BIO From The Editor and Guest Columns

  1. How Do FDA, MHRA, & Russia’s Ministry of Health Evaluate & Escalate Inspection Findings? 10/21/2020

    Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.

  2. 4 Tips For Biotech Financing From Afar 10/20/2020

    Gone—for a while, anyway—are the days of pressing the flesh, pounding the pavement, and cross-crossing the conference scene with your pitch deck. Here’s how one successful startup biotech is maintaining its conduit to cash, despite travel restrictions and social distancing.

  3. HQ Move Fuels Fountain’s AI Drug Discovery Machine 10/19/2020

    Fountain Therapeutics’ unique AI discovery platform prompted an invitation from Eli Lilly & Company to move Fountain headquarters to Lilly Gateway Labs. Here's how company CEO John Dimos, Ph.D. is squeezing the value out of the move, despite its execution during the height of the COVID-19 pandemic. 

  4. COVID-19 Vaccine Manufacturing Challenges Spark Surge In Outsourcing Deals 10/19/2020

    As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.

  5. A Quality Agreement Primer: What To Include & Who To Assign It To 10/16/2020

    Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.

  6. How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data 10/14/2020

    Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

  7. The Past, Present, & Future of Biosimilar Manufacturing 10/14/2020

    A recent publication entitled "Approval of Biosimilars: A Review of Unsuccessful Regulatory Filings" revealed the most common manufacturing issues the FDA and EMA flagged in biosimilar applications. Here, the lead author discusses his findings from the past, current manufacturing challenges, and which technologies could be most impactful for the future biosimilar industry.

  8. Biosensors & Big Data: Implications For Biologics Developers 10/13/2020

    Dr. Caroline Loew’s company, Glympse Bio, develops injectable, tunable biosensors that she says will help biologics developers test and measure disease progression in vivo, enabling valuable, early visibility into therapeutic efficacy. 

  9. Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity? 10/12/2020

    Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.

  10. A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity 10/9/2020

    This is part two of a three-part article on quality agreements. Part one discussed identifying key risks in partnering with contract companies and working with vendors. This second part explores the regulations and enforcement activities that apply to quality agreements.