Agenda – Tuesday September 22, 2026Tuesday, 22 September 2026

• Dive into the latest trends shaping biotech commercialization, from market access hurdles to innovative pricing strategies and the critical role of pre-launch planning
• Understand how to align portfolio strategy with market trends and unmet needs

• Analyze Most Favored Nation policy implications and Inflation Reduction Act provisions that reshape market access and commercialization approaches
• Examine regulatory compliance requirements and policy adaptation strategies for successful launches under evolving government controls
• Develop stakeholder engagement tactics for interfacing with policymakers and advocacy groups to influence favorable policy conditions

• Explore innovative pricing frameworks to align with market demands and payer expectations
• Develop pricing strategies that ensure patient access while maintaining sustainable margins, addressing challenges in competitive and rare disease markets
• Embed pricing considerations into pre-launch activities, including contracting strategies, payer negotiations and market access planning, to optimize launch outcomes

• Implement strategic timelines for engaging with key stakeholders, including market access, trade, patient services, pricing/contracting, marketing, sales and operations, at optimal pre-launch intervals to maximize product value and ensure alignment across all functions
• Foster collaboration between commercial, trade, and marketing teams to design effective distribution models that align with broader business objectives and customer needs
• Highlight the importance of seamless communication and shared goals across marketing, sales, operations and other departments to drive a unified approach to pre-launch activities and ensure a successful product introduction

Statistically, only 40% of pharmaceutical product launches are successful, and a mere 10% meet their commercial goals. The leading indicator of launch success? Medical Affairs readiness. In this session, Dr. Soliman, CEO of the Accreditation Council for Medical Affairs (ACMA), shares exclusive insights and new data from recent roundtables and research sessions conducted with Chief Medical Officers from leading pharma and life sciences organizations. Drawing from ACMA's forthcoming consensus statement on successful product launches, Dr. Soliman will explore the real-world actions, strategies, and solutions that Medical Affairs teams must implement to drive launch excellence.

• Design patient identification approaches that scale appropriately from the focused rare disease setting to broader specialty markets
• Implement competitive positioning tactics that account for different stakeholder landscapes and treatment alternatives
• Create resource allocation models that optimize investment across the different demands of rare and mainstream therapeutic areas

• Evaluate various distribution models, including specialty, open and limited distribution, with a focus on their operational and financial implications
• Access the impact of distribution strategies on key stakeholders, such as manufacturers, specialty pharmacies, providers and payers, highlighting challenges like inventory management and patient access
• Define KPIs and milestones to measure the effectiveness of distribution strategies and ensure continuous improvement

• Enhance forecasting, market segmentation and decision-making with AI-powered analytics to optimize launch strategies
• Leverage AI tools to create tailored support programs, improve adherence and drive better treatment outcomes
• Use real-time AI insights to monitor performance, adapt strategies and ensure sustained market success

• Understand GTN dynamics and their impact on launch profitability
• Uncover strategies for managing discounts, rebates and payer negotiations to optimize GTN outcomes
• Benchmark on financial planning frameworks to align GTN with broader commercialization goals

• Implement "watchtower" data aggregation systems for patient-level visibility into the treatment journey
• Design cross-functional governance models to maintain launch-team integration well beyond initial market entry
• Develop strategic approaches to hub program design that balance control requirements with access optimization
• Create intervention protocols to quickly address reimbursement hurdles and access challenges as they emerge