Archives for the month of: April, 2017

The Easter holidays came to an abrupt end with the PM’s call of a snap General Election on Tuesday morning. With 522 votes to 13, Parliament strongly voted in favour of the early election on Wednesday.

We responded to the PM’s announcement with our initial thoughts. Last Friday we posted a blog that outlines what looks set to happen to existing workstreams now the general election has been called. It’s well worth a look. This week the key thing to watch is parliamentary “wash up”- especially government legislation to enable UKRI and the medicine supply bill. Also expect to see a flurry of select committee reports published hastily. This was the first in a series of BIA blogs on the election that we’ll be publishing over the coming weeks to keep you informed. Future topics will include:

  • Which MPs are standing for election and who is standing down
  • What the parties have recently said on Life Sciences and in their 2015 manifestos. We will then follow up with an analysis of the new party manifestos
  • Key messages from our sector for MP candidates

The BIA has created a timeline of key dates leading up to the election and beyond. Our Parliament day on 6 July will ensure that our members are fully engaged with the new Parliament and Government less than a month of its establishment.

timeline

On behalf of the sector and our members, the BIA has responded to the Government’s Industrial Strategy Green Paper on the Wednesday before Easter. In our response, we highlighted that the UK has some of the world’s most exciting science, a supportive business environment, and strong companies led by experienced management team. The Industrial Strategy is an opportunity to build a global bioscience cluster on par with the leading clusters in Boston and the San Francisco Bay area.

While the General Election creates further political uncertainty for policy proposals like the Government’s Industrial Strategy, the BIA is ready to work with the next Government to reflect the potential and ambition of our sector. In our response to the Industrial Strategy, we outlined what the Government can do to further promote and support the life sciences including addressing the UK’s chronic shortness of scale-up capital and attracting global management talent. We will be sharing these with all the major political parties as they produce their new manifestos. Read our full response here.

On Thursday, the BIA organised one of our popular Networking Breakfasts. This time, the panel discussion focused on the Patient Capital Review and what it means for the biotech sector.

It was great to see and talk to many of our members. We heard interesting discussions from our outstanding panel with representatives from the Treasury, Wellcome Trust, the London Stock Exchange, Perella Weinberg Partners, and the Industry Advisory Panel for the Patient Capital Review. Many thanks to the panel and for Taylor Wessing for kindly hosting the event.

Today, we published the first Quarterly Update for 2017 as a part of our ongoing series of documents “Influencing and shaping our sector”. The update gives an overview of key policy developments and the BIA’s continued engagement with policymakers, regulatory authorities and wider stakeholders on behalf of the UK life sciences industry, from January to April 2017.

The BIA will continue to represent the interest of our members throughout the election process to ensure that our sector is given a prominent voice. The blogs we have planned will also provide a timely commentary on the election process and party positioning on issues important to our sector.

Best,

Steve

The call for a General Election means that Parliament will be dissolved on 3 May and the official campaign period will begin, with all major Government announcements and consultations on hold until the new administration is formed.

Below we have pulled together all the outstanding Parliamentary and Government business important to the bioscience sector and explained what will happen to it. All is subject to which party (or parties) forms the next Government.

The Life Sciences Industrial Strategy and Accelerated Access Review

The BIA has been feeding into a Life Sciences Industrial Strategy being led by Sir John Bell. Work will continue on this but it will now not be published until after the election, probably July at the earliest. Of course, this work depends on which party is in power. If it is the Conservatives – and Greg Clark remains the Business Secretary – we expect it to be business as usual. We were also expecting the Government’s response to the Accelerated Access Review to be published around the same time as the Life Sciences Industrial Strategy so this will also be delayed.

Work within Government on the wider Industrial Strategy will likely now be slowed but no announcements were expected until the autumn anyway.

Legislation

Given the now pressing need to get Bills through Parliament before it dissolves for the General Election, it looks like the Government will need to make some concessions, particularly in the House of Lords. This process of pushing Bills through at the end of a parliamentary session is referred to as wash-up.

Health Service Medical Supplies (Cost) Bill

The Government has tabled an amendment in line with Lord Warner’s amendment to the Health Service Medical Supplies (Cost) Bill. Lord Warner’s amendment requires the Government to consider the impact of cost restriction measures on the life science industry and patient access to medicines. The House of Commons rejected Lord Warner’s amendment but the Government were defeated when the Bill went back to the House of Lords on 5th April. The new Government amendment will now be debated and voted on by the House of Commons on 25th April. After this the Bill will go back to the House of Lords on 26th, when we expect it will be approved.

