In February 2011, ResearchDx, based in Irvine, CA, launched the first-ever Contract Diagnostics Organization (CDO). The CDO facilitates simple, straightforward options to initiate the development of companion diagnostics in synergy with drug development. The use of companion diagnostics in conjunction with custom pharmaceuticals is expected to continue to expand as personalized medicine continues to evolve. In this context, the CDO fills a need in the co-development of diagnostic tests and drug therapies – a need significantly different than the current pharmaceutical development model meets.
Pharmaceutical Outsourcing recently interviewed Philip D. Cotter, PhD, and Mathew W. Moore, PhD, Principals and Co-Founders of ResearchDx, to discuss the concept of a Contract Diagnostics Organization (CDO) and how this new business model stands to impact personalized medicine and revolutionize management of the co-development of companion diagnostics.
1. How would you describe the role of companion diagnostics in medicine today?
Broadly speaking, companion diagnostics can be used in one of three categories: (1) Patient Stratification; (2) Drug Dose Determination; or (3) Monitoring Treatment. In the case of Patient Stratification, companion diagnostics can assist in identifying patients who will – and perhaps equally as important, who will not – benefit from a particular therapeutic treatment. With regard to Drug Dose Determination, biomarker information derived from companion diagnostics can be used to calculate appropriate drug dosage. In the area of Monitoring Treatment, companion diagnostic assays are used to monitor the effectiveness of a given therapeutic treatment. All of these applications – patient stratification, drug dose determination, and monitoring treatment – are integral to the overall concept and emerging era of “personalized medicine.”
2. Can you tell our readers more about personalized medicine and the role of companion diagnostics?
Personalized medicine refers to the customization of medical treatment to the individual characteristics of each patient. In essence, it’s the “right” drug, at the “right” dose, at the “right” time for the “right” patient. With more and more biomarkers being discovered and validated, many of the assays that allow customization of treatment are based on patients’ genetic profiles. Methods to determine genetic variation have included testing for variations in genes, gene expression, proteins, metabolites and the targeting of molecular mechanisms. More recently, the use of composite biomarker signatures is commonly seen in the clinical development of therapeutics.
The use of companion diagnostics is now known to be a key component in the customization of therapeutics. These companion diagnostics are clinical laboratory diagnostic assays, in which biomarker data derived from these assays is used to support decision-making in the use of a particular therapeutic agent. This essentially allows for the use of a companion test, such as a laboratory-developed test, to predict whether a drug will work for a particular patient or in what does a particular patient should take a given drug treatment. Companion diagnostic + therapeutic agent = personalized medicine.
3. ResearchDx is the first-ever Contract Diagnostics Organization (CDO); what is a “Contract Diagnostics Organization”?
With a shared passion for, and experience in, the field of personalized medicine, ResearchDx created the concept of the “Contract Diagnostics Organization” in response to our personal experiences in the companion diagnostics development process. With our team’s extensive experience in managing clinical laboratories, designing and managing clinical research, and navigating the complex regulatory environment specific to diagnostics, we saw the opportunity to fill an unmet need for partnership with the biopharmaceutical and diagnostics industries. In essence, we observed pitfalls and challenges in this area that we believed a CDO could more effectively address. As a result, ResearchDx provides all of the services necessary to develop a companion diagnostic in an integrated, technology-independent manner that stays focused on our customers’ business objectives. As a CDO, ResearchDx offers clinical research, a clinical laboratory, manufacturing, and consulting all in one organization – eliminating the need for outsourcing to multiple partners. This also builds in flexibility and the ability to implement an efficient, nimble strategy that may naturally shift as development continues.
4. From your team’s experience in the companion diagnostics development process to-date; what are some of these issues in this area of co-development and how can ResearchDx help companies combat these challenges?
