Annual Review & Directory 2020/2021 Q4 Update
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Contents Welcome ......................................................................................................... 4-6 Meet the Team .................................................................................................. 7 Our Corporate Supporters ............................................................................ 8 Our Corporate Patron ............................................................................... 9-10 One Nucleus Partners ............................................................................ 11-12 As A Member You Can .................................................................................. 14 Facilities Management ................................................................................. 15 Member Savings ............................................................................................. 16 East of England Data ............................................................................... 17-18 Patient Perspective .................................................................................. 19-20 COVID-19 Updates .................................................................................... 21-44
Member Listings: Research & Development ...................................................................... 46-48 Research & Development Space ......................................................... 49-50 Research & Development Services .................................................... 51-55 Talent ............................................................................................................ 56-57 Advisory ....................................................................................................... 58-64 A-Z Listing ................................................................................................... 65-72 Find Out More .................................................................................................. 73
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A Warm Welcome from Tony Jones In a year of rapid change and uncertainty, it’s a pleasure to be updating the welcome section of our Annual Review & Directory to take stock of what our members and wider network continue to achieve in such challenging times. Absolutely, the past few months have been a time of extraordinary challenge due to the emergence of Covid-19. The review this year includes a section looking at some of the ways in which our members and stakeholders have responded to the call to action directly, maintained their day-to-day businesses where possible and pushed ahead with innovation in all areas. I am grateful to those who have contributed articles to share their insights and thoughts around the topic. Against such an on-going backdrop, it may be timely to look at the bigger picture regarding the sector. Recent reports about the achievements of the sector paint an astonishing picture all things considered. In fundraising alone, Covid-19 has stimulated something of a boom with the Nasdaq Biotech Index up 20% since January 2020. Investment has flooded into the sector with the UK alone seeing quarterly biotech fundraising exceed £1Bn between June and August 2020. This within the global context of biotech companies having raised £7.5Bn. The pattern seems set to take the UK to record levels of finance raised during the year for certain, raising more that the £2.2Bn record set in 2018 (cf: Melanie Senior, Mike Ward and UK Bioindustry Association). Notable too in the third quarter has been the increase in early-stage venture investment after this was hit hard by the Coronavirus lockdown in Q2. The region has provided several of the very significant deals within that headline figure above. These have included the Freeline Therapeutics Nasdaq IPO (£119M); NodThera series B round (£41M); ReViral series C round (£33M); and BitBio’s series A (£32M). There have been successes outside of investment of course. Sosei Heptares triggered a $5M milestone payment under its collaboration with Pfizer designing small molecule modulators of GPCR targets. In medical devices, CMR announced their first success in one of its biggest markets for its surgical robots, France. The emerging fields such a synthetic biology and artificial meat have also seen successes with Evonetix announcing its collaboration with US-based Analog Devices to fast track the scale up of its desktop DNA writer and Higher Steaks relocating to the region, respectively. Rising stars such as Domainex, Metrion Biosciences, Arecor and Isogenica continue to thrive, growing their revenue base, teams and collaborations. These successes highlight the strength of the region’s Life Sciences sector and the exceptional leadership being shown throughout the pandemic. The disruption to normal business practice has been felt across the board and the switch to online events and meetings required with social distancing and travel bans imposed has made almost everyone consider their outreach and engagement strategies now and for the future. This has been the case for One Nucleus also whilst maintaining support for all our members and stakeholders. The past six months have enabled us to reflect on our activities, lessons being learned and future plans with our network. The need to utilise online meeting technology leading us all to have to wonder whether business can work through a zoom lens. The reported deal flow and successes mentioned above suggests the answer must be yes, although probably not everyone has had a good experience through 4 | One Nucleus Annual Review & Directory 2020/2021
this period if we looked at all the data not just the headlines. In September, we surveyed our network to gain insight into which aspects of events were being missed the most or indeed welcomed. The results were as follows: Event Aspect Missed or Welcomed Missed: The chance conversations during face-to-face networking not related to the presented content Welcomed: Reduced travel, time and cost of attending online compared to face-to-face events Missed: Being able to follow up immediately with the speaker/s in person at face-to-face meetings Missed: Ability to discuss the presented content with other delegates during face-to-face networking Welcomed: On-demand access post event to the recorded sessions following online events Welcomed: The option to share comments and questions with other delegates via ‘chat box’ as they arise during presentations Welcomed: Use of the randomly allocated virtual breakout rooms at online networking events to increase delegate-to-delegate introductions
% of responses 76% 64% 43% 40% 34% 15% 10%
The results have helped One Nucleus planning for our future events strategy, not just the delivery during this socially distant phase. The suitability and effectiveness of the much-hyped hybrid event approach is yet to be proven. Yes, it will enable geographically remote delegates to engage in the events whilst some delegates will be physically present. It is conceivable too that the usual dynamic of debate, partnering and knowledge exchange could be significantly disrupted when there are effectively two audiences, each wishing the other was doing as they were. Fully digital events, such as our ON Helix conference in July have clearly shown that live streaming of programme sessions does attract engagement and attendee Q&A. We have also seen how virtual online 1-2-1 partnering can be successful. As highlighted in the results above, the gap perhaps is the serendipity of the face-to-face networking and immediate follow up of discussions around the topic post-session. On the flip side, attendance has often increased, delivery costs (and hence delegate prices) have dropped, recording for on-demand viewing is routine and the danger of those seeking to acquire innovation, products or services being in the one audience whilst the providers of those assets being in the other is avoided. To stress, there is no suggestion that physical events with face-to-face networking will not return and be successful, they most certainly will since the value of networking is unchanged. Equally, it will be a surprise if the wholly digital events disappear given the advantages and increasing engagement they are seeing. It is also not the case that hybrid events will never feature more. One Nucleus may indeed go that way if more proof that additional logistical barriers and costs for a fully hybrid event, rather than simple streaming of a physical conference online and an ability to connect via an app comes forward. Afterall, the increased resources to deliver these events well is a cost ultimately bourn by the delegates, exhibitors and sponsors. In the near term, the One Nucleus approach to hybrid events will be reflected in our portfolio which will contain a mix of face-to-face (when permitted) and digital. We have seen excellent content sharing and interaction via our digital events since March 2020. The possibility to share insights and best practice peer-to-peer, present global opportunities and encourage further engagement has seen speakers and participants from all parts of the globe be part of our ecosystem. Listening to the feedback and our survey means we are continually evolving the formats and diversity in order to support our members so do keep checking in on our web site for upcoming events and opportunities to work with us. Returning to face-to-face networking events when possible will complement the lessons learned online so we fully expect this approach to hybrid events will create a highly effective set of circumstances to enable deal flow.
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Whilst recent months have been dominated by the disruption caused by the Covid-19 pandemic one must not forget the changes arriving to start 2021. Brexit is still happening and we look for every opportunity to be informing and supporting our members into the new world. From preparing such that their laboratory supplies arrive on time, sharing information around immigration rules and maintaining our strong collaborative links with European counterpart membership groups, One Nucleus is committed to helping our members to thrive and find the right partners. Adding to that, we also of course maintain and grow our connectivity with numerous non-European cluster organisations as well as our peers within the United Kingdom. Maintaining our ‘little black book’ of connections, reaching out to help our members connect with potential new markets, partners and investors is something we take seriously and utilise where possible. Being collaborative is almost always the best way to be competitive with many of the challenges to address unmet patient needs requiring collaboration and scale. The One Nucleus local and global ecosystem is there to facilitate and support those developing the muchneeded health solutions for patients. The autumn always brings with it a certain buzz. Entering the prime conference season with BioEurope at the centre for this continent and with our annual Genesis conference just around the corner. We are delighted to be continuing our collaboration with EBD Group as they take BioEurope digital, enabling 1-2-1 partnering at scale. With experience and the lessons learned from a successful ON Helix back in July, Genesis Digital affords a true sense of anticipation. A great international line up of speakers and on-demand content developing as this publication goes to press, the event app will enable delegates to connect, 1-2-1 partner and follow all the sessions like never before now that everything is online. Illustrating the benefits of ON Helix Digital, we are now able to make the recorded material from ON Helix available to Genesis delegates on-demand, adding even more to the depth and breadth of knowledge exchange available. Further details and how to get involved are set out later. Day-to-day support for our members continues to include access to the Group Purchasing Scheme and Marketplace, posting of news, jobs and their own events, promotion of the membership and region to potential investors and partners, submissions to policy makers and access to expert advice and resources when required. As always, it is a pleasure to include in this edition review articles from our members, highlighting some of their excellence, strategies and insights. The level and breadth of expertise across all aspects of the life science industry as well as the other sectors with which it interfaces is key to why this region is successful in translating great science to great patient benefits. This is increasingly important as innovation through convergence means the fields of biomedical R&D, technology and data science are aided by the respective strengths of those fields in the region. Strengths that supply cross-over thinking, talent and outcomes. The suite of One Nucleus activities is completely targeted at creating mechanisms to convene the excellence based here and to attract inward engagement from around the World in order to provoke great questions of each other, initiate new deals and collaborations. Raising awareness of the latest advances and opportunities for our network sits at the heart of the One Nucleus ethos. The breadth of our membership and how we seek to demonstrate that ethos will be evident from this directory for all to peruse. We look forward to being part of your journey! Best wishes, Tony Jones, CEO 6 | One Nucleus Annual Review & Directory 2020/2021
Meet the Team
Tony Jones
Chief Executive Officer
Debbie Flicos
Finance & Systems Administrator
Alicia Gailliez
Business Development Manager
Richard Dickinson
Chief Technical Specialist
Laura Bacchus Finance and Data Administrator
Claire Abrams
Director of Events & Communications
Jean
Chief Operating Officer
Aline Charpentier
Head of Innovation Support
Jasmin Bannister
Events & Communications Administrator
Laura Hicks
Marketing Manager
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Corporate Patron
Corporate Sponsors
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Our Corporate Patron
One Nucleus is delighted that AstraZeneca will continue its long-held relationship as Corporate Patron. Over the decade of support to date, AstraZeneca has provided a number of its leadership as Board members, delivered strategic guidance as one of the region’s key stakeholders and presented thought-leaders for our key annual events. The breadth of this engagement means we have formed a strong and productive relationship with AstraZeneca, based on shared ambitions for the Cambridge and wider UK life sciences community. Driven by innovative science and an entrepreneurial culture, in 2019, AstraZeneca announced a simplified organisation designed to position itself ready for its next stage of strategic development. The changes further integrated research and development to enhance innovation and deliver sustainable growth. Highlighting AstraZeneca’s commitment to the partnership with One Nucleus, it is with pleasure that we recently welcomed Penny James, Chief Operating Officer BioPharmaceutical R&D, to the One Nucleus Board. The shared ambitions for the region’s life science cluster to be the world-leading bioinnovation hub is key to both of our organisations. One Nucleus strives to enable knowledge sharing on the latest innovations in the scientific, business and investment aspects of the sector. AstraZeneca’s willingness to dedicate strategic resource to us, such as event speakers and updates, significantly enhances our delivery. Their engagement provides insight to the nascent companies, their founding entrepreneurs and investors, on how exceptional scientific innovation can be translated into patient benefit globally. This fits well with the collective aspirations of our cluster’s ecosystem; to create life changing technologies and products that have a global impact on lives. AstraZeneca’s role as a global leader and regional champion has never been more evident as in their response to the COVID-19 pandemic. Its partnership with the University of Cambridge and GSK was key to the creation of the Cambridge COVID-19 Testing Centre on the Cambridge Biomedical Campus to support the government’s national screening programme. www.onenucleus.com | 9
This, in addition to their focus in finding new preventative and treatment approaches to combat the pandemic, exemplifies why the UK has such a strong reputation in life science innovation. Their dedication to supporting the UK’s efforts to fight COVID-19 gives even extra pleasure to count AstraZeneca as the One Nucleus Corporate Patron. AstraZeneca has been headquartered in Cambridge since 2016, and now has more than 3,000 employees in the area. AstraZeneca continues the build of its Global R&D facility on the Cambridge Biomedical Campus with the involvement of Ms James on the Programme Board. AstraZeneca is as deeply committed to our life science community as we are at One Nucleus. As well as world class science, AstraZeneca has collaboration at its core, and we look forward to working collaboratively with our them to the benefit of our members and to the benefit of our sector, in Cambridge and beyond. Tony Jones, CEO
Milner Research Labs Functional Genomics Centre Laboratory of Molecular Biology Cambridge Institute
Energy & Data Centre and planned R&D Enabling Building
School of Clinical Medicine
R&D centre under construction
Anne McLaren Laboratory of Regenerative Medicine
Opened 9th July 2019
Collaboration is at the heart of the Cambridge Biomedical Campus
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Addenbrooke’s Hospital The Rosie Hospital
One Nucleus Partners Babraham Research Campus
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• • • • • • • •
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Where Life Meets Science Chesterford Research Park offers state of the art laboratory and office space alongside superb central facilities - a community perfectly positioned for today’s thriving pharmaceutical, biotech and technology companies.
www.chesterfordresearchpark.com
savills.co.uk
01223 347 000
Did You Know? Connect with groups in the EU, US and Asia
Post job vacancies on our website Showcase your company at events
Save ÂŁ on third party events and services
As a member you can...
