Part two of a multipart series explores Pharm-Olam International’s forward-thinking approach to risk-management, safety monitoring and analysis in drug development and post-marketing.
It’s no small task to ease the burden of regulatory requirements on sponsors, while at once maximizing patient safety and privacy. But for Pharm-Olam International’s Pharmacovigilance (PVG) team, that’s exactly the mission.
Alerts, expedited safety reporting and preparation of regulatory updates come standard in Pharm-Olam’s suite of PVG services. The team of Pharmacovigilance experts at Pharm-Olam doesn’t stop at ensuring compliance with regulatory mandates. They work to ensure the longevity of products long after clinical trials have ended.
In the throes of drug development, it’s natural to think of Pharmacovigilance, or for that matter any regulatory mandate, as ancillary to the goals of a clinical trial. Anthony Kohut, Associate Director, Pharmacovigilance at Pharm-Olam International, understands the temptation.
“I think there’s a perception that Pharmacovigilance doesn’t enroll patients; it doesn’t help to provide a primary efficacy endpoint; it doesn’t contribute to the primary operational aspects,” says Kohut.
But Kohut is quick to remind sponsors that study success has a boolean definition: approved, or not approved. And while efficacy often dominates the conversation for sponsors, marketers and clinicians, from the regulatory perspective, only one criteria ultimately matters.
“Drugs are approved on safety first.”
That’s the main reason Pharm-Olam International, a global mid-size CRO, has invested so heavily in Pharmacovigilance. Today, PVG is part of a complete Medical Affairs service offering, which also includes Medical Monitoring, Data Management and Medical Writing. For Pharm-Olam’s part, robust Pharmacovigilance processes are an absolute must.
“The first thing they teach you in scuba diving is you plan your dive, and you dive your plan,” says Kohut. “In PVG you might say the same thing. We work in a regulated industry. You don’t deviate from the plan, because that’s when you get hurt.”
Executing to plan is a company-wide philosophy, but for PVG perhaps more than any other department, it informs the team’s managerial focus and daily operations. When Kohut joined the Pharm-Olam team in 2012, one of his first initiatives involved rewriting the group’s Standard Operating Procedures, or SOPs. Instead of relying exclusively on his experience, he and the Quality Assurance team collaborated. The team retained a former European Medicines Agency inspector to conduct a systems audit. The SOP updates, driven by the findings of the audit and the experience and suggestions of the team, have worked to great effect.
"Drugs are often approved on safety first."
“Our SOPs are written so that we execute the same way all the time, consistently, and those processes are written so that they are compliant with the law. And we all follow them. We do the same thing again and again for every case.”
Enforcement of SOPs is an important task, especially given the breadth of talent that comprises Pharm-Olam’s PVG operation. The team of medical monitors and safety officers spans many professional backgrounds. Many, in fact, are classically trained physicians. Kohut coaches team members to “align thinking toward meeting regulatory obligations,” which he believes produces more precise, concise narratives.
“You’re not looking at medical charts and reading them so that you can diagnose the patient. What we do here is help to condense information in a meaningful way so that both the sponsor company and the regulatory agencies can look at this data and quickly extract details that are important to the potential implications of the trial, and of the product that’s being studied.”
In practice, PVG also reduces the burden on sites by reviewing and spot-checking reporting. That leads to better overall impressions of the sponsor and, Kohut says, more engagement and productivity among global teams.
“When you have a good relationship with your sites, you tend to get better input. You get faster responses. So that’s important.”
Focusing on the Essentials
Many sponsors view PVG as a commodity, or an aspect of proposals that can and should be price-shopped. Kohut, who’s been working in Pharmacovigilance since the early 2000s, doesn’t see it that way. From first-hand experience, Kohut knows some CROs have PVG processes that are “often muddy,” and defined by “lengthy, complex” SOPs. His team is a deliberate contrast.
“It’s extremely lean here. A decision is made, and it’s pretty much implemented at that point.”
While other CROs often have an intricate, layered infrastructure, Kohut describes his team as comparably autonomous. That autonomy, he says, affords more attention to his team, the sponsor, and—most importantly—the standard of operations that Pharm-Olam clients have come to expect.
“There’s not a lot of bureaucracy, and that’s a plus.”
A lean organization is a plus especially because of Pharm-Olam’s global footprint. Kohut knows it’s important to provide the same quality of coverage seven days a week. Whether it’s clinical trial operations or post-marketing, Kohut says, his team has “people in both Europe and the United States providing oversight, and making sure there are seamless operations.”
Patient Privacy and Sponsor Liability: HIPAA, the EU and Beyond
In the United States and around the world, privacy is a sensitive topic. That consideration isn’t lost on Pharm-Olam’s PVG department. On a daily basis, as a result of their roles and processes, Kohut and his team encounter medical records that contain personal information.
“Getting our hands on medical records is part of our due diligence,” says Kohut. “So in a sense, I now become potentially aware of personal information.”
Informed Consent summarizes the risks and benefits of trial participation, as well as the use and protection of personal information and medical records. While patient health records are protected by the Health Insurance Portability and Accountability Act of 2003, or HIPAA, some patients may not realize the act exempts clinical trials.
“ We conduct the most conservative possible analysis of the law, and then we take one step beyond what that law requires, as to ensure that under no circumstances could the sponsor ever be found to be negligent in maintaining privacy.”
But in service to the sponsor, and to patients, Pharm-Olam takes the position that HIPAA applies as much to trials as it does to hospitals and medical facilities. If any HIPAA-defined private information is found exposed, the team takes ownership and redacts it. In service to sponsors and patients, Pharm-Olam takes no chances.
“For us—for pharmacovigilance—the laws are not always entirely clear about to what extent information has to be protected. But we approach all data with the same level of care and protection.”
In the EU, for example, local privacy requirements surrounding protected personal information, or PPI, are equally important. These requirements vary by country, and sometimes change with little notice. Regulations in the EU resemble a worldwide trend toward greater security of PPI. It’s the primary reason why Pharm-Olam takes a conservative approach to protecting all patient information.
“At Pharm-Olam…there is not any possibility that any law could catch up with us and find us unprepared. We conduct the most conservative possible analysis of the law, and then we take one step beyond what that law requires, as to ensure that under no circumstances could the sponsor ever be found to be negligent in maintaining privacy.”
The Importance of Safety
Kohut also acknowledges that drug developers view risk as a cost of doing business, and so risk-management can appear cumbersome against rigorous timelines and deadlines. But in the rare occurrence of an SAE, proper PVG measures really begin to count.
“PVG is like safety systems in an airplane. Day-to-day, most of them are unnecessary, but when there’s a problem, if you don’t have [those systems], the problem becomes quite monumental. So I’d say yes, safety seems redundant, it seems unnecessary most of the time; however ... when there is a problem, everyone is grateful those systems are there.”
When sponsors grow frustrated over legal mandates and regulatory requirements, he encourages sponsors to remember the big picture.
“If you have a drug that is very effective but not safe to use, it’s not going to get approved.”
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