Taking a therapy from discovery into the clinic – and ultimately toward commercial supply – requires companies to make decisions across science, CMC, regulation, manufacturing, funding, and market access. For emerging and established biopharma companies alike, each stage brings different risks and requirements.
For Biopharma Vital Signs, we asked industry leaders for their views on the state of biotech and biopharma today – including the conversations likely to dominate BIO 2026, the trends shaping development, and the practical challenges companies are navigating as programs advance.
Explore the full Biopharma Vital Signs series here.
In Part 3, we ask:
Where are companies feeling the greatest pressure as they try to move therapies from discovery into the clinic and, ultimately, toward commercial readiness?
Kevin Schaab, Sr. Drug Development Consultant
Companies are feeling the greatest pressure at the preclinical-to-clinical transition, where companies must demonstrate both safety and tolerability and define a path forward beyond healthy volunteers and into early patient trials. This includes exploring appropriate dose ranges to establish margins of safety in humans vs. preclinical species, seeking to establish an early understanding of exposure-response relationships using biomarker data (where possible), and even studying the initial effects of food on drug exposure. At this stage, capital risk is highest, and programs must show a credible path toward differentiation and Phase 2 success to justify continued investment.
David Claveau, Vice President, Business Development, North America, Sygnature Discovery
The greatest pressure is decision quality under constrained time and capital. Emerging companies must show momentum, but every rushed decision can create downstream risk – weak target validation, poor developability, unclear translational biomarkers, or insufficient differentiation. The challenge is especially acute because investors and partners now expect a more complete story earlier: why this target, why this modality, why this molecule, why this patient population, and why now. The answer is not simply to generate more data; it is to generate the right data in the right sequence. Integrated discovery helps because chemistry, biology, DMPK, translational science, protein sciences and computational approaches can inform each other in real time. That shortens feedback loops and enables better go/no-go decisions. For companies moving toward the clinic, commercial readiness begins much earlier than many assume: with a product profile, a differentiated scientific rationale, and evidence that the program can survive scrutiny.
Jeremy Skillington, CEO, Poolbeg Pharma
Funding has always been a primary focus with companies typically having between a 12- and 18-month cash runway. It is critical that stated milestones are reached so that funding tranches can be unlocked or new fundraisings achieved. Clearly the further into development you are the more expensive it will be so funding rounds need to be larger. Thankfully the IPO window has finally opened and there seems to be a trend to attract large investment at the outset so that the company can be focused on development activities. Parabalis Medicine raising $670M in June is a good, recent example of this.
Thankfully, pharma is also active on the M&A front with Lilly deploying its substantial GLP-1-driven revenues to acquire Centessa for $8.1B and Kelonia for $7B. These significant exits provide VCs with liquidity that can be reinvested in new biotech companies, helping to keep the innovation cycle turning.
Alison Clayton, Strategic Projects Director, Symbiosis Pharmaceutical Services
One of the greatest pressures facing companies today is balancing speed with long-term readiness. In a competitive and capital-conscious environment it is no longer enough to demonstrate scientific promise without also considering whether a product will still represent a compelling commercial opportunity by the time it reaches market. Development timelines can span many years, and competitive landscapes can change significantly during that period.
This challenge is particularly evident for complex biologics and advanced therapies, where manufacturing processes, analytical methods and supply chain requirements become increasingly demanding as programmes progress. Decisions made early in development can have significant implications for future scalability, cost and commercial viability, making it essential to maintain long-term perspective while continuing to advance at pace.
Resource constraints remain a significant factor, especially for emerging biotechs. Lean teams are often required to manage increasingly complex development programmes, increasing the importance of accessing external expertise and capabilities at the right time.
Ultimately, organisations are navigating scientific, regulatory, operational and commercial uncertainties simultaneously. Those that can take a holistic view of these interconnected challenges and balance immediate objectives with future market realities are often best placed to achieve commercial success.
Cora Griffin, Head of Business Development, Curve Therapeutics Ltd
I would say the number one pressure that companies are facing currently is capital efficiency. With a general reduction in funding, especially for emerging biotechs, and higher costs, many biotech companies are facing difficult decisions regarding the prioritisation of programmes. The US biotech sector dominates global funding, attracting over 63% of life sciences venture capital compared to just 7% in the EU, this disparity creates a significantly more competitive funding environment for European biotech companies.
Furthermore, a major bottleneck that remains is the failure to translate preclinical success into clinical outcomes, with high attrition in proof of concept studies. There is also the high cost and competitive intensity of clinical development. For smaller biotechs operating in crowded spaces such as oncology, not only are trials more expensive, but the bar for differentiation continues to rise. The vast majority of biotechs rely on CDMOs for clinical trials, however capacity is tight, and an ever-changing regulatory environment only adds to the uncertainty.
