• Tue. Dec 7th, 2021

From Assobiotec-Federchimica a new model for access to advanced therapies

Byeditorial

Nov 24, 2021

“Advanced therapies have an intrinsic complexity, but they are offering incredible therapeutic opportunities because they not only treat symptoms but also the disease, and it is proving to be applied in some of the rarest diseases, for which up to now there was no a therapeutic solution “. Thus Maria Luisa Nolli, member of the board of directors of Assobiotec-Federchimica, introduced this morning the webinar “Advanced therapies in Italy: today and tomorrow” organized by the Higher Institute of Health and Assobiotec-Federchimica. The goal is to improve interventions in all phases of advanced therapies (known as Atmp, Advanced Therapy Medicinal Products): from preclinical to clinical development, up to authorization and administration to patients. Advanced therapies – which include cell and gene therapies and tissue engineering – are representing a real revolution for medicine: they are personalized drugs, based on biological material (cells or tissues, possibly engineered, or nucleic acids) that aim to heal the patient with a single administration. They have proved effective with hemoglobinopathies, haemophilia, skin and eye diseases, neurodegenerative and neuromuscular diseases and with primary immunodeficiencies. Institutions, companies and stakeholders have agreed on the need to network to promote one rigorous development of advanced therapies and their transfer as quickly as possible to the patient’s bed, under the banner of sustainability and fairness. “For companies and institutions it is a duty to guarantee patients with serious illnesses, and without satisfactory therapies, the right to access potentially effective treatments – explained Patrizia Popoli, director of the National Center for research and preclinical and clinical evaluation of drugs of the ISS – with the difficult task of providing regulatory support to companies, guaranteeing the development of effective and safe drugs, adopting evaluation strategies that adapt to the complexity of advanced therapies while maintaining the necessary methodological rigor “. 4 new Atmp approved by Ema. Today, 14 are already on the market in Europe, of which 7 have received reimbursement from Aifa, while 6 are being evaluated. The data from the latest Atmp Forum Report also say that the new trials underway are for about twenty pathologies and that the most involved therapeutic areas are oncology and hematology. A photograph that clearly shows how the number of these therapies is destined to grow rapidly, as also confirmed by the data of Alliance Regenerative Medicines: more than 2,600 trials worldwide, of which 240 are already in phase 3 (158 carried out by the bio- pharmaceutical industry, 85 from academia, governments or other institutions). “To overcome the challenge of rapid access to innovation, a permanent alliance between research institutions, innovative companies and regulatory bodies is required – declared Riccardo Palmisano, president of Assobiotec-Federchimica – for this reason we propose to strengthen the collaboration born last year in the round table with Iss, Ministry of Health, Aifa, Regions, with the establishment of a permanent discussion table which will have the aim of highlighting and resolving the many knots that still exist. today they meet along all the different stages of development of these therapies. The progress of science is unstoppable and all the players in the health system must work together to guarantee patients the maximum benefit “.

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