Speed, flexibility, and resilience have become increasingly important in biopharmaceutical development. As companies work with more complex modalities, tighter timelines, and changing external pressures, the capabilities required to move programs forward are also evolving
For Biopharma Vital Signs, we asked industry leaders for their views on the state of biotech and biopharma today – including the trends shaping development, the pressure points slowing progress, and the practical challenges companies are navigating as programs advance.
Explore the full Biopharma Vital Signs series here.
In Part 5, we ask:
What capabilities are becoming most important for companies that want to make drug development faster, more flexible, and more resilient?
Jeremy Skillington, CEO, Poolbeg Pharma
You cannot look beyond the promise of AI to accelerate drug development. I say promise as there has been a lot of enthusiasm and confidence about what can happen but we are early in the application of AI to drug development to be fully convinced. AI is being applied across the drug development pathways such as drug target identification and validation by Recursion Pharmaceuticals and Isomorphic Labs, as well as drug design and lead optimisation by Xaira Therapeutics and Insilico Medicine.
Perhaps the more immediate benefits will be in clinical trial design where large data sets can be analysed and optimal dose levels, likely responders and appropriate endpoints can be accurately determined by AI. These clinical trials will then be more focused and have a greater probability of success, thus reducing the failure rates and overall cost of clinical trials to the industry. More efficacious drugs will make it to market.
Tony Thomas, Director, Technical Consulting, Ecolab Bioprocessing; and Fiona Stack. Global Technical Consultant, Ecolab Life Sciences
What’s clear is that there isn’t a single capability that solves this. It’s really about how different capabilities come together to support speed, flexibility and resilience at the same time.
One of the biggest shifts is toward more flexible manufacturing models. Modular facilities, single-use systems and platform approaches allow companies to move more quickly, adapt to different products, and scale without the same level of disruption or reconfiguration that you would have seen traditionally.
At the same time, digital capability is becoming essential. More connected, data-driven operations give companies better visibility across development and manufacturing, which helps with everything from decision-making to maintaining consistent quality as processes scale. That becomes particularly important when you’re operating across multiple sites or regions.
There’s also a growing focus on supply chain strategy. Capabilities like dual sourcing, regional manufacturing and strategic inventory are becoming standard, not optional. Companies are actively building resilience into their supply networks so they can respond to disruption without slowing down development timelines.
Underneath all of this is the ability to maintain control as things move faster and become more complex. That means having robust contamination control strategies, strong regulatory alignment and the technical expertise to apply them consistently across sites.
Ultimately, the companies that are moving fastest are the ones that can combine flexibility in how they operate with the discipline to stay compliant and in control as they scale.
Gavin Murdoch, SVP of Commercial Strategy, Abzena
As drug developers become increasingly specialized in complex technologies, they need partners who can match that sophistication while simplifying the program’s path forward. That often means bridging traditionally isolated scientific disciplines into a more continuous, efficient path from discovery to patients, with unified oversight, faster decisions, better data, and seamless scalability.
Achieving this requires dismantling the organizational silos that slow progress and replacing them with leadership that can coordinate the full development continuum. Supply chain security is an equally important driver. A US-based drug substance capability, for example, can provide a hedge against geopolitical instability, tariff exposure, and trade disruption. These risks are no longer theoretical, so resilience must be built into the supply chain architecture from the start, not retrofitted after a disruption occurs.
The organizations best positioned for faster, more flexible development will be those that can reduce handoff risk, miscommunication, and delays while maintaining accountability across the development journey.
Alison Clayton, Strategic Projects Director, Symbiosis Pharmaceutical Services
While technical expertise remains fundamental, one of the most important capabilities today is the ability to adapt. Drug development rarely follows a perfectly linear path, particularly for novel and complex therapies, so organisations need the flexibility to respond effectively to changing data, evolving programme requirements and external challenges.
Cross-functional collaboration is also becoming increasingly important. Development, manufacturing, regulatory and commercial considerations are more interconnected than ever, and organisations that can bring these perspectives together early are often better equipped to make informed decisions and avoid downstream obstacles.
Another critical capability is access to specialist knowledge. As therapeutic modalities become more sophisticated, companies increasingly rely on expertise that may not exist within their own organisations. The ability to identify and engage the right external partners can therefore have a significant impact on programme success.
Finally, resilience depends on visibility and proactive risk management. Whether addressing supply chain challenges, capacity constraints or development risks, organisations that can anticipate issues and respond quickly are often better positioned to maintain momentum and achieve their objectives. In an increasingly complex environment, agility and foresight are becoming just as valuable as scientific excellence.
Brad Rowe, Senior Director, Integrated Development; Quotient Sciences
Overall, companies are prioritizing efficiency and de-risking development stages to remain competitive in a constrained funding and increasingly complex commercialization environment. This shift is towards more adaptive, asset-specific development strategies rather than rigid, linear plans.
There is also increased emphasis on designing scalable fit-for-purpose formulations and manufacturing processes approaches early. This is especially true for complex delivery routes, also considering pediatric patient populations.
