preclinical white papers and articles

81. Pathology's Best-Kept Secret 3/25/2021

    Chief Pathologist John Cochran discusses how clinical trials offer pathologists the opportunity to work at the forefront of diagnostic discovery.

82. Elevating Effective Outcomes With Companion Diagnostics 3/22/2021

    Companion diagnostics (CDx) is a keystone for pharma to create more precise drug therapies as personalized medicine accelerates. Here’s why a CDxcentral laboratory partner is necessary.

83. 3 Ways To Survive The Shifts In Life Sciences 1/6/2021

    Over the past 20 years, the life sciences industry has undergone massive changes, and new software and partners have emerged. There are three key ways that business can serve the dynamic needs of modern drug development.

84. 3 Ways To Mitigate Data Manipulation Risk In Drug Development 1/6/2021

    A critical output of the drug development process, besides the compound itself, is data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.

85. Immunogenicity Assessment: As FDA Guidance Shifts, How Can You Reduce Clinical Hold Risks? 5/9/2020

    Biotechnology entrepreneurs face many challenges as they push to bring potential new drugs into the clinic, whether that means raising the necessary funds for a clinical trial or conducting adequate assessments that ensure drug safety and efficacy. One main concern is often challenging: keeping up with an ever-evolving regulatory guidance.

86. Six Issues To Consider For Rare Disease Pre-IND Meetings 9/10/2019

    Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. By proactively preparing for this meeting, sponsors can set themselves up for productive discussions which may help in identifying areas of regulatory flexibility.

87. Seven Essentials For Successful Drug Development 8/5/2019

    In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. This article reminds of the essentials so that effective therapies have a greater likelihood of reaching patients in need.

88. Reducing Late-Phase Trial Costs, Failures 8/5/2019

    Identifying appropriate dose ranges for pivotal trials remains a major drug development challenge, particularly for new molecular entities (NMEs). Multiple Comparison Procedure – Modelling (MCP-Mod) is a powerful statistical tool that greatly improves the design and analysis of dose finding studies for more accuracy on the targeted dose range. Combined with the adaptive study design, simulation and modelling capabilities of ICON’s ADDPLAN® neo, adaptive MCP-Mod may significantly enhance drug development efficiency.

89. Making Sense Of The Biosimilars Market - Strategies And Recommendations To Achieve Optimal Market Access 7/16/2019

    Biosimilars are generally expected to offer a competitive price advantage to appeal to healthcare organizations and payers which make them an attractive business opportunity.. This whitepaper provides an introduction into key regulatory and development concerns for sponsors, including a discussion of the factors that affect biosimilar uptake for the United States and Europe and recommendations to address these issues

90. Is Gut Microbiome Behind Our Next Breakthrough Therapy? 5/6/2019

    We’re now only beginning to understand how the microbiome influences our health and behavior and vice versa. As we learn more about its connection to a host of diseases and disorders, we expect to see specific bacterial molecules as potential druggable targets.