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Clinical-stage innovation is at the heart of our mission to advance meaningful medicines that improve patients’ lives. Read more about our approach below.
Clinical trials are a critical part of our journey to evaluate investigational treatments and seek approval from health authorities such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
At Lakefront Biotherapeutics, we organize clinical trials in various therapeutic areas, conducting research that paves the way for innovative solutions.
Informed Consent
Information for trial participants is crucial as it respects autonomy, protects individuals from harm, fulfills ethical and legal obligations, fosters trust and transparency, and ensures regulatory compliance.
Given the nature of clinical research – and despite the strong safeguards and regulations that are in place – participants may expose themselves to potential risks. Joining a clinical trial can be a demanding experience and requires courage to help bring a potentially much-needed medicine to the market.
Read more on our efforts below.
As part of the requirements for conducting a clinical trial, Lakefront Biotherapeutics has to provide potential participants with a document called the informed consent form. It contains everything from the details of a study to the associated risks and potential benefits. This document can be quite complex as it contains scientific, medical and legal language, which is not always well understood by everyone. One also has to keep in mind that the circumstances surrounding an individual’s decision to participate in a clinical trial can bring additional strain and worry for the potential participants.
This may lead them to miss out on some important information or simply not understand all the details provided in the informed consent form. In some cases, this could mean that a person would participate in a trial without fully understanding what is expected, or, conversely, that someone decides not participate because something was misunderstood.
To help potential participants take a well-informed decision, we have been working on improving the Lakefront Biotherapeutics informed consent form. Together with patients and writers, clinical trial managers, doctors, site and patient engagement leaders, quality monitors, regulatory advisors, scientists, legal and data privacy officers, we have reviewed, revised and redesigned the template informed consent form for participants in clinical trials, with the goal to increase readability and clarity and to remove duplication.
Lakefront Biotherapeutics Policy
(“Compassionate Use”)
Lakefront Biotherapeutics NV (Lakefront) is committed to developing safe and effective therapies for the treatment of autoimmune diseases. Participation in clinical trials is the best way to access our investigational medical products, and patients are encouraged to speak to their doctors about whether a clinical trial is right for them. Treating physicians can find more information on our ongoing clinical trials by visiting clinicaltrials.gov or by contacting Lakefront at clinicaltrials@lakefrontbio.com. Lakefront will acknowledge inquiries as soon as possible, usually within 5 business days of receipt.
Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of a clinical trial. Guidelines for considering Expanded Access have been provided by the US Food and Drug Administration (FDA). Based on these guidelines, Lakefront may consider requests for Expanded Access in rare circumstances when an individual cannot participate in a clinical trial and no comparable or satisfactory alternative therapy options are available. Treating physicians who are considering Expanded Access may contact Lakefront at clinicaltrials@lakefrontbio.com. Lakefront will acknowledge inquiries as soon as possible, usually within 5 business days of receipt.
Pursuant to the 21st Century Cures Act, Lakefront may revise this policy at any time and this policy does not serve as a guarantee of access to any specific investigational therapy for any individual.
Link to FDA’s Expanded Access information for patients:
https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients
Link to FDA’s Expanded Access information for physicians:
https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians
Innovating together!
Lakefront Biotherapeutics supports external research activities that complement our product pipeline and clinical expertise, adding medical knowledge. This external research can supplement the comprehensive data generated in registration studies by supplying valuable information about the safety, efficacy, pharmacology and tolerability and economic value of our drug candidates and medicines.
Lakefront supports external research through unsolicited funding requests. These are evaluated through our Investigator Sponsored Research (ISR) process.
Dear Investigator,
Thank you for your interest in Investigator sponsored research (ISR). Kindly note that Lakefront Biotherapeutics is currently not supporting any new ISR proposals. New guidance on areas of interest and review timelines will be provided in due time. Please contact your local MSL should you want to further discuss.
To be eligible for funding, the proposed research activity must be
The ability and experience of the investigator(s) will be considered, and the feasibility of the study will be assessed.
New guidance on areas of interest and review timelines will be provided in due time.
Your request will be reviewed by our cross-functional committee that may suggest to improve the scientific merit of the proposal and enhance consistency with Lakefront Biotherapeutics’s approval criteria described above. However, the study sponsor, the principal investigator will have full and final discretion and responsibility for all aspects of the study design, implementation, data analysis, and data dissemination, including compliance with all laws and regulations applicable to research sponsors.
The terms under which Lakefront Biotherapeutics will supply support are described in a signed contract. Lakefront Biotherapeutics gives no guarantees that the external research support supplied will fully fund the entirety of your work, and Lakefront Biotherapeutics is thus not liable for changes in budget after acceptance.
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Pipeline
We focus on the key therapeutic areas of immunology and oncology, where we have developed a deep scientific expertise in multiple drug modalities, including small molecules and cell therapies.