Applying Agile methodologies in CDMOs Authored by: Mr. Saurabh Gurnurkar- Executive Director,Uquifa

In order to truly help biotech and pharmaceutical companies in their journey from drug development to commercialization, contract development and manufacturing organisations (CDMOs) have begun to incorporate the latest innovations in all aspects of their operations. Whether this implementation happens in science, in manufacturing equipment, or communication technologies, CDMOs are pushing the boundaries and making changes.

One area that may be less tangible is the management of the relationship with their customers, as well as the management of the customers’ programs. Sponsor companies and their suppliers are starting to work together more collaboratively than ever before, to ensure positive outcomes. Successful delivery of a program on time, first time, translates into time and cost savings. The main driving force behind this evolutional change revolves around the need for reduction of drug development costs which in turn opens new avenues for better patient care. However, there are still companies hesitant to enter into completely open and collaborative partnerships. Some CDMOs, thus, have taken it upon themselves to incorporate leading edge solutions to help streamline project and customer management.

The industry’s standard approach revolves around employing a single, dedicated network, with multiple, consecutive phases or gates. In some cases, there are separate end-users with complex contractual terms as well. The common denominator is the sequential nature, the static planning, and the transfer of risk and liability among the parties, which contributes to a siloed effect—curbing the collaborative experience during a project. Such a rigid approach is growing increasingly fragile.

Fit-For-Purpose Agile Methodologies

Back in 2000 a group of IT thought-leaders set up the principles of Agile methodology principle.  It was articulated thus, “We are uncovering better ways of developing software by doing it and helping others do it. Through this work we have come to value: ‘Individuals and interactions over processes and tools, working software over comprehensive documentation, Customer collaboration over contract negotiation, responding to change over following a plan’.

The process from tech-transfer to developing an efficient new drug API at a CDMO seemed to be made-to-order for the Agile methodology. We at Uquifa adopted it to ensure that flexibility, collaboration, individuals and outcomes rather than process, documentation or contracts become the basis of our CDMO process. To further raise the bar in the delivery of pharmaceutical ingredients Uquifa created fit-for-purpose Agile methodologies for small API molecule development, manufacturing capabilities, and project management. These Agile methodologies have helped significantly in overcoming barriers and constraints, resulting in a lean and efficient manufacturing culture. At the core of this Agile methodology adoption was our Integrated Project Teams (IPT) have helped improve throughout the lab-to-commercialization journey are open communication, flexibility, responsiveness, and excellence in customer service.

Heavily influenced by IT agile principles, every project is implemented streamlined with various execution and delivery processes. Understanding the specific requirements of the new drug is naturally crucial, and our expert professionals gain comprehensive insights and expectations for each new drug development project directly from customer inputs and feedback. This helps tackle one of the industry’s biggest challenges, viz, the transfer of technology effectively without loss of time and know-how. Our Agile methodologies go the extra mile to eliminate constraints and create a cooperative environment that promotes enthusiastic participation as well as a commonly shared vision helping in tech transfer and overall project management. This has become even more important when marrying the high-quality culture of regulated international markets while ensuring low operational and overhead costs for clients has become second nature, giving efficient and of timely delivery of such molecule.

And, through the years we have seen that a shared vision through these adapted Agile methodologies helps in consistently achieving a shared outcome for clients.