Next Tuesday, 28 February, is Rare Disease Day.

Rare Disease Day takes place on the last day of February each year. The main objective of the day is to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives.

Watch the video below to find out more, or visit the website.

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

Earlier this month, representatives from across the synthetic biology community gathered at the Royal Society to take part in an open discussion – Synthetic Biology: does industry get it? The conference, organised through the Royal Society’s Science, Industry and Translation Programme, was co-organised by BIA CEO Steve Bates, along with Professor Ben Davis FRS (University of Oxford) and Professor Paul Freemont (Imperial). Speakers discussed the potential of synthetic biology to address some of the key challenges of our time, as well as the barriers to fulfilling its full potential. Read on for our highlights from the day.

What is synthetic biology?

Synthetic biology is an interdisciplinary area that involves the application of engineering principles to biology. The field, in its broadest sense, is opening up a suite of possibilities for the design and redesign of biology to create new products and processes – advances in research and new toolkits could see the application of synthetic biology across a variety of industry sectors from pharmaceuticals to energy.

Improvements in the speed and cost of DNA synthesis in recent years have driven innovation at an exponential rate. Many international bodies predict that synthetic biology will have a significant impact on the economy, growth and jobs over the coming years, with the UK well positioned to play a leading role in the development of this burgeoning field.

A wealth of potential

Morning presentations from Professor Christina Smolke, Stanford University and Dr Jason Kelly, Ginkgo BioWorks both highlighted the strength of biotechnology as a manufacturing platform, offering nanoscale precision at continent scale production.

50% of our medicines are derived from nature, with 50% of those originating from plants – one obvious example being opioids. However, as explained by Professor Smolke, there are limitations to relying on nature directly to produce these and other products – a point also picked up by Jason Kelly when describing the manufacture of rose oil. Manufacturing with biotechnology has the potential to transform supply chains, providing a more cost effective and efficient route.

In an inspiring presentation, Dr Kelly shared his vision for the future: consumer biotech product launches (think Apple’s latest iPhone but for a synthetic spider silk shoe). From clothing made of bioengineered spider silk, to recreating the fragrance of extinct flowers, the falling cost of genetic engineering is opening new markets to biotechnology. And investors are interested – in the first half of 2016, over $900 million was raised by synthetic biology companies.

Synthetic biology also has the potential to catalyse the re-invention of industries and technologies. Presentations from Dr Andrew Phillips, Microsoft and Dr Jeremy Shears, Shell looked at applications from programming biology, to its role in the energy transition as we steer towards lower carbon and renewable energy sources.

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Credit: Royal Society

Does industry get it?

Across a multitude of sectors, there were some clear examples of uptake by industry on show at the conference. Multinational companies are becoming increasingly involved in the synthetic biology field, some funding research within their own companies but collaboration with SMEs and academia playing a more significant role.

Embracing this kind of disruptive technology can lead to great success for companies, but at a risk. Pfizer’s Dr Edmund Graziani emphasised the importance of driving internal innovation within a company – if not us, then someone else will capitalise on this opportunity. He sees collaborations as a useful way for larger companies to approach new technology and keep up with the rapid pace of innovation.

This was echoed by a number of the larger companies present on the day, including Dr Phillips, Microsoft who highlighted their work with BIA member company Synthace, and GE Healthcare who recently signed a collaboration with Synpromics, another BIA member. Dr Jeremy Shears also spoke to Shell’s network of research partnerships with universities, looking to academics for unique and experimental technologies.

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However, challenges to the wider uptake of synthetic biology by industry remain. These include the clear need to demonstrate profitability in order to displace existing processes; concerns over public perception and difficulties around the language and definitions used in the field. Critically, these barriers risk meaning that the full potential of synbio is not well understood.

So what else can we do to ensure the success of this flourishing industry? Persistence is key, it appears, when it comes to industry. And as synbio technologies begin to drip into the mainstream, building public trust through transparency, openness and dialogue from the beginning is paramount to its success – with companies such as the UK’s Oxitec already leading the charge in this area.

