Francesco Lanucara

WORK HISTORY

EDUCATION

SKILLS

ABOUT FRANCESCO LANUCARA

Regulatory Affairs CMC Director, with a solid background in cell and gene therapy products. My experience includes senior roles in the management of large, multisite CMC teams, development of CMC and regulatory strategies, interaction with regulatory agencies in different jurisdictions and authoring of regulatory documents (FDA Type B and Type C meeting briefing documents, EMA Scientific Advice/Protocol Assistance briefing documents, IND, IMPD, BLA and MAA dossiers). I have supported many Cell and Gene Therapy programs targeting both US and EU marketing authorisation at different stages of development. I have worked with a variety of products including adeno-associated viral vectors for in vivo and ex-vivo gene therapy; allogeneic and autologous cells modified with lentiviral vectors and/or mRNA; CRISPR technologies for in vivo and ex vivo gene therapy. I have worked with both large biopharmaceutical companies, academic spin-offs and small and medium-sized enterprises (SMEs). My involvement in these programs has included definition of regulatory strategies from nonclinical to first in human studies according to FDA and EMA regulatory expectations; enrolment in enhanced regulatory support schemes such as PRIME and ILAP; CMC development through clinical milestones and up to the final pivotal clinical studies; interaction with FDA, EMA and EU national Health Agencies; assessment, selection and management of CDMOs and CROs and associated changes in supply chains; authoring, reviewing and gap analysis of IND, IMPD, Module 2.3 and Module 3 of BLA and MAA dossiers and briefing documents for meetings with Health Agencies. Areas of expertise include- Solid understanding of US and EU regulation of Cell and Gene Therapy Products - Authoring and reviewing of Module 2.3 and Module 3 sections of IND/IMPD and BLA/MAA dossiers - Preparation and review of regulatory documents for FDA Type B and C meetings - Preparation and review of regulatory documents for EMA Scientific Advice and Protocol Assistance - Preparation of responses to questions from Regulatory Authorities at different stages of developments - Support of cell and gene therapy programs for EMA PRIME and UK ILAP schemes - Characterisation and comparability studies of in vivo Gene Therapy (adeno-associated viral vectors) and ex vivo cell therapy (lentivirus and mRNA-modified allogenic and autologous cells) products according to current regulatory guidelines - Solid understanding of biophysical techniques for Cell and Gene therapy product characterisation