Earlier this week, BIA member company Modern Biosciences announced it has entered into a collaboration with Janssen to develop their novel bone-protective compounds for the treatment of rheumatoid arthritis. The collaboration was facilitated by another BIA member company, Johnson & Johnson Innovation.

There are four Johnson & Johnson Innovation Centres located across the globe in Boston, California, London and Shanghai. The Innovation Centres were created to access the best science and technology in the region, and also to meet the needs of entrepreneurs and scientists developing important medical device and diagnostic technologies, consumer healthcare products, and pharmaceuticals.

Today’s member video features a case study of a previous Johnson & Johnson Innovation collaboration with Merus Biotherapeutics.

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

Following a trade mission earlier this month, we consider the burgeoning field of synthetic biology, the benefits of the mission and the role of the BIA’s Synthetic Biology Advisory Committee.

One of the government’s eight great technologies, synthetic biology (or ‘synbio’) is defined as “the design and engineering of biologically based parts, novel devices and systems as well as the redesign of existing, natural biological systems. It has the potential to deliver important new applications and improve existing industrial processes – resulting in economic growth and job creation”.

The Bento-Lab, a portable molecular biology station,  from UK start-up Bento Bioworks

The Bento-Lab, a portable molecular biology station, from UK start-up Bento Bioworks

While synbio’s applications are diverse, spanning all ‘colours’ of biotech, the unifying factor is the use of engineering principles to design biological solutions. Some companies are developing tools and techniques such as novel promoters, oligos and chassis, while others are using these synbio approaches to develop methods for cost effective and sustainable production of chemicals, for tackling the spread of disease by mosquitoes, for detection of bacteria or explosives, or even for the development of colour-changing plants.

Increasingly, the synbio community is working at the interface of biology and digital systems, tapping into and learning from big data and using in silico modelling to optimise pathways and automate high-throughput processes.

The trade mission and conference

The UK delegation in San Francisco

Earlier this month the BIA led a synbio trade mission with UK Trade and Investment (UKTI) to San Francisco to coincide with SynBioBeta, the leading conference for the synbio R&D, investor and policymaker community. The UK delegates comprised successful applicants from 14 companies, as well as key stakeholders from government organisations and SynbiCITE, the synbio Innovation and Knowledge Centre based at Imperial College. More information on the companies represented, and the UK’s strengths and offering in synbio, can be found in the booklet accompanying the mission.

Over two days the delegation visited six companies in the San Francisco Menlo Bay and Downtown areas to meet the teams and hear about a range of business models. The host companies included: Transcriptic and Emerald Cloud Lab who are developing remote and automated systems for molecular biology experimentation and complex data collection; Twist Bioscience and Cambrian Genomics who are working to reduce the cost of error free DNA synthesis to a few cents per base pair; Teselagen who are producing DNA assembly software; and Autodesk who are applying their experience in manufacturing software to analyse and learn from biological processes such as self assembly.

Sean Ward from Synthace announced the launch of Antha, an open language for biology

Sean Ward from Synthace announced the launch of Antha, an open language for biology

The final day of the mission was the SynBioBeta conference, now in its third year at San Francisco, with attendee numbers doubling at each successive event. SynBioBeta will return to London over 22-24 April 2015.  All the UK companies lightning-pitched their businesses to a packed UKTI sponsored session at the SynBioBeta welcome reception, and many also presented during the conference itself, including Synthace’s Sean Ward who announced the launch of Antha, a new open source language for reproducible work flows in biology.

J Craig Venter addressing SynBioBeta SF 2014

J Craig Venter addressing SynBioBeta SF 2014

A highlight for all attendees was the opportunity to hear from keynote speaker J Craig Venter – regarded as one of the leading scientists of the 21st century for numerous contributions to genomic research, and entrepreneur and founder of multiple companies dealing in genomics, synbio and human longevity. Venter spoke about his body of work and the fields he is turning his attention to now, such as remote DNA sequencing and synthesis with a view to testing for life on Mars.

