Companion Diagnostics: The New Engine
Companion diagnostics’ impact on pharmaceutical development is like dropping a new engine into a classic car. Faster speed. Better performance. More efficiency. Companion diagnostics is changing the way we develop, test and market new therapies—with full-throttle power.
Today, we often have the ability to test a patient to see what drugs will work—or not work—and watch for mutations and triggers down the road. But back up a bit: we can also design drug trials to include subjects with the correct biomarkers for the treatment. And back up a bit more: we can develop drugs and biomarker tests together for the most effective combinations of disease targets, drugs and patients.
WORLD CDx Insight
The WORLD CDx conference in Berlin this spring brought together about 100 representatives from the industry’s main players: pharmaceuticals, diagnostics companies, contract research organizations (CROs) plus providers of samples and instruments. While not all participants brought deep experience bringing companion diagnostics to market alongside drug development, the need is definitely on the radar screen around the globe. The conference provided these attendees with new perspectives on how to drive CDx development, harness new technologies and incorporate reimbursement and regulatory considerations. As an expert in the field, I fielded a number of questions as a conference panelist which I thought I’d pass along with my responses:
- How do you choose the best in vitro Diagnostic (IVD) company as a partner for CDx development? When choosing a diagnostic partner, it is important to engage a company with true experience in the field. Although hundreds of IVD companies are touting expertise in developing CDx, only a handful have true experience executing CDx development programs. Choosing the wrong partner can be costly for your drug development program—in terms of both time and money.
- What are some of the emerging technologies in the CDx space? The development generating the greatest interest is detecting mutations in circulating DNA—the liquid biopsy approach—which could augment or replace the need for tissue biopsies. Covance continues to evaluate the latest technologies in this area, and, with LabCorp, recently announced a strategic collaboration with Sysmex focused on the development of blood-based molecular diagnostic tests to advance precision medicine in oncology.
- How do you decide when to implement a new technology? As a leader in Companion Diagnostics development, Covance brings its experience to meet specific client needs for clinical trials. Diagnostic companies routinely approach us, requesting that we implement their new platforms in support of upcoming clinical trials. However, we pull the trigger only when we receive requests directly from the drug sponsors. With the aggressive timelines on CDx development, we have to balance response to sponsors’ needs with being receptive to new opportunities.
- What is the biggest challenge in drug/CDx co-development? Timelines. Drug development sponsors do not want to invest in the diagnostic until it’s clearly needed. This means that often development begins late, and we have to accelerate the speed to implement new assays. Greater visibility of the pipeline of drugs that may need a CDx would significantly enhance our ability to respond to client requests.
Speed to Market
As an industry, we are moving from generalized drugs for widespread audiences to targeted treatments for specific receptors. We are bringing the development of diagnostics from “after” pharmaceutical development to “alongside” drug development.
Today: We are integrating drug development with biomarker and CDx development.
Tomorrow: We will see seamless co-development between drugs and CDx. Could we reduce costs and timelines by 25 to 30%?
We know that not every drug works for everybody. Testing and marketing general treatments has a high cost and a high rate of failure. Now, we can determine exactly which patient will respond, not respond or respond negatively. Now, we can drive trial design by identifying the best participants. Now, we don’t always have to test 5,000 patients. Instead, we can test perhaps only a few hundred—with more efficacy, faster approval and lower costs.
Have you ever wondered how many drugs from the past failed in trials, but could have been successful with a more evolved CDx-driven, targeted approach? Today, we understand pathway sequencing, and genomic analysis shows us how patients will respond. Could this lead to the resurrection of compounds we previously failed in trials?
The promise of using biomarkers for personalized medicine is a reality. With the technology to identify genetic makeup, biomarker assays are being approved for incorporation into clinical trial design. We can identify the best trials and accelerate their speed. Approvals will be smoother, with treatments arriving on the market with more predictability and better patient results.
The new co-development model is on everyone’s radar screen. With costs of $1.5 billion to bring a drug to market, and a marketing premium as payback for those that work, pharmaceutical companies are eager to collaborate with diagnostics companies. We are bringing regulatory agencies and healthcare companies in earlier, streamlining their processes and cutting their costs. The research organization stands in the center as Gatekeeper, keeping traffic moving and ensuring on-time arrival.
Bring it Home
When we utilize Companion Diagnostics successfully, it is a win-win situation for all partners. Most of all, this new model represents a win for the patients. The honest truth is that we all want to make a difference in someone’s life. When we think of it that way, the evolution of companion diagnostics is truly game-changing. Let’s keep the throttle open on this new engine called CDx.
Access our webinar at “Pathway Considerations to CDx Development and Commercialization.”