Docetaxel

Senior leaders from Bayer and Bristol Myers Squibb shared insights on navigating strategic constraints facing the pharmaceutical industry during Fierce JPM Week in San Francisco. Large drugmakers once had more room to absorb failure, both financially and reputationally, particularly during the height of the pre-pandemic era. Blockbuster franchises could offset years of uneven R&D returns, and missteps could more easily be managed.That room has narrowed. Revenue declines after patent loss are steep, with branded sales eroding quickly as generics or biosimilars enter the market. By 2030, more than $200 billion in biopharma industry revenues will face loss-of-exclusivity exposure, with another $200 billion at risk in the early 2030s as additional exclusivity cliffs hit.At the same time, scrutiny of pricing, patient access and corporate behavior has intensified from regulators and the public alike. That pressure is increasingly being reflected in how the industry is perceived.Declining satisfaction and perceptions of value, along with shifts in how younger people consume health information, have left the pharmaceutical industry facing a trust deficit. Combined with ongoing concerns about pricing and corporate motives, that gap suggests the pandemic-era boost to pharma’s reputation is fading and will require greater transparency and engagement to rebuild. The environment has created a narrowing margin for error, which was reflected in two conversations I had with senior executives from Bayer and Bristol Myers Squibb during Fierce JPM Week in San Francisco last month. One focused on pipeline discipline, the other on trust and corporate credibility. Both pointed to an underlying shift, with pharmas making earlier, harder decisions about development and capital while balancing competing demands from regulators, policymakers and the public. Decisions made years in advance  Time is never neutral for companies built on blockbuster drugs. Patents expire, revenue erodes, and replacement products must be in motion long before losses show up in quarterly earnings reports.Christine Roth, Bayer’s executive vice president and head of global product strategy and commercialization, was direct about the typical timeline for major patent cliffs: planning needs to begin nearly a decade in advance.“It doesn’t happen in 12 months,” Roth said. “These are decisions you make eight years out.”The company spent the past five years pruning programs that were scientifically intriguing but commercially unlikely to differentiate, per Roth, while narrowing its focus to areas where it believed it could sustain scale, particularly oncology and cardiology.The German conglomerate made those decisions in anticipation of significant sales drops across key franchises. Xarelto, the blood thinner that began facing generic competition after its U.S. patent expired last year, saw sales fall 32.7% to 540 million euros in the three months ended Sept. 30. Pressure is also building elsewhere in the portfolio. Bayer, which handles ex-U.S. commercialization for Regeneron-partnered ophthalmology blockbuster Eylea, is facing a new biosim threat in Europe as of November. To help offset the revenue losses and drive growth, the company is relying on newer launches and indication expansions. Bayer’s Nubeqa was first cleared in 2019 for use in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with metastatic castration-sensitive prostate cancer. In June 2025, it gained approval for use alongside ADT in patients who cannot tolerate chemotherapy.That expansion has begun to show up in the numbers, with Nubeqa sales up 50% year over year in the three months ended Sept. 30. In the same period, momentum began to build for Bayer's chronic kidney disease drug Kerendia, which was first approved in 2021 and picked up a second indication for heart failure last summer. Sales rose 75% year over year.Preparing for exclusivity losses also involved major changes to who gets a voice early at Bayer. Commercial teams are now embedded in discovery, weighing in on modality, formulation and competitive positioning well before a candidate reaches the clinic, Roth said. Questions that once surfaced at launch now arise at target selection.The shift is about timing. It results in fewer projects, earlier stops and capital concentrated on assets that clear both scientific and market hurdles, according to Roth. That discipline is being imposed as the economics of drug development grow less forgiving. A 2025 analysis of Deloitte data found that while overall return on investment in drug R&D ticked up modestly, the average cost to bring a new drug to market remains high, roughly $2.2 billion per asset, and peak sales forecasts per asset are slipping in many therapeutic areas outside GLP-1s.Those economic constraints are now shaping behavior inside companies.At Bayer, Roth described a cultural shift away from what she called “progression-seeking,” the instinct to push a program forward because it belongs to your team, toward “truth-seeking,” where teams evaluate their projects against the broader portfolio and step aside when necessary.