Brandon W. Higgs's Books

Genomic Biomarkers for Pharmaceutical Development

Chapter 7. Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration

By: Philip Brohawn,Brandon W. Higgs,Koustubh Ranade,Bahija Jallal,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 7. Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration

By: Philip Brohawn,Brandon W. Higgs,Koustubh Ranade,Bahija Jallal,Yihong Yao

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.

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Elsevier Inc. Chapters

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ISBN 10

0128063564

ISBN 13

9780128063569

Genomic Biomarkers for Pharmaceutical Development

Chapter 3. Personalized Healthcare in Autoimmune Diseases

By: Cornelis L. Verweij,Brandon W. Higgs,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 3. Personalized Healthcare in Autoimmune Diseases

By: Cornelis L. Verweij,Brandon W. Higgs,Yihong Yao

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 therapies are not efficacious for all patients diagnosed with such a disease, and selection of therapies is still conducted on a trial-and-error basis. With the rapid advances in modern genomics and genetics technology, there has been some encouraging progress made in the last several years in developing genomic biomarkers as pharmacodynamics markers to evaluate target neutralization for dose selection in pivotal trials, and to identify and evaluate potential predictive markers for efficacy in targeted therapies. This chapter provides highlights and case studies in this field.

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ISBN 10

0128063521

ISBN 13

9780128063521

Genomic Biomarkers for Pharmaceutical Development

Chapter 1. Application of Translational Science to Clinical Development

By: Koustubh Ranade,Brandon W. Higgs,Ruth March,Lorin Roskos,Bahija Jallal,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 1. Application of Translational Science to Clinical Development

By: Koustubh Ranade,Brandon W. Higgs,Ruth March,Lorin Roskos,Bahija Jallal,Yihong Yao

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 patients who may be less likely to benefit from a new therapeutic. We believe that this goal can be achieved by putting the patient first, i.e., by investing in understanding of disease heterogeneity at the molecular level, and then tailoring new therapeutics to subsets of patients. Using examples from the literature and our own experience, we describe current and emerging translational approaches that employ genomic and genetic methods in the areas of cancer, inflammation, and metabolic and infectious disease to this end. We use simple simulations to demonstrate how such translational strategies can significantly reduce the size of clinical trials or increase the likelihood of success of early phase trials. We end by discussing genomic approaches to understand adverse drug reactions.

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0128063505

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Book's by Brandon W. Higgs

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

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