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Welcome back following the bank holiday weekend. As we head into September, our summer of hard work and participation in the UK EU Life Sciences Transition Programme will culminate in the presentation of a final report on 6 September to the UK EU Life Sciences Steering Committee, including Lord Prior. In advance of this presentation, BIA and ABPI will be holding a webinar on 2 September (this Friday), open to members and stakeholders, where we will run through the final report. If you would like to attend, please click here to register. Once registered you will receive a confirmation email containing information on joining the webinar.

In other policy news, the Government has issued further information and guidance on how the Apprentice Levy will operate – available here – and are consulting on some aspects of this including Apprentice Training Agencies (ATAs), such as Cogent Skills. Two key points to note regarding ATAs which members may wish to give feedback on are:

  1. The government is proposing that no Apprentice Levy digital funds can be transferred from a company to an ATA until 2018.
  2. From 2018, only up to 10% of a company’s digital fund can be transferred to an ATA. i.e. 90% of the fund will only be able to be spent on apprentices directly employed by the company

The consultation closes on 5 September and can be accessed here if you want to have your say.

Last week it was announced that Chris Molloy has been appointed the first CEO of the Medicines Discovery Catapult. Over the past few years, as CEO of the RSA Group and a valued member of our People Advisory Committee, we’ve worked closely with Chris around progressing the talent agenda in the sector. I’m delighted to hear that he’ll be working as part of the fantastic network of Catapult centres we have here in the UK. Many congratulations to Chris and we’re very much looking forward to working with him in his new role from November.

Also in the news, it was interesting to hear AstraZeneca announce their agreement with Pfizer to sell the development and commercialisation rights to their late-stage small molecule antibiotics business, reinforcing their commitment to focus on three main therapy areas: respiratory, oncology and cardiovascular and metabolic diseases. Pfizer has been actively engaged in global discussions on combating anti-microbial resistance, including those led by the UK Government, and is one of over 100 industry partners to sign the Declaration on Combating Anti-Microbial Resistance, announced in January this year at Davos. I was interested in the perspective of Pete Jackson, Chair of the UK’s AMR Centre,who said: “Pfizer’s deal with AstraZeneca presents opportunities for further investment in developing the next generation of antibiotics.  The UK must maintain its leading role in driving forward the global agenda on combating anti-microbial resistance (AMR).  The AMR Centre at Alderley Park – part of the transatlantic CARB-X consortium – is stepping up to take on this fight and calls on Government to accelerate funding for the Centre, alongside the private sector, to maximise the immediate opportunity to deliver a new pipeline of antibiotics.”

Finally, a quick reminder that the Royal Society are inviting research teams to submit proposals for the 2017 Royal Society Summer Science Exhibition. More details here if of interest.

Best

Steve

Our member video showcase this week comes from the Centre for Process Innovation (CPI).

The CPI utilise the state-of-the-art equipment and technical expertise of their National Industrial Biotechnology Facility to help clients to de-risk process development and provide proof-of-concept testing at scale, through their range of technology development, business and technical services.

View the video below.

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

Bioscience is a fundamentally important sector for the UK’s health and wealth. Last year we published our report Celebrating UK bioscience: unravelling the stories behind UK bioscience success, which details just some examples of UK bioscience success. 

Harnessing the power of the immune system to target cancer, in the field commonly known as cancer immunotherapy, is an area where the UK has taken a leading role. The UK has also been at the heart of a new generation of personalised medicines aimed at patients with specific genetic mutations that mean they’re most likely to benefit from treatment.

Cancer infographic

Download the series of infographics here

Keep an eye out for the next phase of our Celebrate project, launching at this year’s UK Bioscience Forum on 20 October…

Bioscience is a fundamentally important sector for the UK’s health and wealth. Last year we published our report Celebrating UK bioscience: unravelling the stories behind UK bioscience success, which details just some examples of UK bioscience success. 

The antibody-humanising technologies developed in the UK and which were the foundation of Humira’s success have also been used in the development of over half of marketed antibody therapies today, including multiple sclerosis drug Lemtrada.

Multiple Sclerosis

Download the series of infographics here

Keep an eye out for the next phase of our Celebrate project, launching at this year’s UK Bioscience Forum on 20 October…

Celebrate infographics for Newscast

Celebrating UK Bioscience – download our infographics here

Our work on the UK EU Life Science Transition Programme continues to build in the lead up to the meeting with Ministers of the new government on 6 September. Following the culmination of the subject workshops held over the summer, last week I participated in a strategy workshop with the ABPI and BIA Co-Chairs from the subject workshops as well as representatives from other trade associations in the life sciences sector. This meeting brought together the findings of the workshops, identified common themes that have emerged and considered the final output of the work. The first report draft, compiled by PwC, will be made available later today for those who have participated in the process. If you’re a BIA member interested in providing feedback but haven’t as to now participated in the process please email us for a copy. Note that we will need any comments as soon as possible and these must be received by this Thursday 25 August.

