In part 2 of this 2-part interview, Jason Bock, founder and CEO of CTMC provides input on how the FDA's proposed manufacturing registration rule may impact personalized therapies.

FDA revises draft guidance for 17 generic peptide products, including semaglutide and tirzepatide, updating testing standards ahead of a September comment deadline.

GSK invests £400M ($455 million) in a new Cambridge Biomedical Campus R&D hub, closing Stevenage by 2029 and expanding Ware's manufacturing scale-up capacity.

Jason Bock, founder and CEO of CTMC, provides his perspective on the FDA’s proposed rule to streamline registration for single distributed manufacturing establishments, and what the change may mean for personalized medicines.

In part 2 of this 2-part discussion, our panelists explain how to maintain technical oversight without micromanaging and how one can align tech transfer and regulatory strategies to avoid commercial supply gaps.

Pharma manufacturing and development experts reassess their 2026 predictions for the industry and look ahead to the second half of the year.

European biotechs are utilizing AI to identify novel immunoinflammatory targets in respiratory diseases.

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.

Megha Sinha, Kolter AI explains how Pharma has automated drug discovery and manufacturing AI, but not regulatory execution.

FDA advisers vote to allow pharmacy compounding of unapproved peptides BPC-157, KPV, TB-500, MOTs-C despite thin safety data and industry ties.

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.

Brent Wilhelm of Cencora talks about real-time demand data, last-mile carrier risk, and a $1 billion investment in cold chain pharma resilience.

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

The FDA approval of Jideytro (zidesamtinib) for previously treated ROS1-positive NSCLC has implications for drug developers.

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.

Novo Nordisk’s complaint contends that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide) currently on the market.

BMS is scaling AI drug discovery with new NVIDIA infrastructure, cutting research timelines via faster, more efficient computing power.

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.

Checking in at 2026's midyear mark, LGM Pharma's Mike Stenberg revisits his 2025 predictions on inspections, onshoring, GLP-1 delivery, and AI adoption.

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.

The future of compliant AI is not better content generation. It is better control over what happens next.