PharmaSource Podcast

“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.

“Traditional staff augmentation says, ‘Here are the people you asked for.’ An outcome-led model says, ‘Here is the service or capability you asked for, and we are accountable and responsible for making it work.’” — Aisling Flanagan
Aisling Flanagan, Global SVP of Professional and Managed Services at Catalyx, leads people-based services for regulated manufacturing environments. She works alongside Mike Barrett, Catalyx’s director of sales and operations for the UK and Europe, who focuses on translating client needs into measurable delivery.
In this PharmaSource podcast interview, Aisling and Mike explain how pharmaceutical manufacturers can improve staffing outsourcing in pharma manufacturing by buying capability, capacity, and results instead of contractor headcount. Their recommendations cover supplier consolidation, GMP expertise, workforce retention, governance, and performance-based KPIs.
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