We are delighted to announce the appointment of Monica Pianella as Associate Director of Regulatory Affairs.
With over seven years’ experience in advanced therapies, Monica joins Boyds from the Cell and Gene Therapy Catapult (CGTC) where she was Senior Regulatory Affairs Manager working in early drug development with a strong focus on CMC and cell and gene therapy regulatory requirements.
Prior to this, Monica was a Senior Scientist in Formulation Development within the cell and gene therapy group at GlaxoSmithKline, where she first started working on regulatory filings for ex-vivo gene therapy products.
Monica holds an MSc in Pharmaceutical Chemistry and Technology from Sapienza University of Rome, specialising in drug delivery and targeting. Her thesis, partly developed at the University of Rhode Island, focused on coated niosomes for targeted delivery of therapeutic agents for the treatment of amyotrophic lateral sclerosis and solid tumours.
Previously, Monica was a secondee for the MHRA British Pharmacopoeia’s ATMP Working Party, contributing to the development of best practice documents in relation to advanced therapies. She also holds a RAPS 9-module programme certificate in regulatory affairs for pharmaceuticals.
In her role at Boyds, Monica will offer guidance and operationalise regulatory strategies for therapy developers, including interacting with regulatory agencies and preparing regulatory documentation for submission to the competent authorities.
Commenting on joining Boyds, Monica said: “I am excited to utilise the wealth of knowledge and skills I have acquired during my time in the pharmaceutical industry, as well as my experience in a not-for-profit innovation and technology organisation whilst working with a variety of early-stage collaborators. My varied expertise means I can bring a diverse perspective to any challenges or opportunities that may arise.
“I was attracted to Boyds as I was looking to expand my experience in later-stage clinical development. My role at Boyds will allow me to delve into cutting-edge science, navigate diverse markets, and work on different therapy type at various stages of development, all whilst being part of an experienced regulatory team.”
Patrick Ginty, Senior Director of Regulatory Affairs at Boyds, added: “We’re thrilled to be once again growing our regulatory affairs team, responding to increasing interest from biotechs and academic groups seeking our guidance and support in the development of their medicinal products. Monica’s unique blend of expertise across science, pharmaceuticals, and innovative advanced therapy products, coupled with her regulatory affairs knowledge, will prove invaluable to our clients as we guide them through the various procedures needed to bring their product to market.”