My name is Jacqueline Schwarz and I have been working as a pharmacy intern in Clinical Supply Management at Bayer AG in Berlin since November 2017. Our department acts as the interface between chemical and pharmaceutical development and clinical functions in the drug development process. We are responsible for establishing and supervising the supply of study drugs for all phases of clinical trials around the world. The close coordination among numerous internal departments, external suppliers and study teams in interdisciplinary meetings makes this logistical and organizational feat possible.
Participating in development
My pharmaceutical/chemical and technological background was a tremendous help in working with colleagues in Formulation Development and Analytics. For example, in a meeting with the Technical Development Team (TDT) we would discuss the stability requirements a tablet needs to meet in order to scale up production. I also gained insight into the mechanisms of action and therapeutic areas of potential new Bayer products, and learned more about the heart of any pharmaceutical company: its drug pipeline.
The responsibilities of a clinical supply manager
As head of the Drug Supply team, the clinical supply manager’s main task is to fulfill the requirements of the study protocol to the best of their ability by establishing an on-time, efficient and compliant supply of the study drug. Meetings are held to determine the best package design for a given study (e.g. blister packs, bottles, additional medical devices, etc.), whether a study is open-label or blinded and placebo-controlled, and how to integrate hospital staff and patients. The clinical supply manager is also an extended member of the clinical team for a given product.
Insight into other departments
At regular study team meetings, I had the opportunity to learn more about all of the steps involved in a clinical trial, beyond the work of my own department. Through direct contact with the various professionals involved in these large, interdisciplinary teams, I gained extensive insight into all aspects of a product development plan, including timelines, ethical/legal issues and the establishment of clinical parameters.
Room for personal development
This complex set of tasks demands a high degree of organizational talent, confidence in communicating with experts and agility when responding to unexpected changes. Working on an international team, I was able to expand my English technical vocabulary and familiarize myself with the landscape of the industry.
During my pharmacy internship, I had the opportunity to support a number of products under development through multiple study phases and to represent the Clinical Supply Management department on the various teams. Together with other colleagues, I was also responsible for all bulk material logistics between the production and packaging sites. Here, our focus was selecting the right transport conditions and overseeing the required approval processes.
My supervisors put their confidence in me and for that I am very grateful, because it enabled me to actively contribute to the various teams and independently support a large number of projects. My internship in Clinical Supply Management allowed me put my theoretical knowledge about clinical trials into practice. I experienced first-hand what the real implications of terms like “double-dummy design” and “patient compliance” are, and what a challenge it is to integrate these concepts into study protocols.
Many thanks for all the valuable insight!
This post is also available in: German