08.18.26 -- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing

Discover how early engagement with European regulators helps smaller drug developers reduce uncertainty, clarify requirements, and de‑risk innovative programs through early dialogue.

Uncertainty in media stability can limit efficiency and scalability in biologics manufacturing. See how a data-driven approach enables more predictable planning and reduces operational strain.

JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.

SMC experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.

Meeting tight launch timelines requires more than speed. Smart kit design, controlled production workflows, and scalable processes come together to deliver complex packaging programs quickly.

By collecting, harmonizing, and contextualizing data to support predictive insights and real-time monitoring, manufacturers can improve operational responsiveness and make more informed decisions.

Operational excellence in drug manufacturing comes from predictability. Standardized, consistent processes reduce volatility and ensure steady, high‑quality progress.

Watch to explore various aspects of environmental monitoring essential for the transfer of materials into controlled areas as well as recent advancements that can facilitate this task.

Incorporate amorphous form screening early in development to unlock solubility advantages, improve bioavailability, and accelerate your path to market.

Experts examine permeation enhancers for drug absorption, PBPK modeling for formulation design, and fast-dissolving orally disintegrating tablets (ODTs) shaping drug development.

Agentic AI is reshaping how FDA review, surveillance, and inspection activities operate, raising the bar for expectations. Delve into how these changes will redefine regulatory engagement.

Successful E&L planning starts before testing begins. Aligning study design, partner expertise, and timing helps teams focus on the right risks, avoid surprises, and support stronger development.

Advanced X-ray inspection, metal detection, and checkweighing technologies ensure fill accuracy, eliminate contaminants, and protect nutraceutical brands.

API-in-capsule offers a fast path for early clinical data, but it can't eliminate the need for full formulation development. Weighing the potential for higher total development time and cost is critical.

By adopting these best practices, biotech sponsors can foster more transparent, efficient, and productive collaborations with their CDMO partners.

Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.

Navigating life sciences AI compliance requires strong governance, expert human oversight, and transparent, low-risk deployment strategies.