Market Access: STC Global Value Dossier
Situation: A pharmaceutical consulting company specialising in market access approached me to support their team. Their client, a top pharma company, had developed an innovative product for the treatment of stem cell transplantation (SCT) complications. To secure global market access, they needed a comprehensive Global Value Dossier (GVD) highlighting the therapy’s clinical and economic advantages.
Task: I was tasked with crafting several sections of the GVD, including the burden for stem cell transplant, product information, and the health economics sections. The GVD needed to effectively communicate the product’s unique value proposition to payers, healthcare providers, and decision-makers worldwide.
Action: I conducted an exhaustive review of clinical trial data, real-world evidence, and economic modeling outcomes. Collaborating closely with cross-functional experts, we synthesized the data into a comprehensive GVD, highlighting the therapy’s efficacy, safety, and cost-effectiveness in improving patient outcomes post-SCT.
Results: The GVD served as a crucial tool in the company’s global market access strategy. It facilitated productive discussions with healthcare stakeholders, leading to successful pricing and reimbursement agreements in multiple countries. As a result, the innovative SCT therapy gained good access in multiple markets, benefiting patients globally.
HEOR: Breast Cancer Systematic Literature Review
Situation: A pharmaceutical company developing a novel breast cancer therapy needed robust data to support their Health Economics and Outcomes Research (HEOR) initiatives but faced the challenge of scattered and varied literature.
Task: I led the project to conduct a systematic literature review to comprehensively gather and synthesise evidence on breast cancer epidemiology, treatment outcomes, and economic implications.
Action: We meticulously conducted the review, systematically assessing a wide array of peer-reviewed publications. Our analysis revealed trends in treatment effectiveness, patient-reported outcomes, and economic burden. This evidence formed the foundation for HEOR models and economic evaluations.
Results: The systematic literature review enabled the pharma company to develop compelling HEOR models that demonstrated the cost-effectiveness and clinical benefit of their therapy. This evidence played a pivotal role in pricing and reimbursement negotiations, ensuring that the novel breast cancer therapy was accessible to patients while delivering favorable financial outcomes for healthcare systems.
Medical Education: Hepatitis C Training Module
Situation: A top pharmaceutical company aimed to educate healthcare professionals about the latest advancements in hepatitis C management, while recognising the critical role of Key Opinion Leaders (KOLs) in disseminating credible information.
Task: I was entrusted with developing a comprehensive medical education module on hepatitis C in collaboration with renowned KOLs in the field.
Action: I engaged the KOLs to provide expert insights, ensuring content accuracy and relevance. Together, we designed an interactive, accredited online module covering disease epidemiology, latest diagnostic approaches, treatment, and emerging therapies. The module incorporated real patient cases and the latest clinical trial data.
Results: The medical education module received high praise from healthcare professionals, who consistently rated it 5/5 stars and left very encouraging comments. Subsequent monitoring and evaluation revealed that the programme successfully enhanced healthcare providers’ knowledge of hepatitis C management and the company’s commitment to advancing patient care, solidifying its position as a trusted partner in the field.
Publications: Ischaemic Heart Disease Manuscript
Situation: A group of 12 cardiologists from across the globe aimed to challenge the existing paradigm of ischaemic heart disease management with a ground-breaking therapy. They were sponsored by a pharmaceutical company to develop a strong scientific argument for a change in the paradigm of treatment.
Task: I led the team entrusted with orchestrating a publication strategy that would align the KOLs’ expertise with the pharma company’s innovative approach, ultimately reshaping the conversation around ischaemic heart disease.
Action: We facilitated extensive discussions and research collaborations between the KOLs and the wider community of healthcare professionals via live webinars and Q&A sessions. Leveraging their collective insights, we crafted a compelling manuscript that challenged conventional practices, emphasising the potential benefits of the new approach to therapy.
Results: The publication garnered significant attention within the medical community. Although published recently, it has already sparked discussions and influenced treatment guidelines, beginning a shift the the ischaemic heart disease management paradigm (The publication is available here.)
Regulatory Writing: Respiratory Device Study Protocol
Situation: A medical device company aimed to secure regulatory approval for its test device, designed to diagnose respiratory conditions in children under five. To meet regulatory requirements, they needed a meticulously crafted study protocol.
Task: I led a regulatory writing team to develop a research protocol that would comprehensively outline the methodology for assessing the device’s accuracy and repeatability in a controlled clinical setting involving young children with respiratory symptoms.
Action: We collaborated closely with clinical experts and a medical statistician, carefully designing the protocol to ensure robust data collection and analysis. The document detailed patient selection criteria, testing procedures, data collection methods, and statistical analyses. We also designed an informed consent form and other data collection tools to go with the protocol.
Results: The research protocol provided the foundation for a successful clinical trial. It met regulatory requirements and received approval, enabling the company to conduct the study. The trial’s results ultimately supported the device’s regulatory submission, paving the way for its introduction into the market, benefitting young children with respiratory issues.
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