30 January, registration is open now.

The BIA has been blogging for a year now. Alongside posts from myself and others on the BIA team we have featured contributions from BIA members and other key stakeholders in the sector. Contact Rob Winder if you have a suggestion for a topic to cover. As awareness of the blog grows, I thought you might be interested in the top five most read posts thus far:

We are always looking for pieces that are of interest to BIA members so do contact Rob Winder if you have a suggestion or would like to contribute an article or video.

As introduced last week, the BIA AGM will take place on 10 October – alongside the Bioscience Forum. I’d like to invite nominations from individuals interested in joining our Board from 1 January 2014. Nominations close on 27 August. Please contact Rowena Gardner for further information.

Over the next few weeks you will notice some changes to Newscast and how it is delivered. First, we are planning to highlight the policy and regulatory news updates through the blog in what we hope is a more visually appealing style. Second, as we change our mailing service provider, I hope you notice a few visual improvements to the newsletter (especially if you read BIA material on a phone or tablet) and you will receive it from a different address.

Best
Steve