Pharma’s Almanac Q1 2017
In today’s pharmaceutical marketplace, speed to market is absolutely crucial. CDMOs with built-in flexibility are ideally situated to help drug companies shorten development and commercialization time lines. Flexibility can take many forms — from rapid tech transfer within an internal network to agile manufacturing configurations and use of automation, to the ability to rapidly respond to changing market and customer needs.
Need for a New Level of Flexibility
Responsiveness has always been a key expectation for contract manufacturers providing services to the pharmaceutical industry. Today, however, with increased competition, the growing importance of evidence-based medicine, the expanding focus on orphan drugs and rare diseases and the rising use of accelerated approval pathways, responsiveness alone is insufficient for meeting the needs of sponsor companies. Flexibility combined with responsiveness has become essential.
CDMOs must, in fact, find mechanisms for providing flexibility in all aspects of their operations. Drug companies of all sizes are now seeking service providers that can offer flexible deal structuring. They also need outsourcing partners with the capability to implement adaptable manufacturing configurations and production schedules. Rapid and efficient technology transfer, including formulation and process development when necessary, is also crucial to shortening project timelines.
Some of these capabilities — particularly flexibility in manufacturing operations, including technology transfer — are established over time and can be found at CDMOs with track records of excellent service performance. Others require investment in innovative technologies, such as state-of-the-art automation solutions, advanced management systems and a culture that encourages efficiency without compromising on quality and safety.
Leveraging Built-In Flexibility at Servier
Servier is a highly respected, globally recognized French pharmaceutical innovator and manufacturer, developing patient-centric, targeted therapies using advanced technologies. The company invests nearly 25% of its yearly turnover in R&D to ensure the development of the most advanced drug candidates in oncology, cardiology, metabolic diseases, neuropsychiatry and rheumatology. Its 11 facilities located around the world form a wide-ranging manufacturing and research network that supplies even the most challenged markets and patient populations. Since 1995, Servier has also produced generics through its Biogaran business unit, which currently sells more than 200 specialties and holds a 25% market share in France.
Considering the various implications of the significant changes occurring in the pharmaceutical industry in recent years, Servier Group sought a new operational model that would allow the company to convert its manufacturing division from a cost center into a profit center. Reducing costs and implementing lean management and operational excellence would not be sufficient. Leveraging its experience in supplying contract manufacturing services to the Biogaran business unit, which Servier has done for over 10 years, seemed a practical solution.
In 2015, therefore, Servier Group began to pursue the formation of Servier CDMO, a business unit that would capitalize on Servier’s expertise in the development and synthesis of APIs, formulated products and extensive global resources as a large pharmaceutical company. We have established aggressive revenue goals and anticipate achieving the switch for manufacturing from a cost to a profit center within the next five years.
Deal Making, Accommodating and Structuring
As part of a larger pharmaceutical manufacturer with extensive financial resources, Servier CDMO has significant flexibility when it comes to deal structuring and project implementation. Many smaller pharmaceutical companies have limited resources across the board and operate under highly constrained financial conditions. Servier CDMO recognizes this issue and, because of its position within Servier Group, is able and willing to participate in tailored financial arrangements that include a wide range of unique financial parameters to accommodate the needs of its customers.
For instance, Servier has worked with companies that have minimal cash reserves and thus have difficulty committing to regularly scheduled payments, but are pressured to get their candidates into clinical trials. For these customers, Servier CDMO issues invoices to match funding schedules. Without financial pressures, these sponsor companies are able to focus on the important tasks required for the development and testing of their candidate drugs.
With the deep financial resources of Servier Group, Servier CDMO is also in a position to invest in new technologies for clients, depending on the specific project details and facility situation. Investments of this type have occurred, for instance, at the Servier Russia and Servier Ireland facilities. This approach not only helps meet client needs, it allows Servier to develop additional capabilities with high market demand.
Flexibility in production capabilities is also crucial in today’s pharmaceutical industry. Rapid development and fast commercialization are necessary to remain competitive. It is becoming increasingly important for CDMOs to offer customers support with activities across the entire drug development lifecycle — on a global basis.
