An integrated model approach to improve the management of marketed products

Insight brief Regulatory and safety integration An integrated model approach to improve the management of marketed products Leo Dodds, Principal, Quintiles Advisory Services John Rogers, Engagement Leader, Quintiles Advisory Services John Klein, Engagement Leader, Quintiles Advisory Services Improving operations with an integrated approach Executive summary Biopharma companies face significant complexity working in a global environment governed by rigorous regulatory and safety requirements that vary by market. Understanding and managing local regulatory requirements presents a significant burden. Few companies are able to fully maintain a current global regulatory intelligence database that captures all local variations and updates. Many companies struggle to maintain core data sheets, safety information and labels aligned globally. Likewise, few companies have fully scalable infrastructure to handle rapid increases in safety related activities and risk management. To effectively manage your portfolio, you need to do more than simply meet regulatory requirements. By aligning all aspects of marketed product maintenance, including regulatory, safety and benefit-risk management, you can improve compliance, and reduce complexity and cost. Key considerations for success

Table of contents Executive summary 1 Background 3 Industry trends and drivers 3 Current operating model 4 Improving operations with an integrated approach 5 Key considerations 6 What Quintiles can do 6 Conclusion 8 About the authors 9

Background To respond to the challenges of today s healthcare environment including growing regulatory, financial, development and regional pressures biopharma companies must optimize resource allocations. While promising new products are an obvious place to invest, established marketed products cannot be ignored; as products age, the pressures to shrink maintenance costs and grow or maintain revenue continue to increase all while ensuring regulatory compliance and reducing risk (Figure 1). These dynamics present unique challenges for managing established products and require innovative and cost-effective approaches that help ensure patient safety and compliance while continuing to meet ever-increasing regulatory demands. Managing the maintenance of marketed products on a global scale is an increasingly complex and costly endeavor. Figure 1: Pressures on aging products Growth Maintenance Net Revenue As products age, the pressure to shrink costs and grow revenue continues to increase Area of revenue maximization and cost minimization Development Post Market Approval Current Trajectory Re-balanced portfolio Reduce risk and ensure compliance throughout the lifecycle Maximize revenue Minimize costs Ensure regulatory compliance Reduce risk Industry trends and drivers Biopharma companies are facing an increasingly complex environment for established products, including: Significant cost to maintain High degree of fixed assets in high-cost regions, coupled with little or no visibility to actual costs/activities in LOCs Limited resource pool The same pool of resource is ensuring that innovative products are marketed and that established portfolio are compliant Heightened focus on data Regulators are demanding that companies supply both more information and greater data consistency Evolving emerging market regulations Emerging markets are rapidly increasing their expectations about regulatory documentation, impacting established products Increased emphasis on risk assessments Evolving regulatory requirements for marketed products, including EU GVP requirements for ongoing benefit-risk assessments Today s healthcare environment requires innovative and cost-effective approaches that help ensure patient safety and compliance while continuing to meet ever-increasing regulatory demands. 3 www.quintiles.com

Governments and payers are scaling back reimbursement and increasing pressure to prove the value of products. Enhanced regulatory scrutiny is also resulting in larger financial penalties related to deficiencies in documentation and oversight of marketed products. In addition, marketed products have recently been the subject of numerous merger and acquisition (M&A) discussions and portfolio swaps, adding to the complexity of the current environment. Current operating model Based on Quintiles extensive discussions with clients from emerging to mid-size and large global biopharma about how they manage their established products, one identified outcome was that typical approaches to managing safety, regulatory and benefit-risk for marketed products are siloed and inefficient. In the current model, safety, regulatory, benefit-risk management and medical affairs many times operate as separate groups. These disparate functions often have inefficient, manual process handoffs, and use multiple vendors providing related services, resulting in both gaps and redundancies. Each function may have separate processes and technology, with duplicative management oversight and challenges managing relationships between corporate headquarters and local operating companies (see Figure 2). In addition, regulatory affairs work requires localization, which translates to employees, offices and other overhead in markets in which a biopharma company sells its products. Figure 2: Current operating model Disparate functions / silos Safety Vendor 2 Safety Vendor 1 Safety Vendor 3 Local Affiliates Regulatory Corporate Local Affiliates Local Affiliates Local Affiliates Multiple vendors providing related services Separate processes & technology Duplicative management oversight Inefficient, manual process handoffs Compliance issues Benefit-Risk Mgmt. Inability to meet commitments Lack of global visibility Challenges managing relationships between corporate and LOCs High cost resources / locations 4 www.quintiles.com