Find out more about the synthetic biology start-up scene in Europe here.

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Last week the Science Industry Partnership (SIP) launched their Strategic Skills Action Plan. This follows their Skills Strategy launched in 2016. Today’s guest blog from Malcolm Skingle, Chair of the SIP board, takes a look at the changing image of vocational education.

We are currently witnessing the most far reaching changes to further and higher education in decades – including to the funding environment (the Apprenticeship levy) and across technical education more broadly (The Post-16 Skills Plan). And the Government has also set a target for three million more apprentices “to deliver the skills employers need” in this Parliament.

Alongside this education reform, the Government is building its new Industrial Strategy and its Green Paper is out for consultation. One of the Paper’s 10 ‘pillars’ is to build a “proper system” of technical education.

The Science Industry Partnership has been working hard to influence all of this, and indeed has been very positive about what it sees as an unprecedented opportunity to position academic and technical qualifications on an equal footing. We want to ensure that, in future, technical and vocational education is a distinctive, prestigious, high-quality offer in its own right and a positive, informed choice for young people.

Our employer members have always delivered high-paid, high-skilled jobs; but in recent years, we have put out a clarion call for much better, higher quality, vocational education to meet the demands of our high skill STEM occupations.

Along with the BIA, the SIP recently responded to the Science and Technology Committee’s inquiry “Closing the STEM Skills Gap” to further build the evidence base around pressing STEM skill shortages and the need to reduce them. We set out, in our response, what our SIP Skills Strategy had told us – that there are a range of occupations where appropriately skilled people are in critically short supply.

And the solution? The continued pursuit of excellence in delivery of science vocational skills, supported by industry. The need to build greater capacity in the college and university system for evolving skill areas. And the appropriate funding to sit alongside this.

For example, new degree apprenticeships carry parity of value and esteem for both learners and employers.  They offer a fantastic route to a STEM career, creating a new type of graduate who becomes technically competent through undertaking advanced work-based learning while studying.

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Strategic Plan

The SIP has developed a Strategic Skills Action Plan that has a five year horizon. This sets out the cross sector collaboration with a range of key partners that is required in order to deliver on this high skill, vocational agenda.

A clear part of this plan is to create a network of vocational science Higher Education Institutes (HEIs) around the UK. HEIs have a critically important role to play, and some may have to depart from traditional frameworks of study and create even stronger relationships with employers, to ensure a fit-for-purpose curriculum supported by industry.

The newly announced Institutes of Technology are also set to play a key part in STEM education. These will bring supply and demand together, working across Further and Higher Education and in partnership with local employers to create community bodies that really add value.

Our “Trailblazer” employer group is playing a vital role too, in developing new Apprenticeship Standards and assessment of competence that are creating a clear, accredited route through to the top of the most advanced science professions. We know that the apprentices in our sector are ambitious to achieve professional status. We were delighted to announce recently that ten apprentices from leading science-based companies, Lucite and Pfizer, were the first to successfully complete the new STEM Trailblazer Apprenticeship Standards. They met the Standard across many different disciplines ranging from complex manufacturing of active pharmaceutical ingredients, drug product formulation design, synthetic organic chemistry and analytical research & development, all underpinned by an extensive training programme in the workplace.

Finally, while we are wholeheartedly supportive of this newly developing model of high quality, vocational education, we do continue to call for much more flexibility in the use of the levy. For example how might we make best make use of unused Apprenticeship Levy within the science sector to optimise employer engagement on training and to support upskilling of the workforce?

The forthcoming Industrial Strategy gives us an opportunity to work together to maximise this investment. We are developing a proposal for skills, as part of the “Sector Deal” for science, a much welcome invitation which was put forward from Government in its Green Paper.

