Big data is only beginning to transform everything from R&D to clinical trials.
The future of big data is already visible in several corners of the healthcare field.
Each time we pick a program on Netflix or scroll through our Facebook feeds, we witness high-powered data processing at work. But no field stands to offer more positive impact to society through this technological sea change than healthcare, where big data promises to detect diseases earlier, develop appropriate medicines faster, and identify personalized options more effectively.
To be sure, we’ve only scratched the surface of this reality. But in research labs and healthcare facilities around the world, data-driven efforts that would marvel many of Silicon Valley’s best minds are already well underway.
In research and development, big data is playing a critical role in unlocking key insights that are revolutionizing drug discovery. By linking real-world clinical, genomic, and lifestyle data, researchers are identifying new disease pathways and improving the drug discovery process. For example, through a partnership with genetic testing startup 23andme, Pfizer researchers have been able to study the genetic profiles of patients with lupus to determine which ones are most likely to experience severe flares, as well as those most likely to respond to our treatment. Armed with that information, we are now able to explore customized treatment options that vary with genetic, dietary, and lifestyle factors.
Pfizer’s Precision Medicine Analytics Ecosystem, which is designed to connect the dots between several large, disparate datasets, also enables us to create targeted drugs based on what we know about patients. In lung cancer, for example, medical research revealed that about 5% of patients weren’t engaged in high-risk lifestyles, like heavy smoking, coal mining, or other activities that abused their lungs. Their common thread was a mutation in their ALK gene. Supported by predictive analytics, Pfizer succeeded in developing a drug approved in 2011 specifically for lung cancer patients with the ALK gene mutation.
Another area ripe for big data-fueled innovation is clinical trials. Pfizer has worked to integrate sensor data into our clinical trials to ensure medication compliance, predict events, evaluate new clinical endpoints, and demonstrate how treatment impacts a patient’s overall quality of life. We have completed at least 10 studies with wearable devices during the past five years, and, going forward, many of our studies across a range of indications will include companion technology, such as wearables, to generate consistent streams of data from participating patients.
Big data can also help determine which patients may benefit most from a drug and therefore should be included in clinical trials. And it enables us to target very specific patient profiles. For example, subsequent to such an analysis, we could elect to focus a study only on female breast cancer patients over age 50, of Asian ancestry, who have tested positive for the BRCA1 gene mutation, and have failed first-round chemotherapy, and develop a more meaningful treatment for this specific population. Without big data, that kind of granular pinpointing just wouldn’t be possible.
Still, despite the incredible progress, we, as a sector, have much to overcome. To start, healthcare organizations must improve mechanisms for protecting and securing patient data. Deidentifying and anonymizing patient data is one necessary step. And, of course, more must be done to prevent data breaches in the healthcare field (2015 was dubbed the “year of the healthcare hack,” unfortunately for good reason). Regulators should do more to facilitate the use of these data by public or private organizations (provided the anonymity and security of data are well guarded). This will enhance our ability to produce medical solutions and better serve public health interest.
Additionally, although FDA and other regulatory bodies around the world are moving swiftly to accommodate big data, private and public sector organizations must work closer together as we transition to a more data-driven paradigm. Increasing access to clinical trial data and results holds a great deal of promise, but simply opening the floodgates is not the answer. Regulators will also need to address issues with pharmacovigilance reporting that will emerge, as a result of mining and correlating massive databases.
We must work as a healthcare community to define and build robust and sustainable ways to share data and ensure interoperability. To that end, we are working with a group of multinational government, patient, and industry stakeholders to identify practical strategies for advancing clinical trial transparency in fair and respectful ways. Together with academic institutions, nonprofits, healthcare companies, and others in the global research community, we’re establishing data-sharing models that will ensure meaningful and scalable progress.
CONTINUE READING: Access the complete article in mddionline, where it was originally published.
Albert Bourla, Group President of Vaccines, Oncology and Consumer Healthcare
Albert Bourla is the Group President of Vaccines, Oncology and Consumer Healthcare at Pfizer, three businesses that are integral to the company’s innovative core and growth strategy. He is a member of the Company’s Executive Leadership Team. Pfizer Vaccines includes Prevnar 13, the world’s leading pneumococcal vaccine, and Trumenba which prevents invasive disease caused by meningitis B as well as a promising pipeline of preventative and therapeutic vaccines. Pfizer Oncology is improving the standard of care for cancer patients with products such as Sutent, Xalkori and Inlyta. Under Albert’s leadership, Pfizer received FDA accelerated approval of Ibrance, the first new medicine approved in more than a decade for the first-line treatment of postmenopausal women with certain kinds of advanced breast cancer. Pfizer Oncology’s extensive pipeline includes potential medicines for early-stage breast cancer, as well as for a range of other tumors, including non-small cell lung, prostate, ovarian, renal and brain tumors. He also spearheaded a partnership with Germany’s Merck KGaA to advance Pfizer’s immuno-oncology program. Pfizer Consumer Healthcare is among the largest over-the-counter (OTC) health care product businesses in the world and markets two of the top ten global consumer brands – Advil and Centrum, as well as markets Nexium 24HR, the OTC formulation of the well-known heartburn medicine.
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