11.07.25 -- Will It Not Die? The BIOSECURE Act Back With Iterations

De-risking oral clinical development with a technology-agnostic approach, resulting in the most appropriate formulation within 8 weeks. This ebook explores how you can tackle poor oral bioavailability with a structured early formulation strategy, making informed decisions using minimal API and delivering results for highly sensitive timelines. Click to learn more.

Understand the distinct roles of CROs, CMOs, and CDMOs in the journey from molecule to market. Choosing the right partner for your drug development stage is critical for success.

A panel of product development experts examines blind spots that can plague early development strategies, as well as important considerations when navigating the path toward an IND submission.

A structured contamination control strategy uses the Plan, Do, Study, Act model, focusing on EMPQ, meticulous planning, trend analysis, and continuous improvement with CAPA and change control.

Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.

Regulators are increasingly favoring in vitro methods to prove bioequivalence, though differing guidelines and a new focus on matching reference product structures pose challenges.

Integrating spray dried dispersions with CR strategies addresses poor drug solubility and the need for tailored release kinetics. Explore considerations to ensure stability and sustained supersaturation.

This session is designed to provide practical solutions for enhancing bioavailability and scalability in pharmaceutical formulations, eliminating the need for complex manufacturing methods.

Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.

Review several examples of smarter SAD/MAD trial designs, including multi-part and hybrid protocols, regulatory foresight, recruitment considerations, and operational strategies.

Discover how our global network can streamline your development process and simplify your outsourcing strategy, helping you bring your program to market faster.

As the ADC market continues its robust expansion, the demand for specialized manufacturing expertise is paramount. Entrust in a complete end-to-end solution that simplifies the value chain.

Uncover how our advanced CESS® technology and expanded GMP capacity can bring precision and performance to your manufacturing programs.

Our drug product manufacturing services provide the expertise, flexibility, compliance, and speed you need to get your product to clinics around the globe.