Pharmaceutical. The word itself is fraught with subjective inference. As a society we project so many things onto the idea of pharmaceuticals. You think, among other things, Big Pharma. And let’s be honest, that’s a term growing increasingly loaded with pejorative overtones. Now think about this word: Medicine. You are immediately teleported somewhere positive. You aren’t lost in negative conjecture and presumption. Okay, now add “personalized” to that warm and fuzzy feeling. Forget it. Eureka.
And why is that? It’s quite simply because personalized medicine is the perfect foil to the perceived malpractices of Big Pharma.
Personalized medicine negates the mass-market economies of scale that open the healthcare industry up to ethical and financial scrutiny. Core to the application of personalized medicine are medical devices and diagnostics. Hence, core to the future of healthcare is pharma’s ability to partner with device and diagnostic companies.
Novel Application of an Old Idea
Patient centricity is a mindset celebrated by virtually all pharma companies and is nothing new. Personalized medicine is the same thought reconstituted as a novel therapeutic approach. In fact, it’s a thought that’s been referenced in many ways over the last few years. President Obama’s 2015 State of the Union Speech launched the Precision Medicine Initiative on a national scale. As he said, “Until now, most medical treatments have been designed for the ‘average’ patient. As a result of this ‘one-size-fits-all’ approach, treatments can be very successful for some patients, but not for others.
Precision Medicine, on the other hand, is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles. It gives medical professionals the resources they need to target the specific treatments of the illnesses we encounter, further develops our scientific and medical research, and keeps our families healthier.”
Other people have referred to this approach as genome-based medicine. Regardless of the exact phrasing of the approach—it’s all about having the right medicine for the right patient at the right time.
For Whom the Therapy Tolls
Who is the target audience? The precise answer to that commonly asked axiom has been historically elusive. Pharma marketers and their agency partners are sitting in giant conference rooms across the country workshopping that answer this very minute. Another well-understood axiom—you shouldn’t try to be all things to all people—means that defining your target audience is paramount to maximizing the reach of the message or the benefit of the product. In most cases, the answer ends up being a subjective decision formed by objectively collecting as much data as possible. “We’ve looked at it eight ways to Sunday, and as a result, our very-well informed hypothesis led us to the insight that we should target…” But there it is. It’s still just a guess masquerading as well-heeled fact. However, the identification of genetic, genomic, and clinical information with diagnostic implications empowers healthcare practitioners to stop guessing and start knowing. That’s what’s so exciting.
The new health frontier is a very personal matter. Advancements in science and technology have allowed for improved diagnostics, treatments, and innovative solutions in the form of medical devices. As we move closer and closer to personalization being the standard of care, the quality, consistency, and accuracy of diagnostics and the availability of novel technology to facilitate effective improvements becomes imperative. The Human Genome Project, completed back in 2003, puts within reach the power to examine a large portion of a person’s genome in order to not just assess individualized risk predictions, but also make treatment decisions. If technology is defined as the practical application of science to commerce or industry, then the distinction between technology and therapy is beginning to evaporate. Medicine will forevermore—be more than just a pill.
Prognostic to Diagnostic to Predictive
Our understanding of the molecular biology of cancer has grown exponentially in the last decade. The challenge has been to translate this wealth of information into increased health (technology) for cancer patients. Numerous tumor biomarkers, such as HER2+, are now routinely used to interpret likely progression of disease as well as provide diagnostic direction for treatment decisions. Trastuzumab is now the standard of care for HER2+ breast cancer patients in the metastatic and adjuvant setting thanks to the widely understood utility of the biomarker. It’s in everybody’s best interest, and in some cases, literally a matter of life and death to maximize the utility of biomarkers for diagnostic insights.
Similarly, the ability to use tumor molecular profiles to readily identify clinical trial participants holds immense promise. The predictive knowledge of being able to efficiently segment patients based on the most salient therapeutic strategy for them is the crux of personalized medicine, and will eventually be deemed necessary from a payer perspective. Prognostic implications, diagnostic direction and predictive modeling—it’s happening in cancer care and will begin to infiltrate every crevice of healthcare.
Bedfellows That Make Perfect Sense
As proof of concept that the health frontier is changing for the personal, more and more therapies are launching with companion diagnostics. Companies looking to commercialize a therapy are beginning to see the value in packaging the offering with a diagnostic tool that ensures the proper application of their agent.
These formal business agreements between diagnostic products and clinical therapies are propelling the timely and appropriate use of laboratory testing in the patient journey. Therefore, the determination of the appropriate patient type that a healthcare provider has to make for a new drug is transforming from clinical experience and gut feel to a decisive empirical decision.
But questions abound.
- Will physicians ask for a specific diagnostic companion?
- What are the marketing implications for a therapy launching with a companion?
- What happens if industry guidelines don’t explicitly call for testing throughout lines of therapy?
- How will health insurance companies handle the cost implications of increased laboratory testing?
Time will tell, but patient health empowerment is the promising byproduct of therapies formally partnering with diagnostics.
There’s a Device for That
Medical devices have always been a departure from the traditional but it’s only recently that they’ve become so applicable to everyday healthcare. While traditional medicines have focused on managing symptoms, devices have looked to fix and prevent. Today, medical devices run the gamut from wearable technology to robotic surgical interventions.
More and more of healthcare is relying on medical device technology in one form or another. Whether it’s to monitor a condition or to improve the function of an organ, medical devices have made staggering achievements over the last few decades. Furthermore, technological advancements in areas such as computers and robotics continue to drive medical innovations further. It’s easy to see the future of medicine dominated more by devices than drugs. Medical devices also create additional opportunities for patients and physicians. Some devices act as alternatives to more invasive procedures and in some instances act as opportunities for patients who have seemingly run out of options.
Medical technology is also inherently personal and takes into account the broad spectrum of unique individuals that may encounter it. Right now, we have replacement heart valves that adjust to meet the needs of a wide range of anatomies. When not being placed into or on a body, devices still tend to focus on enhancing care with personal information. For instance, advances in point-of-care glucose monitoring have helped hospitals collect more reliable and accurate data as well as reduce contamination risks.
Devices are also getting smaller and more connected, creating wireless information feedback loops. Data is not only being collected but also being transmitted back to applications, electronic health records, and personal trackers. Personal health data is now easily and continuously being fed, making patients more savvy and better advocates for their own health. All of this leads to proactivity in preventative care, which is also associated with a decrease in healthcare costs.
Big data initiatives are underway en masse across business sectors far beyond healthcare. But it’s in healthcare where big data has the potential to save lives and literally alter the trajectory of how humans are cared for. Projects such as IBM Watson are not just collecting huge swaths of clinical data but translating it into actionable insights. As devices, diagnostics and electronic health records proliferate into everyday practice, the data out there will only get richer and richer.
Health economists are about to have their day in the sun. Outcome-based incentives will rightly rule the roost. But when you subtract money from the value equation, what’s the true role of technology moving forward in the modern health experience? You have to evaluate the true value on an individual level. That’s where small data comes in. It’s when you can drill down from big data to create an aperture focused on a single person’s health, that’s when our countries overindulgence on sickcare will bloom into healthcare. That’s when partnerships between therapeutic companies and device companies will bear tangible fruit. That’s when technology itself becomes medicinal.