Technical services and regulatory affairs consulting group Diamond Pharma Services Ltd has received both the Futures and Support awards at The Organisation for Professionals in Regulatory Affairs (TOPRA) Awards. The Awards recognise the role of the company’s expert regulatory services in supporting Kite Pharma Inc’s successful development of its CAR-T cell immunotherapy product for lymphoma and leukaemia.
Established in 2010, the TOPRA Awards recognise the achievement of individuals, teams and organisations in the regulatory affairs community. The Futures Award acknowledges the role of regulatory scientists in realising the potential of cutting-edge technologies and the Support Award recognises the critical role supporting organisations play in the drug development process and life cycle of a drug. Diamond won both categories for its services to Kite Pharma Inc; supporting the successful development of its breakthrough CAR-T cell immunotherapy product, YESCARTA through to Marketing Authorization Application (MAA). Diamond has been previously recognised by TOPRA with the Innovation Award (2012) and Futures Award (2015) for playing an integral part in the European regulatory approval of the first gene therapy product, Glybera, and subsequently paving the way for existing regulatory framework for such products.
Diamond’s regulatory team supported Kite Pharma Inc in all European regulatory activities, including engagement with regulatory authorities, dossier writing, scientific advice meetings, orphan designations for six conditions, ATMP classifications, paediatric investigation plans, clinical trial applications, GMO applications, and the coordination and leadership for MAAs across several EU countries.
For further information about Diamond Pharma Services visit www.diamondpharmaservices.com
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