Please can you give a brief introduction to companion diagnostics?
Companion diagnostics is critical in helping to pave the way for personalized medicine, in which the treatment is adapted and precisely tailored to the patient.
Companion diagnostics makes it possible to determine which treatment is most likely to be effective for a specific patient instead of paying for procedures or treatment that may not work. Also, in the early stages of drug development, companion diagnostic tests can be designed and developed to best identify clinical trial subjects.
Why is this important? Today, unfortunately, 20–50% of medications do not work on all patients, meaning that valuable time and money can be wasted before efficacy is ascertained for each specific case.
Siemens recently collaborated with Janssen to develop a companion diagnostic test associated with an early-stage heart failure drug. Please can you outline the aims of this agreement?
Siemens has entered into a collaboration with Janssen Pharmaceutica NV to design, develop and commercialize a companion diagnostic test associated with an early-stage compound being developed by Janssen. This compound targets autoantibodies directed against the human β1-adrenergic receptor (β1-AR) that may contribute to the development of heart failure.
Under the agreement, Siemens will work with Janssen to design immunoassay-based companion diagnostic tests for use in Janssen's clinical studies. The Siemens Clinical Laboratory (SCL), an innovative, high-complexity testing laboratory designed to advance personalized medicine, will develop the assay that will be used in Janssen’s clinical trials.
In parallel, Siemens will develop and validate an in vitro diagnostic test as a companion diagnostic for the Janssen therapeutic product. The companion diagnostic test will be broadly commercialized on Siemens' automated immunoassay systems designed for central laboratories.
Please tell me more about the SCL and its role within Siemens Healthcare Diagnostics and companion diagnostics.
As a wholly owned entity of Siemens Healthcare Diagnostics, a global leader in clinical diagnostics, the SCL is tied to a long standing, successful history of advancing the field of diagnostics and, ultimately, human health.
Further, as a provider of molecular testing services for nearly two decades, and supported by a worldwide leader in healthcare, SCL utilizes proven diagnostics expertise to support its pharmaceutical partners at every stage of the therapy development process—from test conceptualization through development for companion diagnostic applications. The SCL can also provide its pharmaceutical partners new opportunities for test deployment through Siemens’ worldwide customer base.
What are the hurdles involved in creating a companion diagnostic test and how can Siemens help companies such as Janssen overcome these impediments?
Developing companion diagnostic tests is a complex, highly regulated process. Pharmaceutical companies looking for a companion diagnostics partner need a reliable co-developer with both technical and regulatory expertise in diagnostics and a comprehensive global reach. Also, successful co-development projects require partners who can align their development programs early and work closely throughout the entire process.
The SCL combines a diverse array of leading-edge technology with extensive regulatory, quality and design control process expertise, making it an ideal partner that can accommodate the most demanding diagnostic needs of next-generation therapeutics.
How do you think the future of companion diagnostics will develop?
Demand for companion diagnostics is expected to continue to grow. I anticipate that we will see an increasing number of regulatory approvals for new medical treatments that result from a marriage of specific tools to obtain precision drugs, devices and companion diagnostics. As a result, the pathway for new medical treatments will become shorter and be targeted more precisely to defined patient populations. Also, the treatment precision should allow for an improved benefit-to-risk ratio for those receiving treatment.
What are Siemens Healthcare Diagnostics’ plans for the future?
Siemens plans to continue growing its presence in this emerging market and anticipates pursuing additional leading-edge opportunities for co-development of companion diagnostics in the future.
Where can readers find more information?
Readers can learn more about Siemens’ activities in companion diagnostics by visiting our SCL website at: https://www.siemens.com/global/en.html.
About Trevor Hawkins
Dr. Trevor Hawkins was appointed Senior Vice President of Strategy, Innovation and Business Development for Siemens Healthcare Diagnostics in April 2012, and is also the head of the Next Generation Diagnostics business initiatives.
As the past Director of the Human Genome Project for the U.S. Department of Energy, Dr. Hawkins has built a 20-year career in the healthcare industry spanning business, academic innovation and as an entrepreneur.
Prior to joining Siemens, he held several senior executive roles, as Chief Scientific Officer of Royal Philips Electronics focusing on healthcare; CEO of the Philips Molecular Healthcare business unit; CEO of GE's Molecular Diagnostics business; and President of Amersham's Genomics business.
Dr. Hawkins has served on several public and private boards and is currently involved in non-profit organizations in California.