艾昆纬-为中型制药公司提供综合药物开发、监管战略和人工智能创新

Empowering Mid-size PharmaCompanies with IntegratedDrug Development, Regulatory MICHELLE GYZEN, Senior Director of Strategic Regulatory Solutions, IQVIABRIAN HEALEY, Global Head of Drug Development and Regulatory Strategy, IQVIACLAIRE DAVIES, Senior Director, Regulatory Affairs, IQVIA Table of contents Introduction1The consultative, end-to-end CRO model2A robust regulatory approach3The strategic role of AI in mid-size pharma companies4An IQVIA customer success story4Secure your competitive advantage4About the authors5About IQVIA5 Introduction Mid-size pharma companies sit at a distinct intersection in the currentpharmaceutical landscape. While their teams have the agility to innovate quickly,they may lack the scale, infrastructure, and resources of larger companies,creating both risk and opportunity. Without robust support, promising assets Though many mid-size organizations may avoidthe CRO route for fear of high costs, loss of control,or insufficient support, a strategic partnership canbe activated to mitigate these concerns and transform A consultative, tech-enabled CROcan help small to mid-size pharma The consultative, end-to-end Each company has distinct needs. Because of this, it iscritical to collaborate with a CRO that offers a flexiblemodel in which services can be adapted to suit customergoals. A CRO with previous mid-size pharma experience Given the unique qualities of small to mid-size pharmacompanies, these organizations need an experiencedand adaptable partner that offers end-to-end services, If a company has limited resources, a CRO can providestrategic guidance on how best to execute a portfoliostrategy based on the highest probability for successand ROI, helping a customer prioritize their resources So, what does an end-to-end model look like in practice?First and foremost, companies will have access to ateam of experts to interact with across every stageof the product lifecycle. Drug development, clinical, A robust regulatory approach IQVIA’s lifecycle management services support: •New pharmaceutical forms and dosages, For companies looking to launch their first productsuccessfully or expand their portfolio into new regions,real-time monitoring of regulatory standards is critical.At IQVIA, customers have access to the Regulatory •Renewals to keep licenses active. •Chemistry, manufacturing, and controls •Labeling updates as pharmacovigilance •Administrative variations and changes to licenses. •Tracking systems maintenance and IQVIA’s experienced regulatory team includes formerreviewers from the FDA, EMA, and other globalregulatory authorities as well as team membersstrategically positioned around the world to provideguidance on local regulatory expectations. These •Withdrawals and deactivations due to safety •Marketing authorization transfers (MATs) •Project management. •Regulatory intelligence and development •Authoring. •Health authority interactions. Our breadth of regulatory offerings empowers customersas they engage with global agencies across all stages This strategic support continues into the post-approvalsetting where lifecycle management and regulatoryoperations teams provide end-to-end support, allowingcustomers to transition seamlessly from clinical tocommercial strategy. Bolstered by human expertise, IQVIA’s experienced regulatoryteam includes former reviewersfrom the FDA, EMA, and other The strategic role of AI in mid-size pharma companies AN IQVIA CUSTOMER SUCCESS STORY IQVIA is currently in collaboration with acustomer to develop their portfolio moreextensively. The mid-size company has twoassets in clinical development across fiveindications, with the potential for these assetsto be developed in additional indications.Although the customer had the funding toexpand clinical development activities for these For many mid-size pharma companies, AI may feel likea future-state aspiration: powerful but out of scopedue to cost, complexity, or uncertainty about ROI. Companies can leverage AI tools to directly supportclinical and regulatory performance. From reducingsubmission timelines to enhancing document quality and The IQVIA Regulatory Intelligence Assistant platformleverages machine learning and project-specific datato generate real-time reports and regulatory guidancequeries, allowing teams to design smarter submissionstrategies, anticipate regulator concerns, and reducecostly rework. AI also supports the automated authoring Secure your competitiveadvantage Mid-size pharma companies do not need to operate ata disadvantage. In fact, a strategic CRO can unlock theinfrastructure, technology, and global reach of largepharma companies while maintaining the agility that When thoughtfully deployed, AI is a pragmatic lever toincrease speed, consistency, and confidence across thedevelopment lifecycle for mid-size companies. When About the authors MICHELLE GYZENSenior Director of StrategicRegulatory Solutions, IQVIA Michelle has over 20 years o