How myTomorrows Supports HCPs Through Seamless EAP Execution

An Interview with Romina Dibra, Site Manager at myTomorrows 

At myTomorrows, facilitating Expanded Access Programs (EAPs) is a crucial way to bridge the gap between investigational treatments and patients in need. To better understand the pivotal role that myTomorrows plays, I spoke with Romina Dibra, a Site Manager whose expertise and dedication have been instrumental in ensuring the successful delivery of these programs. Here, Romina shares her journey, insights, and experiences.  

Can you introduce yourself and share a bit about your background?

My name is Romina Dibra, and I am originally from Albania. I am a qualified physician with nearly 17 years of experience in the pharmaceutical industry. My career began as a general practitioner, which provided me with a solid foundation in patient care.  

Over the years, I’ve worked with leading organizations like AstraZeneca and Novartis, where I contributed to innovative projects, new product launches, and collaborated with multidisciplinary teams. My passion for blending clinical knowledge with strategic operational insights brought me to my current role at myTomorrows.  

How has your professional journey evolved since you first joined myTomorrows?

I joined myTomorrows over three years ago as a Patient Navigator. In this role, I was the first point of contact for patients and caregivers seeking information about investigational treatments and clinical trials. This work deepened my understanding of patient needs and strengthened my communication and empathy skills. After a year, I transitioned to the role of Site Manager, where I now focus on operational and logistical aspects of facilitating access to investigational treatments via EAPs.  

This journey has equipped me with a unique blend of patient advocacy, operational expertise, and strategic thinking, which are essential for successfully supporting EAPs.   

How do Expanded Access Programs (EAPs) operate at myTomorrows?

EAPs are designed to provide patients who have an unmet medical need – and who are ineligible for clinical trials – with access to investigational drugs under the care of their physicians. These programs can be critical for patients with serious or life-threatening conditions.  

At myTomorrows, we streamline this complex process by ensuring compliance with diverse regulations, simplifying access pathways, and offering transparent support to all stakeholders. Through our platform, we aim to empower all relevant stakeholders by having access to the right data, in the right way, at the right time, so that critical treatments can reach the patients who need them most. 

 By acting as a bridge between healthcare professionals (HCPs), patients, and BioPharma companies, we guide all stakeholders through the necessary steps to ensure timely and effective treatment delivery.  

What is the role of a Site Manager in the context of EAPs?

Site Managers like me serve as the main point of contact for HCPs seeking treatment for their patients under EAPs.  We guide HCPs through every step of the process, from verifying patient eligibility, either ourselves or by ensuring the necessary information is submitted for approval in line with program requirements, to fulfilling country-specific regulatory requirements. Additionally, we coordinate with various teams, including Regulatory, Quality, and Supply Chain Logistics, to manage documentation, shipments, and data collection. 

Collaboration is a key aspect of the role. For instance, we align with Program Managers, Quality Assurance teams, and BioPharma sponsors to ensure smooth program operations. Our ultimate goal is to ensure patients receive treatment as quickly and seamlessly as possible by providing full support to HCPs. 

Can you walk us through the process of fulfilling an EAP request?

 When we receive a request from an HCP, the process begins with onboarding the HCP onto our platform, which serves as the central hub for all stakeholders involved in managing the EAP – myTomorrows site managers, sponsors, and physicians requesting access. Once the HCP is onboarded, a confidentiality agreement (CDA) is established between the hospital and myTomorrows. This allows for the secure exchange of product and patient information. Next, we discuss the patient’s medical condition with the HCP to confirm eligibility based on the drug’s inclusion and exclusion criteria. 

Once the agreement is signed, the HCP can enroll the patient using our Electronic Data Capture (EDC) system, which is integrated into the myTomorrows platform. This system allows the HCP to enter data directly into the system, which helps to ensure data quality and integrity. At the same time, our Regulatory team handles the country-specific regulatory requirements and approvals needed to import the drug. Simultaneously, our Supply Team manages the shipment timelines and takes care of all the necessary paperwork to keep everything on track. 

Through our centralized platform, HCPs, sponsors, and our Site Managers can efficiently manage the entire EAP process with full transparency and control. Our platform is ISO 27001-certified, which means stakeholders can trust that their sensitive data is handled securely and meets the highest standards of confidentiality and integrity. With real-time updates, integrated reporting tools, and seamless collaboration, we aim to make it easy for everyone involved to stay aligned and make timely decisions. 

 Additionally, we provide comprehensive guidance and support during the entire EAP journey, helping HCPs navigate complex administrative and logistical challenges. Our goal is to ensure timely access to treatments, while maintaining the highest standards of quality and security. This allows healthcare providers to focus on delivering the best possible care to their patients. 

How do you handle urgent cases where timely access is critical?

In urgent cases, we are able to prioritize with speed and efficiency. For example, we once received a request late on a Friday for a patient in Germany with a life-threatening condition. By working closely with our internal teams – including Regulatory, Quality, and Supply – we managed to validate the site, complete the necessary documentation, and prepare the shipment over the weekend. By Monday afternoon, the order was processed for express delivery, ensuring the patient could be treated promptly. 

 This level of collaboration and dedication is what allows us to meet the needs of urgent cases without compromising on compliance or quality. 

What makes myTomorrows’ service unique in supporting EAPs?

Our robust platform combined with our global expertise sets us apart. But what truly differentiates us is the human touch we bring to every interaction. From hands-on support to personalized guidance, we are committed to making the process as seamless as possible for all stakeholders. 

Can you share a moment in your career where you felt particularly proud or impactful?

One memorable case involved a 2-year-old pediatric patient who gained access to treatment under an EAP. After the treatment, the doctor expressed their gratitude for our immediate and seamless support for that case, which helped ensure the patient could receive the treatment. Knowing that our work directly impacts lives in such meaningful ways is incredibly rewarding and motivates me to continue making a difference. 

Romina’s dedication and expertise embodies the vision of myTomorrows of helping all patients get access to all possible treatment options. Her insights highlight the critical role Site Managers play in ensuring streamlined and compliant program execution, ultimately bringing treatments to patients in need. 

If you are a physician seeking an Expanded Access Program (EAP) for your patient, or a BioPharma company looking to learn more about how we can support with EAPs and/or Real-World Data (RWD) collection, we are here to help. 

We welcome you to reach out and contact us using this form.