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In part 1 of this 2-part discussion, our panelists explain how to structure a tech transfer package, handle gaps in process understanding, and qualify analytical methods.

AI is reshaping discovery, manufacturing, and supply chain routing. Manufacturers are investing in capacity and resilience.

Campbell Bunce, chief scientific officer at Abzena, provides an update on the momentum in antibody-oligonucleotide conjugates development and the operational pressures shaping CDMO/CRO strategy for the rest of 2026.

Megha Sinha, Kolter AI, discusses how pharma's AI bottleneck shifted from technology to readiness as execution across 60 markets stays manual.

Campbell Bunce, chief scientific officer at Abzena, revisited his 2026 industry predictions on the direction of the biologics and bioconjugate market and gives an update on ADCs.

Neuland's Saharsh Davuluri checks in on Chinese out-licensing, peptide capacity, and CDMO agility six months after his December 2025 predictions.

Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, explain a company’s regulatory affairs department is subject to inspections by regulators and should, therefore, be prepared.

Brent Wilhelm, Cencora, comments on cold chain pharma growth, a $1B supply chain investment, and a 2027 hub built to curb drug shortages.

Neuland's Saharsh Davuluri revisits his December predictions for 2026, reporting steady progress on India manufacturing and AI adoption at midyear.

Megha Sinha, Kolter AI, talks on how orchestrator roles surged in pharma AI, but teams need computed plans, not titles, to close the skills gap.

The use of artificial intelligence is facing harder questions of governance and data quality, and regulators in the United States and the European Union are streamlining pathways to market.

Brent Wilhelm, Cencora, talks on last-mile drug delivery risks, carrier network visibility, weather disruptions, and how AI could improve routing.

Megha Sinha, Kolter AI, discusses how digital twins run pharma supply chains but miss the regulatory execution needed to launch changes across markets.

Brent Wilhelm, Cencora, discusses why pharma supply chains still run on historical demand data and how AI could close the real-time visibility gap.

Richard Jaenisch surveys pharma's biggest recent AI deals with Chris Cole in part one of a two-part breakdown of the major moves.

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.

June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.

This episode of Ask the Expert takes a look at recent regulatory actions impacting biologics manufacturers.

This week, the industrialization of advanced biologics, sustained regulatory and investment momentum behind next-generation therapeutics, and an ongoing push across the supply chain to improve standardization and efficiency were themes covered on PharmTech.

AI is reshaping GMP documentation and quality workflows, but human accountability remains non-negotiable, and the regulatory consequences for over-relying on AI are real.

MilliporeSigma's Sebastián Arana breaks down CGT manufacturing's biggest scale-up gaps and why supply chain collaboration is now essential.

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships play a role.

At BIO 2026, Thermo Fisher's Anil Kane explains how AI is reshaping CDMO workflows and what biotechs should prioritize when choosing a development partner.

MilliporeSigma's Sebastián Arana explains why modular, digital, platform-based manufacturing, not raw capacity, will define biomanufacturing's next decade.

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

AI governance, nitrosamine risks, and surging US manufacturing investment reshape quality systems, deals, and workforce needs.

Success in emerging biopharma depends not only on speed, but also on making confident, data-informed decisions early in development while managing increasing molecular complexity.

Karianne Gelinas, LVEDC, outlines workforce strategies to fill 850 technical roles ahead of Eli Lilly's major Lehigh Valley manufacturing investment.