Current position and relevant professional experience:
I am a senior regulatory consultant (semi-retired) and former regulatory, pharmacovigilance and quality and compliance consultancy company director and owner.
I have supported a wide variety of regulatory areas throughout my career with a special interest in rare diseases. This includes assisting with the regulator input for over 20 orphan products at various stages of development.
Stand-out authorisation examples:
• PAXENE (Paclitaxel) for Kaposi's sarcoma (1999)
• Colobreathe for cystic fibrosis (2012)
• Glybera (the first EU gene therapy product) for familial lipoprotein lipase deficiency (LPLD) (2012)
• Yescarta (one of the first CART cell authorisation in EU) for oncology indications (2012)
• Waylivra (Volanesorsen sodium) for familial chylomicronaemia syndrome (FCS) (2019)
Current or previous involvement in TOPRA activities:
I am a Fellow of TOPRA and previously Chaired the TOPRA Basics of Regulatory Affairs course for 10 years alongside presenting on the Introductory Course. I am a previous winner of the TOPRA Award for Innovation based on our work on the first gene-therapy product approved in Europe. In 2015, I also won the TOPRA Award for Futures.
Personal statement:
Having been in Regulatory Affairs since before King Henry VIII, when TOPRA was called BIRA, I fully engrossed myself in Regulatory Affairs and in BIRA. In the early days I took part in many working groups developing programmes, contacting speakers etc. I attended a number of conferences and symposia. I was one of the first regulatory professionals to be awarded the Diploma in Regulatory Affairs organised by BIRA and Cardiff University. I chaired the Basics Course for probably over 10 years and presented on the Introductory Course.
As my career progressed, I encouraged my staff to join TOPRA and to get involved, as I truly believe the importance it holds for Regulatory professionals, new and established.
When I started my company, Diamond Pharma Services Limited, we were honoured to be awarded several of the TOPRA awards for our work within industry.
My career has spanned all areas from the ground up, from new chemicals, to generics, established use, biologics, biotech, cell andgene therapy, having involvement in all disciplines - CMC, nonclinical, clinical etc. It would be good to finally finish my time in Regulatory Affairs with a position on the Board of TOPRA.