BIO From The Editor and Guest Columns

  1. Can Valneva Do What SmithKlineBeecham Couldn’t? 11/11/2020

    As marketability goes—and despite a growing unmet medical need—Lyme disease vaccine programs have suffered a futile fate. With its VLA15 candidate, French specialty vaccine company Valneva is trying to change that. Recent positive Phase 2 data bodes well for the effort.

  2. Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions 11/11/2020

    In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.

  3. Human Performance In Biopharma Operations — Your Problem Isn’t Error 11/9/2020

    This is Part 1 of a two-part roundtable Q&A focused on human performance in pharmaceutical operations. In this part, we discuss key drivers for human performance improvement, compare lean manufacturing and human performance programs, and provide perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. 

  4. Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products 11/6/2020

    This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"

  5. Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity 11/4/2020

    Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants. 

  6. Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA 11/3/2020

    In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product and when is it appropriate and at what level of detail it should be for each stage of interaction with the FDA.

  7. Best Practices For Selecting & Implementing New Technology In The Life Sciences 11/2/2020

    Software tools and their supporting hardware can undoubtedly enable greater performance within your medical device, pharmaceutical, or biotech business. Regardless of the type of technology implementation, how you select technology and how you implement it are two critical factors for any organization.

  8. Evaluating The Potential Impact Of Anti-BCMA Therapies In The Multiple Myeloma Space 10/30/2020

    There are more than 70 ongoing clinical trials in development investigating over 30 B-cell maturation antigen (BCMA) targeting agents, each utilizing innovative technologies and strategies such as antibody-drug conjugates, bispecific antibodies, and CAR T cell therapies. This article reviews three key anti-BCMA therapies in late-phase clinical development that are likely to impact multiple myeloma treatment.

  9. An Inhalable mAb For COVID-19? 10/29/2020

    An at-home, self-administered, inhalable COVID-19 therapeutic is in the works. Given recent transmission spikes, troubling immunity data, and skepticism of a timely vaccine, it might be a critical tool in the effort to flatten the second curve.

  10. How Ancient Fish DNA Could Contribute To Cancer Therapy 10/29/2020

    Multiple of this company’s clinical-stage CAR T-Cell therapy candidates for solid tumor and blood cancers took cues from a discovery made by a renowned biologist trying to grow a genetically-engineered super fish.