How We Help Transform Rare Disease Care

Patient Voice Integration

We help build authentic patient input into every stage of your treatment or service development process, ensuring regulatory requirements are met. This includes establishing patient advisory boards, conducting meaningful patient research, and creating feedback loops that satisfy regulatory expectations while truly influencing product and service development.

Regulatory Strategy & Compliance

We help navigate the evolving regulatory landscape where patient-centricity is now mandatory, not optional. From FDA’s new Rare Disease Innovation Hub requirements to EMA’s strengthened patient engagement expectations, we ensure your approach meets current and emerging regulatory standards.

Diagnostic Pathway Optimisation

We help reduce diagnosis time by identifying barriers in current pathways and designing solutions that eliminate misdiagnosis while improving access to specialist care.

Treatment Access & Efficacy

We support you in developing treatment approaches that not only work clinically but are also accessible, manageable, and align with patient quality of life goals

Patient-Led Research Partnership

The industry has shifted toward patient-led clinical research, with patient organisations increasingly taking the lead. We help you adapt to this new dynamic, building genuine partnerships with patient-led initiatives and navigating the evolving power structures in rare disease development.

Organisational Culture Development

We help embed patient-centricity into your company culture, helping teams to think from the patient perspective and creating systems that maintain this focus over time.

Core Focus Areas

Addressing the regulatory imperative for authentic patient-centricity in an evolving landscape where patient voices drive approval decisions.

Quicker Diagnosis

Eliminating the often multi-year diagnostic journey through patient-informed pathway design

Eliminate Misdiagnosis

Creating clear diagnostic pathways using real patient experience data

Regulatory Alignment

Ensuring your patient engagement meets regulatory requirements for patient-focused drug development

Reduce Treatment Burden

Developing manageable treatment regimens that reflect patient priorities and real-world constraints

Better Long-term Outcomes

Focusing on quality of life measures that matter to patients and satisfy regulatory expectations

Stakeholder Ecosystem Navigation

Connecting you with the patient-led research movement and governance bodies shaping the future

For more information please contact us at clive@makingthemostofnow.co.nz or +64(0)21771624.