Archives for the month of: April, 2014

Stephen Minger_smallMarking the BIA’s 25th anniversary, our inaugural annual lecture will be delivered this week by Dr Stephen Minger, Chief Scientist for Cellular Sciences at GE Healthcare Life Sciences. In the lead up to his speech tomorrow, here Stephen shares his reflections on the past quarter of a century and provides a preview of three themes which he believes will play a key role in the biotechnology industry over the next 25 years.

I am very much looking forward to speaking at the BioIndustry Association’s annual lecture tomorrow, which comes during its 25th anniversary year. Much has changed in the biotechnology industry over the last quarter of a century, and the BIA has been instrumental in creating the right environment for the industry to flourish. During my lecture I will be sharing some reflections on how the sector has evolved since 1989 when the BIA was founded, as well as discussing three key areas of interest for the next 25 years, all against the backdrop of some striking cell imagery courtesy of the finalists from this year’s GE Healthcare Cell Imaging competition.

There are many advances we take for granted these days which were unknown or at the very early stages of development back in 1989. For example, the field of cell therapy and regenerative medicine was only just emerging; 25 years on and cell therapy is one of the most promising areas of development within the sector, and one of the three key areas I will be discussing in my lecture.

After a number of years in the pipeline, the concept of precision medicine is also beginning to become a reality. The molecular make-up of many diseases is gradually being decoded, allowing us to distinguish between different types of the same disease and therefore target therapy appropriately. The potential reward for patients from precision medicine is vast, and may alter the way we treat certain diseases in the future.

Another area which I believe will have a large impact on the industry over the next 25 years is the use of Big Data.

Cell therapy, precision medicine and big data are only three examples from a number of exciting developments which will advance the biotechnology industry over the next quarter of a century. These developments will bring new challenges for the sector, but promise to ensure that biotechnology enjoys another 25 years of innovation and excitement.

I am very much looking forward to discussing these exciting future trends with attendees at the lecture tomorrow.

CEO and Investor Forum 2014_720x215V2Over Easter a rush of media coverage of our sector included a major story – GSK’s deal with Novartis – and some major speculation which was confirmed today – Pfizer’s bid for AstraZeneca (see this piece in the Guardian and more commentary in our sector news section). I’m delighted that GSK have promised to provide an update for our blog on what their deal means for our sector.

Elsewhere members have had a very busy week. In the City new BIA member Tiziana Life Sciences made a great debut on AIM, reversing into the shell of Alexander David Investments. This developer of novel molecules in the area of oncology more than doubled in price on opening, valuing the company at £23.3 million. Today the abolition of stamp duty on AIM-quoted shares comes into force, which should help to make the UK market more attractive still.

It was great also to be at UCB in Slough on Friday for the official opening of their new antibody development laboratories. It’s fantastic to see the commitment of UCB to developing the next generation of monoclonal antibodies here in the UK – and to see the role that R&D tax credits (which the BIA has tirelessly argued for) have played in helping the company make this investment here. But what is really exciting are UCB’s plans to enable researchers from outside the company work alongside their own scientists in the new facility. I’m sure we’ll here more on this in the coming weeks.

The two Catapults in our sector also continue to develop at pace. Ground was officially broken at the National Biologics Manufacturing Centre in the last weeks in Darlington and the Cell Therapy Catapult published an important overview of the growing UK cell therapy sector. We will be pleased to highlight the difference these schemes are making to UK biotech in our submission to the Hauser Review of Catapult Centres that we will submit to government shortly – any last minute inputs are welcome.

The Department of Business, Innovation and Skills released their update on the government’s Industrial Strategy last week (to surprisingly little fanfare). It was good to see the progress in biotech and life sciences well represented but I think it’s important to ensure the government stays focused on the long term nature of these structural interventions to reshape the UK economy. We will continue to press the case and the continuing need for focus on our sector and the UK’s science base.

I really enjoyed our BIA breakfast in Nottingham last week and the lively debate about whether there was a dearth of lab space for UK companies, which will help inform our manifesto development. One thing I was struck by is whether a lack of appropriate follow-on space is keeping some companies in incubator spaces which they should rightly have grown out of. Do let me know what you think and thanks to those who have also given views on how we might improve engagement with the clinical infrastructure in the NHS.

The coming week is a busy one. Today we’ve hosted over 100 people at our explainer event on the Early Access to Medicines Scheme with the ABPI – don’t worry if you weren’t there, as we will be producing a definitive guide to Early Access as a publication in the coming weeks. I look forward to seeing over 200 of you on Thursday for our inaugural lecture with Dr Stephen Minger at Bloomberg, which promises to be an exciting evening. We also taking bookings now for our CEO & Investor Forum in July.