Voice your views on policy and Government support in the sector
Save ÂŁ via the Purchasing Scheme
Get in touch to find out more about membership benefits: info@onenucleus.com 14 | One Nucleus Annual Review & Directory 2020/2021
Develop yourself and your team via Training Write an article or blog for publication
Facilities Management Facilities management can be a real problem for small technology companies with challenging demands for laboratory, workshop and office space. One Nucleus provides a range of Facilities Management Services to help our member companies to expand or relocate. We can provide project management for office and laboratory fit-outs (no job too small) and can help with laboratory service contracts, maintenance contracts, cleaning contracts, utility bills, insurance, purchasing and budgeting. As with all our services, these are provided at discounted rates to our members. Our Facilities Management Services and Purchasing Scheme are managed by Richard Dickinson, One Nucleus’ Chief Technical Specialist, who has more than 20 years’ experience in laboratory and facilities management. Richard has extensive local contacts and is also NEBOSH certified in health and safety.
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Looking for space to start or grow your business?
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Recent projects and clients include: • Alloy Therapeutics (UK) Ltd • Aqdot Ltd • Artios Pharma Ltd • Enplas Europe Ltd • Inivata Ltd • Isogenica Ltd • Microbiotica Ltd • o2h Ventures • QKine Ltd
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Ask me about our Facilities Management services. We can provide project management for all your laboratory fit-out needs. Richard@onenucleus.com | 01223 896453
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Member Savings Gold Member Savings
All One Nucleus Gold Members have access to the Purchasing Scheme which gives them discounts on goods and services purchased from our preferred suppliers, listed below. Those Gold Members using Fisher Scientific also receive a growth rebate on their annual spending at the end of the year. The overall savings made easily cover the cost of a Gold Membership. See a breakdown in savings per company size here. The One Nucleus Purchasing Scheme has been running since 2000 with an annual member spend exceeding £7 million before discount and with more than 100 members. It is the longest-running purchasing consortium of its kind in the UK, saving members over £3 million per annum. We currently have seven Preferred Supplier Agreements (PSAs) in place who undergo a rigorous tender process and are selected, not by One Nucleus, but by the members of the Purchasing Scheme. These deals are only available to our Gold Members. We can perform a cost-benefit analysis for our members thinking of upgrading to Gold membership (and therefore access to PSAs) or companies thinking of becoming a Gold Member. Current PSAs: • Air Liquide • Air Products • BOC • Deliver Plus • Fisher Scientific • Harts Office Supplies • STARLAB
Savings For All Members
All our member organisations and their employees can benefit from substantial savings through our Member to Member discount arrangements. Visit our Marketplace page on our website for up to date information on the discounts and offers open to you through your One Nucleus membership. For more information on Member Savings, please contact Richard at richard@onenucleus.com. 16 | One Nucleus Annual Review & Directory 2020/2021
Developing Tomorrow’s Drug Pipeline – an Overview of the East of England Collective Assets No one will argue with the success of Cambridge and the East of England as a therapeutics life science cluster. We’ve all seen these figures of the scientific excellence – 61 Nobel prizes in relevant subjects; economic powerhouse – £6bn turnover growing about 10% annually. But is it enough to be the place of choice to develop tomorrow’s therapeutics? In an ever-increasing complex sector with more convergence of technologies it’s not just about having innovative ideas and the right amount of cash – although it helps… but it’s about having the right value chain to supply technology support, fuelling the talent cross fertilisation and creating a virtuous circle of value creation. So how does the East of England drug pipeline look and what does it tell us about the regional strengths? An overview of the current drug pipeline A representation of the regional drug pipeline like here helps us understand the development stage and dynamic of companies developing these therapeutics. Deliberately excluding the large Pharmaceutical companies emphasizes on the group dynamic rather than the individual leader. The learning here is that with just under 100 SMEs having a recorded drug pipeline, the overall distribution is rather early stage, about 2/3 of the pipeline is in non-clinical phases which, compared to the reference cluster Massachusetts, is two-fold higher. Digging into the data it appears that only a quarter of the pipeline is small molecules, the rest being spread between antibodies, biologics, cell and gene therapy and new modalities. And without surprise, oncology dominates the therapeutic areas of application accounting for a third of all indications. This rather early stage pipeline mainly in innovative modalities requires strong technology support to develop which is actually what the other 70+ life science innovative SMEs in the East of England are doing.
Innovation in drug discovery With only 10% of what is considered as the ‘druggable genome’ targeted by approved drugs and most of the current research, there is a big potential for disturbing the drug discovery game that East of England companies are clearly addressing. About a dozen companies are deploying their expertise in -omics, epigenetics disease biomarkers, exploring the ‘dark genome’ as well as scouting ‘cryptic’ druggable sites. And these claims are not only trendy technologies, they are exciting the curiosity of drug developers like Boehringer Ingelheim and Otsuka, to name a few with no R&D presence in the cluster, who are increasing their outreach to these companies, providing credibility and expertise to these local companies to keep fuelling an innovative drug pipeline.
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The power of data If there is one concept that cannot be foreign to a drug pipeline it is ‘Data’. Whether it’s for disease modelling, chemistry simulation, patient segmentation, there is a range of strong expertise in the East of England thanks to world renowned leading academic institutions like EBI as well as the deep knowledge of therapeutics development brought by a long history of pharmaceutical company presence. But with the rise of so called ‘biodata’ or ‘AI’ experts, comes the difficulty to discern the credible companies to the ones surfing the trends and here again regional stakeholders stand out by the quality of collaborations, capacity to attract investors – over £100M cumulative in the last 12 months – and a clear objective of developing wet lab research – BenevolentAI 5,000 sq. ft. on Babraham Campus. Making drugs But of course, all this innovation in disease understanding and new targets identification would not mean anything without the capacity to actually develop therapeutics. And here again the East of England is home to over 20 really innovative technology service companies covering an outstanding range of scientific expertise. It is with no surprise that half of them specialise in therapeutics antibody development. But what is making this ecosystem so strong is the span of company size, ranging from the smaller companies with a strong niche expertise like Metrion in ion channel, to the large international corporate like Charles River or Lonza with the ability to cover multi-disciplinary projects. These companies not only represent a necessary asset to support the regional drug pipeline but often overlooked benefits are also their great source of economic growth – by being mostly revenue driven companies – and talent development. These companies are home to over 1200 scientific employees who are exposed to the most innovative technologies in the context of drug discovery and development. Optimising processes Finally, often neglected contributors in the drug development game are the tools providers and here again the East of England has a tremendous innovative capacity translating in drug development process optimisation. Optimising process is not just about the cost, it is a crucial element of scientific data consistency essential to innovation. For example, in the region, the classic antibody or cell line producers become innovative powerhouses like Abcam or Horizon Discovery spreading their scientific expertise worldwide as well as attracting public market investment on the London Stock Exchange. But with the development of more complex modalities to understand for example, the rise of cell and gene therapy, scientific tools must be more sophisticated and this is where more recent companies like bit bio, Mogrify or Qkine come into the play contributing to the high level of innovation in the East of England pipeline. Taking a step further and looking at the converging discipline capacity, the East of England is also home to companies with high levels of engineering innovation in the field of automation of cell screening like Lightcast Discovery or organs on chip like CN Bio or Stemnovate with successful on going collaborations with drug developers that are other strong assets in the region drug pipeline development. Nurturing local sources of uniqueness If the East of England has a strong innovative value chain built around a rather early stage drug pipeline, it is also not short of great headlines about tangible patient benefits. Examples like Astex Pharmaceuticals getting another FDA approval for a cancer drug or Astrazeneca contributing to the development of a vaccine against SARS-CoV-2 show how our sector and the East of England in particular is delivering tangible society benefits. This review was not intending to overlook these but to highlight that these headlines may not be possible without the strong technology and innovation regional base that contributes to the regional attractiveness. An example is the level of investment so far in 2020 which is reaching a cumulative $100M in ‘technology support’ companies, an impressive figure for companies less cash demanding and with potential for revenue generation. Working through the East of England drug pipeline was a way to deliver an honest picture of the regional collective assets and question its potential weaknesses – is an early stage drug pipeline a cash burner? Or to convert into a strength, how it could be perceived as a very innovative and much more agile ecosystem being more attractive to talent, technology solutions and investors. Which in that sense could constitute these ‘local sources of uniqueness’ a certain Michael Porter mentioned as the key to cluster competitive advantage and therefore so important to know and nurture. 18 | One Nucleus Annual Review & Directory 2020/2021
Patient Perspective Parkinson’s Concierge is a revolutionary new concept to the healthcare sector. Run by, and for the benefit of people living with Parkinson’s. We are unique. We are different. Co-founders Russ Bradford, and Charlotte Allen, both of whom fall into the category of idiopathic young-onset (RB diagnosed at 40, and CA at 36yrs old), bring to the table their wealth of business acumen, as well as an understanding of what people living with this incurable condition use, need, and potentially may require, in their lives. Sourcing new business partners who can offer products and services to benefit, as well as enrich the lives of people living with the condition, is one of our business passions, but we also provide much more. We campaign for the community nationwide, and globally. Parkinson’s Concierge are also heavily involved in fundraising ideas and patient engagement. Listening to the issues faced by people with Parkinson’s, we take action as appropriate, for change. We actively participate in, and encourage the community to enlist and take part in research, appropriate to their ability and area. For people diagnosed in the earlier years – Young Onset – we fully understand the additional issues faced, such as the financial impact mortgage, employment, career, etc, as well as the stress the diagnosis can have on family relationships, young children, spouse, family and friends. Despite Parkinson’s being the fastest growing neurological condition globally, you are not alone. Approx. 164 people per day (60,000 per year) are diagnosed across the world, with an estimated 10 million currently living with the condition. It is however, worth noting that every case of Parkinson’s presents different symptoms at different times. Through our extensive network of specialists, Parkinson’s nurses, neurologists, movement disorder specialists, etc, as well as the personal experiences of the team, we are able to offer support and guidance through every stage of the condition. With practical tips and tricks that our team have personally found beneficial, and the products and services we can offer from a personal perspective. We offer blogging, webinars, and regularly uptake public speaking opportunities. We aim to offer a go-to place for every aspect of the condition, with presence on all social media channels, as well as signposting to sources of information and sites that are tried and tested for the benefit of the community. We actively collaborate with, and sit on the panels of numerous steering committees, and work on the issues that affect us all. We have produced educational video’s for Russ’s recent Deep Brain Surgery, and are currently working with manufacturers who offer alternative therapies. We are working on a platform of educational mini seminars for GP’s and healthcare workers, to CPD standards. Many people diagnosed with this condition at a younger age, tend to feel “robbed” of their future. Many have to give up their careers, due to the symptoms of not only the condition, but quite often, the many side-effects of the medication. We aim to provide a work finder solution for the ones who have the ability and desire to work at a pace that suits them.
