Tag Archives: post-approval strategies

Q&A: Gauging Impact of Comparative Effectiveness Research

While at DIA’s 50th Annual Meeting, we got the chance to speak with Nancy Dreyer, chief of scientific affairs and senior VP at Quintiles Outcome, the CRO’s real-world and late-phase research division, about the current tide for comparative effectiveness research (CER). Dreyer is the leader of the GRACE Initiative, which has developed good practice principles for […]
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Takeaways from the Post-Approval Summit

Dr. Richard Gliklich, president of Quintiles Outcome and a professor at Harvard Medical School, highlights the most prominent post-approval issues and risks coming out of this year’s Post-Approval Summit, held on May 7th-8th. Brand managers prodding products across the regulatory finish line to commercialization are finding themselves in yet another race, instead of in the […]
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Post-Approval Regulatory Priorities: Progress or Pile-Up?

An enduring falsehood about the pharmaceutical industry is that the heavy lifting ends with a successful new drug registration. What comes after is the equivalent of a well-funded retirement, where providers embrace the therapy, payers meet the price, and patients push the boundaries of clinical practice toward lucrative new indications. The reality, however, is starkly […]
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