Change to meet new regulatory standards

The pharmaceutical industry continues to be rocked by a succession of blows which are forcing it to redesign its business models.  Following on from the healthcare cost containment challenges in the '90's, the latest issues include a series of extremely high profile drug safety cases which are hitting public confidence and leading to regulatory transformation.
 
Previously, regulators had tried to keep control by inspecting the degree to which companies maintained compliance.  A little bit like a school exam, if you managed to cover the right question on the day, you passed.  As we all know this doesn't always represent the full story and this was also the case with the pharma industry.  The regulators are now encouraging companies to design quality in at source, in a way which proves they are in control of their processes.  The approach being taken is risk-based, which means the FDA and others like them will assess the degree of risk a company presents and hence the degree of rigour to which they will receive regulatory oversight.  There is a new awareness that Pharma has public responsibilities way beyond ordinary business ethics.  Public safety is paramount.

Time to Change

Pharma organisations realised they had to change to meet the new regulatory standards.  This meant reviewing some of their most established business processes - and realising they were now often unfit for purpose.  Good governance, let alone regulation, demands that compliance be at the heart of the drug development process.  Quality must be built in, not inspected in and companies are now busily seeking ways in which to achieve this.

WCI have worked with one leading pharma company over the past two years to build a Quality Risk Management approach into their drug development processes.  The project has been so successful that the client wishes to remain anonymous because of the extent to which they realise this approach has given them competitive advantage.

A Case Study

The company is one of the world's leading innovative pharma companies with new and breakthrough treatments in areas of unmet medical need.  The client recognised early the need to move ahead with new techniques to build in quality and compliance into their processes.  They have been taking a leading position within the industry on the application of Risk Management for many years in their overall business strategy.  In 2003 they asked safety specialists WCI to assist them in their latest initiative - introducing Risk Management in Development Quality.

WCI worked with the client team to develop the concept of Risk Management in development: agreeing the operating principles and devising a technology solution that would support a proactive approach to risk identification and mitigation.  The model was based on the principles or Failure Mode, Effects and Criticality Analysis (FMECA) which have been in use in other industries for many decades and are recognised as particularly appropriate for risk management in the pharma industry by the FDA.

A tool like this enables the Quality function to move away from the traditional "policing" type role and into a new one of advising, supporting and consulting the operational areas on risk, quality and compliance.  The end result is greater confidence in the data generated for regulatory approvals of new drugs as well as a more effective use of scarce resources.

It's all very well having the tools and techniques, but what about the people?  Risk Management technology won't work without matching culture.  Pharma's traditional fire-fighting reactivity won't do - neither regulators nor the public want fires at all!  Pharma needs a 180º culture shift, to thorough plans, systematic procedures and consistent standards.  But people don't like change, especially when they're comfortable with their ways of working.  And it will take more than top management enthusiasm to bring everyone involved on board.

So, the key question for the client was, how could they develop a Risk Management system that would meet the company's business and compliance needs, yet be actively accepted by those operating it, making it self-sustaining?

Using new technology to lead the way

The company set up cross-functional project teams, with senior members and leadership, in their main development sites in Europe and the US.  WCI worked closely with the teams as they adapted proven practice to develop their own change-management programme.  Risk Management process and a risk analysis tool were also designed and prototyped.

The team had identified for themselves what needed doing and why, and were quickly committed to the success of the new approach.  Similarly, the tools they wanted were developed alongside the systems and they were keen to use them.  They were determined that Risk Management would build quality into the business yet free up resources from traditional activities in order to focus on real business priorities and more value-adding tasks.

The IT tool WCI designed applies Risk Management to the quality of process, product and outcome. Web-based, the application was developed using ASP.Net., on a Sequel server database with Crystal Reports for all reporting.

The tool displays risk on various criteria as status: green (in control), amber (steering correction) or red (major action now). It also offers history and trends and shows earlier actions and the resulting impacts.

This simple-seeming approach is highly effective in helping teams manage their effort so as to direct it for maximum effort for minimum input.

The stand alone application will eventually be integrated with existing and planned IT applications to maintain data, derive new risk situations and manage mitigation actions.

The benefits to quality and compliance

The final robust version of the tool derived from the trialling of the prototype. It provides easy analysis of risk profiles in a variety of forms.  Its use enforces and builds in consistency of risk assessment process and criteria.   

Assessors update, input and review criteria.  The information is also accessible to the 200 strong Development Community.  It will promote synergy and spread learning faster than ever before.  The company also expects operational savings in the use of internal resources as their efforts are better focused as well as a more optimal use of external partners.  This will free up financial budgets for investment in developing new drugs.

The most important benefit will be the achievement of a drug development process in which risk is properly recognised and managed in good time.  It enhances in the standing of the company with regulators and will save time and resources in satisfying regulatory requirements.