“There are 437 active clinical trials in radiopharmaceuticals, and 100 companies developing them. If your logistics are not better, there is no other differentiator. You need to compete by experience.”

When Kostja Paschalidis and his co-founders left their roles developing one of the leading radiopharmaceutical products, they recognised a fundamental shift in pharmaceutical manufacturing. Unlike traditional drugs where marketing drives commercial success, radiopharmaceuticals demand something entirely different: flawless service delivery.

As co-founder and head of systems and logistics at Firm, a design consultancy specialising in radiopharmaceutical services, Kostja has identified why operational excellence—not clinical superiority—will determine market winners.

In the latest PharmaSource podcast episode, he explains why radiopharmaceutical companies must become service-centric organisations to succeed and how a lack of standardisation and suitable technology creates barriers to scale.

“We’re not trying to be everything for everyone. Our specialized focus has been very exciting for me.”

Franco Negron, CEO of Simtra BioPharma Solutions, has transformed a 65-year sterile manufacturing legacy into an independent CDMO since the company’s carve-out from Baxter International (Baxter) in October 2023. Franco has led over $500 million in capital investments to double capacity and create mirrored capabilities across sites in Indiana, US, and Halle/Westfalen, Germany.

Franco brings industry experience from Procter & Gamble, Johnson & Johnson, Novartis, and Patheon, which became part of Thermo Fisher Scientific, where he helped shape integrated CDMO strategies.

In this PharmaSource podcast, recorded at CPHI 2025, Franco explains how Simtra is navigating supply chain challenges, tariff uncertainties, and injectable manufacturing complexity, from GLP-1s to antibody drug conjugates.

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“Process chemistry alone is no longer the whole story—it needs to be connected with engineering solutions, digital tools, and data utilization.”

Stefan Randl, Chief Scientific Officer at Siegfried, joined the Swiss-based CDMO in January 2025 after 16 years at Evonik, where he led innovation management for healthcare, ran drug substance operations in the US, and headed sales across Asia.

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