Emerging biotech companies face a development environment shaped by complex science, selective funding, manufacturing constraints, and rising expectations from regulators, investors, partners, and payers. In this context, early decisions around strategy, manufacturability, external support, and long-term commercial goals can have lasting consequences.
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 6, we ask:
What practical advice would you give to emerging biotech companies navigating today’s development, funding, and manufacturing environment?
Gavin Murdoch, SVP of Commercial Strategy, Abzena
Know your ultimate goal and what it will take to get there. Is it partnership, acquisition, or go-to-market? Build your development strategy from there. Utilize consultants, advisors, and CDMOs to help stress-test your assumptions, frame risks, and look beyond the next inflection point.
Investors reward companies that have navigated development cleanly, without costly revisions, repeats, or tangled decisions from earlier shortcuts. Select your CRO/CDMO carefully and early. Evaluate not just capabilities, but geography, cultural fit, and IP ownership. Try to avoid cheap, quick options that bring licenses and complexity at later steps, as you may end up owning those decisions.
The best partners should be able to work well with other providers, bring relevant expertise to the table, and help address the specific challenges of the program rather than simply pushing their own solution.
Jeremy Skillington, CEO, Poolbeg Pharma
It is a terrific industry to be part of. The ultimate goal is to help alleviate the pain and suffering of patients so clearly a worthwhile mission.
Building on a solid scientific foundation and rationale is a critical starting point and tapping into expertise is essential to navigate the correct path forward. Thankfully it is a highly networked industry so the knowledge is out there so it is important to get the right people as part of your team.
You need to clearly articulate the mission for whatever the disease you are tackling. However this is not a ‘build it and they will come’ scenario. Significant work and effort will be needed to fully understand the unmet need, competition in the space, market size and payer’s perspectives.
Intellectual Property is also critical so do not cut corners on protecting your medicine.
With all these pieces in place, or at least in progress, then the necessary financing can be raised to pursue the mission of getting drugs to market to help patients.
Thomas Kledal, CEO, Synklino
Stay relentlessly focused on solving an important clinical problem. Strong science is essential, but it is differentiation and relevance to patients, clinicians and healthcare systems that ultimately determine success.
Design development programmes to answer the most important questions first. Generate evidence that demonstrates not only biological activity but also why your approach could improve outcomes, fit naturally into existing clinical workflows and create value for the wider healthcare system. Those are the milestones that attract investors, partners and future adopters.
Build capital-efficient organisations by leveraging specialist external expertise instead of recreating every capability internally. When engaging potential partners, think beyond the science. Be clear about the strategic and commercial value your asset creates - not only for patients and healthcare systems, but also for the partner. Demonstrating how your programme can strengthen a partner's competitive position and support a successful commercial business is often as important as the underlying data.
Finally, engage regulators, clinical experts and future stakeholders early. Their perspectives help shape stronger development strategies, reduce execution risk and increase the likelihood that promising science translates into real-world impact.
Alison Clayton, Strategic Projects Director, Symbiosis Pharmaceutical Services
My first piece of advice would be to think beyond the next milestone. Funding pressures can understandably create a focus on immediate objectives, but it is important to consider how early development decisions may affect future clinical progression, manufacturing scalability and commercial readiness.
Engaging experienced partners early can be particularly valuable. Whether the challenge relates to manufacturing, regulatory strategy or CMC planning, gaining expert input at the right stage can help avoid delays, reduce risk and ultimately make better use of limited resources. It is often more cost-effective to address potential issues proactively than to correct them later when programmes are further advanced.
I would also encourage companies to be selective when choosing external partners. The right partner should offer more than capacity; they should bring relevant expertise, a strong quality culture and a genuine understanding of the specific challenges associated with the therapy being developed. For complex biologics and advanced therapies especially, deep technical knowledge can be a significant differentiator.
Lastly, maintain a clear focus on the patient and the intended commercial outcome. Scientific innovation remains fundamental but successful programmes increasingly combine strong science with thoughtful planning, strategic partnerships and a realistic understanding of the path to market.