Improving operations with an integrated approach Against this backdrop, integrated regulatory and safety operational expertise is essential in maintaining marketed products to meet the demands of three converging areas: regulatory affairs, safety and benefit-risk management. The challenge is to continue to help ensure regulatory compliance, patient safety and risk reduction while minimizing associated costs, thus maximizing net return on a product or portfolio. Major biopharma players are strategically reconsidering cost-effective ways to manage marketed products, while smaller companies seek the scale and competencies required to bring global products to market. Based on these market dynamics, it is clear that biopharma companies need to change their current processes for how to handle marketed products. Biopharma companies currently organize regulatory, safety and benefit-risk management as separate groups. Integrating the safety, regulatory and benefit-risk management siloed functions into one cohesive operating unit will maximize product safety knowledge, and leverage synergies and cost-efficiencies. Integrated regulatory and safety operational expertise is essential in maintaining marketed products to meet the demands of three converging areas: regulatory affairs, safety, and benefitrisk management. Figure 3: Integrated model Safety & Medical Information Global Regulatory Requirements Comparative Effectiveness & Patient Use Case processing Assessment Benefit-Risk Management Monitoring Literature search Pharmacovigilance Aggregate reporting Signal detection Integrated Marketed Product Maintenance Mitigation Maintenance QMS Strategy & interaction Global labeling Regulatory Compliance Complexity Costs Integrated Technology & Analytics Platform This transformative approach allows companies to maximize investments and enhance productivity. Additional potential economic benefits occur when companies transition from in-house (with most or all related in-house services, non-integrated processes and technology, and majority of staff in high-cost countries), or multiple vendor outsourcing (with services outsourced by function across separate vendors using non-integrated or even incompatible technology) to one biopharmaceutical services provider. Advantages of the one provider outsourcing model include integrated and synchronized safety, regulatory, benefit-risk management services delivered via globally integrated processes using a unified technology platform designed to interface with in-house customer legacy systems. Benefits of an integrated approach leading to improved management of marketed products include: Technology-enabled integration, providing visibility needed to help proactively identify, manage and mitigate compliance risks Centralized & standardized oversight to help reduce complexity Global delivery model designed for high quality, cost effective results 5 www.quintiles.com

Key considerations Companies with marketed products can benefit from this differentiated approach to global infrastructure and expertise in regulatory, safety and benefit-risk management. Useful characteristics for vendors seeking to meet these needs include a presence across ICH (International Conference on Harmonization) regions, follow the sun (or 24-hour, seven-day-a-week) service coverage, fluency in multiple languages, and experience across a broad range of therapeutic areas. An ideal global delivery model involves a cost-effective mix of: The right people, with expertise where it is needed, including a global footprint, deep experience across major therapeutic areas and geographies, and exceptional regulatory knowledge and insight. Optimized and synchronized processes, focused on operational excellence and synergies, such as: integrated, optimized processes across the scope of services; streamlined standardized operating procedures (SOPs) and templates; and a scalable solution to manage entire portfolios. People Mitigate compliance risks Reduce complexity Cost-effective results An integrated technology suite, underpinned by data and analytics capabilities, providing: transparency to operational metrics; enhanced signal detection and insight generation; the ability to view product information globally; and improved management of and interactions with affiliates and internal stakeholders. This can provide optimized data for improved compliance and reduced risk. Technology Processes What Quintiles can do Quintiles utilizes an Advise to Operate model to move clients from concept to continuous operation. During the Advise phase, the strategy is developed, a model is designed that fits the organization, and a business case and roadmap are developed to allow transition. The people, process and technology capabilities are developed and implemented for the new model. A governance structure with metrics is established, and transition is driven through change management. The Operate phase then begins with the establishment of the global team needed to execute the new model, and continuous improvement is performed. This Advise to Operate model makes Quintiles a true end-to-end partner to help drive success in maintaining established products. 6 www.quintiles.com

