PROCESS DEVELOPMENT
USA. The Bothell facilities were ultimately upgraded and expanded to include in-vitro biology assay development, high throughput screening, mechanism of action studies and related in-vitro biology capabilities to support drug-discovery initiatives.
As the company evolved, AMRI’s services and capabilities were expanded to allow the company to support the industry across all phases of the discovery and development of new medicines, including chemistry, biological testing, DMPK, API commercial manufacture, formulation development, analytical chemistry and dosage form development and synthesis, including parenteral dosage form manufacturing. In addition to broadening its capabilities and technologies to better serve customers, AMRI also undertook a global expansion through the establishment of new discovery laboratory facilities in Singapore (2005) and Hyderabad, India (2005), the purchase of manufacturing assets in Aurangabad, India (2007), discovery library and custom synthesis capabilities in Budapest, Hungary (2006), the purchase of development and manufacturing assets in Holywell, UK (2010) and the purchase of parenteral dosage form manufacturing capabilities in Burlington, Massachusetts, USA (2010). These expansions were supported by significant investments in new facilities and equipment.
Meeting customer demand AMRI’s growth has largely been driven by customer preference and demand. For example, early in AMRI’s history, the company specialised in lab-scale discovery and development chemistry, and had developed a robust and successful chemical development and GMP lab-scale synthesis offering. For larger batches, the client was referred to AMRI’s strategic partner, Cambrex, and that relationship functioned into the late 1990s. As the use of and comfort with outsourcing grew, customers began to become more discriminating in their decision-making. It became clear that preference was shifting towards suppliers that could not only develop the chemistry and execute early batches, but could also scale up larger batches to commercial scale. Technology transfer between different organisations was often too slow. More importantly, every time a process was transferred, there was a risk that something might not work well or be optimally configured for a particular manufacturing plant environment. This evolving preference by customers in the late 1990s was a catalyst for AMRI’s investment in and ultimate acquisition of its large-scale manufacturing assets in Rensselaer starting in 1999.
Similarly, discovery demand for more integrated capabilities drove the addition of in- vitro biology and DMPK testing services.
As AMRI’s business has grown, the company also expanded geographically, in part to be near to customers in various regions around the globe, where geographic proximity can be a competitive advantage. Expanding into lower-cost- structure locations has allowed the company to be competitive in the very cost-conscious
environment of the past several years. More recently, AMRI has responded to shifting customer preferences by closing its Budapest, Hungary facility and consolidating those resources into its Hyderabad, India and Singapore locations.
‘Succeeding more efficiently’
AMRI’s corporate headquarters in Albany, New York, USA.
For many years, the pharma industry had been focused on ‘failing cheaply’. In some respects, this strategy was an acknowledgement that the majority of new drugs entering clinical trials fail to reach the market. By conducting critical path experiments earlier in the process, companies might avoid the need for costly and ever more expensive and expansive clinical trials later in development. Perhaps the focus on failing cheaply confused the need to make good scientific decisions earlier in a project with conducting outsourcing for the cheapest price. The real concept of ‘failing cheaply’ should mean to ‘succeed more efficiently’. Recently, there has been a realisation at many pharma companies that the strategies of massive growth through acquisition and attempts to industrialise drug discovery have failed to replenish ageing pipelines, as patent cliffs have wiped out – or are threatening to wipe out – large and profitable revenue streams. In response, 2011 saw a period in which many pharma facilities were closed and thousands of R&D scientists and support staff were terminated, putting employees with years of experience and drug industry know- how in the unemployment line. New R&D
strategies are emerging in pharma with stated goals to use outsourcing more strategically to advance R&D portfolios. For smaller biopharmaceutical companies, which are reliant on venture or other sources of private funding, the ability to raise capital is more difficult than ever and the scarcity of funding is shifting more of these new companies to a virtual model, where a majority of research functions are outsourced. Both of these trends are positive for the outsourcing industry, but also point out the need for suppliers to be able to contribute at a higher level versus the commoditisation that occurred throughout much of the past decade, as many customers focused on the lowest price. In the past several years, AMRI has been able to capitalise on the industry reorganisations and has brought a number of experienced senior- level industry professionals on board.
Broad capabilities on a global basis For some time, AMRI has also been focused on building out a global footprint that provides the same high standards for performance, productivity, quality and problem-solving ability regardless of location. AMRI’s introduction of SMARTSOURCING™ is the
July/August 2012 sp2 Inter-Active 17
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