R&D Planning and Governance

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.