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Our global roll-out of our business model is further testament to our dedication to support the community. This will also allow for the opportunity to offer tried and tested products and services from a much broader, wider market. Our supporting partners are numerous, and from an immense variety of offerings. In combination with our platform, we will assist to promote products with a route to market. We will soon be offering discounted rates on everyday essentials, as well as products and services for every aspect of the wellbeing of people living with Parkinson’s. From the latest tech – such as haptic feedback and monitoring devices, to virtual sleep retreats, and online fitness and yoga sessions. Our team are dedicated to helping support the community. Each have a special role to play within our network, and each bring an assortment of experience to the Parkinson’s Concierge team. Parkinson’s Concierge supports All people affected by Parkinson’s. “We will be seen and heard” as a voice for People with Parkinson’s. We educate and advocate. Our ambitious plans are numerous, but achievable. To date, we have achieved so much. But just like the condition we live with, we will not give up. Article by Russ Bradford, Parkinson’s Concierge
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Covid-19 Updates
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Reflections whilst within Covid-19 Disruption Covid-19 has changed what any one of us would consider normality. Social distancing, international travel bans and Open Innovation on a scale we could never have imagined as we have collectively sought to navigate through the disruption. There can be no doubt of the importance of testing, vaccines and treatments to the way out of this period. As rapidly as 23 March, the day the UK Government announced our version of lock down, the Quadram Institute announced how it was part of the £20M national programme to use whole genome sequencing to start to understand the spread of Covid-19. We saw UCL, UCLH and Mercedes AMG engaging as innovation at the highest level in engineering and medicine combined to address the shortage of ventilator capacity. Further down the East Coast we have seen how tenants such as Pfizer, A4PBio, Wren Therapeutics and others at Discovery Park have all been engaged in activities around novel anti-virals, assisting pharmacists during Covid-19 and enabling others to keep their non-Covid-19 related clinical trials progressing. By the 7 April we saw three of the region’s major players, AstraZeneca, GSK and University of Cambridge come together to support the creation of a new testing lab. We also saw great work from Cambridge Clinical Laboratories in coordinating the ‘smaller testing ships’ in the region in offering up support. This led to them joining with the national COVID-19 Volunteer Testing Network to provide support to the work of the PHE and NHS testing laboratories. Pulling these numerous smaller providers, some not diagnostics labs but with molecular expertise to offer, presented a key opportunity in building sustainable testing capacity. A wonderful example of how our region is enabled by champions willing to play their part. One of the strengths of the cluster here is the proximity of the different industrial sectors when it comes to needing inter-disciplinary solutions. There have been some excellent examples of collaborations across the divides. Avacta collaborating with Cytiva springs to mind as life science meets engineering with the aim of developing, validating and manufactureing their point-of-care test in double quick time. Even within their own field, we saw manufacturers respond to divert normal manufacturing lines into producing much required Personal Protective Equipment (PPE). Just north of our patch we saw a great example at BoxMart. Their normal business is to produce bespoke cardboard packaging for everything from personalised gifts to hampers. Answering the call for PPE, BoxMart transitioned to focus on making single-use, reinforced PPE face shields, even finding scope to develop rainbow patterned child friendly versions. An innovative and rapid change of direction when they knew our real heroes needed them. Availability of PPE became a serious matter as we are all aware. The University coordinated an extremely effective campaign seeking donation of PPE for NHS staff and there were many anecdotal mentions of our members donating PPE to the front line cause.
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And what of vaccines and treatments. It will be a huge and international R&D effort to discover, test, manufacture and distribute effective vaccines and therapeutics that is certain. Competition falls by the wayside when such a pandemic is upon us and collaboration at a global scale is what is required. We see AstraZeneca collaborating with Oxford University teams on developing a novel vaccine at scale for example. Further, through the US Government DARPA programme, AstraZeneca is collaborating with institutions from US and China to discover neutralising antibodies. The drive to develop new therapeutics and vaccines against Covid-19 is not only happening in our region or indeed the UK. Through our collaboration with GlobalData we have been able to get regular snapshots of the global product development pipelines both in terms of development stage and type of product as illustrated below from May 2020. Covid-19 Pipeline
Covid-19 Pipeline by Molecule Type
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Remdesivir already the front runner in development but a strong pipeline of >500 potential treatments sitting behind. Large molecules dominating the R&D pipeline is not unexpected. It is interesting to see the geographic breakdown of the developments. The UK is well represented with a significant share of the European pipeline. The critical mass of the US-based activity accounting for almost half of the pipeline overall.
The innovation, collaborations and talent available in the region was reportedly a major draw for AstraZeneca’s major relocation here and I am sure that engagement pipeline will play its full role in influencing how we emerge from Covid-19. The enforced and rapid on-set of the disruption has seen great leadership come to the fore. Whether directly involved in Covid-19 research or indeed remaining active in other therapy areas, the adaptability of the life science base at company and individual level has been remarkable in many quarters. There have been a variety of approaches taken as one would expect in a sector that has such diversity of businesses and business models in play. Changing shift patterns and segregating teams to enable lab research to continue was taken forward by some, others took a step back to ensure that had thought out their strategy and team dynamics before returning to drive their innovation forwards. Much has been learned and shared around how to engage and motivate remote working teams, how to communicate effectively and perhaps around individual health and wellbeing that may change everyday awareness and practices post Covid-19. Within the One Nucleus team we have adapted our operations and engagement activities to be able to support our members through the disruption. Learning as we go along from feedback and sharing lessons with our peer group organisations arranging virtual events, it has been remarkable to see the rising level of engagement in innovation webinars, Digital BioWednesdays and online training as examples. Planning for a digital ON Helix has been challenging and exciting in equal measures.
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Now we are able to increase the breadth of content, international engagement and legacy creation in a manner we would not have previously dreamed of for instance. A particular highlight for me was chairing a webinar discussing with members how they have adapted, what advice they would give and why some approaches have worked. Emma Sceats, CEO Isogenica and one of those conspicuous leaders I mention above, I feel summarised the key points well as follows: • Communicate regularly with all key stakeholders (partners, investors, employees) you’re in this together • Make your team integral to planning and COVID-related process development • Be honest about the level and type of support you can offer national/global COVID efforts and how becoming involved might impact your business in the shorter and longer term • Plan now for the post-pandemic business environment – it will be different and your business may need to adapt to survive and succeed Very sage advice and all of it applicable to any leaders whether Covid-19 disruption related or not in my view. It has also been brilliant to hear how our businesses feel that having to work remotely from their business partners has had limited impact due to them building strong and trusted relationships from the outset. A key aspect of any successful collaboration. Perhaps in an industry where partnering, collaboration and deals are the norm for moving science and business forward, then the well-honed alliance and relationship management skills always required have rendered our businesses more resilient to such disruption. Maybe it is the fact that dynamic, innovation-led companies in an industry such as life sciences also need to always be adapting to change that has also helped here. That said, I suspect it is also true that such leadership has always been present and this period has just seen them deploy those skills to the challenge in hand. It should not be forgotten that the ability to respond in such an impressive way, whether regionally, nationally or via international collaboration has been possible through prolonged investment, both public and private, to create such a world class ecosystem for research, innovation and enterprise. One can only hope that the legacy of Covid-19 includes a realisation that investing in excellence, encouraging free thinking, enabling entrepreneurs and incentivising private capital is key to delivering global health resilience and patient benefit. Moreover, the younger citizens amongst us have now been given an insight into what biomedical science means and what life changing impacts it can make, so perhaps in the future when asked “what do you want to be when you grow up?” some will answer that they want to be a scientist! Foreword by Tony Jones, One Nucleus
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How Will Covid-19 Influence Site Selection for Future Trials By Phil Barrington, Senior Partner, tranScrip and Karen O’Hanlon, VP Clinical Operations, Boyds The impact of COVID-19 on clinical trials has been a trending topic over the last few months and will continue to be a point of discussion as ongojng trials are disrupted and the initiation of new trials is delayed. On 2nd September, One Nucleus hosted a BioWednesday Webinar entitled ‘How Will COVID-19 Influence Site Selection for Future Trials?’. Key considerations discussed included the disruptions experienced in ongoing trials, and the potential plans for future trials, with a focus on building in resilience to the design and implementation of new trials. When considering the impact of COVID-19 on clinical trials, the following aspects must be considered; ongoing trials, opening a new trial, opening a new trial site in an existing trial, ongoing recruitment and continued involvement of participants in the trial, and the Risk-Benefit Assessment for the trial (particularly in trials where healthy subjects who do not derive clinical benefit). The evaluation of the potential impact of COVID-19 on a trial should take into account national recommendations, including travel restrictions and confinements of trial participants, the resource available at the sites to perform visits and data entry into the Case Report Form (CRF), the notification of serious adverse events and, more generally, ensuring the safety of trial participants. Phase 1 units have continued conducting studies throughout the COVID-19 pandemic, enabled by the use of rapid turn-around COVID-19 PCR testing, whereby subjects are only allowed into the facility for screening when they have had a negative test result. This testing requirement is used for all study visits to the study site. Site staff also have regular COVID-19 PCR tests to minimise any transmission to study participants. In phase 2 and 3 trials, we have seen positive changes to study designs, e.g. where a trial participant is unable to attend the site, other measures, such as home nursing, or contact via phone or telemedicine, may be utilised to dose patients, identify adverse events and ensure continuous medical care and oversight. In future, when writing protocols for these studies, flexible study visit schedules should be considered. A balance is needed to ensure that any flexibility built into the trial design maintains data integrity. Some trials are clearly affected more than others, with oncology trials becoming difficult when dosing and investigations such PET/MRI/CT scans and tumour biopsies are part of the study protocol rely on limited trial resource at the study sites. When attendance at the study site is mandatory for the patient, help with transport (e.g. offering taxis rather than public transport) could be considered. From a regulatory perspective, the EMA acknowledge that the COVID-19 situation is likely to result in larger numbers of protocol deviations. It is expected that the Sponsor will escalate and manage such deviations in accordance with their standard procedures. A proportionate approach will be taken by the regulatory authorities when such deviations are reviewed during inspections, to ensure in all cases that the best interests of the participant have been maintained, and that the participant has not been put at risk. Remote monitoring of study data is becoming more common but on-site data monitoring is still required for most trials. This pandemic has accelerated the shift from traditional ‘site based’ trials to ‘online’ home-based trials with e-consent/e-data collection, web meetings, telemedicine and wearable devices to record real-time data. In summary while a pragmatic approach should be adopted by Sponsors, investigators and study participants during this pandemic there are exciting advances in clinical trial technology that will benefit us into the future. 26 | One Nucleus Annual Review & Directory 2020/2021
Communicating Our Way Out of COVID The COVID-19 pandemic has thrown everything into flux. Communications and marketing have been no exception. With both staff and customers being largely remote, conferences and events disrupted, and a growing sense of product apathy among the public, companies have a serious communications hurdle to overcome. Many companies have seen this as an opportunity to update their websites and refocus their communications, both internal and external. As advertising and marketing budgets are down for almost everyone, organisations are turning to low cost ways to promote themselves, such as social media. However, the huge increase in LinkedIn users and oversaturation of posts has made it difficult to cut through the noise. People over products These issues have come with a consequent change in behaviour, and successful companies will take advantage of emerging trends: people are now actually reading their emails1. This, however, doesn’t mean they are necessarily following calls to action: therefore, in order to promote your business effectively, make it as simple as possible. A clear concise subject line that can be read in full before opening the email, and a big shiny call to action button, are paramount. In addition, people are responding less to corporate advertising, and more to real people. LinkedIn recently shared data on the kinds of posts its users were reacting to most positively, and the results unsurprisingly showed that those sharing authentic personal experiences had the most interactions.2 Internally, up to date information is more essential than ever. As lockdown rules and advice change almost daily, it’s important for employers to ensure the entire team is briefed on those changes and how they affect the organisation. Employers have an added responsibility they have arguably never had before: ensuring the social aspect of the office continues when everyone is so socially distant. This involves informal video chats, quiz nights, WhatsApp groups entirely dedicated to employee’s pet selfies; whatever the best way to engineer the organic conversations that usually happen over the office kettle boiling. Platforms A new area of focus is video conferencing, for both meetings and conferences. With the demise of Skype, many video platforms have emerged to fill the hole, including Microsoft Teams, Zoom and Google Meet. Events production platforms are using creative means of encouraging attendees to interact, with virtual exhibition spaces, meeting rooms and “mingling” spaces. Online platforms have also meant that many events that were previously confined to just one region or country are now accessible to international attendance, creating more opportunities. Taking the positives A positive and unintended consequence of video conferencing is that everyone’s voice is at the same volume, and the speaker’s face centres on the screen. This makes it easier for more softly spoken speakers, often women, to be heard and have their contributions acknowledged. Whether it is cats on keyboards or kids joining calls, we are seeing folk as people, not just professionals. Companies which have been able to cut through the noise are those which have recognised the power of people: focusing on wellbeing and equality, giving a voice to their employees, letting customers speak on their behalf. Predicting the future It’s hard to know what the future will bring, but it’s clear that life, comms and conferencing won’t return to “normal” anytime soon. Perhaps in 2021 we’ll see more ‘hybrid’ events mixing online and in-person conferencing, or outdoor events. However, it’s clear that communications must adapt to changing times. So far, those who have focused on people and purpose over products have been the most effective. Article by Agility Life Sciences 1 2
