"At Kindeva, we want to be viewed as a fully Annex 1 compliant facility and partner that can pivot when needed and supply uninterrupted to the patients that need it."

Tommy Shornak, Senior Vice President of Sterile Injectables at Kindeva, brings nearly 20 years of sterile manufacturing operations experience from organizations including AMRI, Thermo Fisher Scientific, and Gilead Sciences. Since joining Kindeva in 2025, Tommy has been at the center of the company's investment strategy.

In the latest PharmaSource podcast, Tommy explains why Kindeva's approach to sterile injectable CDMO services, anchored by a $200 million facility investment, a no-single-source supply policy, and a shift toward flexible commercial models, is designed to position the company as a one-stop partner for drug sponsors navigating an increasingly complex outsourcing landscape.

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“The right CDMO is not the one with the biggest plant or the lowest price. It’s the one with the judgment, the systems, and the incentives to protect your molecule when complexity, scale, and scrutiny converge.”

Alessio Piccoli, Chief Commercial Officer at PI Health Sciences (PIHS), a CDMO and CRO with discovery and process R&D capabilities in Jaipur and Hyderabad, India, and EU cGMP manufacturing in Lodi, Italy – a site holding FDA, AIFA, and KFDA approvals. The organization is backed by PI Industries, a global life sciences powerhouse with over 80 years of legacy in turning complex science into scalable real-world outcomes.

In this episode of the PharmaSource podcast, Alessio explains why the most consequential differentiator in CDMO selection is control. He shares how PIHS is building a model defined by scientific accountability, digital execution, and a partnership mindset that links development decisions to commercial reality.

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"If you feel the rules are changing every five minutes, that's not going to help you — because this is a long-term industry."

Jan Ramakers is an independent consultant with over two decades of experience tracking the fine chemicals and pharmaceutical ingredients market. A chemist by training, Jan has worked across pharma, agrochemicals, and the financial sector, spanning market intelligence, competitor analysis, and M&A due diligence.

In this PharmaSource podcast episode, Jan explains why the API outsourcing market is at an inflection point shaped by geopolitical uncertainty, supply chain fragility, and the evolving race among CDMOs to differentiate. Drawing on career-long pattern recognition, he outlines what is actually happening on the ground versus what the industry often gets wrong.

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