Alejandro Barquero Lemus
Regulatory Affairs Manager Almirall
Alejandro Barquero is a biopharmaceutical professional with experience spanning project management, quality, regulatory affairs and CMC development strategy, supporting innovative therapies from early development through clinical translation and commercialisation.
His expertise is centred on biological medicines, with a particular focus on cell and gene therapies. Having worked across both biotechnology start-ups and established pharmaceutical companies, Alejandro brings a cross-functional perspective on the development challenges involved in advancing complex therapeutic products.
He is particularly interested in helping translate scientific innovation into clinically and commercially viable treatments, with a focus on bringing potentially curative therapies to patients with serious diseases.
Seminars
- Clarifying EMA & MHRA expectations for mRNA drug substance, drug product, biodistribution, toxicology & immunogenicity as therapeutic applications diversify
- Understanding how regulatory requirements differ across vaccines, protein replacement, oncology, gene editing & other emerging mRNA applications
- Addressing the regulatory classification of mRNA products, including where non-genome-altering mRNA and mRNAenabled gene editing fit within existing frameworks
- Keeping pace with evolving global guidance while identifying where RNA-specific regulatory expectations remain unclear
