PROCESS DEVELOPMENT
case for the move to AMRI. As a result of the study, this customer has moved substantially all of its in vitro biology to AMRI and the particular director has come out of this looking extremely insightful.
In this particular case, cost was measured in terms of compound design cycle time; and the number of cycles (compounds made, tested and new compounds made based on the SAR data generated) required to progress from a lead to a clinical candidate, and how that translates into the overall costs of the biology programme for that effort. In addition, while not related to cost, the director performed a head-to-head comparison between AMRI and the Asian CRO of the target screen using the same compounds and reference agents. AMRI data generated had a better correlation to the customer’s own internal data with fewer outliers obtained. The customer came to several conclusions from their own analysis:
1. AMRI was a 50 per cent to 75 per cent cheaper option for the biology support for their lead optimisation programme, even though AMRI’s FTE rates were significantly higher than the lower-cost competitor. This was achieved by AMRI being able to dedicate half the resources that the competitor did. AMRI’s performance did not require the customer to dedicate its own resources to oversee the work, saving salary and travel costs, and AMRI was able to generate SAR- quality data in about half the time of the low- cost CRO. The overall enhanced design cycle time enabled the customer to progress from a lead to a clinical candidate in about half or a third of the amount of the time that the low- cost CRO required.
2. Additional savings could be made by avoiding poor compound design decisions made in the absence of testing data for the most recently synthesised compounds, because the typical synthesis cycle was one week for new compounds. 3. Working with AMRI, the clinical candidate could likely be obtained in half the time, providing extended patent life and increased net present value (NPV) for the eventual licensing candidate.
On a different scale, a recent example of a long-term partnership is AMRI’s six-year insourcing contract with Eli Lilly, announced in November 2011. With this insourcing agreement, AMRI will hire in excess of 40 FTEs during 2012 who will be based in the laboratories of Lilly in Indianapolis, Indiana, USA. These AMRI employees will provide organic chemical synthesis to support the medicinal chemistry efforts of Lilly scientists across a broad range of programmes. AMRI was awarded this contract as part of a
AMRI's Singapore Research Center, Pte. Ltd.
competitive process because of its strong brand for discovery chemistry performance and its prior experience in establishing company systems to support remote locations, which it has done in Singapore and India. The news of this groundbreaking new business model has already generated significant insourcing or hybrid insourcing/outsourcing inquiries from other organisations. It is only a matter of time before variations of this insourcing model will be adapted by others, and is a good example of SMARTSOURCING™, by utilising excess laboratories and equipment already in place to create a collaboration in which co-location enhances communication and productivity, and leads to improved efficiency and project advancement.
Meeting the end goal The introduction of AMRI
SMARTSOURCING™ has been positively received by a number of customers as well as by the company’s employees. The rollout of SMARTSOURCING™ has coincided with the shifting of outsourcing decision making by some customers from procurement back to the scientist end-users. That doesn’t mean that budget and cost are not important, but the end goal of research programmes and outsourcing decisions should be the success of the project, and ultimately drugs in the clinic and new drugs approved to market. Too often in the recent past, the need to manage budgets has led to a misguided focus on saving money and conducting outsourcing for the cheapest price. Researchers were forced to make choices based less on good science and more on lowest price. Many department group leaders and middle managers enthusiastically backed this approach,
because going with a low-cost provider often meant that company individuals managed the decision-making and problem-solving of an ‘army’ of hands-on technicians. All creativity and idea generation therefore became concentrated in a very small percentage of the actual manpower dedicated to the project. Drug discovery is a team effort, however, and history has demonstrated that individual superstars rarely are successful in a team environment. Furthermore, innovation is not a commodity. The recent period of declining industry productivity has coincided with the rapid rise and use of low-cost, Asian outsourcing. While it is not appropriate to blame pharma’s productivity drought entirely on this trend, neither is it a ringing endorsement of this strategy. In the new and more competitive environment that pharma and biotech companies find themselves in today, efficiency is critical and efforts that are not optimal can no longer be wasted. AMRI has a proven track record of helping its customers discover compounds worthy of clinical nominations, and has exported its performance standards to multiple locations around the globe.
Nevertheless, the need to be able to achieve more per budget dollar is a worthy endeavour. The recent expansion of discovery services in India is indeed a reflection of the implementation of the SMARTSOURCING™ approach at AMRI. The company has relocated its compound library design and synthesis capabilities to its Hyderabad, India facility, moving equipment and know-how from Hungary and integrating this technology with expanded medicinal chemistry SAR synthesis and computational chemistry groups. The ability to make sophisticated
September/October 2012 sp2 Inter-Active 17
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