Zachary Zubulake

GSK boosts oncology pipeline with Nuvalent acquisition, advancing FDA-designated ROS1/ALK inhibitors for NSCLC and expanding kinase inhibitor drug development in lung cancer.

Pharmaceutical suppliers face growing pressure to calculate product carbon footprints as customer requirements and global regulations tighten.

J&J and Roche commit billions to protein degrader platforms, signaling a new era in oncology drug development with major manufacturing implications.

Tom Sellig, Adare Pharma Solutions, shares how the CDMO is positioning for growth amid US reshoring and oral dose innovation trends.

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, spoke about how the pharma industry faces tariff volatility and reshoring pressure. She warned FDA wants actionable supply chain plans, not slogans, with quality built in.

At CPHI Americas, Delaware Gov. Matt Meyer argues domestic pharma manufacturing is a national security priority and positions Delaware as the ideal reshoring hub.

At CPHI Americas, Delaware governor Matt Meyer outlined the state's biopharma vision: fostering workforce talent, industry collaboration, and regulatory speed to market.

FDA instability, staff turnover, and evolving review standards are reshaping drug development. Richard Pazdur, formerly with the FDA, shares what sponsors need to know now.

FDA approves inhaled insulin Afrezza for children aged 6+, expanding pediatric diabetes care and highlighting inhaled biologics' manufacturing complexity.

Pfizer and Innovent's $10.5B oncology collaboration spans 12 cancer programs, signaling a new model for global pharmaceutical development and cross-border drug partnerships.

FDA extends AstraZeneca’s camizestrant's review deadline to assess additional data after its advisory committee failed to reach a majority vote in April.

Sandra Coufal, Toragen, discusses her team's research targeting precancerous cervical cells, backed by a Gates Foundation grant and world-class advisors.

Lilly acquires three biotech firms for up to $3.83 billion, targeting vaccines that may prevent not just infection but also downstream neurological and oncological disease.

Sandra Coufal, Toragen, shares promising Phase I results showing dramatic HPV DNA reductions and tumor shrinkage, with Phase II set to confirm efficacy and safety.

Bristol Myers Squibb collaborates with Anthropic to accelerate drug development, manufacturing quality systems, and regulatory documentation via AI integration.

Sandra Coufal, MD, Toragen, discusses advancing TGNS15 with strong IP, liquid formulation, and an accelerated FDA pathway, potentially saving millions on IND-enabling studies.

Lilly’s Engage Bio acquisition adds a preclinical non-viral DNA delivery platform to its genetic medicines development portfolio.

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher, discuss automation, single-use technology limits, and predictive control shaping continuous bioprocessing's future.

Sandra Coufal, MD, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of the oral cancer drug.

The FDA replaced acting heads of its drug and biologics centers, deepening leadership instability that raises concerns for pharmaceutical developers.

2026 regulatory shifts are accelerating rare disease drug approvals and reshaping clinical development, evidentiary standards, and pharmaceutical manufacturing strategies.

Bryan Poltilove discusses how distributed, point-of-care manufacturing is reshaping biopharma supply chains and cutting carbon footprints.

George Kwiecinski, Global Key Solutions Corp, breaks down GMP inspection risks, global supply chain compliance, and AI's growing role in FDA regulatory scrutiny.

Valerie Bandy, Tecsys, explains how proactive vendor relationships, strategic drug allocation, and end-to-end visibility can prevent costly pharmaceutical supply disruptions.

Bristol Myers Squibb’s Hengrui agreement underscores how China-based early development may influence portfolio and manufacturing decisions.

Valerie Bandy, Tecsys, discusses how manufacturers are adopting data-driven supply chain strategies to reduce drug shortages, control costs, and get the right inventory where it's needed.

Valerie Bandy, Tecsys, shares how manufacturers can build resilient supply chains, navigate drug shortages, and better support health systems.

Ryan Kelly, Rx360, shares how aligning quality, supply chain functions, and auditing deeper is key to pharmaceutical patient safety.

Lilly expanded its Indiana manufacturing investment by $4.5 billion to support tirzepatide, oral glucagon-like peptide-1, and genetic medicines.

Richard Sanderson of IPS discusses risk management, predictive controls, and innovation to address skilled labor shortages in pharma construction.