New year, new challenges
I would like to thank you for your continuing support for TOPRA, as a professional membership organisation representing the interests of both members and the wider community. I acknowledge the support of the Board (both old and new) and Thomas Kühler, Past-President; continuity is important in the development of our organisation and I fully endorse the strategy developed by the Board over the past few years. However, our profession and our society will face new challenges for which we must be willing to adopt novel solutions that build on the solid foundation formed over many years.
It is more than 30 years since I qualified as a pharmacist in the UK. My first experience of regulatory affairs was as a formulation scientist and then as a pharmaceutical reviewer during the 1980s. At this time the regulation of medicines was managed nationally, based on EC65/65, with only limited international cooperation.
When I left the UK Regulatory Authority in 1990 to join Zambon, a mid-size Italian company which had just opened a UK subsidiary, it was certainly beyond my expectation that within five years the EU would have established an effective collaborative regulatory procedure and created the European Medicines Agency (EMA) in London. In the same year, I had the pleasure of attending the inaugural meeting of the International Conference on Harmonisation (ICH) in Brussels in April 1990. From my perspective, this is a tipping point that allowed drug developers to conceive of truly global development programmes – something that we now take for granted.
In 1996, while at Pfizer, I was involved in the first of several centralised submissions based on a global development programme filing simultaneously in the US and the EU. This submission was also built electronically, available as both paper and electronic “review aid” and delivered to regulators on a laptop.
This is also the time when a brand new regulatory discipline emerged and many companies established a regulatory operations/submission function with specialists in project planning, document and information management. This specialism has developed into a critical function providing a great deal of added value, enabling both global submissions and the management of post-approval maintenance activities. It has also formed the basis of a rapidly growing outsourced sector, as specialist consulting and regulatory information technology firms have emerged.
It is now routine for large and mid-size pharmaceutical companies to submit in multiple countries and most regions of the world within weeks of the first submission, and overall review times have been reduced. The level of partnership between regulators has also increased, not only in the development of guidelines but also in the review of applications and post-approval monitoring. Regulators have developed their role from gatekeeper to being an active participant in the innovation process – this is represented in the emergence of “regulatory science”, an endeavour aimed at the application of decades of knowledge into a rational framework for development and evaluation of new therapeutics.
While at Pfizer from 1993–2008 and subsequently at AstraZeneca from 2008–2014, I had the opportunity to see the growth and evolution of our profession from a liaison function between internal teams and the regulatory authority to a range of disciplines including regulatory intelligence, regulatory operations, regulatory strategy and an ever closer collaboration between regulatory and safety functions.
In many cases, these functions have combined to support both development and commercial operations, allowing regulatory professionals to contribute in many ways and build meaningful and rewarding careers.
During my term as President of TOPRA I hope to meet many members to further understand the needs of the profession, and alongside the Board build on the work of the past leadership and our fabulous team in the London office.
Bob Clay, TOPRA President