Even aside from the financial assistance offered by UKTI, the benefits of the trade mission were several-fold; bringing the UK delegation together to exchange knowledge and ideas over three immersive days in San Francisco, highlighting the UK’s synbio strength to a key overseas community, and building strong connections.

Follow these links to read SynBioBeta’s blog on the UK contingent, to see more photos from the mission, or for more information on trade mission opportunities.

BIA’s Synthetic Biology Advisory Committee

Earlier this month the recent Emerging Technologies and Industries Strategy 2014-2018 from Innovate UK was announced alongside £50 million investment aimed towards improving translation in seven areas including synthetic biology, and the BIA’s Synthetic Biology Advisory Committee (SBAC) was recognised in the Strategy as a key UK strength in synbio.

SBAC was formed in 2013 and is currently represented by 13 companies, large and small. The Committee meets quarterly and acts both as a sounding board for the BIA’s synbio interests and as a forum for members to share ideas and best practice. An important consideration for SBAC members is how to undertake innovation in an open and socially responsible way – indeed ‘responsible innovation’ is upheld as a key priority for the UK synbio community.

SBAC is keen to interact with other companies in BIA membership who might not necessarily class themselves as synbio companies. Take a look at the web pages for more information on SBAC and its members.

Last Tuesday, delegates descended upon the London Stock Exchange for the Consilium Strategic Communications Annual Healthcare Conference.  For those who couldn’t make it, here they’ve provided us with a handy round-up of the day’s highlights.

The pressure on healthcare R&D productivity is a familiar refrain for the pharmaceutical and biotech industries. Former Science Minister and Powderject founder Lord Drayson, opening the Consilium Strategic Communications Annual Healthcare conference, offered two fresh twists on this issue – both borrowing from the tech industry – which he thinks may offer an interesting roadmap for healthcare.

Lord Drayson highlighted the work of the Structural Genomics Consortium, which uses an “open source” approach to identifying new targets, and also talked about the huge potential offered by digital health and the need for the healthcare industry to move away from models based around treating disease towards models based around keeping people healthy.

His speech struck the right note in kicking off a wide-ranging afternoon meeting covering the following topics:

  • Novel funding mechanics –various approaches to drug development funding
  • Go West: “Attractiveness of the US market” –focusing on the lure of the US listing for European biotech, its merits and shortcomings
  • Big Data – “The future of healthcare?” how data will shape the patient experience and the industry business model
  • Capturing Value in Innovation –looking at IP and how to protect and enhance it
  • An Interview on Big Pharma – “does M&A create value or reduce costs?”

The funding mechanics panel explored different approaches to financing, from the funding round to newer strategies such as the royalty bond, and asked whether European investors in general have become more comfortable with risk. The panel showed as wide a range of views on financing methods as the companies themselves, from the CEOs of Zealand Pharma and Helsinn, David Solomon and Riccardo Braglia, discussing the virtues of bonds to Adaptimmune’s CEO James Noble who, in his own words is “allergic to debt”.

With more European companies eyeing US listings, the “Go West” session examined the benefits and debunked some myths about US listings. The consensus was that while there are advantages for a European company– a bigger pool of specialist investors and greater stock liquidity among them — listing shares in the US is no panacea for the problems of an up and coming European biotech. As Edwin Moses, CEO of Ablynx put it: “You have to look at the company fundamentals and not just assume that tipping across the Atlantic will increase the valuation.” Justin Gover, CEO of UK-based GW Pharma – which has made a success of a Nasdaq listing – agreed that while GW’s US-listing has brought benefits, it has not been without drawbacks, among them the need for constant shareholder education, a significant compliance burden and increased cost.

Capturing Value in Innovation looked at how to turn some of the formidable science from Europe’s universities into valuable companies. London’s deputy mayor, Kit Malthouse, a backer of the MedCity initiative, was vocal about the importance science plays in creating wealth, and the need to connect the investment which is abundant in London with the world class science in the UK’s universities.  “We have lots of money in the City, but not enough is finding its way into life sciences,” he said.

