Q2 2018

<h3><span style="color: #78b6e4">DEK here: Members of the pharmaceutical industry have a responsibility to guarantee both the supply of high-quality medicines and the safety of their personnel. Servier has implemented a global business continuity management strategy to reduce the likelihood of incidents and minimize any consequent impact on its operations.</span></h3>
<h4><span style="color: #286fb7">Subtitle: Understanding Business Continuity Management (BCM)</span></h4>
<p>Business continuity refers to the ability of a company to continue to perform critical business functions in the case of disruptions such as natural disasters, fires, computer system crashes and geopolitical events. Business continuity management (BCM) involves the development and implementation of a management strategy to ensure that the necessary infrastructure and procedures are in place and personnel are prepared to appropriately respond when incidents do occur. A business continuity plan includes elements of emergency response, crisis management, disaster recovery, supply chain security and organizational/operational relocation.<sup>1 </sup></p>
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<p>BCM matters because it impacts a business’ competitiveness and provides assurances to the buyers of contract services. Companies that are recognized as resilient to potential disasters will be able to attract new customers and those that continue operating in the event of a disruption will retain their existing customers. Having an effective BCM strategy also ensures a company can continue operating — and thus keep its employees working.</p>
<p>BCM activities typically fall under the aegis of quality and risk management departments, but also involve governance, information security and compliance groups. Commitment from top management is essential to implementation of an effective BCM strategy. The effort begins with performance of a business impact analysis (BIA) to identify the critical operations, facilities and equipment that may be vulnerable to disruptions, determine what the potential impacts are, and reveal gaps in the ability to overcome these losses.<sup>2 </sup></p>
<p>There are global, regional and country-based business continuity standards that can be used to guide the development of BCM strategies and programs. For instance, ISO 22301:2012, “Societal security — Business continuity management systems — Requirements”<sup>3</sup> and related ISO 22313:2012, “Societal security — Business continuity management systems — Guidance”<sup>4</sup> support the development of formal BCM strategies.</p>
<p>There are also over 100 regulations relating to numerous industries including the healthcare sector<sup>1</sup> that demand some level of Business Continuity Management.&nbsp;</p>
<h4><span style="color: #286fb7">BCM and the Pharmaceutical Industry</span></h4>
<p>Business continuity planning can be particularly challenging for pharmaceutical manufacturers. It is not often feasible to move regulatory-approved, GMP manufacturing operations to another site in the event of a physical disaster. Ensuring a secure supply chain can also be difficult given that each supplier must be audited and validated, which often results in the use of a limited number of suppliers for even critical raw materials. On the other hand, the consequence of disruptions — such as shortages in the supply of crucial medicines, for instance — can be life-threatening.</p>
<p>Pharmaceutical manufacturers, including contract development and manufacturing organizations (CDMOs), have a social and patient responsibility to ensure that the production of drug substances and final drug products are not disrupted. Beyond the need to ensure the ongoing supply of important medicines, drug companies have a responsibly to mitigate threats to their business operations and assets in order to protect their employees, the environment and the local community.</p>
<p>Business continuity management is an effective structured approach to meet these obligations. It is also an effective method for achieving competitive advantage for contract service providers. CDMOs with a successful BCM strategy can demonstrate to potential customers the long-term sustainability of their business. Clients have greater confidence in manufacturing partners that have organization and resources in place to rapidly respond to potential threats to their operations. Projects are more likely to be successful and stay on schedule even if unexpected incidents occur.</p>
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<h4 class="callout-title"><span style="color: #78b6e4">Call out Here. Business continuity refers to the ability of a company to continue to perform critical business functions in the case of disruptions such as natural disasters, fires, computer system crashes and geopolitical events.&nbsp;</span></h4>
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<h4><span style="color: #286fb7"><br />BCM and the Embedded CDMO</span></h4>
<p>As an embedded CDMO within a large, global pharmaceutical company, Servier has over six decades of know-how and a strong record in quality, combined with empathy with our innovative customers. Our long-tenured, deeply experienced leadership team has an understanding of the needs of our clients and recognizes the importance of business continuity management.</p>
<p>Our BCM strategy has been developed and implemented to complement other key company initiatives, including our Lean Six-Sigma program, continuous improvement activities applied to equipment and processes, mitigation of operational risk through our “Safety-First” approach, and a quality culture that has supported more than 50 commercial launches.</p>
<h4><span style="color: #286fb7">Servier’s Commitment to BCM</span></h4>
