DC Decoded: How Section 232 Tariffs and FDA Upheaval Are Reshaping US Contract Manufacturing

Gil Roth, President of PBOA, and Marta Wosińska, Senior Fellow at the Brookings Institution, told CDMO Live Americas that the headline tariff rate matters far less to contract manufacturers than who actually pays it.A 100% tariff sounds like a powerful reason to move drug manufacturing to the US. For most of the contract manufacturing market, it is not. That was a takeaway from Marta Wosińska, Senior Fellow at the Brookings Institution, in a fireside chat with Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA), at CDMO Live Americas 2026 in October.Roth opened the session by discussing a Washington agenda he called 'contradictory', chasing lower drug prices and domestic manufacturing at once. Wosińska then took the audience inside the Section 232 tariffs at its center.Download Partnerships Under Pressure, the full report from CDMO Live Americas 2026

Policy shifts, tariff threats and a wave of U.S. investment announcements have left outsourcing leaders asking the same question: do you consolidate to fewer, deeper CDMO partnerships, or spread out to protect supply?That was the debate at CDMO Live Americas in Boston, where a panel session explored manufacturing network optimization. The session, sponsored by ROIS, brought together:Joseph Graskemper, General Manager, Early Phase Development & Manufacturing, BiogenGretchen Peck, Senior Director, Strategy & Program Management, PfizerAmber Meriwether, Corporate Strategy, AstellasKimberlee Steele, Chief Commercial Officer, ROISRead the full article

Recorded live from CDMO Live Americas 2026.Marta Wosińska senior fellow at The Brookings Institution, Reza Oliyai, president and CEO of Oliyai Consulting, and Kenneth Drew, vice president at Flamma, joined an interactive panel at CDMO Live Americas in Boston, reacting to live audience polling on the forces shaping contract manufacturing in 2026.Seventy percent of the audience at the CDMO Live Americas opening panel called themselves optimistic about the next 12 months. The panel agreed on the near term, then spent half an hour on what could go wrong over the next five years. In a plenary session sponsored by Flamma, Wosińska, Oliyai and Drew responded to live audience polls on tariffs, reshoring pledges, China and the talent gap, and the room’s answers shaped the discussion at each stage. Five takeaways stood out.

“If our suppliers fail, we’ll fail, and if they succeed, we’ll succeed.” That’s how José Francisco Vallejo Cabrera of Sanofi describes big pharma’s relationship with its suppliers on sustainability, and it was a message repeated in every conversation at the CPHI Milan 2026 Sustainability Summit.PharmaSource spoke to five sustainability leaders on the show floor. José Francisco Vallejo Cabrera, Global Head of Environment and Environmental Sustainability at Sanofi, has more than 25 years in sustainability, spanning environmental certification, energy management, health and safety, and human rights. He was joined by Marc Roodhuyzen de Vries, Cofounder and CEO of sustainability consultancy Nexio Projects, and his colleague Rachit Paliwal, lead ESG consultant. The other guests were James Swinyard, senior director of investments and partnerships at the nonprofit My Green Lab; Hywel Woolf, Global Sustainability Manager at Sharp Services; and Simon Hodgson, Industry and Technology Sector Lead for Europe at SLR, which provides the secretariat for the Pharmaceutical Supply Chain Initiative (PSCI).In the latest PharmaSource podcast episode, they explain why pharma supply chain sustainability is moving from targets to delivery. They also cover what buyers and suppliers each need to change to get there.Read the full article.