In the Big Data session Lord Drayson, flanked by Ken Noonan from LEK Consulting and Povl Verder from SIME diagnostics, discussed the threat of disruption to the healthcare industry from the big players in tech, among them Google, Amazon and Oracle.

The conference was rounded off by a lively discussion between the Financial Times pharmaceutical correspondent Andrew Ward and Francois Maisonrouge, senior managing director at Evercore Partners.  Maisonrouge put up a spirited defence of the role played by M&A in shaping the healthcare sector and helping companies adapt to change. He noted that while crude deal integration can destroy value, some deals don’t get credit until long after the event, such as AstraZeneca’s ground-breaking 2007 $15.6 billion acquisition of MedImmune. Regarded at the time as an expensive disappointment, this is now credited with laying the foundations for the company’s new pipeline. Asked whether Pfizer’s recent approach to AstraZeneca was driven by the value of its pipeline or by Pfizer’s hunt for a lower tax jurisdiction, Maisonrouge said: “I don’t think Pfizer were going after AstraZeneca’s pipeline. I think everyone discovered AstraZeneca had a pipeline in the course of the [deal] defence.”

Deloitte SouthamptonLast week the UK and German governments jointly proposed changes to tax regimes which incentivise intellectual property such as the Patent Box. Richard Turner, Managing Director for Tax and Innovation at FTI Consulting, looks at how the proposals could change the scheme.

The proposal suggested by the two governments is to adapt the nexus approach put forward by the OECD in its Countering Harmful Tax Practices More Effectively, Taking into Account Transparency and Substance report, which was published as part of its Base Erosion and Profit Shifting Project. The principal objective of the proposal is to establish the requirement for substantial economic by requiring tax benefits to be connected directly to R&D expenditures.

In broad terms, the Patent Box benefit will be reduced by a fraction determined by qualifying (good ‘in country’) R&D over total R&D and any cost of acquisition of IP rights. Detailed definitions and rules are yet to be finalised.

It is anticipated that the modified nexus approach will be introduced and the existing UK Patent Box rules will be closed to new entrants in June 2016 and the old rules will eventually be abolished by 2021. Organisations most likely to be impacted by the requirement to link R&D expenditures to income will be:

  1. Groups migrating to the UK
  2. Foreign headquartered groups licensing rights to a UK company to manufacture and distribute patent products
  3. UK companies acquiring IP rights
  4. UK companies outsourcing R&D to affiliated companies outside the UK (note: there would be no restriction for UK companies who outsource to third parties)

This is certainly not the Death Knell of the patent box. Many companies are unlikely to be affected if all of their R&D has been and will be undertaken in the UK, although the compliance burden from having to track R&D expenditure is likely to increase. Companies in-licensing technology may see a reduced patent box benefit and this may result in a trend to corporate acquisition over licensing so that acquirers inherit the R&D history.

As the new rules are being formulated it is important that industry expresses any concerns or key requirements. One aspect that is essential for life science is the retention of the inclusion of exclusive licenses and another helpful measure would be the ability for SMEs with losses to monetise the benefit.

The BIA is currently setting up a working group on the Patent Box. If you’re interested in joining, please contact Pamela Learmonth.

ClinigenGAP_BioEurope_panelclose_editLast Thursday morning a number of key announcements were made by Life Sciences Minister George Freeman during a No10 breakfast meeting I attended alongside life science industry leaders, regulators and heath officials.

The latest rounds of Biomedical Catalyst (BMC) funding were revealed, with four BIA members amongst the winners – Modern Biosciences, Domainex Ltd, Heptares Therapeutics Ltd and Ingenza Ltd. It’s great to see BIA member companies amongst those selected for this latest round. Topping £100 million in business-led research funding is also a great milestone and it is satisfying for all of us who called out so strongly for the establishment and refilling of the BMC to see how far it has come.