https://www.campaignmonitor.com/resources/guides/covid-19-email-benchmarks/ https://www.searchenginejournal.com/linkedin-suggests-4-types-of-posts-to-share-amid-covid-19-lockdowns/357378/#ok
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The Cambridge COVID19 Test Centre Steve Rees, VP Discovery Biology, AstraZeneca In March 2020 AstraZeneca, GlaxoSmithKline and the University of Cambridge came together to establish the Cambridge COVID19 Test Centre as part of the UK Government’s National Testing Strategy for COVID-19 infection. Over a six week period the centre was established in the University’s Anne McLaren Building on the Cambridge Biomedical Campus. Establishing the centre involved designing laboratories, purchasing new robots and borrowing laboratory equipment from the three partner organisations, designing a testing process, establishing a supply chain for all critical reagents, building an amenities centre for staff breaks, and recruiting and training over 160 volunteer staff to work in the centre. Volunteer staff included secondees from both pharmaceutical companies and over 100 University of Cambridge post-doctoral researchers who were unable to access University laboratories at that time because of the national lockdown. Creating the centre involved an unprecedented level of collaboration between the three organisations with problems being solved in days that would normally take weeks to months. This was achieved through the energy, commitment and innovation of the many volunteers involved. The Test Centre started to receive patient swab samples in May following validation of the laboratory process by NHS England and has since worked to test patient samples alongside the government Lighthouse Laboratories. The centre, equipped with state-of-the-art laboratory automation and innovative scientific processes tests many thousand samples each day for the presence of SARS-CoV2 viral genome. Samples are collected across the UK as part of the national testing strategy and delivered to the centre on a daily basis with results reported back to the individual through the NHS. The test involves taking a nasopharyngeal swab from the patient, extracting the viral RNA genome from the swab sample and using a highly sensitive and specific quantitative Reverse Transcriptase Polymerase Chain Reaction assay to detect copies of the viral genome in the swab sample. In addition to providing testing capacity the centre has focussed on improving the efficiency of the testing process having implemented automated sample handling to simplify the initial receipt of samples, a 384-well assay protocol that reduces the number of PCR machines by 75% and a miniaturised assay that reduces reagent costs by 50%, with further innovations in development. As the many volunteers returned to their original roles at the end of lockdown, the Cambridge-based contract research organisation Charles River Laboratories joined the collaboration to recruit up to 200 members of staff to enable the continued operation of the centre, a process which will complete in September. The creation of the Cambridge Test Centre has been a hugely exciting, challenging and rewarding project for all the scientists and laboratory support staff working within the centre as well as the many people involved in procurement, buildings management, Human Resources, Legal and many other functions required to create and operate the centre. This continues to be so as the centre delivers testing capacity while continually working to optimise and improve the testing process. Establishing this centre has only been possible through outstanding collaboration across the Cambridge ecosystem, drawing upon expertise from AstraZeneca and GlaxoSmithKline, Charles River Laboratpories, many academics within the University and experts at Addenbrookes Hospital. This partnership has demonstrated new ways of working that will continue long after the pandemic is over. 28 | One Nucleus Annual Review & Directory 2020/2021
Developing and Implementing a Travel Policy Post Covid-19 Given the increased risk of exposure inherent in travelling, employers may want to implement a temporary travel policy related to COVID-19 which does not replace the standard overarching policy, but rather supplements it. The below guidelines are intended to assist travel managers in developing and implementing such a policy. Planning Prior to booking, you must consider the regulatory status of not only the origin country but also the destination, including any transits. Essential considerations will be around border restrictions, travel insurance, PCR tests for travellers, quarantining and social distancing rules. If the borders allow travel, we strongly recommend an assessment of the traveller’s willingness to make the trip and if there are any health risk for them or the people they come into regular contact with at home or in the office. Make it clear what the COVID-19 symptoms are and strictly prohibit travel if they are displaying any of them. It is advisable at this point to run a risk assessment relating to the rate of COVID-19 infection in the destination(s) and set policy on each country. If the risk is high, i.e. over 20 cases per 100k, you may block the trip; if it is intermediate (10-19 cases), you could set limitations. Some of these could relate to length of stay, number of travellers and mode of transport for instance. Clearly trips should also only be authorised if the investment in time, resources and money can be justified. Therefore, it is recommended to include the trip purpose in any pre-authorisation phase. Ideally requiring sign off from risk, departmental and human resource departments. Booking Given the dynamic threat of COVID-19, we strongly recommend mandating bookings through a single preferred vendor, referred to as a travel management company (TMC). An audit of your TMC’s services is recommended. During the Trip Your company travel policy should stipulate the employee’s ‘Duty of Loyalty’ to the guidance provided; i.e. use of PPE, social distancing and preferred suppliers. Advise against unnecessary detours; i.e. sight-seeing and a preference to use vetted taxi or vehicle hire services for ground transportation as opposed to public transport. The traveller should be made aware of procedures in case of emergency. Return On return from the trip, the traveller should be advised to shower, sanitise equipment and clean all clothes which were taken on the trip. The policy should stipulate what do if the traveller suffers any COVID-19 related symptoms, advising to book a test and quarantine. It is recommended to also encourage travellers to complete a feedback form on not only the vendors they used but also any recommendations they feel other travellers may find helpful. Based on recent McKinsey research, we believe business travel recovery will vary by proximity to the destination, reason for the trip, and industry sector. Destination Domestic trips will likely see a return before international travel. International travel will take longer to rebound because of the complexity of government regulations, mandatory quarantines, and the high risk of fastchanging policies. Reason for Travel Other than critical supply-chain-related projects, travel for sales and client-related meetings is most likely to be among the first to return. Travel for internal meetings, incentives, events, and other off-site gatherings may not return until well into 2021 or later. And some travel for internal purposes might be permanently replaced by virtual meetings and collaboration. Industry Sector While the COVID-19 pandemic affected all industries, some (such as energy and retail) were hit harder and may face more budget Article by Gray Dawes Consultancy
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Accessing Capital in a Post Covid-19 World More than six months into a global pandemic which has had an unprecedented impact across life and business, we are beginning to see the effect on the healthcare industry and to make sense of the repercussions for investment in the sector. As we enter a second wave of staggered lockdowns around the world, companies need to continue to evolve and learn to perfect the art of digital engagement. Investors believe this is an exciting time for the sector and are positive about the opportunities. They are looking at a wide range of therapeutic areas to invest in, not just coronavirus-related therapies and vaccines, as well as health technology, medtech and services. This has been demonstrated in the past few months, with European biotechs raising $9.98 billion in the first nine months of the year, versus last year’s total of $7.74 billion[1]. Standing out in the ‘New Normal’ The healthcare sector is in the spotlight as never before, investment and funding is available, seemingly at unparalleled levels. Generalist investors have become increasingly engaged with healthcare and VCs have substantial funds to deploy, are actively looking to invest, and are prepared to increase time spent on new investments. Especially in Europe, where there is more money available for investment in healthcare companies than ever before, with new investments in companies and VCs raising new funds. To successfully ride this wave, European companies need to communicate a strong and compelling investment story. Technology has and continues to rise to the challenges, and it is crucial that companies adapt to the new ‘virtual reality’ to create buzz and excitement around their story and ensure they are on the investment community’s radar. A handful of priorities stick out as particularly important: • It is crucial for companies to continue to take care of employees and set the right balance between developing their pipelines and getting products and services to customers. Communal responsibility is increasingly valued. Having the right ethos and principles is important, and it is essential to have these aligned. • Since investors state that the quality, track-record and strength of management teams is critical to their investment, now is the time for company managements to self-assess strengths and weaknesses, to be more proactive in their communications and promotion, and to have up-to-date credentials. • Companies should be thinking about scenario planning for the next 12-18 months, which look likely to remain at least partially disrupted. They need to continue to revisit strategic plans and clinical development. Will they enable you to get to data points that are value drivers with current funding? • It is important to be on the radar of potential pharma partners. Companies should actively look to strengthen existing collaborations and seek new ones, and earlier than before. This could positively impact cashflow. • Changes across the whole manufacturing and supply chain are happening - so be prepared, be adaptable, communicate to find out which end-user needs are changing and where. • Strengthen the balance sheet through accessing finance from exiting investors, opening rounds to new investors or doing deals earlier. Supriya Mathur, Director at the leading international strategic healthcare communications consultancy, Optimum Strategic Communications (Optimum) said: “The pandemic has underscored the importance of science and innovation. Investors have been quick to respond and are investing across the healthcare spectrum in new modalities. Clear and open communication is key to attracting this investment. Companies need to know and understand their investors and must harness the shift to ‘virtual’ to engage their target audiences as early as possible.”
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Abcam Abcam is a global life sciences company that identifies, develops and distributes highquality biological reagents, proteomic and cellular tools. Serving the healthcare and life science sector, Abcam provides products and services that enable research and drug discovery for in vitro diagnostic and therapeutic applications. Abcam has been at the forefront of the commercial antibody industry for over two decades. Their antibody development approach ensures high performance, batch-to-batch reproducibility from lab scale to full-scale manufacturing, for individual binders as well as complex multiplex assay configurations. The contribution of expert biological reagent developers to the global life science community has been highlighted by the coronavirus pandemic. Abcam has been playing its part by continuing to support the on-going research and development efforts to understand and defeat SARS-CoV-2 and its related conditions. As of May 2020, the organisation’s activities spanned collaborations in the UK, US, and China focusing on recombinant antigen expression, antibody discovery and development, bioinformatics, un-biased assay cascade development, screening, and clinical assay development. Moving at speed in any area of research can’t be at the cost of scientific rigour. The need to ensure data integrity and experimental reproducibility is a key objective for the life science community. Abcam is committed to leading the sector in its efforts to combat the global “reproducibility crisis” related to reagents such as lack of antibody specificity. A central element of the programme has been the routine use of knockout (KO) validation, using gene-edited KO cell lines that provide “true” negative controls. With over 2,500 KO validated recombinant antibodies to-date, the initiative was recognised with a 2020 CiteAb award for KO validation. More recently, Abcam has been focused on expanding the depth and breadth of its offering, with targeted partnerships and strategic acquisitions enhancing the organisation’s capabilities and associated capacity. A key focus of the expansion strategy has been extension of antibody conjugation and labelling capabilities to address industry demand for conjugation-ready solutions. In the last six-months this has included: • Acquisition of Expedeon’s proteomics technology and portfolio providing key labelling platforms for enzymes, metals, oligos, and fluorescent proteins • Partnership with BrickBio developing proprietary quantitative conjugation technology that have application for both quantitative labelling and production of complex antibody constructs suitable for use in development of antibody-drugconjugates • Acquisition of Marker Gene Technologies, delivering additional assay development capacity and labelling capabilities based on biology, organic synthesis and fluorescence chemistry expertise www.onenucleus.com | 31
• Acquisition of Applied StemCell cell-engineering team to facilitate ready access to CRISPR-edited cell lines Combined with its existing antibody and protein-based offerings, these capabilities are expanding Abcam’s portfolio, and creating new value-added products to support diagnostic and therapeutic development. Understanding biology and deploying that knowledge to create the diagnostics and medicines of tomorrow is an exciting field in which to work. A field where collaboration and partnerships are playing an ever-increasing role in achieving successful outcomes at speed. To date, Abcam has delivered custom-engineered antibodies using proprietary RabMAb® technology for over 3000 collaborative projects. Abcam remains committed to its role of supporting ground-breaking research around the world.
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Consistency in Innovation: How Companies From Across the Bruntwood Scitech Network Are Supporting the Fight Against Covid-19 Phil Kemp, CEO, Bruntwood SciTech The COVID-19 crisis has already had a global impact, in particular the way businesses operate. The world is rapidly attempting to find solutions to the myriad of challenges caused by the COVID-19 crisis, and nowhere else is this more true than across the Bruntwood SciTech network. Life science and tech businesses across Manchester, Cheshire, Birmingham and Leeds are shifting and refocusing their priorities in order to help the national effort in the fight against the pandemic. Firstly, Alderley Park-based Medicines Discovery Catapult (MDC) were approached by the UK government to coordinate the establishment of the national megalabs for testing COVID-19. Within 3 weeks, the Medicines Discovery Catapult had established one of three national ‘Lighthouse Lab’ testing centres which together have created the biggest network of diagnostic testing facilities in British history. Now the laboratory is home to over 80 scientists and volunteers working around the clock to test samples and enable thousands of NHS and key workers to return to the frontline. At Citylabs, part of the UK’s largest NHS Trust - Manchester University NHS Foundation Trust campus, businesses have been using their world-class facilities to manufacture COVID-19 tests. International molecular diagnostics company, Yourgene Health signed a contract with Novacyt - a specialist in clinical diagnostics, to support the production of tests, as well as expanding its lab capabilities to support the surrounding NHS Trust hospitals. Collaborations have also really come to the fore over the last few weeks; at Alderley Park Stream Bio are collaborating with MIP Diagnostics on a rapid diagnostic and mass screening test for COVID-19, whilst at Manchester Science Park, global molecular diagnostics company QIAGEN, in partnership with fellow campus member Affinity Biomarker Solutions and the University of Manchester have been supporting patient testing on high-throughput automation platforms; allowing labs to perform many and continuous PCR-based tests while continuing to research and create new commercial tests for patients who need them urgently. The ‘research’ phase of the government’s action plan aims to better understand the virus, Alderley Park-based Peak Proteins is supporting the race for treatments, working closely with Medicines Discovery Catapult and Retrogenix as they collaborate to identify target receptors for COVID-19, further driving the understanding of the virus. But it’s not just life science companies that have been contributing to the fight against the pandemic. Many digital and tech businesses from across the network have been adapting their online platforms and tech for good.
