Patient Advocacy
Clinical trials are the main way for patients to access investigational drugs.
Genventis’s clinical trials are conducted to test the safety and effectiveness of investigational drugs so that regulatory authorities — such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) — can decide whether or not these drugs can be approved as a treatment for a disease. Genventis strives to design and run clinical trials that will provide these regulatory agencies with the data they need to determine if an investigational drug is beneficial to people.
Patient centricity is fundamental to the work we do at Genventis. We focus on ensuring the patient voice is always represented, creating a positive patient journey and reducing burden where possible when designing Clinical Trials or Early Access Programs.
What is Early Access?
Early access is a potential pathway for patients diagnosed with a serious and/or life-threatening disease or condition to gain access to an investigational drug for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy options are available. In these instances, a patient’s treating physician can request an investigational drug prior to regulatory approval, where allowed by local laws.
Who is Eligible for Early Access Programs?
Genventis considers granting early access to investigational drugs when all the following criteria are met:
The Early Access Program is intended for patients with serious or life-threatening conditions who have limited or no available treatment options and cannot participate in a clinical trial. Eligibility is determined by medical need, the treating physician’s assessment, and the availability of investigational therapies that show potential benefit based on existing clinical data.
Our Early Access Guiding Principles
Genventis Bio is committed to advancing patient access to investigational therapies under ethical, scientific, and regulatory standards. We enable early access for eligible patients when no suitable alternatives exist and maintain transparent communication with healthcare providers, patient communities, and health systems regarding program availability.
Patient Advocacy
Our Patients. Our Partners.
Patient centricity is fundamental to the work we do at Genventis. We focus on ensuring the patient voice is always represented, creating a positive patient journey and reducing burden where possible when designing Clinical Trials or Early Access Programs.
We listen and we learn from lived experience. Then we weave everything we know into our programs, involving patient experience in every protocol design from the beginning.
That starts with how we onboard our patients and continues throughout their journey, taking into account trial considerations, pain points and burdens, and acting on that information to continuously do better.
We engage stakeholders including KOLs and regulators to develop new methods of capturing and quantifying patient outcome changes.
our patient advocate team
Along with our global Patient Advocacy team, we support all stages of the clinical development pathway, from preclinical phase to commercialization. Through early, often and transparent engagement with the patient community, the team fosters positive and mutually beneficial relationships.
Our established partnerships with patient advocacy groups uniquely position us to collaboratively deliver patient centric Clinical Trials and Early Access Programs. Here are some of the activities that we are responsible for:
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Landscape Analysis
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Focus Groups
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Steering Committees
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Advisory Boards
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Surveys and Education
Patient Advocate Engagement
In rare pediatric diseases, we use the caregiver’s observations to design outcome measures that have the potential to demonstrate the effects of intervention in the short term.
Our lead project involves the quantification of the quality of movement captured by caregiver video.
Because the design of patient-reported outcomes depends entirely on a deep understanding of the patient experience, we’ve developed an interview technique designed to uncover potential changes in patient quality of life that can be reflected in an outcome measure.
Education
In response to the patient community, we have created educational materials to support the understanding of the Clinical Trials and Early Access Programs. You can find more information and access these resources within our Press section.
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What is an Early Access Program?
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Janssen Guide to Expanded Access
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‘Key Patient Focus Considerations to Operationalize a Successful EAP’
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‘Inviting Patients as Equal Partners in the Drug Development Process’
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‘The Rare Disease Podcast 4 Medics, Clinical Trials and Early Access Programs with Bionical.
Principles of positive patient engagement
Early, often and transparent patient engagement is a crucial part of clinical development. Considering the patient perspective and incorporating the insights from the patient community can improve feasibility, accelerate timelines to approval and reduce patient and family burden. We listen and learn to truly understand a patient’s condition, their unique, personal experience and specific needs before we begin.
We are committed to ensuring patients are considered as a true partner in the clinical development pathway, working together with patient groups to gather insights and incorporate the patient and family voice, from design to delivery of all of our Clinical Trials and Early Access Programs.
Science & Innovation
Clinical Trials
Science & Innovation
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