Michele Intorcia MSc

Driving international HEOR strategy to support the value demonstration and market access of innovative therapies in liver and metabolic diseases. Leading evidence generation and payer value strategies to support global and regional submissions. Partnering cross-functionally with Medical Affairs, Clinical, and Market Access to embed payer-relevant endpoints early in development. Representing HEOR in executive leadership discussions to guide data-driven access and pricing decisions.

- Developed and executed the Evidence Generation Plan for an innovative C3 inhibitor across multiple indications in the International Region. - Crafted robust HEOR and Health Technology Assessment (HTA) strategies in line with regulatory requirements to highlight the unique value proposition of the C3 inhibitor. - Represented HEOR expertise to the Senior Leadership Team (SLT) and external stakeholders, effectively communicating the strategic importance of HEOR in shaping product development and market access strategies. - Provided insights from comprehensive HEOR and HTA analyses, contributing to informed decision-making at internal and external levels. - Led non-interventional research, overseeing the design and implementation of studies generating real-world evidence supporting the C3 inhibitor's effectiveness and value in diverse patient populations. - Contributed to a comprehensive understanding of the product's impact in routine clinical practice, addressing gaps traditional clinical trials may miss. - Co-created economic models, collaborating closely with cross-functional teams to ensure alignment with overall product strategies. - Captured the economic impact of the C3 inhibitor through economic models, providing essential insights for market access and reimbursement discussions. - Actively liaised with external experts and Key Opinion Leaders (KoLs) to enhance the credibility of HEOR initiatives. - Facilitated knowledge exchange, insights, and best practices through collaborations with external experts, strengthening the quality and relevance of HEOR projects. - Built a network of influential voices advocating for the C3 inhibitor's value in the broader healthcare community.

- Developed the Evidence Generation Plan, HEOR, and HTA strategies for an innovative C3 inhibitor in the International Region for several indications. - Represented HEOR expertise to the Senior Leadership Team (SLT) and external stakeholders. - Led non-interventional research and co-created economic modeling, including Phase 2 and Phase 3 post-hoc analysis. - Liaised with external experts and Key Opinion Leaders (KoLs) on HEOR projects.

Established and led the company’s first HEOR Center of Excellence, integrating evidence generation and value communication across the portfolio. Built and managed a multidisciplinary HEOR team to deliver global and local evidence packages. Developed frameworks aligning clinical development, market access, and medical affairs strategies. Drove inclusion of PRO and health economic endpoints in pivotal and post-marketing trials. Partnered with global access teams to ensure payer-relevant evidence informed launch and lifecycle decisions.

- Developed comprehensive Evidence Generation Plan that aligns with Access Strategy through collaboration with Global Market Access and Global Development teams. - Held bottom-line accountability for the successful execution of Global Health Technology Assessment submissions. - Spearheaded the development of Health Economics and Outcomes Research (HEOR) evidence, including database analyses, economic models, cost-effective approaches, global value dossiers, and various analyses to assess the burden of illness, treatment patterns, and associated outcomes. - Successfully guided the launch of Xgeva (Denosumab) in Multiple Myeloma. - Educated and advised the global healthcare community through written publications, conferences, and academic events, with more than 70 publications.

- Oversaw the development of an International Access Plan, including situation analysis, key tactics, and the data generation plan. - Delivered inputs to the global team on regional perspectives for Phase III pivotal studies, Global Value Propositions, and Economic Modelling. - Developed, assessed, planned, and monitored effective drug programs. - Offered rationale and defense of the Internal Evidence Generation Plan budget before the Global Product Team. - Successfully guided the launch of Prolia (Denosumab) in 28 European countries. Devised and established a multi-country $1.6M Patient’s Chart Review Study in four months. - Won a $6M grant for an Observational Study in EU5 and the US.

Health Technology Assessment (HTA): Conduct systematic evaluations of health technologies, considering clinical effectiveness, safety, cost-effectiveness, and broader social, ethical, and legal aspects to inform decision-making for equitable, efficient, and high-quality health systems. Outcomes Research and Pharmacoeconomics: Develop and execute OR and PEcon studies to support pricing and reimbursement strategies for new biologic drugs, particularly in rheumatoid arthritis (RA), schizophrenia, cardiovascular and metabolic diseases, and oncology. Stakeholder Engagement: Present OR data and HTA findings to internal and external customers, including payors, budget holders, and KoLs, to inform reimbursement and coverage decisions. Training and Education: Design and implement training sessions in OR, PEcon, and HTA for internal and external stakeholders, including lecturing in international master's programs and providing training to key account managers (KAMs). Portfolio Support: Defend drug portfolios from price erosion and expand access to treatments across various therapeutic areas, including schizophrenia, cardiovascular and metabolic diseases, and oncology. Team Leadership: Hire, develop, and coordinate a team of professionals to execute research and market access strategies effectively. Cross-Functional Collaboration: Work within a matrix organization to align with pricing, reimbursement, market access, and marketing strategies, ensuring robust support for the value propositions of drugs. Notable Achievements: Designed, executed, and disseminated a cohort study involving 703 RA patients, contributing to the launch of Orencia® (Abatacept). Successfully launched multiple drugs, including Entecavir® (Baraclude), Orencia® (Abatacept), and Spycel® (Dasatinib).

Managed a UK-wide cost-effectiveness study on Verteporfin Photodynamic Therapy. Taught postgraduate courses in Health Economics and Public Health.

Director of Research for this company leader in Social Survey and Marketing Research (120 employees, € 25 million turn over). Responsible for the Italian NHS customer satisfaction program (Quality Perception in Health Care System), I carried out three surveys, elaborated data, wrote the reports, presented the findings to clients and gave several public presentations on the topic. I produced two marketing researches on pharmaceutical products positioning.

I worked in a team of three professionals in a Health Program on New Born Babies, a Regional Epidemiological Surveillance conducted by Naples University. I was responsible for the Statistical System, Data Collection, Analysis and Reporting on Epidemiological Surveillance findings. Related to the program’s aims, I supervised and lectured Local Health Authorities staff in Epidemiology and Statistics using the EPIINFO statistical software. I produced two reports and one scientific article and presented the results in several public scientific seminars (both to academics and to policy-makers).

As a Research Fellow I worked on two studies of prevalence of Hepatitis B and C in a South Italian province. I developed pilot and definitive questionnaires and conducted the first interviews and subsequently trained and supervised interviewers. I carried out the preliminary statistic elaboration and wrote a report and a scientific article.