Joe Fleishaker, senior vice president and Head of Clinical Pharmacology and Exploratory Development (CPED), talks about his passion for clinical pharmacology and his views on early-stage drug development. Find out what Joe had to say about his career, Astellas and what he likes to do in his free time.

What drew you to the pharmaceutical industry, and to Astellas specifically?

As a pharmacy student, I became very interested in pharmacokinetics and drug metabolism. This interest led me to pursue graduate education in this area, and the pharmaceutical industry provided a great opportunity to apply the skills I had learned to develop drugs to enhance patients’ lives. Astellas provided further opportunity to apply these principles initially to the early development of projects in Immunology, Central Nervous System and Pain. In my current role, I lead the application of clinical pharmacology principles across Astellas.

How long have you worked at Astellas? Where else have you worked before?

I joined Astellas a little more than five years ago. Prior to that, I had worked for 25 years with one company, which was The Upjohn Company, Pharmacia & Upjohn, Pharmacia, and finally Pfizer. I have worked in clinical pharmacology, translational medicine, drug metabolism, indications discovery and project leadership functions during my tenure in the pharmaceutical industry. It has been a fun ride.

What is different/special/unique about Astellas compared to other places you have worked?

What I find attractive about Astellas is that it is a mid-size pharmaceutical company; it is big enough to have everything needed for success, but small enough for an individual to have an impact. The culture is also one that fosters collaboration, which can be unique in this industry. I also enjoy the close collaboration with colleagues in different geographical regions; that did not arise routinely in previous companies.

What project/activity that you have worked on has given you the greatest sense of pride? Why?

Two projects at Astellas have given me particular pride:

I led the Development Due Diligence team that culminated with the acquisition of ASP1807 from Chromocell. This was the first successful in-licensing project for me at Astellas, and this compound for treating neuropathic pain is an important addition to the pain portfolio.

I value my involvement in the FASTEN project, which led to a significant streamlining of exploratory development programs. We now progress projects from the first dose in a healthy volunteer to the first dose in a patient study more rapidly and at a lower cost than in the past.

Please tell us about Clinical Pharmacology and Exploratory Development

Very simply, we study the time course of what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics). Our mission is to use this knowledge to make sure we get the right drug to the right patient at the right dose to have the desired therapeutic effect in a safe manner. We do many studies in healthy volunteers to get this information. We also collaborate with Medical and Clinical Science to obtain this information in patients, particularly cancer patients.

What advice would you give to others working in M&D?

The Astellas Way has Patient Focus as it first point. If we focus on the patient, the things we need to do in the various M&D functions, such as making the appropriate decisions on our portfolio, driving our projects with a sense of urgency, streamlining our processes to eliminate non-value added activity, maintaining our compliance, monitoring patient safety, and others should happen as a matter of course.

How does your team collaborate with other M&D functions to advance the M&D strategy?

As a member of the Global Project Teams, we naturally have close working relationships with many M&D functions. We work very closely with Medical Science and Data Science in developing the overall clinical pharmacology plan and executing our studies in healthy volunteers. These groups and Clinical Sciences are key partners for us when we are collecting samples from patient studies for pharmacokinetic and pharmacodynamics. In fact, Clinical Sciences and CPED are co-sponsoring an initiative to enhance tracking, collection, shipment analysis and storage of bio samples from our clinical studies. We work with Regulatory Affairs for regulatory filings to support our clinical studies and to assist in authoring our section of marketing applications. Since we are involved in conducting clinical trials, we also work with our pharmacovigilance colleagues regarding subject safety. We also collaborate with Medical Affairs to address questions about the clinical pharmacology of our marketed products.

What do you like to do outside of work?

I enjoy golfing, but I do not play enough to be terribly good. I am a baseball fan, and I travel occasionally to see my favorite team, the St. Louis Cardinals. I also enjoy reading and spending time with my family.