Archives for the month of: May, 2014

Following the submission of our response to the Hauser report, this week’s member video features the Cell Therapy Catapult. The Cell Therapy Catapult’s vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapy, where businesses can start and confidently grow.

Cell-based therapies have the potential to treat and cure a number of the difficult diseases which affect our population, and as such are one of the most important areas of healthcare for the next generation. This video describes the role of the Cell Therapy Catapult in the growth of the UK cell therapy industry, by supporting the development and commercialisation of promising early-stage research.

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Earlier this month, Eva Diagnostics was announced as this year’s winner of the OneStart award. Here Oliver Hardick, CEO and founder of last year’s winner Puridify, gives an account of how winning the award in 2013 has propelled the company over the last twelve months right up to this week’s news of an £850,000 seed financing round.

On the evening of the 15th May I was sat next to Toby Basey-Fisher, founder of Eva Diagnostics, at the gala dinner for this year’s OneStart award ceremony. Having addressed the audience earlier in the evening, detailing the leaps and bounds that Puridify had made over the past year and thanking the organisers and sponsors for what is a truly ‘company-life changing’ opportunity, I ended by giving the following advice: “I urge all ten fantastic finalists to make the most of this opportunity whether or not they win tonight, because the people that you will have met along the OneStart journey will be the people that you need to make your venture a success.”

When Jens Eckstein, President of SR One, announced the winners as Eva Diagnostics I can’t say I was surprised; I had seen Toby and Millie (Clive-Smith, also part of the winning team) in the semi-finals where they delivered a concise pitch that had a clear plan to effectively use £100,000 over the next 12 months to generate further value in Eva Diagnostics and to bring their anaemia diagnostics product (AnemiStat) to market. I certainly wish the team all the best and sincerely look forward to hearing more on their progress over the coming months.

At the 2014 OneStart awards: Jen Eckstein (SR One); Rob Balfour (Eva Diagnostics); Ian Tomlinson (GSK); Toby Basey-Fisher (Eva Diagnostics); Millie Clive-Smith (Eva Diagnostics)

At the 2014 OneStart awards: Jen Eckstein (SR One); Rob Balfour (Eva Diagnostics); Ian Tomlinson (GSK); Toby Basey-Fisher (Eva Diagnostics); Millie Clive-Smith (Eva Diagnostics)

The beginnings to Puridify started in 2008 with a discussion between Dr Daniel Bracewell (University College London; UCL) and Dr Robert Stevens (Rutherford Appleton Laboratory; RAL) which bore life to my Engineering Doctoral project based between the Advanced Centre for Biochemical Engineering and RAL. I was tasked with developing new materials to overcome the establishing limitations of downstream bioprocessing, or more specifically, the purification of therapeutic proteins by affinity chromatography. Four years later, with a couple of papers and a patent application under my belt, I secured an enterprise fellowship with the Royal Society of Edinburgh funded by the Science and Technology Facilities Council. This was a unique opportunity which supported me for 12 months, through funding and mentoring, to spin-out the technology that I had developed during my doctorate. Half way through this year an old classmate, Iwan Roberts, drew my attention to an email he had received from Oxbridge Biotech Roundtable advertising OneStart. This was the beginning of Puridify as an entity and the formation of the three man management team: myself, Iwan and Tom Haywood (UCL alum now studying for an MBA at London Business School).

Through the help of a countless number of mentors and advisors (Barbara Domanye-Hayman, Andy Sandham, Michelle Scott & Will West to name but a few), and to our deep surprise, we won the inaugural OneStart competition. We’ve had a very busy year since then, raising over £780,000 in non-dilutive capital through three separate Technology Strategy Board awards. We were invited to present our technology at two leading international conferences, and we now have an extensive list of global biotechs in line to help develop and evaluate our platform purification technology. Our team is expanding; currently with four full-time scientists on board, where work focused on commercialisation is taking place in our labs at the Stevenage Bioscience Catalyst and UCL’s industrial pilot plant. Most significantly, however, we are incredibly pleased to announce our first equity funding round led by Imperial Innovations & SR One.

