Newsletter | May 22, 2026

05.22.26 -- Patient Trust And Engagement In The Age Of Decentralized Trials

FEATURED ARTICLE

Building A New Antibody Discovery Platform With Infinimmune's Wyatt McDonnell

On this week's episode of the Business of Biotech, Wyatt McDonnell, Ph.D., cofounder and CEO at Infinimmune, talks about how single-cell biology and computational rigor led to the formation of Infinimmune, and a new way to discover human-derived antibody drugs.

INDUSTRY INSIGHTS

Foreign Action Notification To Health Canada

Health Canada is tightening foreign action reporting expectations. MAHs need to understand what the updated draft guidance means for their compliance and monitoring processes now.

MTP And "The Ballroom Concept": Agile Manufacturing For Pharma

Modular automation is reshaping manufacturing by enabling faster changeovers, reduced downtime, and built‑in compliance. Learn how the “ballroom” approach helps teams adapt to shifting demand.

When Time Is Rare: Advancing Toward Gene Replacement Therapy

See how one family managed to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

Patient Trust And Engagement In The Age Of Decentralized Trials

To truly maximize enrollment in decentralized models, sponsors must invest in human connection to build the trust needed to move patients from awareness to active participation.

Paying Trial Participants With Prepaid Cards? You Need To Hear This

Examine the complexities of participant payments in clinical trials with a focus on prepaid cards and other payment methods.

Eliminating Barriers To In Vivo And Ex Vivo CAR-T Delivery

Learn how lentiviral vector processes evolve for in vivo and ex vivo CAR‑T—covering yield, purity, scalability, and shifting regulatory demands for safe, consistent systemic delivery.

Understanding And Mitigating Oxygen Heterogeneity In Large-Scale Bioreactors

Oxygen heterogeneity, caused by pressure variations and other factors in large-scale bioreactors, can significantly impact cell growth and product yield.

Planning For Success: Supply Resiliency Strategies For Bench To Production

Build scalable material sourcing strategies for R&D and early phases through to commercialization and learn how to accelerate the development process and ensure the scalability of your biologics.

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