IMG_1677_600x300We had a great morning in Stevenage last Thursday at the latest in our series of BIA Science and Finance Breakfasts (pictured above). Our guest speakers – Dr Malcolm Weir of Heptares, David Miles from AKL Research and Development, and Dr Andrew Lightfoot from Peptinnovate – provided lots of food for thought across a range of financing issues. We’ll have a blog from David Miles later this week, providing an account of their decision to re-domicile the company in the UK in order to benefit from the current UK business environment, as told at the breakfast.

Another hot topic at Thursday’s breakfast – and indeed across international media last week – was the tale of Hilary Clinton, Turing Pharma and the drop in US biotech stock prices. Having reached out to Jim Greenwood at BIO as the story began picking up speed, it was good to see that BIO have taken decisive action kicking out Turing pharma from membership. As Jim told me the company and its leadership do not reflect the commitment to innovation and values that are at the core of BIO’s reputation and mission. Even so, I fear that the industry’s reputation has already been damaged, and that the story of Turing pharma will be the prism through which the debate about prescription drug pricing will be seen in the coming US Presidential debates.

Some lively discussion as always – many thanks to those of you who came along to the breakfast, and to our speakers. Our next port of call as part of the series will be at BioCity in Nottingham on 22 October, more information available here.

We’re in the midst of party conference season now. Today and tomorrow BIA will be at the Labour conference in Brighton to get the current lay of the land in Labour politics and to host our regular breakfast roundtable, organised together with the AMRC and our Life Sciences UK partners ABHI, ABPI and BIVDA.

Last week our Public Affairs and Policy Manager Zoe was at the Lib Dem conference in Bournemouth, as we seek to stay engaged with politicians across the board. At the Health Spokespersons’ Q&A session, Norman Lamb MP said the NHS needs up-front investment now in order to meet the challenges of the near future, and responded enthusiastically to the suggestion that updating NHS infrastructure in line with digitalisation, big data and self-monitoring technologies will lead overall to better patient health and efficiency savings. Former party leader Nick Clegg MP and new leader Tim Farron MP were clear about the party’s line on remaining in the EU and that the referendum is ‘far too important for ambivalence’; a topic that was discussed at length in relation to UK science, by a panel and audience of scientists and engineers at a Science Council fringe event. And at a session focused on effective financing for company development – with Liberal Democrat Spokesperson for Economics Baroness Kramer, the British Venture Capital Association and the London Stock Exchange – the UK life sciences industry was mentioned several times in the context of scaling up ‘hard tech’ businesses. Circassia in particular was mentioned as a public listing that has helped to give the confidence to other company ‘peers’ to grow and invest in the UK, and sparked interest in UK biotech amongst specialist and cross-over investors.

In other news from last week, many congratulations to former BIA Chairman, Tim Edwards who was appointed to the Innovate UK board by Business Secretary Sajid Javid. With his knowledge and experience in this innovative sector – Tim is currently Executive Chairman at BIA member, Atopix Therapeutics, and a Non-Executive Director at the Cell Therapy Catapult – he will make a fantastic addition to the board.

On the regulatory front, we joined forces with the Association of the British Pharmaceutical Industry (ABPI) and the British Generic Manufacturers Association (BGMA) to welcome NHS England’s new publication “What is a biosimilar medicine?”. The publication is a result of collaborative working between the Medicines and Healthcare product Regulatory Agency (MHRA), NHS England, National Institute of Health & Care Excellence (NICE), the Royal Pharmaceutical Society (RPS) and the pharmaceutical industry trade associations.  The BIA has a long heritage in this debate and, along with our members, we have been happy to contribute to the development of this new document which we hope will be a useful guide to healthcare professionals and ensure that patient safety remains the primary driver when considering the introduction of biosimilar medicines to the NHS. You can download the report in full here.

I was interested to read Sir Bruce Keogh’s outline strategy for personalised medicine in the NHS, also released last week. The paper sets out the concept of Personalised Medicine within the NHS, the underpinning principles and sets out the work that will now be undertaken to develop a Personalised Medicine Strategy. I look forward to seeing the strategy develop and ultimately the use of precision medicine embedded within the NHS to improve patient outcomes.

On 17 September 2015, the ABPI, in partnership with the Academy of Medical Sciences, held a workshop on ‘real world evidence’. The meeting bought together industry, regulators (both EU and FDA) as well as policy makers to explore the acceptability of real world evidence for regulatory and HTA decision-making.  The BIA was represented at the meeting, which provided some full and frank discussions as participants shared their aspirations for how real world evidence might be accepted and used in a regulatory context by 2020, and the key challenges that will need to be overcome to achieve this as well as the practical steps that could be taken to address these challenges. A key theme that emerged was the need to have some established and agreed nomenclature and definitions, as well as the view that to progress the project further would require a coordinating body. For those of you who are interested, a video from the workshop can be found here, and a report of the workshop will be published in due course.

Finally, on Friday Professor Dame Sally Davies confirmed that she intends to step back from the day to day leadership role for Research and Development in the Department of Health and make space for another to take over. The Department of Health has therefore invited applications for the post of Chief Scientific Adviser & First Deputy Chief Medical Officer Department of Health. The letter from Dame Sally is available here and the job description is available here.

Best

Steve