Pharmaceutical companies—having outsourced R&D functions to CROs and collaborated with biotechs, drug companies and academic groups for innovative products and platforms—are now embracing a different type of innovation: technology.
As they turn to smart phone apps, educational websites, social media platforms, wireless devices and other programs, the result has the potential to transform big pharmaceuticals from developers and marketers of medications to a more holistic healthcare entity providing services to improve overall health outcomes through disease management and coordinated care.
That’s the finding of Progressions: Building Pharma 3.0, Ernst & Young’s annual global pharmaceutical report released last month. The professional services firm based its results on publicly disclosed initiatives—those cited in news reports and analyst reports, and only those with price tags attached.
Smart phone apps launched in 2010 spanned 14 disease categories, ranging from tools to help patients track vaccination schedules and manage infusions for hemophilia to those that find cancer clinical trials within 150 miles of their homes.
For some in the clinical trials industry, the use of social media along with online sites that bring people together is not new. But data mining large pools of dissimilar health data can help companies develop more cost-effective clinical trials and distribute marketing materials to the people who need them.
This wealth of information can also provide a lower-cost approach to gaining insights and perspective into the comparative cost-effectiveness of medications. The data can fundamentally alter how evidence is gathered and demonstrated for comparative effectiveness decisions, from value based on clinical research to value based on data mining or value mining.
“Such data mining will be done far more cheaply and quickly than biomarker identification, which takes years of bench research,” the report noted.
Already, many leading hospitals and some drug companies are actively mining electronic hospital records to improve outcomes. Partners Healthcare in Boston is teaming with the FDA, the eHealth Initiative, Johnson & Johnson, Eli Lilly and Pfizer to mine its four million-strong EHR database for possible adverse drug reactions.
The use of existing data—not a new clinical study—also enabled Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, to conduct an analysis that claimed to find an increased risk of heart attacks for patients taking Avandia, the GlaxoSmithKline drug. He arrived at his conclusion, which prompted an FDA drug warning, using a “meta analysis,” a statistical technique that combines several existing studies to look at larger trends.
“To a great extent, we have lost control of the data and, in many ways, our traditional position as information providers,” David Norton, Johnson & Johnson pharmaceutical group chairman, said in the Ernst & Young report. “Patients and others now have much more information than we do. They can identify issues such as adverse side effects or inappropriate use of our products much earlier than we can. How will they use this control? Will pharma companies benefit from richer information so that we can deliver better outcomes?”
The changes outlined in the report stem from the pharmaceutical industry’s movement from its long-standing vertically integrated blockbuster-driven model, defined by Ernst & Young as Pharma 1.0, to today’s Pharma 2.0 business model, which the report describes as “a complex, dynamic and independent ecosystem.”
Now, pharmaceutical companies are focused on improved productivity and financial performance by outsourcing clinical trials and many non-core functions, pursuing more targeted therapies and broadening portfolios of products and capabilities through partnerships with biotech firms and universities.
Information technology companies, large retailers and telecommunications firms are strategically poised to capitalize on the rapid changes taking place in healthcare as pharmaceutical companies pursue innovative ways to collaborate with these new players to improve health outcomes for patients.
Managing an increasingly complex network of partners will pose new challenges for pharmaceutical industry leaders, for example:
* As leading hospitals and payers mine electronic health records for correlations between prescribing patterns and patient outcomes, pharmaceutical companies lose the exclusive control they once had over outcomes data. This poses reimbursement risks and forces strategic decisions to be made while it builds new proficiencies in data analysis.
* The smart phone apps and other technologies will play an increasing role in how patients manage their health, leaving pharmaceutical companies largely on the sidelines, hampered by a regulatory framework governing patient interactions that has been slow to evolve.
— Ronald Rosenberg