Simona Guidi

Associate Director, Product Lifecycle Management

ProPharma Group

Simona Guidi has 25 years of experience in CMC for biological products and cell and gene therapy products (ATMPs). Ms. Guidi has significant experience in compliance assessment for the early stages of ATMPs product development, both for the production process and quality control strategy for batch release purposes.

Ms. Guidi actively supported several central/decentralized ATMPs facility teams to achieve the first manufacturing authorization for somatic cell therapy, gene therapy and tissue engineered products in EU-non EU countries for clinical/commercial purposes.

During her career, Ms. Guidi has collaborated with the design teams of ATMPs production sites to assess their compliance with Eu/US GMPs and participated in numerous remediation plans after EMA/FDA regulatory inspections to upgrade production sites to GMP/GMO compliance.

A new era in cancer care
Thursday, March 13, 2025
Immunotherapy has transformed the field of oncology by harnessing the immune system’s innate ability to mount targeted attacks on cancer cells. Building on this foundation, cell and gene therapies take immunotherapy to the next level by reprogramming genetic blueprints and engineering immune cells to deliver highly personalized, possibly curative treatments. Together, these innovations could dramatically improve outcomes, with the potential to transform cancer into a more manageable condition — or even eliminate it.
From centralized to decentralized
Wednesday, February 04, 2026
A decentralized model for cell-based products offers various benefits including fresh tissues and drug products, reduced costs, and shorter treatment times.