Also on the BMC, Innovate UK and the MRC have appointed Ipsos MORI to conduct an independent evaluation of the scheme. In early 2015 they will be undertaking a survey among applicants (both successful and unsuccessful) to gauge views on and gather evidence and data relevant to, the issues to be explored by the study. Innovate UK has emailed applicants of business-led projects from all BMC competition rounds to date to enable opt-out from the survey. If you didn’t receive the opt-out email and want to be sure that your current email address is added to the mailing list of BMC applicants to be shared with Ipsos MORI, please contact: Elaine.evans@innovateuk.gov.uk.

At the No10 breakfast, George Freeman also announced the new ‘Innovative Medicines and MedTech Review’. This review provides a good opportunity to design a new speedier path to get innovative drugs to patients. It provides a timely vehicle to discuss how clinical trials can be made faster and more efficient, how early access can be delivered and rapid uptake ensured for all NHS patients.

Alongside all the announcements, the sector was also buzzing with a number of conferences and events going on last week – from the financial (Jefferies), to the industrial (FT and ABPI) and also charities (AMRC). It was great to see BIA members represented, doing business and moving forward.

The Consilium/Covington & Burling Annual Healthcare Conference gave lots of food for thought with discussion ranging from open source development, to the potential of digital healthcare and impact of big data, what US investors are looking for, liquidity issues and the benefits of M&A. Keep an eye out for a guest blog on the conference coming soon.

There was an interesting update from Professor Mark Caulfied of Genomics England on the pilot of the 100k Genome Project at the ABPI conference and George Freeman provided attendees with further details on the government review to accelerate access to innovative medicines that was announced at No10 that morning (having nipped across town from the AMRC conference having delivered a similar update to the medical research charity).

It was great also to see some of you at the Manchester Science Park for a really interesting breakfast discussion on the different types of funding available and the ‘strings’ that come with each. For those who couldn’t attend, the top advice from the morning is to ensure you are fully using R&D tax credits and it was also pointed out that the straightforward nature of the BMC makes it very useful for companies.

On the topic of funding, on 15 December the KTN will be holding a webinar on ‘EU Funding opportunities for the Regenerative Medicine Industry’ – more info here. Also I was happy to see the Cell Therapy Catapult, in collaboration with the KTN, AMRC and UK Regen Med Platform launched a UK cell therapy database of research funding last week.

On AMR, last week saw European Antibiotic Awareness Day with new initiatives unveiled including the Longitude Prize opening.

On Early Access, we’ve recently published a report of a panel I chaired at BIO Europe with Clinigen, which provides a broader look at the challenge of early access for companies taking a global view. We’ve also posted a blog on the topic here and you can view the panel in full here.

Finally, a quick reminder that the ABPI skills survey closes this Fri 28 Nov – have your say before it closes.

Look forward to seeing you in Liverpool for Bioprocess UK later this week

Best,

Steve

This week we’re featuring a series of video interviews from Scrip Intelligence on the topic of antimicrobial resistance (AMR). There are five interviews available to watch, including one with BIA CEO Steve Bates which was recorded at this year’s BioInfect conference.

In the video, Steve considers the growing issue of AMR – he tells Scrip more about what is needed for a solution; and current initiatives working in the area of drug resistance. He also discusses the Jim O’Neill review into the economic issues around AMR.

SB on AMR_ScripThe videos appear as part of Scrip’s microsite dedicated to antimicrobial resistance. The videos can be viewed under the ‘Opinions’ section of the microsite.

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

ClinigenGAP_BioEurope_panelclose_editToday, in partnership with Clinigen Global Access Programs, the BIA has published a post-event report on “Early Access in Practice”. The report is based on a panel session on early access which was chaired by BIA CEO, Steve Bates earlier this month at BIO-Europe. 

Early access is a mechanism that enables patients with an unmet medical need to be provided with access to a medicine, prior to it being made available in that country. The definition sounds simple enough, but successfully navigating the rapidly evolving and highly regulated early access space is challenging. There is increasing pressure from informed, mobilised patients and their physicians as a result in part of more transparency of drug-development pipelines online. This means that pharma and biotech companies need to carefully consider their early access strategy and be prepared before receiving a first request for access to a medicine.

