From Molecules to Medicines
How teams and decision making influence drug discovery and development.
October 22, 2013 - It takes a high performing team with diverse technical and organizational skills to discover, develop, and deliver a new medicine. Scientists and leaders, both in and outside the laboratory and clinic, do much of this work. Many scientists are trained in universities where projects are very individualized – one person, one aspect of a project. This model works for academic science and works very well for training and building technical skills.
However, putting a new medicine in the hands of patients is vastly more complex and requires large teams of experts. They all need to work together toward a common goal and with a singularity of purpose. In order to work effectively towards this goal, it’s important for scientists and leaders to cultivate new skill sets in addition to technical prowess. Two of these leadership skills are particularly important: building high performing teams and strategic decision making.
Strength in numbers
There is a public perception of scientists as loners who toil away in a laboratory. They struggle until they make a breakthrough discovery and singularly claim credit. And for the academic scientist that could be true, in some cases. But there is also another reality – that of a team who all works together – to do something amazing, something that requires tremendous energy and collaboration. Consider the engineers and scientists at NASA who pooled their collective efforts to land a rover on Mars – or teams of particle physicists at CERN who discovered the elusive Higgs boson. A similar amount of collaboration is required to discover, develop and deliver new medicine for a disease like cancer.
Developing a new drug isn’t like a relay, where responsibility is passed from one individual to another. It’s more akin to rowing where everyone has to work together.
The entire drug development process is collaborative. Biologists work with chemists and antibody engineers to design and build new drug candidates. Pharmacologists, toxicologists, and biomarker scientists help find safe and effective therapies at optimal doses for relevant patient populations. Manufacturing engineers and scientists scale up processes to supply drug to patients across the globe. Clinical and commercial colleagues help us understand the competitive landscape and what it takes to be the next standard of care. As we begin clinical studies, our doctors work with biostatisticians, regulatory, and operational experts to conduct trials that can enroll thousands of patients around the world. At Genentech, all these diverse experts work closely together on cross-functional teams led by project team leaders and managers. Individualized effort is amplified on project teams, where the expertise of many are needed to deliver the right drug to the right patient.
Making decisions and taking risks
Science can be complex and does not always give us clear-cut, right and wrong answers. Rarely do we have the entire picture. When it comes to drug development, we generate data, assess scenarios and risks, and make necessary decisions under a great deal of uncertainty. For us this means, do our pre-clinical data warrant further study in clinical trials? Does a promising therapy work better for certain types of patients but not others? Which programs do we advance or terminate in our pipeline?
To enable best decisions and to mitigate risk aversion, we do several things. One is to designate clear decision-making goals and roles for individuals on teams and committees. We also strive to master both technical and organizational elements of strategic decision making. Technical approaches include decision analysis, which enables us to map out numerical estimates of value and risk to understand which path may be the best out of many options. Organizational culture is also crucial for decision making. We have focused on building a strong organization that makes decisions based on deep science, robust data, and an unwavering commitment to patients.
At times, we know it is critical to take calculated risks to test new ideas and advance medicine. In the case of moderate-to-severe asthma, the need for a diagnostic became clear for one of our key molecules as some competitor medicines failed in trials. In a novel proof-of-concept study, our cross-functional team demonstrated that a new diagnostic marker was a way to determine whether a patient may respond to our experimental drug. By following the science and taking risks, this team took an important step towards identifying appropriate patients with a heterogeneous and difficult disease.
Highest performing teams encourage active debate and diverse views, which often generate new ideas and key decisions with technical and organizational impact. Examples of team-driven innovations include the following:
- Advanced technologies in antibody engineering, including bispecific and dual action therapeutic antibodies that are designed to hone in on multiple cancer targets
- Novel studies combining different therapies, such as a cancer immunotherapy designed to activate patient’s immune system to combat cancer
- Innovative deal structures led by our business development team, including one that fully aligned partner incentives and won a Breakthrough Alliance industry award
- Accelerated and creative clinical trial strategies for a new infectious diseases therapy to enroll patients across the world
Discovering and delivering new medicines can be extremely challenging and often takes years of effort. Our goal at Genentech is to find and develop truly innovative drugs for serious and life-threatening diseases. Through world-class science and teams, we are dedicated to making the best decisions to help patients.