Client Oriented Project Management
By Devan Patel
Outsourcing in the pharmaceutical industry is vital in delivering capabilities and capacity for biopharma companies as they face increased competition fueled by innovation and rooted in a better understanding of patients and their needs. The industry has recognized for some time the value of contract development and manufacturing organizations (CDMOs) to reliably deliver drug substances and products.
Several years ago, the global pharmaceutical outsourcing market was valued at over $70billion with an expected annual growth rate of 6.6% 1. We estimate that on any given day, hundreds, if not thousands, of outsourcing projects are being carried out.
When surveyed, biopharma companies typically cite CDMO selection criteria that falls under the heading of capabilities and capacity. Does the CDMO have the technical know-how™ I need, and can they do the work on my timeline? However, project management operations serves as the conductor that advances projects unimpeded. With the significant amount of outsourcing being done by the pharmaceutical industry, we believe project management has earned the right to be a critical factor in CDMO selection and deserves some exploration and understanding.
Over our 26-year history and having successfully completed over 400 development projects, Pii has developed and refined project management operations to ensure outcomes are achieved and customer expectations are exceeded. We have found that excellent project management has seven distinct features.
Seven Features of World Class Project Management
One project-lifecycle manager.
Our experience tells us that changing project managers is highly disruptive for a project, contributing to confusion, potentially causing delays, and sometimes even project failure. Rather, we’ve learned the value of assigning a single project manager for the entire lifecycle of the project, this best serves the customer’s needs and best leads to project success.
Project Manager Professionalism
For contract development and manufacturing organizations (CDMOs), projects have a defined beginning and end and are therefore temporary, but project managers should not be. Ad hoc assignments of personnel to project manager roles is not a best practice. Project management teams ought to be comprised of professionals who find project management to be their life’s work. CDMOs should continuously improve their project management operations through ongoing development of their project managers, both with formal education and training, and with company internal development programs.
An agent for the customer
What we’ve learned over time is that project managers should serve as agents for the customer. First, they must take the time to fully understand the project from the customer’s perspective including project-specific nuances. All customers want their projects completed on their timeline, but project managers should understand the negative impact of not meeting the timeline. E.g. missing a critical timeline milestone will lead to the loss of 50% of the customer’s expected funding. Understanding how distinctive aspects of the project may negatively impact the customer enables the CDMO to exceed expectations.
Experience, Skills and Collaboration
A CDMO customer should have access to the best talent, experience, and skills of the CDMO, best aligned with the project’s needs. Great project managers will not only gain a full understanding of the customer's project, they know their own organizations, and will facilitate assembling the best team for the customer’s outcomes. With more situational understanding than anyone else on the team, the project manager can facilitate collaboration across the CDMO’s functional areas. E.g. rather than pursuing a formulation recommended during concept development, a simpler formulation could be less costly and developed faster. See the Pii case study: Creating a New Dosage Form from an Approved Drug for a New Rare Disease Indication.
To work efficiently on multiple projects simultaneously, CDMOs must have effective internal communications systems, but so do their customers and often those systems are not the same. Great CDMO project management operations adapt how they communicate and share data to methods that are preferred by the customers. The project manager serves as chief interpreter, ensuring and timing that best supports the customer’s critical decision-making.
Strategic Project Managers.
We mentioned earlier about the need for project managers to understand the nuances of projects with customer’s perspective. However, they should also bring additional experience and skill to the partnership, and a focus on the overall objective: a long view to the project. At Pii, the relationship between the project manager and the customer begins before a contract or quality agreement is signed. Great project managers will ask questions that the customer has not considered that can avert problems, advance the work more quickly, and anticipate what FDA will want to see in filings. The project manager facilitates on-boarding, sets-up the kick-off meeting, ensure key technical aspects of the project is clear, and communicates strategies within the scope of work.
Finally, great project management operations have the visibility of senior decision-makers at the CDMO. At Pii we have two weekly meetings that review customer projects in which the senior executives participate. The first is an R&D review, focused on the technology challenges related to our customers work and ways to overcome them. The second is projects review meeting focused on milestones and customer deliverables. Having our senior leadership team enables us to exercise agility in decision making on behalf of our customers.
We’ve heard the project management role described as be similar to herding cats or pushing a wet noodle across sandpaper. At Pii we see it differently. Superb project management provides project continuity, serves as the customer’s agent, facilitates collaboration across functional areas, maintains a strategic view while working to help advance daily outcomes, adapts the CDMO’s communications for the customer’s needs, and has the trust of the CDMO’s senior leadership to exercise agility on behalf of the customer.
1. “Outsourced Pharmaceutical Manufacturing Grows To $76 Billion” by Louis Garguilo, Chief Editor, Outsourced Pharma
Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) located in Hunt Valley, Maryland. The experienced scientists, engineers, and staff at Pii pride themselves on adroitly employing a phase appropriate method of drug development for the prudent use of their customer’s resources as they solve challenging problems. In addition to offering end-to-end development services, Pii manufactures a variety of dosage forms to include complex parenteral drugs and has a wealth of analytical testing capabilities. Its Hunt Valley campus has four aseptic suites with lyophilization capabilities. Our talented professionals stand ready to help!
ABOUT THE AUTHOR
Vice President of Client Services
Devan Patel, who joined Pii in 2012, is Vice President of Client Services where oversees Pii’s Business Operations functions. He previously served as Pii’s Senior Director, Project Management since 2012. In that role, Devan played a key role in Pii’s development and commercial programs for orals and injectables. With his leadership, Pii has built a world-class Project Management Organization (PMO) consistently characterized by superb customer experience. Over the years, Devan has used his knowledge and technical skills to play a vital role for the Operations team, managing key initiatives for the Parenteral/Sterile business unit, including managing the overall scheduling and planning of all Aseptic Operations. His collaborative style when working with cross-functional teams across Pii’s business units and ability to anticipate problems before they occur as raised the role of project management to an artform. Devan delivers a positive, outcomes-focused experience for our client-partners, from initial contact through successful completion of each project.
Devan earned his Bachelors in Cell Biology and Molecular Genetics from the University of Maryland and a M.B.A. from Johns Hopkins University.