Tom Haywood, Oliver Hardick and Iwan Roberts of Puridfy, at the 2013 OneStart awards

Tom Haywood, Oliver Hardick and Iwan Roberts of Puridfy, at the 2013 OneStart awards

I can confidently say that we would not be in this strong position today if it wasn’t for OneStart. Part of the prize was a years’ membership with the BIA who have been a fantastic support for Puridify, and me personally, while facilitating exposure of Puridify to the biotech scene. In particular I would like to highlight the CEO Investor Forum, a great event that allowed me to interact with a number of key industrial people. Also, the BIA Manufacturing Advisory Committee of which I have been a keen participant, has fostered new collaborations for Puridify and highlighted current issues in the industry. We have utilised access to reduced rate services like OAMPs insurance and of course the UK Bioscience Forum, a great event highlighting key industrial developments of the past year followed by the fantastic BIA Gala Dinner.

I stand by the advice I gave at the OneStart gala dinner in that it’s the people that make ventures a success in biotech, and not only the ones immediately around you. The one thing I’ve been amazed by in my short journey so far is how willing so many people are to give their time and share their expertise; it’s certainly allowed Puridify to flourish and I hope we’re able to do the same for companies like Eva Diagnostics in the future.

Longitude Prize_600_300I hope you enjoyed the Bank Holiday weekend. It gave me the chance to take stock on the BIA’s activity in the first part of the year and looking back I’m delighted to see the impact we’ve had on the the launch of the Early Access to Medicines Scheme, the Chancellor’s Budget and the rare disease debate – you can see an overview in our policy impact update for January – April 2014. Indeed our write up of our Early Access event and accompanying summary blog are worth a read if you didn’t come along. Modernising the regulatory system to ensure patients get innovative therapies as soon as possible is a key goal of the BIA and that is why I’m looking forward to discussing with the EMA how the adaptive licensing pilot will work at our event with CASMI and the ABPI next Monday.

Last week it was good to see many members at the World Stem Cell Conference in London and there were some exciting announcements from the Cell Therapy Catapult who were able to impress many global visitors with their progress with tours of their labs. The Cell Therapy Catapult are currently surveying the sector’s perceptions and priorities for the centre for 2014 and beyond – click here to give your views.

In order to identify the trends driving life sciences hiring in the UK at present, BIA member Hays Life Sciences has undertaken a comprehensive analysis of salary and benefits data across clinical, drug safety, quality assurance, regulatory, commercial, health economics, medical information and biometrics to produce their 2014 Life Sciences Salary Guide & Market Overview. It will be launched at a free-to-attend launch event and networking evening on 5 June, and you can get a sneak peak at their top-line findings here.

There’s also still a chance to join us at our upcoming events at our breakfast event in Oxford next Thursday 5 June and at our regulatory conference with the MHRA on 19 June.

The Hauser review of Catapult centres is taking evidence as we speak and the BIA will submit written evidence this week. If you have an interest in this area the TSB are holding consultation events in Oxford, Rotherham and London in the next few weeks where you can input directly – if you would like to attend, contact Zoe for further information.

If you got the voting bug from last week’s European election use your voice again and vote on the BBC Horizon website for the challenge you want tackled by the Longitude Prize 2014. It’s good to see several BIA priority areas in the shortlist. Also, the Drug Discovery of the Year Competition 2015 is now open for nominations.

Finally, Antonis Papasolomontos leaves us this week for a new role at member AbbVie. We will miss him and I’m sure I speak for all of us in thanking him for his fantastic contribution to the BIA and wishing him good luck in his new role. We are actively seeking a new Head of Public Affairs and Communications and would welcome recommendations.

Best,
Steve

This week’s post features BIA member organisation Tissue Solutions, who supply high quality and ethically sourced tissue samples to biotech companies, the pharmaceutical community and contract research organisations worldwide.

The Glasgow-based company works in partnership with histology and image analysis companies HistologiX and OracleBio to provide a “one stop shop” to major pharmaceutical research organisations. Here, Morag McFarlane, Tissue Solutions CEO, explains their role in the partnership.

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In order to identify the trends driving life sciences hiring in the UK at present, Hays Life Sciences has undertaken a comprehensive analysis of salary and benefits data across clinical, drug safety, quality assurance, regulatory, commercial, health economics, medical information and biometrics to produce the 2014 Life Sciences Salary Guide & Market Overview. Ahead of  a free-to-attend launch event and networking evening on 5 June, to discuss how the sector can act now to ensure a long-term sustainable future, Hays Life Sciences share their top-line findings here.

