Insights On Pharmaceutical Packaging

  1. "Relentless Transparency" Needed Between CDMO And Biotech Customer 5/15/2024

    Vincent Kosewski, VP, Manufacturing & Supply Chain Management, Kala Pharmaceuticals, explains his phrase for how outsourcing communication needs to be handled.

  2. Speed To Clinic, Cost To Get There, And FDA Expectations 5/15/2024

    GSK’s Ben Stevens provides an indepth analysis of the variables regulatory bodies and developers need to balance when considering fast track designations, and the overall rush to get to the clinic.

  3. When Outsourcing, Get The Right Professionals On Your Internal Team 5/15/2024

    In our Outsourced Pharma Live titled “How Can CMC Keep Up With The Rush To The Clinic?”, our speakers all agree: Hire strategically internally for the best results.

  4. A New Acronym – CBMC? Put "Biology" In CMC? Our Panelists Think Not. 5/15/2024

    Chief Editor Louis Garguilo asks our panel if CMC – chemistry, manufacturing, and controls – might be outdated, and whether biology should be added to the acronym.

  5. Consultants Know: Emerging Biotechs Have Outsourcing "Disconnects" 5/15/2024

    Missing an analysis of all the pieces involved in development outsourcing, and a loose connection between the C-suite and reality, can slow down a biotech’s program.

  6. Speeding Up The Regulatory Side Of Outsourcing 5/15/2024

    Benjamin Stevens, Director CMC Policy and Advocacy at GSK provides some initial thoughts on the regulatory aspects related to moving programs to and through the clinic as quickly as possible.

  7. You Need A Gap Analysis Before Outsourcing 5/15/2024

    Vincent Kosewski, VP at Kala Pharmaceuticals, believes there’s a gap when it comes to biotechs performing the necessary gap analysis before initiating outsourcing activities.

  8. Outsourcing Not Plug-And-Play 5/15/2024

    Joanne Beck, Chief Technology Officer, Aerium Therapeutics, starts our Outsourced Pharma Live with a caution: Working with CDMOs is less like a plug-and-play model, and more like a custom-fit set of activities.

  9. Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics 5/9/2024

    Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

  10. De-Risking The Aseptic Drug-Filling Process And Optimizing Production 4/17/2024

    Aseptic drug-filling poses significant risks for manufacturers that can increase costs and timelines. Leveraging proven expertise and efficiency can ensure the production of safe, efficacious products.