Compared with the 2016 Drug Industry Association (DIA) Pharmacovigilance and Risk Management Strategies Conference, the 2017 conference in Washington, D.C. had a much better start. Although I was not at last year's conference, I read the epic testimonials of snowstorms, canceled flights, lockdowns and other interesting events, which were all very entertaining.
This year's DIA Pharmacovigilance and Risk Management Strategies Conference, which I attended, was less eventful, and yet, still full of encounters, lively discussions and as always, laughter.
Let me take a moment to reflect on a few takeaways and potential solutions that I consider relevant to pharmacovigilance (PV) and risk management (RM) organizations throughout the industry. Two themes defined the talks I had with my contacts over the course of the three and a half days: more for less and more for more.
More for less
PV organizations have now fully embraced outsourcing services to external vendors, either partially or completely. In the last three years, organizations have not only looked to move systems to the cloud but also to accelerate the externalization of some of the heavy lifting required by the regulations. PV departments currently want to find the lowest cost to process individual case or expedited reports, regardless of vendor actions. As long as the vendor passes the audits and can deliver consistent quality and turnaround times, cheaper is better.
The main driving force is the budget, of course, but an increase in incoming adverse event (AE) reports is forecasted due to multiple factors:
- We are in a new era of medical breakthroughs that will result in new expressions of side effects.
- There are new sources for AE collection, from more specific market programs to in-house pharmacies or social media.
- There are new regulatory expectations in terms of transparency and patient advocacy involvement/relations.
- Safety objectives are required earlier and earlier in pipeline development (pre-clinical safety).
So, what does this mean for Bioclinica?
Yes, our PV services are the best in terms of quality and service level agreements (SLA); however, don't take my word for it. You can simply listen to what our customers are saying through our success stories that follow the same pattern:
- An organization is struggling with a system migration or a compound acquisition.
- Bioclinica assists and manually enters the related individual case safety report (ICSR) into the target system.
- This is completed with the fastest turnaround and highest quality the customer has ever seen.
- When the need for a new vendor for ongoing case processing or other PV services arises, the customer chooses Bioclinica and remains satisfied with the services.
As a result, Bioclinica has the ability to provide solutions to:
- Harness the data from the large numbers of AEs.
- Verify, evaluate and aggregate the AE data to provide insight and knowledge.
- Share insight with the Marketing Authorisation Holder (MAH) or sponsor.
Guess what? Bioclinica has the technology to do just that. We can easily dedicate a cloud environment with pluggable APIs, configured for a given source. We can then organize the collected data using predefined data standards, while applying services such as master data management (MDM), data standardization and data demystification. The latter is the capability to semi-automatically analyze data patterns and data correlations in real time using advanced analytics and parallel processing.
Does this all sound alien to you? Let me rephrase. How about a solution in which we can capture the existing relevant literature on one side, gather public data for similar therapies on the other side and produce a set of dashboards showing how this combination is different than what you had accumulated so far in your own safety system?
That's what I'm talking about.
More for more
So, more for less is well known, but what is more for more? Well, if we keep the analogy as in the previous use case, you do not want to mix your clean, very active, always up-to-date safety data with external noise and raw datasets. However, now you want to learn more about how what you have compares to what you could get. What can you learn from the other sources that you did not already know? How can you share that within your organization?
Let us say that you have all the Sentinel data on one side and all the World Health Organization (WHO) data on the other side. Could you find a solution that allows you to run certain heuristics on the following?
- Sentinel data only
- WHO data only
- Combination of both
- Difference between each source on its own and combined sources
And, I do realize that the WHO data cannot be downloaded. However, what if the technology allowed you to dynamically query this Vigibase as if it was stored behind your screen? That's what Bioclinica can do. Plug. Consolidate. Share.
Don't be surprised if I stop there, as many more ideas originated from my discussions at the conference. I look forward to not only going back to the conference next year but also the opportunity to have more discussions with my peers within the industry in 2017.
The future has never been brighter. If you'd like to continue the conversation, please reach out to me at Francois.Audibert@bioclinica.com.