Articles by Jeffrey S. Buguliskis, PhD
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BIOSECURE Act And The 8 Supply-Chain Lessons Sponsors Can't Ignore
5/26/2026
For sponsors rethinking China-exposed supply chains, BIOSECURE is less a warning label than a stress test for redundancy, oversight, data control, and operational resilience.
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At INTERPHEX 2026 A Smarter Outsourcing Playbook Comes Into Focus
4/28/2026
From AI explainability to geopolitical sourcing strategy, the Contract and Outsourcing Exchange Stage at Interphex 2026 delivered a clear message for drug sponsors: the days of passive, transactional CDMO relationships are over.
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Globalization vs. Localization: Where To Outsource In A Changing World
3/18/2026
Geographical strategy for outsourcing is a pressing issue: balancing historical global supply chains with current pressures to reshore/nearshore parts of operations. In this fireside chat, editorial board members Lynn Cinelli, and Kent Pryor help us navigate the geographical pressures of modern outsourcing, the root causes of global supply chain breakdowns, the hardest assets to move across regions, and whether time-sensitive sponsors should simplify their chain or hunt for best-in-class partners globally.
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Choosing The Right Outsourcing Model (CRO vs. CDMO vs. FSP)
3/18/2026
There are various outsourcing models in pharma—from CDMOs (for formulation/production) to CROs (for clinical trials) to FSPs (supplying specialized talent). Which is the right fit, and how do you choose? In this episode, editorial board member Tom Holmes talks about how to choose the right outsourcing model, balance speed-to-clinic, manage blended models, and course-correct midstream.
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Strategic CDMO Partnerships: From Vendor To Collaborative Partner
3/18/2026
Many pharma companies are shifting from one-off, fee-for-service deals to deeper long-term partnerships with their CDMOs, emphasizing shared goals and transparency. In this episode, editorial board members Doug Bakan and Kim Burson discuss how to transform the sponsor-CDMO dynamic.
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Six Specialized Modalities Testing CDMO Readiness In 2026
2/27/2026
As biopharma pipelines shift toward more complex therapies, sponsors are finding that CDMO readiness now depends less on general capacity and more on highly specific technical capabilities.
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End-To-End ADC Manufacturing Works Best With Active Sponsor Oversight
2/6/2026
ADC success is less about perfect execution and more about early signal detection, tight communication, and decisive governance.
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7 Outsourcing Behaviors for 2026 That Will Protect Timelines
12/29/2025
Protecting manufacturing timelines in 2026 means converting speed from a hope into a contractual commitment through strategic prepayment, integrated partnerships, and formalized accountability.
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The Top 10 Nations Redrawing The Outsourcing Map
12/8/2025
There was a time when your outsourcing strategy could be managed with a simple spreadsheet and a focus on cost-per-liter. Those days are gone…
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How AI Is Rewriting Tech Transfer Timelines
11/26/2025
By replacing trial-and-error with virtual simulations and predictive analytics, AI is giving even small biotechs the process development capabilities once reserved for Big Pharma—and slashing tech transfer timelines in the process.