“You have to have something to work on together. You have to have something that you both are invested in. In this case, moving the molecule forward,” says Martin Meeson, CEO of Axplora.That shared ambition is at the heart of Martin’s approach to strategic CDMO partnerships. By understanding what success looks like for each customer, he believes manufacturing partners can focus their expertise and investment where they make the greatest difference—helping promising medicines progress toward patients.Martin Meeson has been CEO of Axplora since April 2024. Before that, he spent more than 15 years at Fujifilm Diosynth Biotechnologies, where he was CEO through the pandemic. Axplora now runs 10 sites across three continents and works with more than 900 customers.Pharma companies are moving away from transactional supplier relationships and toward long-term strategic partnerships. In the latest PharmaSource podcast episode, recorded at CPHI, Martin explains what strategic CDMO partnerships look like from the CDMO side of the table. He covers why listening to customers shapes Axplora’s investment decisions, including its recent move to make exatecan itself, and what CDMOs need from sponsors in return.Read the full article.

“To us, it’s exactly the opposite of a marketing slogan. If we make a decision that has a negative impact on a patient, we’ve made a bad decision,” says Stuart Needleman.Stuart Needleman is Chief Commercial Officer and Chief Patient Centricity Officer at Piramal Pharma Solutions. Before Piramal, he was President of Laurus Synthesis and President and COO of Aptuit, and he held earlier roles at Cambrex, Oxford Asymmetry, ChiRex, and Rhodia Pharma Solutions. He has spent 46 years in the CDMO industry and joined Piramal about a decade ago.In the latest PharmaSource podcast episode, recorded at CPHI Milan 2026, Stuart explains what patient centricity looks like inside a CDMO. He covers why Piramal made it a formal, company-wide structure rather than a tagline, and why he believes most of the industry won’t follow. He shares the practical details: volunteer councils at every site, mandatory training, and a simple decision rule for when the patient and the quarter’s revenue pull in different directions. Stuart will take these questions further as moderator of a roundtable on patient centricity at CDMO Live Americas in Boston this October.Read the full article.

“If the data you give it is weak, the model becomes a liability rather than an asset. In regulated industries, that’s not just a technical failure; it’s potentially a compliance and an ethical failure as well,” says Amie Harpe.Amie Harpe spent 23 years at Pfizer’s global IT organization, leading quality and manufacturing systems programs worth up to $40 million across 65 manufacturing sites worldwide. She’s now the founder of Sakara Digital, a boutique consultancy helping pharma and biotech organizations get more value from digital transformation, with a focus on quality management systems, pharma data quality, and AI readiness.In a recent PharmaSource podcast episode, Amie explains why pharma’s digital transformation gap persists and what separates organizations that get lasting value from their technology investments from those that don’t.Read the full article.

At CDMO Live Europe 2026, Alexander Schäfer, Business Development Manager at Sharp, laid out the scale of the GLP-1 packaging challenge and identified the three collaboration failures most likely to prevent CDMOs and their pharma partners from meeting surging demand.Read the full article.

Container closure integrity (CCI) is a critical element of sterile product quality, but evaluating a CDMO’s CCI capabilities requires more than confirming that testing is available.The appropriate approach depends on the drug product, container closure system, manufacturing process, lifecycle risks, and applicable regulatory requirements. For pharmaceutical companies selecting or qualifying a CDMO, understanding how a manufacturing partner approaches these variables can provide useful insight into the maturity of its overall quality program.Oliver Stauffer, CEO of PTI (Packaging Technologies and Inspection), has more than two decades of experience in container closure integrity testing and quality risk assessment. In a recent PharmaSource podcast, he discussed several considerations for assessing CCI strategies across vials, prefilled syringes, autoinjectors, and other sterile product formats.The discussion points to six areas sponsors should consider when evaluating a CDMO’s approach to container closure integrity.Read the full article.

At CDMO Live Europe 2026, Giulio Cavalli, Principal Lead External Manufacturing, J&J Innovative Medicine; Neil Stevenson, Director, CMC Logic Consultancy; Marine Joly Battaglini, Founder, PharmDev; and Susan Reasoner, Chief Commercial Officer, BioDuro, examined how early-stage biotechs can avoid common selection mistakes, manage capacity concerns, and build CDMO relationships designed to last beyond Phase 1.