Kevin Schaab, Sr. Drug Development Consultant; and Brad Rowe, Senior Director, Integrated Development; Quotient Sciences
Schaab: Emerging biotech companies should prioritize integrated development strategies that align formulation, manufacturing, and early clinical planning from the outset. Avoiding unnecessary complexity and generating actionable data early can strengthen regulatory engagement and investor confidence while minimizing capital at risk.
Rowe: I would emphasize the need for more deliberate early-phase decisions around formulation and manufacturability. Companies can’t afford to defer these considerations. Companies that take a holistic approach that links CMC, clinical, and regulatory activities are better positioned to manage funding constraints, de-risk development, and ultimately produce a more valuable asset.
Cora Griffin, Head of Business Development, Curve Therapeutics Ltd
For me, it is important to remember that investors and partners are not primarily buying your science, instead they are buying your ability to reduce risk in a structured, predictable way, and provide a clear value proposition. The biotechs attracting capital and partnership interest right now are those that have built their narrative around milestones, value inflection points, and credible exit paths.
Corporate venture arms from large pharma are evaluating strategic alignment as much as financial return, they want to understand how your platform or asset fits their pipeline priorities. In comparison, pure-play biotech investors are focused on capital efficiency and risk-adjusted value creation. Forms of non-dilutive funding such as grants, milestone-structured partnerships and royalty arrangements can extend runway significantly without eroding equity at the moments that matter most.
On manufacturing, use CDMOs strategically, but make sure you understand your future manufacturing requirements well enough to negotiate those relationships from a position of knowledge. Many early-stage companies underestimate how much manufacturing complexity can slow a partnership discussion later on. Your CMC (Chemistry, Manufacturing and Controls) story is part of the due diligence that large pharma runs before signing.
Tony Thomas, Director, Technical Consulting, Ecolab Bioprocessing; and Fiona Stack. Global Technical Consultant, Ecolab Life Sciences
One of the biggest things we would highlight is the importance of thinking about your development journey end to end while building the right partnerships around that early on.
Successful companies tend to make the most of strategic partners at each stage, whether that’s supporting early development, preparing for regulatory review, or scaling into commercial manufacturing. The organisations that do this well are the ones that treat partners as an extension of their own team, bringing in the right expertise at the right time rather than trying to build everything in-house.
There’s also a clear need to be more deliberate about how you design for scale. The earlier you think about things like manufacturing approach, facility strategy and compliance, the more flexibility you have later, particularly as expectations from regulators, investors and payers continue to rise.
The companies that navigate this environment most effectively are the ones that combine strong science with the right external expertise, and who use partnerships not just to solve problems, but to build capability as they grow.
Gina Eagle, Clinical Research Physician, Kither Biotech
Have knowledge: ensure all disciplines work as a team, that they understand and/or appreciate each contribution and that they remain curious.
Have a vision: strategically plan the entire development program starting from Phase 1, including manufacturing.
Have flexibility: read each data set diligently, let the data guide the program forward, understand confounds, follow regulatory precedents, and explore all potential differentiators.
Have fun: ensure the team feels fulfilled and enjoys their work and collaboration.
Greg Plunkett, CEO, Accelagen
For the emerging biotech industry, the priority should be retaining focus. In an environment where funding opportunities may be limited, it is critical to be clear about the value inflection points that matter most and to deploy capital against those with discipline. That means defining what outcomes will materially strengthen the asset, what can wait, and where to benefit from external support and what can accelerate progress without adding unnecessary complexity.
It is also important to think earlier than many teams expect about manufacturability, regulatory strategy, and future commercial requirements. These all are not issues to solve after proof of concept, however early decisions around product design, development pathways, and operational model can have a major impact on cost, timeline, partner interest, and eventual market access.
Finally, leadership teams should be realistic about where they need depth and where they need leverage. The strongest emerging companies are not those that try to build everything internally, but those that make deliberate choices, partner well, and maintain a development plan that is both ambitious and executable. In the current market, credibility comes from focus, clarity, and consistent execution.
