For as long as I can remember, Humpty Dumpty had a great fall that put him in a tragic state. This rhyme has always been one of my favorites. The story first appeared in 1870, in James William Elliott‘s National Nursery Rhymes and Nursery Songs. Humpty Dumpty is a memorable and versatile teaching lesson, even […]
Kari Blaho-Owens
Kari Blaho-Owens, Ph.D., received her graduate degree in pharmacology and clinical therapeutics from LSU Medical Center in New Orleans, Louisiana, US. She was the Research Director and clinical toxicologist consultant in an inner-city Emergency Department at UT College of Medicine and has spent much of her career in the life sciences industry working for pharmaceutical and device companies, as well as CROs. She also served as the global head of PV at a major company. Kari is currently the head of PV at Perficient, where she leads a team that implements fit-for-purpose technology solutions and provides pharmacovigilance consulting. She is also a peer reviewer for the DIA.
Blogs from this Author
Pharmacovigilance and Medical Information Call Centers by “I Love Lucy”
The medical information (MI) call center is part of a complex pharmacovigilance system. It may be the only opportunity to gather adverse and product quality data. It’s imperative that it operate efficiently. With a growing number of calls, it’s easy for a center to overrun. That can lead to team burn out, long wait […]
Let’s Talk About Our Relationship (and Pharmacovigilance)
Due to social distancing, many of us found ourselves with extra time during COVID-19. Recently on a sunny day, I was prepping some of my beehives for the upcoming winter. (By the way, anyone who thinks beekeeping is easy, please come and help! It’s hot, heavy, complicated, and completely rewarding. It’s the perfect mix of […]
The Future of Pharmacovigilance
Previously, I discussed how pharmacovigilance can work, when implemented correctly. In the final installment of this blog series, I look at the future of pharmacovigilance. How can you close the knowledge gap and move pharmacovigilance from a state of reactive to proactive? While the presented earlier is merely an example, it is based on real […]
Why Proactive Pharmacovigilance Can Work
My last two blogs compared a hypothetical example of reactive and proactive pharmacovigilance (PV). My next installment in this series outlines how PV can work. Rather than reacting to the data, in the second hypothetical scenario, Company A pivoted with ready-planned interventional pharmacovigilance practices at the level of the intake system and took a patient-centric […]
Perficient Wins Award for Its Pharmacovigilance Intelligence Solution
We are very excited to receive recognition for PV Hawk. Not only is it an honor, but it shows the value and flexibility of Perficient’s enthusiasm for bringing common sense to complex problems and the success of our cross-functional teams that contributed to getting this solution out. For many years, I, along with many others, […]
Proactive Pharmacovigilance: Another Real-World Example
My previous blog provided a hypothetical example of reactive pharmacovigilance. This blog will examine the opposite, proactive pharmacovigilance and the success it can bring. Company A launches a first-in-class drug/device combo biologic for the treatment of psoriatic arthritis. The drug has a novel mechanism of action. In clinical trials, ACR response was 26 weeks. The […]
Reactive Pharmacovigilance: A Real-World Example
Previously, I examined the best ways to overcome challenges with a new pharmacovigilance system. I now want to provide a hypothetical example of reactive pharmacovigilance. Company A launches a first-in-class drug/device combo biologic for the treatment of psoriatic arthritis. The drug has a novel mechanism of action. In clinical trials, the American College of Rheumatology […]
Overcoming Challenges with a Pharmacovigilance System
My last blog outlined the potential for increased return on investments when pharmacovigilance is implemented. The next blog in this series discusses the best ways to overcome any challenges with new systems. Looking at a pharmacovigilance system holistically, there are interconnected, interdependent parts. Understanding how those individual parts function independently, as well as their impact […]
Pharmacovigilance: The Return on Investment
Previously, I analyzed the history of pharmacovigilance (PV), AEs and clinical therapeutics. This post examines the potential for increased return on investments when pharmacovigilance is implemented. All AE data holds value; how that value is determined takes an astute scientific approach to surveillance. In 2001, the medical literature began to include the results of a […]
Historical Perspective of AEs, Pharmacovigilance, and Clinical Therapeutics
My last bog talked about mitigating data overload with proactive pharmacovigilance (PV). The next blog in this series analyzes the history of PV, AEs and clinical therapeutics. As early as the 1980s, it was recognized that prostaglandins were important in renal function, especially in hypertensive patients. Prostaglandins preserve and maintain renal blood flow and thus […]
[Guide] Mitigate Data Overload with Proactive Pharmacovigilance
Surveillance of pharmacovigilance (PV) and product quality-complaint (PQC) data is not a new activity. For years we have known that adverse events temporal to drugs occur. Moreover, they are consistently underreported, impacting analysis of the data in unknown ways. Nearly every regulatory authority across the world has guidance and requirements in place for marketing authorization […]