Higher Education and Research Bill

The Higher Education and Research Bill has just completed its passage through the House of Lords, where several non-Government amendments were inserted in to the legislation, including one to prevent international students from being included in net migration figures. It has not yet been announced when the Lord’s amendments will be debated by the House of Commons but it is expected that Theresa May will have to back-down in relation to her long-standing opposition to removing foreign students from immigration figures if she wants to ensure the Bill is approved before Parliament dissolves.

Ratification of the Unified Patent Court

The Government announced in November that the UK will proceed with ratification of the UPC Agreement to bring this pan-European patent system into force. The secondary legislation to make this happen has cleared Parliament but one piece to establish the Life Sciences Division of the Court in London has not, meaning it will now not happen until after the election.

If this can happen quickly after the election then the UPC may be able to stay on track to be operational in December. However, this timeline could easily slip. Bioscience companies should consult their legal advisers now about how the UPC could affect their IP assets.

Parliamentary inquiries

Parliamentary Committees, such as the House of Commons Science and Technology Select Committee, will disband when Parliament dissolves and they will need to be re-formed following the election. In the House of Commons the membership of the Committees will undoubtedly change quite considerably. The membership of each Committee will depend on how many seats each party holds in the House and who they nominate to represent them. The Chair of each Committee will need to be elected. This process can take some time.

Being a snap General Election, the Committees are not prepared for the end of the Parliamentary session. Many of them have ongoing inquiries. A summary of what will happen to those of interest to the sector is provided below. If a Committee has published their report for an inquiry, the newly formed Government will be obliged to respond. Therefore, we can expect a flurry of Committee publications before 3rd May.

House of Commons Inquiries:

commons inquiries

House of Lords Inquires:

lords inquiries

Kisqali was developed by Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex announced in December 2005. Kisqali is a selective CDK inhibitor, a new class of drugs that help slow the progression of cancer by inhibiting two proteins called CDK 4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly.

Theresa May called a snap General Election from the steps of Downing Street this morning, expected to be held on Thursday 8 June, if approved as expected by parliament tomorrow.

In order for there to be an election, the Prime Minister will require two thirds of MPs to support the motion – that’s 434 MPs.

For UK life science companies the coming weeks are a period of further political uncertainty as policy proposals like the Government’s Industrial Strategy and the Life Science sector’s response to it, are formally put on hold for the period of the General Election campaign.

Similarly any further clarity or certainty on the UK’s approach to Brexit will have to await the outcome of the election – and only then become the focus of a debate with the European Union.

General Elections are also an opportunity – and the BIA will use this period to ensure that the role of, and key issues to, our sector are given a prominent voice as each of the parties prepare their manifestos. We will also provide timely commentary on the process itself, and insight into the party positioning on issues relevant to our sector through the campaign to members – starting in Newscast next week.

As with any election there are likely to be changes of personnel, new and retiring MPs, and at least some, or perhaps full scale, change in Ministerial lineup. We will use our Parliament day in July to ensure our members are comprehensively engaged with the new parliament and government within weeks of its establishment.

Best,

Steve

swiss trip

BIA ran its first Discovery Trip last week – with Switzerland chosen as the destination due to its importance as a base for life sciences, and its status outside of the EU.  We were looking to learn and be inspired by initiatives and policies that enable the country to remain at the forefront of biotech research and at the top of the list in terms of worldwide innovation rankings.  We were fortunate to work with Tekiu in terms of organisation and we attracted delegates from the Office of Life Sciences, MHRA, and a range of our member organisations.

Meeting with representatives from Zurich, Western Switzerland, Zug and Basel gave us an insight into the differences between the different regions and a view into the highly competitive canton system.  Visits to the Commission for Technology and Innovation and ETH (Zurich University) provided an insight into the robust innovation support offered to entrepreneurs and scientists, and new schemes such as Baselaunch helping to get spinouts off the ground.  Meeting the Swiss regulators Swissmedic enabled us to probe further into the challenges and opportunities of being a regulator working with, but outside of the EMA.

It was great to be able to hear the Neurimmune story first hand, and to visit their collaborative partners – BIA members Biogen – to learn more about their operations in Switzerland and their CHF 1 billion investment in biologics manufacturing in Solothurn, Switzerland.  Great also to visit more BIA members – Shire and also Novartis, who welcomed the delegation to their fascinating campus for the afternoon on the last day.  A fitting end to a thought-provoking, productive and enjoyable trip for the delegation.

Last week, the BIA also gathered with the vibrant global synthetic biology community at Imperial College for the fifth SynBioBeta London Conference.  The UK’s scientific excellence and strong start-up base puts us far ahead of our European neighbours in the field. The conference included a mix of panel discussions, business presentations, and networking opportunities. As always, it is inspiring to hear about the latest innovations being developed in our exciting industry. You can read our summary of the highlights of the conference here.

