Build vs. Buy in Expanded Access Programs: Finding the Right Balance for Patient Access
As expanded access and managed access programs become increasingly important components of patient access strategy, biopharmaceutical companies face a critical question: which capabilities should be developed internally, and which are best supported through external expertise and technology partners?
During a recent webinar hosted by MedaSystems, industry leaders explored the evolving landscape of expanded access and shared practical guidance for organizations navigating build-versus-buy decisions. The discussion was introduced by Aimee Caton and featured insights from Stephanie Petrone, Founder and CEO of Navigate Clinical, and Annmarie Galli of GSK. The session was moderated by Matt Rosen, Founder and EVP of MedaSystems.
Drawing on experience across pharmaceutical development, patient access, and program operations, the panelists examined how organizations can create scalable, patient-centered programs while maintaining compliance, efficiency, and strategic oversight.
Why Build vs. Buy Matters More Than Ever
The decision to build internal capabilities or engage external partners is rarely an all-or-nothing proposition. Instead, organizations must carefully evaluate which functions are core to their mission and expertise and which can be effectively supported by specialized vendors.
Factors influencing this decision include:
Internal experience and available resources
Anticipated patient demand
Drug supply considerations
Geographic and regulatory complexity
Technology requirements
Program timelines and urgency
The panelists emphasized that successful programs often combine internal leadership with external operational support, allowing organizations to maintain control over critical decisions while leveraging specialized expertise to scale efficiently.
Planning for Expanded Access Early
One of the strongest themes throughout the discussion was the importance of early planning.
Before launching an expanded access or compassionate use program, companies should assess:
Drug safety and benefit-risk profile
Available product supply
Level of unmet medical need
Expected patient population size
Clinical development milestones
Upcoming data releases and publications
Positive clinical data can dramatically increase demand for patient access. Without sufficient preparation, organizations may struggle to respond effectively to requests from physicians and patients.
Limited drug supply presents additional challenges. Companies may face difficult allocation decisions and must establish fair, transparent processes for evaluating requests while maintaining patient safety and regulatory compliance.
The speakers also stressed the importance of evaluating technology needs early in the planning process. Establishing structured workflows and scalable systems before demand increases can significantly improve responsiveness and operational effectiveness.
Building Managed Access into Pipeline Strategy
Expanded access planning should begin long before commercialization.
According to the panelists, managed access teams should work closely with clinical development organizations to assess pipeline assets and anticipate future access needs. Early collaboration helps organizations identify resource gaps, evaluate outsourcing requirements, and prepare for potential patient demand well before regulatory approval.
By integrating access planning into broader development strategies, companies can avoid reactive decision-making and establish sustainable processes that support both patients and internal stakeholders.
What Should Stay In-House?
While outsourcing can provide valuable expertise and scalability, the panelists agreed that certain responsibilities are best maintained internally.
These include:
Medical review and oversight
Patient eligibility determinations
Benefit-risk assessments
Strategic governance and decision-making
Safety monitoring and escalation
Internal teams possess the deepest understanding of the product, development program, and clinical context. Retaining these responsibilities helps ensure consistency, accountability, and alignment with corporate objectives.
What Can Be Outsourced?
Operational activities often lend themselves well to external support, particularly when organizations lack dedicated infrastructure or need to scale quickly.
Commonly outsourced functions include:
Request intake and portal administration
Program coordination
Logistics and drug shipment
Labeling and packaging
Regulatory support
Data management
The discussion highlighted that outsourcing should be viewed as a collaborative partnership rather than a simple vendor relationship. Effective partners become extensions of the sponsor team and contribute to both operational efficiency and patient access goals.
Managing Access Requests Efficiently
As program demand grows, informal processes can quickly become unsustainable.
The panelists strongly advised against relying on email as the primary mechanism for request management. Instead, organizations should implement structured portals and workflow systems that provide transparency, consistency, and auditability.
Technology platforms can support:
Request triage and tracking
Eligibility review workflows
Communication management
Documentation and compliance
Safety reporting
These systems become especially important during periods of rapid growth, when request volumes can increase dramatically following positive clinical results or public data announcements.
Lessons from Rapid Program Launches
The discussion included examples of expanded access programs that experienced sudden increases in demand following promising clinical data.
In one case involving pancreatic cancer, positive results generated significant interest and required a rapid program launch. Such situations demonstrate the importance of having scalable processes and communication systems already in place.
The speakers emphasized several key success factors:
Physician education and training
Prepared communication materials
Clearly defined escalation pathways
Efficient safety communication processes
Adequate staffing and oversight
Organizations that prepare proactively are better positioned to support patients while maintaining compliance and operational effectiveness.
Managed Access as a Bridge to Commercialization
Managed access programs increasingly serve as a bridge between clinical development and commercial availability.
For late-stage and Phase III products, these programs help ensure continuity of care while supporting patients who may not yet have access through traditional reimbursement channels.
The panelists noted that commercialization does not eliminate access challenges. Companies must continue planning for patients who:
Do not qualify for reimbursement
Face payer restrictions
Live in markets where commercial access is delayed
Require ongoing treatment following clinical trial participation
Long-term success requires sustainable policies and procedures capable of adapting to changing business, regulatory, and market conditions.
The Growing Importance of Data and Technology
Expanded access programs have evolved significantly in recent years.
In addition to supporting patient care, many organizations now seek to generate real-world insights, support post-trial access, and better understand treatment outcomes across broader patient populations.
As these objectives expand, technology plays an increasingly important role.
The panelists highlighted the value of centralized systems that provide a single source of truth for patient and program data. Such platforms help eliminate spreadsheet-based processes, improve visibility, and support more informed decision-making.
At the same time, data collection must remain practical for physicians and healthcare providers. Successful systems balance regulatory requirements with ease of use, ensuring that data capture supports patient care rather than creating administrative burden.
Building Community and Sharing Best Practices
The discussion also underscored the importance of collaboration across the expanded access community.
For organizations developing new programs, external networks can provide valuable guidance and perspective. Industry conferences, professional forums, academic initiatives, and peer networks all contribute to the sharing of best practices and operational lessons.
The panelists discussed efforts to build stronger communities of expanded access professionals, creating opportunities for organizations to learn from one another and advance the field collectively.
Looking Ahead: Agility and AI
As technology continues to evolve, agility is becoming an increasingly important consideration in build-versus-buy decisions.
Organizations evaluating vendors today must consider not only current functionality but also future readiness. The panelists emphasized the importance of selecting partners that can adapt alongside changing industry needs and emerging technologies.
Artificial intelligence is expected to play a growing role in workflow automation, data management, analytics, and decision support. Organizations that establish flexible technology foundations today will be better positioned to capitalize on these innovations in the future.
Key Takeaways
The webinar underscored that successful expanded access programs are built on thoughtful planning, strong governance, and the right balance of internal expertise and external support.
Organizations should retain ownership of critical medical and strategic decisions while leveraging specialized partners for operational execution, technology, and scalability. Early planning, cross-functional collaboration, and adaptable technology are increasingly essential as programs grow in complexity and importance.
As patient access needs continue to evolve, organizations must develop scalable processes, invest in flexible technology, and cultivate collaborative partnerships that can support both current demands and future opportunities. Whether building capabilities internally or leveraging specialized vendors, the ultimate goal remains the same: delivering timely, safe, and sustainable access for patients who need it most.