Gina Eagle, Clinical Research Physician, Kither Biotech
The most important capability is cross-functional integration. Faster development does not come from simply doing more activities in parallel; it comes from ensuring that science, clinical development, regulatory strategy, CMC, operations, and business planning are fully aligned.
For Kither, this is particularly important because KIT2014 is a novel inhaled peptide with a differentiated mechanism and potential across several respiratory indications. Development therefore requires strong translational thinking: understanding the biology, the patient population, the clinical endpoints, the formulation, and the evidence needed to support differentiation.
Flexibility is equally important. Assumptions can change as new data emerge or as clinical feasibility, site feedback, regulatory input, or manufacturing considerations become clearer. A small, experienced, and motivated team can react quickly, adapt the plan, and keep the program moving without losing scientific rigor or long-term strategic focus.
Cora Griffin, Head of Business Development, Curve Therapeutics Ltd
Three capabilities that stand out as genuinely differentiating right now are AI infrastructure, supply chain agility, and translational excellence. On AI, the industry has moved decisively past the pilot stage. The question is now not whether a company is using AI, but whether it has been embedded into a dependable, end-to-end R&D workflow – and how this is impacting development timeframes. However, it must be remembered that AI cannot replicate the complex realities, unforeseen biological variables, and physical hands-on execution of true wet lab experiments.
Geopolitical uncertainties have had a profound impact on manufacturing and supply chain. Biotechs that have built modular, diversified manufacturing relationships are proving significantly more resilient than those dependent on single-source suppliers.
The third capability is translational excellence, the ability to move insights from biology to the clinic with rigour and speed. Having the biomarker strategy, patient stratification logic, and clinical proof-of-concept design in place well before you need them are all vitally important here.
Thibaut Brugat, Director of Corporate Strategy, Kainova Therapeutics
The capabilities that matter most are those that create integration, adaptability and resilience across the development chain. When companies operate through shared decision frameworks that connect scientific ambition to operational and market realities, issues around development, manufacturability and commercial viability can be addressed much earlier. In this context, this is especially important for GPCR-focused biotech, where scientific, translational and operational considerations converge early and need to be aligned to keep programs moving efficiently.
In practice, this requires flexible operating models and scenario-based portfolio planning, especially as partnerships increasingly span early development through commercialization and bring the right expertise at the right time. AI and digital tools are helping inform decisions across this chain, but the differentiator is not the tools themselves, it is the ability to embed them into governance, culture and processes. Ultimately, resilience depends on adaptive, interconnected operating models that can respond quickly while staying strategically coherent.
Elizabeth Holt, Chief Business Officer, iOnctura
The most important capabilities are data-driven decision making, organizational agility, and cross-functional integration. Companies need to generate insights quickly, adapt to changing development conditions, and align research, clinical, regulatory, manufacturing, and commercial strategies. AI and advanced analytics can help improve speed and efficiency, but resilience ultimately comes from having the right expertise, partnerships, communication and operational discipline to make informed decisions throughout development.
Mike Cooke, Co-Founder & CEO, AmacaThera
The most important capability is connecting science, product design, development strategy, and commercial reality early. Drug development is not just about the molecule. It is also about how that molecule is delivered, how long it acts, where it acts, how it is administered, whether it can be manufactured and scaled, and whether the value proposition is clear to clinicians, patients, and payers.
Flexibility is becoming increasingly important. A platform that can support multiple therapeutic modalities, release profiles, and anatomical targets gives a company more options. For companies working in drug delivery, this means designing technologies that can adapt across programs rather than being limited to a single product concept.
Manufacturing readiness also matters. A technology may be scientifically interesting, but if it cannot be made reliably and cost-effectively, it will struggle to move forward. Practical administration is equally important. Features such as injectability, compatibility with standard clinical workflows, scalable manufacturing, and a clear economic rationale are not secondary details – they are part of making a product clinically and commercially viable.
Greg Plunkett, CEO, Accelagen
The most important capabilities today are those that: improve decision quality and speed of execution, and create organizational resilience.
Scientific depth remains essential, but it is no longer enough on its own. Companies also need strong cross-functional leadership, data-driven decision-making, regulatory credibility, and the operational discipline to move quickly without creating avoidable risk.
Digital capability is becoming increasingly important, particularly where it improves visibility across development, manufacturing, and clinical operations. The value of AI and advanced analysis methods lies not in novelty, but in helping teams prioritise better, identify issues earlier, and reduce cycle time. At the same time, these tools only create advantage when combined with experienced people, robust processes, and clear governance and quality frameworks.
More broadly, the organisations that perform best are those that can integrate strategy and execution. They are able to adapt quickly, manage complexity across functions, and make high-quality decisions under pressure. In a more volatile funding and development environment, that combination has become a significant competitive advantage.
