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Commentary: Companion diagnostics--Making drug delivery personal
February 2014
by Trevor Hawkins  |  Email the author
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As a patient-centric shift continues to sweep our healthcare system, pharmaceutical companies are increasingly seeing the value of targeting treatments to specific patient populations, making the therapy more personal. In this age of personalized medicine, companies are looking for ways to develop more specific, efficacious and cost-effective treatments that are tailored to a patient’s needs rather than focusing solely on blockbuster drugs that have dominated the industry over the past few decades.
 
Some companies have found novel ways to accommodate for this shift, including adjusting their business models to focus on healthcare outcomes and collaborating with payors and providers to simplify reimbursement and provide tools and technologies to increase medication adherence. Still, there exists a widespread need for additional innovations in testing, beginning in the early stages of the therapy development process, in order to produce assays that eventually become the required companion tests once therapies are approved. Companion diagnostic tests represent an opportunity for pharmaceutical and diagnostics firms to collaborate in a way that places the unmet clinical needs of patients at the center of the drug development process.
 
It goes without saying that pharmaceutical companies are constantly pursuing ways to streamline their development processes, which can often become costly and time-intensive due to the unique circumstances of each patient population. Companion diagnostic tests present companies with a way of making informed decisions around which specific drugs or therapies are likely to be better suited for certain patients, and conversely, which treatments may not be effective with certain patients—an important advantage considering research has shown as much as 20 percent to 50 percent of medications do not work on all patients.
 
Among their strengths, companion diagnostic tests help pharmaceutical companies to optimize patient selection and treatment monitoring and to determine the appropriate protocol to ensure patients get the most out of their therapies. These “precision medicines”—treatments that enable the ability to adapt therapies to an individual’s precise characteristics—represent a pathway for delivering personalized medicine.
 
The use of companion diagnostics in the drug development and commercialization process has become a more realistic and necessary model for an increasing number of companies. In addition to assisting with clinical trial patient recruitment by ensuring trials are optimally enrolled, companion diagnostics can be designed and developed to determine proper therapy dosing for patients based on their personal profiles—another key component of personalized medicine.
 
Seeing the potential
 
The potential for companion diagnostics to usher in a new approach to bringing treatments to patients is already being realized across the industry. The market is currently the fastest-growing segment in the in-vitro diagnostics industry, with worldwide sales expected to reach $3.45 billion by 2015, which marks a sizable increase from an estimated worth of $1.5 billion in 2010.1 At the time of this writing, the FDA has approved nearly 20 in-vitro companion diagnostics tests and imaging tools2—a number that will continue to grow in the near future.
 
At Siemens Healthcare Diagnostics, we view the heightened awareness of and investment in the development and commercialization of companion diagnostic tests as one of the industry’s most game-changing advances of the past few years. As such, we are making a significant investment into the development of these tests at our CLIA-licensed and CAP-accredited laboratory operation based in Berkeley, Calif. Our recent master agreement with Pfizer to provide clinical diagnostic solutions, specifically in-vitro diagnostic tests, is just one example of the confidence the pharmaceutical and diagnostics industries have in companion diagnostics. Collaborative relationships like this represent the next generation of partnerships between pharmaceutical and diagnostics firms. This strategic approach will gain traction as personalized medicine continues to become a necessity for therapy development programs.
 
A complex landscape
 
Some may wonder whether companion diagnostics have the staying power that other enhancements to the drug development process have had in the past. Others can question whether developing these tests is worth the complex, highly regulated processes that are required.
 
These concerns are understandable. As with any innovation, companion diagnostics will become increasingly utilized as they show tangible evidence of improving patients’ experiences with treatments and as they help demonstrate their cost effectiveness when the therapies are commercialized. When some hear the term “companion diagnostics,” they think of the earliest tests that were developed and used after the treatments went to market, and were not always a perfect match for these therapies. However, the approach being taken by many companies to collaborate on therapies and diagnostics in parallel will result in tests with greater application and accuracy. Additionally, companion diagnostics’ ability to accelerate development pathways for treatments and improve the benefit-to-risk ratio for patients receiving these treatments will go a long way in proving their worth to pharmaceutical companies that adopt them early in the development process.
 
Another sign that companion diagnostics are a reality is the growing level of interest regulatory bodies have shown in them over the past few years. With the posting of the U.S. FDA’s July 2011 draft guidance for in-vitro companion diagnostic devices, pharmaceutical and diagnostics companies received some clarity around the collaborative efforts to develop these tests.3 Perhaps more importantly, the FDA’s draft guidance validated the efforts of organizations that had engaged in or were in the process of engaging in partnerships to bring these tests to life, and gave companies a better understanding of how they could move forward with their companion diagnostics in an attainable, expedient manner. Outside the United States, the regulatory environment is less clear but we believe it is likely to trend towards the U.S. FDA-type regulatory model. True, there are still challenges when it comes to regulatory processes surrounding companion diagnostics, but as with any groundbreaking area within healthcare, as more tests are developed, there will be greater clarity on the regulatory path forward.
 
The physician’s role
 
While pharmaceutical and diagnostics companies have much to gain from their investment in companion diagnostic tests, physicians are also playing a pivotal role in their growth throughout the industry. Whether they are participating in clinical trials that are pioneering companion diagnostic tests or are involved to some other extent, physicians are constantly seeking ways to improve their patients’ experiences with their medications, and ultimately improve outcomes.
 
Companion diagnostics are intended to assist physicians in making more informed and personalized treatment decisions for their patients. Therefore, it is critical that pharmaceutical and diagnostics companies involve physicians in the process of developing and deploying innovative clinical tests so they can in turn communicate the benefits of these tests to their patients. This is important because patients are taking a more active role in their healthcare thanks to the availability of advances such as mobile healthcare apps and comprehensive personal health data via electronic health records. Considering these innovations are front-and-center in patients’ lives, they inspire patients to inquire and learn more about the treatments and tests they are being prescribed.
 
It is true that companion diagnostics are still in their infancy when compared with other pharmaceutical models, and companies pioneering these clinical tests will need to continue to pave the way so that others will see their value and also invest in them. We and others are adopting a patient-centered approach through collaborations with pharmaceutical organizations, and we believe this is only the beginning of an exciting new chapter in the pharmaceutical and diagnostics industries’ quest to help bring more effective, affordable therapies to the patients who need them most.
 

Dr. Trevor Hawkins is senior vice president of strategy, innovation and business development for Siemens Healthcare Diagnostics. He has built a 20-year career in the healthcare industry spanning business, academic innovation and entrepreneurship.
 

1Companion Diagnostics. World Market Outlook 2011-2021. Available athttp://www.pipelinereview.com/store/toc/sample_pages_vg0159.pdf. Accessed 4/22/13.
 
2Companion Diagnostic Devices: In vitro and Imaging Tools. Available athttp://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm. Accessed 1/7/14.
 
3Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices. Available athttp://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm262292.htm. Accessed 1/7/14.

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