By adopting a proactive business strategy for pharmacovigilance, biopharma firms can gain competitive advantage by delivering higher quality, lower cost products that the market requires, while improving quality of life for patients.
Pharmacovigilance: A Practical Approach to Reshaping Patient Safety
• Cognizant 20-20 InsightsPharmacovigilance: A Practical Approachto Reshaping Patient Safety Executive Summary • Rigorous analysis, interpretation and “real- time” decision making on safety signals and Ensuring the safety and efficacy of pharmaceu- proactive remediation. ticals and biotechnology products is one of the top challenges in healthcare today. With drug • Leveraging pre- and post-marketing safety recalls continuing to make headlines, consumers patterns and insights for clinical trial design and other stakeholders across the healthcare and safety analysis to balance the risk-to- ecosystem are demanding more oversight and benefit ratio of new products, therapeutic regulators around the globe are responding to directions and early “go, no-go” decisions these pressures by increasing their scrutiny and advancing drug candidates. compliance requirements from the industry. • Allowing for convergence of the evolving regulatory environment and the integrated Despite the heightened focus on drug safety PV/safety operations and analytics into a source and the direct link between reactive safety of innovation and competitive advantage. and numerous risks to business — financial, regulatory, brand loss, etc. — many biopharma- This paper will examine the key challenges faced by ceutical companies today still have inefficient the industry, some of the practical approaches to drug safety operations and detect safety signals overcome these challenges and tangible benefits with suboptimal latency. Inefficiencies and redun- that can be realized in implementing proactive dancies in pharmacovigilance operations result pharmacovigilance as a business strategy. in higher costs and undermine efforts to signifi- cantly increase overall performance. Global Drug Safety: Key Challenges and Solution Approaches As the pharmaceutical, biotechnology and Based on our experience helping biopharma medical device industries renew their focus on companies with thorny PV challenges, we becoming lean and more effective in bringing recommend the following. safer, newer products and therapeutic value to patients in a timely manner, they must transform • Establish a safety and compliance culture. their drug safety operations. Proactive phar- Until recently, many companies have adopted macovigilance — enabled by globally integrated a piecemeal approach to managing safety process, people and technologies — can help and compliance. What is required, however, is the industry achieve its objectives. This can be a holistic vision and approach — one that accomplished by: guides the whole company towards a culture cognizant 20-20 insights | october 2011
of compliance — that allows the staff to business risk management that is tracked understand that compliance makes good and monitored for proactive remediation. business sense. Such a cultural change cannot be brought to bear overnight and will need > Make informed and early decisions on “go, no-go” on products in the pipeline based to be implemented in a phased but timely on signals/safety analytics from launched manner. products and products in advanced clinical > Establish the “safety first” vision and studies. re-emphasize the need for proactive safety and compliance, RiskMAPs and benefits that > Implement specific actions and programs that are focused on “getting it right the can be realized with the entire team — both first time” to avoid intensive/overtime fire- internal and partners — through structured fighting work and costs. governance/communications from execu- tive and senior management. > Ensure safety risk assessment as part ofCase Study >>Proactive PharmacovigilanceBusiness Situation: A biopharmaceutical com- delivery model. Cases are processed around thepany’s global safety organization wanted to close clock, around the world, with virtual teams ofits cases within a business day, regardless of the globally-based experts and operational teamstime or locale of origination. Cases were sometimes sharing data.backing up because of holidays, time differencesand vacations and lack of available staff (capacity). Benefits: In collaboration with the client, we are developing a globally integrated and networkedChallenge: Achieving the 24-hour resolution goal model of operating centers that are governed byapparently would require the company to invest a single leadership team and a set of innovativein new call centers, case processors and medical systems/tools. We are taking accountability forreviewers around the globe as well as virtual delivering the cases in a timely manner withtools and workflow technologies and dashboards/ increased quality and reduced cost of operationsportals. The centers would be expensive to set up, across a scope of activities including casestaff and operate. booking, processing, medical review and closure. Because of our participation in global clinical dataSolution: The company elected instead to work management, we also can provide insights to helpwith us to adopt an outcome-based service the client to anticipate potential issues.A Better Approach to PVHere is how we collaborate with this client to make PV more proactive. Objective Solution 1 “Real-time” collection of appropriate data. Pre- and post-marketing safety data collection across the globe is critical. 2 Proactive analysis of “safety signals” and Allows early dissemination of information prepare robust “risk ma.nagement plan.” to patients, regulators and physicians. 3 Continuously meeting the evolving global Globally harmonized process, organization regulatory requirements. and technology. 4 Leverage automation to enable decisions Invest in seaml.essly integrated technology (workload management). with PV processes. 5 Increase operational efficiency and Ensure ability to distribute and process safety reduced cost of operations. cases globally within one business day.Figure 1 cognizant 20-20 insights 2