Organised by Clinigen Global Access Programs (GAP), the panel, entitled “Mind the GAP? Meeting an emerging demand for access to medicines in late-stage clinical trials, prior to commercial launch”, explored the practical ways that pharma and biotech can meet this demand for new therapeutic alternatives by enabling pre-launch access to drugs in late-stage clinical trials. Bringing together experts from across the sector, the panel represented the wide range of stakeholders involved in getting unlicensed drugs to patients, and there was a lively discussion of the different challenges and opportunities of early access.

ClinigenGAP_BioEurope_panel_editWhether a top 5 Pharma like Pfizer, or a smaller Biotech like PTC Therapeutics (both represented on the panel), companies can face a range of different regulations for each territory and considerable legal and logistical challenges in providing 24/7 access to a drug over a huge range of territories. Reimbursement can be a key factor for a biotech if their product is still in development and not generating revenue, but is also important for pharma for whom international access programmes can be very costly.

The UK’s Early Access to Medicines Scheme (EAMS), which was explained in a previous report from the BIA and ABPI, is now six months old and the panel evaluated the success of this approach to date and possible elements of the scheme that require review, in particular reimbursement. The scheme is one approach for one country; however it is often part of a wider access strategy encompassing multiple territories and including the cumulative regulatory hurdles, timelines, and crucially costs of different national mechanisms.

Based on their experiences, the panel also provided a number of important considerations that pharma and biotech companies must agree on before deciding to initiate an early access programme. These included; agreement of the objectives for the programme amongst all stakeholders at the outset; a consideration, acceptance and planned mitigation of risk and importantly, an agreed exit strategy.

A fundamental point to consider was whether the structure of a business is amenable to providing 24/7 access to a drug, with a requirement to receive the request and supply the drug to a critically ill patient within a matter of hours. If not, a decision whether to outsource the management and logistics to a specialised service provider should be made.

Mark Corbett, Clinigen GAP

Mark Corbett, Clinigen GAP

The panel was timely as more and more pharma and biotech companies start to receive requests for access to their drugs, in fact Mark Corbett of Clinigen GAP believes every biotech and pharma company whose drugs meet a high degree of unmet need, should have an early access strategy of some form in place as a prerequisite of their drug completing phase II trials.

This awareness of, and increasing commitment to providing new therapeutic alternatives to patients with unmet medical needs was reflected by the large turn-out to the panel and the wealth of questions posed both during the panel and afterwards to the panellists. We hope that companies can take these points into their organisations to ensure that a full and open discussion can take place, and the necessary strategies and mechanisms put in place before a patient request comes through.

Six months on from the launch of EAMS, the BIA would welcome your feedback to ensure that the scheme can maximise the benefit to patients. Please address your comments to Pamela Learmonth, BIA Director of Communications and Public Affairs.

The full report is available to download here.

Soon after the announcement of the establishment of the Medicines Manufacturing Industry Partnership, this lively workshop at the UK Bioscience Forum enjoyed significant engagement across the community. Overall themes running through the case studies on new facility builds presented in this session include:

  • the importance of funding
  • collaborative approach with the MHRA
  • the opportunities single-use technologies bring, but not without supply chain challenges
James Christie, Oxford BioMedica

James Christie, Oxford BioMedica

Background

James Christie, Head of Manufacturing at Oxford BioMedica, opened the session by highlighting the significance of the sector to the UK economy. The UK medicines manufacturing industry is one of our leading manufacturing sectors, worth £22bn in exports, generating a trade surplus of £4.9bn in 2012 and Gross Value Added (GVA) per head of £149k, significantly higher than any other industry.

In 2012, 84% of the global pharmaceutical market by value was small molecules and 16% biologics/cell and gene therapies. Industry pipelines suggest that this will move towards a 50/50 split. Today, already 70% of the top 10 globally selling medicines are biologics compared to only 20% in 2006.