The biopharmaceutical industry and government need to take the long view, and do something to resolve the professional skills shortage now facing us in the UK. The war for talent is real, and as an industry we need to start thinking about where, and how, new skills will be channelled into the life sciences industry now, and in the future. As demand for innovative, more cost-effective and better value healthcare solutions increases, we will need more scientists, engineers and technicians, and need to think ahead about where this talent will come from.

Life sciences is a specialised business that, except for the high profile roles of doctor, pharmacist and vet, has failed to successfully attract the necessary talent resources. Long-term vacancies are already daily currency in some specialities – Statistical Analysis System (SAS) programming for biometrics is one such discipline – and we believe that the need to resolve the talent shortages is now urgent. A solution needs to be found sooner rather than later so this is not something that can wait until university. It must start even in primary schools. Which is why we associate ourselves with organisations such as CoderDojo that involves school children in coding.

At Hays we believe passionately in developing thought leadership and in encouraging this debate. It is imperative that we change the culture in life sciences recruitment and shift the needle from cost to partnerships and collaboration. Life sciences recruitment is now focused on creating sustainable relationships that will carry biopharma and its supporting organisations safely into calmer waters.

Here is a snapshot of some of the findings from the report.

Some summary findings of Hays Life Sciences’ benefits survey

To find out more please come along to our free-to-attend launch event and networking evening hosted jointly with BIA on 5 June, or request your copy of the report on 0203 4650090.

 

Steve Bates, BIA CEO, speaking at the event in April.

Today we have published a write-up of an event we held in late April on ‘Understanding the Early Access to Medicines Scheme’ (EAMS). Click here to view the write-up.

Whenever we embark on an event like this, there needs to be a clear aim and a clear appetite for information. We certainly knew this was the case when we decided to host this joint event, bringing in the expertise of both the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA). We hosted the event to increase understanding about the scheme to help companies to make an informed decision about their participation.

The scheme will benefit patients, the NHS and the UK clinical research community, of which our industry is a part. The regulation and development time for any new medicine is long and complex and the scheme should ultimately help patients with life-threatening or seriously debilitating conditions, without adequate treatment options, get faster access to innovative medicines. The concept of getting medicines to patients faster, without compromising safety, was first highlighted by Sir David Cooksey in his Review of UK Health Research Funding and was also considered at a Ministerial Industry Strategy Group (MISG) event in September 2007. The ABPI and the BIA responded to the MHRA consultation in 2012, highlighting the importance of continuous feedback and addressing concerns throughout the implementation process. Both organisations were also part of the Expert group on Innovation in the Regulation of Healthcare, which was set up following publication of the 2011 Life Sciences Strategy. Despite all this engagement, things have moved slowly and the first application deadline for EAMS was only earlier this month and it remains unchartered territory for the companies which are being encouraged to utilise it. The Government’s commitment to launch the EAMS was a major milestone, having taken many years to reach this point, but it soon became apparent that we were far from having the full picture about the scheme, and our member companies fed back to us that much more detail would be needed to allow them to fully evaluate the utility of EAMS.

We needed to get these unanswered questions answered if the scheme was going to get off the ground and benefit patients. To this end, we gathered all the key stakeholders, MHRA, NHS England, Government, patient groups and NICE and also members of the industry who could talk about their own experiences and impressions of the scheme so far.

The day was hugely productive, as the write-up highlights. There’s no doubt that everyone went away from the event with a clear understanding of the three-step process, expertly navigated by MHRA’s Daniel O’Connor. Also evident was the interest in the scheme – the room was full to capacity, and the MHRA alluded to several conversations which have already taken place with companies, although of course it remains to be seen how much of this interest will result in actual applications.

The other positive clearly evident at the event was the eagerness from all stakeholders to work collaboratively, flexibly and, in partnership with, industry. In practice, this will require timely feedback from industry to the MHRA on their experiences of using the scheme – which they encouraged multiple times throughout the event – and early, confidential dialogue with NICE to signal the direction of travel with PIM designations.

The potential of the scheme certainly came across for both industry and patients; however, this potential can only be realised once there is greater certainty.

The event went some way to addressing some of the key questions surrounding the scheme, such as making clear that the EAMS will sit alongside the EMA’s adaptive licensing scheme – for those who want to hear more about the adaptive licensing pilot, the ABPI, the BIA and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) are holding another joint “one-stop shop” on 2 June, to register click here.