<p>Overall, we have two main goals: <strong>[1]</strong> to reduce the probability, as much as possible, that a disruption of our operations will occur, and, <strong>[2]</strong> in the event of an incident, to reduce the impact. We recognize that not all incidents can be prevented. But with a BCM plan in place, we are prepared with equipment, procedures and strategies designed to reduce any impact and ensure continuity or at least rapid resumption of operations. The result is the protection of our people, the environment and Servier’s business. This commitment to business continuity sets us apart from other CDMOs, underscores our acceptance of our responsibility to the patients, our employees and clients, and makes Servier CDMO an excellent strategic partner.&nbsp;</p>
<h4><span style="color: #286fb7">Project Management Strategy</span></h4>
<p>Our approach to business continuity management at Servier is very much a project management strategy. All of the business units within the Servier group are involved. An overall coordinator ensures that all business units work together to assess the risks — taking an operational approach and considering the key drivers for the company.</p>
<p>The first step of the project is to identify the key products driving the turnover and margins. In the second stage, product mapping is performed using innovative methodology; this allows us to follow the volumes and costs of materials that flow through the buildings and equipment at our 15 global facilities. Based on this information, at the third stage, we are able to model several loss scenarios and evaluate the impact (in terms of disruption time, financial impact, etc.) for any situation. Finally, at the fourth step, we identify mitigation solutions to reduce our exposure.</p>
<p>Wherever possible, multiple suppliers are approved. The supply chain not only includes raw materials for API synthesis, but all elements involved in the manufacture of products — whether APIs or formulated drugs. Packaging suppliers are equally important, for instance. It is essential to ensure that suppliers in diverse locations (i.e., North America and Asia) with exposure to different risks are validated for all aspects of the production process to mitigate risk. This goal can be achieved by using two sources of supply for materials, or by using one supplier with multiple facilities</p>
<h4><span style="color: #286fb7;font-family: 'Roboto Slab', serif;font-size: 20px;background-color: transparent">Resource Challenges</span></h4>
<p>Companies typically face three key challenges when developing and implementing business continuity plans: <strong>[1]</strong> finding the time to conduct evaluations and generate actions plans, <strong>[2]</strong> gaining access to the appropriate resources, and<strong> [3]</strong> appropriation of the necessary funds. Servier’s management made a commitment to ensure that all three of these issues are continually addressed. The business continuity team has the ability to access external resources when needed. The area of fire protection is an important example. While our internal experts can identify the need for improved building protection, they might not have the ability to determine the best specific protective measures to implement.</p>
<p>External resources and suppliers are used to bring in the best knowledge and skills, ensuring that the investments being made are appropriate and adequate to address the identified risks. In this case, these resources include engineering firms, prevention specialists from insurance partners and other such experts. Servier’s management has committed to funding business continuity efforts through a global fund rather than having each site fund its own activities. The decision-making process and prioritization of projects takes place at the corporate level.</p>
<h4><span style="color: #286fb7">Embedded Business Continuity</span></h4>
<p>Successful BCM is not static — rather, it constantly evolves to meet changing market and customer needs. Servier CDMO is no exception. Each year, we not only have new projects, new customers and new suppliers, but new equipment and technologies as well. Business continuity management at Servier is, therefore, also a constantly evolving process. Each year the BIA is updated and this could result in a new BCM strategy, including the generation of a new action plan.</p>
<p>We focus on the implementation of backup solutions for key pieces of equipment and processes, protection of our equipment and facilities, and extensive auditing and management of our suppliers. The overall goal is to ensure the quality, safety and security of our manufacturing operations.</p>
<p>Notably, our BCM strategy often drives our operational strategy. Process mapping is performed whenever moving or changing equipment is proposed or when taking on a new project. This approach allows us to determine the choice that provides the least risk for the entire Servier group — anytime risk is reduced, performance is improved.</p>
<p>Finally, having a business continuity strategy has provided our employees with more transparency regarding risk within the company. While there was some resistance initially due to the additional effort required when first implementing the BCM strategy, today the thorough mitigation of risk is embedded within Servier’s culture. Every employee recognizes his/her responsibility to protect the patient, the business, our customers and the broader community. &nbsp;</p>
<h4>References</h4>
<ol>
<li>“What is Business Continuity Management?” DRI International. Web.</li>
<li>Kim Lindros, Ed Tittel. “How to Create an Effective Business Continuity Plan.” CIO. 18 Jul. 2017. Web.</li>
<li>“Societal Security — Business Continuity Management Systems — Requirements.” International Organization for Standardization. Jun. 2012. Web.</li>
<li>“Societal Security — Business Continuity Management Systems — Guidance.” International Organization for Standardization. Dec. 2012. Web.</li>
</ol>
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22 State-of-the-Art Biologics Manufacturing in an Unexpected Location