PharmTech Weekly Roundup-May 22, 2026

This week, PharmTech focused on three industry themes: increased regulatory flexibility for rare diseases, a critical shift toward automated, data-driven manufacturing, and strategic acquisitions in genetic medicine. As the FDA experiences leadership transitions, manufacturers must stay agile, adopting “just-in-time” logistics and predictive process controls to maintain a competitive edge in a rapidly evolving landscape.

In news this week, Eli Lilly’s acquisition of Engage Biologics adds a non-viral Tethosome platform to its portfolio, aiming to overcome traditional barriers in genetic medicine, such as nuclear localization and innate immune sensing.

A look back at recent regulatory news and actions finds that persistent leadership turnover at the FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research has created a pattern of instability that could disrupt review timelines and internal prioritization for sponsors.

In rare disease news, the 2026 regulatory environment is moving toward greater flexibility, utilizing the “Plausible Mechanism” framework and observational data to accelerate approvals for ultra-rare conditions.

In this month’s Ask the Expert, Susan Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, discussed the need for a robust out-of-specification program that requires a shift from reactive troubleshooting to holistic trend analysis and process mapping that identifies recurring issues across methods, personnel, and equipment.

In the oncology field, Sandra Coufal, MD, CEO of Toragen, explained that by leveraging decades of existing safety data and composition-of-matter patents, Toragen is streamlining the development of a liquid formulation cancer drug designed specifically for patients who cannot swallow pills.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explained why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients. The inherent nature of radioactive decay necessitates a transition from traditional inventory models to high-precision, "just-in-time" delivery networks supported by specialized radiation safety infrastructure.

In manufacturing, Deborah Smook, co-founder and co-owner of TurboFil Packaging Machines, explained how managing complex liquid viscosities requires tailored filling methodologies and the integration of AI for predictive maintenance to prevent out-of-specification production.

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher, talked about how automation is no longer optional in continuous bioprocessing, as the industry shifts from reactive set-point controllers toward predictive, model-based "process steering" to maintain consistency.

And finally, experts from Thermo Fisher, explained that in order to resolve bottlenecks caused by high upstream titers, manufacturers are adopting footprint-neutral intensification strategies, real-time analytics, and modular single-use skids to future-proof biologics production.

Staying ahead in this industry means embedding scalability and automation into early-stage design while remaining vigilant of the changing regulatory guard. Be sure to watch the various interviews and read these features on PharmTech.com.