Drug Discovery Featured Articles & Applications

71. A Payday For Payloads: The Transactional Landscape Of ADCs 2/16/2023

    In the last five years, ADCs deals have netted some of the biggest payouts in oncology drug development. The transactions signal excitement for the evolving modality's long-term exclusivity potential and robust targeting capabilities.

72. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

73. Examining Protein Domains For Targeted Biologic Drug Delivery 2/10/2023

    The use of individual protein domains that have been well characterized to create hybrid proteins with desired combinations of biochemical properties is a promising new approach to biologic pharmaceutical agents. I share recent work with regard to the parathyroid hormone, which has important roles in regulation of calcium and bone.

74. 4 Focus Areas To Expand The Success Of Antibody-Drug Conjugates 2/9/2023

    Antibody-drug conjugates (ADCs) represent a significant advance in therapeutic engineering. They combine an antibody, a linker, and a payload designed into a single molecule for delivery to a specific target. Why do discontinuation rates remain high, and what are the novel strategies that we as drug developers can use to maximize success?

75. The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act 2/7/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.

76. Antibody-Drug Conjugates: Increasing Investment In R&D And Partnerhip 2/1/2023

    DeciBio’s Antibody-Drug Conjugates 2023 Industry Survey points to progress in ADC development. Respondents anticipate lower regulatory, financial, and R&D barriers as the technology matures. Senior Life Science Expert Joe Daccache, Ph.D. gave us an insider's look at the numbers.

77. After Decades Of Biomanufacturing Workforce Development, What’s Next? 2/1/2023

    We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.

78. Defining The RNA Therapeutics Industry In 2023 1/16/2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

79. AI/ML In Drug Discovery & Development: Potential And Challenges 1/11/2023

    Selecting the wrong target molecule or focusing on the wrong area of investigation can cause major delays and waste valuable time and resources. Artificial intelligence (AI) and machine learning (ML) can help drug discovery researchers minimize these missteps in a few key ways.

80. FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections 1/9/2023

    The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.