London – Arena International announced today the first-ever Direct-to-Patient and Virtual Clinical Trials (https://arena-international.com/dtpvirtual/) will be held as a Digital Experience on Thursday, 9 July 2020. As COVID-19 has forced the market to move towards decentralized and remote models, this event provides the perfect opportunity for clinical trial professionals to hear, meet and learn from top-class speakers around the world to discuss challenges and innovations in this critical time.
Pharma R&D Outsourcing
Pharmaceutical companies are increasingly outsourcing their R&D activities, including early-stage research programs, to third party organizations -- academic institutions, biotech startups, and private contract research organizations (CROs) -- as a means to stay competitive, flexible, and profitable against all odds.
Economically, there are factors such as increasing downward pressure on drug pricing by governments, an impending “patent cliff” threatening $198 billion worth of sales during 2019-2024), and downturns in income due to the increasing competition from generics and biosimilars.
From the innovation's point of view, there is a boom in life sciences, stimulating the emergence of novel biological targets, therapeutic modalities, and even whole new areas of drug discovery -- adding opportunities, but also complexity and uncertainty to research programs. In fact, according to Deloitte’s report, return on late-stage pipelines dropped for the top 12 pharma companies from 10.1% in 2010 down to 3.7% in 2016.
Technologically, there is an unfolding “digital revolution”, bringing even further complexity and investment cost to the table -- in a form of artificial intelligence (AI), data mining and big data technologies, data-driven diagnostics, and digital health.
Finally, the rise of the personalized medicine paradigm forces companies to rethink their research pipelines and “one-size-fits-all” product development programs, as well as reconsider their market strategies.
This post was originally published on Quora, answering the question: "How do drug manufacturers select the right contract research organization(CRO)?"
Selecting the right contract research organization (CRO ) obviously depends on what activity is outsourced and with which regulations the outsourced processes need to comply. However, the following criteria certainly apply to pharma companies.
Typically, we would request evidence on how often the CRO has performed the activity, i.e., what their relevant experience is from a technical operation point of view. However, it is also very important to understand how they deal with Quality Assurance, Training, Disasters, and if they have been inspected by health authorities before, if upon inspection there were any critical findings, and how they managed these findings.