Executive Role Description: US Diagnostics Lead (DIAG) 
 
Overview of US Diagnostics Lead 
The main responsibility of the US Diagnostics Lead is to develop and manage US diagnostic initiatives that lead to faster diagnosis and improved patient outcomes across our treated or anticipated disease states. Also, this role coordinates with internal and external stakeholders to implement best practices for diagnosis.  
 
Interactions with Customers  
 
Gaining understanding  
The DIAG teams with disease and diagnostic experts (e.g., physicians and laboratorians) to understand diagnostic pathways for patients with rare diseases. These experts focus on diagnostic challenges, appropriate testing, and testing systems. 

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Also, the DIAG gathers insights from external stakeholders and diagnostic experts—including key opinion leaders (KOLs) and their networks—to improve diagnostic access, quality, and awareness.  
 
Launching Initiatives 
The DIAG role supports diagnostic initiatives and education for field-facing teams and provides internal clinical and scientific education to help Alexion cross-functional partners who work with HCPs. 

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This work includes developing initiatives that lead to earlier patient diagnosis and high-quality testing in product pre- and post-approval phases. The DIAG uses analytics and digital platforms to help develop digital diagnostic capabilities.  
 
Improving Testing  
When it’s appropriate, the DIAG provides educational materials on protocol or algorithm changes for the testing/retesting of patients and diagnostic interventions that shorten the patient journey. 

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Part of this process includes identifying laboratory capabilities and supporting improvements in quality and access to diagnostic tests. The DIAG role also advises on laboratory process quality and presents financial considerations to laboratory teams (about expected, not current, capabilities). 
 
Interactions with Colleagues 
 
Broad Collaborations  
The DIAG is a capable collaborator, interacting with many cross-functional areas within Alexion, including Sales, Marketing, Medical, Legal, Health Economics and Outcomes Research (HEOR), Market Access, Strategic Accounts, and Business Operations.   

This role works closely with internal specialists such as TLLs to identify KOLs in diagnostics. Also, the DIAG receives and acts on feedback from the field (e.g., physicians who request approval to search EHR for potential patients.  
 
Guardrails (what the US Diagnostic Lead doesn’t do) 
 
No Promotional Activities 
The DIAG role is non-promotional. DIAGs can have non-promotional discussions about Alexion products, but only in the pre- and post-approval phases. 

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DIAGs might be involved in quality and access improvements that involve a transfer of value to stakeholders, but a DIAG must not directly or indirectly offer, promise or give something of value that could be seen as inducement or reward. 
 
Objectivity Is a Must  
It’s inappropriate for a DIAG to make individual patient testing or diagnosis decisions, or steer patient providers or patients to particular laboratories. A DIAG provides only objective, clinical information about tests. 

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A DIAG cannot interact with patients or patient personal data; discuss investigator-sponsored research (instead, guide people to the online portal); discuss Continuing Medical Education grant requests; communicate potential financial benefits from Alexion products; or discuss field reimbursement. 
 
Also, the DIAG should not answer off-label questions about Alexion products. 
 
Bringing It to Life: Scenarios  
 
Streamlined Diagnoses 
In one scenario, the Diagnostics team identified the need to streamline the diagnostic journey of patients with rare disease. Physicians and advocacy groups asked for the ability to leverage electronic health record (EHR) data to uncover patients who needed further clinical evaluation.  

Diagnostics responded by assembling an EHR toolkit, working closely with Alexion legal, compliance, medical, and regulatory groups, as well as external partners such as statistics experts. The toolkit leverages code in EHR to find appropriate patients for further evaluation (see www.deciphEHRrare.com).  
 
Connecting Experts  
Another scenario took place when Diagnostics saw an opportunity to create a platform to connect rare disease experts, providers, and diagnostic professionals to interact in a disease-specific community (little is known about rare diseases, especially in the community setting).  

The Alexion DocMatter platform involves 30,000 institutions and allows HCPs to connect with experts for disease-specific conversations. DocMatter is a fully supported, regulatory compliant online collaboration platform that drives education, improves diagnostic adoption, and increases medical product/medicine utilization.  

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The Diagnostics team worked closely with Business Operations to create a dashboard that tracks key performance indicators for the DocMatter community, including volume of discussions, percentage of engagement, and the number of HCPs who participate. 
 
Improved Access   
KOLs shared with Diagnostics that smaller hospitals that run flow cytometry need easier access to reagents used for PNH high-sensitivity flow cytometry. The team identified the need to make dry reagent tubes available by developing an off-the-shelf test that they keep in storage and use to get a specific result, rather than using the manual process of piping reagents into tubes.  
 

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