Alex Bloom
Alex Bloom is Chief Technology Officer at Aviado Bio.
CPD SupplementThe Olaratumab experience
As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...
CPD SupplementCase Study- Luxturna
The ATMP Luxturna (voretigene neparvovec) is a GTMP which utilises a recombinant adeno-associated viral vector serotype 2 (rAAV2) capsid as a delivery vehicle for the human retinal pigment epithelium 65 kDa protein (hRPE65) cDNA to the retina. Luxturna is approved for patients with retinal dystrophy associated with biallelic RPE65 mutations ...
CPD SupplementUnderstanding the basics of ATMP regulation
Advanced therapy medicinal products (ATMPs) are biological products which comprise a diverse group of medicinal products that are often complex and diverse in nature. As these products are regularly developed for diseases of high unmet need, the requirements for evidence generation to support marketing authorisation often require innovative development plans. Within this continuing professional development supplement we investigate the regulation of ATMPs in the EU and US [see also Regulatory Rapporteur October 2020 and February 2020 for articles by Harriet Edwards on ATMPs].
CPD SupplementExpedited drug development regulatory pathways in the EU and the US
This continuing professional development (CPD) supplement focuses on the regulatory framework available to drug developers for expediting their products’ development and review processes in the EU and US. These mechanisms are relevant for products which address an unmet medical need in the treatment of a serious and/or life-threatening condition.