Harnessing the Digital Exhaust: Incorporating Wellness into the Pharma Model

The increasing availability of devices capable of tracking biomarkers presents major opportunities in contemporary healthcare. Herein we advocate a new role for the pharmaceutical industry to capitalize on these opportunities and, in doing so, incorporate wellness and patient engagement programs into their standard business models. Medical-grade decision-making using diagnostic, prognostic, and monitoring biomarkers will require coordinated approaches between the pharmaceutical and technology industries and the careful design of longitudinal clinical studies to validate their efficacy. These studies will also require data capture, archiving, curating, and sharing on a previously unprecedented scale, and raise additional concerns with regard to data security and ownership. Concurrently, systems-based approaches to the capture and interpretation of a new class of digital biomarkers are emerging, and they hold promise for heightened levels of patient engagement and remote sensing. Collectively, if these new opportunities are approached within the context of the patient-provider ecosystem, major repositioning of the pharmaceutical industry may be possible in the near future.

[1]  P. Moyle Progress in Vaccine Development , 2015, Current protocols in microbiology.

[2]  Christoph Franz Innovation for Health: Success Factors for the Research-Based Pharmaceutical Industry , 2017 .

[3]  Derek Tseng,et al.  Targeted DNA sequencing and in situ mutation analysis using mobile phone microscopy , 2017, Nature Communications.

[4]  R. Fair,et al.  An integrated digital microfluidic lab-on-a-chip for clinical diagnostics on human physiological fluids. , 2004, Lab on a chip.

[5]  B. Madea,et al.  The post mortem external examination: determination of the cause and manner of death. , 2010, Deutsches Arzteblatt international.

[6]  J. T. Jørgensen,et al.  Companion diagnostics-a tool to improve pharmacotherapy. , 2016, Annals of translational medicine.

[7]  K. Warner,et al.  The lifetime distribution of health care costs. , 2004, Health services research.

[8]  Bin Zhang,et al.  Screening and identification of potential biomarkers in triple-negative breast cancer by integrated analysis. , 2017, Oncology reports.

[9]  Carlos Rodarte,et al.  Pharmaceutical Perspective: How Digital Biomarkers and Contextual Data Will Enable Therapeutic Environments , 2017, Digital Biomarkers.

[10]  Xiao Li,et al.  Digital Health: Tracking Physiomes and Activity Using Wearable Biosensors Reveals Useful Health-Related Information , 2017, PLoS biology.

[11]  Peter A. Cariani,et al.  The homeostat as embodiment of adaptive control , 2009, Int. J. Gen. Syst..

[12]  Garry P Nolan,et al.  Single-cell Mass Cytometry for Analysis of Immune System Functional States This Review Comes from a Themed Issue on Host Pathogens Basic Concepts of Mass Cytometry , 2022 .

[13]  R. Klopfleisch,et al.  The pathology of the foreign body reaction against biomaterials. , 2017, Journal of biomedical materials research. Part A.

[14]  John C. Earls,et al.  A wellness study of 108 individuals using personal, dense, dynamic data clouds , 2017, Nature Biotechnology.

[15]  John R. Engen,et al.  Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars , 2012, Nature Reviews Drug Discovery.

[16]  L. Thurfjell,et al.  Amyloid PET imaging in Alzheimer’s disease: a comparison of three radiotracers , 2014, European Journal of Nuclear Medicine and Molecular Imaging.

[17]  Bruce W Bode,et al.  Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. , 2016, JAMA.

[18]  Rung-Shiang Cheng,et al.  Using OBD-II data to explore driving behavior model , 2017, 2017 International Conference on Applied System Innovation (ICASI).

[19]  Yunqing Du,et al.  Noninvasive glucose monitoring using saliva nano-biosensor , 2015 .

[20]  Sven Meister,et al.  Digital health and digital biomarkers – enabling value chains on health data , 2016 .

[21]  M. Phillip,et al.  Closed loop insulin delivery in diabetes. , 2015, Best practice & research. Clinical endocrinology & metabolism.

[22]  Daphne Zohar,et al.  Building a business model in digital medicine , 2015, Nature Biotechnology.

[23]  John Torous,et al.  The New Digital Divide For Digital Biomarkers , 2017, Digital Biomarkers.

[24]  Susan M. Huse,et al.  A Core Human Microbiome as Viewed through 16S rRNA Sequence Clusters , 2012, PloS one.

[25]  Krista Wager and Graham Jones The Forward Path for Biopharmaceuticals and Biosimilars: Emerging Options in the Selection of Host Cell Systems , 2012 .

[26]  J. Benjamin,et al.  Administration of high-dose ketoconazole, an inhibitor of steroid synthesis, prevents posttraumatic anxiety in an animal model , 2000, European Neuropsychopharmacology.

[27]  I. Ojanperä,et al.  Drug concentrations in post-mortem femoral blood compared with therapeutic concentrations in plasma , 2013, Drug Testing and Analysis.

[28]  F Foroudi,et al.  A Comparison Of The Needle Biopsy Post Mortem With The Conventional Autopsy , 1995, Pathology.

[29]  Sohee Jeon,et al.  Dopamine oxidation mediates mitochondrial and lysosomal dysfunction in Parkinson’s disease , 2017, Science.

[30]  Ieuan Clay,et al.  Physical Activity Monitoring in Patients with Neurological Disorders: A Review of Novel Body-Worn Devices , 2017, Digital Biomarkers.

[31]  M. Haffner Adopting orphan drugs--two dozen years of treating rare diseases. , 2006, The New England journal of medicine.

[32]  F. Collins,et al.  A new initiative on precision medicine. , 2015, The New England journal of medicine.

[33]  Courtenay C. Brinckerhoff,et al.  Patent watch: Have the biosimilar floodgates been opened in the United States? , 2015, Nature Reviews Drug Discovery.

[34]  A. Hollis,et al.  New approaches to rewarding pharmaceutical innovation , 2011, Canadian Medical Association Journal.

[35]  Jill L. Maron,et al.  How Sensors, Devices, and Biomarkers Can Transform Precision Medicine: Perspectives From a Clinical and Translational Science Institute. , 2018, Clinical therapeutics.

[36]  Asher Mullard New drugs cost US$2.6 billion to develop , 2014, Nature Reviews Drug Discovery.

[37]  Ryan F. Donnelly,et al.  Transdermal Drug Delivery: Innovative Pharmaceutical Developments Based on Disruption of the Barrier Properties of the stratum corneum , 2015, Pharmaceutics.

[38]  Sandeep Kumar Vashist,et al.  Commercial Smartphone-Based Devices and Smart Applications for Personalized Healthcare Monitoring and Management , 2014, Diagnostics.