Integrated launch planning

New drug launches are complicated, costly and inherently inefficient. The breadth of people, processes and technologies required to prep for commercial launch is staggering, and managing multiple project plans and third-party vendors creates process inefficiencies and program management complexity.

RSM professionals understand—through firsthand experience—the challenges of launching a new drug on the market. That’s why we’ve developed an integrated launch planning solution—a portfolio of services and technologies designed to reduce launch complexity, cost, and time, enabling you to focus on what matters most: the science.

Our integrated launch planning team is made up of experienced consultants who not only have a deep understanding of critical functional areas, but also appreciate the importance of coordinating launch plans to help ensure success. The key: a single point of contact for the services that support your critical constituents— including finance, accounting, legal, commercial, market access, technology, compliance and operations—throughout the launch process.

RSM’s consulting team consolidates all your service needs into one plan of action with a comprehensive, collaborative strategy and execution across several key business functions. Our experienced advisors know the biopharma industry from preclinical through commercialization, and we utilize effective program governance for each step in the launch process. Whether this is the first time you’ve launched a drug, you’re entering the U.S. for the first time and need extensive support, or you’re experienced and need to supplement existing internal expertise, we can deliver the efficient solutions you need.

If you need ongoing post-launch support, our team can seamlessly transition you into any of our operational and consulting strategies, including revenue contract management, a managed services offering that addresses government pricing, gross-to-net, market access and launch needs.

Integrate key processes to increase launch efficiency and insight

With a deep understanding of the clinical trial lifecycle and approval landscape, we can recommend the appropriate time to assess your readiness, and craft and execute a launch plan. Our experience enables us to build comprehensive and agile launch plans that take major gating items and decisions into consideration along your journey. Our team aligns within the holistic launch governance process and works well with your other business functions and third parties.

Accounting and finance

We can help you establish repeatable, timely gross-to-net methodologies and meet complex inventory, revenue recognition, and other accounting and finance requirements to create efficient and repeatable processes and help bridge the gaps across accounting, finance and market access.

• Gross-to-net: We establish a gross-to-net methodology that suits your business based on our best practices, tools and enablers. Our team can integrate financial planning and analysis, accounting, and the commercial decision-making process into an outsourced solution.
• Accounting advisory and design: We work with your stakeholders and auditors to assess and design policies and procedures that are critical to support commercial operations.

Operations

We help you develop effective strategies to predictably produce, manage and distribute your drug.

• Supply chain: We establish the processes to mitigate supply disruptions though both sales and operations planning and material requirements planning.
• Inventory management: Our team helps you establish the processes and controls for real-time inventory tracking to improve cash flow and expedite the financial close.
• Track and trace: We help you comply with the Drug Supply Chain Security Act and leverage new technology for additional inventory process controls.
• Distribution strategy: We work with you to connect the end-to-end value chain and enhance cash flow through consistency and predictability.

Pricing and access

We help you establish and maintain compliance with government and commercial agreements.­

• Governance and risk: We help you maintain compliance in a changing regulatory and commercial landscape, such as aligning with Sunshine Act requirements.
• Reimbursement and access strategy: We work with you to establish, develop, strategize and operationalize government and commercial reimbursement and market-access contracts.
• Government pricing: Our team helps you navigate the complex government pricing landscape, leveraging our best practices and tools to establish policies and procedures. 

Technology strategy

With targeted support across IT organization strategy and governance, data analytics, and business applications, we help you balance internal resources with specialized third-party insights, guiding technology decisions and aligning information technology investments with business objectives.

• IT organization strategy and governance: We assist clients in determining the optimal head count for their IT organization, providing guidance on when to consider insourced and outsourced labor to help ensure a flexible, balanced and efficient allocation of resources.
  
• Data analytics: We empower clients to make informed decisions by leveraging specialized data sources, including pharmacy transactions, sales (direct, chargeback and/or EDI 867), Medicare and Medicaid data, and rebates (managed care, purchase-based), as well as finance and operations data to enhance the strategic and compliance-related components of commercial operations.
  
• Key business systems and infrastructure: We assist clients in identifying key system needs and determining the optimal timing of those investments by thoroughly documenting and understanding project and system interdependencies to deliver a return on investment that aligns with client financial goals.