Because of the Bank Holiday next week our next Newscast will be published on Tuesday 6th May.

Best,

Steve

Translational collaborations are essential to the life science sector, ensuring that the innovative research undertaken in the UK’s world-leading science base can be appropriately taken forward to market and, ultimately, made of use to patients. Following engagement with our membership, the BIA recently submitted a response to the House of Commons Business, Innovation and Skills (BIS) Select Committee’s inquiry into business-university collaboration. 

Our response focused on three key areas of the inquiry with most relevance to BIA members – the UK’s innovation system in relation to business-university collaboration, the Catapult Centre model, and government focus – such as on the ‘eight great technologies’ – to drive inward investment.

The UK innovation system and tech transfer

The strength of the UK’s science base is often commented upon as a core reason for the location of life science research and development activities in the UK. Initiatives such as the Biomedical Catalyst scheme have helped to support collaborations and ensure the smooth transition of promising science from universities to industry. From a UK public policy perspective, sustaining a high quality technology transfer environment is important to ensure that research with its origins in the UK can be effectively translated here in the UK.

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Attendees at a BIA Breakfast in Stevenage discussed tech transfer strengths and weaknesses

Technology transfer is one of the topics currently being evaluated in more detail as part of the BIA’s Life Science 2015-20 manifesto in partnership with Bionow, BioPartner and One Nucleus. Whilst there are examples of excellent technology transfer activity within the sector, early feedback from members suggests that the experience for SMEs can be variable and more could be done to improve the alignment of incentives between SMEs and universities. Difficulties that arise can range right from identifying potential projects for collaboration, through ascertaining what assets are available and who to contact, to the complications which can arise over valuation of the asset.

Role for Catapult Centres in facilitating collaboration

Our response noted that the network of Catapult Centres holds significant potential to facilitate collaboration between businesses and academia. The Cell Therapy Catapult, with which we have worked closely, has proven to be successful, rapidly establishing collaborations with both large and small companies to address the challenges that come with the translation of emerging technology. Our inquiry response emphasises the need to further raise international awareness of the Catapults and, crucially, the importance of appropriate funding to ensure that they can continue to deliver their aims in the future. This sentiment is one that we will echo in our response to the current Hauser review of Catapult Centres. BIA members have asserted that it would be more beneficial to have a smaller number of well-resourced Catapult Centres rather than a larger number of under-funded centres. The recent Budget 2014 announcement of an additional £52 million for the Cell Therapy Catapult to establish a Cell Therapy Manufacturing Centre is certainly a positive indication for the future.

Focused support

The final key area of comment in our response was related to the interest of our members in two of the ‘eight great technologies’, namely regenerative medicine and synthetic biology. The government’s focus on these technologies has been welcome, with political support helping to attract inward investment leveraged by strong academic and industry research alike. Alongside this focus, a supportive tax and investment landscape are critical for the long term future success of innovative bioscience translation. Our 2013 joint report with EY demonstrated that the UK has one of the most competitive tax frameworks for the establishment of an innovative company.

In summary, while difficulties are reported to exist in tech transfer processes at some institutions, there are examples of best practice in the sector from which lessons can be learnt. Together with support and focus from government, and with successful initiatives such as business-led Catapult Centres to bring together industry and academia experts with other stakeholders, the outlook should be positive for business-university collaborations.

This week’s post features Dr Ian Hudson from the Medicines and Healthcare Regulatory Agency (MHRA), discussing the Early Access to Medicines Scheme (EAMS).

The EAMS aims to provide patients who suffer from life threatening or seriously debilitating conditions access to unlicensed medicines when there is a clear unmet medical need.

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

BIA member Taylor Wessing is a law firm with a division, Synapse, specialising in law for life sciences. In this showcase of content from the Synapse web resource,  Daniel Rooke writes about different funding opportunities for early stage life science companies. 

Fundraisings of early stage life science companies can be complicated affairs, not just from the point of view of negotiating and settling the legal and other documentation, but also from the point of view of actually securing the funds from investors in the first place. Fundraisings of early stage life science companies are often of a higher value than fundraisings for other types of technology companies due to, in a large part, the resources that are needed to research, develop and trial their products, ensure that they comply with government regulations and the projected cash burn associated with these. Fortunately, there are a number of ways for early stage life science companies to raise funds and in this section we discuss the types of funding that are typically available for an early stage life sciences company.

The types of funding that are typically available

As with most types of early stage investments, a life sciences company raises funds either by issuing shares or by borrowing money from individuals, venture capital bodies or lending institutions.

