Editorial Perspectives On Cold Chain

  1. New FDA Guidance For Clinical Trials Disrupted By COVID-19 3/19/2020

    During this unprecedented time full of unanticipated challenges for biopharmas, FDA has issued new guidance that offers advice on adjusting clinical trial protocols in the midst of the fast-spreading and ill-understood virus SARSCoV-2 and its resulting COVID-19.

  2. Why EU's New Med Device Regs Matter To Biopharma 10/4/2019

    Pharma's CMC regulatory affairs staff, R&D leadership, manufacturing, quality and compliance professionals take note: the EU MDR is real, it becomes effective next May, and it brings with it new challenges and regulatory uncertainty for manufacturers of combination products.     

  3. AbbVie's Dr. Howard Jacob: Improving The Drug Pipeline With Genomics 8/21/2019

    The relationship between therapies and genetic composition is incredibly important to the future of medicine, and the way it's manufactured. I sat down to discuss the topic with Dr. Howard Jacob, who's working to improve the drug pipeline at AbbVie using genomics tools.

  4. Are Drones Feasible In Biopharma? 7/25/2019

    Back in March, UPS and autonomous drone technology provider Matternet announced they had collectively begun delivering medical samples via unmanned drones at WakeMed’s flagship hospital and campus near Raleigh, N.C.

  5. Is Your Supply Chain Ready For the Biopharma Tidal Wave? 6/19/2015

    In order to manage risk in your supply chain, you have to know where it exists. The same logic is applied when quantifying risks during a process change. Just as a lack of quality affects the patient, so does a lack of supply. So what can you do to ensure your supply chain provides a safe and efficient delivery of your product?