Drug Discovery Featured Articles & Applications

61. Add Efficiency From Development To Validation With Design Of Experiments 3/10/2023

    A statistically-based design of experiments shortens development timelines while reducing product development and validation costs. This works by shrinking the total number of experiments required to evaluate parameters while strengthening analysis.

62. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

63. Tackling Safety Issues Of Adjuvanted Vaccines 3/8/2023

    An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.

64. ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity 3/7/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.

65. 4 Lessons Learned Developing Cancer Immunotherapy Treatments 3/3/2023

    The ability to build up cancer-attacking T cells in cancer patients remains a major limitation of current immunotherapy approaches. PDS Biotech's CEO and CSO share four lessons they have learned along the way in developing their lead product, PDS0101, an immunotherapy targeting HPV-positive cancers.

66. Platforming Strategies To Increase Throughput With Better Standardization 3/2/2023

    Biologics development and manufacturing platforms should fit their target product profile. Here are four considerations for building more efficient platforms.

67. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

68. Strategic Procurement For Emerging Pharmas & Biotechs 2/27/2023

    Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

69. Expanding Treatment Options With Oral Therapies For Immune-Mediated Inflammatory Diseases 2/24/2023

    One of the greatest advancements in treating immune-mediated inflammatory diseases (IMIDs) has been the advent of targeted biologic injectable therapies that target cytokines. However, oral cytokine inhibitors hold significant promise as next-generation options, offering the potential for improved safety, durability, and adherence.

70. Trends In FDA FY2022 Inspection-based Warning Letters 2/21/2023

    We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.