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With Public Health England and the Department of Education closing many schools, colleges and universities, for the majority homeschooling has now become the norm and it’s been the edtech sector’s time to shine. Northcoders, who are based at both Circle Square and Platform in Leeds, have launched a new eight-week full-time and fully remote course to teach people how to code from home. Dicey Tech have been supporting the NHS in their call for more PPE, using their 3D printing facilities to create vital face shields for NHS workers; as have Innovation Birmingham-based Barclays Eagle labs and Energym using their machines around the clock. At Alderley Park, CRUK and Blueberry Therapeutics have also been producing much needed PPE. What’s more, our Citylabs team have been helping the MFT Charity to store, package and deliver care packages for frontline NHS workers, with over £500,000 worth of goods being donated to the cause from UK businesses keen to help. At Bruntwood SciTech, we’re proud to enable and facilitate collaboration; supporting some of the UK’s most innovative minds who are adapting and coming up with new ideas everyday to support the fight against COVID-19. From testing to tech, one thing is consistent during these ever changing times: innovation continues.
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Biocair Responds During COVID-19 Despite the challenging situation, Biocair, a specialist in life sciences logistics, is fully committed to delivering continuity of service within the global supply chain and ensuring safety to its clients, patients and employees. The vital work we support does not stop in times of crisis. Clinical trials, organ transportation, the very attempts to produce a vaccine for COVID-19 are all underpinned by a global logistics system that moves live materials safely and swiftly. And of course, the continued production of life-saving pharmaceuticals and treatments depends on the movement of active ingredients from around the world. Whether you are moving urgent Personal Protective Equipment, COVID-19 test kits or blood samples, we understand the importance of meeting all necessary regulatory, customs, time and temperature requirements. We are designing and implementing new solutions 24/7 to ensure our customers’ critical shipments are transported both safely and effectively, despite the extremely challenging situation. Speaking about the role Biocair plays in the life sciences supply chain, Gary Parker, Business Development Manager, comments that “since the global outbreak of COVID-19, many airlines have suspended their operations leading to restrictions on passenger flights. During these challenging times Biocair has remained fully committed to service provision and has implemented swift service updates, including using alternative carriers, chartering flights and using different routes and entry points.” Recent custom solutions include: • • • •
Temperature-controlled COVID-19 plasmids from the US to South Africa Medical devices from China to several destinations across Europe 200,000 urgent N95 face masks from China to a leading medical hospital in New York Air charter of temperature-controlled, dangerous goods
Biocair is proud to play a vital role in the global supply chain and, as we know that transport networks are being disrupted, we aim to provide the best service we can, including - as always - giving you a dedicated Biocair contact who will oversee your transportation from beginning to end. Biocair’s specialist services include GDP and GMP-compliant transport of critical shipments, monitoring and tracking capabilities, temperature-controlled packaging and the ability to complete international import/export documentation wherever possible. For more information visit www.biocair.com.
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Biocair recently managed the urgent transportation of 14, 000 face masks from China to front line workers in Albania
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BoxMart BoxMart, an award winning Staffordshire based packaging company, has, in response to COVID-19, turned its hand to PPE. Working closely with its supply chain, which brings together materials specialists, constructional design and manufacturing capabilities, the packaging company has brought to market single use face shields in just a few days. BoxMart usually specialises in UK-made, recyclable packaging solutions for a range of industries, from healthcare and pharmaceuticals, to food, beverages, cosmetics and gifts. Having a wide range of clients across different sectors, all with different markets and specifications, means they’re well-rehearsed at cross-pollinating ideas from different industries and thinking innovatively about materials, constructional design and packaging solutions. Their creative approach has meant BoxMart packaging projects have regularly won coveted awards, such as the international Worldstar awards from the World Packaging Organisation, numerous UK Packaging Awards, and a clutch of Starpack awards, which are promoted by the IOM3. Taking this innovative approach a step further, and responding to reports of PPE shortages and specific material shortages and uncertain supply chains, the shields make use an innovative material supplied by sister company Swanline Paper and Board called Cygnus Eco Board ™ - a fibre-based material which displays excellent moisture resistance properties while being completely recyclable. An excellent alternative to plastic and plastic coated materials, the board is often used for outdoor displays, point of sale units and other water resistant applications. For the face shields, the material acts as a strengthening frame enabling use of different grades of plastic window as the market allows, and its printable surface has allowed for a paediatric friendly rainbow design and company branding. They are quick to manufacture here in the UK, and bring with them the ability to scale up to thousands of units per day. The disposable shields retail at just £0.77p per unit in packs of 250, and are being made available to NHS clients, care homes, laboratories, retailers and other frontline workers. Thanks to the company’s long established expertise in Point of Sale units, the face shields are being offered alongside free standing and counter and desk top workspace and customer cough screens and partitions. Together these deliver a range of products which will help many businesses get back to work when appropriate to do so. The shields and partitions aren’t the only COVID-19 related project the company has helped with in recent weeks. In March they turned around several orders for custom made cartonboard boxes in just a few days to enable client Clinical Health Technologies to get their antiviral product to market quickly. BoxMart’s off-the-shelf packaging service, which carries a wide range of boxes and delivery packaging in stock with immediate despatch, has also been invaluable to companies delivering food parcels and isolation hampers to customers and the vulnerable, as well as gifts for NHS workers and other charitable projects. www.onenucleus.com | 37
To find out more about BoxMart - their face shields, workspace partitions or packaging service - visit www.boxmart.co.uk or call the team on 01543 480163.
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The Covid-19 Volunteer Testing Network The Covid-19 Volunteer Testing Network is a voluntary organisation I helped to set up with the purpose of helping private labs use their facilities to test health and care workers for the virus. Testing is done regularly and at no cost to the workers, who can be tested regardless of whether they are displaying symptoms. This is vital to keep crucial workers safe, and to protect vulnerable members of the public from infection. When the coronavirus pandemic got to Britain, a number of symptomatic doctors from local GP surgeries approached my private research company, Systems Biology Laboratory, to ask whether we could test them for Covid-19. We said yes, and tested those who asked us to. We have since extended the service to cover 18 GP practices, now testing frontline workers twice a week if they are asymptomatic, or typically within half a day if they start showing symptoms. Generally we can return results within the same day. We realised that if one lab could test all these practices, then many thousands of healthcare workers could be screened regularly if this testing was expanded across the country. Our model can be scaled up. This is why I have personally donated £1m to help labs meet the costs of converting to Covid-19 testing. The network has grown quickly since its launch at the end of March. We now have six labs regularly testing health and care workers, with over 25 currently in the pipeline and expected to start testing in May and June. These range from large university or private commercial labs to smaller research labs. Although it is often very straightforward for labs to join the network, since they tend to already have the necessary RT PCR equipment, getting hold of consumables like swabs, RNA extraction kits and reagents can be difficult. Demand for these products is increasing across the world, and supply has not yet caught up. The network also helps to procure these items on labs’ behalf. Though consumables can be difficult to get hold of, we are not competing with the UK government for supply. Instead, we can provide an element of diversity in approaches to procurement. We look far and wide at a range of suppliers all over the world, and we have the agility to adapt to different sources. Our work has already had excellent results. For example, the Pangbourne GP surgery near Reading would have had to close down without the help of one of our labs, leaving 13,000 patients without its vital medical care. The practice suffered an outbreak of the virus amongst its staff, and it was only thanks to SBL’s testing that was able to stay open. The lab tested 21 of its staff over two days, delivering results within four hours. This helped confirm and monitor the spread of the virus - most of the staff did have the virus, and this information helped the surgery to manage its team more efficiently. This helped to protect other staff members and patients. The network’s labs have also protected people in the care sector. For example, Davis French & Associates tested the staff of a community care provider who suspected they may have been transmitting the virus across their clients. Eight of the 20 swabs they took came back positive. This was especially valuable since none of them were at that point symptomatic, yet were still at risk of shedding the virus. This testing helped the care provider to isolate staff who were infected, and more safely manage the continued care they could give to vulnerable people in the community. The Covid-19 Volunteer Testing Network has already proved a very effective way to help expand private labs’ testing capacity, which has contributed to keeping many healthcare staff and patients healthy and safe. It is set to continue this valuable work in the future. Interested labs and healthcare staff should visit www.covid19-testing.org. www.onenucleus.com | 39
The Domainex response to Covid-19: 4 Days On, 4 Days Off On the very same day (23rd March 2020) that the UK Prime Minister announced the lockdown in response to the growing threat posed by the Covid-19 pandemic, Domainex began its ‘4 Days On, 4 Days Off’ working arrangement across 7 days/week to maximise social distancing on site (by having over 50% fewer staff present) and thus protect the wellbeing of our staff while also allowing us to continue to serve our clients. This article describes the steps we took to reach this decision and our experiences since then. Domainex is a profitable, mid-size drug discovery contract research organisation based just outside Cambridge, UK. In 2019 we catered to over 40 organisations, with 55% of our revenues coming from the UK and 45% from overseas clients in Australia, Europe and the United States. We help our clients to invent new therapeutic drug candidates to treat a variety of human diseases. The majority of our staff are laboratory-based chemists and biologists. As the response of the UK authorities to the Covid-19 pandemic evolved during February/March we held a series of leadership team meetings at Domainex to consider our response. Of paramount importance in our thinking was the health and wellbeing of our staff and their families. The view that we formed to the guidance issued by the UK government that travelling to and from work would be allowed where work could not be done from home as was the case for our laboratory scientists but that we would need to put various safeguards in place to protect them. The timetable to the decisions we took and the announcements we made to our staff is summarised in Table 1. We managed to stay a step or two ahead of the UK government’s guidance as it was emerging. Looking retrospectively back, it is apparent that our policies evolved rapidly in the space of just 19 calendar days. Date 4th March 5th March 13th March 17th March
Guidelines issued to staff Washing hands, hygiene posters displayed; request to notify company of any contact to persons from affected areas; new guidelines issued for visitors. Anybody displaying any cold/respiratory infection symptoms asked to stay at home for few days and self-monitor. Staff asked to self-isolate for 7 days if they develop a fever or a persistent cough, only calling NHS 111 if symptoms still present. Shift working pattern announced: •
Non-laboratory staff asked to work from home
•
Labs to stay open for 7 days/week
•
Lab-based staff to be split equally into 2 teams
•
Each to work for 4 consecutive, extended days and then have 4 days at home
•
Staff with carer responsibility given option to take holiday or unpaid leave if required
•
Senior management to be present on site each day
•
Extra cleaning, e.g. of door handles
•
Laboratory technician to work across the 2 teams but extra safeguards put in place
•
No more visitors (other than essential maintenance)
•
No more face-to-face business meetings
•
Numbers allowed in meeting rooms limited
40 | One Nucleus Annual Review & Directory 2020/2021
19th March
20th March
Composition of 2 Teams finalised with new office seating so that no staff would have to sit directly next to or opposite anybody on their shift. New working arrangements communicated to our clients. Updated guidelines issued: •
Laboratory opening hours extended (6.30am to 7pm)
•
Fire wardens and first aiders present on each Team
•
Mix of lab work (80-90% of time) on 4 ‘on’ days and home working (10-20% of time) on 4 ‘off’ days (e.g. lab book writing up) finalised
•
23rd March
Holiday allowance converted to hours and bank holidays to become normal working days (except for the Easter weekend) to allow for uninterrupted work 4 Day On, 4 Day off working pattern starts with Team A on-site.
27th March
Team B begins its first shift after Team A had finished its last ‘on’ day 12 hours earlier.
