Virtual Clinical Trials: Pfizer’s Digital Transformation of Pharmaceutical R&D
Pfizer is betting big on “the internet-of-things” 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.
Pfizer is betting big on “the internet-of-things” 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] Collaborating with IBM Watson’s 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 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.
About Parkinson’s disease
Parkinson’s 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’s disease each year.[2]
The business of drug discovery
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.[3] Pfizer’s 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.
Virtual clinical trials: Value capture in R&D, regulatory, and channel partnerships[4]
While not yet developed, Pfizer’s 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.
Pfizer can realize R&D savings with virtual clinical trials through reductions in costs associated with patients’ 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] 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’s late-stage development, for example, may be hastened, leading to improvements in patient safety and limited expenditure on failed trials.
Moreover, data gathered through Pfizer’s 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’s 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]
Finally, Pfizer’s system is intended to measure a range of health indicators central to understanding Parkinson’s 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’s medication as the disease progresses and modify patients’ treatment regimes. Licensing agreements with healthcare providers and hospitals could serve as an additional revenue stream for the firm.
Pfizer’s continued experimentation with virtual clinical trials and sensor-enablement for improved patient management suggests that early movers in this arena can realize tremendous value.
Looking toward the future of clinical trials: Chips-in-pills
“…One area that remains elusive [in clinical trial design] is the collection of real-time physiological data to support disease management,” says Arvind Krishna, Senior Vice President and Director of IBM Research.[7] As a next step to compliment their virtual clinical trial strategy, Pfizer might consider investing in “chips in pills” 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.
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[1] Nick Paul Taylor. 2016. Pfizer enlists IBM for IoT-enabled clinical trials by 2019. [ONLINE] Available at: http://www.fiercebiotech.com/it/pfizer-enlists-ibm-for-iot-enabled-clinical-trials-by-2019. [Accessed 18 November 2016].
[2] Neurological Disorders: Public Health Challenges. 2013. Global Burden of Neurological Disorders Estimates and Projections. [ONLINE] Available at: http://www.who.int/entity/mental_health/neurology/chapter_2_neuro_disorders_public_h_challenges.pdf?ua=1. [Accessed 18 November 2016].
[3] Tufts Center for the Study of Drug Development. 2014. Briefing: Cost of Developing a New Drug. [ONLINE] Available at: http://csdd.tufts.edu/files/uploads/Tufts_CSDD_briefing_on_RD_cost_study_-_Nov_18,_2014..pdf. [Accessed 18 November 2016].
[4] Christine Douglass . 2016. Pfizer Taps IBM for Research Collaboration to Transform Parkinson’s Disease Care. [ONLINE] Available at: https://www-03.ibm.com/press/us/en/pressrelease/49475.wss. [Accessed 18 November 2016].
[5] Sujay Jadhav. 2016. Virtual Clinical Trials: The Future of Patient Engagement?. [ONLINE] Available at: http://www.appliedclinicaltrialsonline.com/virtual-clinical-trials-future-patient-engagement. [Accessed 18 November 2016].
[6] Ibid, 5
[7] Ibid, 4
Jacqueline, it’s really interesting to read about a real application of IBM’s Watson after learning about it in class today — thanks for the post! I think that leveraging digital health to monitor Parkinson’s is a great idea, primarily because I imagine that motor functions can be monitored remotely via technology. I wonder if this translates to other CNS disease areas, where endpoints may be more subjective (e.g. mood, anxiety etc) and will need human intervention.
Another concern I have is that even though large biopharma companies like Pfizer as well as smaller start-ups like Denali will rapidly adopt such technologies, regulators like the FDA will go through a long, winding path to evaluate these before they will accept such clinical trial results. I imagine there will be push back not just from regulators but from competitors who haven’t adopted these technologies yet, as clinical trial data comparisons may be apples to oranges now. Companies like Pfizer should to work closely with regulators and keep them in the loop, so regulators are a part of the development process of new ideas and are more likely to expedite approvals. Lastly, regulators in each geography will approach this differently, so global companies have a mammoth task to drive this adoption of technology across the value chain.
This is a very interesting angle to consider, especially when we compare to how another company, Indigo, tackled the issue of a costly development funnel in big pharma. I am really interested in the chip-in-pill concept discussed at the end of the post, but I also know I’m an engineer that is fascinated by pushing technology to the limits. How do you think consumer behavior could cause push back on a technology such as this? Could Pfizer get a large enough population of patients to trial this to make it successful?
Jacqueline, thank you for the very interesting blog post! I had no idea that pharma companies were starting to use technology in this format, but it sounds like a huge opportunity. I am very curious how the actual virtual clinical trials will look when Pfizer has completed development. I would guess that there would be some concerns to overcome with patients reporting their own conditions instead of having those documented by a medical professional onsite at a trial location. From a data integrity perspective, I am sure this is something they will have to work out as a company and with the FDA. I love the idea of the microchip pills, as a way to get around potential human error, but I am sure that trial participants might have a sense that this toes the “big brother” line.