Archives for the month of: November, 2012

Steve Bates explains why he’s impressed with the MRC/TSB Biomedical Catalyst, from its straightforward application process to the encouraging signs already seen from investors. This post first appeared on the MRC Insight blog.

The announcement this month of almost £40 million research funding under the first full round of the Biomedical Catalyst, which aims to accelerate research through the ‘valley of death’ and deliver new therapies to patients, is a welcome boost to the UK bioscience sector.

Of that figure, the Technology Strategy Board (TSB) awarded almost £30 million to 22 business-led projects aiming to develop products and technologies in areas where there is unmet medical need. By backing companies in this way, the Government is demonstrating its commitment to the bioscience sector and helping to attract additional private finance for medical research.

Now that the awards have been made, with MRC money going to academic-led projects and TSB money to industry, there is an opportunity to take stock, examine how the process has worked and look ahead to the future awards.

First and foremost, I think the efforts of the MRC and the TSB, as the joint administrators of the Biomedical Catalyst, should be recognised. It can’t be easy to bring together two separate organisations, one focused on academia and one on industry, each with their own processes and application guidelines, to set up such a programme in such a short time frame. There was an encouraging number of applicants from industry-led collaborations in the first round (125) and I think this will only improve as the life sciences sector gets used to the process.

I have been impressed by the willingness of both the organisations to reach out to educate industry, and their openness to feedback. This spirit of partnership has led to a quicker and more efficient application process, which is a real positive for small, time-pressed bioscience companies. We are also pleased to see that the scheme, in essence, is always ‘open for business’. It is for these and other reasons that feedback from BIA members has been largely positive.

In many ways the coming together of the MRC and TSB in this way simply reflects what is happening in the bioscience sector. Research and development is a collaborative exercise with academia, industry, public funders and private investors all involved. Science Minister David Willetts is right to be considering this model for other sectors.

And by supporting small and emerging research-intensive bioscience companies the Government is helping to de-risk private investment in this space. These latest awards have brought significant private finance into the sector, boosting the overall value of projects to around the £63 million mark. Because private investors have faith in the rigour and calibre of the process and assessors, a successful Biomedical Catalyst application can act as a ‘stamp of approval’ for a company project.

Finally, I would stress that there is always a need to keep the application process under review to ensure it remains fit for purpose. There is still a significant amount of Government funding available and we need to constantly communicate that to the sector. The BIA is helping to educate the industrial sector, in part by coordinating a series of events to explain the dos and don’ts of the process.

For those who think they have a project that fits, I strongly recommend putting in an application. Reach out to the BIA and we can help you with your questions. Ultimately, it is behoven on the sector to make this funding work for patients, companies and the UK economy.

I was struck by one particular comment that Professor Guido Rasi, the Executive Director of the European Medicines Agency (EMA) made at our BIA Regulatory Affairs Advisory Committee dinner discussion last week. He said that companies that engage with the EMA early for scientific advice have triple the success in gaining regulatory approval compared  to those that don’t.  He added that 76% of the companies who sought this advice were large pharma- despite the fact that the process had initially been set up to aid and help smaller companies as they develop drugs.

In its 2011 report the EMA SME office said that the uptake of scientific advice and regulatory assistance by SMEs has remained at a high level, but that many companies were still seeking advice at a late stage or were not taking advice into account in their development. The EMA stressed the importance of opening up an early dialogue with the Agency on all aspects of development, including quality. The EMA encourages companies unfamiliar with the EU regulatory approval process to seek regulatory assistance and approach the SME office to discuss their planned regulatory strategy.

As the still relatively new boy I wonder why companies are not taking up the EMA’s assistance and whether there are things that we as a trade association can do to enable member companies, especially the smaller ones, take up this opportunity, which obviously has consequential benefit.

What are the barriers for small companies to seeking early scientific advice?

  • Is it that companies without developed regulatory affairs departments are unaware of the opportunity?
  • Is it that using the route is looked upon negatively by investors? Possible but I doubt it.
  • Or is it that amongst all the other things that biotech companies have to juggle this issue seems too far off to worry about when the key thing is to get the next piece of research done to get to a milestone.

If so, are we as a sector missing a trick – through using this as a quicker way to improve valuation – or are we scared to ask the question in case the answer isn’t the one we want?

I’d welcome your views – my perception is that regulators are more ready than we might believe to help companies think through their strategies and an early meeting may save time, cost and heartache later down the line.

P.S. I am not sure the early discussion advice argument is jut related to the regulatory field.  I’ve also heard similar arguments made about thinking through and engaging on manufacturing (particularly scale up manufacture) and health technology assessment strategies at an early stage in the drug development lifecycle.

Chris Watkins, the Medical Research Council’s (MRC) Head of Translational Research, has written about the exciting collaboration between the MRC and AstraZeneca. The announcement was warmly welcomed by the BIA and this blog post has been reproduced from the MRC. You can also find out more by reading Graeme Wilkinson’s piece on AstraZeneca’s LabTalk

We’re at an exciting time for medical research. Barriers are coming down, boundaries are blurring, and researchers are coming together more and more to crack important questions.

The term ’open innovation’ is bandied about a lot, but real examples of where it’s worked are only now beginning to emerge. That’s why I’m so enthusiastic about what we’ve announced today — working with AstraZeneca, the MRC has provided UK academic researchers access to 22 well-characterised compounds and the funding to undertake studies which will lead to a deeper understanding of human disease and speed up the development of potential new treatments.

A major focus for the MRC over the past five years has been on research which translates the results of basic science into improved healthcare, products and services. Translational research is a pivotal part of MRC’s strategy and part of my job is to develop ways to make this happen.

There are many scientists, and research funders, who have recognised the potential of getting access to well-characterised small molecules to help research. The challenges are finding out which compounds are available, knowing how useful they might (or might not) be — and getting the funding to use them.

All large pharmaceutical companies have ‘deprioritised’ compounds which have reached various stages of the clinical pipeline, and then not progressed. They may have passed rigorous safety testing, but didn’t act as anticipated during testing or trials. For a number of years, I’ve wanted to launch an initiative which helps academics to access these valuable compounds. When the opportunity finally arose during discussions between the MRC and AstraZeneca in 2011 we both jumped at the possibility. Between us we came up with a solution which we hoped would make things happen.

The AstraZeneca/MRC scheme is the first of its kind. Other than areas already probed by these compounds, scientists were invited to submit applications in any area of research — not limited by the research interests of either the MRC or AstraZeneca. We both wanted to see great science being undertaken, with clear benefit to patients.

And UK academic researchers delivered. Fifteen fantastic projects have been funded, including a University of Bristol project investigating whether a compound originally evaluated for the treatment of prostate cancer could delay, or even reverse, the progression of Alzheimer’s disease; a team at the University of Manchester conducting a small clinical trial of a new treatment for chronic cough using a compound developed to treat heartburn; and scientists at the Royal Veterinary College, University of London hoping to re-purpose a lung disease drug to treat muscular dystrophies.

This is a really smart way of working. It’s the perfect synergy of AstraZeneca compounds, MRC funding and scientists’ innovative thinking. Not only has the initiative funded an array of high-quality projects, it has also fostered a number of partnerships between researchers from academia and industry that will lead to future collaborations across the sector.

We’re already talking to a number of other companies about the possibility of launching similar schemes. And I think there’s a broader opportunity in using shelved compounds to study rare diseases. Ultimately I’d like to see this kind of initiative evolve to become a core part of MRC business, fostering groundbreaking discovery and clinical science.