Archives for the month of: December, 2015

Imanova

Imanova, a London-based translational research company and a world leader in molecular imaging technologies, announced two major successes last month. Established in 2011 as a joint venture between the UK Medical Research Council (MRC), Imperial College London, King’s College London and University College London, Imanova is focussed on putting London on the map as the innovator in imaging sciences. Read their blog below to find out more.

At the start of November, Imanova announced an important collaboration with Imperial College London as part of Dementias Platform UK’s (DPUK) new Imaging Network, creating the first nationally coordinated PET-MRI network anywhere in the world.

The aim of DPUK is to accelerate research progress and develop knowledge leading to new drug treatments and other therapies that could prevent or delay the onset and progression of dementias. In October 2014, the Chancellor announced £37 million funding for networks of clinical research infrastructure which is being used to establish three national networks for imaging, informatics and cell biology, to significantly enhance the UK’s research capacity in the dementias.

As part of the Imaging Network, DPUK will be purchasing five PET-MRI machines from GE and Siemens, as well as funding 50% of the 3T MRI scanner at Cardiff University.

Positron Emission Tomography (PET) enables visualisation of specific molecules, including key markers of dementias, such as the misfolded proteins Amyloid-beta and tau that are the pathological hallmarks of the disease. Magnetic Resonance Imaging (MRI) enables imaging of brain structure and physiology. Combining these two powerful imaging techniques will provide researchers and drug developers with a unique tool to better understand disease progression and to monitor the effectiveness of novel therapies.

In collaboration with Imperial College, one of the DPUK funded PET-MRI scanners (GE) will be installed at Imanova in its West London Centre for Imaging Sciences. Through this investment, Imanova will have a total of five clinical scanners to complement its extensive PET radiochemistry facilities that include two cyclotrons and 24 hot cells, placing the company in a unique position to support academic research and drug development for the pharmaceutical industry.

Later in November, Imanova announced its collaboration with Teva Pharmaceuticals and University of London (UCL) on a study aimed at building a better understanding of the role of inflammation in neurodegenerative disease. Imanova will be providing structural and molecular brain imaging with key biomarkers at its state-of-the-art facility based in West London, with the study performed at the Dementia Research Centre and UCL, led by Dr Mummery.

The role of inflammation is key in the field of neurodegeneration, resulting in some of the most devastating neurodegenerative diseases. Microglia play a central role in neuro-inflammation, and defining reliable biomarkers of microglial activation, and their changes over time, will provide crucial information for developing treatment trials with neuro-inflammation as a novel therapeutic target.

Using PET imaging, the Pilot Longitudinal Study in Alzheimer’s Disease of Central Markers of Microglial Activation (PADMMA) will assess the prevalence and pattern of CNS microglial activation in individuals with prodromal Alzheimer’s disease with mild cognitive impairment or mild Alzheimer’s disease.

Imanova has always taken pride in acting as a conduit between industry and academia to facilitate a bilateral flow of information, allowing the knowledge of academics to be applied and benefit from the industry experience and vice versa. The PADMMA study is a great example of such collaboration and Imanova is excited to bring the knowledge and expertise of our academic partners to facilitate innovation within the industry.

For more details on Imanova’s collaboration with Imperial College London, click here.

For more information on their collaboration with Teva Pharmaceuticals and UCL, click here.

Web banner 720 x 215 96 dpi_FOMRounding off the year in style, it was great to catch up with a number of you at Genesis 2016 last week. A fantastic programme with plenty of discussion around innovation in the sector and some positive messages from presentations and panels throughout the day. I was delighted to be able to take part, chairing the panel session on “Generating an Infrastructure for Innovation” with representatives from Norwich Research Park, BBSRC, Stevenage Bioscience Catalyst, Manchester Business School and Charles Russell Speechlys. Thanks to our United Life Science partners, One Nucleus, for a fantastic conference – a great way to tie up 2015. If you want to catch up on some of the discussions from the day, check out the event hashtag on twitter #ongc15 or @OneNucleus.

Also last week, representatives from across the sector joined Understanding Animal Research for the 79th Paget Lecture and Second Annual Openness Awards 2015. Many congratulations to all this year’s award winners, including Fiona Fox OBE, Chief Executive of the Science Media Centre, for her outstanding individual contribution to openness on animal research. The University of Cambridge was awarded a prize for its fantastic animal research video – a well-deserved winning piece, which highlights how mice are used in the fight against cancer, as well as discussing animal welfare and the search for alternatives. It’s encouraging to see so many great examples of openness from the sector – read the UAR blog from the event here to find out more.

