Maman Ibrahim: Addressing Cyber Risks in the Pharmaceutical Sector
A cyber incident in pharmaceuticals can do more than expose sensitive information. It can prevent medicines from reaching patients and undermine the integrity of records that regulators rely on. In pharmaceutical organizations, cyber resilience ultimately depends on whether leaders can make sound decisions when the evidence is incomplete and the stakes are high.
For Maman Ibrahim, Founder of The Decision Layer and a cyber and digital risk executive with more than 20 years of experience, the stakes in pharmaceutical cybersecurity are ultimately about patient safety and the uninterrupted availability of medicines. “The easy and short answer is doses,” Ibrahim says. “It’s about medicines.”
Cyber Risk Can Threaten More Than Data
Ibrahim identifies three immediate areas of exposure: the supply of medicines, the right to sell manufactured products, and the integrity of pharmaceutical records. A disruption at a manufacturing site or critical supplier can mean products do not reach patients on schedule. The consequences can extend across the supply chain, particularly when organizations depend on single sources for critical components. Drug shortages can also become public health concerns, taking what began as a company-level cyber incident into a much wider arena.
Then there is the question of whether a company can legally release products already made. Restoring servers does not necessarily restore the ability to sell inventory. Manufacturing processes may need to be revalidated, while records covering sterilization, cold-chain conditions, and other quality requirements can determine whether a product is releasable.
“Recovery and release have different meanings in pharmaceuticals than in other business sectors,” Ibrahim says.
The third risk is data integrity. In an industry where processes must be documented and validated, an alteration to a system or clinical trial record can create questions that emerge long after the original incident. “It’s always integrity,” Ibrahim says of the priority in pharmaceutical cybersecurity. Without a reliable record of what happened, organizations can struggle to demonstrate compliance and maintain confidence.
Turning Risk Activity Into Board Decisions
Pharmaceutical companies are often strong at documenting risk. Deviations, corrective and preventive actions, risk registers and other controls can be recorded to rigorous standards. The challenge is making sure that information reaches the people responsible for acting on it. “A site engineer logs a supportive control system entry, and that entry lives in a community or engineering system,” Ibrahim explains. “The decisions that will fix it – capital allocation, requalification or change of supplier – get made in another forum and another cycle.”
The result is a disconnect between quality governance, operational risk and enterprise decision-making. Supplier concentration illustrates the problem. Procurement may see a commercial dependency, quality may see an approved vendor, and security may see an outdated technical risk. Each view can be accurate, yet no single decision may connect them. “When a decision is made, the risk work changes. If you can’t, you have a reporting function rather than a governance one.”
Testing Whether Manufacturing Resilience Is Real
For boards, resilience cannot be measured solely by the existence of plans, reports, or recovery procedures. It needs to be tested against decisions that are difficult to make under pressure. Ibrahim suggests asking three questions:
• “Who owns the site’s resilience posture?”
• “What does the current evidence say?”
• “What would it cost to close the gap?”
“If the answer takes a week to assemble, you’ve learned that the evidence isn’t live,” he says.
The harder test is whether organizations have rehearsed decisions, rather than simply technical recovery. A pharmaceutical site may regularly practice restoring a server, but Ibrahim explains, “few have practiced the call on whether to release a batch that was in process, while systems were compromised.” He further emphasizes, “That’s the decision that ends careers, and it gets skipped because it has no clean answer.”
Preparing For Supplier And AI Risk
Third-party risk requires the same decision-oriented approach. Boards need to understand exposure by product. The meaningful question is whether the organization knows what happens to specific medicines if a supplier stops operating. “If this company stops, this product is stopped in six weeks,” is the kind of statement Ibrahim believes boards should be able to make.
That clarity also allows decision rights to be established before an incident:
• Who can authorize an alternate supplier?
• Who communicates with regulators?
• Who approves products affected by a compromised component or production window?
Answering those questions during an incident can consume time that the organization does not have.
Over the next 18 months, Ibrahim sees another decision rising quickly on the pharmaceutical agenda: who has authority over AI in good x practice (GxP)-critical systems. The issue is not simply which technology to adopt, but who decides whether a model can be trusted, validated and stopped. Traditional GxP asks whether the process was controlled. AI-era GxP must also ask whether the decision was controlled. “Who holds decision rights over AI in quality-critical systems?” he asks. For systems that learn or change over time, traditional validation assumptions become harder to apply. Boards that leave the question unanswered risk allowing authority to emerge through individual pilots rather than deliberate governance.
Cyber Resilience Is Ultimately About Trust
For pharmaceutical executives, cyber resilience is about preserving the conditions that allow medicines to be manufactured, released and trusted. The strongest organizations will be those that connect technical exposure to business consequences and establish decision rights before a crisis forces the issue. “The first one, you can’t fix anything. You can only decide.” In a sector where a cyber incident can affect patients as well as shareholders, the quality and speed of those decisions may be the most important measure of resilience.
