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Pfizer Clinical Trial Agreement

2020/12/15 07:53

If the current studies are completed, Pfizer and BioNTech expect to obtain emergency approval or administrative approval as early as October 2020. Companies currently expect to produce up to 100 million doses worldwide by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final selection of doses from their clinical trial. In addition, Cory Lewis, Cook Pharmica, said last week at BIO International in San Francisco that the company was seeing more sponsors requesting clinical trial agreements to make the touch points of management more routine – and include it specifically in the contract. Related Tags: Clinical Trial, Contract Research Organization, Contract, Pfizer While the length of Parexel`s agreement has not been announced, analysts expect it to be similar to the Icon agreement. Parexel`s current five-year contract began in June 2011 with an unspoken end date at some point this month. In a recent survey of clinical trial professionals (including pharmaceutical sponsors, CROs, site representatives and suppliers), interviewees indicated that… This press release contains forward-looking information about Pfizer`s efforts to combat COVID-19, mNAR`s BNT162 vaccine program, a collaboration between BioNTech and Pfizer to develop a potential COVID 19 vaccine, an agreement with the United States on the production and supply of BNT162 and other potential agreements, including their potential benefits, production and distribution, as well as the expected date of clinical trials and regulatory submissions, which could result in significant risks and uncertainties that could lead to actual results being significantly different from expressed or implied results. Risks and uncertainties include, among other things, research and development uncertainties, including the ability to meet expected clinical criteria, start and/or completion dates of clinical trials, time frames for submitting legal approvals, approval dates and/or launch dates, as well as the possibility of new adverse data for preclinical or clinical trials, and complementary analysis of existing data for preclinical or clinical trials; The risks associated with the provisional data; the risk that data from clinical trials will be subject to different interpretations and evaluations, including during the peer review/publication process, in the scientific community in general and by regulators; whether and when data from the BNT162 mSA vaccine program will be published in specialized scientific journals and, if so, when and with what modifications; Whether regulators will be satisfied with the design and results of these preclinical and clinical and future trials; Whether and when applications for authorisation of biologics can be submitted in all legal systems for potential vaccine candidates as part of the cooperation; whether and when such applications can be accepted by regulators, this will depend on countless factors, including determining the benefits of the product over its known risks and determining the efficacy of the product, if approved, whether these vaccines will be commercially successful; decisions made by regulators regarding labelling, manufacturing process, safety and/or any other issue that may affect the availability or commercial potential of these vaccine candidates, including the development of products or therapies by other companies; Capacity or production capacity, including the ability to produce the estimated number of doses over scheduled periods; Whether and when a future production agreement is reached with the United States; If and when other delivery agreements are concluded Uncertainty about the possibility of obtaining recommendations from technical immunization committees and other health authorities on these vaccines, as well as uncertainties about the commercial impact of these recommendations; and the evolution of competition.

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