The ability and appropriateness of either type of funding will often depend on issues such as:

  • the personal financial position of the initial shareholders and related persons;
  • the type of business and products that the life science company is trying to develop;
  • the stage of development of the technology (i.e. is it just an idea at the time of the fundraising or has IP already been developed which can serve as a platform for the future development of a company e.g. a spin-out);
  • the financial position of the business; and
  • the asset position of the business.

Early stage investments in life sciences companies often take the form of equity, loan notes or a combination of both. These, together with other types of funding, are discussed in more detail below.

Equity

Equity is a term which covers all types of shareholding investments in a company. Equity has the following characteristics.

  • it gives the equity holder ownership of a stake in the business;
  • it is unprotected, so on a liquidation or winding-up the shareholders will not recover their funds until all creditors and other costs of winding up the company have been paid in full;
  • when a company is limited by shares the liability of those shareholders can never be more than the amount which they invested; and
  • a shareholder has rights in the company; these are set out under statute and common law and can be varied by agreement between shareholders through the articles of association and/or a shareholders’ agreement. We have produced a separate article setting out the key documents and terms of investments into life science companies.

Debt

Debt is a term which covers all types of borrowings by companies and has the following characteristics:

  • debt ranks ahead of equity on an insolvency of a company. Secured debt ranks ahead of unsecured debt;
  • if it is secured, this means that the company has charged or pledged certain of its assets to the lender in order to obtain funds;
  • from the company’s point of view a secured loan will restrict its ability to deal with the assets which have been charged;
  • many lenders (particularly banks) will not risk funds in companies with little trading history and/or tangible assets without taking some form of personal security from the shareholders and/or director; and
  • the advantage to the shareholders and the company of borrowing money is that it allows shareholders to retain their shareholdings without dilution.

Loan notes

Loan notes can be a halfway-house between equity and debt and be a flexible alternative.

A third party will lend money to a company and the loan will be convertible into shares at a future date or on certain events happening. There would usually be interest payable on the capital amount of the loan notes. That capital sum may be secured against assets of the company. Loan notes are often convertible into shares at prescribed prices in certain circumstances or, instead, will be repayable within a certain period or on certain events happening.

Statutory restrictions to raising funds

Companies seeking finance from investors are, in effect, promoting investments and must therefore ensure that in doing so, they comply with the relevant legal and regulatory requirements which have been put in place to protect the investor.

Section 21 of the Financial Services and Markets Act 2000 (`FSMA 2000′) prohibits financial promotion communications in the UK unless they are made or approved by an ‘authorised person’ (that is, a person authorised under FSMA 2000 to engage in regulated activity) or unless there is an available exemption. There are exemptions available where the target audience is restricted to institutional investors such as venture capital funds, existing shareholders or creditors and certain high net worth and sophisticated individuals such as business angels (or groups of them).

Company law prohibits private companies from offering shares or other types of securities to the public (including any section of the public). However, private limited companies can offer their shares by private placement in certain circumstances.

In additional, companies must ensure compliance with or be exempt from Section 85 of FSMA 2000, under which it is provided that where securities are offered to the public (or a section of the public) in the UK for the first time, the offeror must publish a prospectus unless the issuer falls within one of a long list of exemptions from this requirement.

Boris_MedCity_Imanova_scan_600_300You may well have noticed the launch of MedCity in the media this week. This is a really promising initiative which will impact our sector and has already involved several BIA members. Boris Johnson is pictured above testing out Imanova’s 3D scanning technology in honour of the event, and there’s a great five minute clip of Bloomberg interviewing Eliot Forster (Chairman of MedCity and CEO of Creabilis) on what MedCity will do. With members from across the UK, I maintain that together we are the most vibrant cluster in Europe – and that many companies and academics outside the south east have multiple links with firms and academics within the south east. For me having MedCity as a champion of life science – influential in the financial hub of the City of London – will stand to benefit our sector as a whole. As Kit Malthouse, Deputy Mayor of London for Business and Enterprise, writing in our blog argues, MedCity will drive investment here from around the world.

If you’re looking for an opportunity to chat with members of the science and investment communities or to meet with Kit and the MedCity team come along to our Science and Finance in the City networking evening on 15 May. Last year’s was a great success, and we’ll be back in London’s Living Room at City Hall.

If you are not in the south east perhaps getting to our next BIA Breakfast in Nottingham, on Thursday 24 April fits well with your diary. We’ll be keen to pick your brains on topics that will inform our manifesto policy development with OneNucleus, BioPartner UK and Bionow. For a chance to vent your views come along or contact us on manifesto2015@bioindustry.org – recent topics have included Biomedical Catalyst funding, tech transfer and the availability of lab space.

