Translational Medicine and Early Development (TMED)
Overview:
The Pharmacokinetics, Dynamics, and Metabolism (PKDM) function is a part of the TMED department at Sanofi and contributes to the safe and effective therapeutic treatment of each patient by applying appropriate pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development and accelerating the process, where possible. PKDM generates, integrates, and leverages clinical and non-clinical PK, PK/PD and metabolism knowledge to support dose selection/study design, de-risking of drug-drug interactions, benefit/risk assessment, and formulation development, with the use of model-based drug development approaches (e.g., Population PK, PBPK, PK/PD and exposure-response analyses), and contribute to regulatory submissions/interactions for projects from first in human dosing through life cycle management. The PKDM fellowship program will expose the fellow to both clinical pharmacology aspects and model-based drug development of clinical projects to provide intensive training and hands on experience in the component of most interest.
Goal:
To provide the fellow with exposure to clinical pharmacology aspects and principles of model-based drug development in pharmaceutical R&D settings. Upon successful completion of the program, the fellow will have gained considerable expertise in the chosen field of interest in the setting of an innovative R&D organization in a large biopharmaceutical company.
Objectives:
-
In the initial months, the fellow will be introduced to various activities supported by PKDM by closely working with various scientists within the function. It will include quantitative clinical pharamcology strategies for programs across different therapeutic areas and learning principles of model-based drug development in the pharmaceutical R&D setting.
-
In the selected field of focus, the fellow will be closely mentored by a staff member and will gain hands-on experience in quantitative pharmacology aspects.
-
The fellow will also attend seminars and other group meetings to ensure a deep and broad learning experience.
Sanofi Component:
-
Understanding the drug development process: How does a bio-pharmaceutical company proceed from the toxicology studies in animals to give an experimental medicine to a healthy volunteer or patient for the first time? How is the dose chosen? How PK, PD, biomarker, efficacy, and safety data are leveraged at various stages of development by conducting integrated quantitative analysis to support critical decision making?
-
Teamwork/Leadership: The fellow will work in a dynamic team setting, in which collaboration is key. The fellow will have the opportunity to lead one or more aspects of selected projects.
-
Communication: For the teams to be effective, communication is critical. The fellow will participate in various meetings essential to the drug development process. The fellow will have the opportunity to present their work, with guidance from their mentor so that the fellow can optimize their communication skills.
-
Networking: The fellow will have extensive opportunity to interact with Sanofi staff in various disciplines, as well as the other fellows.
-
Innovation: The fellow will learn how Sanofi is exploring new quantitative techniques to bring medicine to patients faster. The fellow is encouraged to make proposals for additional innovations based on their experience in graduate school training – great ideas come from multiple sources.
Ideal Candidate:
-
PhD degree in Pharmaceutical Sciences, Statistics or Applied Mathematics
-
An educational background in PK/PD, pharmaceutical sciences, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, or chemical/biomedical engineering
-
Experience in data modeling, data science, data visualization, machine learning with computing technologies.
-
Strong interest in clinical development with a passion for bringing medicines to patients
-
Strong written and verbal communication skills
-
A desire to learn in a dynamic team environment