Table 1. Timetable of key events leading up to Domainex implementing its ‘4 Days On, 4 Days Off’ working pattern Given that we have now completed 8 weeks in this new working pattern what have been our experiences? After some early misgivings, everyone at Domainex has adapted well to the new working pattern. Most importantly, all of our staff have stayed free of the apparent symptoms of Covid-19. Inevitably with over 50% fewer people on site on any one day it’s been a much quieter place to work at and given our scientists greater access to instruments. Switching to an 8-day rolling week has meant laboratory staff have worked over the weekends on occasions– in all 8 out of 28 ‘on’ days (or 28.5%) for each 7 week cycle. The upside though has meant that they’ve been able to enjoy 4 ‘off’ days every week (other than for spending half to one whole day working remotely from home), sometimes for 4 weekdays, potentially covering childcare/home education while their partners work. Our clients have responded very positively, grateful we’ve been able to keep their projects on track. Given the wonders of modern technology we have all become even more familiar with using Teams to videoconference with clients who often have been calling in from their homes. Above all else, the response of our staff has been nothing short of phenomenal. While millions have either been furloughed or made unemployed, through their willingness to embrace change, we have been able to preserve their wellbeing and livelihoods. While it has become our ‘new normal’ it’s been a strange time too in many ways - such as collecting a working colleague off a train on the weekend from a completely deserted local railway station. What for the future? Well as I write this piece none of us know how long we will be required to continue with this working pattern to maintain social distancing. We do not expect social distancing rules to be lifted any time soon. We are looking forward to the day when we can all be reunited. As to when things do eventually return to normality, it will be interesting to see whether our working practices revert back to the way they were or if the Mon-Fri working week evolves into new ways of working. Our current way of working has effectively doubled our capacity, giving us greater operational leverage and the opportunity to take on more work and employ more scientists which bodes well for our future. By Tom Mander, CEO
www.onenucleus.com | 41
OpenCell Modular Testing Laboratories in Shipping Containers Testing is a key resource in this crisis period and strategies to optimise access to testing are essential. Automated platforms are an important way to reduce pressure on healthcare systems ensuring individuals infected undertake appropriate isolation procedures. In synergy with central tests which are rightly prioritised for patients and key workers, we propose a solution that serves local businesses and communities directly. Shortage in reagents supply and not laboratories is the perceived bottleneck to effective volume of tests. Nonetheless, hidden costs come from sampling, packaging and shipping, identification of appropriate spaces, definition of tailored samples workflows, accreditation of the single sites, disruption when tests depend on kit-based methods. This, particularly at the level of local communities and networks of businesses and across multiple sites.
OpenCell has developed BSL2+ testing laboratories in 300sqft shipping container. A purpose-built proof of principle modular lab has a current capability of 500 tests every 5h, over 2000 RT-PCR tests in 24h. We use OpenTrons liquid handling robots for RNA extraction and adapt to several RT-PCR reagents, to avoid supply shortages. Each sample is logged with a unique identifier. Clinical samples have been tested in collaboration with King’s. This is a unique opportunity to establish a mid-term solution to the problems of scale faced by local communities and businesses. The containers can be (1) deployed and relocated reaching effectively different locations directly, (2) retrofitted with combined solutions on as improved testing becomes available, (3) optimise significantly the resources needed compared to any alternative option available based on packaging and shipping. OpenCell has several years of experience in handling containers and turning them into laboratory spaces and is hosting 70 converted labs for tenants in their Shepperd’s Bush site in London. The StemCellHotel at King’s College London led by Davide Danovi has been actively supporting this project bridging across sectors, bringing access to samples, advise on analytics, and engaging in seeking funding to scale. Solutions can be discussed for a costing model per test when outsourced entirely including infrastructure/reagents/operators and depending on the number of tests needed and the length in time they are needed for. Equally, single containers can be engineered to fit existing accredited tests. More information are available at www.opencell.bio or please contact info@opencell.bio or davide.danovi@kcl.ac.uk. 42 | One Nucleus Annual Review & Directory 2020/2021
PrecisionLife – AI Enabled Precision Medicine Patient Focused Innovation Started in 2015, PrecisionLife has a base near Oxford as well as offices in Cambridge, MA, Copenhagen and Warsaw. Our mission is to find better therapeutic options for patients with unmet medical needs. We are committed to working both with drug discovery teams to find and validate novel approaches to disease as well as with healthcare providers to identify the best treatments for patients, personalized to provide the most effective, safe and affordable therapies. New Analytical Tools for Better Patient Stratification Complex disorders like dementia, COPD, cardiovascular or metabolic disease don’t have simple, single gene explanations, so why should we expect analysis tools that find single SNP associations to give us a full picture of the drivers of disease in a population? Complex diseases are driven by networks of interconnected causative factors and metabolic processes. Patients’ disease risks and responses to therapy vary enormously due to combinations of their mutations, predisposing phenotypic features, co-morbidities and environmental influences. The key to understanding these diseases at a deeper level and finding better therapies is to identify combinations of these factors (disease signatures) that distinguish one patient sub-group from another. Using a powerful new mathematical framework, we have developed a unique analytical platform that looks deeper at patient populations and reveals the factors driving complex diseases at unprecedented resolution. We find combinations of genomic, clinical and epidemiological features that help us to understand why some patient sub-groups have higher disease risks, different progression rates and outcomes, and different responses to specific drugs. The PrecisionLife Approach These unique insights are used in new drug discovery and repurposing approaches, especially to address unmet medical need, finding innovative new targets and candidates for patients who do not benefit from existing drugs. New targets and lead candidates undergo stringent validation and are fully annotated to provide a complete in-silico data package. Selected targets/leads may then be validated biologically in patient derived and other assay/model systems. The same disease signatures are also used to provide highly predictive patient stratification biomarkers that help select the right responder cohort for clinical trials, and within our clinical decision support framework to help clinicians to choose the most effective medicines for specific patients. We have analyzed large scale patient populations in multiple neuropsychiatric, neurodegenerative, respiratory, inflammatory and metabolic diseases. We’ve published case studies identifying new patient sub-groups and therapeutic approaches in diseases such as ALS, asthma, schizophrenia and Sjögren’s syndrome. Most recently, we identified www.onenucleus.com | 43
a series of risk factor genes shared between sepsis and severe COVID-19 patients, both diseases where traditional genome analysis tools have so far failed to identify the main disease causes. We disclosed 70 new disease associated genes and 59 potential drug repurposing candidates to aid in the identification of the most at-risk COVID-19 patients and the trials of new treatments for late-stage severe disease1. PrecisionLife’s analytical platform is efficient and highly scalable and has generated a pipeline of highly innovative disease programmes, whose development we are supporting in collaborations with multiple commercial and academic partners. Our DiseaseBank™ database contains deep insights into the factors driving these complex diseases, revealing the detailed architecture of patient sub-groups and the potential treatment options relevant to them. We work with a wide range of biopharma, disease charity and healthcare organizations to: • Identify innovative early stage drug discovery/repurposing opportunities • Select patient stratification biomarkers for clinical trials design and recruitment • Build personalized combinatorial risk scoring tools • Develop personalized therapy selection / clinical decision support tools • Find better options to treat patients’ unmet medical needs 1
Pre-print available at https://www.medrxiv.org/content/10.1101/2020.05.05.20091918v1
Detailed view of the communities (sub-groups of patients and the SNPs driving their form of the disease) identified by precisionlife in a population of patients with schizophrenia, which is a very highly heterogenous disease.
44 | One Nucleus Annual Review & Directory 2020/2021
Member Directory
www.onenucleus.com | 45
Research & Development Abingworth LLP
Epsilogen Ltd
Actigen Limited
Freeline Therapeutics Limited
Adrestia Therapeutics Ltd
Grünenthal GmbH
Agenus UK Limited
Healx
Alloy Therapeutics UK Ltd
Higher Steaks Ltd
AMR Centre
Immodulon Therapeutics
Antikor Biopharma
Immune Regulation Limited
Apollo Therapeutics LLP
ImmuPharma
Artios Pharma Limited
Inivata Limited
Astex Pharmaceuticals Ltd
iosBio Ltd
AstraZeneca
Kymab Limited
Autolus Limited
LEX Diagnostics Limited
Babraham Institute Enterprise Limited
LifeArc
Beauchamp Tecnology
Macomics Limited
BenevolentAI
Merck KGaA
BicycleTx Limited
Mestag Therapeutics Limited
Biosceptre UK Limited
Microbiotica
Boehringer Ingelheim
Mission Therapeutics Limited
Cambridge Enterprise Limited
MSD
Cambridge Innovation Capital
Nanna Therapeutics Ltd
Cambridge Rare Disease Network
National Physical Laboratory
CamPhos Therapeutics
Nationwide Laboratories
Cancer Research UK
o2h Ltd
Cancer Research UK-AstraZeneca Antibody
Origin Sciences Limited
Alliance Laboratory
Perfexia Health Technologies Ltd
Capella Bioscience Limited
Phico Therapeutics Ltd
Cerevance Ltd
PhoreMost Ltd
Closed Loop Medicine Limited
PolyProx Therapeutics Ltd
CN Bio Innovations
Public Health England
Daiichi Sankyo Co Ltd
Precision Life
Diosynvax Ltd
Quadram Institute Bioscience
Dr. Reddy’s Laboratories (EU) Ltd
Queen Mary BioEnterprises Ltd
Eli Lilly
Queen Mary Innovation Ltd
EMBL-EBI
Queen Mary University of London
Empyrean Therapeutics Ltd
- (Business Development)
Epidarex Capital
Richmond Research Institute
46 | One Nucleus Annual Review & Directory 2020/2021
start something amazing We're now accepting applications for our second cohort of companies commencing August 2020 We drive the success of truly disruptive healthcare and life science start-ups How we help: ÂŁ250K seed investment Unique access to the Cambridge Cluster State-of-the-art lab and office facilities at the Milner Therapeutics Institute Expert mentors across financing, fundraising, marketing, business development, IP, commercialisation and many more
Early stage start-up companies in the life sciences and healthcare space are invited to apply via the website www.startcodon.co/application-formÂ
www.startcodon.co
@StartCodon
@Start Codon www.onenucleus.com | 47
Research & Development Roche Royal Veterinary College
TranSINE Therapeutics
Scale DX Ltd
Trio Medicines Ltd
Sense Biodetection Ltd
University College London
Shionogi Europe
University College London - SysMIC
Simcere
University of Cambridge
Start Codon Ltd
University of East Anglia
STORM Therapeutics Ltd
University of Essex - Research and Enterprise Office
Talisman Therapeutics Ltd
University of Leicester- Enterprise & Business
The Botanical Extract Company Limited
Development Office
The Brain Tumour Charity
University of Nottingham - Corporate Partnerships
The Institute of Cancer Research
Vernalis Ltd Wellcome Sanger Institute Wren Therapeutics Limited
Your employees are your most valuable asset, and training is an investment in the future of your business. Register your employees for a One Nucleus Training Course today. 48 | One Nucleus Annual Review & Directory 2020/2021
Research & Development Space Arise Innovation Centres
Lab Fit
Babraham Bioscience Technologies Ltd
Labstract Ltd
BioMed Realty
London BioScience Innovation Centre
Bridge Partners Ltd
NBBJ
Cambridge Relocations
Newcastle BioSphere
CAM-SCI
Norwich Research Park
CBRE Limited - Healthcare Division
Quality Care Cleaning Limited
Chesterford Research Park
Restore Harrow Green
Creative Places LLP
Sahlgrenska Science Park
Deliver Plus Limited
SmithsonHill
Discovery Park Limited
St John’s Innovation Centre Ltd
Harts Business Solutions
Stevenage Bioscience Catalyst
Imperial College London ThinkSpace
Tuspark Cambridge
Kao Data
UKSPA Wellcome Genome Campus
www.onenucleus.com | 49
Start-up mindset, scale-up capability One of the UK’s leading campus’ to support early-stage bioscience enterprise. Situated on a 430-acre parkland estate near Cambridge, world class research and business come together to promote innovation and strengthen links between academia and the commercial world.
www.babraham.com
Research & Development Services Supporting the Biotech Journey - An Evolving Biotech Landscape Scientific breakthroughs are occurring at unprecedented speed, creating exciting opportunities and associated challenges for the biotech industry. The most universal challenges identified by our small and emerging biotech customers are those that limit speed and effectiveness. They tend to be aligned around “moment of truth” milestones which may include lab start-ups, building commercial scale and everything in between. In a highly fragmented industry, there are multitudes of fragmented, overlapping and incomplete solutions, but true end-to-end, scalable solutions are elusive. That’s where Thermo Fisher Scientific enters the picture, with a commitment to address this gap with a carefully constructed and constantly growing portfolio of solutions - designed to help you succeed from early R&D through commercialization. Developing and executing a winning competitive strategy requires expertise, informed by broad industry knowledge and focused application knowledge – in research, operations, development, process scale up, regulatory and manufacturing. Driven by science, we are uniquely positioned to support your strategy across the value chain. Key Trends Shaping Drug Development Evolving Landscape • Favorable demographics driving demand for medicines • Increasing importance of APAC • Increasing regulatory complexity and compliance requirements Changing Product Mix • Rapid adoption and acceleration of biosimilars • Increased complexity of new molecules • Shift to specialty drugs: cell therapy, orphan drugs, steriles (biologics and small molecule) Shifting Business Dynamics • Mismatch between drugs in the pipeline and manufacturing capabilities and capacity • Increasing pressure to drive cost efficiency, maximize operational flexibility and accelerate time to market • Big Data-driven insights informing every step of the process How We Support the Biotech Value Chain
www.onenucleus.com | 51
Early Discovery and Research Although our solutions span the entire value chain, in this article we focus on key R&D services which support young biotech companies, by helping to manage capital expenditures, address talent gaps and provide access to industry-leading technologies. For those companies in the start-up phase, we offer special programs and expertise from lab design to complete workflow solutions & integrated systems of instruments, reagents and software. Combined with financing options and technical/application expertise, we’re able to get you up and running and help you prepare for your next milestone. Once labs are operational, solutions for ongoing lab management and support are available, with scaled procurement solutions (from simple p-card options to full web integration), inventory management options, and services like glass wash, instrument management and others that enable scientists to focus on mission critical activities. Technical expertise is available in person from our team of application experts and also through rich web content at thermofisher.com. As you sharpen your research focus, our portfolio of market-leading services can help you increase your lab’s productivity and efficiency with a comprehensive suite of services, customized just the way you need them. Our wide range of services, highly trained staff, proven solutions and commitment to your project will help you meet even your most challenging research goals. From custom manufacturing, business consulting and protocol development, to instrument repair and optimization, we draw upon our wide range of premium, high-quality products to create customized, scalable, efficient solutions for your research.
