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We were delighted to welcome Lord Drayson to the BIA’s UK Bioscience Forum to deliver a keynote speech. Having previously worked both within government and as a CEO within the sector, Lord Drayson promised to be an ideal speaker to bridge the policy and commercial considerations of our sector and on that front his speech did not disappoint.

Concurrent with an overall theme of celebrating success that emerged throughout the day, Lord Drayson was keen to emphasise the positive developments for the sector both in terms of policy progress and commercial success.

Lord Drayson echoed many other endorsements we heard during the UK Bioscience Forum about how good a place the UK is for life sciences: its science base, the clusters of world class companies around leading universities, the level of investment into research and the tax and fiscal environment. He congratulated the BIA on the publication of the UK Life Sciences Manifesto 2015-2020 and underlined how important the fiscal measures introduced by the current and previous government had been. He also welcomed the figures outlined in the BIA/EY State of the Nation report showing unprecedented levels of financing compared to recent years.

However his core message was that the UK biotech industry should be far from complacent and needs to build on the momentum it has already achieved. In a message that would be quoted throughout the day in the networking coffee and lunch breaks, he said “we need to add a nought or two to the jobs and growth we are achieving”.

He set out a number of challenges and ideas to build on where we are now, including:

  • Focus on transforming start-ups into seriously large companies
  • The role of university technology transfer departments in incubating such start-ups further and helping accelerate growth of these companies in their early years
  • Government work to redress the balance between short and long term investing; potentially introducing tax incentives for both investors and management teams to hold their shares for more than 10 years
  • Cultivate a management culture of “proactive evolution” within biotech businesses and ditching the “knitting” when circumstances change

His final vision statement “delivering better health, more jobs and more wealth for the nation” left us all with food for thought.

Picture 182What does it take to be a leader in the biotechnology sector? Earlier this month at the UK Bioscience Forum, our ‘Game-changing Leaders’ panel session discussed the different attributes required to lead a company and how this evolves through the lifecycle of a business. Here are some of the key points to take away for any aspiring entrepreneurs and CEOs of the future:

  • There are many behavioural determinants for a successful leader, however as a business evolves these requirements will change. Businesses go through phases and require different leadership at each stage
  • Failure can be key to future success
  • Diversity within an organisation is essential to encourage innovation
  • Having a clear culture within an organisation is important, both to encourage the best from your employees and to attract the right talent.

Later this week, BioBeat14 will explore leadership in the bioscience sector and celebrate its female leaders at the ‘50 Movers and Shakers’ event. Below, Miranda Weston-Smith, founder of BioBeat, discusses disrupting the status quo in biotech and recognising the contribution of biotech’s leading women.

Biotechology has shaken up the business environment, creating new ways of thinking and a model for open innovation that is being adopted by other industries. I have advised many biotech entrepreneurs and looking back over the last 10 years can see the impact that they have made both on the pharma industry and beyond.

Biotechnologists came straight from academia and started to commercialise their work without first joining one of the large established companies. This created a major disruptive influence on the status quo. For the first time, instead of innovation being produced from within the organisation, there became scope for pharmaceutical businesses to fill their product pipelines by ‘purchasing’ interesting molecules and technology from small organisations.

Large pharmaceutical companies started to outsource the elements of their businesses that were not core competencies and to look outside for new ideas and approaches. As a result, the life sciences sector has seen a radical restructure with the growth of clusters of businesses with mutual dependencies. This is continuing with new communities which, by working collaboratively, are increasing our understanding of the action of therapeutics at a gene level.  This has led to the detection of novel biomarkers, stem cell treatments and has created opportunities for personalised and preventative medicine.

The result is not just diversification of the industry, but it has also driven the creation of new business models and a need for a variety of skills sets.

Although I have seen an increasing proportion of women in leadership roles at all levels in bio companies this has not been reflected by the number of women on the podium, cited as thought leaders in the media, or on investor panels. As a result, the industry has been missing their insights and the valuable role models they can provide to younger scientists.

To address this issue I developed the concept of ’50 Movers and Shakers in BioBusiness 2014′ and challenged the industry to recognise the contribution that senior women are making. I saw the potential for female leaders to inspire the next wave of bio innovation and build a stronger life sciences sector.

Research suggests that women adopt different strategies for business growth; from novel ways of building companies and working in teams, to raising funds and attitudes to risk.

BioBeat14 aims to look at the next generation of business ideas with a debate on ‘Leading in a Collaborative World’ to tease out how bio companies can stay ahead with new ways of working and adapting to ever changing global health needs. As the biotech industry comes of age, the entrepreneurs who benefitted in the early wave now have the money, and the appetite, to invest in new approaches.