“People need to put on their enterprise hat and think, based on what I’ve seen across the pipeline, is my project still one of the highest-impact opportunities?” Roth said. “Or is it time for us to free up resources so we can either start something that looks more promising or pour some gas on something that’s really moving ahead?”Pharma R&D has historically been tribal, with scientists fiercely protecting their programs. Getting people to kill their own work voluntarily requires a completely different incentive structure.Bayer's answer is what the company calls “dynamic shared ownership,” rolled out in 2024 and 2025 under CEO Bill Anderson, who took over in early 2023. Strip away the corporate jargon and, per Roth, it means this: every role exists to serve a product, a customer, or the teams that support them. “If you're not in service of a product, a customer or a product and customer team, then you probably won't be at Bayer for very much longer,” Roth said. That carries weight. Bayer has cut more than 13,500 jobs under Anderson's leadership.Describing what things look like now, Roth said the company ties budgets to specific development milestones, such as filing an investigational new drug application or reaching clinical trial benchmarks, rather than fixed annual allocations. Funding flows based on progress, and teams are judged on whether they hit objectives rather than how much of a budget they spend. Trust as currency  On the same stage that day, Wendy Bartie, Bristol Myers Squibb's executive vice president of corporate affairs, was addressing a different constraint: credibility.“It is rare, if ever, that our industry or our companies aren't managing through some topic or issue that has the ability to impact reputation,” she said. “It's just the world in which we live and operate.”For BMS, trust is not optional. Bartie calls it “the trust advantage,” which she said determines whether a company has a seat at the table to advocate its position and whether it receives the benefit of the doubt when difficult issues arise.Her formula is straightforward: “You tell people what you're going to do and you actually show up and you do it.”The public, policymakers, investors and other stakeholders “will always view us through the lens of their vested interests,” Bartie said. She described the framework she uses internally to help teams navigate competing stakeholder expectations.“What is always consistent, irrespective of who your stakeholder is: I want you to tell me what you're doing. I want you to be really clear about what you're doing. I want you to explain the trade-offs and why you made the decisions that you made,” she said. “And I want you to operate with the highest degree of integrity.” Corporate affairs, in her view, serves as the connective tissue across an organization, translating business strategy into credible narratives for diverse stakeholders while bringing external expectations back into internal decision-making. That internal discipline, Bartie argued, matters most when it shows up in how patients actually access care.Access to care is where credibility ultimately gets tested, she said. “How you look, who you love, [and] where you live should not determine if you live,” she said, framing equity as a strategic necessity rather than a peripheral concern.She pointed to BMS’ work in Africa, where the company has expanded beyond HIV and AIDS into mental health, sickle cell disease and cancer. In the U.S., BMS is using community pharmacies for cardiovascular monitoring and virtual models for mental health in rural areas.These efforts are central to how the industry earns and preserves its credibility, she said. A  common thread Roth and Bartie were addressing different audiences about different problems. One focused on the internal economics of drug development—the other on the external politics of trust. Taken together, their remarks point to a common reality: the constraints around the traditional pharmaceutical model are tightening.Capital is being allocated more selectively, reputational flexibility has thinned and decisions that once could be delayed are being pulled forward. The old playbook hasn't disappeared. What has changed is the degree of tolerance built into the system, both in how companies develop drugs and in how and when they explain their choices to the world around them.

AstraZeneca has announced that Imfinzi (durvalumab), in combination with standard of care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. Imfinzi and FLOT form a perioperative regimen that includes neoadjuvant Imfinzi and chemotherapy prior to surgery, adjuvant Imfinzi and chemotherapy, and finally Imfinzi as a monotherapy. The CHMP’s positive opinion is based on results from the phase 3 MATTERHORN trial. The trial showed that the Imfinzi-FLOT regimen reduced risk of death by 22% compared to chemotherapy alone. Around 69% of Imfinzi-FLOT-treated patients were alive at three years, compared to 62% of patients in the comparator arm of the study. The safety profile of the combination treatment was consistent with the established safety profiles of each component, and the rate of Grade 3 or higher adverse events was consistent across both arms. Results from the trial were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. Gastric cancer is the fifth highest cause of cancer deaths worldwide, and almost a million people are diagnosed with it each year. There were around 43,000 patients treated for early-stage and locally advanced gastric or GEJ cancer in the US, EU and Japan in 2024. By 2030, around 62,000 patients across these regions are expected to be newly diagnosed with early-stage and locally advanced gastric or GEJ cancer. Imfinzi is approved in the US and various other countries for the same indication, with approval following the MATTERHORN data. Additionally, Japan and other countries are currently reviewing regulatory applications for Imfinzi. Susan Galbraith, executive vice president, oncology haematology R&D at AstraZeneca, said: “The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi-based regimen in the EU.”