Maximizing the commercial value of personalized therapeutics and companion diagnostics

Abstract

803 Cynthia H. Zhang is at Agilent Technologies, Singapore, and Y. Philip Zhang is at Milstein Zhang and Wu LLC, Newton, Massachusetts, USA. e-mail: philip.zhang@mzwiplaw.com maceutical side, and with identification of stratification markers and development of a test, on the diagnostic side. Potential markers are analytically validated in conjugation with the preclinical development of the drug to ensure that the test is sufficiently predictive and selective to meet regulatory requirements for use in clinical development. The goal of establishing the clinical utility and validation is to establish that the diagnostic test can detect and predict the associated disorder in patients and evaluate the risks and benefits for patient management (Fig. 1). It appears that the FDA considered this model optimal for co-developing drugs and companion diagnostics in a scientifically robust and efficient way, as the model was incorporated in the agency’s 2011 draft guidance on companion diagnostics4. Within this synchronized and collaborative paradigm, C approaches to therapeutics discovery and development are pathologyand symptom-based, with the objective of finding a blockbuster drug useful for all patients suffering from a disease or condition. Similarly, traditional diagnostics development has been ‘one size fits all’ and is conducted largely independently of the development of therapeutics. Although therapeutics and diagnostics were once viewed as distinctive segments of the healthcare industry, there is a growing consensus that an integrated and personalized diagnostic and therapeutic approach offers synergistic benefits, as disease onset and progression involve complex biological pathways and factors implicating both individualized genetic complexity and external variability. Advances in genomics and proteomics research have helped highlight the restraints of the onesize-fits-all model and have led to the emergence of the field of personalized medicine. In the paradigm of personalized medicine, the development of a therapeutic must be united with its companion diagnostic. Personalized medicine calls for medical treatment tailored to the characteristics of a patient or patient group. It does not necessarily mean the creation of drugs unique to each patient, but rather the ability to classify individuals into subpopulations with differing susceptibilities to a particular disease or responses to a specific treatment. Preventive or therapeutic interventions can then be applied to the people who will benefit from them, avoiding side effects and expenses for those who will not1. Integrated co-development A companion diagnostic is a biomarkerbased tool that provides biological and/or clinical information to aid decision making about a potential drug therapy2. The genetic or genomic information of a patient population can also facilitate drug development. An increasing number of pharmaceutical and diagnostic firms support the idea of developing drugs and diagnostics together. A number of models have been proposed for how to structure, plan and coordinate such codevelopment. A co-development model first proposed by the US Food and Drug Administration (FDA) involves setting up an integrated team from an early stage of drug and diagnostic research to oversee a parallel and synchronized development3. The codevelopment starts with target selection and compound identification, on the pharFigure 1 Drug and diagnostic co-development pathway and patent filings. Coordinated patent filings with joint efforts from both the pharma and the diagnostic companies are critical to a strong and integrated patent portfolio that helps maximize the commercial value of a drug-diagnostic pair. Highlighted are the key steps along the co-development pathway and various types of patent filings that may be considered at different stages. Basic research Prototype design/ discovery Preclinical Clinical trials Phase I Phase II Phase III FDA approval and launch

DOI: 10.1038/nbt.2679

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Cite this paper

@article{Zhang2013MaximizingTC, title={Maximizing the commercial value of personalized therapeutics and companion diagnostics}, author={Cynthia H Zhang and Yunqing Zhang}, journal={Nature Biotechnology}, year={2013}, volume={31}, pages={803-805} }