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Guest post by Lorna Elmslie.

The UK life sciences industry is estimated to contribute around £10 billion per year to the UK economy. Made up of pharmaceutical, medical biotech and medical technology companies, the importance of this sector to our economy is reinforced by the government’s support for life sciences illustrated in its Strategy for UK Life Sciences report.

“The UK will become the global hub for life sciences in the future … and [Life Sciences] will continue to be vibrant in the UK and will be a key contributor to sustained economic growth.”

Extract from Page 6 – Strategy for UK Life Sciences report

With global businesses including GE Healthcare, GSK and AstraZeneca basing their headquarters in the UK, it is perhaps little wonder that the government are keen to see the industry survive and thrive within the UK.

Although the life science sector appears to be well-supported and booming, if you are a start-up life science company, there are a number of key challenges you may face. The 2011 UK Life Science Start-up Report inevitably focuses on developments in the financing landscape, but also shows how the sector is evolving to cope with the new ecosystem, hopefully indicating a positive, if different, future for the industry.

Illustrated below are just some of the challenges a start-up life science company may face:

Access to Finance and Raising Capital

For any start-up company this is a huge challenge, and start-ups worry first and foremost about running out of capital before generating revenue.

Actually raising the capital can be a daunting task and this article from PharmaPhorum outlines some guidance and tips for doing so. Once you’ve raised enough capital, organisations such as BioCity Nottingham and Edinburgh BioQuarter offer incentives for start-up companies to locate there, and could prove beneficial as other start up life science companies will be based there also.

Help can also be provided from the recently launched Angels for Life Sciences (A4LS) – a network which aims to address the need for a UK-wide angel investment network. ‘Angels’ are provided with the opportunity to invest in high-quality, emerging life science businesses and provide these businesses with an important funding channel. The organisation was established to help overcome the perceived challenges of investing in early-stage life sciences companies, and should hopefully prove to be a huge support for start-ups looking to raise capital.

Moreover, an additional challenge start-ups may face is the protection of their intellectual property (IP) – start-ups have the added challenge of very limited resources and knowledge to effectively do this. Unverified and unprotected IP can have disastrous effects, not only for the survival of the company, but also for obtaining funding from investors.

Manufacturing & Regulatory Challenges

A company has to effectively meet its market needs while working in a highly-regulated environment and with a limited budget. The implications of non-compliance are clear, and significant attention to detail is essential to satisfy strict regulatory requirements in the life science sector.

One of the greatest challenges is the regulatory environment. It is often difficult to prioritise resources for compliance with the whirlwind of other problems associated with starting a business.

Whether it’s managing your documentation – policies, procedures (SOPs), training programmes, audit processes, CAPA procedures, suppliers or equipment, it is imperative you have an efficient and effective Quality Management System (QMS) in place from the outset that works for your business and your staff.

Have a look at how Scottish Pharmaceutical services company Symbiosis addressed and overcame their regulatory challenges with an effective QMS.

Management of Human Resources and Recruitment

Human resources management imposes a key challenge. While start-up teams tend to be extremely under-staffed and usually consist of high-calibre scientists, it is important to keep a reasonable balance in the workload assigned to team members. The best results are achieved by focused teams. However, scientists often find themselves working on public relations, marketing and other tasks outside of their area of expertise. This might be a reflection of the lack of resources. Having significant resources also attracts good quality people, another key requirement for success. The challenges of Sales and Marketing are also something to consider, and management must develop a strategy to address and overcome the sales and marketing challenges it will face.

The challenges mentioned above no doubt only scratch the surface of what life science start-up companies need to consider. The good news is that the creation of organisations like Angels for Life Sciences and the UK Government’s support will bolster and encourage growth of this vitally important sector for the UK economy.

If you are a start-up life science company, what challenges did you face and how did you address them? What support did you get?