Webinar — Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

About the Webinar

Transitioning a cell and gene therapy from the clinical development stage to market requires a coordinated evolution in terms of regulatory strategy, improvement of the quality systems, expansion of the manufacturing infrastructure and organisational capabilities.

In this webinar, we will explore the key challenges of approaching commercialization, focusing on the responsibilities of the Marketing Authorization Holder (MAH) and manufacturing readiness. We will discuss how regulatory expectations evolve from the clinical to the commercial stage, including the increased CMC requirements, inspection readiness and post-authorization obligations. We will also explore how facility and operational processes must be optimized to lead to a more mature quality management system for routine productions. A shift in mindset is required to support commercial supply and align organizational structures and competencies.

Through practical insights and real-world experience, the webinar will demonstrate how an integrated, end-to-end approach is essential for mitigating risk, avoiding delays and establishing a sustainable, robust pathway to commercialization of cell and gene therapies.

What You’ll Learn

Key regulatory and quality challenges when transitioning from clinical to commercial supply, including regulatory authorities’ interactions, dossier expectations, and post‑authorization obligations.
How to assess the organizational readiness and be prepared for commercial operations: mindset shifts, QMS maturity, personnel competency, MAH vs CMO roles.
Critical elements of facility and manufacturing preparedness, from operational controls to interactions with clinical partners.

Who Should Attend

Leaders and managers responsible for regulatory affairs, CMC, quality assurance, and manufacturing operations.
Professionals working in:

Emerging biotechs preparing for first time commercialization
CDMO scaling their manufacturing to commercial products.
Cell & Gene Therapy development
Regulatory and quality functions
Manufacturing science & technology (MSAT)
Technology transfer and supply chain
Clinical operations

Unable to join? Register and you will receive the recording after the live session.

Meet the Speakers

Michela Palmisano

Senior Cell and Gene Therapies Consultant

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Daniela Celeste Profico

Senior Cell and Gene Therapies Consultant

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Michela Palmisano

Senior life sciences professional with extensive experience in regulatory affairs and quality management for Advanced Therapy Medicinal Products (ATMPs). She holds a PhD in Molecular Medicine and a Postgraduate Master’s in Regulatory Affairs & Market Access.

Michela spent over 10 years in academic research, focusing on stem cell biology, oncology, and regenerative medicine. Over the past decade, she has held roles of increasing responsibility in the biotech and pharmaceutical industry, progressing from Quality Control to Regulatory Affairs Manager and Qualified Person, managing CMC strategies for cell and gene therapy products across clinical and commercial stages. She led CMC regulatory strategies for gene therapy programs from early development to commercialization, including products developed, manufactured, and marketed in both the EU and US, with direct interaction with EU national authorities, EMA, and FDA.

In parallel, Michela served as European Quality Expert for ATMPs at the EMA, contributing to the assessment of quality dossiers.

Daniela Celeste Profico

Biotechnologist with over 17 years of experience in the development of Advanced Therapy Medicinal Products (ATMPs). Since 2008, she has focused on pioneering work for the treatment of neurodegenerative diseases, contributing to phase I and II clinical trials. Daniela has worked as Head of manufacturing, Quality Assurance Manager and Qualified Person in academic facilities overseeing GMP manufacturing, batch release, regulatory compliance, and quality systems for ATMPs.

Daniela holds a Master’s degree in Preclinical and Clinical Research and a Bachelor’s degree in biotechnology. She is also a faculty member for the international Master’s program in ATMP manufacturing at the University of Granada.

Beyond her core responsibilities, Daniela has contributed to scientific literature with numerous publications on neural stem cell therapies and regenerative medicine. She joined Propharma in 2025 as Qualified Person and Senior Consultant for Cell and Gene Therapies.