Our Approach

Participants

Global Patient Dialogues enable innovators, researchers, and other key stakeholders, such as regulators, health system leaders, policymakers, and payers to benefit from an impactful and memorable dialogue with patients and their care partners in specific, selected disease areas.

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Interested participants simply register for the global patient dialogue meeting with an appropriate registration fee – no contracting or grants involved.

There is a pre-meeting survey sent out to all registrants to tailor the global patient dialogue to the interest of registrants.

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Patient Organizations

Specific to the disease of interest, patient organization leaders will co-design individual disease-specific meetings, provide key content expertise, identify individual patient experts and manage patients’ expectations, and payment based on fair market value. Patient organization leaders are key collaborators and will facilitate the discussion at the Global Patient Dialogue with patients.

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Patients

Patients provide insights into daily life with specific medical conditions, interfacing with delivery systems, and calculating benefit/risk decisions, and specify the ultimate value of innovation. Patients want clinically effective treatment and prevention options that are relevant to their personal circumstances and individual goals. They draw from this knowledge to co-create more effective and efficient therapies, aimed at what patients genuinely care about. Patient partnerships improve the discovery, development, and evaluation of new and effective medicines and medical devices to aid healthcare providers and innovators with strategies that are sustainable for patients and ensure greater access and quality of care.

Our Methodology

1) Identify representative patient population and engagement approach with leading patient organization partner(s)

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We will assemble a representative population of patients. The term, representativeness, means a sufficient number of and types of people are included in the engagement activity to ensure that those engaged can speak on behalf of the target population. It refers to “who” and “how many” individuals to include in an interaction in order to, as closely as possible, engage with individuals that represent the broader target patient population. Patients will be engaged in a respectful and trusted manner so that expectations are met, and they understand the Global Patient Dialogue objectives and audience. They will be paid Fair Market Value ( FMV) for their participation.

2) Global Patient Dialogue organized through a consortium of trusted collaborators

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A Global Patient Dialogue is provided through a Consortium of Trusted Collaborators – Patient3i brings together a consortium of trusted collaborators to support the Global Patient Dialogue Series. Each collaborator has a key role for each meeting as follows:

  • Patient organizations — specific to the disease of interest — provide key content expertise and individual patient experts and manages patients’ expectations
  • EU partners and collaborators will mirror the US consortium approach for a planned Global Patient Dialogue: all stakeholders, participants and patient organizations will benefit from a global perspective for the disease condition

3) Patient3i drives all project management and logistics

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Patient3i provides the platform for the series, handling all logistics for the meeting with specific policies and procedures to ensure high quality and transparency; coordinates with Global Patient Dialogue Series Partners.

4) National Health Council as consultant, provides and ensures implementation of regional and national guidance and frameworks

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National Health Council, a respected collaborator in the US, guides the process by providing standards for patient engagement, training, representativeness, primary contact with FDA, and will bridge global standards and methods with multiple stakeholders

5) Participants register, attend, and participate in the Global patient Dialogue and receive final report(s) to inform their patient centered strategies

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Health Care Innovators/participants register for the meeting, attend, engage with patients and can receive Global Patient Dialogue Reports for both US and EU Global Patient Dialogues. It is expected that patient insights gathered by participants at this meeting will inform real-world discovery and development strategies throughout medicines and device development as well as strategies to optimize the patient care pathway. Patient organizations will learn from questions that they receive during the dialogue from participants.

Global Patient Dialogues

Global Patient Dialogues will be considered the patient informed, transformative approach to bring enlightenment to stakeholders for medicines and device development and health system care pathway improvement, resulting in strategies to optimize patient outcomes.

It will be the “go-to” trusted method for patient organizations to directly inform global medicines development and care innovation in a scientific, high-quality, and efficient manner that is consistent with national and regional regulatory guidance and scientific standards. There is a continued lack of focus on insights from patients in early discovery and basic research in medicine’s development. Global Patient Dialogues addresses this gap.

This venue would not focus on specific therapeutics or devices but instead focus on learning about patient challenges and solutions throughout their patient journey, which informs all phases of medicine development. It provides a foundation for benefit-risk assessment based on what patients and those who care for them would consider preferred tradeoffs.

Global Patient Dialogues will inform multiple stakeholder perspectives and will make for a trusted engagement environment upon which to drive innovation. Attendees will take away an informed understanding of the patient journey to help internal planning within their organizations and drive impactful decisions.

The Global Patient Dialogue is a novel, cost-effective and trusted, externally-led live meeting that brings together patients and those who care for them in a forum that is driven by the expertise and interests of Patient Organizations.

Through Global Patient Dialogues, patients’ experience, perspectives, needs, and priorities are captured and disseminated so that they can be meaningfully incorporated into the medicines and device development lifecycle as well as strategies to optimize the patient care pathway.

We will deliver the patient perspective to inform an integrated patient pathway and aligned and sustainable solutions that enable patient empowerment. It is imperative that multiple stakeholders work together to ensure that the healthcare system works as effectively as possible to serve the patient’s needs at the right time.

Additionally, these meetings enable participants to benefit from an impactful dialogue with patients and their care partners in specific, selected disease areas. We may implement both a US and EU meeting with close timing with each other as innovative participants have a global perspective and impact. Our unique capability to learn from patients across the globe is expected to provide sustainable interest and value to all stakeholders.

Global Patient Dialogue Report

The Global Patient Dialogue Report will include organized Patient Perspectives (US and EU) with the following major subject headings:
  • Health effects and daily impacts that matter most to patients.
  • Patient perspectives on current approaches to treatment.
  • Patient perspectives throughout their care pathway based on health care systems experience.
  • The representative patient analysis that drove the patient experts who participated during the Global Patient Dialogue.
  • Results of surveys implemented before and after the Global Patient Dialogue. All attendees of a Global Patient Dialogue will be offered both the US and EU Global Patient Dialogue Reports for their internal use as part of their registration specifications.

Our Guiding Principles

Guiding Principles…why, what, and how we do it matters…

Patients and those who care for them matter

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We are driven by the power of patients and we are dedicated to channeling their hope and determination into innovations that are relevant to them, those who care for them and for those who come after them

Innovation based on patients’ perspectives matters

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We facilitate respectful and efficient discussions between patients and other innovation leaders who are dedicated to seeking their insights to impact the discovery and development of medicines, devices and healthcare systems

Patient Organizations matter

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We believe that Patient Organizations are critical as the lead partner to enable appropriate patient insights

Literacy and cultural sensitivity matters

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We ensure that we neutralize and equalize literacy discrepancies between patients and stakeholders to make sure that they understand each other

Patient representativeness and inclusion of diverse populations matters

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We embrace the National Health Council model of patient representativeness to ensure that our approach and patient selection is representative of all patients and those who care for them

Inclusion of multiple stakeholders matters

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We believe that multiple stakeholders (industry leaders, patient organizations, patients, care partners, health care providers, policy leaders, regulators, payers, and researchers) are critical to transforming health care; Innovation is sustainable when all stakeholders are included and benefit

Consistent documentation of scientific and validated approaches matter

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We believe that for the science of patient input to be realized, it needs a consistent all-stakeholder- informed incubator model

The regulatory landscape matters

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Our commitment to all stakeholders is to keep up with the pace of change and incorporate learning into our model and process