Author: Dr. Chitra Lele, Sciformix Corporation
Pharmacovigilance is evolving from a position of reactive safety oversight to a more proactive, clinically relevant approach that combines seamless analysis of pre- and post-approval data and input from all stakeholders.
According to a recent report by McKinsey & Company, $217 billion worth of originator products will have lost patent protection by 2018, with $150 billion of this predicted to be lost between 2010 and 2017. Although the amount of blockbuster drugs coming off patent year-on-year is set to slowly decrease up to 2017-2018, innovative drug companies are increasingly picking up the defi cit by expanding their portfolios into new markets. Thanks to their spending power and potential for high volumes, these markets are set to expand by 15-20% over the next five years.
This new model involves fostering synergistic partnerships across multiple stakeholders, data exchange agreements and data hand-offs. However, the multitude of collaborators can increase operational complexities, resulting in enhanced exposure to safety and regulatory risks. Companies must therefore pay extra attention to their pharmacovigilance or product vigilance (PV) policies and practices.