TOPRA Awards for Regulatory Excellence were established in 2010, in order to recognise excellence in regulatory affairs and the achievement of individuals, teams and organisations both within TOPRA and in the wider Regulatory Affairs community.
The Awards are judged by a panel of respected figures in the regulatory industry. This year saw the creation of a new category: Futures.
The winner of this new category, as announced on the evening, was Maureen Graham from Diamond BioPharm Limited.
Speaking shortly after the event, Maureen said;
“The nominations in the Futures award category, which was (befittingly) a new category this year, were all amazing. It is truly an honour to have won against such tough competition. . We are privileged at Diamond BioPharm Limited in having the rare opportunities to work with some exciting advanced therapies that are in development and in the early stages of being commercialised. We are a small part of taking these forward to patients but with innovative thinking and creative regulatory solutions, we hope we are really expediting patient access to such life changing treatments.”
The Futures Award acknowledges the role of regulatory scientists in realising the potential of cutting edge technologies. The shortlist of nominees were:
The Advanced Therapies Forum Regulatory Team of PPD (from Belgium, Germany, Sweden, the UK and USA) – The idea to create this group arose from the recognition of the evolving regulatory landscape for cutting-edge technologies. The founders recognised the unmet need and the expertise they could bring to knowledge expansion in the regulatory affairs and clinical community.
Alexis Cockroft, Biopharm CMC Regulatory Affairs, GlaxoSmithKline – For the past 4 years, Alexis has worked on the CMC regulatory strategy for commercial processes, comparability and validation, and led the CMC content of the Marketing Authorisation Application for the first gene therapy medicinal product of its type. Her work paves the way for all future products of this type in Europe.
Maureen Graham, Managing Director, Diamond BioPharm Limited – Maureen and her team at Diamond made a significant contribution to the successful marketing authorisation for Europe’s first gene therapy product. The Glybera approval procedure has resulted in much discussion and may have helped with the proposal for future innovative regulatory pathways.
Lindsay Ham, Global Neuroscience Regulatory Head, Roche, Switzerland – In support of the clinical work package of EU-AIMS, an IMI funded project in Autistic Spectrum Disorders, Lindsay recommended and coordinated five separate CHMP Qualification Advice Procedures in 2014. The aim was to gain regulatory authority acceptance of valid biomarkers in ASD and is an important step towards a shared understanding of biomarker criteria between academia, industry and regulators.