here is well-founded skepticism surrounding the value of Project and Portfolio Management (PPM). Organizations often become enamored with the HOW, the tools and techniques of PPM, for their own sake rather than as a viable solution to a stated problem. Organizational goals would be better served, and PPM would be more valued, if organizations internalized their own vision (the WHY), defined their mission (the WHAT), and only then worried about the individual tools to design the strategy and execute the plan (the HOW). Indeed, this is the right order in which to discuss PPM.

WHY

An everyday example of how one defines their vision (the WHY) is Habitat for Humanity® (HFH), which is known as an organization that builds homes for the less fortunate. The vision statement on their website is incredibly clear: A world where everyone has a decent place to live. It is noteworthy that they are not saying WHAT they will build exactly, or HOW they will build it. One of the reasons this is such a valuable example is that home construction is a good metaphor for PPM in drug R&D – where the WHY is the intent to benefit patients and improve their health and lives.

WHAT

For HFH, the WHAT question is around the type of homes that should be built. It is driven by the unmet need with respect to the type of housing, the technical and scientific advancements in building affordable housing, the question of who will pay the costs, how much they will pay, and all local regulations. In short, it is necessary to consider the recipients, the science of building, the regulations, and the payers. It is about defining the blueprint.

One way to visualize defining the blueprint of the putative drug is to imagine the final product as a virtual structure. The end product could be a drug, a genetic assay, or a device.

But this is only the roof of our structure. Like any an actual building project, one must start with the foundation. In this virtual structure, the foundation is everything known about the asset in terms of the scientific body of knowledge, the unmet medical need, etc. Just like any physical structure, the foundation needs to be current and strong; otherwise, the entire structure is weak.

The next most important part of the structure are the pillars to support each level of information. These are science-based questions. Questions may be asked at the pre-clinical or clinical level depending on the “floor” of the structure. After the data is available to address these pillars, a “floor” is added. There may also be a need to refine the original questions and strengthen the pillars before adding the next “floor;” this is another distinction between building a physical structure and a viable drug product. The key is that the structure is built from a strong foundation, with pre-clinical pillars leading up to clinical “proof-of-concept” (POC) that leads to post-POC questions and, finally, a finished structure.

HOW

We have defined our WHY and WHAT. The HOW occurs at three levels:

1. Delivering a core strategy
2. PPM tools, technique, and processes
3. The individual PM

Delivering a core strategy can be complex. As mentioned, the pillars of the structure are the questions asked, with each level of the structure built up from a new set of questions. For drug R&D, these questions are about efficacy, safety, stability, dosing paradigm, and so on. These questions will define the scope of work. Like any scientific question, there are multiple ways to get to the answer (this is truer in drug development than in an actual construction project). After considering the various options and making choices (each with unique time, cost, and risk), the end product is the strategy.

Considering the right PPM tools, techniques, and processes to implement this strategy requires keeping in mind that there is no absolute “book of best practices” nor any standalone reason to implement any tool. To choose the right tools and techniques, one must ensure they:

1. Establish a “single source of the truth” with regard to all scope, time, cost, and risk.
2. Confirm that all processes and tools implemented are:
1. transparent to anyone who needs to see the information,
2. transferable across the organization for efficient information sharing, and
3. scalable from the smallest to biggest possible portfolio.
3. Represent a consistent methodology that meets the organization’s needs.

Success at the individual PM level requires understanding that there are two parts to PPM:

1. The Science of PPM, which includes:
1. Tools, techniques, templates, etc.
2. Scope, time, cost, and risk management tools
3. Communication tools, management reports, decision logs, risk logs, etc.
2. The Art of PPM
1. This is how you use those tools to do what you do
2. Team management and soft tools such as negotiation skills, cultural training, etc.
3. Leadership and ability to internalize the WHY
4. Communication skills

Thus, the ideal PM that can implement PPM is one who possesses:

1. Familiarity with PPM methodology
2. Scientific/therapeutic knowledge
3. Knowledge of drug, assay, and/or device development
4. Leadership

Summary