James then discussed the factors that make the UK attractive for medicines manufacturing. These include:

  • support from the Trade Associations and The Knowledge Transfer Network (KTN)
  • fiscal incentives such as the Patent Box
  • a great skill base that is now being supported further through the Science and Industry Partnership (SIP), which received £65.7m of public and private investment and involves 100 employers
  • BIS funding through the Advanced Manufacturing Supply Chain Initiative (AMSCI) which has resulted in two successful bids led by Oxford BioMedica (centre of excellence for gene based therapies) and GSK (continuous manufacturing) totalling £30.7 million. There has been a recent announcement by BIS of a further round of AMSCI funding to the tune of £100m.

To ensure that medicines manufacturing continues to be the UK’s No1 export earning sector through 2020 and beyond by differentiating, defending and growing the existing manufacturing base, recent government interest has resulted in the establishment of the Medicines Manufacturing Industrial Partnership (MMIP) which brings industry together to work towards this common goal of creating an attractive and innovation-driven environment for all types of medicines manufacturing.

Other recent government investments to support manufacturing include the National Biologics Manufacturing Centre (NBMC) in Darlington, and funding for a manufacturing facility for the cell therapy catapult totalling £55 million, which will allow the UK to work towards anchoring manufacturing of this growing sector in the UK.

As well as new manufacturing in the UK, re-shoring is equally as important. The announcement by GlaxoSmithKline that a new biologics manufacturing facility would be built at Ulverston was a testament to the competitiveness of the UK.

UKBSF_manufacturing_panelCompany Case Studies

Crawford Brown, CEO of Actavis Biologics, a biosimilars manufacturer in Liverpool, ran through the history of the company. This facility started out as the government-funded project known as the National Biomanufacturing Centre, and following its acquisition by Actavis is now the Global Centre of Excellence for development and manufacture of all biologic medicines within the Actavis Group. The biologics R&D site has state-of-the-art facilities and world-class development and manufacturing technologies.

Chris Major, BioProcess Manager of GE Healthcare, presented a complete solution to manufacturing in growing economies where governments are investing for self-sufficiency. KUBio and Flex Factory enable a GMP factory to be constructed out of the box, using single use technologies, which includes validation, training and even the finance to fund the project if required.

Single Use technologies were also championed by Mike Quin, Asset Manager at FUJIFILM Diosynth Biotechnologies, as a key component of their recently opened cell culture manufacturing facility in Billingham. As they run a multi-product facility, single use technologies reduce changeover times and minimise cleaning and validation, but the reliance on supply chain is greater. Input from the MHRA was sought from the design stage to ensure a future-proof factory was built and a modular design allows for an expandable facility

Simon Saxby, Interim Project Director at Cell Therapy Catapult, outlined how the government initially conceived the Cell Therapy Catapult to address key industry barriers in the area, and then went on to invest further in the Cell Therapy Manufacturing Centre, which will operate as an Advanced Therapy Medicinal Products (ATMP) manufacturing hotel to anchor cell therapy manufacturing in the UK. This facility will be modular, flexible, expandable and employ single use technologies, with final site selection to be announced soon.

These topics and more will be explored at the Annual bioProcessUK Conference in Liverpool on 25 – 26 November 2014. Why not join us!

Following on from last year’s event in Brussels, Thursday 13 November saw key opinion leaders, life science investors, analysts and advanced therapy companies gather in central London for the 2nd Annual EU Advanced Therapies Investor Day. Hosted by the Alliance for Regenerative Medicine (ARM) in cooperation with GE Healthcare Life Sciences, Bryan Garnier & Co and Cell Therapy Catapult, the one day event provided attendees with an insight into the latest technologies and therapies for a variety of indications.

Kieran Murphy, CEO, GE Healthcare

Kieran Murphy, President and CEO, GE Healthcare Life Sciences

Morrie Ruffin, Managing Director, ARM opened the event followed by a keynote presentation from Kieran Murphy, President and CEO, GE Healthcare Life Sciences. In his presentation, Kieran outlined the huge potential of the field due to the sheer number of patients affected by diseases that advanced therapies have the ability to treat, such as cancer and diabetes. He described how ‘bringing regenerative medicine to the mainstream’ will require more than biopharmaceutical companies alone – including global academic collaborations, government input, gaining the confidence of regulators, investment and sophisticated novel supply chain processes.

