Insights On Drug Development

1. Smarter CMC Strategies To Accelerate Next-Gen Biologics To The Clinic 10/23/2025

   Learn how process design and cross-functional collaboration mitigate risks and accelerate the path from early development to FIH manufacturing through real-world case studies of practical approaches.

2. How Lipid Nanoparticles Enable Next-Gen Delivery 10/20/2025

   Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.

3. Spray Dried Dispersions In Controlled Release Formulations 10/16/2025

   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.

4. From First-In-Human To Proof-Of-Concept — Quicker, Smarter, Streamlined 10/14/2025

   Explore examples of smarter SAD/MAD trial designs including multi-part and hybrid protocols, regulatory foresight, recruitment considerations, and operational strategies that keep programs moving.

5. Top 8 Considerations For Choosing A PDX Model 10/7/2025

   To guide your decision-making, we’ve outlined the top 10 criteria to consider when evaluating PDX models for your next oncology research or drug development program.

6. Sniffing Out Solutions In The Nasal Drug Delivery Revolution 10/7/2025

   As research continues to advance, nasal drug delivery stands at the intersection of innovation and practicality — offering a unique opportunity to expand therapeutic reach while rethinking how medicines are administered and experienced.

7. What Are The Keys To Making Rare Disease Drug Development Sustainable? 9/30/2025

   This roundtable weaves together diverse perspectives, providing a multifaceted look at what it will take to create a sustainable path forward in rare disease drug development.

8. Utilizing Flow Cytometry For Humoral Immunogenicity Testing: Cell & Gene Therapy 9/29/2025

   Discover strategies to overcome immunogenicity challenges in cell and gene therapies, with a focus on harnessing flow cytometry to enhance ADA and NAb assay development, strengthen validation, and ensure regulatory readiness.

9. Streamlining Biologics Development: Leveraging Small-Scale Studies For Greater Efficiency 9/25/2025

   Uncover how a data-driven approach to small-scale studies not only accelerates development timelines but also enhances decision-making and resolves full-scale manufacturing challenges across diverse biologic modalities.

10. Overcoming Unique Client Challenges With A Strong Collaborative Partnership 9/23/2025

    Through close collaboration, proactive communication, and agile project management, our partnership accelerated an oncology program and helped overcome complex preclinical hurdles.