Jane Rhodes, CEO, AstronauTx
Clinical translation remains one of the greatest challenges to drug development. Having reliable and sensitive measures of clinical benefit that perform well across different biological mechanisms and stages of disease is critical. However, the level of complexity and sophistication of biomarker use is often curtailed by budget pressures in both small and large companies. This limits what we can learn from clinical studies, whether they succeed or fail.
The challenge is not only identifying measures of clinical benefit, but also ensuring that those measures are sufficiently reliable and sensitive throughout the development process. This becomes increasingly important when programs involve different biological mechanisms and disease stages, where consistency and confidence in the data are critical. The need for meaningful insight remains constant across therapeutic areas and development programs.
Marjorie Sidhoum, Vice-President Business Development & Corporate Communication, Kainova Therapeutics
The greatest pressure comes at the point when scientific promise must become a clearly differentiated clinical and commercial opportunity. In today’s market, novelty alone is no longer enough. Programs need to show they address a meaningful unmet need, follow an optimal translational path and can compete in a more selective cost-constrained environment well before late-stage development. This is why programs shaped with development discipline and long-term value creation in mind from the outset are drawing attention.
At the same time, companies must balance speed with robustness. What matters now is not only generating data, but generating the right data, the kind that de-risks development, strengthens regulatory and access confidence and supports future partnering.
Tony Thomas, Director, Technical Consulting, Ecolab Bioprocessing; and Fiona Stack. Global Technical Consultant, Ecolab Life Sciences
What we’re hearing consistently is that the pressure really starts to build once a therapy moves beyond early development. Getting strong clinical data is still critical, but it’s no longer enough on its own.
On the regulatory side, there’s been a shift toward faster, more streamlined pathways, but that comes with higher expectations. With fewer pivotal trials in some cases, the quality of the data and the ability to support it with broader evidence becomes much more important. There’s less room for rework, which raises the stakes earlier in development. That’s where having the right regulatory expertise and support becomes critical, helping teams navigate evolving requirements and avoid delays that can have a material impact on timelines.
At the same time, the move to commercial-scale manufacturing remains one of the biggest pressure points. Tech transfer timelines can stretch to 18 to 24 months, and the level of investment required is significant. That’s forcing companies to think about scalability much earlier, rather than treating it as something that happens post-approval.
Overlaying all of this is a much tougher commercial environment. Pricing and reimbursement are increasingly tied to demonstrated outcomes, so companies need to clearly show not just that a therapy works, but that it delivers meaningful value in the real world.
There’s also growing competitive pressure, whether that’s biosimilars in established markets or faster, lower-cost development models emerging globally.
When we combine these factors, it creates a situation where companies have to balance scientific progress with operational readiness and a very clear value story from day one.
Elizabeth Holt, Chief Business Officer, iOnctura
The greatest pressure is balancing scientific innovation with execution. Companies must generate compelling clinical data, demonstrate clear differentiation, manage limited capital, and think about manufacturing and commercialization much earlier than before.
In oncology especially, stakeholders expect a clear path to patient benefit, reimbursement, and scalable supply. Success increasingly depends on integrating clinical, regulatory, manufacturing, and commercial planning from the outset rather than progressing them sequentially.
Mike Ford, Director of Sales and Business Development, Kindeva
The journey from discovery to commercial readiness is more complex than ever, with operational pressures at every stage. Capacity constraints in sterile fill finish are directly affecting speed to clinic and commercialization. Maintaining supply chain resilience for critical components and device parts remains a core focus, alongside cost pressures across materials, labor, and infrastructure.
Regulatory compliance introduces another layer of pressure, particularly when planning for stringent Annex 1 expectations in aseptic processing. This requires investment in automation, isolator systems, and robust quality practices. Companies can reduce friction by considering manufacturability and regulatory requirements earlier in development. Failing to address these issues can slow timelines and delay patient access to critical therapies.
Gina Eagle, Clinical Research Physician, Kither Biotech
The greatest pressure centers on the development timeline. This pressure creates a sense of urgency that must be properly managed, so it doesn’t place undue pressure on program costs and, more importantly, on data quality. Companies must find the right balance, and this is most important for small biotech companies that need to focus on generating interpretable and meaningful data early on. Early-stage data (Phases 1-2) lays a foundation that incrementally derisks the development program as it heads toward pivotal studies and commercial readiness. Countries and clinical sites must be selected judiciously to ensure data quality that is acceptable for regulatory review.
Greg Plunkett, CEO, Accelagen
Companies are reporting that they are experiencing the greatest pressure at key inflection points, namely where scientific promise must be translated into clinical data that leads on to operational and commercial readiness. Moving from discovery into the clinic requires more than a strong asset; it requires alignment across CMC, regulatory strategy, trial execution, and capital planning. In many cases, that alignment happens too late.
