Navigating IND delays: strategic options for early-phase biotech development

For early-stage biotechnology companies, the most important factors in early development are time and money as both can be used to leverage funding and the continuation of programmes. However, across the industry, timelines for initiating first-in-human (FIH) studies are stretching longer than many sponsors anticipate. At the centre of this challenge sits the US Food and Drug Administration’s (FDA’s) Investigational New Drug (IND) application, a process that was once considered the main gateway into clinical development but is now increasingly causing development bottlenecks.

With regulatory oversight intensifying, submission packages growing more complex and external pressures reshaping review priorities, IND delays can quietly erode momentum for emerging biotechs. In response, many sponsors are rethinking how, where and when they generate early human data – including adopting alternative strategies that allow them to move forwards without waiting for the IND green light.

This shift marks a broader evolution in early-phase development philosophy from linear, jurisdiction-dependent models towards parallel, globally informed approaches designed to protect timelines and preserve optionality. This article examines the factors contributing to prolonged IND timelines and how sponsors are responding by adopting alternative early-phase strategies and parallel geographic pathways to accelerate the generation of human data.

How IND delays can lead to development risks

For companies operating with finite capital and milestone-driven funding models, early clinical data is a critical inflection point. Phase I results inform scientific direction, underpin partnership discussions and often determine whether an asset can attract the next round of investment. Thus, if IND timelines slip, the consequences can cascade far beyond the clinic.

Several factors are impacting the length of IND review timelines in the US, including:

• Growing submission complexity, particularly for advanced modalities such as cell and gene therapies, RNA-based products and novel delivery platforms
• Higher expectations for preclinical evidence, especially for first-in-class or assets with novel mechanisms of action
• Increased regulatory caution, shaped by evolving policies around accelerated approvals and post-market safety
• More reviewer–sponsor interactions, which can trigger multiple rounds of clarification and ‘stop-the-clock’ delays.

Although the FDA’s IND framework remains grounded in scientific rigour, the combined effect of these dynamics is a process that can feel unpredictable for early-stage sponsors. Even modest delays can push development milestones out by months, with direct implications for burn rate, investor confidence and strategic optionality.

Broader geopolitical and economic factors are also indirectly influencing agency workloads and expectations. These include supply-chain instability, shifting public health priorities and global regulatory harmonisation efforts. For small and mid-sized biotechs, these variables are largely outside their control, but they materially affect development velocity.

The cost of IND delays and the search for alternative pathways

As IND timelines lengthen, sponsors are increasingly unwilling to let their programmes sit idle. Consequently, rather than viewing the US IND as the sole entry point into human research, many companies are now exploring alternative pathways that allow them to generate high-quality early clinical data while regulatory reviews continue in parallel.

Regions like New Zealand offer a regulatory environment that emphasises speed, clarity and alignment with global expectations without sacrificing data credibility.

One approach gaining traction involves initiating early-phase studies in jurisdictions where an IND submission is not required to begin human research, such as New Zealand, provided that trials meet internationally recognised scientific and ethical standards. Regions like New Zealand offer a regulatory environment that emphasises speed, clarity and alignment with global expectations without sacrificing data credibility.

Importantly, this strategy is not about bypassing regulatory rigour. Rather, it reflects a growing recognition that high-quality clinical data is defined by how a study is designed and conducted, not solely by its location.

What makes New Zealand an attractive place for early-phase development?

Not all regions are equally suited for early-phase research. As sponsors reassess how to protect early clinical timelines, New Zealand has emerged as a leading destination for first-in-human and other early-phase studies.

Several defining features of New Zealand’s system contribute to its appeal. Sponsors submit applications through a centralised process that integrates both scientific and ethical review, allowing assessments to proceed in parallel rather than through sequential regulatory steps. This structure is supported by direct, real-time interaction with review bodies, enabling questions to be addressed efficiently as they arise. Together, these elements deliver a high degree of predictability, with decision timelines typically fixed and capped at 45 calendar days.

These characteristics allow sponsors to model development timelines with a high degree of confidence – an increasingly valuable asset for early-stage companies operating under capital and milestone constraints.