Looking forward to January, which will be upon us sooner than you think, JP Morgan and the Biotech Showcase mark the beginning of the 2016 global biotech calendar. Our webinar on 6 January will give you the lie of the land as to what’s happening at the 2016 event, with a focus on what UK travellers and companies need to know. We’ll have expert input from colleagues who’ve been there and done it, including myself, to help save you time as you prepare for one of the busiest weeks of the year. Now in its eighth year, Biotech Showcase 2016 is expected to attract upwards of 2100 attendees. Make sure you’re on the list to attend, with discounts available – more information here. Details on some of the networking opportunities available during the week can be found here.

Also in January, tickets to 2016’s Gala Dinner are now limited. It’s your last opportunity to dine with Dippy before he is removed to make way for the blue whale skeleton which is set to welcome visitors through the Museum’s main entrance from summer 2017. More details available and reserve your spot here.

Further to the publication of the Accelerated Access Review interim report at the end of October, and the subsequent workshops and surveys we have made members aware of that have been taking the outline of the interim report, stakeholder engagement will be concluding early next year before the review team goes into report write-up mode. A final workshop on the pharmaceutical pathway will take place on Friday 15 January 11am-1.30pm, location TBC. Following that there will be a final stakeholder event on the AAR on the afternoon of Monday 8 February. Details are still to be confirmed by the government but if you would be keen to participate please contact Pamela Learmonth.

Beyond January and looking to the rest of 2016, we have numerous events planned throughout the year – from our flagship favourites to smaller regional events – do download our Events Flyer and get the important dates in your diary.

Finally, as the last Newscast of 2015, all that remains is to wish you all a Merry Christmas and a Happy New Year. 2015 has been a great year across the sector and I’d like to say a big thank you to all our members and supporters.

A reminder that our office will close at 5pm Thursday 24 December 2015 and will re-open Monday 4 January 2016. Newscast will return in the New Year. Have a good break and see you all in 2016.

Best

Steve

ARUKAlzheimer’s Research UK has appointed three Chief Scientific Officers to drive its £30 million Drug Discovery Alliance, a unique drug discovery venture in dementia research.

Below, we speak to the Chief Scientific Officers of the three Drug Discovery Institutes that make up the Alliance; Dr John Skidmore (University of Cambridge), Dr John Davis (University of Oxford) and Prof Paul Whiting (University College London).

What is the aim of the Alzheimer’s Research UK Drug Discovery Alliance?

JS: The Drug Discovery Alliance will accelerate the discovery of novel, effective therapeutics for Alzheimer’s and other neurodegenerative diseases. We’re looking to couple the deep disease knowledge of academia with our own in-house drug discovery expertise.

Our objective is to explore new biological targets – for each target we will aim to develop lead compounds suitable for proof-of-concept studies in cells, tissue and animal models. Over the next five years we aim to generate six such lead series, each of which will have the potential to deliver an experimental drug. But to do this we need to engage with the research community, to find targets previously unexplored for dementia research which we can then build drug discovery projects around.

What are you looking for in a target?

JD: Targets come in all shapes and sizes and we will aim to be open minded with regard to the rationale behind the target and the proposed approach to tackling the target. Ideally there will be some links to the human disease and some validation data using molecular knockdown techniques. Additional factors that we need to consider, but which are not always at the forefront of a researcher’s mind, are the tractability of the specific molecular target and the possible side-effects of a particular approach.

What degree of validation do you want to see in target proposals?

JS: We’re keen to engage in informal discussions at any stage about disease mechanisms or pathways that researchers are exploring, but we will prioritise targets that have a degree of target validation.

PW: Target validation is often a challenge. There can be a disconnect between the degree of validation carried out in academic labs, and the levels required by the pharmaceutical industry to ‘de-risk’ early-stage drug discovery projects. The beauty of the Drug Discovery Alliance is that we can work with teams with interesting targets, to robustly validate these approaches before embarking on further development within the Drug Discovery Alliance. Some questions we’d be seeking to answer are whether the target should be blocked or activated or are any knockdown studies complemented by small molecule or antibody approaches. One of the earliest challenges for our biology teams will be designing the right assays to probe the novel targets that come on board.

JD: Alongside our call for novel targets implicated in Alzheimer’s and other causes of dementia, the University of Oxford houses a state-of-the-art screening facility, which forms part of the £8 million UK-National Phenotypic Screening Centre. Phenotypic screening is a powerful method for drug discovery because it offers the opportunity to go beyond a focus on single drug targets and broaden the search to pathways involved in disease progression. Together with its counterpart at the University of Dundee, the screening facility represents the most advanced in the UK.

JS: We want to have an open dialogue with the research community. Rather than putting up boundaries to halt the translation of promising targets, we will take a supportive approach, working with scientists to develop their ideas further.

How will the three Drug Discovery Institutes work together?

PW: While we will draw on individual strengths within our host institutions to drive innovation and progress, the three Institutes will keep an open dialogue to maximise potential for developing promising targets.

