From The Editor

  1. Solving Pharma’s Public Opinion Crisis
    10/17/2019

    Americans' view of the pharma industry is at an all-time low. NSF Health Sciences Global VP Martin Lush says to change that, something radical will have to happen.

  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. FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics
    9/30/2019

    While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

  4. Abcentra Chief Looks Beyond The Clinical Horizon
    9/26/2019

    Why Bert Liang, M.D., Ph.D. obsesses over at-scale manufacturing and regulatory challenges from the outset of clinical trials. 

  5. Does Gender Disparity In Biotech Really Matter?
    8/29/2019

    Why it does, and how one startup is winning the biotech talent wars with a diversity-centric strategy.

  6. 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.

  7. Inside NIIMBL And Its New FDA Partnership
    8/19/2019

    Last month, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware, on behalf of NIIMBL, has entered into a Collaborative Research and Development Agreement (CRADA) with the FDA. Effective July 15, the agreement gave FDA and NIIMBL the ability to “collaborate in a pre-competitive environment to strengthen research, innovation, training, and collaboration in the biopharma manufacturing industry.”

  8. A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    8/14/2019

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

  9. Cutting Through The Noise: The Bright Side Of Biosimilar Progress
    7/29/2019

    Because negative news and opinions seem to create greater waves, I thought I would take stock of the positive news that may not have come over your desks or (more realistically) cellphones in the past few weeks. While it’s easy to get bogged down by negative speculation, there’s progress being made and companies and experts fighting daily to keep this industry moving forward, even if it feels glacial.

  10. 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.