Inside GCSG 2026: Clinical Supply Impact On Patient Experience

By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

Clinical supply decisions rarely make headlines, but sponsor companies and patients feel the consequences of them every day — often in ways that directly shape how and whether treatment is received.  Steven Jacobs, president of Global BioPharm Solutions, a ~28-year veteran of the Global Clinical Supplies Group (GCSG), and a member of the Board of Directors – as well as emcee for the GCSG 2026 U.S. Conference – explained, in this recap of key lessons from the event.

For example, connections between clinical stability testing and clinical supply execution emerged, highlighting opportunities to improve patient experience. Candid conversations about AI, trial complexity, and collaboration also offered an unfiltered look at how clinical supply and operational choices ripple downstream.

Here, Jacobs draws on his industry expertise and past role as head of U.S. clinical supply operations at J&J Pharmaceutical R&D to share his take on the event, which offered onstage and behind-the-scenes insights with real-world implications for patients, sites, and sponsors across the clinical supply ecosystem.

Where Trial Operations Become Personal

Jacobs described a testimonial given by Michelle Stump-Kerry, a patient who endured what he referred to as “a horrific site experience” with ovarian cancer. To Jacobs, her story showed how closely the clinical and clinical supply functions intersect — and how that connection is felt most directly by the patient, even when the supply function itself remains largely invisible.

Stump-Kerry presented her experiences at two different clinical trial sites. At the first one, she felt invisible. Jacobs recounted, “She just didn’t feel welcome. She didn’t feel like they said thank you. She didn’t feel like they cared about her time.” He added that basic questions — How are you doing? or Is there anything we can do better for you? — were missing, leaving her with the sense that she was just another appointment on the schedule rather than an actual person and patient.

The second site, on the other hand, “delivered everything she had hoped for.” Jacobs explained how the principal investigator was deeply engaged and supported by coordinators who, in his words, “really bent over backwards to see if she was okay and consistently checked in with her treatment.” They took the time to discuss each step of the trial, answering questions and making sure she understood what challenges might lie ahead. That direct human interaction made the process far more acceptable than reading treatment documents alone.

Informed Consent: ‘An Absolute Nightmare’

Jacobs contrasted those thoughtful interactions with the reality of the informed consent process. “The informed consent form can be an absolute nightmare, the way it’s written,” he said, arguing it often reads like a document that focuses on liability rather than patient information.

Rather than clearly explaining treatment arms — placebo, comparator, or investigational medicinal supplies (IMPs) — the patient experience often feels like a barrage of warnings. Jacobs put it bluntly: “Instead of saying: here are all the different arms you could be on, what it really sounds like is: if you take this, you may die. And: if you do this, you may die.”

His point was not to diminish clinical risk, but to argue that intent and tone matter. “Let’s make it more of a document that cares for the patient, rather than one that doesn’t,” he said. This is especially true when treating children, where documents are reviewed by their parents, as Lindsey Wahlstrom so eloquently stated when she was a patient testimonial speaker for her daughter, Rona, at a previously GCSG even (see Rona's Fun Lab https://www.ronasfunlab.org.)

(During the interview, I agreed, emphasizing the need for plain-language versions of informed consent that are accessible to people without scientific or regulatory backgrounds.)

When Supply Chain Gaps Become Patient Burdens

One of the most striking moments in Stump-Kerry’s story involved a breakdown in clinical supply coordination. Chemotherapy and treatment-related fatigue wore her down for days, after which on one occasion, she traveled two hours to a clinical site for treatment only to find that the drug had not arrived – a failure on the parts of trial supply planning, site resupply execution, and site-to-patient communication.

Jacobs emphasized how avoidable the situation was, noting that instead of calling Stump-Kerry in advance, the site “just had her come out, and then couldn’t dose her.” The result was five hours lost — time she could have been spent resting, which underscores how supply chain breakdowns translate directly into patient burden.

