Archives for the month of: March, 2013

In a few weeks time the Cystic Fibrosis Trust is holding its research strategy meeting at the Wellcome Trust.

I believe the relationship between innovative companies and patient organisations is changing. So the BIA is trying something different with our charity partner this year. Traditionally the BIA has raised funds for our charity partner at our Gala Dinner in January, but I believe we as an association have more to offer to charities committed to medical research than simple tin rattling.

Charities increasingly are important partners in research and many have played leading roles in funding projects that have underpinned breakthrough therapies.

So as well as being the focus for our fundraising at our Gala Dinner, where Oli Lewington gave an inspiring speech (see video below), the Cystic Fibrosis Trust has presented its plans for a renewed research strategy to the BIA Board in order to gain insight from the commercial world about their direction of travel.

I believe this is something that no other organisation is capable of doing as a partner, and I hope it is a simple way in which we, as a trade association, can help ensure breakthroughs are delivered to patients as speedily, efficiently and safely as possible.

It’s timely to focus on cystic fibrosis (CF) in 2013 because in January a breakthrough biomedical treatment became available for the treatment of a specific mutation of CF.

Kalydeco has been developed by longstanding BIA member Vertex. The drug was trialled in part in the UK, approved by European regulators at the end of July 2012, and English NHS commissioners decided to make it available to NHS patients here from the beginning of this year.

This is what makes all the hard work of our members worthwhile: delivering transformational drugs to patients with unmet medical need.

I think we can all learn something from this story:

  • Genomics is delivering real patient outcomes : Kalydeco is the first drug to address the underlying cause of cystic fibrosis for patients with a specific genetic mutation.
  • Industry working with patient groups is key to success: Kalydeco would probably not exist were it not for the US Cystic Fibrosis Foundation, which funded its early development. That research in turn built on the discovery of the CF gene in 1989, work partially funded by the Cystic Fibrosis Trust in the UK.
  • The UK remains a vital location for high quality research, hosting trial sites for Kalydeco.
  • England’s (the UK’s) new NHS structures have set a precedent and proved they can make timely reimbursement decisions on important breakthrough therapies outwith a NICE review

I am proud of the partnership the BIA and the Cystic Fibrosis Trust have established and hope both our organisations can grow and learn from our work together this year.

Mark SmalesCreating a multidisciplinary community for biopharmaceutical bioprocessing as part of the BBSRC’s industrial biotechnology programme will be the next step for the Bioprocessing Research Industry Club, says Mark Smales, Professor in Mammalian Cell Biotechnology at the University of Kent.

In 2003 the Bioscience Innovation and Growth Team (BIGT) report, Bioscience 2015, highlighted the need for new tools and methods which will contribute to accelerating development of biological products. To address the research challenges in this area BBSRC, EPSRC, bioProcessUK (originally a TSB-funded Knowledge Transfer Network, and now part of the HealthTech and Medicines Knowledge Transfer Network) and industry launched the Bioprocessing Research Industry Club (BRIC), with the aim of strengthening the UK research base in this area and improving academic and academic-industrial links.

BRIC is successfully delivering for the sector:

  • Excellent multidisciplinary research is being funded through BRIC with the expectation of longer term delivery of commercial value.
  • BRIC has provided a critical mass of research, people and facilities that would not have been possible through responsive mode funding alone.
  • BRIC is building an active bioprocessing community with members having access to leading expertise, facilities and materials.
  • Academics have a much broader sense of the industrial challenges than would be achieved through individual 1:1 collaborations.
  • Post-doctoral research assistants and postgraduates funded in bioprocessing gain invaluable skills in training at the commercial interface with a greater understanding of the problems faced by industry.
  • BRIC provides a great opportunity for the post-doctoral research assistants to work closely with some of the leading bioprocessing industrialists and to gain an advantage over other post doctorate researchers for their future careers.

However, funding for BRIC is coming to an end and the BBSRC is changing how its funding programmes run.
You may be aware of the current BBSRC call for Network proposals in Industrial Biotechnology and Bioenergy (NIBBs) – under which biopharmaceutical bioprocessing now falls. BBSRC has allocated £15 million for this networking initiative and aims to fund approximately 10 networks of varying scales. The BBSRC aims to:

  • support a number of networks in industrial biotechnology and bioenergy and through them, facilitate the development of internationally competitive cross-disciplinary communities capable of undertaking innovative research and attracting further investment from UK and international sources
  • provide the resources to support proof of concept funding for a range of research projects identified by the networks, ultimately leading to more competitive, collaborative, cross-disciplinary and integrative research proposals to BBSRC and elsewhere
  • encourage the interaction between the academic research base and technology-deploying, associated value-chain and end-user businesses, promoting the translation of research particularly involving genomic, systems and synthetic biology
  • enable the supported networks to provide the leadership to develop, in collaboration with business, challenges to be addressed by the IB Catalyst fund

Additional information on the NIBB call is available from the BBSRC website.

With regard to this call, a working group from across the biopharmaceutical industry and academia, which I am leading alongside Alan Dickson (University of Manchester), is currently developing a vision and proposal for one of these networks on behalf of the bioprocessing community.

The aim of the network will be to create a multidisciplinary bioprocessing community with international connections populated by the integration of research and industrial professionals from life sciences, biochemical, chemical and process engineering, technologists, biophysics, analytical and mathematicial specialists to address the challenges encountered to establish innovative bioprocessing solutions required to produce affordable biopharmaceuticals and biomolecules for sustainable and healthier lifestyles.

We are particularly keen that industrial members from all areas and of all company sizes can contribute and benefit from this network. We therefore ask for you to

  1. register your interest for involvement in such a network, and
  2. contribute your thoughts on a vision for such a network.