Investors invest in people, and the suggestion is that recruiting the ‘same again’ is detrimental to the future growth of a company.

Increasing the visibility of dynamic women in companies, research, hospitals, finance and advisory roles with their visions and boldness brings fresh thinking and opportunities for bio entrepreneurs. We can double our life science business potential.

BioBeat14 is taking place on 23 October at St Catharine’s College, Cambridge. For more information please click here.

Cogent _SIP_shutterstock_600_300The BIA has teamed up with JP Morgan, Numis Securities, the London Stock Exchange, MedCity and One Nucleus to organise a ‘Future of Healthcare Investor Forum‘ which will be held at the London Stock Exchange on 29 January 2015, the day of our Gala Dinner. I am really excited that this event can showcase the best of UK life science companies, from the largest to some of the most exciting emerging companies, and  explain to a broad investment community the opportunity in our sector – of which BIA members are significant players. Hopefully we can bring to the UK investment community some of the buzz that happens around the JP Morgan event in San Francisco each year.

Last week I met with George Freeman MP as he held a key meeting of the UK life science ecosystem as he works towards a 21st century landscape for life sciences. He was particularly focused on the way in which data will transform healthcare in the 21st century, on what the new model for drug and medtech discovery, design, development and procurement will look like, and on new ways of catalysing faster uptake of innovation. This promising meeting gives me confidence that many of the issues we advocate for are at the top of George’s agenda.

It’s an important week for Simon Stevens, the recently appointed boss of NHS England, as he’ll deliver his forward vision for the NHS this week. We’ll be watching for commitments to (and any detail on processes to) deliver an innovative organisation with research and new ways of doing things embedded in the NHS’s DNA.

In parliament this Friday the Lords will debate the Medical Innovation Bill championed by Lord Saatchi. This week the government has given the bill its backing. It aims to make it easier for doctors to try out new treatments on patients without the fear of being sued. This is not an issue that members have asked us to prioritise, as it has not been raised as a major impediment to innovation in the NHS. We will keep a watching brief and intervene as necessary.

I’m reflecting on the implications of the calling off of the Abbvie/Shire deal and would welcome member input and thoughts on this. It seems to me that whilst we have spent significant time and effort in the UK to develop, build a political consensus for and legislate for an attractive fiscal environment for life science companies, the policy position in the USA has been executive, administrative and hasty – which is neither predictable, nor long term nor certain for companies. I’d welcome your views.

As we approach BioInfect 2014 next month, which looks at the critical issues relating to the development of new anti-infectives and the endemic problem of resistance, I was delighted to see that the UK is home to the world’s first antibiotic resistance research charity. Just formally launched last week, Antibiotic Research UK looks to find at least one drug before end of decade.

As you will know, our sector needs a supply of staff with often wide ranging or very specialised skills. It was good to hear that a number of BIA member companies were not only represented but taking a leading role at last week’s annual skills forum for the Science Industry Partnership (SIP). Members from both FUJIFILM Disoynth Biotechnologies and Pfizer spoke about the SIP scheme for employer-led skills training and the value it has brought to their organisations. SMEs can claim back up to 50% of the cost of a SIP-accredited workforce development opportunity, so I’d encourage you to take a look at courses on offer – look out for the SIP logo.

And also on the skills front, following on from the ABPI’s survey of the UK STEM skills landscape in 2008 they are revisiting the skills review to benchmark and assess current and emerging skills needs in our sector today, and to identify actions which could be taken to address those needs. Please do take a moment to complete the parts of the survey that are relevant to you (as either an individual, a department or a company) – whether you see a lack of people with a niche or key skill, or whether you are happy with the talent available, it is really valuable to feed that back.

Best,

Steve

This week (11-18 October) is Biology Week 2014, organised by the Society of Biology. Over the summer in the run up to Biology Week, hundreds of young people were inspired by the BioArtAttack Competition to bring science and art closer together.

The prize winners from over 100 entries from schools, science clubs and individuals worldwide were announced on Tuesday, and this week’s video features the winning BioArtAttack in the under 11 category, Cefnllys Science Club’s video ‘Bees: How Honey is Made’!

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

EuropeanBiotechWeek_600Last week, from 6 to 12 October, the second edition of European Biotech Week took place across Europe through more than 100 events and activities related to biotechnology in 14 European countries. Here EuropaBio, the the European Association for Bioindustries and the organisers of European Biotech Week, give us an overview of the week-long celebration. 

