Consultations on cell therapy and advanced therapy medicinal products

Consultations on cell therapy and advanced therapy medicinal products by our Biotechnology expert Dr. Ancans are based on five years of expert experience as a member of EMA Committee for Advanced therapy products and Cell product working party, professional involvement in the classification and marketing authorization evaluation procedures, and participation in the drafting process of related guidelines.

This has been followed by professional experience with both public and private sector projects, including European Commission and KPMG.

Our expert consultations have helped such public and private clients as:

References:

“Manufacturing, characterization and control of cell-based medicinal products: Challenging paradigms toward commercial use” (2015);
Regenerative Medicine:
https://www.futuremedicine.com/doi/full/10.2217/rme.14.65

“Regulatory evaluation of Glybera in Europe – two committees, one mission”; (2013),
Nature Reviews Drug Discovery:
http://www.nature.com/nrd/journal/v12/n9/full/nrd3835-c1.html

“Mesenchymal stem cells in solid organ transplantation (MiSOT) fourth meeting: Lessons learned from first clinical trials” (2013),
Transplantation:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3737392/

“Cell therapy medicinal product regulatory framework in Europe and its application for MSC- based therapy development“ (2012), Frontiers in Immunology:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3418507/

“Challenges with advanced therapy medicinal products and how to meet them” (2010),
Nature Reviews Drug Discovery:
http://www.nature.com/nrd/journal/v9/n3/full/nrd3052.html

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info@medrego.com
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Medrego Consultations

Janis Ancans Medrego Chief Scientist
Expert on cell therapy and advanced therapy medicinal products

PhD. Dr.biol. Janis Ancans