myTomorrows Launches Expanded Access Management SaaS Platform to Empower BioPharma and Broaden Global Pre-Approval Treatment Availability

The first-of-its-kind, configurable platform enables BioPharma organizations to streamline expanded access management by seamlessly navigating complex regulatory requirements, generating real-world evidence, and addressing unmet medical needs.

AMSTERDAM, May 28, 2025 /PRNewswire/ -- myTomorrows, a global health technology company that connects patients and physicians with pre-approval treatment options, today announced the launch of its new AI-enhanced Expanded Access (EA) SaaS platform. The platform enables BioPharma companies to independently manage end-to-end global EA programs with greater speed, compliance, and operational efficiency.

When no satisfactory treatments are available, EA programs provide critical pathways for physicians treating patients with serious or life-threatening conditions. Yet, navigating the regulatory complexity, documentation, and operational workflows of these programs can be highly burdensome, often resulting in prolonged treatment access and missed opportunities to collect valuable real-world data.

myTomorrows' new platform addresses these challenges head-on, offering BioPharma organizations a dedicated, configurable solution for the end-to-end management of EA requests from physicians and programs. Drawing from over a decade of global expertise in expanded access operations, the platform is built to simplify the entire process, from regulatory alignment and physician communication to case tracking and program oversight.

Designed for flexibility, the platform supports both structured programs and urgent, ad-hoc requests, enabling organizations to scale their EA operations globally while remaining fully compliant. Companies can choose to manage programs autonomously or combine the platform with myTomorrows' strategic support services, offering a hybrid model tailored to internal capacity and program complexity.

Key features include centralized request management, customizable workflows, real-time physician communication, integrated analytics, and built-in global regulatory intelligence. Moreover, the platform optimizes compliance, can seamlessly facilitate the collection of actionable real-world data, and provides strategic guidance to BioPharma companies from initial planning through commercialization.

"For too long, BioPharma companies have lacked the infrastructure to manage expanded access efficiently and consistently across borders," said Michel van Harten, MD, CEO of myTomorrows. "Our new platform changes that. It gives companies a purpose-built system to streamline processes, ensure regulatory compliance, and ultimately bring emerging therapies to patients faster." He added, "We've successfully implemented this platform within our own international operations to deliver programs globally, ensuring it meets the real-world needs of both BioPharma and physicians."

The launch marks a significant step forward in myTomorrows' mission to close the gap between medical advancement and patient access. Already supporting over 50 BioPharma partners, the company combines technology, regulatory expertise, and patient-centric operations to advance global access to investigational treatments. myTomorrows is ISO 27001 certified, GDPR and HIPAA-compliant, ensuring compliance across regulatory, quality, and data security requirements.

By eliminating bottlenecks, supporting complex workflows, and offering global regulatory intelligence, the new platform helps BioPharma companies accelerate time to treatment, particularly in regions where commercial availability is delayed. For patients and physicians, this translates into faster, more reliable access to emerging therapies - when and where it matters most.

To find out more about the platform click here.

About myTomorrows:

myTomorrows is a global healthtech company dedicated to breaking down barriers for patients seeking treatment options. To make this a reality, the company has built a unique and powerful proprietary technology that conducts a comprehensive and accurate search of clinical trials, and where appropriate, Expanded Access Programs, from global public registries. This functionality efficiently connects patients, physicians, trial sites and BioPharma to simplify and accelerate access to drugs in development. Headquartered in Amsterdam with an office in New York City, myTomorrows has helped more than 15,300 patients and 2,400 physicians across 240+ sites in over 128 countries.

mytomorrows.com

myTomorrows Media Contact:
Kate Schoenstadt
Headline Media
[email protected]
+972-54-7776684

SOURCE myTomorrows