This week we’ll be submitting our response to the Government’s Industrial Strategy green paper, which we have welcomed as a great opportunity for our sector to work with Government to build the third global biotech cluster. Thank you to everyone who came to our member workshops, and took part in online surveys and interviews to inform our submission. Keep a look out on our website for the final document later this week.

Best,

Steve

 

Acute respiratory distress syndrome (ARDS) is a serious condition characterised by widespread inflammation in the lungs and represents a major cause of morbidity and mortality in the critical care setting. Here the Clinical Operations team at Cell and Gene Therapy Catapult and Anthony Ting, Vice President of Regenerative Medicine, Athersys inc. discuss the ongoing clinical study using Multistem to treat ARDS.

This week, the great and the good of the synthetic biology community gathered at Imperial College for the fifth SynBioBeta London, a key two-day conference on synthetic biology, its applications and challenges.

The annual conference brings together the vibrant global synthetic biology community and fosters the dialogue between entrepreneurs, business executives, tech practitioners, technology scouts, academics, and investors.

The conference opened with an overview of the sector, highlighting how strong the UK sector remains. Although the US is leading globally with over $278M already invested in 2017’s first quarter, the UK is leaps and bounds ahead of our European neighbours with our scientific excellence and strong start-up base.

synbio investment

Graph showing the increase in global investment into synthetic biology.

The conference included a mix of panel discussions, fire-side chats, and business presentations. It was inspiring to hear the latest innovations being developed in synthetic biology. Some of the key themes from this year’s conference included:

Engaging the public in the conversation

Keynote speaker Drew Endy, serial entrepreneur and researcher, highlighted the importance of the public’s understanding of the sector referencing the recent yes-vote in a Florida county on the use of GM mosquitoes to fight Zika. To tackle fears and preconceived ideas of the community, the pro-campaigners engaged with local communities by going door-to-door and organising town hall meetings with experts.

Endy emphasised that the sector should learn from this type of successful grassroot-engagement, reminding us that we cannot rely on technology to get our messages across but instead we need to get face-to-face with people and connect. We need to understand why people feel the way they do, to be able to build bridges between sectors and ideologies in order to overcome fears.

Think big changes; think long term

Lord Prior, Parliament Under Secretary of State at the Department for Business, Energy and Industrial Strategy (BEIS), delivered a keynote speech where he talked about how we are on the verge of a fourth industrial revolution driven by scientific breakthroughs. One of the goals of the Government’s Industrial Strategy is to ensure how the UK can stay “ahead of the curve” to become the world leader of innovation.

However, with technological change comes many challenges. Lord Prior emphasised that the technology of the future needs to bridge inequality gaps between regions instead of increasing them. This relates to regional pillar of the Industrial Strategy, where the Government aims to spread growth across the country.

The success of bridging this inequality gap will partly rely on highlighting the usefulness of the technologies to the wider public. “The British are incorrigibly incrementalist, and not willing to make leaps like Google”, Lord Prior said. “We have to win the argument as to why we need these technologies for the betterment of society.”

UK’s continued access to “talent from all over the world” after Brexit will also be necessary to remain a premier science and research hub.  “We also must win the global battle for talent. Britain should not be considered synonymous with a tight immigration policy,” Lord Prior commented.

Investment

Tim Fell, CEO Synthace and our Engineering Biology Advisory Committee (EBAC) Chairman, interviewed the ever-impressive entrepreneur Hermann Hauser on why he invests in synthetic biology, and what he looks for. “There is a tsunami of exciting research results coming out of labs,” Hauser commented.

Hauser stressed that above all else, he looks for passion among people in a company. Following on, he considers:

  1. Size and growth rate of market;
  2. Quality of the skills of the team (there needs to be 1-2 key management figures);
  3. The technology they are developing.

Funding announcement

Data Collective (DCVC), a venture capital fund investing in entrepreneurs applying deep tech to transform giant industries, announced at the conference its partnering with Dr. John Cumbers to launch a pre-seed and seed venture capital fund, the DCVC SynBioBeta Fund, to invest in synthetic biology start-ups. Read more here.

Next conference

The next SynBioBeta conference is in San Francisco October 3, 2017 – October 5, 2017. Mark your calendars now, and read more here.

UCL 1

The new UCL Future Targeted Healthcare Manufacturing Hub has been established to address manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society. This national asset is valued in excess of £20M over 7 years (2017–2024).

The Hub engages leading academics across the UK as Spokes and the research will span stratified protein medicines targeted to particular patient groups through to truly personalised cell-based medicines. The Hub is unique in the biomanufacturing space, and is being supported by a large number of the leading manufacturers and suppliers in the biotherapeutics industry and non-governmental associations, including the BIA. BIA members can also engage with the hub by becoming members of the Industrial User Group.