The European Biotech Week was inspired by the long standing Canadian National Biotech Week and launched in 2013 in Europe, on the 60th anniversary of the discovery of the DNA molecule. Europe is a collection of Member States each with their particular strengths in the different sectors of biotechnology and all facing the common challenge of how to better communicate about the science, the benefits and the role the technology has in today and tomorrow’s society.

European Biotech Week offers the opportunity to raise the visibility of the sector across the whole of Europe during one week in the year and gives all stakeholders from industry to academia to public and private institutions to individual citizens the opportunity to engage in awareness raising and discussion about the science, the products and the benefits that biotechnology brings to the societies and economies of the European Member States. It is meant to rally and showcase the unique talent and resources of the European biotech sector so as to showcase and discuss the added value biotech brings in areas as diverse as healthcare, agriculture, food, energy, water sanitation and biochemical processing among diverse audiences using different media and initiatives.

European National Biotechnology Associations joined forces this year with charities, large and small biotech companies, universities, cultural and research centres, government institutions, policy makers as well as end users such as patients and farmers to highlight biotech’s achievements to date and to debate future opportunities for the sector. Some of the most notable events included high level policy debates, award-winning industry events such as the UK Bioscience Forum, workshops and career fairs for students, company site visits, social media competitions, theatrical performances, photo exhibition, and flashmobs as well as roving laboratories with hands-on biotech experiments. There was something for anyone with a curious mind and an interest to find out more about biotech.

For a flavour of this year’s events take a look on twitter at #biotechweek. Next year’s European Biotech Week will take place in the week of 12 October 2015.

UKBSF_BBSRC_LAlpheyIn this session at the UK Bioscience Forum, BBSRC Innovator of the Year 2014, Professor Luke Alphey, discussed Oxitec’s genetic engineering approach to controlling mosquito-borne diseases such as dengue fever. BBSRC are currently accepting nominations for the 2015 award. The Innovator of the Year competition is open to all BBSRC-funded scientists and recognises and rewards individuals and small teams who have harnessed the potential of their excellent research. More information is available from BBSRC.

Dengue fever is the fastest growing mosquito-borne viral disease, with around 40% of the world’s population living in areas where there is a risk of dengue transmission. The World Health Organization estimates that between 50 and 100 million infections occur per year, carrying an estimated economic burden of $5 billion.

Symptoms of the disease include joint pain, muscle pain and high fever with around 5% of clinical cases resulting in the potentially fatal Dengue Haemorrhagic Fever (DHF). The virus is carried and transmitted primarily by female Aedes aegypti mosquitoes that remain infected for life and thus the virus can be transmitted every time they bite. Presently, there is no specific preventative treatment or vaccine for the disease, highlighting the need to address this global unmet health challenge.

Current dengue vector control measures include eliminating the places where female mosquitoes lay their eggs, such as by draining stagnant water sources. Fogging with insecticide is also a common measure conducted in endemic areas; however its effectiveness is debated as well as bringing noise and air pollution issues.

Oxitec, a spin out company from Oxford University, aims to combat insect borne diseases such as dengue through genetic engineering approaches. Their technology has the potential to provide clean and environmentally friendly control of mosquitoes. It uses engineered male mosquitoes, which are able to mate with wild females but their offspring do not develop into fully functional adults due to inherited lethal genes.UKBSF_BBSRC_slide

When the Oxitec males are released in large numbers they out-number the wild type males, meaning that the chance of a female mating with an Oxitec male is greater. The Oxitec males are indistinguishable to females from wild type males, periodic release will therefore cause the population of Aedes aegypti to collapse accompanied by a reduction in the incidence of dengue fever.

Many trials of the technology have taken place in dengue endemic countries. After gaining regulatory approval, the Oxitec mosquitoes were initially released in the Cayman Islands in 2009 where the sustained release of Oxitec males successfully suppressed the field population of Aedes aegypti mosquitoes. Several field trials have since been conducted in countries including Brazil and Malaysia.

Professor Alphey described the challenges of taking new technology to the field from technical, regulatory and community perspectives. He discussed how Oxitec engages with local communities through presentations, TV and radio broadcasts, local festivals, educational leaflets and meetings with local residents, and how these  are  adapted to local cultures and social structures.

Overall, the local response has been very positive and communities show great support for the technology. This technology presents an innovative approach to treating mosquito based diseases. You can keep up to date with the latest news and field trials via Oxitec’s website. Oxitec have also produced an eBook entitled ‘Dengue Fever. The fastest growing mosquito borne disease’ which can be downloaded here.

Following European SME Week, which took place from 29 September to 5 October, the European Medicines Agency (EMA) discusses the importance of supporting the work of SMEs in driving innovation in medicines. See the original post here.