Providing further opportunity for members to stay up-to-date on the progress of the Programme,  we held another town hall meeting in conjunction with the ABPI on Thursday. The meeting also provided a chance for us to hear your views on the work so far and outline for the draft report. To keep you updated the BIA and ABPI will be holding a further webinar on 2 September, open to members and stakeholders, where we will run through the final report in advance of its delivery on 6 September. Please click here to register. Once registered you will receive a confirmation email containing information on joining the webinar.

The work doesn’t stop there and if you’re interested in finding out more about the activity and discussion that went on in the lead up to the publication, we’ll be covering the topic at a range of BIA events occurring throughout the Autumn, including our Stevenage Breakfast and the UK Bioscience Forum – take a look at our Events page for more details.

All of this work is key to ensuring that the UK remains on track to become third global biotech cluster.

We’ve all been inspired by Team GB’s performance at the Rio Olympics so it’s no surprise to see the read across into Britain’s potential in other areas – like the government’s industrial strategy has been briefed this weekend by government sources.

In a bid to emulate the success of Britain’s cyclists and rowers in Rio, min­isters will unveil plans this aut­umn to turbocharge sectors of the economy where the UK can lead the world. Greg Clark, the business and energy secretary, told The Sunday Times: “By making the most of our strengths, improving our facilities, developing the skills of athletes and coaches alike, we have become a world-beating sporting nation. We have a real opportunity to apply many of the same insights as we bring together a long-term strategy for our industrial and commercial future. Recognising our strengths — from science to the creative industries — and making sure they are nurtured and encouraged.”

From the life science perspective its encouraging to see science spoken of in this context. First, it shows the UK has the positive outlook and the attitude needed to be world beaters – just as the entrepreneurial talent you find in the UK life science sector has. Second, nurturing and encouragement via long term support pays off – which is why successes like the Biomedical Catalyst fund should be renewed. Third, listening to experts who understand their sport (or their sector) is vital to becoming world beaters. I’ll leave it to you to decide if our sector is most like hockey, cycling or rowing (our consensus is that life sciences is definitely a team sport but not one done exclusively sitting down) but I’m certain that we are all inspired by the spirit of Team GB and look forward to harnessing their positive attitude for our own endeavours, and government policy, in the months ahead.

In other news, you may have heard that NICE intends to introduce charges for the Technology Appraisal and Highly Specialised Technologies programmes in 2017. NICE has approached the BIA to ask for our comments on their proposed arrangements by 30 September. For more information, and if you have any comments you’d like to put forward by 23 September then please get in touch.

I’d like to welcome Matthew Spears to his key new role which he starts today as the CEO of the Department for International Trade’s (DIT) Life Sciences Organisation (LSO). Matthew takes over from Dr Mark Treherne and will lead a team of civil servants and sector specialists working together to support the government’s international trade and investment strategy for our sector.

And finally, congratulations to BIA member Ingenza who successfully applied for EU H2020 SME Instrument funding of €50,000 for Phase 1 of its innovative SYNBIOMAN project – a great achievement.

Enjoy the bank holiday – Newscast is back next Tuesday

Best

Steve

This week’s video showcase from BIA member Amgen describes cell culture and the scale-up and manufacturing process of biologics. Watch it below.

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

Bioscience is a fundamentally important sector for the UK’s health and wealth. Last year we published our report Celebrating UK bioscience: unravelling the stories behind UK bioscience success, which details just some examples of UK bioscience success. 

Today we take a look at Humira, the world’s top-selling medicine that helps almost half a million people across the world to live with a range of debilitating and often painful conditions, including rheumatoid arthritis and Crohn’s disease. Humira was the first ever “fully human monoclonal antibody” treatment and it was conceived at the heart of UK bioscience.

RA infographic

Download the series of infographics here

Keep an eye out for the next phase of our Celebrate project, launching at this year’s UK Bioscience Forum on 20 October…

In May the BIA launched a briefing paper on Orphan Medicinal Products that looked into the 15-year application of the Orphan Regulation in Europe.

The paper coincided with the European Conference on Rare Diseases & Orphan Products, which was held in the UK for the first time and brought together stakeholders from across the rare disease community.