However, other areas still require greater clarification, such as:

  • The timeline and framework for commissioning within the NHS
  • How many centres will take part in EAMS
  • How the pathway for gaining commissioning approval will work
  • The process for NICE evaluation and at what stage they will be involved in the commissioning

Of the concerns raised, of most significance was the lack of funding for the scheme, which was a much discussed topic and is a key feature which the ABPI and the BIA will continue to push for, particularly at a one-year review. It was extremely positive to get these questions and concerns out on the table, and heard first hand by the organisations and individuals who will be taking this scheme forward. We hope these points will now be taken back to organisations and addressed as a matter of urgency so that the scheme can quickly begin to benefit patients. There was without doubt a very encouraging level of interest and debate at the event, and we encourage those of you who would like to know more to read the write-up available here, and to feed back your comments directly to us at the BIA and the ABPI.

Steve Bates Chief Executive Officer of the BIA

Stephen Whitehead Chief Executive of the ABPI

Science_in_City_2014_Christian_Groendahl_600_300It was great to see so many of you at our Science and Finance in the City reception hosted by Kit Malthouse, the Deputy Mayor of London, last Thursday. It was particularly special that on the night our newest member Kymab were able to reveal their successful new £40 million raise – including the largest ever investment from the Bill and Melinda Gates Foundation’s investment arm; CEO Dr Christian Grøndahl is pictured above. It was a busy evening for UK life science elsewhere too as the OBR OneStart award for a European start up company went to EVA Diagnostics of London, who not only win £100,000 and space at the Stevenage Biocatalyst but also a year’s free membership of the BIA. They are developing AnemiStat, a low cost, portable device which diagnoses different types of anaemia. And congratulations are also due to BIA members Fujifilm Diosynth Biotechnologies, UCB, GSK, LGC UK and Actavis UK for their leading roles in developing the skills base of our sector, rightly recognised at the Cogent Life Science Skills Awards.

Keeping members at the forefront of regulatory developments is a mission of the BIA and I’m delighted that we are able to offer the opportunity for BIA members to be the first to gain a real understanding of the EMA’s adaptive licensing pathway. We’ve teamed up with the ABPI and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) to offer a one stop shop which will enable you to find out all you need to know in a convenient half day in just two weeks’ time on the morning of 2 June. All the key players will be there including Hans Georg Eichler of the EMA as well as the UK government, MHRA, NICE and CASMI who can explain why the UK is well set to be able to pioneer this opportunity.

The MRC have shortlisted an interesting bunch of nine academic applicants for their disease-focused stratified medicine consortia, who are now required to submit full applications by 17 July 2014. The MRC are calling on the UK research community – clinical, academic and industry – to join these consortia, with the aim that each consortium should provide an inclusive, internationally competitive, dynamic platform for research that will create opportunities for further funding and collaboration and develop clinically valuable therapeutic and diagnostic outputs. This is a good opportunity for BIA members given that existing consortia have each received support from the MRC to the tune of £4.3 million on average. Further details on the the MRC’s flexible model for supporting academic-industrial collaborations can be found on the MRC Industry Collaboration Application webpage, and Dr Jonathan Pearce, Translational Programme Manager at the Medical Research Council is the key contact.

Neil Woodford’s plans to launch his new fund are gathering pace. The long term UK biotech investor’s new venture is now up and running following the recruitment of a range of managers and support staff, and he is expected to launch his new Woodford Equity Income fund on 2 June. The offer period for investors will then run until the 19 June, and the fund will start trading on 20 June after the offer period closes.

So as you can see lots of great things moving our sector forward – as I’ve stressed to politicians of all colours this week – beyond the headlines of Pfizer’s offer to AstraZeneca.

Best

Steve

Following the launch of the Concordat on openness on animal research in the UK, this week’s sector video showcase comes from Understanding Animal Research (UAR). UAR provide factual information about the role of animals in medical, veterinary and scientific research in the UK.

Animal research has contributed to a variety of important medical breakthroughs in the last century, from insulin to asthma inhalers. Here, UAR list ten medical breakthroughs whose development was made possible through the use of animal testing.

Further information on the use of animals in research, including the Concordat, is available from UAR.

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