Insights On Drug Development

  1. Does A One-Site CDMO Make A Difference In Drug Development? 11/7/2025

    A one-site CDMO streamlines drug development by co-locating R&D, GMP, and manufacturing. This integration accelerates tech transfer and decision-making, significantly compressing project timelines.

  2. API In Capsule Vs. The Lost Art Of Formulation Development 11/5/2025

    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.

  3. AI Based Screening And Selection Of Co-Formers For Co-Crystallization 11/4/2025

    Explore how AI and quantum chemistry are accelerating co-crystal screening and solving solubility challenges in drug development, as well as key technical considerations for identifying optimal co-formers.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.