Thermo Fisher is committed to contributing to the success of biotech companies like yours. Foreword by Ashley Box, Director, Business Development of Thermo Fisher Scientific
52 | One Nucleus Annual Review & Directory 2020/2021
Research & Development Services 4basebio Limited
Catalent Pharma Solutions
A4PBio
Causaly Ltd
Abcam plc
Celerion GB Limited
Agenda Life Sciences
Cerba Research
Aglaris
Charles River
Air Liquide UK Ltd
Collaborative Drug Discovery
Air Products PLC
Congenica Ltd
Amphora Research Systems
Covance Inc
AMS Advanced Medical Services
Cytocell Limited
AMS Biotechnology
Diagenode UK
Anatomise Biostats Ltd.
Domainex Ltd
Applied Biotech Ltd
Emberion Limited
Aptamer Group Ltd
Enplas (Europe) Limited
Aptus Clinical Limited
Essen BioScience Ltd
Aqdot Ltd
Eurofins CerepPanlabs
Arecor Limited
Eurofins Discovery - UK
Astrea Bioseparations Ltd
Evonetix
Atelerix Ltd
Evotec UK Ltd
Biocair - UK
Fisher Scientific UK
Biocrucible Ltd
Fusion Antibodies PLC
BiologIC Technologies Ltd
Galvanize Bio Ltd
BioPharmaLogic LLC
GENEWIZ UK Ltd
Biosynergy (Europe) Ltd
Greenleaf Processing Ltd
bit bio Ltd
Haier Biomedical UK Limited
BOC
Healx Ltd
Cambridge Crystallographic Data Centre
High Force Research Ltd
Cambridge Design Partnership LLP
Histocyte Laboratories Ltd
Cambridge Epigenetix Limited
Horizon Discovery Group plc
Cambridge Research Biochemicals
Illumina Cambridge Ltd
Camena Bioscience Ltd
Innomech Ltd
Camlab Ltd
IONTAS Ltd Isogenica Ltd
www.onenucleus.com | 53
Accelerate your research: outsource to our R&D scientists Using state-of-the-art technologies, our expert team can help throughout the early drug discovery workflow. With more than 20 years of experience in developing reliable, high-quality solutions, trust our team of scientists to help ensure the best workflow options for your research goals. Our wide range of service capabilities leverages a diverse portfolio of quality and consistency, built by some of the most recognised life science brands in the industry, including Applied Biosystems™, Invitrogen™, and Gibco™. Thermo Fisher Scientific™ is a technology outsource partner you can trust. Contact us at: europeservices@thermofisher.com or call +44 141 814 7798 to speak to a member of the team today.
Complete Optimisation and Validation Solutions for Drug Discovery Target ID and validation
Assay development
Screening and lead ID
Lead optimisation
Identification of gene targets and linkage to diseases
Creating test systems to evaluate the effects of compounds on a target
Rapid identification of active compounds
Demonstrate efficacy, optimise specificity and establish safety of drugs in cellular models
siRNA screening
Biochemical assay technologies • LanthaScreenantibodies as well as Adaptaand Z’-LYTE kinase assay kits
Bulk screening reagents • Custom protein production service • Antibody labeling services
SelectScreenprofiling services—cellular • GPCR
• Bulk kinases and assay reagents
• Nuclear receptors
• Cell provisioning services
• Biochemical
SelectScreenprofiling services—biochemical • Kinase
Drug metabolism • P450
Cell line production • Stable cell line generation -Transfection -Lentiviral transduction
• Nuclear receptors
Drug safety • hERG
• Jump-In and Flp-In for stable expression
• Directed evolution (mutagenesis) services
CRISPR screening • LentiArrayCRISPR libraries Gene to protein services • Applications from target ID and validation to assay development and screening Custom peptides Solutions across the drug discovery workflow: • PEPotecSRM Libraries • HeavyPeptideAQUA standards • Standard peptides Custom Antibody Production • Monospecific polyclonals • -Monoclonals
Cellular assay technologies • GeneBLAzer, CellSensor, and Tango cells Genome editing • TALs and CRISPR
• BacMam reagent for transient expression
• -ABfinity™ Recombinant Antibodies
Stem Cell Services • Reprogramming
• -Hybridoma Expansion (to 100L)
• Genome editing
Screening Loss of function Screening:
• Differentiation
• siRNA, Silencer Select
Cell line characterisation • Karyostat assay
• -CRISPR, LentiArray Libraries
Library screening services • Custom library screening
• Cas9-iPSC
• PluriTestAnalysis Tool • TaqMan PSC Scorecard Panel Custom peptides • HeavyPeptideAQUA custom synthesis service Immunoassays • Assay development & testing services
Find out more at thermofisher.com/customservices For Research Use Only. Not for use in diagnostic procedures. © 2020 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. We hereby disclose that this email communication is for commercial purposes. COL19989_1 0320
54 | One Nucleus Annual Review & Directory 2020/2021
• Cryohepatocytes
• Nuclear receptors Custom peptides • AQUA-grade peptides
Research & Development Services Isomerase Therapeutics Ltd
Pharmaron
IXICO Plc
Precision for Medicine (UK Labs) Ltd
Johnson Matthey PLC (Cambridge)
Prosynth Ltd
Kelyon
Quotient Sciences Ltd
Leaf Expression Systems
Rare Biotech Ltd
LGC Group
Reading Scientific Services Ltd
Lonza Biologics Plc
Richmond Pharmacology Ltd
Metrion Biosciences
Roslin Cell Therapies Limited
Microsens Biotechnologies
Selcia Limited
MIP Diagnostics Ltd
Sequani Ltd
Mogrify Limited
Somaserve Ltd
Mitsubishi Tanabe Pharma Corporation
STARLAB (UK) Ltd
Mursla Limited
STEMCELL Technologies UK Ltd.
Neuroservices-Alliance
Swift Molecular Diagnostics Limited
New England Biolabs (UK) Ltd
Sygnature Discovery Ltd
New Path Molecular Research Limited
TCR UK Solutions
Nexcelom BioScience Ltd
Theradex (Europe) Ltd
Nexus Intelligent Engineering
Thermo Fisher Scientific
Novogene (UK) Company Ltd
Trajecture Ltd
Nuclera Nucleics Ltd
TTP plc
Oak Zone Biotech UK Limited
UK Laboratory Services Limited
OMass Therapeutics
Vector Laboratories Ltd
Oxford Nanopore Technologies Ltd
Veratrak Limited
PCI Pharma Services
Waracle - Digital Health WuXi AppTec UK Ltd
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Talent Etheo Limited
Odgers Berndtson
ExecMind International Executive Search
Pharmaceutical Training International
George James Ltd
PharmaGuide Ltd
Grovelands Resourcing Limited
PiR International
Horton International Global Healthcare
Platform First Ltd
Hyper Recruitment Solutions
PPMLD Ltd
Integrated Resources Ltd
RiverRhee Consulting
Kathryn Simpson Consulting Limited
SIP Cambridge
Life Science Leaders
SRG
Luka Bio
Steed Consulting Ltd
Managing Resources Ltd
VirdisGroup Ltd
Medscape Education
Wallder Limited
Up to 30% off Training Courses for One Nucleus Members Courses include: • • • • • •
Introduction to Drug Discovery Biological Safety: Management and Practice Introduction to Drug Development Laboratory Health and Safety Introduction to Contracts The Safe Use and Management of Laboratory Gases
Visit onenucleus.com/training-courses to see the list of current training courses we have to offer. www.onenucleus.com |
57
Advisory Insurance for young life science companies The Gallagher UK Life Sciences Practice looks after around 400 life sciences clients, ranging from start-up to multinational companies. The team has been together for over 25 years, with experience across a diverse range of innovative companies operating in the life sciences sector. Our extensive experience and long-standing relationships with specialist insurers enables us to leverage the market to provide comprehensive, competitive and at times exclusive insurance products for our clients. We have a sub-team within our Practice called The Lab, entirely devoted to supporting and guiding early stage companies. What makes The Lab special: service team made up of 4 brokers dedicated exclusively to early stage life sciences companies; two yearly events designed to create networking opportunities for our clients; the ability to benchmark our client’s requirements against a large peer group of life sciences companies, providing tailored advice on the necessary insurance covers our clients should be considering at various stages of their journey from early stages and R&D development through to commercialisation and expansion - whether you require advice on navigating the international insurance market or help understanding your supply chain or products liability exposure. You may not want to commit a large section of your budget to insurance, but a comprehensive policy could be the key to a successful business venture and a sensible form of business continuity planning in the early stages of development. We understand the need to minimise start-up costs, while still securing comprehensive cover from specialist insurers who understand the needs of your business. Some of the types of companies we help advise: • Digital Health/Telemedicine • Biotechnology
•
Contract Manufacturing
•
Clinical Research
•
Medical Technology
•
Contract Research
•
Medical Devices
•
Nutraceutical and Food Health
•
Pharmaceutical Development
•
Research Parks and Facilities
•
Pharmaceutical Distribution
•
Specialist Storage
•
Life Science Service Providers
• Diagnostics •
Analytical Laboratories
Key insurance considerations for early stage life sciences companies
Additional insurance considerations for life sciences companies •
Cargo, Supply Chain and Stock Throughput Protect your stock throughout your supply chain.
•
Intellectual Property Insurance Intellectual property has no real value if you cannot enforce the monopoly it provides. Intellectual property insurance policies can be tailored to cover IP defence costs, IP infringement pursuit costs or specific contractual indemnities.
•
Clinical Trials cover If you are undertaking clinical trials then you cannot obtain ethics committee sign-off without providing proof that your research subjects are protected by a clinical trials insurance policy. Such an insurance policy is designed to respond in the event that your research subjects suffer injury or illness as a result of their participation in the trial.
