A BioPharma Guide to Expanded Access Program Management and Real-World Data

We’re excited to announce the launch of our latest eBook, “Optimizing Opportunities for Expanded Access Delivery”. This comprehensive guide is designed to provide BioPharma companies with an understanding of how partnering with myTomorrows can facilitate the effective consideration and implementation of Expanded Access (EA) programs, including opportunities for Real-World Data (RWD) collection.

Why this eBook Matters for BioPharma Professionals

Companies worldwide face the challenge of striking a delicate balance. Between compliance with often complex local regulatory requirements, they also have internal operational and commercial goals to meet. myTomorrows is here to help.

This eBook explains the fundamentals and value of Expanded Access Programs, demonstrating how myTomorrows can support BioPharma companies with deep industry expertise, tailored solutions and proprietary technology that aims to streamline Expanded Access Program management.

A Glimpse Inside the Guide

To make your journey through this guide as easy as possible, we’ve organized the eBook into different sections. Here’s a sneak peek of some of the sections and what they cover:

Solutions we offer

At myTomorrows, we provide tailored support to help BioPharma companies navigate the complexities of Expanded Access Programs. Our solutions include:

• Strategic Consultancy: Guidance on Expanded Access policy and framework development, GAP analysis, program optimization, and expanded access education and design, ensuring a solid foundation for successful Expanded Access Programs.
• Expanded Access planning, implementation and management: Comprehensive support for setup and execution including transition to commercialization, with a centralized platform and dedicated site management for compliant and transparent case handling.
• Real-World Data Collection: Purpose-driven RWD strategies and integrated expanded access physician workflows for optimal and streamlined data collection and analyses.

We complement our Expanded Access expertise with our patient recruitment services for clinical trials. By integrating both capabilities, we more effectively connect stakeholders and provide a comprehensive tailored solution across all pre-approval treatment options

How Expanded Access Delivers Value

• Meeting unmet medical needs: Providing pre-approval access to therapies for patients with serious conditions who have no other treatment or satisfactory options may address unmet medical needs.
• Building a Trusted Presence: Early engagement with medical communities and regulatory agencies, where appropriate, can support patient groups who have exhausted the standard of care.
• Delivering Real-World Clinical Insights: Expanded Access Programs provide valuable observations on Real-World clinical use which can help to refine product positioning and support broader awareness and market-adoption.
• Informing Approvals and Reimbursement pathways: Real-world data collected through Expanded Access Programs can provide valuable evidence to inform payer and regulator decision-making, helping to pave the way for future approvals and reimbursement pathways.

Our Distinct Approach

Discover what makes us different! We combine cutting-edge technology with a personalized, patient and physician-centric approach, proactively addressing the complexities of Expanded Access management. Here’s how we support your strategy:

• Patient and Physician-Centric Focus: Our approach delivers concierge-level, white-glove service, ensuring seamless, hands-on support for both patients and physicians. We proactively address operational challenges with proactive solutions and tailored care.
• Bespoke Solutions: We design tailored strategies aligned with each client’s clinical and commercial goals, aiming at offering solutions that meet their unique needs.
• Dedicated Support: Each project is supported by a dedicated site and program management team, ensuring personalized service and smooth program execution.
• Global Expertise: With deep, industry-specific knowledge, we navigate regulatory, reimbursement and supply chain complexities and anticipate challenges across diverse markets

Our Expanded Access Capabilities

At myTomorrows, we provide a range of services to streamline global access to investigational therapies by serving all stakeholders through dedicated and specialized teams.

Explore the eBook to find a full list of our services and capabilities, however a few include:

• Strategic Planning: Comprehensive program strategy, policy development, and asset-specific design.
• Program Management: Full program oversight & real time reporting, governance, risk identification & mitigation plans
• Operational Support: Patient eligibility assessments, hands-on site management, regulatory and payer communications, demand forecasting, and logistical coordination.
• Real-World Data: RWD strategy consulting, collection, analysis and reporting.
• Quality, Safety & Compliance: Pharmacovigilance, quality assurance, Privacy and legal expertise
• Education and Advocacy: Physician and patient education, advocacy engagement, and compliant communication.

Our track record

We create success by defining tailored solutions that align with our clients’ objectives and needs, ensuring a cost-effective and efficient project plan.

Here’s what we’ve accomplished so far:

• Helped patients in 125+ countries
• Worked with 50+ BioPharma companies including 5 of the top 10
• 2,200+ physicians enabled with submission and referral support
• 13 Years of proven expanded access support
• Purpose-built platform streamlining expanded access from request to delivery
• 10+ expanded access publications

Wrapping Up

Managing Expanded Access Programs can be complex. BioPharma teams face hurdles such as aligning with regulatory requirements, gathering consistent data, and managing the logistics of pre-approval access across multiple markets. Without a streamlined approach, companies can struggle with high resource demands and a lack of consistent, actionable data from these programs. Our goal? To ensure that Expanded Access Programs meet patient needs, deliver reliable data, and align with broader market goals, while running smoothly and efficiently for all stakeholders involved.

Ready to Take the Next Step?

Request a copy of our eBook today, speak to the team and start transforming the way your company approaches Expanded Access and Real-World Data programs. Together, let’s work to simplify Expanded Access Program management, maximize RWD value and help improve patient outcomes globally.

Interested in hearing more? Book a call with us to start discussing your project and outline your tailored plan.