Quintiles Advisory Services (QAS), working with regulatory and safety experts within the Quintiles organization, addresses the Advice phase by helping companies assess the value, strategy, and key activities required to integrate their regulatory, safety and benefit-risk management (BRM) capabilities. Key data and information related to established products and current regulatory & safety operations is collected to allow for analysis. Our regulatory and safety experts perform a detailed diagnostic, including assessments of portfolio, operational capabilities and financial impact, to develop a solution that fits sponsor s specific needs. Through this diagnostic, we help companies align on a strategic direction and define an appropriate future state model and business case, based on product, functional and regional priorities. In addition to defining the future state, we create a roadmap and help companies plan and manage a successful transition to the new model, to allow reducing complexity, improving compliance and minimizing costs. Key activities are outlined below in Figure 4. Figure 4: Key activities Portfolio assessment and prioritization Review of new and mature product portfolio to determine potential product candidates and propose integration prioritization Organization design including governance models Create organization design and governance model reflecting integration to drive new behaviors and reinforce change Financial analysis and modeling Develop modeling to determine financial impact of integration, and to support ROI needed for business case Strategy/core vs. non-core activity identification Develop regulatory and safety strategies through identification of core and non-core activities to integrate Process optimization and harmonization Leverage industry-leading practices to optimize performance and minimize risk while improving quality and compliance outcomes Future state and business case development Develop future state model for regulatory and safety integration, along with the case for action Roadmap and transition/change management Identify prioritized steps to achieve the future state model, and drive a change plan and communications to foster rapid adoption of the new model 7 www.quintiles.com

Our overall project approach includes four main sub-phases: Discover, Analysis, Business Case Development, and Roadmap Development. These are depicted in Figure 5. Figure 5: Overall project approach Discovery Analysis Business Case Roadmap Gather needed data and information related to regulatory and safety operations to allow analysis for integration Quantitatively and qualitatively examine collected data and information to determine integration options Develop recommendations for a future state model, including associated ROI Clearly define and layout initiatives needed to get to future state model for integration, including transaction activities Project Management Conduct weekly project management reviews to monitor and manage project plan; manage cost, quality, risks and issues and report project status and interim findings Conclusion Whether you may be seeking the scale and competencies required for your products in order to compete globally, or you re just looking for more cost-effective ways to manage marketed products, Quintiles can help you maximize your product s ROI, no matter what your goals are. Also, biopharma companies that want to outsource the end-to-end management of marketed products can achieve lower costs, greater visibility and better decision-making. This approach can help capture both quality and efficiency benefits from a fully integrated regulatory and safety services offering, thus delivering real value to customers. Deliverables are provided with minimal oversight/input, allowing the customer to refocus existing resources. 8 www.quintiles.com

About the authors Leo Dodds Principal, Quintiles Advisory Services Leo Dodds provides global pharmaceutical process and Quality subject matter expertise, and program management support. With over thirty years experience in developing and delivering process improvement solutions for various companies, Leo is a Quality subject matter expert. He has extensive experience in regulatory, pharmacovigilance and large scale program implementations with international focus. Prior to Quintiles, Leo was in a global leadership role in with a NJ-based pharma company where he led extensive process improvements in the areas of inspection readiness and global R&D. Prior, he supported commercial IT applications for a large global pharma company and worked in actuarial and risk management. Leo earned his B.S in Applied Mathematics and Statistics from University of Western Ontario, in London, Canada and an MBA from Concordia University in Montreal, Quebec. John Rogers Engagement Leader, Quintiles Advisory Services John Rogers provides global regulatory, compliance and validation consulting services to pharmaceutical, biotechnology and medical device companies. John develops strategic regulatory strategies in the areas of quality systems development and optimization, new technologies (e.g. mobile, apps, cloud computing), FDA enforcement solutions, validation and bioresearch monitoring. John has 25 years of life sciences experience with a background in Project Management, R&D, Manufacturing, Quality Systems, IT, Audit and Compliance, Risk Management, regulated SDLC and FDA Regulations. He has worked with many Life Science companies helping them manage implementations of systems and technology to address various aspects of their operations, including R&D, manufacturing, supply chain, document control, training, CAPA/ auditing, maintenance and IT infrastructure. John is a certified Project Management Professional (PMP), a Certified Software Quality Engineer (CSQE) and licensed Professional Engineer (P.E.). 9 www.quintiles.com

About the authors John Klein Engagement Leader, Quintiles Advisory Services John Klein provides leadership in regulatory and clinical process redesign while maximizing compliance for life sciences organizations. John s expertise focuses on process optimization and project management, with an emphasis on technology solutions that streamline data acquisition and decision-making in pharmaceutical development. He also focuses helping companies navigate global regulatory requirements. John has helped organizations define their future state processes and implement solutions to realize real gains in productivity, compliance and minimizing redundant activities. John has more than 20 years of life science experience focusing on process optimization and project management, with an emphasis on technology solutions that streamline data acquisition and decision-making in pharmaceutical development. John has worked with diverse functional areas to identify opportunities for process change and workflow redesign for both domestic and global projects, In addition, workshops and training sessions have been conducted in many countries, incorporating regional variations into global processes and workflow. 10 www.quintiles.com

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