Bruce Davies

Q. Now in its 28th year running, what was the original role of the ISPE within the pharmaceutical industry and how has this evolved to what it is today?

ISPE was established in the US by a group of industry professionals that were seeking a forum to exchange information on engineering and technical matters in the pharmaceutical industry. The principles of cooperation, networking and technical exchange are still strong foundations of the Society today and are, perhaps, indicators as to why it has grown into the successful international non-profit organization it is today. It prides itself on being global, as is exemplified by the Board of Directors, half of which originate from the US, with the rest coming from Europe and Asia-Pacific.

Bruce Davis

Q. ISPE offers a variety of educational and training opportunities to its members. In the current climate of credit crunch and job insecurity, how important do you think this training is?

I prefer to use the term 'education', though clearly this embraces training as well. No matter where we as individuals are in our career cycle, we all benefit from education. Information on basic training may be as applicable as advanced education and ISPE tries to provide a variety of opportunities to satisfy a range of needs. Yes, life is getting tougher in the pharmaceutical industry, but ISPE develops and maintains a suite of education programmes, tools, resources and best-practice documents that help, guide and inform individuals.

Q. You are one of the leaders of ISPE's Product Quality Lifecycle Implementation Initiative (PQLI). What is it and who is it aimed at?

PQLI is a very exciting initiative that aims to help establish practical, pragmatic implementation of International Conference on Harmonisation (ICH) guidances Q8, Q9 and Q10 (pharmaceutical development, risk management and pharmaceutical quality systems), and it may also extend to additional ICH guidances. Three teams were initially established to consider criticality, design space and control strategy, and, later, a fourth team for legacy products. I have been privileged to lead the control strategy team.

One of the key intentions of PQLI is to ensure all three ICH regions — the US, EU and Japan — are engaged. We are pleased with progress so far, as excellent programmes have been held in Arlington (VA, USA) in June 2007 and Copenhagen (Denmark) in April 2008, both of which involved extensive discussions with regulators and the industry. Also, ISPE's peer-reviewed Journal of Pharmaceutical Innovation has recently published five articles that summarize work to date.

It is a challenging exercise to develop best practices in this area, yet PQLI brings industry leaders and regulators together to achieve these goals. It is hard work, but it is also exciting, particularly as a volunteer. One genuinely feels the output will help industry establish current practices from this new way of working.

Q. What are the main problems encountered by pharmaceutical companies when implementing Quality by Design (QbD)? Have these increased in recent years?

QbD is very important and is, fundamentally, about establishing product and process understanding, and then ensuring manufacturing processes are efficient and well understood. The concept is not new to many industries, but for the pharmaceutical industry it requires some new approaches. The key part of QbD is to establish a good balance between product and process understanding, and regulatory expectations.

Q. ISPE's Annual Meeting will take place at the end of October in Boca Raton (FL, USA). What is ISPE hoping to achieve with this event and which sessions or features are you personally looking forward to?

Boca Raton will be the end of my year as Chairman, a year that I have thoroughly enjoyed. Our annual meetings are always a great success. Last year, I was pleased to introduce our largest ever meeting in Las Vegas (NV, USA). This year, we will, again, try to embrace as many aspects of the society and industry as we can to appeal to a range of participants be they students or seasoned professionals. In particular, I am looking forward to meeting up with regulators from around the world.