{"id":19521,"date":"2016-11-18T16:56:07","date_gmt":"2016-11-18T21:56:07","guid":{"rendered":"https:\/\/digital.hbs.edu\/platform-rctom\/submission\/virtual-clinical-trials-pfizers-digital-transformation-of-pharmaceutical-rd\/"},"modified":"2016-11-18T16:56:07","modified_gmt":"2016-11-18T21:56:07","slug":"virtual-clinical-trials-pfizers-digital-transformation-of-pharmaceutical-rd","status":"publish","type":"hck-submission","link":"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/virtual-clinical-trials-pfizers-digital-transformation-of-pharmaceutical-rd\/","title":{"rendered":"Virtual Clinical Trials: Pfizer\u2019s Digital Transformation of Pharmaceutical R&D"},"content":{"rendered":"

Pfizer is betting big on \u201cthe internet-of-things\u201d to transform the clinical trial design and data acquisition for its experimental Parkinson’s drug PF-06649751, which is slated to begin Phase III clinical trials in 2019.[1]<\/sup><\/a> Collaborating with IBM Watson\u2019s research team, the company hopes to develop a sensor-enabled remote patient monitoring system to revolutionize clinical trial design and therapeutic delivery. Pfizer hopes to gain insight into the activities and health of Parkinson’s patients when they are not<\/em> at clinical trial sites to understand, for example, how the time at which the medication is taken impacts patient outcomes. Approximately 200 participants will serve as a sample set to test the technology, gather data, and allow Pfizer and IBM to consider ways to improve the system for in-home use.<\/em><\/p>\n

About Parkinson\u2019s disease<\/em><\/p>\n

Parkinson\u2019s is a progressive, neurological condition that limits patient quality of life and causes uncontrolled movement, lowered cognition, and myriad debilitating symptoms. Sixty thousand Americans are diagnosed with Parkinson\u2019s disease each year.[2]<\/sup><\/a><\/p>\n

The business of drug discovery<\/em><\/p>\n

As a research-based, global biopharmaceutical company, Pfizer generates revenue from the sale of medicines, vaccines, medical devices, and consumer healthcare products. Pfizer operates in a strictly regulated industry and its business model is highly dependent on drug approval authorities like the U.S. Food and Drug Administration, payers that approve reimbursement based on patient outcomes, and healthcare providers with prescribing power. Currently, the average cost for new drug approval, including drug candidate attrition, hovers at $2.6 billion. Of this, approximately 30% of R&D spending occurs during pre-human, target identification, and 70% of expenditures are incurred during the clinical trial and approval phases<\/strong>.[3]<\/sup><\/a> Pfizer\u2019s product price competitiveness depends heavily on its ability to manage R&D and other operational costs. Ultimately, reductions in R&D spending for new drug approvals have the potential to reduce the cost burden for payers and patients.<\/p>\n

Virtual clinical trials: Value capture in R&D, regulatory, and channel partnerships[4]<\/strong><\/sup><\/a><\/em><\/p>\n

While not yet developed, Pfizer\u2019s system and data are likely to usher in an era of virtual clinical trials, improved regulatory efficiency, and competitive positioning to license its remote monitoring technology to healthcare providers.<\/p>\n

Pfizer can realize R&D savings with virtual clinical trials through reductions in costs associated with patients\u2019 frequent travel to study sites, cost savings from automated data collection, and acquisition of unbiased patient behavioral data. Medication adherence, for example, can be misrepresented when patients are away from trial sites and substantially influences trial data reliability.[5]<\/sup><\/a> Moreover, virtual clinical trials supported by remote monitoring have the potential to increase patient engagement and retention, reducing attrition and clinical trial design costs. Other R&D cost savings include the ability to access monitoring device data in real-time to support efficient data cleaning and adaptive clinical trial design. Decisions to terminate a drug\u2019s late-stage development, for example, may be hastened, leading to improvements in patient safety and limited expenditure on failed trials.<\/p>\n

Moreover, data gathered through Pfizer\u2019s remote monitoring system will allow it to provide objective information to regulators as they pass through the stage-gate approval process. To the extent that sensor-based remote monitoring technologies like Pfizer\u2019s can be easily adapted to measure patient outcomes important to physicians, government agencies, and patient advocacy groups, these can be accounted for early and updated as new patient outcomes are prioritized. Providing diverse stakeholders opportunities to play an active role in the study design may lead to improved data quality and shorter approval timelines.[6]<\/sup><\/a><\/p>\n

