Inside the Shifts Redefining Biotech Strategy, Regulation, and Precision Medicine
While regulatory uncertainties and funding pressures create headwinds, breakthrough advances in artificial intelligence, biomarker science, and global clinical capabilities are opening unprecedented opportunities—particularly beyond oncology's traditional boundaries.
In a recent fireside chat with DeciBio titled "Navigating the Pharma R&D Service Market: Trends and Projections through 2029", Dr. Deborah Phippard, Chief Scientific Officer at Precision for Medicine, shared her perspective on how these forces are reshaping the landscape for biotech sponsors and their service partners. With over 30 years leading biomarker-driven clinical programs from early discovery through commercialization, Debs offers a unique vantage point on where the industry is headed.
The Strategic Shift? Biotechs Playing the Long Game
One of the most significant trends Debs observes is Biotechs fundamentally changing their development strategy. "I'm certainly seeing that they're hanging on to their assets longer," she notes. "The whole concept of “you do a proof of concept and then they get picked up by big pharma”—I see that timeline extending out and [the sponsors] want to take their own assets through phase two and potentially even registration studies."
This shift has profound implications for service providers. Biotechs that once sought quick partnerships after Phase I are now building deeper capabilities and requiring more sophisticated, long-term support. At Precision, we've adapted our engagement models to support this evolution, providing flexible partnerships that can scale from late stage pre-clinical through post-market approvals.
One of driving forces behind this trend are Biotechs who want to maximize their asset value and have sufficient funds to do so clearly. To navigate complex clinical development independently, they likely need strong partners.
Navigating Global Regulatory Complexity in Biomarker-Driven Drug Development
Perhaps nowhere is the industry's uncertainty more apparent than in designing an optimal regulatory strategy. Debs describes an "existential angst" among sponsors trying to determine the optimal path for clinical development.
"On the one hand people are a little bit twitchy about do I want to start my clinical study in the US," she explains, "and then on the other hand they say well if I go to Europe what does IVDR mean to me? I need to screen patients okay fine but what about my other assays?"
The regulatory landscape presents a complex puzzle:
- US market: Uncertainty around FDA accelerated approval pathways
- Europe: IVDR requirements creating new validation burdens for assays
- Asia: Attractive patient populations but questions about FDA acceptance of non-US data
For sponsors developing biomarker-driven therapies, these decisions are somewhat about geography, but more about fundamental development strategy. "Everything we do in precision medicine is about accelerating getting drugs to patients," Deb emphasizes, "and I think there's a lot of angst with so much changing as to what is the best route to get started."
Precision’s expertise and laboratories across US, European, and Asian markets allows sponsor partners to more confidently navigate IVDR requirements, FDA pathways, and APAC expansion.
How Precision Medicine Is Moving Beyond Oncology With Biomarker Innovation
While oncology remains the established beachhead for precision medicine, Debs sees clear momentum building in other therapeutic areas. Her recent experience at the Alzheimer's Association International Conference was particularly telling.
"It felt like an oncology meeting 15 to 20 years ago,” Debs illustrated as she described biomarker-centric scientific programs. I feel like CNS is starting to get some traction," she observes.
The parallels are striking. In CNS, advances such as the recent FDA cleared test from Fujirebio which measures phospho-Tau/B Amyloid 1-42 ratio now enables diagnosis in patients with cognitive symptoms without an expensive and perhaps not very accessible PET scan. Plus, plenty of scientists/companies are showing data suggesting that accurate risk prediction is possible decades before clinical symptoms appear. This opens up the possibility of early treatment for dementia, much like oncology biomarkers revolutionized cancer care. "You can now theoretically intervene earlier and monitor those markers., certainly in clinical research. Although markers are generally used for diagnosis in patients with cognitive issues at the moment, I do feel like there's a lot of traction in CNS."
Other areas showing promise include:
- Autoimmune & Inflammatory: Leveraging existing inflammatory biomarkers with new therapeutic applications
- Metabolic Disease: GLP-1 drugs creating demand for differentiation through biomarker profiles
- Rare Disease: Though facing headwinds due to small patient populations and high development costs
AI’s Move From Hype to Practical Application in Precision Medicine and Biomarkers
Artificial intelligence has moved far beyond buzzword status in Deb's world. "We're literally using it in every single aspect of everything that we do," she explains, from project management dashboards to complex multimodal data analysis.
The real value lies in AI's ability to extract insights from increasingly sophisticated analytical platforms. "If you had said to me 15 years ago, we will be doing 30 color flow panels, 20 color MIF panels in a clinical study, I would have said, you're crazy," Debs reflects.
This data explosion demands new analytical approaches: "We've got data coming from disparate sources, different OMICS. We've got Flow, we've got MIF, we've got partnerships using AI to build us algorithms."
At Precision, these multimodal analytics are already being applied across CAR-T and immunotherapy programs, where understanding complex immune responses requires integrating flow cytometry, spatial biology, and genomic data in real-time.
However, Debs maintains a balanced perspective on AI adoption: "I spend half my time still repeating to my scientists: Don't trust what AI tells you, go verify. The key is leveraging AI's pattern recognition capabilities while maintaining scientific rigor.”
Managing Gene Therapy’s Promise and Complexity
Gene therapy presents tremendous opportunity and significant operational challenges. Deb's decade of experience developing AAV immunogenicity assays illustrates the field's evolution.
"We started out building really sensitive assays thinking any pre-existing immunity would be a problem," she explains. "You know, we do the experiments, we do the trials, we find out, well, actually, no, you can have a fair amount of pre-existing immunity, still get good infection, and expression of the transgene."
The regulatory requirements for companion diagnostics (CDx) in gene therapy present particular challenges for smaller companies targeting rare diseases. Unlike off-the-shelf solutions, each gene therapy often requires bespoke assay development, validation, and commercialization planning—all before the first patient is dosed.
"There isn't currently one AAV assay that you can just buy off the shelf that works as a CDx. And every gene therapy company I work with really wants that," Debs notes. Success requires early planning, parallel development of therapeutic and diagnostic programs, and partners capable of supporting both clinical and commercial phases.
This challenge has shaped Precision's approach to gene therapy partnerships—we've developed specialized capabilities for AAV immunogenicity testing and companion diagnostic development that can adapt to worldwide evolving regulatory requirements while maintaining commercial readiness.
Watch the Fireside Chat: AI, Biomarkers, and the Future of Precision Medicine
Why Biomarker-Driven Drug Development Is Critical to the Future of Precision Medicine
These trends converge on the central theme that successful biomarker-driven drug development requires partners who can navigate increasing complexity while maintaining scientific excellence. Whether it's supporting biotech's extended development timelines, managing global regulatory requirements, or integrating AI-powered analytics with traditional biomarker science, the bar continues to rise.
Precision for Medicine built capabilities around exactly these challenges, integrating laboratory science, clinical expertise, and regulatory strategy to accelerate targeted therapy development. From oncology's established pathways to emerging opportunities in CNS and autoimmunity, Precision partners with sponsors to turn biomarker insights into successful clinical programs.
