QuintilesIMS Blog

Fresh ideas and insights from our experts around the globe

Brazilians flock to pharmacies: How healthcare companies can bolster sales by embracing this shifting shopper trend
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Paul Kelly
How a new regulatory update will change the way companies file safety reports – and what to do to prepare.
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Robin Douglas
A centralized approach to monitoring has been shown to improve data quality and patient safety while lessening the burden on-site staff.
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Kenne Mountford
How EHR data can help researchers improve clinical trials and demonstrate the real-world value of new treatments.
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Jennifer Christian
How to improve collection of patient reported data, and how it can increase the value of new treatments.
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Susan Tansey
Proving the value of bringing the patient voice into rare disease trial design.
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Margot Stam Moraga
Pharmacovigilance is all about identifying, assessing, understanding and preventing adverse drug reactions. To do that effectively, biopharma companies need to screen the signals that could lead to an adverse reaction. Signal management relates to the safety information we gather from variety of sources, including spontaneous reports, clinical studies and scientific literature, which are potentially caused by a medicine and warrant further investigation, to confirm new adverse reactions or changes to known risks causally associated to this medicine.  Proactively detecting signals for the identification of risks related to a drug is essential for the patients’ safety and can have significant impact on the drug’s marketing status. Approximately 40 percent of the confirmed signals...
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Jean Paty
If you’ve attended a biopharma conference or industry meeting in the past 18 months you’ve probably heard companies touting the fact that they are “patient-centered.” In this increasingly patient-driven healthcare economy we all want to be patient centered – even more so as the Food and Drug Administration (FDA) embraces its “ Patient-Focused Drug Development Initiative ,” an effort to get patients, patient advocates and patient communities more involved in the regulatory process. But for a lot of people “patient-centered” has become one of those phrases, like “people person” or “all natural.” It sounds good, but it doesn’t hold a lot of substance unless companies implement real changes that actually incorporate the patient’s voice into the entire lifecycle for their products – from...
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Risk is an inherent part of every drug development project. Pharmaceutical companies face financial risks, regulatory risks, market risks, and most importantly – patient safety risks. Figuring out how a drug will impact patients across the spectrum of target users, and whether it is safe for all potential patients, is a vital step in validating its safety and efficacy. Which is why risk management planning has become an important part of the drug approval process. Medication risk management plans, which are known as Risk Evaluation and Mitigation Strategies (REMS) in the US, and Risk Management Plans (RMPs) in the EU, have been embedded in the regulatory system for more than a decade as a way to ensure that the benefits of a drug outweigh its risks by as much as possible.  A drug...
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Judith Beach
Quintiles recently provided input to the U.S. Food and Drug Administration regarding the issue of patient engagement in drug development.  The FDA requested comments as part of their ongoing efforts to ‘develop and implement strategies to solicit patient perspectives during the medical product development process and in regulatory discussions‘, as directed by the Section 1137 of the 2012 FDA Safety and Innovation Act (FDASIA). We were excited to share our thoughts on this important topic. Engaging patient feedback in the drug development process has long been a priority for Quintiles, and we have derived extensive insight from the more than 100,000 successful trial designs and 110 product launches we’ve supported. Working with experts from multiple perspectives, we made the following...
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Nigel Rulewski
March 6, 2015 was a landmark day for the biosimilar manufacturers. It is the day that U.S. Food and Drug Administration (FDA) approved a biosimilar version of filgrastim, making it the first biosimilar product to enter the U.S. market. The approval was no great surprise. An abbreviated licensure pathway for biosimilars approval in the U.S. was established in 2010 as part of the Affordable Care Act, and filgrastim offered an attractive package of attributes making it a prime candidate for FDA’s first step into this new product category. A biosimilar version of filgrastim has been on the European market for years, and the makers can provide hundreds of thousands of days of patient outcomes data, post approval, which provides FDA with deep assurances around its safety and efficacy. I...
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