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The rapid decrease in the cost of DNA sequencing that has occurred since 2008 has ignited innovation in the precision medicine area. Dynamic changes in pharma, medicine, technology, and biotech are all occurring simultaneously around the development of advanced capabilities to deliver precision medicine to patients. As expectations for care delivery are becoming more personalized, the traditional model of pharmaceutical manufacturing, distribution, and utilization will be heavily disrupted in the next decade.
"As more comprehensive use cases gain success, the changes to the existing model will be disrupted"
A cancer diagnosis will impact approximately 39.6 percent of men and women during their lifetime. That staggering statistic provokes an intense focus around rapidly bringing new and more effective options for patients. I believe that technology is the way clinical capabilities and outcomes will advance to new levels of excellence in oncology, and the pharmaceutical industry will be a critical component to enable the rapid change to deliver improved and individualized treatment options to patients.
The following are a few examples of areas that I am monitoring closely and believe will have significant impact on the pharmaceutical industry:
1) Imprecision to precision medicine will be a forceful pressure on pharmaceutical companies based on current effectiveness with the top ten highest-grossing drugs in the United States helping between 4-25 percent of the people that take them. Physicians will take into account the lifestyle, genetics and environment of patients to make treatment recommendations that are individualized. When a patient has genomic testing completed, physicians can make treatment recommendations based on targeted therapies that will be most effective for that individual. The expansion of pharmacogenomics is critical in cancer care with current medication ineffectiveness affecting as many as 75 percent of patients.
2) Traditional physician role is shifting to the role of coach due to the rate of new discovery and the pace of information being published. Physicians can no longer rely on the training they had during med school and stay current by reading a few new journal articles per month. Estimates are that by 2020, physicians will face 200x the amount of medical data and facts related to patient care than a human could possibly process.
3) 3D printing could completely transform the manufacturing process in the pharmaceutical industry. It is not difficult to imagine how the advances in personalized medicine could result in the manufacturing of 3D printed medications that are determined to be most effective for each individual patient by leveraging customized dosages and drug combinations. The transformation may be from “one size fits all” medications that are relatively ineffective to individualized treatments that may include combination therapies specifically targeted for a patient’s treatment.
4) Value based care is becoming a reality in healthcare. With pressures being felt by payors and healthcare providers, it is not difficult to take the leap to the expectation of payment for value extending to the pharmaceutical industry around drug effectiveness.
5) Disruption to the clinical trial process is necessary. With the average drug approval process taking 8-12 years, technology advances in the areas of computational computing and synthetic biology are enabling bio-tech garage innovators to achieve break-through in fractions of time and cost of traditional development methods. The use of these new technologies will enable the drug testing and trial period to advance significantly and reduce the risks associated with human experimentation. Patient empowerment is changing the historic relationship between patients and their physician. Patients are now empowered with access to information via the Internet that was not available a decade ago. Consumer behaviors and expectations are also transferring into healthcare in ways that did not traditionally exist. As patients become more educated, they are doing the research to understand treatment options and are making decisions based not only on the clinical condition but the overall option that is best for their personal situation and goals.
6) CRISPR Cas9 genome editing technology has the first human trial planned to start this year. This trial will focus on using CRISPR to edit the T Cells in cancer patients to activate the immune system to destroy malignant cells that are no longer responsive to current treatment therapies.
7) Virtual reality experiences with low cost delivery options such as Google Cardboard may provide empowered patients the ability to evaluate the pros and cons of pharmaceuticals in a new way. Patients can leverage this technology to understand the workings of a drug and could obtain a deeper understanding of the potential side effects through virtual simulations.
8) Direct to consumer testing services empower a patient to have a deeper understanding of their own body and make pro-active lifestyle adjustments to reduce risk of disease. This is enabled by services such as Veritas Genetics, which offers genome sequencing for $999.
As all of these technologies converge, collaboration is occurring between industries in a manner that I have not experienced in the last 20 years within healthcare. It is critical because many of these technologies are being developed in silos or with narrow use cases. As more comprehensive use cases gain success, the changes to the existing model of drug development, testing, regulatory approval and reimbursement will be disrupted. Pharma companies should take note of these trends because if they are not prepared, they may find themselves with a legacy business model that quickly becomes irrelevant.
See Also: The Manufacturing Outlook