PharmaSource Podcast

“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.
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“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.
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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.
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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.
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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.