The SIP recognises that all of this reform and change presents challenges and opportunities for science employers, and our members will continue to work, in conjunction with Government and its agencies, Trade and Professional Bodies, Providers and Higher Education Institutes to meet the skills challenges facing the science sector now and in future.

The power of the sector approach is here to stay.

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As well as the article 50 bill starting its passage through the House of Lords, the government has today responded to the Commons Science and Technology Committee’s report on the implications for science and research of leaving the EU. In its statement, the Government has reaffirmed its commitment to science and innovation and “making the UK the global go-to nation for scientists, innovators and investors in technology”. In particular, we welcome the acknowledgment that maintaining communication with stakeholders throughout the Brexit negotiations will be key, and we look forward to continuing the close working relationship we have with the Government and helping them to maintain confidence within the global life sciences community.

I had the opportunity to talk Brexit with Lord O’Shaughnessy, who recently assumed life science responsibilities in the Department of Health, in a meeting last week. We also discussed, amongst other things, the Industrial Strategy – a conversation I was able to continue this morning at a Life Sciences Industrial Strategy Stakeholder Reception with many BIA members in the impressive but chilly Durbar Court of the Foreign Office (see picture). For all of us attending (and thanks to those Members able to join at short notice) it was great to hear John Bell endorsing our goal of growing life science businesses to scale from the UK as a “grand challenge” and to discuss in detail ideas around financing and investment in life science, policies for the science base and regions and future of regulation. An unannounced appearance at the end of the event by NHS Chief Executive Simon Stevens was a positive sign of NHS England engagement with the process. We continue to advocate on this crucial area and the government hope to publish a new strategy by the end of next month.

Last week the US National Academy of Sciences and National Academy of Medicine published a report on human genome editing, “Human Genome Editing: Science, Ethics, and Governance”. The report outlines several criteria that should be met before allowing germline editing clinical trials to go forward. We welcomed the publication of this cautious but reasoned report and the continued international focus on enabling this pioneering area of biotechnology. With its renowned science base, and a world-leading regulator in the HFEA, the UK is well placed to lead in this innovative genetic revolution.

We are also blessed with expert institutions like the Royal Society, the Wellcome Trust, the Nuffield Council on Bioethics and numerous medical research charities, able to facilitate and contribute to the vital ongoing global public debate needed about the science, ethics and governance of human genome editing. The BIA hopes that a consensus position is reached between UK scientists, society and policy-makers that will enable businesses that may emerge from this frontier science to want to establish themselves in the UK as a supportive and properly regulated environment.

On Thursday we were at the BioHub Birmingham for their BioBrum event. It’s always useful to attend regional hub meetings, such as BioBrum, which provide valuable opportunities to engage with companies in the area. BIA COO Nick Gardiner spoke to delegates about our talent directory and growing desire to understand the education and vocational training environment and talent development available across the industry. Talent remains a key area of focus for the BIA and something our People Advisory Committee will continue to address, including at Friday’s Committee Summit.

Later that evening, back in London, the Science Industry Partnership (SIP) launched their Strategic Skills Action Plan. This follows their Skills Strategy launched in 2016. The Action Plan was set out to deliver the key skills activities needed to achieve the sectors’ skills ambition – including a requirement for  up to 260,000 skilled people out to 2025 – many in new technology-based scientific occupations. This projection includes up to 142,000 professional level graduate-entry jobs and up to 73,000 technical level apprenticeship-entry roles.

It is vital that there is a sustainable future pipeline of knowledge and skills to ensure that the sector can continue to grow and succeed. The Medicines Manufacturing Industry Partnership (MMIP) Advanced Therapies Manufacturing Taskforce (ATMT) worked in close partnership with SIP to align the ATMT action plan launched in November 2016 and the SIP Strategic Action Plan to support this shared goal.

If you’re interested in the skills agenda, read more about the work of our Manufacturing Advisory Committee and their bioproduction leadership initiative that launched in January. In the run up to our annual Committee Summit on Friday, we’ve also published a round-up of the focus of our Intellectual Property Advisory Committee, which has been following the increasing divergence between US patent law and that of other major jurisdictions around the world.

