MyTomorrows

A company facilitating access to investigational drugs

MyTomorrows logo

myTomorrows is a company that provides a platform for patients and healthcare providers to access investigational drugs and treatments that are not yet approved by regulatory agencies. The company operates in the field of expanded access and compassionate use, aiming to bridge the gap between patients with unmet medical needs and pharmaceutical companies developing new therapies.

History

myTomorrows was founded in 2012 by Ronald Brus, a former CEO of Crucell, a biotechnology company. The company was established with the mission to help patients with serious or life-threatening conditions gain access to promising treatments that are still in the clinical trial phase or awaiting regulatory approval. Since its inception, myTomorrows has expanded its operations globally, working with various stakeholders in the healthcare industry.

Services

myTomorrows offers a range of services to facilitate access to investigational drugs:

• Patient Support: The company provides information and support to patients seeking access to investigational treatments. This includes guidance on eligibility criteria and the application process for expanded access programs.

• Healthcare Provider Assistance: myTomorrows collaborates with healthcare providers to identify suitable investigational therapies for their patients. The company assists in navigating the regulatory and logistical challenges associated with accessing these treatments.

• Pharmaceutical Partnerships: myTomorrows partners with pharmaceutical companies to manage expanded access programs and early access programs. This includes handling regulatory submissions, patient enrollment, and data collection.

Expanded Access and Compassionate Use

Expanded access, also known as compassionate use, refers to the use of investigational drugs outside of clinical trials. This is typically considered for patients with serious or life-threatening conditions who have exhausted approved treatment options. myTomorrows plays a crucial role in facilitating these programs by acting as an intermediary between patients, healthcare providers, and pharmaceutical companies.

Regulatory Environment

The regulatory environment for expanded access varies by country. In the United States, the Food and Drug Administration (FDA) oversees expanded access programs, while in the European Union, the European Medicines Agency (EMA) provides guidelines for compassionate use. myTomorrows works within these regulatory frameworks to ensure compliance and facilitate access to investigational therapies.

Challenges and Considerations

While expanded access programs offer hope to patients with limited treatment options, they also present several challenges:

• Regulatory Compliance: Navigating the complex regulatory requirements for expanded access can be challenging for both patients and healthcare providers.

• Supply and Demand: The availability of investigational drugs may be limited, and pharmaceutical companies must balance the demand for expanded access with the need to conduct clinical trials.

• Ethical Considerations: There are ethical considerations in providing access to unapproved treatments, including the potential risks and benefits to patients.

Related pages

• Expanded access
• Compassionate use
• Clinical trial
• Pharmaceutical company