Trends in outsourcing analytical support in pharmaceutical development

By David Beyerlein, MicroConstants, Inc.

David Beyerlein has over 11 years of experience managing laboratory operations, is an experienced analytical chemist, and is highly skilled in the use of the mass spectrometer. David co-founded MicroConstants, a bioanalytical and pharmacokinetic-specialty CRO, in 1998 with Dr. Gilbert Lam, and currently serves as Vice President of Global Operations.

Dominic Moore is a Senior Business Manager in the Waters Pharmaceutical Business Operations team, working to deliver solutions that will positively impact customers’ laboratories and business objectives. Dominic brings several years of experience in pharmaceutical development at AstraZeneca in the UK. Prior to joining Waters, he was pivotal in growing the analytical services business at Charles River Laboratories, a global CRO, focusing on formulation support.

1. What do you see as the main trends in outsourcing of analytical and bioanalytical support for pharmaceutical development?

DB: One continuing trend is the emergence of new "one-stop shop" service providers. While these models seem attractive initially, the overhead for these organizations is often so high that you lose out on the cost savings outsourcing makes possible. Additionally, when choosing an outsourcing provider, drug developers need to ensure that the bioanalytical/analytical support function is indeed the core expertise of the vendor, rather than an ancillary service, or an afterthought. This can be avoided by choosing a CRO that has a niche focus in bioanalytical with strong relationships and partnerships formed with other niche CROs (i.e., a network of complementary providers) to provide services all along the drug development continuum.

DM: Partnerships are the key way forward to pharmaceutical outsourcing relationships.  Every month we see announcements that a pharmaceutical company has partnered with an outsourcing organization to help develop their drug and this extends into the analytical arena.  We are seeing numerous companies that now rely on their outsourcing partners to provide the majority of their analytical and bioanalytical expertise, not just in a routine sense, but from early method development onwards.  As such, the scientific presence in these providers is growing exponentially, thus the demand for state of the art instrumentation and data systems is growing.

2. What are the current expectations of customers in the analytical outsourcing function?

DB: Our clients are always looking for quality above anything else. While cost and timelines are important to any drug development study, if you can't have complete confidence in the data that is produced, then money and time have been wasted. As an outsourcing provider, quality has to be the top priority. Every study needs to adhere to the latest relevant regulatory guidelines in the industry so that there is no question about the validity and accuracy of the results generated.

DM:Customers are looking for quality, timeliness, and then cost.  They want to know the provider can generate good quality scientific data, using high quality, state-of-the-art instrumentation and data systems which are used in an efficient and compliant manner which allows the customer to accelerate their drug development plans. 

3. What analytical tools and techniques are pharmaceutical outsourcers asking for and expecting?

DB: Pharmaceutical and biotech companies are looking for an outsourcing partner that can provide data as quickly and inexpensively as possible. As an outsourcing provider, you have to always look for new instrumentation, software, lab equipment, etc. that will allow you to improve the analysis process and increase efficiency. Most recently, these tools and techniques have included SLE (supported liquid extraction), which can eliminate tedious steps in the extraction process, and multiplex assays which enable simultaneous measurement of multiple analytes in a single run.

DM: Here at Waters, we are seeing that the pharmaceutical companies are leveraging their partnerships with outsourcing providers to mirror the activities that they are performing in house. Within the analytical and bioanalytical field, this is extending to instrumentation. Contract organizations are heavily investing in our solutions (such as ACQUITY UPLC, Xevo MS, and data solutions such as Empower and NuGenesis SDMS) at the request of their customers. By investing in this equipment, the customer and supplier can rapidly transfer methodology and data to allow seamless transition during the partnership process. 

4. What are the main challenges the CRO industry has to face with regards to outsourced analytical and bioanalytical work?

DB: Today every CRO faces challenges with competition, both from foreign markets and with the internal resources of drug developers. But one of the biggest challenges with regards to bioanalytical and analytical work specifically, is with some of the compounds (new chemical entities) CROs are asked to develop methods for. Increasingly, bioanalytical service providers are awarded projects for compounds in which the methods, for a variety of reasons, can be extremely difficult to develop. However, service providers with the most experienced and talented method developers will embrace these challenges and view them as opportunities to be scientifically creative to achieve success.

DM: To remain competitive, CROs need to remain flexible to all of their clients' demands, be able to work efficiently, and have the most productive systems and processes available. In order to do this, they need to invest in the latest rapid and most sensitive solutions, and ensure that processes are geared around getting the highest level of productivity from these investments at all stages of the cycle.  This includes building robustness into methods by using products such as Fusion Method Development Software from S-Matrix, a QbD-ready solution that integrates seamlessly with our Empower Software. We've seen that it greatly helps our customers quickly deliver LC methods that will remain robust throughout the whole product lifecycle.

5. How do you see the analytical outsourcing model changing over the next 10 years?

DB: One of the biggest changes recently in the pharmaceutical industry has been the decreased focus of big pharma's internal R&D functions. This change in in-house capabilities is going to have a huge impact on the outsourcing model over the next 10 years. It has already led to an increase in virtual drug development and outsourcing models which will eventually increase the role CROs play in the drug development process.

Additionally, the increase of drug development and outsourcing being conducted overseas will eventually lead to an increase in quality standards, if not a worldwide set of quality standards regardless of the country. While pharmaceutical companies are sending project overseas because of appealing prices, they continue to conduct critical projects closer to home because of quality concerns. Unless everyone is held to the same set of quality standards, cost will play less of a role in outsourcing selection.

DM: The role of the CRO will increase to a point where they lead the strategic and development efforts for the pharmaceutical companies rather than being a partner in the process.  In order to do this, the CRO industry will continue to innovate in areas of science and operations, ensuring they have the best tools possible to maintain high levels of productivity and quality for years to come.