Accelerated Pathways: How ILAP Gives Developers a Strategic Early Advantage

The pace of medical innovation is faster than ever, but patients often face delays in accessing transformative therapies. The UK’s Innovative Licensing and Access Pathway (ILAP) was created to change that, offering a structured, collaborative route that accelerates patient access while allowing developers to optimise their strategy from the outset.

At Richmond Pharmacology, we help developers leverage ILAP strategically, ensuring that early engagement translates into smarter development decisions, fewer late-stage hurdles, and faster patient access.

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Understanding ILAP

ILAP is an integrated pathway connecting developers, regulators (MHRA), health technology assessment (HTA) bodies, and the NHS. It streamlines regulatory and access processes, but its true value lies in the early, strategic guidance it provides.

Key components include:

• Innovation Passport: The gateway for developers to enter the pathway and access early regulatory and health system feedback.

• Target Development Profile (TDP): A strategic plan that outlines regulatory, clinical, and access milestones, helping developers anticipate and navigate potential obstacles.

By combining these elements, ILAP allows developers to plan more effectively, align with stakeholders early, and reduce costly late-stage changes.

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Why Early Engagement Matters

Developers who engage with ILAP early gain a strategic advantage:

1. Reduced Risk of Late-Stage Delays: Early guidance from MHRA and other stakeholders helps avoid protocol changes, ensuring smoother regulatory review.

2. Optimised Evidence Generation: Developers can focus on collecting the most relevant clinical and health economics data for both regulators and payers.

3. Aligned Market Access Planning: Coordinating with NICE and NHS England early ensures that reimbursement and adoption considerations are addressed alongside regulatory approval.

This early strategic alignment increases the likelihood of successful market entry and faster patient access in the UK.

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Benefits for Developers and Patients

ILAP delivers tangible benefits for both sides of the healthcare equation:

• For Developers: Streamlined processes, tailored guidance, and early clarity on regulatory and access requirements.

• For Patients: Faster availability of innovative treatments, particularly in areas with high unmet need, without compromising safety or efficacy.

By taking a strategic, early-stage approach, ILAP helps transform promising science into therapies that reach patients sooner and more efficiently.

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How Expert Support Strengthens ILAP Planning

Navigating ILAP effectively often depends on clear documentation, well-prepared engagement with UK regulators, and development plans that integrate regulatory, clinical and patient-centred considerations.  

At Richmond Pharmacology, ILAP support is shaped by practical experience within the UK regulatory environment.  For example, Dr Lisa Campbell, our Director of Regulatory Strategy, previously served as Senior Medical Assessor at the MHRA and contributed to the development of ILAP itself. This background means her team is well placed to provide:  

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1. Guidance on Eligibility and Innovation Passport Applications

Supporting developers in understanding ILAP criteria and preparing robust, well-structured applications.

2. Strategic Planning and TDP Development

Facilitating workshops and cross-functional discussions to build a TDP that is realistic, evidence-based and aligned with UK system expectations.

3. Integration Across Clinical, Regulatory and Access Planning

Ensuring ILAP considerations inform trial design, patient involvement activities, and downstream access strategy.

4. End-to-End Regulatory and Medical Writing Support

Preparing concise, high-quality submissions and briefing materials to support clear communication with UK regulators and HTA bodies.

5. Emphasis on Patient Involvement

Embedding patient insights and unmet-need considerations early, reflecting one of ILAP’s central principles.

This support framework helps ensure that ILAP is used not simply as an accelerated route, but as a strategic tool that strengthens development from the outset.

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Conclusion

ILAP offers developers a structured opportunity to engage early with UK regulators and health system partners, supporting more informed decision-making and potentially earlier access to innovation for patients. With the right strategy and preparation, the pathway can become a meaningful asset, improving predictability, reducing risk and

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Read more about our approach to ILAP in The Pharma Letter