Looking forward to seeing you at the Summit on Friday

Best

Steve

Following the outcome of the UK’s referendum on membership of the European Union, the BIA has worked closely with members and stakeholders to identify the threats and opportunities for biotech post-Brexit and to represent the sector.

Our BIA Brexit Briefing webinars will provide a monthly update on government policy, progress of working groups, and how these will potentially affect companies in life sciences – particularly with regards to innovation, financing, regulation and people.

Catch up on last week’s webinar below, delivered by Steve Bates OBE, Chief Executive Officer, BIA.

Visit our website for details on future Brexit webinars.

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

Last week, the BIA wrote to the US Patent and Trademark Office (USPTO) to raise concerns about the increasing divergence between US patent law and that of other major jurisdictions around the world.  The intervention is the latest action led by the BIA’s Intellectual Property Advisory Committee (IPAC), which has been following developments in the US closely to monitor how they might affect the UK biotech sector.

A widening schism in international patent law

Over the past six years, the US Supreme Court has issued a series of decisions – Bilski, Mayo, Myriad, and Alice – that have significantly impacted the legal definition of what is eligible for patenting and what is ineligible (see page 5 of this document for an in-depth background).

As a result, patents involving abstract ideas, laws of nature, and natural phenomena have become prone to challenge in the courts. In biotechnology, this has resulted in a range of diagnostic patents being declared invalid, and even the patent for Dolly the Sheep.

The BIA recently hosted a seminar with Dr Konstantin Linnik from US firm Nutter McClennen & Fish LLP. His slides are an excellent introduction to the implications of the Supreme Court’s decisions, with helpful guidance on how companies should write their patents to gain greater protection.

A consistent and harmonised patent eligibility framework across the globe allows inventors to determine with predictability whether to rely on patent protection (and therefore to disclose their inventions) or, instead, withhold their discoveries and rely on trade secret as an alternative form of IP protection. These two forms of protections are mutually exclusive – one cannot maintain a trade secret in one jurisdiction while obtaining a patent in another.

This can hamper innovation as ideas aren’t shared, and at worst can prevent innovations being developed at all – the risk of losing exclusivity to a technology puts off many investors, meaning companies can’t develop them. As the US is the largest market in the world for medical innovations, their laws will influence decisions made by biotechs and investors everywhere.

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BIA interventions in the US

This threat to innovation and the importance of the US market for UK biotechs has prompted the BIA to intervene in court cases across the Atlantic where there was opportunity for the case law to be better aligned with that of Europe and other jurisdictions.

In 2015, we petitioned – with support from Dr Linnik – the US Federal Circuit to reassess its decision in Ariosa vs. Sequenom, a case in which the case ruled that the PCR-amplified foetal DNA detected by Sequenom’s diagnostic test represented a natural phenomenon. The court didn’t change its view and so Sequenom sought review in the Supreme Court. The BIA submitted a friend of the court brief urging it to accept the review; this time we were joined by several other industry associations, illustrating the global importance of this issue: EuropaBio, AusBiotech, Swiss Biotech Association, HollandBIO, BIOTECanada, and Japan Bioindustry Association. Unfortunately, the Supreme Court didn’t accept the case and so the law remains at odds with that of other countries.

A potential new opportunity to address the schism?

The USPTO has recently launched a public debate exercise, calling for comments on “the legal contours of eligible subject matter in US patent law” and hosting public roundtables. They are also asking for feedback on guidance they have produced.

The BIA has now written to the USPTO raising our concerns and highlighting the international support that the friend of the court brief received from other biotech associations. We hope this demonstrates to the US authorities the importance of the issue not only to US innovators, but those around the world also.

The USPTO is only facilitating a public debate at this stage, but we hope it could be a useful step towards a process that can address the increasing schism in international patent law. The BIA’s IP Advisory Committee will continue to monitor the issue and look for further opportunities to ensure the UK and the international biotech community’s voice is represented in the US.