• Develop/refine capabilities to manage regu- • Technology. Many global life sciences enter- latory changes in “real-time.” Regulators prises find that drug safety data is collected across the globe have varying and continually in silos owned by different departments. changing reporting requirements. To operate Correlating data and signals amongst these globally, life sciences companies must meet usually incompatible systems with their lack of these requirements as well as local timelines, standardized data is often a labor-intensive, reporting formats and translation require- slow process at odds with today’s real-time ments. orientation. > A critical activity is keeping abreast of re- > Develop a centralized database that can gional regulatory changes for registration integrate disparate data and information and reporting. Life sciences companies from different sources internally, third par- need a dedicated group of analysts and ties and physicians. regulatory experts who follow evolving trends and provide guidance on class-wide > Ensure the ability to draw PV information/- insights from case report forms (CRFs) on Risk Evaluation and Mitigation Strategies a “real-time” basis, which may have signifi- (REMS), alignment between global regula- cant value on managing risks. tory agencies (ICH, EU, FDA, Japan, etc.), post-marketing data collection, integration > Implement best practice global work flow, analyti- and analysis, guidance on training, policies cal tools and dashboards Life sciences and reporting to all stakeholders. for real-time insights and companies need a• Implement globally aligned processes, decision making. comprehensive people technology and governance. • People/capability improve- capability review• Processes. To gather comprehensive data, ment. Focusing core pro- that includes their life sciences companies must manage global drug safety operations and coordination of fessional staff on mission- own expertise as well critical activities will have case processing through a “single harmonized a direct impact on cost and as complementing process” with options for local customization efficiency and the ability partners’ expertise to fit regulatory requirements. These include: to move towards “proac- that allows for a > A seamless operating model that integrates tive patient safety.” Retain- flexible and scalable case processing volumes, types and sub- ing core/strategic activities missions timelines (“demand”) with a glob- internally while leveraging staffing model with ally flexible and scalable resourcing (”ca- global partners to provide the right skills that pacity”) model, across the sponsor and the transactional/operational global partners/service providers. case handling processes can adhere to their more efficiently at high “proactive patient > Identifying drug risk profiles using pre- clinical and relevant post-marketing data quality can allow for a robust safety” vision. people strategy. (e.g., population diversity and sample size) before future clinical trials are designed. > Typical internal activities include: > Following up with subjects after comple- – Regulatory interface/submissions related, tion of trials and analysis of adverse-event- policies and reviews. related patient withdrawals. – Risk management/integrated epidemio- > Ensuring that comprehensive post-market- logical and statistical analysis, risk com- ing process including regular case handling, munication and education systems and reporting, labelling changes and active translation of pre-clinical data. querying. – Signal detection/reporting: REMS and > Signal generation, evaluation, adequate processes, complex periodic reports and trend analysis, documentation, disposition integrated review of all emerging signals. and archival. > Typical external, global partners-driven > Assessment and review of risk/benefit anal- activities include: ysis in the context of evolving risk-based understanding. – Best practice adverse event intake and harmonized processing that will allow for continuous productivity improvements. cognizant 20-20 insights 3
– Global safety database management of continuous productivity improvements, and support. synergies between case processing and IT automation/work flow technologies, globally – Global aggregate shared governance and oversight that a reporting/PSUR process. partner can leverage. – Report templates/- • Continuous improvement, innovation and authoring tools. transformation. Applying Lean and Six Sigma principles along with customized – Medical review and quality management plans (QMP) can lead to narrative writing. measurable productivity improvements acrossLife sciences companies need a comprehensive case-handling processes (e.g., data entry,people capability review that includes their own coding). Selected initiatives and benefits fromexpertise as well as complementing partners’ such efforts include:expertise that allows for a flexible and scalable > Improving the accuracy of data entry andstaffing model with the right skills that can adhere coding by 10% to 15%.to their “proactive patient safety” vision. This willalso allow management of case volume fluctua- > Improving the accuracy of narratives by 30%.tions by location and therapeutic class. > Reducing the processing time for cases by• Structured governance. Leading life sciences 20% to 50%, per case type. companies are making a fundamental shift to moving drug safety and clinical development > Reducing time to write narratives by 60%. into a single functional team that has the • More collaboration and better compliance. mandate and authority to define and enact Life sciences companies with global pharma- integrated clinical and drug safety policies covigilance operations will be able to partici- and processes throughout the enterprise (IT, pate more effectively in collaborative efforts packaging, clinical operations, quality assur- with partners, academic organizations and ance and biostatistics) and with partners. This regulatory bodies on such efforts as REMS and means they must: address international regulatory initiatives on > Implement a streamlined governance struc- a proactive/reactive basis. ture that encompasses internal teams, col- • Smarter R&D decision making allowing for laborators and partners around the world safety as a competitive asset. Proactive with clearly identified forums, participants pharmacovigilance also enables life sciences (RACI) and a robust communication plan. enterprises to make better decisions about > Identify and empower a small data stan- current and planned research and develop- dardization unit to continuously develop ment activities. They can correlate incoming and manage the overall safety processes, post-market and trial signals data to related tools and data standards to ensure that product and therapy development. Such corre- policies, new process changes and tools are lations may indicate a planned trial should be only implemented in compliance with these redesigned or that an effort should be ended standards. because it appears unlikely to garner satisfac- tory trial results. Data may also indicate whereThe Rewards/Benefits of Proactive ancillary development efforts could benefitPharmacovigilance another patient population.Developing an integrated and reshaped patient Moving Forwardsafety organization can provide significantbenefits. These include the following: Approaching pharmacovigilance as an enterprise- wide business strategy still is not the norm but is• Reduced total cost of ownership. Having quickly becoming so. Life sciences companies that uniform, global processes, systems and embrace this shift will be able to meet near-term governance will allow efficient data and infor- demands for drug safety assurances from a range mation capture, analysis and real-time decision of global stakeholders. Most approved products making that can directly lead to reduced cost are subjected to risk mitigation plans of some of operations by >30% that is a combination sort. Simultaneously, life sciences companies are cognizant 20-20 insights 4