Managing the future

You have more than 18 years of experience in the pharmaceutical industry. What are the most significant changes you have observed?

The adoption of computers into every aspect of the pharmaceutical industry has been enormous. Some estimates would put productivity and efficiency gains across the pharmaceutical industry at 2–3 times what they were previously. However, they are only just beginning to have an effect in the areas of training and document management, which have traditionally been managed by people and paper systems. With increasingly strict regulations and the growing complexity of processes and training requirements, there are even greater efficiency gains, as well as cost savings, to be achieved by adopting electronic document management systems (eDMS), learning management systems (LMS) and systems for the electronic signing of documents.

Keith Williams

Have these changes had a positive effect in the industry?

On the whole, yes, but software has not necessarily delivered a better user experience. The regulatory tail has generally wagged the business process dog, usually at the expense of things being easier for the user. With the power of collaborative tools configured for regulatory compliance, such as g-docs, the user can perform tasks in Word, Excel, Outlook and Internet Explorer, but in a controlled environment. The user benefits because there is one place to go to work on documents or take training, and the business benefits because document versions and collaborations are conducted on a central server, and all the data and audit trail are in one place too.

In your view, what stands in the way of a company implementing electronic quality management systems?

Usually a combination of:

• 'Not invented here' — we already have a great paper system.

• Not understanding the cost benefits and fear of high implementation cost.

• A fear of change, new skills to learn and failure.

• Compatibility issues with existing software systems. Normally the above occur in that order.

What are the challenges that the pharma industry and, in particular, your sector face?

For all sorts of reasons — too numerous to list here — profit margins in the pharma and biotech sector are being eroded at a very high rate. Freeing people up from none value-added activities, such as attempting to locate documents in cluttered email systems or signing and storing documents manually, to focus on the core business is becoming a priority.

Our target market is always price-sensitive, but in discussions we've had recently with some of the bigger pharma players, they indicated that the value of smaller companies when being purchased, or milestone payments received for licensing arrangements, significantly increased if the smaller companies managed their documents, processes and training in a compliant manner. These areas can be a potentially high risk if managed badly, and this has to be factored in to price. It is a serious consideration for companies contemplating deals at the moment or in the near future.

Do you have any developments in the pipeline?

We are constantly reviewing feedback from the market and we think there is an opportunity in the regulatory agency electronic submissions (electronic common technical document [eCTD]) end of the marketplace and in creating a completely electronic 'trial master file'.

How do you think regulations will change in the future?

If previous experience is anything to go by, regulations will only become stricter and more pervasive.We are already seeing them moving back up the development pathway of drugs into the discovery phase. Our headquarters are in Nottingham (UK) where there are many university spin-outs with good technology in the research stage, and it amazes me that they are talking about regulations. Five years ago they would not have had any idea that their work would eventually fall under regulatory bodies.

This is nothing but good news for us, and companies similar to us, as some systems make compliance affordable and manageable for all businesses. I think we're in the right place at the right time. Check back in 3 years to see if I was right!

The full interview with Keith Williams can be read in the May issue of our online publication Pharmaceutical Technologist, which will soon be available at www.ptemag.com.

Keith Williams is the founder and CEO of Good Products Ltd (UK).