Finally, Pfizer\u2019s system is intended to measure a range of health indicators central to understanding Parkinson\u2019s disease progression, including motor function, cognition, sleep, and daily activities like dressing and eating. Data acquisition of this kind could be a boon for healthcare providers. By monitoring these data, healthcare providers can better understand the effect of a patient\u2019s medication as the disease progresses and modify patients\u2019 treatment regimes. Licensing agreements with healthcare providers and hospitals could serve as an additional revenue stream for the firm.<\/p>\n

Pfizer\u2019s continued experimentation with virtual clinical trials and sensor-enablement for improved patient management suggests that early movers in this arena can realize tremendous value.<\/p>\n

Looking toward the future of clinical trials: Chips-in-pills<\/em><\/p>\n

\"chipsinpills\"<\/a><\/p>\n

\u201c…One area that remains elusive [in clinical trial design] is the collection of real-time physiological data to support disease management,\u201d says Arvind Krishna, Senior Vice President and Director of IBM Research.[7]<\/sup><\/a> As a next step to compliment their virtual clinical trial strategy, Pfizer might consider investing in \u201cchips in pills\u201d and other technologies that passively collect patient data and provide clinical trial teams with objective insights. Chip-embedded pills, once swallowed, can remotely transmit signals to clinical trial teams, indicating patient adherence, and can be used to collect pharmacodynamic data to understand drug metabolism and efficacy, for example. Such technologies represent a new paradigm in health but may be met with significant regulatory resistance.<\/p>\n

Word Count: 799<\/p>\n

[1]<\/sup><\/a> Nick Paul Taylor. 2016. Pfizer enlists IBM for IoT-enabled clinical trials by 2019<\/em>. [ONLINE] Available at: http:\/\/www.fiercebiotech.com\/it\/pfizer-enlists-ibm-for-iot-enabled-clinical-trials-by-2019<\/a>. [Accessed 18 November 2016].<\/p>\n

[2]<\/sup><\/a> Neurological Disorders: Public Health Challenges. 2013. Global Burden of Neurological Disorders Estimates and Projections<\/em>. [ONLINE] Available at: http:\/\/www.who.int\/entity\/mental_health\/neurology\/chapter_2_neuro_disorders_public_h_challenges.pdf?ua=1<\/a>. [Accessed 18 November 2016].<\/p>\n

[3]<\/sup><\/a> Tufts Center for the Study of Drug Development. 2014. Briefing: Cost of Developing a New Drug<\/em>. [ONLINE] Available at: http:\/\/csdd.tufts.edu\/files\/uploads\/Tufts_CSDD_briefing_on_RD_cost_study_-_Nov_18,_2014..pdf<\/a>. [Accessed 18 November 2016].<\/p>\n

[4]<\/sup><\/a> Christine Douglass . 2016. Pfizer Taps IBM for Research Collaboration to Transform Parkinson\u2019s Disease Care<\/em>. [ONLINE] Available at: https:\/\/www-03.ibm.com\/press\/us\/en\/pressrelease\/49475.wss<\/a>. [Accessed 18 November 2016].<\/p>\n

[5]<\/sup><\/a> Sujay Jadhav. 2016. Virtual Clinical Trials: The Future of Patient Engagement?<\/em>. [ONLINE] Available at: http:\/\/www.appliedclinicaltrialsonline.com\/virtual-clinical-trials-future-patient-engagement<\/a>. [Accessed 18 November 2016].<\/p>\n

[6]<\/sup><\/a> Ibid, 5<\/p>\n

[7]<\/sup><\/a> Ibid, 4<\/p>\n","protected":false},"excerpt":{"rendered":"

Pfizer is betting big on \u201cthe internet-of-things\u201d to transform the clinical trial design and data acquisition for its experimental Parkinson's drug PF-06649751, which is slated to begin Phase III clinical trials in 2019.<\/p>\n","protected":false},"author":2507,"featured_media":19599,"comment_status":"open","ping_status":"closed","template":"","categories":[],"class_list":["post-19521","hck-submission","type-hck-submission","status-publish","has-post-thumbnail","hentry"],"connected_submission_link":"https:\/\/d3.harvard.edu\/platform-rctom\/assignment\/digitization-challenge-2016\/","yoast_head":"\nVirtual Clinical Trials: Pfizer\u2019s Digital Transformation of Pharmaceutical R&D - Technology and Operations Management<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/virtual-clinical-trials-pfizers-digital-transformation-of-pharmaceutical-rd\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Virtual Clinical Trials: Pfizer\u2019s Digital Transformation of Pharmaceutical R&D - 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