Francesca Sandrini, JSB Medical Service Consultant, introduces us to the main changes and challenges of the Advanced Therapies sector. How does the drug production and supply process change? What is the role of the patient in this changing process?
Medicine has always been ruled by a linear flow: a drug is created by the Manufacturer (a pharmaceutical company), trasported to the distribution center (pharmacies) and purchased by patients. A production process that over the years has been highly standardized, automated and where issues can be prevented and corrected.
Since the introduction of the Advanced Therapies (gene therapy medicines, somatic-cell therapy medicines and tissue-engineered medicines) into the Pharmaceutical market, this flow has been dramatically changed: from linear to circular. At defined timings, the physician takes a biopsy made of cells or tissues from the patient, which is sent to the Manufacturer. The biopsy is then processed and cells and tissues are modified or cultivated to create a personalized drug, which is returned to the hospital center and administered to the patient. The medicinal product is not charged to the patient but depending on local regulations reimbursed by the hospital center or by the State.
The main change led by these new products involves primarily the patient, who is both the final goal and the starting point of this process, as holder of the drug’s principal ingredient. Then the medical staff as responsible for the sampling, who becomes part of the production process thus have to follow all the regulations to be applied to pharmaceuticals (Good Manufacturing Practice). Another big change affects the pharmaceutical company that still manages commercial and regulatory matters but generally outsources the entire production process by entrusting it to biotechnological companies, universities or hospital centers. The manufacturer itself has to face several issues: the biological nature of the raw material generates slight differences between each production process, requiring a certain degree of flexibility. Standardization and automation are still goal to achieve. Last but not least the courier companies face a radical change: they were used to move numbers of drug products and now they are asked to trasport a single Advanced Therapy Medicinal Product that must reach the patient in few days or even hours after its release.
Since the first Advanced Therapy Product received the Marketing Authorization as pharmaceutical product new challenges have arised for all people involved. Hence the importance of working alongside a partner specialized in this sector, a company offering you services specifically designed for the management of an ATMP and that already has the experience necessary to deal with all these new challenges.
Discover more about Francesca and read her interview on our Blog.
by Valentina Fossati and Angela Simone