Throughout the day there were presentations from 14 advanced therapy companies, including BIA member companies Oxford BioMedica and ReNeuron.

The rationale behind investment in immuotherapies was discussed in a ‘fireside chat’ between Usman (Oz) Azam, Global Head, Cell & Gene Therapies Unit, Novartis and Keith Thompson, CEO, Cell Therapy Catapult. Oz explained how compelling clinical data underpinned Novartis’ decision to create a dedicated business around cell and gene therapies and discussed the progress of their CAR T cell therapy candidate CTL019. The potential of CAR therapies to treat solid tumours was also indicated and the panel agreed that announcements such as the ‘one stop shop’ for regulation of regenerative medicine products show that regulators are receptive to these technologies.

The day continued with a session on targeted immunotherapies for oncology. Discussions covered how the ‘science is ripe’ in regenerative medicine, which will lead to big returns on investment and how scale up of processes and an enabling ecosystem will be key to success. The panel suggested that genome editing platforms such as CRISPR and zinc finger nucleases could revolutionise the cancer immunotherapy field. UCL’s Emma Morris identified funding for phase I studies from global research councils as key to advancing the regenerative medicine field.

ARM_event_panel_600x300

Steve Bates chairs panel session on therapies for ophthalmologic disorders

Steve Bates, CEO, BIA chaired a session on therapies for ophthalmologic disorders featuring panellists from Sanofi, UCL, QMUL and NightstaRx. They discussed how the eye presents an attractive target for cell therapies due to its accessibility and suggested that the ophthalmologic space has the potential for developing blockbuster therapies to treat diseases such as choroideremia, age-related macular degeneration and retinitis pigmentosa. It was questioned what expertise and infrastructure would be required to successfully implement these therapies in a clinical setting.

The final panel reviewed the use of cell and gene based therapies to treat cardiovascular disease. This brought up many interesting ideas, including the possibility of ‘cell free therapy’ – providing the proteins and substances that cells secrete at the right time and in the right quantities to treat diseases. Methods of achieving better delivery and retention of cells in cardiac tissue were also discussed.

If you’re interested in catching up on the day’s events, a webcast of all talks, panels and company presentations will be available within the next two weeks on the event website.

BIA_synbiomission_600x300Last week saw a sudden and unexpected joint proposal from the UK and Germany that would make changes to preferential intellectual property tax regimes, including the UK Patent Box, a key part of the fiscal landscape for attracting and retaining life science companies to the UK.  The proposed changes will be under discussion this week at the OECD/G20 summit in Brisbane as part of the Base Erosion and Profit Shifting (BEPS) project. BEPS is an extremely broad tax project regarding the determination on a country by country basis of the taxable profits of multinationals. Patent boxes are just part of one of 15 workstreams.

This new proposal does not appear to represent any change in the intention of the UK patent box regime, ie it does not propose abolishment of a regime providing a lower tax rate on profits  generated from patents. What it does address are the rules that underlie such schemes and how to define “substantial activity”, in the context of mobile income and assets such as IP. The OECD has suggested three approaches for consideration – value creation, transfer pricing and the nexus approach. The UK patent box scheme is at present based on a transfer pricing approach (as articulated by Treasury Minister David Gauke MP at the BIA’s UK Bioscience Forum) where substantial activity was to be determined in the context of the location of key functions. This new proposal outlines a nexus approach which permits a jurisdiction to provide benefits to income arising out of IP so long as there is a direct nexus between the income receiving benefits and the expenditures contributing to that income.

If the proposal is approved by the OECD/G20 this week the intention would be to work towards a new nexus-compliant UK patent box with effect from July 2016. Existing IP in the current regime at that date will be “grandfathered” and allowed to apply the old rules until 2021.