Elizabeth Holt, Chief Business Officer (CBO), iOnctura
Stay focused on programs with strong biology, clear differentiation, and a realistic path to patient impact. Be disciplined in how you deploy capital and build commercialization, regulatory, and manufacturing thinking into development plans early. Choose partners carefully and leverage external expertise where it can accelerate progress. Above all, remain adaptable. The companies best positioned to succeed are those that combine scientific excellence with rigorous execution and a clear understanding of where they can create the greatest value.
David Claveau, Vice President, Business Development, North America, Sygnature Discovery
My advice is to be ruthless about the critical questions that create value. Know what must be true for your programme to succeed, then design experiments that answer those questions as efficiently as possible. Do not wait until late discovery to think about developability, translational strategy or differentiation; those factors should shape the programme from the beginning. Be equally disciplined about what not to do. In a selective funding environment, focus is a competitive advantage. Build a plan that investors, partners and future acquirers can understand: strong biology, clear patient relevance, credible path to candidate, and a realistic view of risks. Finally, choose partners who challenge the science as well as execute the work. The right partner should help you move faster, but also help you avoid false confidence. Speed matters, but in drug discovery, speed only creates value when it is paired with quality decisions.
Jordi Fàbrega, Co-Founder and CEO, Connecta Therapeutics
Emerging biotech companies should focus on building resilience and maintaining the flexibility to adapt to changing scientific, regulatory and market conditions. As drug development is inherently unpredictable, the ability to adjust strategies based on new evidence or external factors is a key competitive advantage.
Identifying strategic partners early is equally important. Collaborations with academic institutions, contract research and manufacturing organizations, investors and pharmaceutical companies can provide access to specialized expertise, infrastructure, and resources that accelerate development while reducing risk.
A robust fundraising strategy is also essential. Companies should diversify funding sources and secure sufficient capital to reach key value-inflection points while maintaining adequate cash reserves to manage unexpected delays or increased development costs. Investing in milestones that generate robust scientific and clinical data supports informed decision-making and strengthens investor confidence.
Finally, understanding the competitive landscape enables companies to differentiate their programs, refine their value proposition and maximize future partnering, licensing, and commercialization opportunities.
Mike Cooke, Co-Founder & CEO, AmacaThera
My advice is to be very clear about the problem you are solving and to build the development plan around proving that value. Emerging companies have limited resources, so every experiment should help answer a question that matters to patients, clinicians, regulators, investors, partners, or payers.
Second, think about the product early. It is easy to focus only on the science, but the product has to work in the real world. How will it be administered? Does it fit into clinical practice? Can it be manufactured? Can it scale? Does it solve a meaningful problem better than what is already available? And importantly, will the healthcare system be willing to pay for it, even if the need is clear?
Third, use partnerships thoughtfully. The right partner can bring more than capital. They can bring clinical, regulatory, manufacturing, commercial, and market access insight that helps move a program forward faster and with less risk.
Finally, stay disciplined. In this environment, focus is a competitive advantage. Do the work that strengthens the asset, validates the platform, and moves the company closer to patients in a way that is both clinically meaningful and economically sustainable.
Adam Plich, Co-Founder and CEO, Avanzanite Bioscience
My advice would be to start planning for commercialisation earlier than you think you need to – seeking out excellence in downstream execution or playing “Champions League,” as we call it at Avanzanite. Not only do investors, regulators, and other healthcare stakeholders want to understand whether a therapy can achieve clinical success, but they also want to know whether there is a credible pathway to getting that therapy into the hands of patients.
Emerging companies should remain focused on the capabilities that truly differentiate them – typically their science, technology, and pipeline – while being realistic about where external expertise can add value. Building global commercial infrastructure internally isn’t always the most efficient or effective approach, particularly in today's funding environment.
Identifying partners with experience in regulatory strategy, market access, supply chain management, and broad regional commercialisation can help reduce execution risk, preserve capital, and ultimately accelerate patient access. In an increasingly complex environment, success depends on the genius of innovation combined with the genius of a practical strategy to deliver that innovation to the healthcare systems and to patients that need it most, so that no one is left behind.
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