By Paul Stanton, Senior Director, Inceptua Early Access

This article is based on a presentation delivered during the last Operationalise Early Access Programmes (OEAP) Summit held in London. The session explored the often-overlooked role of Medical Science Liaisons (MSLs) in Early Access Programs (EAPs)—a topic that sparked considerable interest and discussion at the event.

The presentation examined how MSLs, despite their scientific expertise and close relationships with healthcare professionals, are frequently left out of EAP planning and execution. Drawing from real-world experience in Early and Managed Access, the session highlighted both the challenges and the opportunities of involving MSLs more strategically.

This article builds on that presentation to unpack the role of MSLs, identify common pitfalls, and propose best practices for integrating them effectively into EAP strategy and delivery.

Who Are MSLs and What Do They Do?

Medical Science Liaisons are scientific or disease area experts within pharmaceutical and biotech companies. Typically holding advanced degrees (PhD, PharmD, MD), MSLs are responsible for building peer-to-peer relationships with Key Opinion Leaders (KOLs) and providing scientific support to internal teams and external healthcare professionals (HCPs).

Their activities include:

• Educating KOLs and HCPs

• Responding to scientific inquiries

• Supporting advisory boards

• Delivering presentations

• Gathering insights from the field

Interestingly, support for Early Access is not traditionally listed among their core responsibilities—something that may need to change.

The Role of Early Access Programs

EAPs are designed to provide patients with unmet medical needs access to medicines that are not yet commercially available or accessible through clinical trials. These programs often have a significant impact for patients with rare, genetic, oncological, or infectious diseases.

The primary goal is simple yet profound: to get life-saving or life-improving treatments to patients who need them, wherever they are in the world.

Where MSLs Fit into EAPs

MSLs can play a valuable role in EAPs by:

• Explaining the program’s purpose and process to HCPs

• Guiding them through registration and compliance steps

• Providing training on product specifics, dosing, and safety

• Offering reactive support and escalating issues when necessary

However, their involvement must be strategic and informed.

When Things Go Wrong: A Disconnect in the System

Despite their potential, MSLs can sometimes hinder EAPs—usually unintentionally. A common scenario involves a KOL, overwhelmed with clinical and academic responsibilities, pushing back on administrative requirements for the EAP, as set by the sponsoring company. The MSL, eager to support their relationship, may escalate the issue to headquarters instead of clarifying the process. This delays treatment and undermines the program’s purpose.

A real-world example from a multi-country program was a situation where complaints only arose in the one country where MSLs were involved. After closer investigation it was found that the MSLs had not received adequate training on the EAP. Once they were sufficiently trained, the issues disappeared in that country, and the program ran smoothly moving forward.

Best Practices for MSL Involvement

To ensure MSLs support rather than obstruct EAPs, consider the following:

• Define their role clearly: MSLs should not solicit participation but can be proactive once a physician is engaged.

• Provide comprehensive training: Equip MSLs with knowledge of the EAP’s technical and regulatory requirements.

• Foster collaboration: Vendors can offer training and attend MSL meetings to align on goals and processes.

• Position MSLs as advocates: They should understand and support the rationale behind each step of the EAP.

The Vendor’s Role and Strategic Collaboration

Vendors like Inceptua support EAPs from strategy development to program close-out. Key areas where MSLs can add value include:

• HCP onboarding and education

• Communication of program requirements

• Support during supply and resupply phases

When MSLs and vendors work in harmony, the result is a more efficient, patient-focused program.

Conclusion

MSLs are often the forgotten front line in Early Access—but they don’t have to be. With the right training, clear role definition, and strategic collaboration, MSLs can become powerful allies in delivering critical treatments to patients in need.

Let’s not overlook this vital resource. Let’s empower it.

Bio: Paul Stanton, Senior Director, Global Strategy, Inceptua Ealy Access

Paul Stanton is the Senior Director of Global Strategy, Inceptua Early Access. With almost 20 years of experience in the pharmaceutical industry, Paul has worked across both the manufacturer and service provider sides of the sector.

For the past six years, Paul has specialized in Early and Managed Access, leading global programs that deliver critical medicines to patients in need. His work spans a wide range of program types, primarily focused on rare and genetic diseases, oncology, and infectious diseases.

Paul is a passionate advocate for patient access and has played a pivotal role in shaping strategies that bridge the gap between pharmaceutical innovation and real-world patient needs.