Life Sciences

Let’s Talk About Our Relationship (and Pharmacovigilance)

Due to social distancing, many of us found ourselves with extra time during COVID-19.

Kari 1

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 art and science.)

The preparation process reminded me of hectic weeks working with my team. Like the bees, we work in multiple places doing multiple things communicate, and in the end, we have something sweet and useful. Like in all facets of life, achieving sweetness requires a commitment to your partners.

Kari 2

I will go out on a limb here and tell you about our safety and pharmacovigilance (PV) practice. And just why, you may ask, do I feel compelled to do so? Often, clients are surprised by our breadth of capabilities and understanding of the space. They don’t realize we do much more than specialize in one particular system or, in some cases, one specific vendor. Nothing could be further from the truth. Just like bees, we do so much more than make honey.

Our team is well versed in the challenges faced by marketing authorization holders (MAH), having dealt with complex challenges working in pharma and the CRO industries. You will not find a more hawkish group in partnering with customers to find the best fit-for-purpose solutions for them, similar to the way a hive above is the perfect fit for its occupants.

In many ways, we can help guide our customers in streamlining their PV operations and technology platforms to become more efficient and flexible for growth, all while remaining compliant and keeping to a sane budget.

The common challenges we work with every day include choosing and harmonizing a PV technical platform that is reliable and capable of supporting a sound strategy that leverages automation and AI. The goal is to gain efficiencies as the regulatory PV burden for compliance becomes heavier.

We do not believe you have to increase headcount because there is more work or if the work is more complex. Instead, it’s about working smarter. For example, the updated GxP IX from EMA requires a thoughtful approach and change in process (i.e., the bee-minded flexibility of using all skills!), and perhaps technology, not an exponential increase in headcount. We can help ensure that, through smart working processes, a harmonized approach within your organization, and the right technology, there is a demonstrable return on investment. It’s the key to success. Perficient champions proactive PV rather than reactive PV. If proactive PV is something that your organization does not have on its radar, or this sounds a bit foreign, please, let’s talk!

If your current partner is not a good fit and is not meeting your needs, we can help. There is no challenge too great for us to step in as a strategic partner and roadmap the path to a harmonized, well-functioning PV system that is based on compliance, efficiency, usable data, and serves as the core tenants of pharmacovigilance. We include all regulatory areas, pharmaceuticals, biologics, vaccines, medical devices, animal health, cosmetovigilance. After all, we all need to be good stewards of patient safety through openness and innovation and by working together as a team.

Perficient currently has several complimentary four-hour consulting sessions that show our bona fides in solving complex PV issues. While four hours won’t solve everything, it is an excellent opportunity for us to demonstrate how we would approach a current issue or a strategic roadmap. Case intake overwhelmed? Data not harmonized and challenging to interpret? No clear path defined for alleviating pain points? Geographical PV groups leading to bespoke processes or technology? These challenges and more are what drives us to partner with our clients in a different and more meaningful way.

Our guiding principle with our clients opens up opportunities to have meaningful conversations that can prevent and solve some of the above issues.

I want to share a mini case study that will hopefully give you a better idea of how we can help companies just like yours.

Problem

The company had geographically separate PV groups. Both teams covered the same products. Cases were processed by the team closest, by distance, to the area where the case was reported. Both teams had the same case processing workflow. Local labeling was identical. The two PV groups worked under one global medical monitoring team, which was based in one of the geographic areas. The two PV groups disagreed on nearly every case regarding seriousness, causality, and reportability.

PV Group 1 took the approach of evaluating the context of the events reported, concomitant medications, co-morbid conditions, etc.

PV Group 2 wanted the approach of using the EMA IME list as an absolute for seriousness criteria. This guidance document was released in its latest form in September 2020.

The request from our client was to configure the database to allow for separate seriousness and causality assessments for the same case by the two different PV groups. This internal compromise between the two groups would have resulted in splitting the medical assessment team and de-harmonizing its data. It would be a difficult and expensive change to its AE database but was as close as the groups could agree.

The client had two options:

  1. Perform the configuration change per the client’s requirements, which would have involved a new SOW and be time- and resource-expensive.
  2. Engage our business development executive with the team, meet with the client, and have an open partnership discussion.

Solution

The client chose #2. We came to the meeting with open ears, listened, and laid out the risks and the benefits of the request. We discussed the request’s impact, including regulatory risk, data integrity, differences in serious case counts for the same set of data, anticipated work to revise internal SOPs, etc.

After a small amount of what we call “partnership stewardship,” we were able to give the client a different view of the impact of its request. It prompted both PV groups to come back to the table to find a neutral ground to avoid the risks, which were not insignificant. We ended up with a more robust collaborative medical assessment and medical monitoring of its product while following regional guidances.

Cost

It was free. We invested our time into the partnership to help a client through a complex PV conundrum.

If your PV partner doesn’t engage in meaningful conversations with your PV team, it might be time to see if you can “connect” with a new partner that genuinely cares about your success.

I am here to discuss your challenges. Please don’t hesitate to reach out to me personally, and tell me you came across this blog post. I’m always interested in hearing how people find us.

About the Author

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.

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