JS: Targets not incorporated into the portfolio of an individual Drug Discovery Institute could be considered by the other two Institutes and there is a strong culture of collaboration and support across the Alliance.

JD: Many researchers have been asking which Institute they should approach with their ideas. We anticipate that existing collaborations with our host institutions will drive much of the dialogue, but this is not a pre-requisite to partner with the Drug Discovery Alliance. We’re keen to hear from researchers across the dementia research community, not solely those working at Cambridge, Oxford and UCL. Proposals can also be sent to DDAenquiries@alzheimersresearchuk.org and will be reviewed by all three Chief Scientific Officers.

How will you partner with the pharmaceutical and biotechnology sector?

JD: Pharma and Biotech are important potential partners who we are hoping will continue some of the drug discovery programmes that we initiate. As a result, we are looking for a continuous conversation with Pharma/Biotech to highlight areas of interest, to form collaborations when appropriate to the execution of a project and to help us progress the projects as they become more advanced.

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Our BIA member webinars are a great opportunity to hear from industry leaders on a range of topics pertinent to the biotech sector. Our November webinar focussed on recent oncology research and developments in the sector with speakers Dr Richard Goodfellow, co-Chief Executive Officer, Scancell and Geoff Muckle, General Manager, Champions Oncology. We’ve summarised some of the highlights below and don’t forget you can watch a repeat of the webinar above, just click to start playing.

The oncology field continues to evolve with a wide spectrum of advances across diagnostics, vaccines and the development of targeted treatments.

There are two main types of cancer vaccines – those designed to prevent the disease and those intended to treat it. A key challenge in the fight against cancer is that many tumours continue to grow by successfully evading the body’s own natural defence mechanism – the immune system. Vaccines that treat cancer are designed to try and stimulate the immune system to recognise and attack cancer cells.

Dr Richard Goodfellow, Scancell, joined the webinar to discuss their first cancer vaccine, SCIB1, which is being developed for the treatment of melanoma. Their initial results have been highly encouraging and suggest that SCIB1 could have an important future role as first line treatment for patients with resected Stage II or III disease, a key area of unmet medical need for which there are no effective and safe treatment options available.

A further boost to the future of cancer vaccines is their potential to increase the response rate to immune checkpoint inhibitors – one of the most promising recent advances in cancer treatment. Checkpoint inhibitors act to expose cancer cells to the immune system, allowing attack. If combined with a cancer vaccine, which enhances the immune response, this could provide a more effective treatment for late stage cancer.

The revolution of personalised medicine marks another important progression in the future of cancer treatment. Each patient’s tumour is unique, with its own distinct set of molecular changes. Personalised medicine classifies tumours according to this genetic make-up, thereby allowing more targeted and effective treatment.

Speaking on the webinar, Geoff Muckle introduced the role of Champions Oncology in the new era of personalised medicine. In order to test a tumour’s response to available treatments, Champions Oncology have developed a method which replicates a patient’s tumour in a mouse avatar model. Their large cohort of models can also be used during the cancer drug development process to test novel therapies on different tumour types.

For details on upcoming webinars in 2016, keep an eye on our Events page.

Sunday Politics4A short note from me this week as policy matters wind down for the festive period. Following November’s Spending Review, I featured on the BBC Sunday Politics show yesterday on the impact of the CSR on the sector. The changing environment at Innovate UK and what the “loans not grants” agenda means in practice is our top policy concern at present and one where we will be communicating on more broadly in the New Year. The Biomedical Catalyst is successful in leveraging private sector investment, and any new financial products developed by Innovate UK must work for business. The devil will be in the detail so for example, any loan product must not impinge on a company’s ability to grow and seek continued investment. If you’re interested in more, you can catch up on the show here – skip to 56 minutes in for the feature.

Last week the BIA inputted to the Treasury’s consultation on revisions to the Patent Box. As per the previous briefing note we published, this exercise really is about transposing new international rules into UK legislation. The Patent Box tax relief will still remain under the new scheme but in the future companies will need to demonstrate the link between the investment made in R&D in the UK and the income created from that to obtain the relief. In our response we emphasise the need for flexibility to comply with the new rules, the need for effective engagement for SMEs with HMRC and that the government ensures that its implementation of new international rules alongside that of other countries ensures that the UK’s Patent Box remains internationally competitive.

Following Professor Dame Sally Davies’ decision to step back from the day to day leadership role for Research and Development in the Department of Health, last week Professor Chris Whitty was appointed Chief Scientific Adviser, with the Research and Development Portfolio for the DH. Congratulations to Professor Whitty will take up his new post during December, reporting to Sally Davies the Chief Medical Officer who remains in post.

Finally, a note that as we begin the wind down to the festive period, next week will be the last Newscast of 2015.