UCL Hub Vision

  • By 2025 targeted biological medicines will transform the precision of healthcare prescription, improve patient care and quality of life.
  • The current “one-size-fits-all” approach to drug development is being challenged by the growing ability to create stratified and personalised medicines targeted to specific sub-populations and even individuals.
  • Without significant manufacturing and supply innovations, the promise of targeted healthcare will remain inaccessible for many. The impact on health and well-being is profound.
  • The Hub will be the first globally recognised consortium for the creation, delivery and dissemination of innovative manufacturing research, underpinning cost-effective, robust manufacture, supply and delivery of targeted biotherapeutics.

UCL Hub Collaboration and Deliverables

The Hub will work with its network of users and academics to deliver the vision, with the core research focusing on:

  • Grand Challenge 1: Transforming supply chain management and economics for targeted biotherapeutics with novel computational decision-support tools
  • Grand Challenge 2: Sustainable manufacturing for future targeted biotherapeutics with novel bioprocesses, analytics and control algorthims

This paradigm shift in manufacturing practice will provide the manufacturing infrastructure needed for sustainable healthcare. 

UCL2

UCL Hub Impact

The benefits of the Hub extend beyond the users who have co-developed the proposal. Our innovations will move the reality of targeted healthcare forward significantly by identifying the necessary technological and logistical solutions. Targeted interventions will provide a step change for many patients in terms of widened access to new treatments. The range of targets is huge and includes treatments for cancers and the re-programming of degenerative disorders such as dementia. This is a radical new opportunity for the industry. The Hub will undertake rapid and effective development of new clinical medicines and promises a new horizon for the sector.

For more information on the Hub, collaboration and how to join the industrial User Group please contact: Dr. Naveraj Gill, Strategic Alliance Director, Deputy Head of Department (Enterprise)

e: naveraj.gill@ucl.ac.uk  | w: www.ucl.ac.uk/biochemeng/research/hub

newscast april3

This week the Brexit Process moved onwards as the Prime Minister triggered Article 50. We welcomed the PM’s commitment to make the UK one of the best places for science and innovation. So far, the UK government has demonstrated its commitment to innovation, and this was further shown through its support for the sector in the Budget announcements these included the investment in UKRI and the refilling of the Biomedical Catalyst. We look forward to building on this engagement via the life science response to the Industrial Strategy. It was also encouraging to see the Prime Minister’s letter mention the importance of prioritising ‘how we manage the evolution of our regulatory frameworks to maintain a fair and open trading environment.’

Now that Article 50 has been triggered, we enter a two-year political negotiation that is likely to result in a period of press speculation, bombast and rhetoric. Early agreement on key issues like: the regulation of medicines; the regime to enable non-UK nationals to work and contribute to the UK life science ecosystem; trade; finance support; market and intellectual property rules; would be the best way to ensure speedy and continuing global investment into the UK and EU. It would also be in the best interest of patients who require access to innovative healthcare.  To find out the latest on the Brexit process join us for the BIA Brexit webinar this Friday.

I am in Switzerland this week with BIA members and representatives from the MHRA and Office for Life Sciences to see what lessons can be learned that could help with the UK negotiations. I will update in next week’s newscast.

On Wednesday, the Medicines Discovery Catapult celebrated its launch at the University of Warwick. One initial focus of the work being undertaken on site will be the increasing threat of anti-microbial resistance (AMR). The site at Warwick has been developed alongside facilities at the Catapult’s headquarters in Alderley Park, Cheshire. They will both drive innovative, fast-to-patient drug discovery supporting collaborations between industry, academic teams and medical research charities, and will help drive UK health and wealth in line with the government’s Life Sciences strategy. You can find out more on their website.

On Thursday, the BIA’s Science & Innovation Advisory Committee (SIAC)brought together representatives from across the biotech/healthcare community to discuss technology transfer (pictured above).  This followed the recent Dowling Report, and also the evidence given and the subsequent report by the House of Commons Science and Technology Select Committee on managing academic intellectual property.  The BIA’s intention is to address some of the issues highlighted, such as friction around IP licencing, by bringing together all the relevant parties and encouraging open dialogue.

Finally, BIA’s Head of Regulatory Affairs joined the DIA EuroMeeting in its 29th year in Glasgow. The overall theme ‘Translational Healthcare: From Bench to Bedside and Back’ reflected the growing impact of back translation of learnings and patient data into research and development of innovative medicines. The conference discussed and shared insights into the evolving European and global healthcare environments from alternative regulatory pathways to developments in HTA and access, bringing together more than 1,500 healthcare professionals from industry, regulatory agencies and patient organisations.

Best, Steve

Scientists at the Francis Crick Institute have uncovered how tumours are able to grow despite significant damage to the structure and number of the chromosomes in cancer cells.