Francesco Lanucara, Senior Manager Regulatory Affairs, CMC

 

I joined PharmaLex in June 2021, coming from my position as Senior Technical Specialist in Allergan biologics (Liverpool) where I was responsible for analytical method development and CMC leadership of several biotherapeutic programs, including gene therapy products.

My interest in CMC and regulatory aspects of gene therapy and other Advanced Therapy Medicinal Products (ATMP) prompted me to pursue a career in regulatory affairs, leading me to my current role in the Regulatory Affairs CMC team (biologics) in PharmaLex UK.

Since the beginning I was lucky enough to get involved in projects across different biomolecules and at different stages of clinical development.

This represented a great opportunity for me to translate my experience in CMC and analytical development into solutions to facilitate the progression of regulatory submissions, while at the same time learning the key elements of the procedures involved in the interaction with regulatory agencies pre- and post-submission.

The variety of the projects in which I have been involved so far has given me an opportunity to get ‘hands-on’ experience on the regulatory strategy for biomolecules that I have not dealt with before, become familiar with new regulatory guidance, as well as understand key aspects of the professional interaction between client and consultant, an element which was entirely new to me.

The first few months in PharmaLex were also an opportunity for me to get involved with business development, thus liaising with colleagues outside of the team and with different professional backgrounds. This interaction helped me to understand the business model of a Regulatory consultancy and how to anticipate and meet the expectations of our clients.

My passion for gene therapy products was met by the opportunity to work with our marketing colleagues on a number of projects to promote our company offering to support ATMP programs, including authoring articles, presenting webinars and even recording our own podcasts on regulatory and CMC aspects of ATMPs.

Regular meetings and interaction with colleagues actively involved in ATMP projects have given me enormous insights into this field, thus furthering my understanding of the associated challenges and broadening the scope of the projects I am now able to support.

I feel I have already grown a great deal professionally, since joining PharmaLex six months ago. Every client and every program come with their own challenges, which represent opportunities for me to learn, advance and further develop within the field. The daily interaction with colleagues within and outside the team, from many different geographical areas and with complementary professional backgrounds is invaluable to my development, and I feel like I am now exactly at the stage I was hoping to be when I decided to join PharmaLex, and I look forward to what I am yet to discover and learn within the company.