An Introduction To Agile Project Management For Pharmaceutical Outsourcing

By Hector M. Samper and Wolfram Mueller

Unquestionably, the pharmaceutical sector will continue to grow globally, while at the same time globalization and digitalization will lead to much more volatility.  Hence, there is a growing need to become more agile — to be able to react to new situations at a very fast pace. In general, it takes 10 to 15 years to launch one new product to the market, and the activities throughout this period require close coordination between multiple internal functional groups and external partners.

North American biopharmaceutical contract manufacturing companies are expected to expand at a CAGR of close to 10 percent during the forecast period of 2017 to 2027,¹ and contract development and manufacturing organizations (CDMOs) are having to respond quickly as drug substances become more complex. Modern sponsor-CDMO partnerships must be agile and flexible, bringing together professionals from multiple disciplines to find solutions that increase efficiency.²

Over the last decades, methods of working have changed and continue to evolve as a result of new technology, digitalization, and globalization. To leverage scaling effects, it was necessary to use outsourcing and focus on lean supply chains. As a result, no one acts as a single entity anymore — we are now knit together in a network of interdependent companies. Collaboration and total integration are the keys to reach the next stage of productivity.

If organizations want to reach new levels of productivity, the key is to focus on a new way to cooperate and gain an advantage for both sides. Therefore, it’s essential to change behavior and apply solutions that help deliver more projects on time, faster, at lower costs without any compromise. Agility is the operative word to accomplish these goals.

Part 1 of this three-part series will discuss what “agile” really is — and it’s more than just a method. In Part 2, we will examine the building blocks of agile project management. Part 3 will discuss how to implement agility it in a no-risk manner.

The Idea Behind Agile

Agile teams and organizations exhibit central values and behaviors of trust, flexibility, empowerment, openness, and collaboration. In essence, they create a project environment with a mechanism to capture changes and an infrastructure for addressing them, without compromising on scope, quality, or risk. The aim is pure, undisturbed flow and, therefore, the scope of an agile approach is to identify the obstacle(s). This can be achieved by applying best practices of Lean, Agile, and the Theory of Constraints (TOC) through Critical Chain Project Management (CCPM).

Predominantly, the TOC is a catalyst — it provides practical steps for how best to exploit a constraint when it is identified; it helps determine the necessary and sufficient processes to achieve more of whatever the goal is by eliminating the obstacles that limit the team from moving forward.

The only requirement is to be open to fundamental paradigm shifts — from common practice to common sense — with total focus on the change, the constraint, and speed for success.

Agile With A Capital “A”

The term Agile emerged in the 1970s and was popularized by the Manifesto for Agile Software Development in 2001,³ under which requirements and solutions evolve through the collaborative effort of self-organizing and cross-functional teams and their customer(s)/end user(s).⁴

There are several key principles that define Agile:

1. Customer satisfaction by early and continuous delivery of valuable results.
   ❖ Focus on customer satisfaction and involvement to deliver value.
2. Deliver working products frequently in iterations (weeks rather than months).
   ❖ Value-added delivery
3. Welcome changing requirements, even in late development.
   ❖ It does not mean changing everything all the time. It’s the attitude of openness to evaluate new inputs, whether or not they are worth implementing. Furthermore, it is a design principle to build the product in a way that it can be changed easily.
4. Projects are built around motivated individuals, who should be trusted.
   ❖ Motivation of the team, with shared goals and objectives is critical to project success.
5. Face-to-face conversation is the best form of communication (co-location).
   ❖ Integrated meetings are held to share information, rather than relying on electronic data sharing (reports, emails, schedules, etc.).
6. Close, daily cooperation between businesspeople and developers.
   ❖ Silos are minimized and close cooperation is encouraged.
7. Working product is the primary measure of progress.
   ❖ Deliver working systems rather than specified contract deliverables.
8. Sustainable development, able to maintain a constant pace.
   ❖ Schedule and resource leveling to maintain a trained, experienced workforce, with project and site-specific knowledge.
9. Continuous attention to technical excellence and good design.
   ❖ The better the end user requirements and scope requirements, the less delay there is in the implementation.
10. Simplicity — the art of maximizing the amount of work not done is essential.
    ❖ Clear and simple work scopes are best for implementation and lowest risk; avoid “gold plating.”
11. Best architectures, requirements, and designs emerge from self-organizing teams.
    ❖ Maximize productivity and quality in manufacturing.
12. Regularly, the team reflects on how to become more effective and adjusts accordingly.
    ❖ Root causes of issues are identified and fixed; improvement ideas are encouraged and sought after by all stakeholders.

These principles are designed to advocate adaptive planning, evolutionary development, early delivery, and continual improvement, and they encourage rapid and flexible response to change.⁴ Agile has since spread to all kinds of management challenges in every sector, not just software but also manufacturing, retail, petroleum, business strategies, human resources, budgeting, auditing, organizational culture.

From Fragile To Agile

Agile, when successfully implemented, is more of a mind-set than a methodology. Thus, most of the largest and fastest-growing firms on the planet — Amazon, Apple, Facebook, Google, Netflix, and Microsoft — are recognizably agile in much of what they do, even though most don’t use standard Agile vocabulary. Their achievement of business agility is an important reason why they have become the most valuable firms in the world.⁵

But these companies are more or less IT companies — they offer mainly digital products.

