Deciphering genomic complexity: Visualizations like Circos plots are essential tools in NGS-driven companion diagnostics for precision medicine. [Image: Adobe Stock]
Jane Li has spent two decades making sure that gap closes on schedule. As senior director of pharma CDx and CRO partnerships at Thermo Fisher Scientific, she has an important role in this complex field; her employer, Thermo Fisher, has achieved 31 companion-diagnostic approvals across the FDA, EMA and NMPA, showing that drug and test can, and should, cross the finish line together.
Over the yerars, Li has launched and scaled NGS-based oncology tests, forged alliances with pharma firms and cancer centers in the U.S. and Asia, and led teams in settings ranging from startups to global corporations. Her aim: translate dense genomic data into bedside tests that give clinicians faster, sharper answers.
In the following Q&A, Li dishes on the meeting cadences that build trust, the cultural clashes that can sink a deal, and the cold-eyed metrics behind successful CDx partnerships.
From your perspective at Thermo Fisher, what are the biggest drivers that make effective CDx co-development strategies critical for pharmaceutical companies, especially in areas like oncology, today?
Li: With the demand for personalized medicine increasing, effective companion diagnostic (CDx) co-development strategies have become critical for pharmaceutical companies to ensure patients have access to therapies as they are approved instead of waiting for an appropriate test to become available. CDx tests play a critical role in personalizing care by helping to identify the optimal targeted therapies for a patient based on their cancer’s unique genetic profile. In 2014, the Food & Drug Administration (FDA) issued a guidance to promote the co-development of CDx tests and target drugs at earlier stages in the drug development process to support patient access as new therapies continue to come to market.
Next-generation sequencing (NGS) has revolutionized CDx by allowing multiple genomic mutations to be analyzed in parallel, rather than sequential testing of one biomarker at a time. With platforms now able to deliver NGS results in as little as 24 hours, there is an opportunity to provide more timely insights to inform care decisions, shortening the time needed to match patients with appropriate therapies or trials while helping reduce the risk of suboptimal treatments. In oncology, this rapid turnaround has the potential to offer hope to patients who once faced limited treatment options.
When a pharma company approaches Thermo Fisher (or vice versa) to explore a CDx partnership, what are the core elements you look for in a potential partner to ensure a successful collaboration from the outset?
- Start early: FDA guidance describes ‘co-development’ at earlier stages.
- Choose proven partners: Check execution records and multi-agency wins (FDA, EMA, NMPA).
- Build flexible contracts and governance: Use paired program managers, regular meetings, clear escalation process.
- Exploit NGS speed: Use fast results for timely matching to therapies/trials.
- Plan for day-one rollout: Ensure the solution supports drug sales post-approval across regions.
Li: Whether initiated by the pharmaceutical company or the diagnostic partner, a commitment to open communication and true collaboration is essential for a successful partnership. For pharmaceutical companies to see the full potential of targeted therapies, they must partner early with a diagnostic provider that can help meet the unique needs of their drug development pipeline and regional launch plans.
As a diagnostic partner, Thermo Fisher Scientific’s ultimate goal is to support a drug submission through approval and successful launch. Pharmaceutical companies should evaluate their potential partner’s execution record and past drug submission success rates. As challenges can arise at any stage throughout the development process, an experienced diagnostic partner who can adapt to sudden changes, mitigate risks and effectively manage regulatory feedback is essential for keeping the drug submission timeline on track.
Thermo Fisher has successfully gone through 31 CDx approvals across countries in the past decade of working with pharma partners.
What are the main considerations and potential sticking points when structuring the initial agreement for a co-development partnership to ensure alignment on goals, timelines, and responsibilities?
Li: The initial CDx co-development agreement often includes a list of activities and deliverables with timelines matching the drug trial enrollment and submission schedule. Often, during program execution, plans may change due to regulatory feedback or drug changes that may require contract amendment with revised activities and schedules. It’s important to allow these flexibilities when structuring the agreement.
Can you share concrete examples of communication strategies, meeting cadences, or shared platforms that have proven effective in bridging the gap between diagnostic and pharma teams?
Li: A CDx program has very structured governance with well documented communications and meeting minutes. At the center of these communications are the two program managers, one from the pharmaceutical team and one from the diagnostics team, who manage their respective core teams. They regularly conduct joint program meetings to update progress, discuss changes, resolve challenges, and align on decisions, tracking toward the same finish line. Part of the governance is an established escalation process to joint steering committee that is comprised of executives from both partners to resolve conflict when joint program teams are unable to reach an agreement. With CDx development programs often being a 2–3-year long process, communication, transparency, and trust are key to a successful outcome.
What are the core ‘best practices’ pharma and diagnostic companies need to implement early on to proactively manage expectations and set a complex co-development project up for success?
Li: To set a co-development partnership up for success, pharmaceutical and diagnostic companies need to align on clear goals and timelines early in the process. With changing regulations in different regions, it’s important to anticipate challenges, proactively plan different scenarios or different regional registration strategies, and seek regulatory feedback early in the development process.
Depending on the regional approval sought, pharmaceutical companies need to be mindful of selecting a diagnostic partner experienced in different country’s regulatory standards (FDA, European Medicines Agency (EMA), National Medical Products Administration (NMPA), etc.) if their goal is to reach a global market. This requires a proven testing platform that is already geographically democratized to quickly activate within the field to allow for the quickest path to clinical impact.
How do you actively foster trust, and transparency between groups from different corporate cultures (pharma vs. diagnostics) who might have different immediate priorities or ways of working?
Li: A solid relationship starts with an understanding of each partner. Pharmaceutical and diagnostic teams speak different languages related to their area of expertise and it’s important to educate each partner on their respective objectives, process, and culture in the beginning of the program execution. Both teams share a common goal of bringing a new therapy to patients. So, when challenges arise, both teams must work on solutions and make decisions towards that same objective with a “one team” spirit. Clear communication is an integral part of the team’s overall success, and partners should create designated communication channels that encourage continuous feedback and openness from both sides. Challenges can arise when teams are resistant to embrace different corporate cultures or working styles, making adaptability and balanced priorities essential to maintaining accountability. Together, these practices set the stage for successful alignment on timelines for drug development rollouts and simultaneous approvals.
What is the single most important piece of advice you would give to leaders on both the pharma and diagnostic sides who are embarking on a new CDx co-development journey?
Li: With the expansion of precision medicine, the number of new technologies and methods for identifying new biomarker targets is only increasing. When selecting a CDx partner, it’s important not to let a technology alone make the decision. Leaders should ask themselves two questions:
- Does the CDx partner have experience and a proven track record to successfully register CDx with regulated agencies in different countries?
- Can the CDx solution be deployed commercially successfully in different countries to support drug sales post approval?
Filed Under: Precision Medicine