We require your input now to develop the outline proposal so that we can incorporate as much input as possible from the community and allow time for a draft proposal to be put to the community for comment. Please let us know what would you like to see from the network and how could you benefit from it.

To participate or view more on this proposed bioprocesssing network please contribute to the discussion on the TSB’s “_connec”t platform: Proposal to set up a bioprocessing for biopharmaceuticals network.

Note: you will need to log in to leave comments. if you are not a member of “_connect” you will need to register before you can make a contribution/leave comments. This can be done as follows:

  1. Go to “_connect
  2. Register using the “join_connect” button if you are not already a member
  3. Go to BBSRC Networks in IBBE site
  4. Click on “discussions
  5. Scroll down to Bioprocessing network and click on the link
  6. Click on first thread by Malcolm Rhodes: Proposal to set up a bioprocessing for biopharmaceuticals network

Ian Hudson, MHRAThe Medicines and Healthcare products Regulatory Agency (MHRA) will be changing from 1 April 2013. Dr Ian Hudson, Director of the Licensing Division at MHRA explains more.

As of 1 April 2013, the National Institute for Biological Standards and Control (NIBSC) will be moving from being a centre of the Health Protection Agency to join the MHRA. We believe that this is an excellent move for both NIBSC and the MHRA, and it coincides with the Health Protection Agency being replaced by a new organisation, Public Health England, with broader responsibilities to deliver public health improvement as well as protection.

From April, the new MHRA will comprise three centres:

  • MHRA Regulatory – focused on the core activities of product licensing, inspection and enforcement, and pharmacovigilance
  • The Clinical Practice Research Data link (CPRD) – which gives access to an unparalleled resource for conducting observational research and improving the efficiency of interventional research across all areas of health, medicines and devices. CPRD joined the MHRA in 2012.
  • The National Institute for Biological Standards and Control

NIBSC’s statutory functions in support of standardisation of control of biological medicines will be unchanged. It will retain its identity, operating from its existing facilities and continuing to carry out its three key activities:

  • Development of international standards and reference materials in collaboration with WHO
  • Testing of biological medicines as the UK’s Official Medicine Control Laboratory
  • Conducting research related to standardisation and control of biologics

Our stakeholders, customers and collaborators can be assured that existing relationships will not be adversely affected by this change. Indeed we anticipate that in many areas they will be considerably strengthened.

The enlarged Agency will have some 1200 staff and through the addition of NIBSC, will have unique expertise in biologics with 350 regulatory and scientific staff covering the complete spectrum of biological medicines. It will also have greater reach and influence through the combined links of its component parts, and this, together with its scientific depth, will strengthen its ability to support manufacturers, help shape rational and proportionate regulation, and facilitate innovative research and development.

Additionally on 11 March 2013, the MHRA launched an ‘Innovation Office’ to help organisations who are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes in order to be able to progress their products or technologies.

The main aim of the ‘Innovation Office’ will be to promote early dialogue between innovative organisations and the MHRA to help facilitate their understanding of the regulatory considerations applicable to their innovation. For example the MHRA can advise on the development of innovative products like advanced therapies, nanomedicines and drug device combinations.

The ‘office’ will be a web-based portal accessed via the MHRA website. Developers of such technologies will be able to fill in a simple form which will be submitted confidentially to the most appropriate person at the MHRA.

Developers of novel technologies or products are often unsure which UK or European regulations apply and we hope that our ‘Innovation Office’ will give them the help they need to understand the regulatory requirements and pathway for progressing their novel product or approach.

This initiative has been developed as part of the Strategy for UK Life Sciences launched by the Prime Minister in 2011 to help create incentives for organisations wishing to promote healthcare innovation. The ‘office’ will help to encourage the growth of the life sciences industry.

At the MHRA we look forward to continuing to work with our stakeholders as the new organisation develops. If you have any queries, please get in touch with the MHRA.

Today the BIA has published a report highlighting the early success of the Biomedical Catalyst and providing new insights and a ‘how to’ guide to help inform companies who wish to make a future application. We did this in association with Bionow, BioPartner, OBN and One Nucleus, and with support from Pinsent Masons and Neusentis, a R&D division of Pfizer.

Additionally, the Technology Strategy Board has announced the next round of award recipients for the Biomedical Catalyst and has awarded £47.2 million to 51 recipients.

In little over a year the Biomedical Catalyst has already proven to be this government’s most effective UK biotech initiative. By successfully unlocking and leveraging additional private sector investment the Biomedical Catalyst is helping biotech companies do more research and grow faster in what is a strategically vital sector for the UK economy.

The report showcases some of the companies delivering the exciting projects the Biomedical Catalyst is enabling. UK biotech firms are often young, small and privately owned, so for those not directly involved it can be difficult to see the quality and variety of excellent businesses we have in the country. I hope the report gives an insight into some of the companies and people involved in our sector. To encourage others to apply the CEOs profiled have provided their ‘top tip’ for others.

BIA member companies have told me that engaging with government led schemes can be complicated and time consuming. That’s why much of the report focuses on a ‘how to’ section that de-mystifies the scheme and encourages others to participate.

Why has this scheme proved so successful? It boils down to a short and straightforward process, a speedy response and decision on the application and expert scrutiny that is seen as de-risking the project and driving investor interest.

The Biomedical Catalyst is a significant and successful policy intervention that I’d encourage biotech companies to apply for. It’s a demonstrable way of showing the public and private sectors working together in the UK and is a key part of the supportive ecosystem. Along with an enabling fiscal regime with policies such as R&D tax credits and the Patent Box, it is a key initiative tackling the so called ‘valley of death’.