TOPRA Announces Regulatory Excellence Award Winners - Release

The winners of the fourth annual TOPRA Awards for Excellence in Regulatory Affairs were announced at a gala celebration in London last night. This year’s Awards were the biggest ever and are a testament to the growing success and recognition of the programme, according to the evening’s host Professor Trevor Jones at the glittering event in London's Institute of Directors.

The winners of the 2013 TOPRA Regulatory Affairs awards are:

HORIZON: Sarah Bentouati, Roche, Basel, Switzerland

INSPIRATION: Chris Griffett, New Jersey, US

INNOVATION: Diamond BioPharm, Harlow, UK

COMMUNICATION: Auditgraph team led by Mauricha Marcussen, Ohio, US

EDUCATION: F Hoffmann La Roche Regulatory Team, Basel, Switzerland

SUPPORT: Triskel team, Triskel Integrated Services, Geneva, Switzerland

ACHIEVEMENT: Professor Kjell Strandberg, MD, PhD

The culmination of this prestigious evening in the regulatory calendar was the announcement of the LIFETIME ACHIEVEMENT Award. This category always attracts a great many nominations from leading figures who have helped shape the regulatory environment be they in industry, agency or CRO. Professor Kjell Strandberg was the delighted recipient of the Award, saying it was as good as 'receiving an Oscar.'

Professor Strandberg has devoted most of his 36-year professional career to improving the regulatory process. Recognizing the need for high caliber in-house staff, he advanced the Medical Products Agency (MPA) in Sweden to become one of Europe’s most respected and frequently used agencies. He also served as the Chairman of the EFTA Pharmaceutical Committee which was responsible for achieving harmonization of national pharmaceutical legislations compatible with the EEC, thus creating a platform for the new system for approval of marketing authorization applications to be put in force in January 1995. Professor Strandberg is currently chair of the NDA Advisory Board.

The Awards program recognizes the excellent contributions of regulatory professionals from across the board at all stages of their careers: from practitioners to educators and communicators; from innovators and service providers; and a combination of all the above.

HORIZON recognizes relatively new regulatory professionals who have shown outstanding skill and promise This year PAREXEL, a global CRO, supported this award which went to Sarah Bentouati whose ‘technical, team working and leadership skills are very impressive for someone who started working in regulatory so recently'.

Acknowledgement of senior regulatory professionals who lead and influence others in the profession is the aim of INSPIRATION, this year supported by Regulatory Professionals. The winner, Chris Griffett, has always championed globalization and pioneered the role of the regulatory representative on project teams, increasing the visibility and voice of regulatory affairs. Chris has inspired colleagues in a career spanning 30 years in companies including Celgene, Schering Plough and AstraZeneca.

INNOVATION was the next category awarded. This was sponsored for the third time by Samarind, which is a previous winner of this distinction. This Award recognises ingenuity, creativity and innovation to improve outcomes for colleagues, clients and ultimately patients and it was presented to Diamond Biopharm for its work on a gene therapy approval which was challenging on many fronts as it was a unique product with a novel mechanism of action, treating an extremely rare disease.

Next to be announced was COMMUNICATION, which was supported for the second year running by global CRO, PPD. In this category, the method of communication can be conventional or innovative but the clarity and success in achieving the objective of the communication is vital. It went to the Auditgraph team, led by Mauricha Marcussen, which used technology to achieve the communication objective. They redesigned regional labelling processes and applied innovative technology to provide unprecedented levels of communication for a global biopharmaceutical company.

EDUCATION is gaining the reputation for being the most popular category for entries and this year was no exception. Out of a very strong field, the winner was the F Hoffmann - La Roche Regulatory Team, Basel, Switzerland. It was recognized for establishing an industry leading, high quality program that allows regulatory trainees to develop in a nurtured environment, thus acquiring the skills necessary to continue a successful career in the world of pharmaceutical regulatory affairs.

Celebrating the crucial role that service providers play in the regulatory process, SUPPORT acknowledges the importance of the quality of the work such companies and consultancies do. This year’s winner, the Triskel team clearly demonstrates a commitment to go the extra mile for clients. As their nomination said, ‘Triskel worked to timelines that were so challenging that they had to work around the clock. Their response was always "okay we will support you as much and as efficiently as we can."

'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. Our eminent judging panel, drawn from agencies, industry, law, academia and patient groups, had a challenging task to assess the excellent nominations we received in every category.'