The challenges faced are numerous, and may include any or all of the following:
- Knowledge-base: need for in-depth diagnostics knowledge
- Strategic – consideration regarding restriction of assay platform options
- Need for an accredited clinical laboratory partner
- Timeline management – coordination of parallel timelines for therapeutic and diagnostic development
- Management of multiple partnerships
In short, ResearchDx offers all of these services – all within one organization. With ResearchDx, there is no need to manage multiple R&D partners; ResearchDx does it all. As a Contract Diagnostics Organization, ResearchDx can build, validate, and perform any assay that a business demands, or alternatively work with competing technology vendors to ensure the best fit for the application. Clients can trust that the focus and motivation from ResearchDx as a CDO are solely on the diagnostic development, with no competing interests. Our partnerships are based on flexibility, allowing us to either build and validate any assay without bias towards existing product platforms, or to work with emerging technology to ensure the best solution. As a CDO, ResearchDx takes contract R&D for diagnostics to the next level. Our partners trust ResearchDx to provide everything they need to develop a diagnostic product, and that we will make their business objectives our priority.
5. Why should pharmaceutical and diagnostics companies consider working with a CDO like ResearchDx versus performing the services in-house?
Because ResearchDx is not locked into a proprietary testing platform, we are able to ensure our clients’ needs are met using the platforms and methodologies that best meet the commercialization strategy. Thus we are supportive of, not competitive with, our clients’ development objectives and timelines. ResearchDx provides all the necessary components of the companion diagnostics development process in an integrated, technology-independent manner that keeps the focus on the clients’ business needs and objectives. ResearchDx can build, validate, and perform any assay that a business demands, or work with competing technology vendors to ensure the best fit for the application. Because ResearchDx has no competing interests, clients can trust that the focus and motivation is on the companion diagnostic development process.
6. Describe the services offered by ResearchDx?
ResearchDx offers services in three key areas of focus:
- Companion Diagnostics Services
- Clinical Laboratory Services
- Manufacturing Services
Within our Companion Diagnostics Services, we offer independent and unbiased guidance, as well as expert and seamless integration of all the services pharma need to develop a companion diagnostic assay. ResearchDx can design, manage, and coordinate all aspects of clinical trials for the development of a diagnostic product from assay concept to assay development, through to regulatory submission and commercialization. We offer our clients unparalleled expertise based on our team’s extensive experience in companion diagnostics. And the structure of our organization compared to the often large R&D units of pharmaceutical companies allows the CDO to offer great efficiencies to our clients. We’re nimble; we’re flexible – yet with the drive, management and personnel to ensure our clients’ success.
Our Clinical Laboratory is CLIA-certified and CAP-accredited, in which we perform high-complexity, esoteric laboratory testing. We are an ideal laboratory partner for companies looking to outsource high-complexity laboratory testing. We allow our clients to confidently offer a broad range of genetic testing and provide outstanding service to their ordering physician clients. Through our Clinical Laboratory Services, we offer seamless integration and industry-leading turnaround times.
As part of our Manufacturing Services, we offer clients a GMP manufacturing partner that will (1) meet the unique specifications of a project; (2) stay on target with the development timelines; and (3) put our clients’ business first. Services include manufacture of a range of products including reagent kit components and IVD kits for clinical trials or product commercialization. Our Manufacturing Services division offers clients unparalleled flexibility, focus and experience. And by outsourcing these services to a CDO, clients may be able to save money as there is limited, to no, capital expenditure for equipment and/or reagents.
While offering services in these seemingly distinct areas, we are able to deliver these services in a seamless manner to the client, in such a way that that the client experiences an integrated services approach, with integration of all the services needed to develop a diagnostic product. We also pride ourselves on operating in a flexible manner that allows us the ability to adapt in order to meet clients’ complex and constantly evolving needs during the diagnostic development process. We focus on our clients’ business needs- our sole focus is our clients’ diagnostic development needs.
7. In closing, tell our readers why they should consider partnering with a Contract Diagnostics Organization (CDO), such as ResearchDx.
A Contract Diagnostics Organization (CDO) like ResearchDx can seamlessly provide everything a company needs, from start to finish, to successfully navigate the landscape of co-development of diagnostics and pharmaceuticals. Companion diagnostics and personalized medicine truly are the future, and to some extent, the ‘now’ of medicine, and a CDO facilitates the development of treatments in this evolving era of medicine.