Pharmacovigilance in personalized medicine: Adapting to a new era of drug development

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One of the ways that the COVID-19 pandemic had a profound impact on the pharma industry was how it highlighted the importance of pharmacovigilance. As personalized medicine gained traction, drug developers had to evolve their strategies to ensure safety and efficacy. In their report, “The Future of Pharmacovigilance,” Dr. Sabine Jeck-Thole and Ben Enejo, partners at Arthur D. Little, discussed the challenges and opportunities in this new landscape.

Embracing the shift in perception of adverse events and side effects

“When we heard about adverse events and side effects, it was not bad news,” Jeck-Thole said in an interview. “It indicated that we understood our drug or vaccine much better than without any safety information.” She emphasized that this shift in perception was essential for the industry as it moved towards pharmacovigilance in personal…

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Why growth for pharmaceutical companies can be dangerous

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Prosperity can be a double-edged sword for pharma companies. While there are obvious financial advantages to selling more drugs, growth phases often lead to an uptick in quality problems, said Craig Wylie, managing partner USA at Arthur D. Little. A solid plan is needed to help pharma companies keep track of their processes as they ramp up manufacturing scale.

One recent case in point is Emergent Biosolutions (NYSE:EBS). Early in the pandemic, the company inked deals to contract manufacture COVID-19 vaccines for Johnson & Johnson (NYSE:JNJ) and AstraZeneca (LON:AZN). Shareholders were enthralled with Emergent’s growth prospects. And on August 14, 2020, the company saw its share price hit a record high of $133.42.

The situation quickly changed when the company admitted that it had to dispose of millions of vaccine doses because of possible quality problems. Emergent has…

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