The briefing paper explores the EU regulatory framework and the setting up of the Committee for Orphan Medicinal Products within the European Medicines Agency (EMA) and raises awareness around the latest regulatory policy developments in this field. The European Commission is currently in the process of considering a review of its Communication (2003/C 178/02) to streamline and adapt the existing guidance to technical progress. This revision is of great interest to BIA members as a large number of biotech medicines are authorised with an orphan indication.

To download the briefing paper go to the BIA website.

omp table

The BIA continues to play an active role at EU level in influencing the regulations that have an impact on how UK bioscience tackles rare diseases. We have seen that the incentives of the Orphan Regulation have been essential in stimulating research and development of orphan medicines for rare diseases.

It is therefore important that the requirements to demonstrate significant benefit of orphan medicines are appropriate, given the complexities of dealing with small patient populations and rare conditions to be treated.

To date, the European Commission has authorised 121 orphan medicines for the benefit of patients suffering from rare diseases. Some 25 orphan marketing authorisations are from SMEs as of January 2016. Furthermore, the European Commission has designated 1,349 products as orphan medicinal products.

The European Commission has launched a public consultation on the concept of ‘similar medicinal product’ in the context of the orphan legislation until 4 November 2016. If members wish to comment on the proposed changes to Article 3 of Commission Regulation (EC) 847/2000 please contact Christiane Abouzeid.

For more information on the latest policy and regulatory affairs work at the BIA, download our quarterly report covering April to July 2016.

Last week, the Working Group stage of the UK EU Life Sciences Transition Programme was completed.  Six workshops have taken place and more than 100 individuals from ABPI and BIA member companies attended, along with stakeholders from organisations such as the MHRA, Wellcome Trust and MRC. I would like to take this opportunity to thank all BIA members who have been involved with and input into the programme over the summer.

PwC are now bringing the outputs of these meetings together for a strategy workshop taking place this week. This workshop will bring together member Co-Chairs from the subject workshops as well as representatives from other trade associations in the life sciences sector. Inclusion of the other trade associations ensures that the final output will represent all aspects of the life sciences sector. The project is still on course to deliver output on 6 September and I know Lord Prior, the Minister in Department of Health with life sciences responsibility, is looking forward to this meeting. If you would like an update on the progress then BIA in conjunction with the ABPI we will be holding another members townhall on the 18th August on the Transition Programme.  The meeting is open to all ABPI and BIA members and will provide the opportunity to hear about the processes and progress of the work, and to ask any questions that you may have.  Please confirm your attendance by completing the online form.  Please note that is event is for ABPI and BIA members only.  We will also be holding a webinar, open to stakeholders and members, on 2 September.

There was some good news from the Treasury this week as the Chancellor agreed to measures to cover the gap that will be left in research funding following the UK’s decision to leave the EU. All structural and investment fund projects signed before the Autumn Statement will be fully funded, even when these projects continue beyond the UK’s departure from the EU. The Treasury will also put in place arrangements for assessing whether to guarantee funding for specific structural and investment fund projects that might be signed after the Autumn Statement, but while the UK remains a member of the EU. Further details will be provided ahead of the Autumn Statement. Where UK organisations bid directly to the European Commission on a competitive basis for EU funding projects while we are still a member of the EU, e.g. Horizon 2020, the Treasury will underwrite the payments of such awards, even when specific projects continue beyond the UK’s departure from the EU.

Chancellor Philip Hammond said: “We recognise that many organisations across the UK which are in receipt of EU funding, or expect to start receiving funding, want reassurance about the flow of funding they will receive. That is why I am confirming that structural and investment funds projects signed before the Autumn Statement and Horizon research funding granted before we leave the EU will be guaranteed by the Treasury after we leave. We are determined to ensure that people have stability and certainty in the period leading up to our departure from the EU and that we use the opportunities that departure presents to determine our own priorities.”

I would like to remind you all that nominations from individuals interested in joining our Board are now open. Nominations must be received by close of business on Wednesday 07 September 2016.

Finally, over the summer we are celebrating UK bioscience on the BIA blog with a series of infographics that look at some of the highlights to come out of our sector that have made a difference to tackling unmet patient need. You can download the series of infographics here.

All the best,

Steve

Genomics England is delivering the 100,000 Genomes Project. The project will sequence 100,000 genomes of NHS patients with a rare disease, plus their families, and patients with cancer.

The aim is to create a new genomic medicine service for the NHS – transforming the way people are cared for. Patients may be offered a diagnosis where there wasn’t one before. In time, there is the potential of new and more effective treatments.

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