GUEST COLUMNISTS

• The US Drug Pricing System Needs to Be Fixed

  Reforms to the U.S. drug pricing environment are required, but to improve patients’ health outcomes, reforms must be grounded in a comprehensive understanding of the current drug pricing system. Otherwise, policymakers will make things worse, not better.

• FDA’s Longtime Approach To New Chemical Entity Designations Now Codified

  New chemical entity (NCE) designations are extremely important to small molecule pharmaceutical developers: they provide a five-year exclusivity period assuring no competition to a new drug product from generics, with or without patent protection. Recently, President Biden signed into law the Ensuring Innovation Act to clarify when a new drug may be granted NCE status.

• The “Resiliency Roadmap” — Next Steps For FDA Inspections

  More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.

• From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs

  The biopharmaceutical industry is poised for a new era of growth, particularly for manufacturing biologics. Workforce development remains a significant limitation, however. This article highlights how the industry workforce training model isn't enough, and what the Albany College of Pharmacy and Health Sciences is doing to address the need for the next-generation workforce.

• Qualification Considerations For A “Factory-in-a-Box”

  The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the "factory-in-a-box," which can be a game-changer for the industry.
   

• Patenting Antibodies: The 4 Tactics To Use In 2021

  With epitope claims less available post-Amgen v. Sanofi, this article examines four useful approaches that you and your antibody patent lawyer can implement in order to improve your chances of obtaining valid antibody claims with functional attributes.

• What Do Artificial Intelligence And Continuous Validation Have In Common?

  Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.

• Outlook: Biotech In 2021 & Beyond

  Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.