Adding Value (How Do I lead My Own Ship as a Formulation Scientist?)

By: Peter Walsh

I work in late stage pharmaceutical development as a biologics formulation scientist. In this role, biomolecules that are placed in general buffer systems are assigned to my area where I and my colleagues further optimize their formula by conducting stressed studies on them. After 3 years of work in the field, I have found there to be inefficiencies and room for improvement that would benefit from a strong leader pursuing these ideals.

  1. Studies are often repeated and the wheel, being experimental design, is often reinvented due to different groups or people.
  2. Experiments should be risk-based.
  3. Stability studies need to be more predictive. Models and Bayesian statistics should be implemented but this can only be done with big data that is shared throughout development groups and molecules and perhaps if possible different companies.

A leader in formulation science should be looking into improving upon these goals. Some of these ideas are radical and long reaching and therefore need a leader whom people can trust in their vision. This leader should start with gathering his colleagues to conduct a think tank where different people can share their insights and connections that would help make these visions a reality.

The ultimate goal would be to get the regulatory industries, primarily the Food and Drug Administration on board. Changes this bold will need their approval and help. As one of my interviewers said, “Pharmaceutical companies should be guiding the regulatory industry, not the other way around.”

Most importantly a leader in formulation science must have courage and determination. Collaborating with so many different groups, agencies, and people can be intimidating. Many hardwired scientists can also be very negative and discouraging of such dramatic ideas and changes. Because the path is a difficult one, it requires a strong leader with true grit. But the best way to become strong is by recruiting followers and this can only be done by going out there and taking action.

Are your experiences similar?  Different?  Can you add some insights?  Please submit to the PSMblog your thoughts, comments and experiences.