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Expanded Access

Tailored Expanded Access Programs

Tailored Expanded Access Programs

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Uniphar simplifies expanded access programs that transform lives and

accelerate product development.

Uniphar simplifies expanded access programs that transform lives and accelerate product development.

Our expanded access programs deliver controlled, pre-commercialization access to innovative therapies for patients with serious conditions who lack treatment options.

Our pillars of service

Strategic partnerships

Our global team are experts in supporting our partners to develop, implement and execute the most appropriate expanded access strategy

Regulatory navigation

Our in-house regulatory team establish the most appropriate regulations to be used, ensuring every program benefits from our 15+ years of regulatory knowledge and experience

Execution excellence

Global supply chain optimization through an integrated infrastructure with program management and customer service teams worldwide

Digital strength

Innovative digital solutions built specifically for EAP. Customized, accessible and on-demand

Patient and HCP centric

Patient-first program design supporting the HCP journey from awareness to treatment

Cell and gene therapy

Our unparalleled experience with multiple cell and gene therapies makes us best placed to support the delivery of EAPs for cell and gene therapy assets into complex markets

Why choose Uniphar for your expanded access program?

Optimal stakeholder value

Our expert, global team supports our partners to develop, implement and execute the most appropriate expanded access strategy. Simplifying execution across geographic boundaries, we successfully navigate the complexity of country-specific regulation and supply chain to deliver compliant and controlled access. Our coordinated expanded access programs provide a unified strategy to transform patient outcomes and accelerate approval.

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160 countries served

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25 years’ EAP experience

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50,000 rare and oncology disease patients treated

Success in expanded access program delivery

Uniphar’s expanded access programs help to provide patients with unmet medical needs with timely and reliable access to emerging therapies for improved patient outcomes. Global reach, local expertise and a passionate team of high-caliber experts ensure global EAP success.

Expanded access capabilities

Uniphar provides a crucial role in facilitating access to investigational treatments for patients with unmet medical needs. We provide a range of services to enable access to experimental therapies.

Common services provided by our expanded access team

  • Strategic overview and planning of program
  • Tailored program design around asset
  • Post trial access programs
  • Global regulatory strategy overview
  • Dedicated project management
  • Real-time program reporting and
    metrics
  • Continued regulatory support
  • Patient eligibility assessment
  • Physician and patient education
  • Storage and logistical supply chain management
  • Real world data collection and reporting
  • Legal and contractual support
  • Ethical oversight of program
  • Compliant communication and patient advocacy
  • Drug safety, monitoring and reporting of adverse events

We are committed to delivering best-in-class expanded access services to the pharmaceutical and biotech industries. Dedicated to providing a personal touch, ensuring the highest level of service for healthcare professionals and patients.

Learn more about our expanded access services

Uniphar provides a crucial role in facilitating access to investigational treatments for patients with unmet medical needs. We provide a range of services to enable access to experimental therapies.

25 years’ experience

Having designed and implemented successful EAPs for well over two decades, we have built enviable global regulatory knowledge, therapeutic area expertise, robust processes and a deep understanding of the needs of different stakeholders.

Specialized, high quality expanded access

We streamline expanded access programs that transform lives and accelerate product development. Our expanded access programs deliver controlled, pre-launch access to innovative therapies for patients with serious conditions who lack treatment options.

Valuable insights Our expert team contributes heavily to the ongoing expanded access global discourse. We have a range of key insights into EAPs which our stakeholders find valuable.

Uniphar expanded access program FAQs

Expanded access can be a complex area, but we can help clear up the many questions different stakeholders — manufacturers, HCPs, patient groups, patients and caregivers — often have.

What is an expanded access program (EAP)?

Expanded access programs provide therapies that are not yet commercially available to patients who cannot participate in a clinical study, but who have a serious or life-threatening disease for which their physician has determined there are no appropriate treatment options. Expanded access programs are also referred to as managed access programs, compassionate use or early access.

Can a sponsor limit the number of patients they include in their EAP?

Yes. In certain cases, a sponsor may choose to restrict the number of patients who can gain access to their EAP. This may be due to limited resources being available or manufacturing constraints, among other potential reasons.

Are sponsors required to have an EAP for their investigational drugs?

There are no regulations that require companies to provide an EAP for their investigational or locally unlicensed drugs. However, as patient and physician demand for access to investigational/unlicensed drugs outside of clinical trials grows, many companies now actively offer EAPs for their therapies for several reasons. First, EAPs help address the unmet medical needs of patients, while also allowing sponsors to build awareness, gather valuable real-world data and assess market demand.

In which countries can you run an EAP?

The vast majority of countries have regulations that allow for patients to access locally unlicensed therapies; however, these vary significantly between countries. Uniphar has significant experience in helping sponsors navigate these complex global regulatory pathways. 

What are the benefits to sponsors of conducting an EAP?

Offering an EAP for a rare disease therapy is now a vital step in the pre-commercial launch process.

Allowing access to a therapy via an EAP can prove beneficial in the following ways:

  • Patients in need get access
    EAPs can help address critical unmet needs, fairly and sustainably
  • Increased awareness of therapy
    Early access to a therapy through an EAP can open doors to new potential prescribers in advance of any commercial launch
  • Positive press and stakeholder engagement
    EAPs strengthen company reputation and CSR
  • Faster post launch prescribing decisions and improved diagnostic knowledge
    Increased awareness and confidence in a therapy as a result of an EAP often translates to faster prescribing decisions post-commercial launch
  • Tests the market
    An EAP will give a good indication of likely demand and expected post-launch sales
  • Ability to collect real world data
    In many cases RWD may be collected from patients participating in an EAP
Can sponsors charge for therapies provided through an EAP?

Yes. In the majority of countries sponsors are permitted to charge for access to a therapy through an EAP. Our team of experts can provide detailed guidance on which countries allow for charging, including any restrictions.

Can a sponsor refuse to enroll patients in an EAP?

As with clinical trials, EAPs have inclusion and exclusion criteria set by the sponsor. The sponsor reserves the right to refuse access requests.

Can sponsors collect data from patients participating in an EAP?

Yes. EAPs offer a great opportunity in which to collect additional RWD from patients on treatment. As a result of this, most sponsors choose to include some element of RWD collection in their EAPs.

The reporting of safety data, such as adverse events during EAPs, is often mandatory and governed by local country regulations.

We utilize our proprietary online portal, uniphi, to facilitate the collection of high-quality RWD, such as patient reported outcomes (PROs), that may be used for a variety of purposes.

Let’s work together

A successful access program is, at its core, about collaboration. Partnering to provide patients with access to emerging and critical therapies, connecting all stakeholders in the access ecosystem. Working together we gather real-world data that assists product development and planning.