One major pressure point is the need to generate robust clinical and regulatory evidence quickly, thereby to maintaining executives and investor confidence, but ensuring the standards align with what is expected by regulators and future partners. Another is manufacturing readiness. As modalities become more complex, companies must think earlier about scalability, quality systems, supply chain resilience, and cost of goods. These issues are no longer downstream concerns; they are central to asset value.
Ultimately, commercial readiness starts well before launch planning. Companies that perform best are those that define the target product profile early, understand the evidence required for reimbursement and adoption, and build development plans that support both approval and market uptake. The pressure is greatest where teams are forced to solve strategic questions late, when options are narrower and costs are higher.
Arya Mehrabanzad, Principal, Ampersand
We’re seeing manufacturing as one of the single largest constraints in translating scientific promise into patient access, particularly for complex therapies. If you look at the depth of the CGT pipeline, the bottleneck is not biology, it is the infrastructure to make these therapies reliably, at scale, and at a cost that allows commercially viable pricing.
The second pressure is access to capital, particularly for earlier stage assets. Biotech funding has genuinely recovered, but the terms have changed versus what we’ve seen over the last 6 or so years. Whereas investors were more willing to fund earlier-stage ideas or platform technologies on thesis alone during the COVID years, they have returned to demanding demonstrated clinical proof of concept before committing capital. Investors do not appear to be rewarding platform stories as much as we’ve seen in recent years, and companies that built broad pipelines on the assumption of perpetual low-cost capital are now making hard prioritization decisions under pressure.
Unfortunately, regulatory uncertainty and pricing pressures compound both of these challenges. Take the IRA, for example, and you can see the newly negotiated Medicare prices taking effect in January 2026 drove discounts off list prices of anywhere from almost 40 percent to nearly 80 percent for the first ten drugs. This is just one example, but broader regulatory uncertainties along with pricing pressures are forcing companies to rethink their development approaches and increasing demand for de-risking R&D by getting to go/no-go decisions sooner (e.g., by leveraging real-world data and market access solutions earlier in development).
Sam Cobb, CEO, Currus Biologics
The greatest pressure is at the point where promising science has to become a controllable, manufacturable, and clinically meaningful therapy. In cell therapy, that pressure is especially acute because companies must demonstrate not only biological activity, but also a credible path to consistent manufacturing, regulatory alignment, and patient access.
For solid tumors, the challenge is even greater. CAR T-cell therapies have transformed treatment in certain blood cancers, but solid tumors present additional barriers, including tumor heterogeneity, trafficking, persistence, immune suppression, safety, and the need to demonstrate clear efficacy in difficult disease settings.
Emerging companies are also operating in a funding environment where investors want clearer evidence of differentiation. Novelty alone is not enough. Companies need to show why their platform matters clinically, how it can be controlled, and how it can move toward commercial readiness.
Thomas Kledal, CEO, Synklino
The greatest pressure today is demonstrating that a therapy is differentiated not only scientifically, but also clinically and commercially. Investors, regulators and future partners increasingly expect companies to show how an innovation addresses a meaningful unmet need, fits into clinical practice, and has a realistic path to adoption from the earliest stages of development.
That means designing development programs that reduce the biggest sources of uncertainty as early as possible. Evidence generated in clinically relevant models, clear translational rationale, regulatory engagement, and endpoints that matter to physicians, healthcare systems and patients all help de-risk development and strengthen the investment case.
Companies also face pressure to use capital efficiently. Rather than pursuing the broadest possible program, successful biotechs are focusing on assets with the potential to create new therapeutic approaches or redefine standards of care, while building lean development plans around clear value-inflection points. In today's market, disciplined execution and compelling differentiation are just as important as scientific innovation.
Jordi Fàbrega, Co-Founder and CEO, Connecta Therapeutics
One of the biggest challenges in moving therapies from discovery to commercialization is navigating the complex and highly regulated development pathway. A well-defined regulatory strategy is essential, particularly for rare diseases, where early and continuous engagement with regulatory agencies can accelerate development timelines, reduce uncertainty and create opportunities to access incentives such as orphan drug designation or expedited review pathways.
Securing sufficient funding is another major challenge, especially as programs progress into expensive late-stage clinical trials that require significant capital investment. Demonstrating clinical proof of concept represents a critical milestone, providing evidence of therapeutic efficacy and safety, reducing development risk and increasing confidence among investors, grant providers and strategic partners.
Equally important is aligning development plans with the priorities of potential pharmaceutical partners. Generating robust clinical, regulatory, manufacturing and commercial evidence ensures that the program addresses partnering requirements, strengthens its competitive positioning and maximizes opportunities for co-development partnerships, licensing agreements or acquisition.
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