A traditional project management approach is performed in a single path or dedicated network, with elaborate sequential and multiple phases or gates that include — in broad terms — project initiation/planning, project execution, project commissioning, project turnover, and close-out. Typical large projects have multiple suppliers and contractors working under a main contractor, with separate company stakeholders and, in some cases, separate end users, with complex contractual terms. The main point in common is the sequential nature, the static planning, and the transfer of risk and liability among the parties, which contributes to a silo effect within the project team.

In our new volatile world, this rigid approach is getting more and more fragile.

While there is much evidence that adopting agile practices and values improves the agility of software professionals, teams, and organizations, the agile concept has begun to evolve in the non-IT sectors. There have been many efforts to improve project cycle management, with initiatives such as lean manufacturing and what is called integrated project management (IPM) or integrated project delivery (IPD). And while they have many core principles in common, agile goes further to eliminate barriers and create a collaborative environment that promotes enthusiastic participation, as well as a common shared vision and goals that keep the project focused.

So, just taking the agile practices out of the IT world and believing they will work in a project environment without recognizing the different needs will also lead to an even more fragile situation.

Agility brings the principles to create an open mind-set and flexible work environment, but to be successful in non-IT environments, the key is to have a broader look and add the well-known best practices of Lean and TOC through critical chain project management.  Core principles for an agile project management and self-organization as a change approach include:

• TOC adds the focus on the constraint — to achieve a huge lever of productivity. It takes effect at the portfolio layer and ensures that focus is on the right projects.
• CCPM brings agility toward projects and the reliability of due dates. Furthermore, it is the key for collaborating throughout the company
• Lean brings the focus on the steady improvement of the flow. It complements the known best practices of Agile and TOC at the team layer. It unites these in the TameFlow Approach, which will be discussed further in Part 2 of this series.
• Self-organization, sometimes called Management 4.0, is the last necessary building block. Self-organization is necessary to delegate as many decisions as possible to those near the market and customer without losing control. Self-organization is also the key to fast but sustainable and no-risk changes with little effort.

In the end, to become agile, transformation is needed on several dimensions:

• Executive sponsorship and empowerment
  • self-organized teams and change processes
• Focus on optimizing the flow -> simple guides to identify constraints in complex systems
• Transparent optimized priorities
  • plan less, fast transparent status, and swift coordination
• Risk mitigation
  • contract for collaboration

Summary

Moving from fragile to agile is not a one-time effort; it’s a one-time transformational journey that requires building the right team with the right frame of mind in order to break dependencies and foster cooperation on all levels. The result is an improved project management process that delivers a project on time in less time, on budget at lower cost, and without compromising scope, quality, or risk.

In Part 2, we will detail how the building blocks, as described above, will look.

References:

1. PHARMIWEB.COM Global Pharma News & Resources / Biopharmaceutical Contract Manufacturing, Dec. 2019.
2. Contract Pharma: The Modern CDMO | Paul Quigley, Head of Drug Substance, Arcinova, May 2019
3. McKinsey & Co.: How to create an agile organization - Oct 2017 | Survey
4. Kent Beck; James Grenning; Robert C. Martin; Mike Beedle; Jim Highsmith; Steve Mellor; Arie van Bennekum; Andrew Hunt; Ken Schwaber; Alistair Cockburn; Ron Jeffries; Jeff Sutherland; Ward Cunningham; Jon Kern; Dave Thomas; Martin Fowler; Brian Marick (2001). "Manifesto for Agile Software Development". Agile Alliance. Retrieved June 14, 2010.
5. Management 4.0 Developing the next generation of managers and leaders - Chartered Management Institute (CMI)

Additional References For Learning And Implementing Agile Practices:

• List and comparison of current vendors of agile CCPM software - https://www.marris-consulting.com/en/points-of-view/critical-chain-project-management-software-solution
• “Hyper-Productive Knowledge Work Performance: The TameFlow Approach and Its Application to Scrum and Kanban (The Tameflow Hyper-productivity),” Steve Tendon and Wolfram Muller, J. Ross Publishing, 2014
• “The CIO's Guide to Breakthrough Project Portfolio Performance: Applying the Best of Critical Chain, Agile, and Lean,” Michael Hannan, Wolfram Müller and Hilbert Robinson, Fortezza Consulting, LLC; 2014

About The Authors:

Hector M. Samper is the principal and strategic advisor at Global Strategic Sourcing Solutions (GSSS), which provides expert advice to the biopharma sector, including strategies to transform and guide cross-functional business/procurement teams to generate maximum value throughout the operations life cycle. He has over 30 years of experience in capital expenditure and manufacturing operations, including indirect spend categories across North America, Europe, and Latin America. His recent experience at Sanofi included creating and leading the Strategic Vendor Management Office for the Global IT function, and heading the North America Operations and CapEx Procurement group. Prior to Sanofi, Samper worked for Amgen, Purdue Pharma, and Merck, where he held roles of increased responsibility in the global engineering, sourcing, and procurement organizations. You can contact him at hmsamper@aol.com.

Wolfram Mueller is principal and expert for agile multi-project management at Consileon Business Consultancy. He is dedicated to speed — either for projects or for changes. He has experience in over 550 agile and classic projects in IT and numerous kinds of mechanical and electronic engineering. The main theme in his work is flow — how to bring organizations to a hyper-productive state. As the author of many books and a well-known speaker, he has inspired companies to do more with less in a very short time. All this led to the invention of BlueDolphin, a community platform for self-organized changes based on the Theory of Constraints (TOC). You can reach him at Wolfram.Mueller@Change-Base.com. For a free, individualized report/benchmark of the symptoms and potential of agile project management in your organization, complete this simple, nine-question survey.