February 2, 2016 PAP-Q1-16-CL-009
By Chris Conway and Raj Shenoy, Albany Molecular Research Inc.
This article focuses on tech transfer in relation to strategic partnerships, with Albany Molecular Research Inc. (AMRI) as an example of an organization that feeds its commercial pipeline through robust capabilities in drug discovery and early phase development.
Although the pharmaceutical industry is experiencing record growth, the market size has narrowed. Globally, the pharmaceutical industry is valued at approximately $300 billion per year and is likely to grow to $400 billion within three years. Over thirty percent of this market is dominated by ten drug companies. This situation has translated into a market shaped by mergers and acquisitions (M&A). Contract discovery, development and manufacturing organization (CDMO) AMRI has contributed to this trend in a big way, announcing six acquisitions from 2014 through 2015. As a leading CDMO that has emerged fighting for greater market share, AMRI is looking to gain customers by forming strategic partnerships based on trust and emphasizing attention to quality, beginning with the use of Good Laboratory Practices (GLPs).
In Nice Insight’s 2016 CDMO Outsourcing survey of nearly 600 outsourcing-facing pharmaceutical and biotechnology executives (2016), 60% of respondents indicated that they are very interested in strategic partnerships. As the dependence on outsourcing continues, the contract development organization that can position itself through partnerships will win out in the long-term.
Building a successful strategic partnership begins with an understanding of the customer. Although large and mid-sized pharma, small biotechs, virtual companies and academia have many different needs and concerns, they do share a number of universal expectations for outsourcing experiences: partnerships that provide quality products and services at reasonable price points. Customers are attracted to organizations that produce products efficiently and who uphold the confidentiality of client molecules from start to finish. Timelines are also key; providers that can guarantee the availability of appropriate equipment, provide minimal batch cycle times, begin preparatory work before startup and implement timely release testing and QA review procedures will be viewed favorably.
Additional results of the same 2016 study by Nice Insight reinforce the importance of the above attributes when clients are selecting CDMOs. Quality was rated as the top factor by an overwhelming majority of 70%. Reliability, innovation, productivity, a positive regulatory track record and affordability also influence the CDMO selection process. These qualities define themes that are universally acknowledged in any strong business relationship and are expressed through trust, transparency and skill.
The skill to take a molecule from the discovery phase into development is greatly dependent on the use of effective and appropriate laboratory practices. Early phase development performed diligently and with a view toward scale up in a reliable and safe manner significantly increases the likelihood of a successful commercial launch from the outset.
The organization that has a demonstrated history of employing Good Laboratory Practices is in a position to be highly successful at GMP; good work in the lab being a key stepping-stone to good work as a contract manufacturing organization. As an outsourcing services provider offering contract research, development and manufacturing support to the pharmaceutical industry, AMRI’s GLP practices have been integral to its capabilities in medicinal chemistry and drug discovery for 25 years. By employing a heightened focus on early phase optimization to ensure easier scale-up, AMRI demonstrates the concept that GLP facilitates GMP manufacturing. It may seem reductive, but when going from small-scale to largescale, it pays to get things right initially; devoting more time early in the process development phase ensures that commercial batches are developed efficiently.
Indeed, efficient timelines are only one facet of successful CDMOs. The capability to develop and manufacture drug intermediates and Active Pharmaceutical Ingredients (APIs) at different scales is a key component of an effective program that is designed to meet various customer needs. AMRI intentionally established its smallscale GMP manufacturing group to address not only the paramount need for smooth tech transfer and facile scale-up of laboratory processes, but to provide small-scale GMP facilities for the production of smallvolume APIs, such as highly potent cytotoxics and controlled substances. CDMOs that have such GMP capabilities located side by side with chemical development are positioned to best leverage their services for customer success.
Of course, there are aspects of discovery, development and tech transfer that are universally challenging across all operations. In situations where a potential issue may arise, transparency stands out; it is better to work up front with customers and explain what might affect their programs later on. This approach mitigates any chances of surprise or upset; challenges are discussed before any chemistry has been performed. Open, two-way communication is central throughout each phase of a program and is essential for truly collaborative efforts. For example, at AMRI, project managers often communicate daily with customers. True transparency and the sharing of data, successes — and failures — openly and quickly build trust and enhance the overall program and customer-provider relationship.
CDMOs with advanced methodologies and the ability to develop optimal and readily scalable processes in minimal time gain the confidence of their customers. They also adopt leadership roles and are typically viewed as ideal strategic partners. Sponsor companies, whether big pharma or small biotech, are looking to their outsourcing partners to provide knowledge and guidance. Successful CDMOs are responding with the development of proprietary technologies or the acquisition of specialized expertise (through M&A and/or the hiring of subject matter experts).
Expertise is in no way one-sided, of course, and generally symbiotic relationships are established between clients and their strategic CDMO partners. The benefits of such interchanges are realized over time; a CDMO with years of experience working on hundreds of programs and numerous chemists on staff is more likely to identify unique solutions that a pharmaceutical company completely focused on drug discovery has overlooked.
Leading CDMOs have an extensive array of successfully completed projects that serve as a foundation for future success and enable efficient problem solving. Indeed, CDMOs that have a demonstrated history of employing a GLP approach to development work while considering the ultimate needs for commercialization will clearly be best suited for these types of relationships. Furthermore, collaborative strategic partnerships with such CDMOs reduce the risks typically associated with outsourcing performed through transactional relationships with tactical suppliers.
AMRI has evolved over the last quarter century as a leading CDMO and continues to do so, encouraging its employees to expand their areas of expertise while also bringing in new and different skill sets. Once focused on discovery, the CDMO is now positioned to provide support from discovery through development and commercial production, and has plans to add further capacity.
This commitment to expansion was mostly recently demonstrated with the opening of AMRI’s Buffalo facility, which addresses the key market need for U.S. integrated drug discovery. AMRI’s integrated drug discovery expertise in Buffalo — which also includes proprietary informatics that enable increased data analysis for accelerated process development, combined with its diversified chemical development capabilities, ensures that product knowledge is not only captured, but maintained at all levels of the organization and throughout a project’s lifecycle. It is this highly collaborative approach to project management/technology transfer that advances lead compounds through the drug development process, from bench scale to commercial production.
Rajesh Shenoy, Ph.D., Vice President, Global Chemical Development at Albany Molecular Research Inc., is responsible for AMRI’s Development, Analytical Operations. Joining AMRI in 1998, Shenoy has held positions of increasing responsibility, including Managing Director of India Operations, Director of Global Project Management, Senior Director of Global Project Management and in 2014, Senior Director of Global Chemical Development. He earned a Ph.D. in organic chemistry at the University of Akron and postdoctoral research at Kent State University.