Arthur J. Gallagher Insurance Brokers Limited is authorised and regulated by the Financial Conduct Authority. Registered Office: Spectrum Building, 7th Floor, 55 Blythswood Street, Glasgow, G2 7AT. Registered in Scotland. Company Number: SC108909. FP544-2020
Advisory Advarra
CW (Cambridge Wireless Ltd)
Agility Life Sciences
Dehns
Alpha MD Limited
Deloitte
Annabella Consulting Company Ltd
DLRC Ltd
Appleyard Lees IP LLP
Dr Clare Sansom Freelance Science Writer
Artemida Pharma
Eastern AHSN
Avidity IP Limited - Life Sciences Team
EBD Group
AZoNetwork UK Ltd
EIP
BioM Biotech Cluster Development GmbH
Elkington and Fife LLP
BioNJ
Embassy of Switzerland
Bionow
ERA Consulting (UK) Ltd
BioPartner UK
Fish & Richardson P.C
BioStrata Marketing
Gallagher Life Sciences Practice (UK)
bioTECH Backstop Ltd
Giggabox Ltd
Biotechnology Innovation Organization
GlobalData
Boult Wade Tennant
Government of Québec
Boyds
Gowling WLG
Bristows LLP
Harlow Council
Brookes IP
HC Pharma Consultancy Limited
Cambridge Employment Law LLP
Health and Safety Works Ltd
Cambridge Network Limited
Highbury Regulatory Science Limited
Cambridgeshire Chambers of Commerce
IDTechEx Ltd
Carlos Pittol
Innovate UK
Canadian High Commission
Instinctif Partners (Life Sciences)
Charles Consultants
IP Pragmatics Limited
Charles River Associates - Cambridge Life Sciences
J A Kemp LLP
Charles Stanley & Co. Limited
KDH BioManagement Ltd
CIMYM BioSciences Ltd
KISS Communications
Citrine Wellness Limited
KPMG LLP (Life Sciences)
Clyde & Co LLP
La Playa Limited
Clive Stanway
LifeSciences British Columbia
CMS Cameron McKenna Nabarro Olswang LLP -
Link China Pharma Solutions
Life Sciences Team
Link-J
60 | One Nucleus Annual Review & Directory 2020/2021
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Onyva the Agency
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Optimum Strategic Communications
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Pharma International
Mewburn Ellis LLP
PIA Commercial Insurance Brokers
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Advisory Protogenia Consulting Ltd
Susan R. Windham-Bannister
QRC Consultants Ltd
Taylor Vinters
Reddie & Grose LLP
Taylor Wessing
Release Life Sciences and Diagnostics Ltd
Taylors Hill Consulting
Sagittarius IP
TCR UK Solutions Ltd
Santander UK
The Communications Strategy Group Inc.
Sciad Communications Ltd
Transcrip
Sky Bio Ltd
TTS Ltd
Sue Rees Associates
Venner Shipley LLP Withers & Rogers LLP
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64 | One Nucleus Annual Review & Directory 2020/2021
Member A-Z Listing
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A-Z Listing 4basebio Limited
A
Astex Pharmaceuticals Ltd AstraZeneca Astrea Bioseparations Ltd
A4Pbio
Atelerix Ltd
Abcam plc
Autolus Limited
Abingworth LLP
Avidity IP Limited - Life Sciences Team
Actigen Limited
AZoNetwork UK Ltd
Adrestia Therapeutics Ltd Advarra
B
Agenda Life Sciences
Babraham Bioscience Technologies Ltd
Agenus UK Limited
Babraham Institute Enterprise Limited
Agility Life Sciences
Beauchamp Technology
Aglaris
BenevolentAI
Air Liquide UK Ltd
BicycleTx Limited
Air Products PLC
Biocair - UK
Alloy Therapeutics UK Ltd
Biocrucible Ltd
Alpha MD Limited
BiologIC Technologies Ltd
Amphora Research Systems
BioM Biotech Cluster Development GmbH
AMR Centre Ltd
BioMed Realty
AMS Advanced Medical Services
BioNJ
AMS Biotechnology
Bionow
Anatomise Biostats Ltd.
BioPartner UK
Annabella Consulting Company Ltd
BioPharmaLogic LLC
Antikor Biopharma
Biosceptre UK Limited
Apollo Therapeutics LLP
BioStrata Marketing
Appleyard Lees IP LLP
Biosynergy (Europe) Ltd
Applied Biotech Ltd
bioTECH Backstop Ltd
Aptamer Group Ltd
Biotechnology Innovation Organization (BIO)
Aptus Clinical Limited
Bishop Simon Limited
Aqdot Ltd
bit bio Ltd
Arecor Limited
BOC
Arise Innovation Centres
Boehringer Ingelheim
Artemida Pharma
Boult Wade Tennant
Artios Pharma Limited
Boyds
66 | One Nucleus Annual Review & Directory 2020/2021
A-Z Listing B Bridge Partners Ltd Bristows LLP Brookes IP
Charles River Charles River Associates - Cambridge Life Sciences Charles Stanley & Co. Limited Chesterford Research Park CIMYM BioSciences Ltd Citrine Wellness Limited
C Cambridge Crystallographic Data Centre Cambridge Design Partnership LLP Cambridge Employment Law LLP Cambridge Enterprise Limited Cambridge Epigenetix Limited Cambridge Innovation Capital Cambridge Network Limited Cambridge Rare Disease Network Cambridge Relocations Cambridge Research Biochemicals Cambridgeshire Chambers of Commerce
Closed Loop Medicine Limited Clyde & Co LLP CMS Cameron McKenna Nabarro Olswang LLP Life Sciences Team CN Bio Innovations Collaborative Drug Discovery Colorifix Ltd Congenica Ltd Covance Inc Creative Places LLP CW (Cambridge Wireless Ltd) Cytocell Limited
Camena Bioscience Ltd Camlab Ltd CamPhos Therapeutics CAM-SCI Canadian High Commission Cancer Research UK Cancer Research UK-AstraZeneca Antibody Alliance Laboratory Capella Bioscience Limited Catalent Pharma Solutions Causaly Ltd CBRE Limited - Healthcare Division Celerion GB Limited Cerba Research Cerevance Ltd
D Daiichi Sankyo Co Ltd Dehns Deliver Plus Limited Deloitte Diagenode UK Diosynvax Ltd Discovery Park Limited DLRC Ltd Domainex Ltd Dr Clare Sansom Freelance Science Writer Dr. Reddy’s Laboratories (EU) Ltd
Charles Consultants
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Giggabox Ltd
Eastern AHSN
GlobalData
EBD Group
Government of Québec
EIP
Gowling WLG
Eli Lilly
Greenleaf Processing Ltd
Elkington and Fife LLP
Grovelands Resourcing Limited
Embassy of Switzerland
Grünenthal GmbH
Emberion Limited EMBL-EBI
H
Empyrean Therapeutics Ltd
Haier Biomedical UK Limited
Enplas (Europe) Limited
Harlow Council
Epidarex Capital
Harts Business Solutions
Epsilogen Ltd
HC Pharma Consultancy Limited
ERA Consulting (UK) Ltd
Health and Safety Works Ltd
Essen BioScience Ltd
Healx Ltd
Etheo Limited
High Force Research Ltd
Eurofins CerepPanlabs
Highbury Regulatory Science Limited
Eurofins Discovery - UK
Higher Steaks Ltd
Evonetix
Histocyte Laboratories Ltd
Evotec UK Ltd
Horizon Discovery Group plc
ExecMind International Executive Search
Horton International Global Healthcare Hyper Recruitment Solutions (HRS)
F
I
Freeline Therapeutics Limited
IDTechEx Ltd
Fish & Richardson P.C
Illumina Cambridge Ltd
Fisher Scientific UK
Immodulon Therapeutics
Fusion Antibodies PLC
Immune Regulation Limited ImmuPharma Imperial College London ThinkSpace
G
Independent - Clive Stanway
Gallagher Life Sciences Practice (UK)
Independent - Martino Picardo
Galvanize Bio Ltd
Independent - Miranda Weston-Smith
GENEWIZ UK Ltd
Inivata Limited
George James Ltd 68 | One Nucleus Annual Review & Directory 2020/2021
A-Z Listing I
Link China Pharma Solutions
Innomech Ltd
Link-J
Innovate UK
LINK Medical Research AS
Instinctif Partners (Life Sciences)
Liz Cole Marketing Limited
Integrated Resources Ltd
London BioScience Innovation Centre
IONTAS Ltd
London Stansted Cambridge Consortium
IP Pragmatics Limited
Lonza Biologics Plc
Isogenica Ltd
Luka Bio
Isomerase Therapeutics Ltd IXICO Plc
M Macomics Limited Managing Resources Ltd
J
Mandeville Technology Limited Marks & Clerk
J A Kemp
Masthead Biosciences Ltd
Johnson Matthey PLC (Cambridge)
Mathys & Squire LLP MedCity
K
Medscape Education
Kao Data
Merck KGaA
Kathryn Simpson Consulting Limited
Mercury Bioscience Consultants Ltd
KDH BioManagement Ltd
Mestag Therapeutics Limited
Kelyon
Metrion Biosciences
KISS Communications
Mewburn Ellis LLP
KPMG LLP (Life Sciences)
Microbiotica
Kymab Limited
Microsens Biotechnologies Mills & Reeve LLP
L
MIP Diagnostics Ltd
La Playa Limited
Mission Therapeutics Limited
Lab Fit
Mitsubishi Tanabe Pharma Corporation
Labstract Ltd
Mogrify Limited
Leaf Expression Systems
MSD
LEX Diagnostics Limited
Murray International Partners
LGC Group
Mursla Limited
LifeArc
MyData-T LTD
LifeSciences British Columbia www.onenucleus.com | 69
A-Z Listing N
P
Nabalu Pharma Services Limited
Page White and Farrer
Nanna Therapeutics Ltd
PCI Pharma Services
National Physical Laboratory
Penningtons Manches Cooper LLP
Nationwide Laboratories
Perfexia Health Technologies Ltd
NBBJ
Pharma International
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Pharmaceutical Training International
New England Biolabs (UK) Ltd
PharmaGuide Ltd
New Path Molecular Research Limited
Pharmaron
Newcastle BioSphere
Phico Therapeutics Ltd
Nexcelom BioScience Ltd
PhoreMost Ltd
Nexus Intelligent Engineering
PIA Commercial Insurance Brokers
NNEdPro
Pinsent Masons LLP
Norwich Research Park
PiR International
Novogene (UK) Company Ltd
Platform First Ltd
Nuclera Nucleics Ltd
PolyProx Therapeutics Ltd PPMLD Ltd Precisionlife Ltd
O
ProductLife Ltd
o2h Ltd
ProPharma Partners Limited
Oak Zone Biotech UK Limited
Prosynth Ltd
Odgers Berndtson
Protogenia Consulting Ltd
OMass Therapeutics
Public Health England
OncoLytika Ltd One Broker Limited Onyva the Agency Optimum Strategic Communications Origin Sciences Limited Oxford Nanopore Technologies Ltd
70 | One Nucleus Annual Review & Directory 2020/2021
A-Z Listing Q
Sky Bio Ltd
QRC Consultants Ltd
SmithsonHill
Quadram Institute Bioscience
Somaserve Ltd
Quality Care Cleaning Limited
Sosei Heptares - Cambridge
Queen Mary BioEnterprises Ltd
SRG
Queen Mary Innovation Ltd
St John’s Innovation Centre Ltd
Queen Mary University of London
STARLAB (UK) Ltd
(Business Development)
Start Codon Ltd
Quotient Sciences Ltd
Steed Consulting Ltd
R
STEMCELL Technologies UK Ltd. Stevenage Bioscience Catalyst
Rare Biotech Ltd
STORM Therapeutics Ltd
Reading Scientific Services Ltd
Sue Rees Associates
Reddie & Grose LLP
Susan R. Windham-Bannister
Release Life Sciences and Diagnostics Ltd
Swift Molecular Diagnostics Limited
Restore Harrow Green
Sygnature Discovery Ltd
Richmond Pharmacology Ltd
Syneos Health UK Limited
Richmond Research Institute RiverRhee Consulting Roche
T
Roslin Cell Therapies Limited
Talisman Therapeutics Ltd
Royal Veterinary College
Taylor Vinters
S
Taylor Wessing Taylors Hill Consulting
Sagittarius IP
TCR UK Solutions Ltd
Sahlgrenska Science Park
The Botanical Extract Company Limited
Santander UK
The Brain Tumour Charity
Scale DX Ltd
The Communications Strategy Group Inc.
Sciad Communications Ltd
The Institute of Cancer Research
Selcia Limited
Theradex (Europe) Ltd
Sense Biodetection Ltd
Thermo Fisher Scientific
Sequani Ltd
Trajecture Ltd
Shionogi Europe
TranScrip
Simcere UK Limited
TranSINE Therapeutics
SIP Cambridge
Trio Medicines Ltd www.onenucleus.com | 71
A-Z Listing T TTP plc TTS Ltd Tuspark Cambridge
U UK Laboratory Services Limited UKSPA University College London University College London - SysMIC University of Cambridge University of East Anglia University of Essex - Research and Enterprise Office University of Leicester- Enterprise & Business Development Office University of Nottingham - Corporate Partnerships
V Vector Laboratories Ltd Venner Shipley LLP Veratrak Limited Vernalis Ltd VirdisGroup Ltd
W Wallder Limited Waracle - Digital Health Wellcome Genome Campus Wellcome Sanger Institute Withers & Rogers LLP Wren Therapeutics Limited WuXi AppTec UK Ltd
72 | One Nucleus Annual Review & Directory 2020/2021
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