Supporting developers of life-changing medicines

Micro, small and medium-sized enterprises (SMEs) are a motor of innovation in the European Union (EU). Between 2010 and 2012, more than one in four new innovative medicines recommended for marketing authorisation in the EU originated from SMEs, as shown in an analysis published in January 2014.

Innovative medicines have the potential to bring significant benefits to patients and address unmet medical needs. As they act in a different way to existing treatments or target patients who can benefit most from the therapy, these medicines offer new avenues to treat patients differently while maximising the benefits and reducing the risks.

Recently, the first medicine authorised for the treatment of the life-threatening disease Duchenne muscular dystrophy (Translarna) originated from an SME. This medicine displays a completely new mode of action that directly targets the cause of the disease. Another recent example is the first non-surgical treatment option (Jetrea) for adults with vitreomacular traction, an eye condition which can cause severe visual disturbance. This new medicine spares patients from having to stay in a ‘head-down’ position for days to enhance the success rate of the surgical procedure.

SMEs are also highly active in the development of advanced therapies, innovative medicines that are based on gene, cell or tissue engineering, as well as in the development of medicines for rare diseases. In these two categories of medicines that can clearly improve patient health, SMEs account for about half of all new medicines under development.

“Supporting the actors in the pharmaceutical industry who contribute to enhancing public health by focusing on innovation is a priority for the European Medicines Agency,” explains Melanie Carr, Head of EMA’s Corporate Stakeholder Department. “Our dedicated structure to support smaller companies as well as our ongoing work to reinforce engagement with the academic world, are both intended to further support the translation of innovation into successful developments in the interest of patients.”

The Agency’s SME Office provides active regulatory, financial and administrative support to registered SMEs in the development of their medicines. Almost one in two SMEs registered with the Agency has less that 10 staff members and 12% originate from academia.

In addition, the Agency supports innovation at very early stages of a medicine’s development through its Innovation Task Force. This taskforce provides a forum for early dialogue with applicants. During free-of-charge briefings, medicines developers can discuss their initial research findings with the Agency’s experts and proactively identify any scientific, legal and regulatory issues and opportunities.

Over the past five years, almost one third of all the taskforce’s briefings have been conducted with SMEs. Two out of three meetings with SMEs concerned either cell-based, gene-based or tissue engineering-based therapies. New medicines for the treatment of cancer represent the largest category.

While there is still a long way to go before these medicines can potentially reach patients, early dialogue between medicines developers and regulatory authorities has proved to increase the chances of obtaining a marketing authorisation in a timely manner, thereby accelerating patients’ access to new medicines.EMA SME blog graph

Lincoln TsangLincoln Tsang, member of the BIA Regulatory Affairs Committee and a partner of Arnold & Porter LLP, provides an account of the European Medicines Agency’s (EMA) latest policy on publication of clinical data. He advised the BioIndustry Association in the negotiations during the development of the EMA Publication Policy and the EU Clinical Trials Regulation.

After nearly 18 months of internal and external consultations, the EMA’s Management Board finally approved the Agency’s policy on publication of clinical data on 2 October. The EMA has characterised this new policy as a landmark step that will provide an unprecedented level of access to clinical reports and set new standards for transparency in public health and pharmaceutical research and development. However, this does not stop third parties requesting for access to documents held by the EMA independently of the proactive publication policy.

The EMA has consistently defended its transparency and data access policy as a necessity in its service delivery to patients and society at large because (a) it instils trust and confidence in the regulatory decision-making process; (b) there is an ethical responsibility to the patients enrolled in the trials; (c) data-sharing can open up new horizon for future research for the benefit of patients and public health.

The proactive publication policy reflects a balanced view of the disclosure of the information within a marketing authorisation dossier, with controls in place if the data might be unfairly used by competitors. The policy also accepts that there is a public interest in clinical trial data being released and considered by academics and healthcare professionals.

The adopted policy will apply from 1 January 2015 onwards for all new marketing authorisation applications that are evaluated under the European Centralised procedure, and for all line extensions of approved products from 1 July 2015. The policy applies to clinical data that have been submitted to the EMA, but clinical data not held by the Agency and pharmacovigilance data on individual case safety reports are not within the scope of the new policy.

The policy will be applied stepwise. To start with, only clinical data contained in clinical reports will be published. Then, individual patient data (IPD) will be published after the Agency puts in place structures to systemically collect and evaluate individual patient data after a targeted public consultation with all concerned stakeholders. The implementation of the IPD publication must be approved by the Management Board and the Agency will also notify the European Data Protection Supervisor to ensure the structures are in compliance with the data protection laws.