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Ian McCubbin, Chair of the Medicines Manufacturing Industry Partnership, is stepping down from the role and reflects on the work achieved by MMIP over the past two years.

After two years of chairing the Medicines Manufacturing Industry Partnership (MMIP) I am now in the process of handing over to Andy Evans, the Head of AstraZeneca’s manufacturing site in Macclesfield. Andy has already thrown himself into the role during what is a very interesting time, for two main reasons.

Firstly, MMIP has really established credibility in the medicines manufacturing community, and with Government and associated organisations. In many ways I know that MMIP is seen as a role model for how we should work with government in the Life Sciences sector. It is also very timely following the vote to leave the EU and as Government starts to design the Industrial Strategy and the Life Sciences Industrial Strategy within that.

As I reflect on our contribution, it’s clear we have progressed significantly with a number of important topics, not least the Advanced Therapy Manufacturing Taskforce (ATMT). The Taskforce published its  action plan in November and, while awaiting an official Government response, we are already seeing progress with a competition to be opened in February for viral vector capability and hopefully other funds from the industrial challenge fund opening soon too. We have progressed how to close the skills gap and we are working very closely with the Department for Business, Energy and Industrial Strategy, Office for Life Sciences and the Department for International Trade on other actions.

Beyond the ATMT, MMIP continues to support the Medicines Manufacturing Innovation Centre and ADDoPT, both of which will contribute to medicines manufacturing innovation, and ultimately commercialisation and the sector’s contribution to the UK economy. The Medicines Manufacturing Innovation Centre will provide an open-access hub where medicines manufacturing stakeholders can collaborate, research and pull through emerging technologies and manufacturing processes into a commercial manufacturing environment. ADDoPT is the Advanced Digital Design of Pharmaceutical Therapeutics, it creates virtual medicine manufacturing systems to make sure they are effective and efficient before creating them in the real world.

With the support of The Association of the British Pharmaceutical Industry, BioIndustry Association, Innovate UK Knowledge Transfer Network and of course all the companies who have committed their valuable time and energy, MMIP has been able to create  momentum at exactly the right time. Some may say luck, but to paraphrase Gary Player, “The more we practice, the luckier we get.” I am very grateful to everybody who has generously thrown themselves into this project and I would urge anybody with a passion for the UK and medicines manufacture to find out more and to contribute to MMIP too.

I think Andy will do a great job as chair of MMIP and I am certain medicines manufacturing will form a very influential part in the future of the UK economy.

For more information about the MMIP, and how you can become involved, visit the MMIP webpage.

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As you may know, Sir John Bell, as the UK Government’s Life Sciences Champion, is leading a life science sector response to the UK government’s industrial strategy. I am delighted to be representing our sector on the steering committee.

The BIA wants to make sure local senior commercial innovators across the country have a powerful voice at the table to complement both academic and big pharma input. As part of that we are running an online survey to get the views from as many of our senior members and non-members as possible – especially those in CEO, CBO, CSO and CMO, Investor and Board Member roles.

This work compliments, but is separate to, the meetings that the KTN are doing at this time on the Industrial Strategy Challenge Fund scoping work. It also compliments the workshops we are running and the 1 on 1 interviews that some of you have given – many thanks for your contributions in this capacity.

This survey focuses on:

  • the performance of the UK in translational research from bench to bedside, and what is working well/how it can be improved
  • your experience with and satisfaction in various government support structures
  • your views on some proposed Innovate UK initiatives, especially the Industrial Strategy Challenge Fund
  • new ideas that, if scaled up, will drive translation.

The survey is open until next Monday 20th February 2017 and I’d be grateful if you could spare 15 minutes of your time to complete it.

