RD Planning and Governance

PM Milestone Project Management Templates

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Ronald P. Evens and Joel Covinsky

Development Schemas and Leadership 34

Clinical Development Strategy 36

Leadership 38

Product Development Paradigm 39

Portfolio Planning Management (PPM) Description 43

PPM Process Components 47

PPM Analyses (Examples) 54

Project Management 60

Summary 62

References 64

A company needs the best people, advanced science, great products, the physical plant, the right operations, the financial wherewithall, the right leadership, appropriate patients, experienced investigators, a good dose of common sense, a vision of the future, and some luck to develop significant new products. Many companies may possess these attributes; however, how well companies can pull all these manifold, often disparate, and sometimes conflicting resources together in turn will differentiate themselves as leading companies. A metaphor for this situation is the pack elephant ("the product") and the five different blind passengers ("the departments") needing to reach a common destination ("approvals"). Each may touch the elephant at different areas, large flappy ears, stumpy legs, long flexible trunk, hard pointy tusks, the tail, or the broad back. Besides their different personal experiences and expectations, they each believe to be holding a different animal with different possible benefits and risks in reaching their destination. Someone or some group must be able to step back and see the whole animal, as well as its parts, to coordinate the individual players, help make the best judgments, and set the best direction. Governance and planning can be best practices in pulling it all together in product development and in differentiating the top companies from the pack. These best practices are needed for the products (the elephants), by the departments (the elephants' passengers), and by the whole company (the elephants' whole environment), as well as for all stages at which a product exists or at any stage of a company in its evolution. It is very easy to be myopic and become lost in the details and not focus on the big picture. In this chapter and book, we are focusing on the many common challenges associated with product development, always keeping in mind the big picture (the big outcome)—product approvals.

Product development over the past 20 years has and is experiencing significantly reduced output of new products, which has been discussed earlier, while costs have risen sharply. Numerous publications discuss a variety of solutions to this dilemma, often highlighting improved drug discovery, more in-licensing deals, better governance and decision-making, operational efficiencies such as use of enabling technologies, teamwork, and also portfolio planning on a global scale. We will attempt to bring these issues together and summarize them in this chapter for the new product researchers in academia and industry [1-22].

The chapter outline is presented above. We will focus on leadership, organizational effectiveness, global resource allocation, and portfolio planning, which directly impact governance and planning. Representative models are presented here for each of these three areas, not as a panacea or sine qua non, but to primarily provide the students and fellows reading these materials with key sample operational frameworks in the industry regarding plans, organizations, and decisions. An overview of the complete product development process first provides the content as a framework for planning and governance for our discussion. We will present the phases of research and their components and then a construct for a global product development plan. Leadership is discussed next as a primary skill set that underpins optimal decisionmaking, governance, and operational effectiveness. Then, the organization and its operational effectiveness will be addressed through a model, the paradigm of product development ("P to the eighth power"). The model incorporates eight major parameters to be outlined below. Then, a description of the portfolio planning management (PPM) is provided, answering the questions why do it, what can be done, and by whom is it done? PPM contains a variety of components, which are presented to address the question how is it done. Analyses are required to establish goals, assess risks, plan resources, and judge progress; some of these analyses of PPM are discussed as examples. For completeness in our planning discussion, a brief review of project management is given, because it contributes to better PPM through planning, coordination, and execution that is directed toward specific projects, such as a product or a component in the plan (e.g., an individual study or new formulation). A well-organized plan should provide a foundation for good timely decisions.

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Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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