This week Health Minister Earl Howe convened a meeting to galvanise the UK community to take advantage of two policy initiatives of recent weeks – the new adaptive licensing pilot at the EMA and the Earlier Access to Medicines Scheme (EAMS) here in the UK. It was truly an example of the “all hands on deck” approach as No. 10, Sir John Bell, the Department of Health, NICE, the MHRA, CASMI, NHS England and trade associations plotted the way forward for UK companies to take full advantage of these innovative schemes.

I hope you’ll have a relaxing Easter break this weekend. There will be no Newscast on Easter Monday so the next edition will be Monday 28 April. That morning we’ll have our joint event with ABPI on EAMS – the event is now fully booked with a waiting list, which just goes to show the appetite in the sector for more information and a chance to discuss this new scheme. I am looking to work with others to set up a similar event on the adaptive licensing process soon too – watch this space – and our conference with the MHRA will also be a good chance to understand the regulatory innovations in the pipeline.

On Easter Sunday 20 April our charity of the year Fight for Sight will be featured in a BBC1 Lifeline Appeal, presented by Judy Finnigan, whose mother lost her sight with Age-related Macular Degeneration (AMD). The appeal will hopefully raise lots of money and awareness of the importance of eye research. Your donations at our Gala Dinner this year have been totted up and verified, and I’m pleased to say that in total you raised very close to £30,000 before gift aid. Fight for Sight have called this a truly remarkable result and said that they are just so grateful for your support.

Best
Steve

This week’s post features Dr Ian Hudson from the Medicines and Healthcare Regulatory Agency (MHRA), outlining the role of the MHRA’s Innovation Office in helping organisations to navigate the medical regulatory landscape more efficiently.

The Innovation Office provides multidisciplinary guidance on innovative medicines in early development, as well as novel methods, manufacturing processes and materials. Contacting the MHRA Innovation Office is free of charge and early engagement is encouraged.

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

MRC_Chris_WatkinsLast week the Medical Research Council (MRC) announced a new partnership with AstraZeneca to create a joint facility in Cambridge for screening compounds. Here MRC’s Director of Translational Research and Industry, Chris Watkins, reflects on the motivations behind the move.

Large pharmaceutical companies like AstraZeneca are used to hosting visiting researchers from universities or research institutes. In fact, one of the ways that the Medical Research Council supports academic researchers to work with industry is by funding them on projects that will require that kind of interaction. There are examples of industry researchers working in academic labs in the early stages of developing a commercial product.

But non-industry scientists working full-time within a company environment is much rarer. That’s just one of the ways that the exciting partnership with AstraZeneca, announced last week, is breaking new ground in the UK in relations between the academic and industrial sectors.

We’re collaborating to create a new facility, the AstraZeneca/MRC UK Centre for Lead Discovery, which will be based in AstraZeneca’s new R&D site at the Cambridge Biomedical Campus. There MRC-supported academic researchers will work side-by-side with AstraZeneca scientists in their high-throughput screening group, working on ways to better understand disease pathways.

These non-industry researchers will have open access to the company’s state-of-the-art high throughput screening equipment. And they won’t just have access to the equipment – they’ll also have access to AstraZeneca’s compound library of more than two million molecules.

The collaboration will run for an initial five years, and we plan to fund up to 15 screening projects per year to be carried out at the centre at steady state, with the possibly of some projects beginning as early as 2015 at AstraZeneca’s existing facilities.

The MRC will assess applications to use the centre in our usual rigorous way, via peer review, and will encourage applications from a broad range of therapy areas and diseases – not just those of core interest to AstraZeneca. The company will have first refusal to negotiate licences for the development of any resulting intellectual property, with the researchers free to pursue other options if they wish.

Sharing the same labs, resources and aims will create a truly transparent research environment where academic and pharmaceutical industry scientists can work together.

We’re anticipating that this kind of innovative access to equipment and resources – and these new relationships – will speed up the identification of new, better validated targets for drug discovery, and ultimately more effective treatments for patients. This research simply wouldn’t have happened without such a collaboration being in place. We hope that by partnering with industry in these kinds of inventive ways, the MRC can help break down barriers to more effective collaborations between the academic and commercial research sectors.

I’ve written recently about why the MRC collaborates with industry – it’s because researchers working across sectors is the only way that we can accelerate research into how diseases develop and progress, and speed up the discovery of drugs and other interventions.

This collaboration is a great example of the kind of truly open and innovative research environments that this mission requires.