Following our successful networking lunch at BioCity Scotland earlier this month, it was good last week to be in the brand new Cambridge building on the Babraham Research Campus for the latest BIA networking lunch. I found it really useful to get member’s perspectives on the BIA’s work on Brexit and Industrial Strategy as well as to get the latest from Harriet Fear, CEO of our United Life Science partner One Nucleus. BIA member Discuva and Innovate UK’s Dr Penny Wilson discussed the Biomedical Catalyst – with Discuva having recently been awarded funding as part of the Biomedical Catalyst 2016. It’s good to see there are several schemes open right now from Innovate of relevance to BIA members – more details of which can be found on our website.

Given member interest in Brexit we are now holding monthly update webinars – the first of which was last Friday, providing an update on government policy, progress of working groups, and how these will potentially affect companies in life sciences. Following a huge amount of interest, the webinar will be available to watch online later this week. You can sign up for our next one, taking place on 10 March, here.

Also last week, we joined forces with 11 other organisations from the private, public and charity life sciences sector to host an event in Parliament to give MPs and peers the opportunity to speak to patients, researchers and industry experts about the opportunities and challenges of Brexit. You can download the event briefing from our website.

It was great to catch up with the synthetic biology community at last Wednesday’s Royal Society conference, “Synthetic Biology: Does industry get it?” – a provocative title and fantastic line up of speakers sparking some great discussion amongst the panels and the audience. The synbio scene has exploded over the past decade as exponential improvements in technology have led to dramatic falls in DNA sequencing and DNA synthesis costs. The huge variety and promise of the sector was evident from the range of topics discussed, from recreating the fragrance of an extinct flower to the powerful application of synbio in manufacturing technologies. BIA members represented on the panels included Oxitec, Pfizer, and GlaxoSmithKline. It was great to here other perspectives from Shell and Unilever. Many thanks to the Royal Society for hosting and to my co-organisers Professor Ben Davis, University of Oxford and Professor Paul Freemont, Imperial College London – you can catch up with the day’s discussions on Twitter using #RSsynbio.

Please note that our joint webinar with Alzheimer’s Research UK has moved to 1 March. Alzheimer’s Research UK is the leading charitable funder of dementia research in the UK. Along with BIA members active in this space, they will provide an overview of the current dementia research and development landscape and funding opportunities available to support the development of dementia treatments. More info here.

Our colleagues at the European Investment Bank are currently undertaking a study investigating the availability of funding for life science SMEs in Europe. The results of this study will help shape both national and European policy actions in support of life science R&D. To ensure the study captures the views of as many UK life science SMEs as possible they have created a 5 minute survey assessing your perspective on the life science funding environment. Do take a look and have your say.

Best

Steve

q-report-cover-oct-2016-to-jan-2017Our blog today, taken from our latest quarterly policy and regulatory affairs update, takes a look at clinical trials hot topics.

Revision of first-in-human clinical trials guideline

Following on from our comments in our last quarterly updates regarding the tragic incident which occurred during a Phase I clinical trial in France in January 2016, the BIA has kept a watching brief on the investigations and any implications for the conduct of first-in-human trials in the EU.

The European Medicines Agency (EMA), in cooperation with the European Commission and EU Member States, has proposed a revision of its guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products to further improve the safety of trial participants.

The EMA published the draft revised guideline for public consultation on 15 November. This follows an initial consultation in the summer on a concept paper that outlined the key areas of the current guideline (adopted in 2007) that need to be amended, taking into account the lessons learnt from the tragic incident, as well as the evolution of practices in the last 10 years.

While the 2007 guideline focused on the single-ascending-dose design used at that time, the practice for conducting first-in-human clinical trials has evolved towards a more integrated approach, with sponsors conducting several steps of clinical development within a single clinical trial protocol. For example, these trials may also include collection of data on food interaction, in different age groups as well as early proof of concept / proof of principle parts and bioequivalence of different formulations.

The BIA intends to respond to the consultation in collaboration with EuropaBio (the European Association for Bioindustries). If members wish to contribute to the consultation response please contact Christiane Abouzeid at cabouzeid@bioindustry.org.

