Ever Think About Outsourcing Your Drug Safety Challenges?

By Rob Wright, Chief Editor, Life Science Leader magazine

Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of adverse effects of medications and medical devices. At a recent conference, Sentrx’ CEO, Michael O’Gorman, sat down with Clinical Leader to answer some questions on some of the trends taking place in the pharmaceutical and biotech industry in the area of pharmacovigilance. His experience as a leader for several technology-focused organizations, as well as his having worked as a consultant with KPMG provide him with a unique perspective on pharmaceutical industry trends, especially when it comes to drug safety.

Clinical Leader (CL): What are some of the major changes you anticipate in the areas of pharmacovigilance over the next three years?
O’Gorman: I think the major changes revolve around the reporting requirements, especially over in the European Union, such as the Developmental Safety Update Report (DSUR). The DSUR, for example, requires companies to pull in more data than ever before to create their annual reports. One of the challenges that pharmaceutical companies have had over the past couple of months in preparing for the DSUR is figuring out how to consolidate all of their safety data that has been either archived or in multiple locations with multiple CROs. Sentrx has, at the moment, fourteen different data migration projects going on, where our customers are pulling together their data for the purposes of getting it ready for DSUR preparation and/or acquiring products from other companies. The DSUR is just one of the many changes in the European Union. Other changes will impact safety reporting, and we are going to stay on top of those changes as best as we possibly can. We utilize Bart Colbert, an independent consultant with a focus on global regulatory changes and updates, for industry intelligence. He provides us some really good feedback on what to prepare for, relative to these changes.

CL: What do you see as some of the most common mistakes made by pharma and bio companies?
O’Gorman: Lack of planning related to next stage pharmacovigilance requirements. Early-stage pharmaceutical companies with a Phase 1 or 2 drug rely on the people that are assisting them in their clinical trials to manage all of their safety needs, including management of their safety data. When they get into Phase 3 and start preparing to market the drug, they really need a cohesive pharmacovigilance plan. Oftentimes, these companies have to scramble to create a pharmacovigilance plan and the last minute rush to pull a cohesive plan together ends up costing them more in the long run. During that rush, companies need to pull all the pieces together in a validated environment and ensure that historical data will be accurately reflected in future analysis. This involves costs associated to data migration, i.e. possible recoding, safety database express set-up, and premiums for resourcing personnel. My suggestion is to start early. Utilize a world-class safety database during the early stages of clinical trials and use a single safety database rather than multiple databases at multiple CROs may cost you a few extra dollars in the early years, but it’ll certainly help in the long run. It’s also good for smaller companies to partner with somebody that does safety, because the experts in safety can ensure that you’re planning properly for the next stage. Signaling is a big issue relative to making sure that you have a cohesive pharmacovigilance plan. Just simply gathering safety data doesn’t cut it anymore. You have to analyze that data to make sure that there’s no underlying safety concern that you haven’t found. That’s really what health authorities are looking for when reviewing case information, reviewing pharmacovigilance plans, reviewing safety information through thunder filing process, and reviewing case information to protect consumers during the commercialization stage.

CL: What would be some of the key components to a good pharmacovigilance system?
O’Gorman: When you talk about world class systems solutions, whatever the system may be, you’re talking about something that has been built over multiple years and has been rigorously tested and validated. For example, at Sentrx we host the Oracle Argus and Oracle Interchange solutions. These solutions were developed by pioneers in safety database technologies, Relsys. Oracle acquired Relsys because their safety technologies had been rigorously tested and received solid recommendations from various users throughout the world. Accordingly, Oracle, one of the largest technology companies in the world, acquired a world class system and will be investing in Argus to ensure that the safety database remains world-class.

CL: What advice would you have for executives on addressing some of the more common mistakes?
O’Gorman: One of the main things to consider in safety is the staffing plan. This is perhaps the trickiest consideration of them all, because adverse events, by their nature, are unpredictable. When trying to create a forecast and staff plan for the upcoming year, how do you create one if you don’t really know how many adverse events will occur? What’s really good about working with a partner such as Sentrx for pharmacovigilance is that we handle any sort of variability - up or down. You pay for what you get. Typically, Sentrx charges a transactional-based fee for adverse events. So if there are ten thousand adverse events, transactional fees are charged for 10,000 adverse events. If there are three adverse events, transactional fees are charged for only three adverse events. This provides a significant risk minimization versus going out and building a staff of 20 people to prepare for the unknown. As a previous chief financial officer, I never liked those types of situations where your management team couldn’t tell you whether or not if the hired staff was going to be productive.

CL: Describe the hybrid pharmacovigilance model?
O’Gorman: What we see is companies are very concerned with analyzing their adverse events from a medical perspective. A majority of the time, these companies have a physician that is responsible for the final review of the adverse event and for the signaling review of adverse events in aggregate. In addition, companies normally have at least one person that is in charge of everything pharmacovigilance and that person can be a liaison to their partner of choice for pharmacovigilance. That really seems to be very effective, because the partner can do all the legwork behind the scenes to gather the adverse event information, analyze it, bring it up to a reportable standard and then share that information with the client, so that the client can properly assess it and submit it to the health authority.

CL: What are some key characteristics for a person serving in a hybrid pharmacovigilance liaison position given the company’s size?
O’Gorman: Sometimes the smaller biotechs don’t have the internal pharmacovigilance expertise. Some small companies consist of a handful of people who are experts in the molecule and clinical development and are scrambling to make their trials successful. In the case where there’s not much pharmacovigilance experience and there’s really not a whole lot of time for people to deal with it, the companies will outsource the entire pharmacovigilance operation. Midsize companies that have had three or more trials going on at the same time typically have a pharmacovigilance person who has been in the industry for many years and they know what they’re doing. Liaising with them is great because they can ask the right questions, they can make sure the service levels are appropriate and they can make sure that all the reports are getting done and submitted to the health authorities in time.

CL: What do you see as being some of the key questions contract manufacturing organizations (CMO) should be asking?
O’Gorman: Aside from the normal metric type questions, I think that they should be focused on the epidemiology of the products that company is developing and commercializing. The CMO should really challenge its partner or internal pharmacovigilance team to do proper analysis of adverse events before these are presented to the health authorities. Try to analyze it so that there is absolutely no question about causality.

CL: What issue do you see as not being adequately addressed in the pharmacovigilance arena?
O’Gorman: I think this has to do with staffing. Why build teams that are going to sit there and wait for adverse events to happen? I really don’t quite understand how a company can rationalize that. I think our solution is the perfect solution in that regard, because we can scale up or down as quickly as humanly possible to handle the adverse event variability. We are able to do that because we started this company over sixteen years ago, and know what it takes to bring in people, train them very quickly on therapeutic areas, and get them ready to begin analyzing adverse events. Also, our experience in handling post-marketed safety enables us to quickly gear up for handling product complaints, medical inquiries, or REMS related programs.