7 Lessons on Pharma Data Quality and Digital Transformation from Sakara Digital's Amie Harpe

“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.

“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 FlanaganAisling 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.Read the full article.

Sponsored by Blue Jet Healthcare, this panel at CDMO Live Europe 2026 brought together Bernhard Boehm, Head of External Manufacturing Animal Health, Boehringer Ingelheim; Philip Coetzee, Director CMO Management, Daiichi Sankyo Europe; Fanny Eberhardt, Director Global Procurement, UCB; and Shiven Arora, Managing Director, Blue Jet Healthcare to debate how pharma companies are making network strategy decisions as cost pressures, geopolitical risk, and the limits of tech transfer collide.Read the full article.

“AI is marketed as such an approachable, ubiquitous thing that everybody thinks they can vibe code it. Unfortunately, a lot of companies are starting to think that way,” says Kat Kozyrytska.Kat Kozyrytska is a portfolio strategy and technology leader in life science technologies who has operated across organizations, including Sartorius and Thermo Fisher, and now advises across the life sciences ecosystem. Her work focuses on translating emerging technologies, including AI, automation, and digital capabilities, into portfolio strategy, partnerships, and business growth.Ahead of CDMO Live Americas, Kat explains why many of the assumptions shaping AI adoption in drug discovery do not translate into biopharma manufacturing. She covers the evolving questions around intellectual property and learning rights, why building AI in-house may be the wrong long-term choice for many companies, and why manufacturers need to move from experimentation toward portfolio-level prioritization if AI is to deliver sustainable business value.Read the full article

“How good is your AI model? That’s the wrong question. The right question is: what does your AI model actually help your company do?”Seungik Cho, founder of Sapiens Health, has spent the past year pulling apart the assumption in biomanufacturing that a better-predicting AI model means a better digital twin. His research argues the opposite: that optimizing AI for prediction accuracy can cause these systems to fail in CDMO environments.Seungik Cho is the founder of Sapiens Health and Director of Strategic Operations at Nucleate. He’s finishing his B.S. in Biological Physics at Rice University, where his research explores the intersection between computational biology and multimodal AI. He describes his work as building AI systems that are “trustworthy and deployable,” not just accurate on a benchmark. His recent publications include work on longitudinal CT lesion prediction (IEEE ISBI 2026) and gene network analysis (IEEE BHI 2025).In the latest PharmaSource podcast episode, Seungik explains why he believes CDMOs are pointing their AI investment in the wrong direction and lays out an alternative model built around diagnosis rather than prediction, explainability rather than confidence scores, and institutional memory rather than one-off forecasts.Read the full article.

At CDMO Live Europe 2026, Dr. Olivier Aebischer, Deputy CEO at Interlabor Belp AG, demonstrated how a structured, dual-path analytical approach can identify manufacturing root causes in days, using two real contamination case studies from the lab’s operations.

“We can adjust and be flexible around equipment configuration, but we can’t be flexible around what is a clear communicator and an honest partner.”Damien Perriman is Chief Commercial Officer at ExoZymes, a Nasdaq-listed company using AI-enhanced enzymes to produce pharmaceutical and nutraceutical compounds without living cells. He spent two decades commercializing biotechnologies at multiple companies, scaling up seven different technologies, before joining ExoZymes just over a year ago.In the latest PharmaSource podcast episode, Damien explains how ExoZymes is running its first major CDMO selection process for a platform unlike anything most contract manufacturers have run before, and why the company is weighing communication and cultural fit as heavily as technical capability.Read the full article.