NDA Group’s Professor Kjell Strandberg (MD, PhD), recently retired chairman of the NDA Regulatory Advisory Board and current counsellor to the chairman of NDA Group, was last Wednesday night awarded the prestigious Lifetime Achievement Award at the TOPRA Awards, held at the IoD in London.
The Lifetime Achievement Award is open to individuals only, awarded for a ‘consistent history of contribution in Regulatory Affairs’. The judging panel comprised of 15 well-respected members of regulatory bodies, academia and the pharmaceutical industry, looking for someone that had demonstrated going ‘over and above the call of duty throughout their career’, together with having an ‘exceptional contribution to TOPRA and/or the profession and development of Regulatory Affairs or Regulatory Science and a significant impact being made on Regulatory Affairs in the healthcare sector.’
“I’ve thoroughly enjoyed working with the pharmaceutical industry over the past 36 years, seeing many new and exciting new medicines being introduced, new technological advances being made, and fundamental process changes to the industry to make the process of new drug development more efficient, all to the benefit of patients. I am truly proud to have been part of these developments and it is an honour to have won this award,” said Kjell Strandberg.
Professor Strandberg has devoted most of his professional career (36 years) to improving the regulatory process. Recognising the need for high caliber in-house staff, Kjell advanced the Medical Products Agency to becoming one of EUs most respected, utilised and appreciated regulatory agencies s over the full range of activities.
To the benefit of patients, industry and regulators alike, Kjell engaged in harmonisation, cooperation and educational activities in order to minimise undue delays in the review of new medicines and safety issues. This rests on true belief in the value of co-operation and a genuine interest in front-line research. It has been accompanied by a willingness to share the MPA positions at conferences aimed at open discussions between regulators and industry representatives; activities which many times Kjell has orchestrated or encouraged his staff to take part in.
After ending his tenure at MPA, Kjell established a truly unique group of ex-regulators supported by former highly ranked Heads of international Regulatory Affairs and former EMA project leaders. Today, the NDA Regulatory Advisory Board consultancy comprises 15 members, including 10 renowned ex-regulators, among them all three former chairpersons of the Scientific Advice Working Party. Approximately, 80% of Big Pharma utilises the Advisory Board’s services, e.g. review of development plans, strategic advice and training sessions, advice on Risk Management Plans etc.
The Advisory Board advice also serves the regulatory authorities well. Thus constructive criticism of strategies, design of pivotal studies often lead to changes, even to projects being permanently put to rest. This twofold effect, i.e. investments saved and scarce regulator resources spared, is of mutual benefit.
‘Once again the shortlisted nominees in this year’s Awards reflected the very best in the regulatory world,’ says Lynda Wight, TOPRA’s Executive Director. ‘The winners – from promising new regulatory professionals to those with a lifetime of regulatory service at the highest international level – are examples of real regulatory excellence and I congratulate them all.’
Lifetime Achievement Awards criteria
The Lifetime Achievement award addressed five different criteria: consistency, quality, contribution, achievements and impact, as outlined by TOPRA below:
Consistency: making a consistent contribution to the profession, not just in performing their job function but over and above the expected call of duty
Quality: demonstrate how contribution has been of a truly high quality over their career, enhancing Regulatory Affairs or the regulatory affairs profession in general
Contribution: the nature and extent of contribution to TOPRA or the profession of Regulatory Affairs as a whole
Achievements: a catalogue of achievements throughout their career, highlighting significant those that were above and beyond their remit
Impact: has made an impact that has a reach or longevity greater than would be expected