Using New Zealand as part of a parallel development strategy

Rather than replacing US development plans, many sponsors now position New Zealand as a complementary component of a broader, parallel early-phase strategy. In this model, a first-in-human or early escalation study is initiated in New Zealand while the US IND proceeds through FDA review.

This parallel approach offers several strategic advantages:

• Earlier human data and insights

Sponsors can obtain safety, tolerability and pharmacokinetic data months earlier than would be possible if they waited solely for US IND clearance. These early signals often inform dose selection, protocol refinement and go/no-go decisions.

• Stronger regulatory preparedness

Having human data in hand allows sponsors to anticipate potential FDA questions, strengthen scientific justifications and refine their IND narrative, potentially reducing the likelihood of prolonged review cycles or clinical holds.

• Improved investor and partner confidence

For early-stage biotechs, demonstrating real-world human data, rather than projected timelines, can materially strengthen fundraising efforts and partnership discussions.

In this way, New Zealand-based early-phase studies are increasingly viewed as proactive tools for de-risking global development programmes.

An ecosystem designed for early-phase execution

The speed of early-phase clinical development is shaped as much by execution as by regulation. This is particularly valuable in early studies, where rapid safety assessment, dose-escalation decisions and protocol adaptations require seamless collaboration across teams. From an operational perspective, this cohesion is reinforced by several ecosystem-level factors that support efficient early-phase execution.

1. Clinical integration and investigator experience

New Zealand’s early-phase environment is characterised by close integration between hospitals and specialised research units, reducing fragmentation and supporting continuity of care. Nationally coordinated pathology and imaging services further contribute to consistent, timely data generation.

Equally important is the depth of investigator and clinical team experience. Clinicians, research nurses and coordinators are well versed in dose-escalation designs, adaptive protocols and intensive safety monitoring, enabling confident decision making and smoother study progression.

2. Enrolment predictability

Recruitment remains a common source of delay in early-phase research. In New Zealand, established healthy volunteer registries, access to treatment-naïve patient populations and centralised healthcare records support more reliable enrolment and screening. This predictability helps sponsors reduce execution risk and plan development milestones with greater confidence.

3. Digital enablement and data visibility

New Zealand has invested in digital clinical infrastructure that supports real-time oversight and rapid decision making. Electronic source documentation, integrated data workflows and live safety dashboards provide continuous visibility into study progress, while secure remote monitoring enables efficient collaboration across global teams.

Ensuring global acceptance of New Zealand-generated data

For sponsors considering New Zealand as an early-phase destination, the acceptability of resulting data is a central consideration. In practice, regulatory acceptance depends on adherence to globally harmonised standards rather than geographic origin.

Clinical trials conducted in New Zealand operate under ICH E6(R3) Good Clinical Practice, which defines consistent requirements for trial design, conduct, monitoring and reporting. As a result, data generated in New Zealand is widely accepted by major regulatory agencies, including the FDA, European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada and Swissmedic.

When early-phase studies meet these expectations, regulators can focus on scientific content rather than jurisdictional context. As a result, data generated in New Zealand can be incorporated directly into IND submissions, scientific advice meetings and subsequent regulatory filings.

Transparency and traceability further strengthen this acceptance. The use of digital systems, real-time safety oversight and clear audit trails enable sponsors to respond efficiently to regulatory questions and demonstrate compliance throughout the study lifecycle.

A more deliberate approach to early-phase development

As IND timelines lengthen and regulatory complexity increases, early-phase clinical development is entering a more deliberate and strategically nuanced era. Jurisdictions with an IND requirement, such as New Zealand, offer sponsors a way to generate high-quality human data efficiently while preserving full alignment with US and European regulatory expectations.

When integrated into a parallel development strategy, New Zealand-based early-phase studies can help sponsors protect timelines, strengthen regulatory interactions and approach investment and partnership discussions with greater confidence.

In an environment where evidence and adaptability increasingly define success, biotechs that rethink traditional development assumptions and design early-phase programmes accordingly are better positioned to move forwards with clarity and momentum.