Advisory Board Member

Dr Margarida Menezes Ferreira

 

Margarida joined the NDA in 2021. She is presently retired from Infarmed, the Portuguese Regulatory Agency for Medicines and Health Products. During her long experience as a Quality assessor of biological products, she has provided more than 150 scientific advices (national and European) and assessed and peer-reviewed several centralised European Marketing Authorisation including one Plasma Master File.  She was actively involved in establishing the EU regulatory framework for ATMPs from the very start, involved in the drafting of the legislation and many of the EMA and European Commission guidelines applicable to ATMPs including Quality aspects for investigational ATMP, cell based and gene therapy products, comparability, GMP for ATMPs, GMO requirements etc. She applies her extensive regulatory knowledge as well as a strong scientific background to provide companies with the best strategic orientation for ATMP development from R&D to market.

Key Areas Of Expertise
  • Quality of cell based and gene therapy medicinal products (ATMP) and of Biological/Biotechnological Medicinal Products
  • ATMP Product development and comparability
  • Good Manufacturing Practices for ATMP
  • Facilities optimization for ATMP manufacturing
  • Compliance with EU GMO requirements for ATMP
  • Compliance with the EU Transplantation and Transfusion Directives
  • Regulatory aspects of combination and combined ATMP
  • Borderline classification between ATMP, transplantation/transfusion products and medical devices
Before Joining The NDA Advisory Board  

Before joining NDA, Margarida worked for 23 years as researcher at Infarmed, having developed, and coordinated the Biological Laboratory of the National Control Laboratory for Medicines and Heath Products (OMCL). She was also senior CMC assessor and Scientific advice coordinator providing national advice by selected experts for the pharmaceutical development and health technologies assessment of medicines and health products including good practices and facilities.

She represented Portugal and acted as expert in Biologicals at the European Medicines Agency (EMA). At EMA, she was member of the Biologics Working Party for 20 years. She was also member of the Cell Products Working Party until its closure. She was the Portuguese member at CAT, the Committee for Advanced Therapies, since its establishment in 2009 until retirement. She was also founding Member of the EU Innovation Network (EU-IN).

Margarida is a biologist by training, PhD in Medical Biochemistry (Université d’Aix-Marseille II in France) and has a post-graduate fellowship at the National Institutes of Health, NIH, USA. Her research focused on molecular endocrinology. She has been guest professor at Lisbon and Coimbra Universities.

Recent Publications

Clinical Development and Commercialization of Advanced Therapy Medicinal Products (ATMPs) in EU: how are the product pipeline and regulatory framework evolving. Boráň, T. Menezes‐Ferreira M, Reischl I, Celis P, Ferry N, Gänsbacher B, Krafft H , Lipucci di Paola M, Sladowski D and Salmikangas P. Human Gene Therapy. September 2017

Regulatory viewpoints on the development of advanced stem cells – based medicinal products in the light of the first EU-approved stem cell product. Egbert Flory Paolo Gasparini, Veronika Jekerle, Tiina Palomäki, Patrick Celis Tomáš Boráň, James W McBlane, John Joseph Borg, Jan Kyselovic, Metoda Lipnik–Stangelj, Toivo Maimets, Margarida Menezes-Ferreira, Guido Pante, Stephanie Prilla, Una Riekstina, Christian K Schneider, Asterios Tsiftsoglou and Paula Salmikangas. Cell & Gene Therapy Insights (september 2015)​

Cell-based therapies for cardiac repair – overview of scientific observations and European regulatory viewpoints. Martina Schussler-Lenz, Claire Beuneu, Margarida Menezes-Ferreira, Veronika Jekerle, Jozef Bartunek, Steven Chamuleau, Patrick Celis, Pieter Doevendans, Maura O'donovan,Jonathan Hill, Marit Hystad, Stefan Jovinge, Ján Kyselovič, Metoda Lipnik-Stangelj, Romaldas Maciulaitis, Krishna Prasad, Anthony Samuel, Olli Tenhunen, Torsten Tonn, Giuseppe Rosano, Andreas Zeiher And Paula Salmikangas. European Journal of Heart Failure (2015).

Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMP) in Europe: the EMA/CAT Perspective. Paula Salmikangas, Martina Schussler-Lenz, Sol Ruiz, Patrick Celis, Ilona Reischl, Margarida Menezes-Ferreira, Egbert Flory, Matthias Renner, and Nicolas Ferry. In Regulatory Aspects of Gene Therapy and Cell Therapy Products. eds Mercedes Serabian and Maria Cristina Galli. (2015)​

​Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use. Paula Salmikangas, Margarida Menezes- Ferreira, Ilona Reischl, Asterios Tsiftsoglou, Jan Kyselovic, John Joseph Borg§, Sol Ruiz§, Egbert Flory, Jean-Hugues Trouvin, Patrick Celis, Janis Ancans, Marcos Timon, Guido Pante, Dariusz Sladowski, Metoda Lipnik-Stangelj & Christian K Schneider. Regen. Med. 10(1), 65–78 (2015)

​Advanced Therapy Medicinal Products for Whom? The Different Facets of Hospital Exemption. Reischl I and Menezes-Ferreira M. Regulatory Rapporteur 10 : 11 (2013)

Challenges with advanced therapy medicinal products and how to meet them. Committee for Advanced Therapies (CAT); CAT Scientific Secretariat, Schneider CK et al. Nat Rev Drug Discov. 9(3):195-201 (2010)

The Regulatory Perspective on the Risk-Based Approach and the Differences in the quality control of Cell-based Products and other Biological Products. Salmikangas P, Menezes-Ferreira M and Reischl I. Drug Development Vol. 5 (2010)

Use of unregulated stem-cell based medicinal products. Schneider CK, et al. The Lancet, 376(9740):514 (2010).

Dr Margarida Menezes Ferreira

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