In addition, sponsor companies are seeking CDMOs that can accommodate projects with minimal waiting time. With many drug candidates developed for small, targeted patient populations, they also prefer service providers with multiproduct manufacturing facilities that have demonstrated the ability to rapidly and safely switch between products, whether intermediates, APIs or formulated drugs. CDMOs that provide efficient and costeffective analytical services are in demand as well.
Servier’s ANPHARM plant in Warsaw, Poland, which provides development andmanufacturing support to drug companies in the region, has invested heavily in these types of capabilities and services. Systems have been automated to improve flow, resulting in significantly reduced lead times. Efforts to minimize product changeover times have also been highly successful. The improvements have not gone unnoticed. In a recent independent benchmarking study, McKinsey & Co. identified ANPHARM’s performance as best-in-class in on-time shipment in full (OTIF) against that of nearly 500 other sites.
Within the last 15 years, Servier Group has expanded its facilities from just four to 11, including the construction of plants in underserved markets such as Russia, China, Brazil and Morocco. Importantly, all of the facilities were designed and constructed to meet the specific needs of Servier. As these facilities were completed, many of the processes developed at the French historical plant of Gidy (near Orleans) were transferred to them so that products of equivalent quality could be manufactured and provided to the local markets. One consequence of this activity was the development of a highly efficient and effective technology transfer process. Customers of Servier CDMO benefit directly from this capability as projects can be transferred rapidly to one or more sites within the global Sevier network. This can be achieved by a dedicated and skilled team that has exercised this specialty for many decades now.
With over 60 years of experience developing and producing intermediates, APIs and formulated drug products, Servier Group has the flexibility to support projects at all stages of drug development and commercialization across numerous therapeutic classes. Over the past decades, the company has launched more than 50 products, developed from scratch. Of course, this count does not include numerous projects that have been stopped in the preclinical or clinical stages. This considerable amount of knowledge (an average of 25 molecules under development per year) will help Servier to reach its goal of launching one New Molecular Entity every three years. Servier CDMO will use this experience to help its client’s achieve their own success.
With access to several state-of-the-art, multiproduct facilities located in both mature and developing markets around the world, Servier CDMO offers its clients tremendous flexibility to reach their customers, whether they are distributors, hospitals or patients. Local experts at each facility also have extensive knowledge of regulatory requirements, from quality to import expectations.
Currently the top-producing sites for Servier Group include China, Russia, France and Ireland. Growth is anticipated in many of the younger markets, including Russia and Africa. In Russia, for instance, beginning in 2020, manufacturers must produce the drug product locally in order to be included on the government list of drugs approved for reimbursement.
Africa is also a rapidly growing market that Servier Group (and consequently Servier CDMO) are continually investing in. The company has plants in both Morocco and Egypt that supply all of Africa, including both branded products and products manufactured for Biogaran. Notably, all the same equipment and systems as those used in EU sites have been implemented at these facilities, which are inspected by French and other regulatory authorities.
Investments are not only taking place at global Servier sites. The company is moving into the biopharmaceuticals space with the construction of a biologics workshop at a cost of nearly $40 million for the development of monoclonal antibodies and cell therapies. A portion of the facility, which will be completed some time in 2019, will be dedicated to projects conducted in collaboration with universities.
Expansion of capacity for the production of highly potent APIs and final drug products is also underway in France, Spain, Ireland and other sites around the world. The first projects will be completed in the beginning of 2017, with the remainder up and running by the end of 2017 and the beginning of 2018.
The addition of the biologics workshop and further high-potency capacity make Sevier CDMO an even more flexible outsourcing partner. These investments are intended to address clear gaps in the marketplace and designed to help our customers accelerate the development and commercialization of novel therapies that will meet significant unmet patient needs.
Flexibility to meet changing customer needs is imperative for the success of CDMOs serving the pharmaceutical market. More than simple flexibility, Servier CDMO offers embedded flexibility — flex-ibility backed by the resources and operational, technical and regulatory expertise of an internationally recognized pharmaceutical manufacturer. Servier’s embedded flexibility includes flexibility for deal structuring, flexibility within scheduling, flexibility of manufacturing technologies, flexibility to rapidly transfer projects and flexibility to support a wide range of products for both mature and emerging markets, including those where few other CDMOs operate.