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Genomic Biomarkers for Pharmaceutical Development
Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, toxicogenomics, and other genetic technologies as they support drug discovery and development. With chapters wri...
AACR 2022 Proceedings: Part A Online-Only and April 10
The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.
Genomic Biomarkers for Pharmaceutical Development
This chapter presents the processes required for the translation of a biomarker discovery from the research laboratory into a validated diagnostic for clinical application. To fully investigate the topic of assay validation, a brief review of the current regulatory guidance will be discussed, and thereafter this is used as the framework for topics surrounding assay validation. The time-sensitive stages in the assay development process and agreement with clinical development timelines are critical to delivering a viable clinic-ready assay. Methods to best maneuver this are presented to help emphasize the necessary level of validation for use of an assay in a clinical setting. Each pertinent stage is then described, and key focus areas are highlighted. For certain stages of the development process, such as cut-point determination, multiple vs. single analyte, classifier training/testing, and precision determination, various statistical arguments are presented to illustrate common misconceptions or potential pitfalls.
Genomic Biomarkers for Pharmaceutical Development
Despite the large and ever-growing investment in pharmaceutical R&D, the number of innovative new medicines that meet significant unmet medical needs has been stagnant, if not declining. There are many potential reasons for this low return on pharmaceutical R&D investment, but one likely cause is the low probability of the success of clinical trials, particularly in early clinical development. Translational science, which we define as identifying the ‘right’ patient for the ‘right’ drug at the ‘right’ dose, promises to improve not only the odds of success of clinical development, but perhaps more importantly, to get the right drug to the right patient, thereby sparing those patie...
What Will People Think?
'So much fun!' KATIE FFORDE Ila has her pride. And she's about to discover just how much trouble that can be... It's 1976 and in the Vile Parle suburb of Mumbai, bastion of the Maharashtrian middle-class, Ila Bendre's mother is determined to get her four daughters married off as soon as possible. Ila has no intention of snaring a proposal from some dull specimen of Marathi manhood so she can pretend to care about cricket for the rest of her life. She wants a career and life of her own, and she'll do whatever it takes to escape married bliss, no matter what the neighbours might say. But when Ila's Bollywood-obsessed younger sister, Latika, takes the matter of marriage into her own hands, it looks as if the Bendre family's reputation in this close-knit community will be ruined once and for all... As we follow the Bendre sisters from dinners to parties to weddings, from Vile Parle to Pune, will love eventually conquer all in this ingeniously witty and charming tale of pride, prejudice and puran polis?
Genome Research
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Genomic Biomarkers for Pharmaceutical Development
Autoimmune diseases constitute a wide range of mostly complex and multifactorial disorders that are difficult to treat. Increasing insight in the pathogenesis of autoimmune diseases has led to development of targeted therapies aimed at regulating key components of the disease pathways. In particular, the advent of biologic therapeutics has led to significant advances in the treatment of autoimmune diseases. However, the multifactorial nature of the different clinical entities, reflected by the uniqueness of an individual’s genetic make-up and environmental factors, create a high degree of molecular and clinical heterogeneity within a clinically defined disease. Consequently, targeted thera...
Genomic Biomarkers for Pharmaceutical Development
The goal of personalized healthcare in the treatment of cancer is to reduce the attrition of novel oncology drugs and improve patient outcomes. The discovery and application of novel biomarkers is essential for the successful implementation of personalized healthcare for cancer patients. This chapter focuses on the types of biomarkers that can be utilized clinically to guide treatment decisions in multiple cancer indications, including pharmacodynamic, predictive, prognostic, resistance, and surrogate biomarkers. Furthermore, multiple distinct examples highlight how the successful implementation of these biomarkers into clinical practice has benefited particular subsets of patients. Although these successful examples represent important first steps in using simple biomarkers to predict patient response, significant challenges still exist in prospectively identifying or co-developing biomarkers as companion diagnostics. The roles next generation sequencing and innovative biomarker-driven clinical trial design may play in overcoming these challenges are discussed.
