From The Editor

  1. International Reference Pricing: The Answer To Rising Drug Costs?
    11/20/2019

    Political leaders on both sides of the aisle are mulling government-mandated international reference pricing as means of controlling the spiraling cost of biologics and other prescription medicines. Here's what that might look like, and why it's unlikely to happen in short order.

  2. Early-Stage Biopharma Funding Advice From A Leading VC
    11/13/2019

    5AM Ventures Senior Associate Jason Ruth, Ph.D. dished some insider advice to biotech fund seekers in the Pittsburgh LifeX Labs community, and BioProcess Online was there to catch his talk. Here are the highlights.

  3. How The Medical Innovation Act Could Stifle Medical Innovation
    11/12/2019

    The reincarnated bill targeting big pharma is exemplary of congressional inefficiency and over-legislation. Instead, congress should get better at negotiating and appropriating settlements in the existing system.

  4. Outsourcing Insights From A Tech Transfer Veteran
    10/29/2019

    Explore tech transfer expert Anthony Grenier's opinions on the most common mistakes he sees, how to avoid them, and planning ahead to beat the CMO capacity crunch.

  5. Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know
    10/29/2019

    Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

  6. 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.

  7. 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.     

  8. 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.

  9. 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. 

  10. 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.