At this stage it is difficult to say what the precise implications could be across the sector if this proposal is adopted. The BIA is working and will continue to work with members, government and wider stakeholders on this issue and it is the top agenda point at our Finance and Tax advisory committee this week. Please get in touch with myself of Pamela Learmonth if you would like to engage directly with us on what will be an ongoing policy project.

Later this week, UKTI plan to launch a new website which will contain a searchable database and map of UK Life Science companies, making public some of the database from which they’ve sourced the ‘Strength and Opportunity’ reports on the sector published in recent years. The draft website can be accessed here http://ukti.cargodev.co.uk and any comments should be addressed to roisin.mcclory@uktispecialist.com. The BIA has endeavoured to help BIS check their data is accurate over the years to the best of our knowledge but we do not own or administer this database. UKTI have asked us to share the following statement with members in advance of the official launch, which gives detail advising on the collection of data and the origin of it.

“The name, location and segmentation  of  companies included in the UK Life Sciences website have been drawn from the Bioscience and Health Technology Database which is owned by the Office for Life Sciences within the Department for Business, Innovation and Skills. Turnover and employment information is sourced from a third party on a commercial basis and drawn from reported figures or estimated figures (where there is no requirement for the company to submit accounts). It is presented in bands as individual company information cannot be released. The data shown for each company and location is sourced at site or location level for employment and for turnover the bands represent UK life science derived turnover estimated to arise from activity at that site.

Information on company names and addresses has been obtained from a  range of sources including web-searches and lists provided by trade bodies and life sciences networks.  The short descriptions of the companies activities have been obtained from their own public website. The segmentation of company activity has been determined broadly by the company’s main business activities in the UK using publicly available information.  No confidential information has been included in the website but there is the option for companies to opt-out if they prefer.”

The BIA has long advocated that enabling global partners to better see the strength and opportunity within companies in the UK life science ecosystem should be core to UKTI’s life science mission and we hope that this new initiative can play a key role. We would also appreciate any feedback you have about this initiative or the website.

Remaining on the topic of websites, the latest version of the Scrip antimicrobial resistance microsite is now live – and free to view. Check it out here: http://www.scripintelligence.com/amr/

Last week’s synbio trade mission brought together a delegation of representatives, pictured above, from 14 UK companies – ranging from start ups to a seed fund and including the BIS synbio entrepreneur in residence plus representatives from the SynbiCITE Innovation and Knowledge Centre and Innovate UK – to exchange knowledge and ideas over three immersive days in San Francisco while visiting local companies and the SynBioBeta conference.

A highlight for all was the opportunity to hear from keynote speaker J Craig Venter on his body of work from the last decades and where he is turning his attention to now, such as remote DNA sequencing, which he terms ‘bio-teleportation’, with a view to testing for life on Mars. Keep an eye out for our blogs from the mission which will be published shortly.

I’ve already heard some very positive feedback from delegates about the opportunities they’ll be following up as a result of the trade mission. Together with BioPartner UK we run many missions throughout the year so if you’re interested do take a look.

It was also good to see Jeremy Hunt talking about the importance of innovation in his speech at the King’s Fund, recognising the role that it plays in unlocking personalised cures for illnesses and stating “we want the NHS to spearhead a global revolution in personalised medicine based on individual genetic characteristics”. He also used the speech to announce Dame Fiona Caldicott as the new National Data Guardian.

The Alliance for Regenerative Medicine’s 2nd Annual EU Advanced Therapies Investor Day also took place last Thursday and I was pleased to be able to attend. It was a great day and fantastic to see presentations from BIA members Oxford BioMedica and ReNeuron, in addition to a keynote speech from GE Healthcare Life Sciences President and CEO, Kieran Murphy. For those of you who are interested, the webcast of all talks, panels and company presentations will be available on the event website in a couple of weeks.

Look forward  to seeing some of you at our Manchester breakfast on Wednesday and the BIA will be out in force at the FT, Jefferies, ABPI, Consillium and AMRC events through the week.

Best,

Steve

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