This is where clinical supply execution becomes key to the patient experience: drug availability, site resupply timing, and confirmation workflows are not just operational tasks — they determine whether a patient can be treated or turned away; comfort versus concern and inconvenience. What might seem like a small logistical delay becomes, for the patient, a deeply physical and emotional burden. This is not just a site issue, this is a clinical supply responsibility; and when it’s done right, it measurably improves the patient’s experience.

Conversely, when clinical supply teams proactively forecast demand, align closely with sites, and confirm inventory before patient visits, they can eliminate missed dosing events entirely, ensuring patients are only asked to travel when treatment is ready and available, quietly improving both patient trust and trial continuity.

Jacobs summed up Stump-Kerry’s contribution as offering “magnificent customer- and patient-oriented opportunities and recommendations” where clinical supply teams can meaningfully improve patient experience, not just operational efficiency.

The Broader Agenda: Technology, Trial Complexity and Proactive Planning

Beyond individual anecdotes, the GCSG 2026 U.S. Conference reflected a broader industry shift — one shaped by rising trial complexity, accelerating timelines, and clearer recognition that clinical supply decisions directly influence patient experience and trial continuity.

Discussions around AI in particular were grounded in practical use – i.e., how tools can support planning, forecasting, and operational efficiency, with downstream effects on dose availability, site readiness, and patient scheduling, as well as data validity outcomes. In other conferences, unlike GCSG's, speculation without application, Jacobs noted, felt like “a waste of time.”

The agenda also addressed the mounting complex pressures faced by clinical supply teams, with sessions on comparator sourcing, constrained planning windows, global distribution challenges, and the demands of advanced modalities. Talks on radionuclide, cell and gene therapies, and advanced therapy medicinal products drew interest, per Jacobs, highlighting where traditional supply models are being pushed to their limits while experiencing a new paradigm.

These evolutions mirror how clinical trials have changed over time. According to Jacobs, historically, early-phase studies allowed more room to learn and adjust. But today, even as trials move through the early stages, programs are under pressure to progress faster and generate data sooner. As this happens, expectations rise quickly from sponsors, sites, and especially patients while timelines shrink and pressure grows.

Within this dynamic, Jacobs said, the clinical supply chain can’t afford to be reactive. Teams must plan for scale earlier, manage variability, improve transparency, and support growing complexity. The closer a trial gets to meaningful efficacy signals, the more critical it becomes for clinical supplies units and vendors to operate as a strategic partner, ensuring patients receive consistent, uninterrupted access to treatment, and ensuring operational execution never undermines patient trust or trial success.

Where Connections Become Currency

Perhaps the real value of GCSG isn’t only on the agenda, however – it’s in the diversity of experiences it brings together, and the connections that emerge as a result. According to Jacobs, some attendees came to build foundational knowledge, while others shared hard-won lessons learned from the field.

What’s more, many of the most valuable insights emerged outside of formal sessions, where candid conversations about constraints and workarounds unfolded. While workshops deliver structure, Jacobs noted, “the place where you learn the most is in the bar afterwards.”

More than 500 clinical supply professionals attended the event, reinforcing its relevance – and having to accept a waitlist of over 100 people who were unable to attend. Sponsors and vendors participated side by side, reflecting GCSG’s deliberately collaborative culture. For Jacobs, that environment fuels both connection and growth. “Every time I go to this conference, I grow my network,” he said. “And my network is my net worth.”

Taken together, the conversations at GCSG 2026 delivered a clear message: clinical supply is a critical function that should have a strong collaborative relationship with Clinical Development and CMC (Chemistry, Manufacturing and Controls). As trials grow more complex and technologies more powerful, clinical supply execution increasingly shapes patient experience, site performance, and trial outcomes — making thoughtful, forward-looking supply strategy easier to achieve and more critical than ever.

Clinical supply execution increasingly shapes patient experience — often without patients ever realizing how hard the people work in the background. Clinical supplies is the unsung hero in many cases and an environment clinical supply professionals learn to live in pretty quickly.