ILTOO Pharma is committed to facilitating access to investigational medicinal products for patients with high unmet medical needs through Managed Access Programs. By adhering to these guidelines and working closely with healthcare professionals and Regulatory Authorities, we aim to provide treatment options to those facing serious medical conditions.
Product Evaluation in Clinical trials
Clinical trials play a crucial role in the development and registration of innovative medicinal products, providing essential safety and efficacy data on investigational products and result in the generation of evidence that may lead to the approval of a medicinal product and registration by regulatory authorities which can make it more widely available to patients.
What are Managed access programs at ILTOO Pharma ?
When no satisfactory therapeutic option is available for patients with high unmet medical needs, local regulations and mechanisms may allow the provision of medicinal products before regulatory approval or commercial availability.
At ILTOO Pharma, we use the term “Managed Access Programs” (MAPs) to refer to a variety of programs that allow patients to access investigational or unapproved medicines. MAPs encompass various terms, including but not limited to Compassionate use, Early access program, Expanded access, Named patient program, Named patient basis, Special access schemes/programs. The specific terminology used may vary depending on the local regulatory framework.
In all situations the request must be unsolicited, and the following conditions must be fulfilled:
- The patient suffers from a serious, life-threatening disease or condition, and no comparable or satisfactory alternative therapy is available to treat the disease or condition.
- The patient is ineligible for enrolment into or unable to access ongoing clinical trials.
- Sufficient data exists to believe the potential benefit of treatment outweighs the potential risk in the context of the disease or condition to be treated.
- Adequate supply of the medicinal product is available to ensure treatment continuity in the MAP without interfering with ongoing clinical trial(s) or with the overall development program
- The country’s regulatory and market access framework is compatible with the conditions of the MAP.
Submitting a Request
Requests for participation in a ILTOO Pharma MAP must be unsolicited and submitted by the treating physician on behalf of the patient. The request process includes the following steps:
The treating physician submits a request through the following email address: aac.ilt-101@iltoopharma.fr
ILTOO Pharma medical teams review the request fairly and promptly, providing a response once all required medical information has been received and, if applicable, national and local requirements or government Health Authority approval.
If the request for MAP is approved, the treating physician must submit, collect, and complete all necessary documents and data to comply with appropriate rules, local regulations, and ILTOO Pharma policy throughout the treatment period.
Contact Information
For any questions related to ILTOO Pharma MAPs, please contact the Medical team: aac.ilt-101@iltoopharma.fr