The policy recognises the need to protect personal data, commercially confidential information as well as to ensure future investment in pharmaceutical research and development is not harmed. The Agency declares that sustained and extensive pharmaceutical research activity is a precondition for future improvements in public health. For this reason, the policy is designed to guard against unintended consequences arising from disclosure such as breaches of intellectual property rights that might ‘disincentivise’ future research and development efforts.

Commercially confidential information is defined as any information contained in the clinical reports submitted to the Agency by the applicant or marketing authorisation holder that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant or holder. The definition in itself is not viewed as controversial, but how the commercial harm is assessed in practice by the Agency will become critical. The policy provides that such an assessment should take into account the justification provided by the applicant or marketing authorisation holder in respect of the nature of the product, the competitive situation of the therapeutic market, the approval status in other jurisdictions, the novelty of the clinical development and new developments by the same company. Annex 3 to the policy contains specific information that may be viewed as commercially confidential to justify redaction. For example, information about the specifications relevant to assay development could be considered as commercially confidential as such information may bring significant advantages to competitors if published.

In order for a third party to access the clinical data, the person is required to agree to the terms of use (ToU). There are two sets of ToU: one for general non-commercial use and the other for academic and other non-commercial research purposes. The data may be viewed on-screen or downloaded. The rules for those wanting to download, save or print are stricter than for those who want to view on screen. If one wants to download the data, then the identity of the person must be provided to the Agency. The applicant for or holder of the marketing authorisation can enforce the terms through third party rights as expressly provided in the ToU.

The new EMA policy should be viewed as a complementary tool to the requirements set out in the EU Clinical Trials Regulation. It is inevitable that the transparency requirements will likely demand greater resources for life science companies to manage the process properly, and the associated costs in an increasingly challenging financial environment.

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I was pleased to welcome today’s announcement of a one stop shop to provide regulatory advice for those working in regenerative medicine in the UK. The BIA has called for a single UK research regulator for regenerative medicine since the Academy of Medical Sciences’ review of regulation and governance of medical research in 2010 and this was a central argument we made to the McCracken review of the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) in 2013. This positive step has the potential to encourage inward investment and incentivise start ups in the field of regenerative medicine and shows that the UK is serious about being the preeminent place in the world to develop advanced therapies.

On Friday the EMA held an exchange day with EuropaBio as part of European Biotech Week, attended by around 50 stakeholders from companies and the EMA itself. Some interesting discussion came out of the session on Facilitating Innovation. Professor Guido Rasi, Executive Director of the EMA, emphasised the need to strike the right balance to enable innovation while ensuring patient safety. He said that, while the EMA is not expanding its remit, he would like to see a more homogenous approach to linking Health Technology Assessment (HTA) with regulatory assessment, and that industry should proactively seek parallel scientific advice between the EMA and HTA bodies from early on in the R&D process. Jordi Llinares-Garcia from the EMA’s Scientific Support Department for human medicines R&D, spoke of reinforcing EMA support for innovation, saying that EMA scientific advice is considered a ‘flagship’ of innovation and emphasising the increasingly important role of patient input in the scientific advice process. To read up on the EMA’s latest policy on publication of clinical data, take a look at our new blog from Lincoln Tsang from the BIA’s Regulatory Affairs Advisory Committee.

Last week, Mayor of London Boris Johnson has called for the establishment of an International Dementia Research Institute in London, supporting the Prime Minister’s pledge back in June for new action to accelerate progress on dementia drugs, with a focus on patents, funding and patient access to new medicines. Parliament was back in session today, and we’ll be working up our engagement with policymakers over the coming weeks and months using the Life Sciences Manifesto 2015-20.

For many of us, waking up on Friday 19 September to find out that Scotland had voted to stay within the Union was a great relief given the many uncertainties independence would have brung for key issues in the sector such as where and how would drugs be regulated. However a vote for no is not a vote for the status quo as it has initiated an unprecedented debate around devolution, not just for Scotland but for throughout the UK. Join me at our webinar this Friday at 3pm to understand better the process for the next 6 months as these issues are debated in Parliament and discuss your key concerns, ideas and questions about the impact of the devolution debate on your business.

Also on the events front, the annual bioProcessUK Conference is almost fully booked – so do act quickly to secure your spot as there are just a handful of places left.

Finally, this week is Biology Week, organised by the Society of Biology. I hope you’re all celebrating the best of bioscience across the UK – particularly following last week’s announcement that UCL researcher John O’Keefe was jointly awarded the Nobel Prize in Physiology or Medicine. Great to see him raising the need for the UK to have sound policies on immigration and animal research in this BBC news article.

Best,

Steve

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