Worldwide havoc caused by the outbreak of Covid-19 sustained fatal. No nation could contain the spread of the virus due to limited knowledge and resources, which led to the surge of clinical trials. These trials are dependent on supplies, which are tools and equipment used for conducting scientific experiments, investigations, Clinical Trial Supplies and clinical research.
According to the market database, stringent handling requirements for bio pharmaceutical products commencing these trials require an improved clinical trial supplies strategy. Many trials have been conducted in the past year, leading to increased research and development expenditures in pharmaceutical and bio pharmaceutical companies. However, the rising cost of drug development and the negative impact of Corona virus are expected to hinder the market growth during the forecast period.
According to the statistics of the number of clinical trials authorized by the Italian Medicines Agency in 2019, chemical active ingredients were involved in 385 trials. Biological/biotechnological active ingredients were involved in 246 trails and 24 of them involved Advanced Therapy Investigational Medicinal Products (ATIMPs).
New Guidance issued by the Italian Medicines Agency
Due to the emergence of the pandemic, the Italian Medicines Agency guided the management of clinical trials in 2020. Since, Sponsors, CROs, and non-profit organizations were addressed, this allowed some derogation. The purpose is to ensure that clinical trials can continue despite the current situation. There are several phases to these trials, including submission of authorization requests, evaluation by Ethics Committees, and management of these trials outside investigational sites.
There are some exemptions from the current EU and Italian legislation in the Guidance. When appropriate, the director of the hospital pharmacy and the principal investigator can arrange direct deliveries to patients. It is important to assess whether the site can maintain trial operations. If it is not available to the public for containment procedures, the trial would be momentarily suspended or patients should be transferred to the adjacent active clinical trial site.
In public health facilities, hematological tests can be performed. The use of private sites is recommended when it is the only method of protecting patients. In addition to telephone and videoconference contact with the site staff, Sponsors and Contract Research Organizations may also be able to do so if these contacts are specified in Standard Operating Procedures by the Data Protection Officer.
When patients incur additional expenses when adopting urgent measures, sponsors are allowed to reimburse them. To manage patients, sponsors may enter into service agreements directly with specialized agencies or companies, such as home nursing services. The principal investigator must be responsible for such activities. The new guidance issued by the Italian Medicines Agency supports clinical trials, propelling the clinical trial supplies market in Italy.
COVID-eVax to propel supply growth
According to the market database, COVID-eVax, a COVID-19 vaccine contender developed by Rottapharm Biotech, began its assessments soon after receiving Italy’s drug regulatory approval. Rottapharm Biotech is a Rome-based company. Contradictory to other vaccines already permitted by the European Medicines Agency, this vaccine forges on a DNA portion, which is unusual from adenoviral-based or mRNA-based vaccines. Phase II of the vaccine is likely to begin soon and Phase III in spring 2022. Naples, Rome, and Monza will be the sites of the trials.
The second Italian vaccine candidate, developed by the Italian biotech firm ReiThera in association with Belgium’s Univercells and Germany’s Leukocare is already in phase II trials. This technology is based on the adenoviral vector. Both AstraZeneca and Johnson & Johnson use it. The market database states that Takis launched a crowdfunding initiative for COVID-eVax in February 2020 but raised just 53,000 euros ($63,923.30). Rottapharm became involved in June 2020, providing funds and looking for investors.
Despite how devastating the pandemic has been, scientists had expected it. With global connectivity at its peak, epidemics are often just a flight away. Since many of the diseases identified by the World Health Organization occur in animals, outbreaks are more likely when animals and people come into close contact. These contagious diseases can spread through habitat encroachment, animal husbandry, and wildlife trade. According to the market database, the recent outbreaks of Ebola, Lassa fever, MERSCOV, NIPAH, Rift Valley Fever, and Money pox, have led many clinical research organizations to commence trials to prevent such outbreaks in the future. Since these trials are dependent on clinical supplies, the growth of this market is highly anticipated. The Clinical Trial Supplies market and its 10-year business outlook can be understood using Global Market Database.