Best,

Steve

Last week’s 12th Annual bioProcessUK Conference saw the launch of a new web portal, developed by the Knowledge Transfer Network (KTN) on behalf of the Medicines Manufacturing Industry Partnership (MMIP), which provides a simple and accessible platform outlining the UK’s strengths and capabilities in medicines manufacturing.

The MMIP had previously discovered there was confusion about UK activity in this sector in terms of the current industry base, academic research and support for innovation in medicines manufacturing. KTN’s Medicines Manufacturing Landscape portal highlights key UK activity, linking to existing initiatives to provide a seamless overview of the sector. In addition, the portal can be used to promote the UK’s capabilities to the UK community and internationally. It is the first example of an interactive tool that pulls together the innovation landscape, company base and manufacturing sites for the entire medicines sector within the country.

The KTN has generated a short video to demonstrate the key features of how to best use the portal, which you can watch in full below. The web portal itself can be accessed here.

 

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

Steve Glass ClinigenTrial design and execution are increasingly put under the microscope as biopharma companies seek improved R&D proficiency. In today’s blog, Steve Glass, Group Managing Director, Clinigen, explores the challenges of comparator clinical trials in this quest for efficiency.

Over the last five years there has been a great deal of disruption and innovation in clinical trial management. As the biopharma industry accelerates development times and consolidates new product pipelines in a quest for improved R&D efficiency, it’s no surprise that trial design and execution has also been under scrutiny. Designing and managing an effective, secure and efficient comparator clinical trial can be challenging for many companies. To succeed, an understanding and adoption of new approaches, novel project planning, and strategic partnerships with specialist providers is vital.

One of the most important of these strategic partnerships is between companies running trials, and specialist medicinal product sourcing and material supply businesses like Clinigen Clinical Trial Services (CTS). Such expert providers enable the implementation of improvements and efficiencies, without compromising supply chain quality, compliance and integrity.

With the top 20 biopharma companies each spending US$75-100m per year on comparator drugs alone (a figure that is predicted to increase by 8% year on year), comparator drug supply is big business and needs to be done right.

Clinical research – An evolving landscape and drivers for change

A number of factors have necessitated a change in how clinical research is undertaken including pressure to streamline study execution and expedite results, innovative and complicated trial designs, a shift in patient recruitment to emerging markets and on-going patient recruitment and retention challenges.

As a result of these top level factors, the sourcing and distribution of trial supplies have been also been affected by specific challenges and newly emerging issues. These include:

  • An increase in globally dispersed, multi-centre studies
  • Escalating costs of active comparator drugs
  • A more stringent and changing regulatory framework for study supply
  • Growth of Randomisation and Trial Supply Management (RTSM) and Interactive Response Technology (IRT) systems
  • A need to minimise shipping costs whilst ensuring security from falsified medicines and rigorous control of temperature

Change and disruption drive innovation

Many clinical trial supply partners like Clinigen CTS are working closely with bio-pharma companies and CROs to evolve new services, state-of-the-art facilities and partnerships to ensure Investigational Medical Products (IMP) and Non-Investigational Medical Products (NIMP), or comparator, sourcing and supply plays an integral part in driving new efficiencies, reducing wastage and maintaining quality.

Bio-pharma companies looking to partner with a strategic clinical trial supply business should carefully consider the following service requirements to ensure the most effective and secure comparator drug and ancillaries supply programme is provided:

  • Technical consultancy and expertise – First and foremost comes understanding. Advice should be underpinned by proven experience and knowledge of the trial supply sector including the complex regulations and strategies for entire studies or programmes. A good partner has the capacity and flexibility to provide clients with extensive options, whilst always mitigating risks.
  • Direct-to-site delivery – Comparator or ancillary drugs often need to reach patients at multiple trial sites quickly. A clinical trial supply partner must have both the global and regional distribution network to be able to rapidly procure and securely ship medicines; maximising the benefits of local, regional or centralised supply and saving time and money.
  • Demand-Driven Labelling and Distribution (DDLD) – By operating on a ‘just-in-time’ basis clinical trial service providers can pool supplies, minimise the wastage of expensive material and maximise efficiency.
  • Coordinated smart supply It makes sense to synchronise the supply of allied requirements such as of ancillaries, standard-of-care medicines, co-medication and rescue medication for trials in one place. A good partner will support not only the supply of comparator drugs for a trial, but also a coordinated supply program for all essential components, removing the need to engage with multiple entities and providing greater compliance and reducing costs.

Whatever the challenges that you face in the rapidly evolving world of comparator drug and ancillary supply sourcing, strategic partnering means that you have an expert on hand to help you overcome them.

To learn more about comparator drug sourcing and clinical trial services visit http://www.clinigengroup.com/cts/our-approach   

Or contact the author at steve.glass@clinigengroup.com