David Claveau, Vice President, Business Development, North America, Sygnature Discovery
The most important capabilities are those that improve the speed and confidence of decision-making. That includes high-quality target validation, translational biology, integrated medicinal chemistry and DMPK, structural and computational sciences, automation, AI-enabled design, and robust project leadership. But the real advantage comes from connecting these capabilities rather than treating them as separate workstreams. Drug discovery is still an experimental science; AI can accelerate and sharpen decisions, but it must be paired with expert interpretation and rigorous laboratory validation. Companies also need modality-aware thinking – small molecules, biologics, peptides, targeted protein degradation and ADCs each create different discovery and developability challenges. Finally, resilience matters: programmes need flexible access to expertise, scalable capacity and the ability to pivot quickly when the data changes. The future belongs to teams that can combine specialist depth with integrated execution.
Arya Mehrabanzad, Principal, Ampersand
Beyond AI, three additional capabilities stand out. The first is manufacturing flexibility. Single-use bioprocessing is central to this as it enables faster turnaround, lower contamination risk, and better scalability without the capital intensity of stainless-steel infrastructure.
The second is supply chain intelligence. Tariffs, changing compliance requirements, geopolitical tensions and other challenges have stressed the global pharmaceutical supply chain. Dual-sourcing strategies, domestic manufacturing investments, and real-time supply chain visibility are becoming a competitive necessity.
Third is the adoption of NAMs in preclinical development. This is a trend that has been long discussed and eagerly anticipated, yet historically limited by technology (including enabling tools / services) and scalability as well as standardization and regulatory acceptance. The industry has made considerable progress on the former two, and we’ve now seen major steps in the latter two with the FDA’s recent announcements and commitments to reducing the use of animal models in development. I think the headlines have moved a bit faster than the industry at this point, as we’re still in the earliest stages of seeing these in vitro and in silico NAMs technologies drive real change across the market, but the promise of faster, cheaper IND-enabling packages is real and adoption is growing.
Thomas Kledal, CEO, Synklino
The most important capability is integrating scientific, clinical, regulatory and commercial thinking from the beginning rather than treating them as sequential steps. Faster development comes from asking the right questions early and generating evidence that reduces uncertainty at every milestone.
A second priority is translational excellence. Companies that can demonstrate robust proof-of-concept in models that closely reflect clinical practice are better positioned to make confident development decisions and shorten the path to meaningful clinical validation.
Operational agility also remains essential. Lean organizations that coordinate high-quality external partners can move quickly without compromising quality or capital efficiency.
Thibaut Brugat, Director of Corporate Strategy, Kainova Therapeutics
The capabilities that matter most are those that create integration, adaptability and resilience across the development chain. When companies operate through shared decision frameworks that connect scientific ambition to operational and market realities, issues around development, manufacturability and commercial viability can be addressed much earlier. In this context, this is especially important for GPCR-focused biotech, where scientific, translational and operational considerations converge early and need to be aligned to keep programs moving efficiently.
In practice, this requires flexible operating models and scenario-based portfolio planning, especially as partnerships increasingly span early development through commercialization and bring the right expertise at the right time. AI and digital tools are helping inform decisions across this chain, but the differentiator is not the tools themselves, it is the ability to embed them into governance, culture and processes. Ultimately, resilience depends on adaptive, interconnected operating models that can respond quickly while staying strategically coherent.
Josep Prous, Jr., Co-Founder and CSO, Connecta Therapeutics
Drug development companies need strong collaboration and partnership management capabilities supported by a clear, partnership-oriented strategy to successfully navigate the increasingly complex biopharma ecosystem. Success depends not only on scientific excellence but also on the ability to build, manage and sustain long-term strategic collaborations with academic institutions, biotechnology start-ups, contract research and manufacturing organizations, regulators, investors and pharmaceutical partners.
Effective collaboration enables organizations to combine complementary expertise, share resources and risks, accelerate decision-making and improve the efficiency of research and development activities.
Early engagement with patient associations is equally important, ensuring that research programs address unmet medical needs, incorporate patient perspectives into study design, improve clinical trial recruitment and retention and generate outcomes that are meaningful to patients and healthcare providers.
In parallel, proactive collaboration with regulatory agencies helps clarify development expectations, supports the use of accelerated approval pathways where appropriate, reduces regulatory uncertainty and ultimately increases the likelihood of successful clinical development, regulatory approval and commercialization.
Adam Plich, Co-Founder and CEO, Avanzanite Bioscience
Resilience today is about much more than scientific capability alone. Companies that anticipate downstream requirements early – whether they are regulatory, commercial, market access, or supply chain-related – are often better positioned to navigate uncertainty and execute successfully.
There is a trend toward more flexible operating models. Rather than building every capability in-house, many companies are leveraging specialist partners who can provide expertise, infrastructure, and market knowledge as needed. This allows R&D organisations to remain focused on innovation while looking to partners for the capabilities required to prepare for launch and commercialisation efficiently.
At Avanzanite, we believe that ultimately, the companies that will be most resilient are those that can combine scientific excellence with the genius of thoughtful planning, adaptable partnerships, and a clear understanding of how to move therapies from approval to broad patient access.
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