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BIA attends EMA meeting on EU Clinical Trials portal and database

In November the BIA participated upon invitation in an EMA stakeholders meeting on the development of the EU clinical trials and Union database as part of the implementation of the EU Clinical Trials Regulation. Discussions focused on user management – a set of features and capabilities that manage user access to the clinical trials system functions according to their role, so the system will display the appropriate data and also the appropriate activities for them.

We will continue our ongoing dialogue with the Agency in order to address industry concerns and ensure that the clinical trials system is fit for purpose.

BIA responds to EMA consultation on clinical trial guideline

In December, the BIA inputted, together with EuropaBio, to a consultation by EMA on a draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials in connection with the implementation of the EU Clinical Trials Regulation. This guideline is of particular interest to members involved in clinical development of biological and biotechnology derived medicinal products in the EU.

Voluntary Harmonisation Procedure (VHP) for clinical trials – 1000th procedure

The Heads of Medicines Agencies’ Clinical Trials Facilitation Group has recently announced receipt of the 1000th application for the evaluation of a multinational clinical trial by the VHP procedure. Established in March 2009, the VHP is a useful tool for the initiation of the authorisation procedure for clinical trials in more than one EU member state by submitting a single application. It is worth noting the VHP served as a model for the new procedure in the EU Clinical Trials Regulation, which will come in to force in October 2018.

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As we gear up to this year’s BIA Committee Summit on 24 February, we’re taking a look at what some of our eight Advisory Committees have been up to. In today’s blog, Kit Erlebach, Deputy Chair of the Manufacturing Advisory Committee, details their bioproduction leadership initiative which launched in January.

On the 17th and 18th January, the BIA’s Manufacturing Advisory Committee (MAC) launched their Skills Networking Tour at FUJIFILM Diosynth Biotechnologies in Billingham. The programme was created to support the development of the next generation of bioprocess leaders, as part of BIA MAC’s objectives of connecting, advising and influencing.

The recent action plan delivered by the Advanced Therapies Manufacturing Taskforce, co-chaired by Minister of State for Universities, Science, Research and Innovation, Jo Johnson MP and Ian McCubbin, SVP North America, Japan & Global Pharma Supply, GlaxoSmithKline, outlined the need for an end-to-end talent management plan to secure the relevant skills for emerging manufacturing technologies. This is an essential pillar to establishing the UK as the global hub of advanced medicinal therapy manufacturing and ensuring the long-term success of this industry in the UK.

The development of managers in the biopharmaceutical and cell and gene therapy industries is an important part of the training landscape to deliver senior leaders of the future. Two key aims of the MAC initiative are:

  • to promote cross-sector learning  by offering an overview of the work of other companies across biopharma, vaccines and cell and gene therapy by seeing them in action
  • to develop a network with peers to promote best practice

A total of 11 BIA member companies are currently taking part in the scheme: Allergan, the Cell and Gene Therapy Catapult, F-star, FUJIFILM Diosynth Biotechnologies, GE Healthcare, Lonza, MedImmune, Oxford BioMedica, Pall, Porton BioPharma and UCL.

As part of the project, the group of 11 participants (one representative from each of the above companies) will attend a series of site tours to offer an overview of the work of other companies in the sector by seeing them in action. Each site visit is preceded by a pre-dinner the night before, to encourage the development of a network of peers.

We were delighted to welcome 10 of the 11 company representatives involved in the tour to the FUJIFILM Diosynth Biotechnologies site in January. We had a detailed tour of two manufacturing facilities and parts of R&D. There were presentations on the site and company as well as the new potent molecule facility, some of the improvements undertaken and a career overview from one of the site leadership team.

The participants were very positive about the day and pleased to be part of the programme, giving some great feedback on the day. We look forward to continuing to develop the programme to deliver on the needs of BIA members and wider industry.