Forest Component
Two separate two-year fellowship programs will be
available, both providing the Fellow with a solid understanding of
the drug development process. One fellowship begins in the
Regulatory Affairs Department and the other begins in the Clinical
Development Department. Both programs provide the Fellow the
opportunity to rotate to other departments during the second
year.
St. John’s University
Component
The Fellow will receive an affiliate faculty
appointment at St. John’s University College of Pharmacy and
Allied Health Professions and will precept entry-level Doctor
of Pharmacy students who are assigned to the Forest Research
Institute for experiential training. Additionally, each Fellow will
have opportunities at the University to participate in activities
that promote professional development including: presentations,
collaborative research projects with St. John’s faculty, continuing
education courses, resident and Fellow seminar series and
undergraduate courses within the College of Pharmacy and Allied
Health Professions.
First Year
The Post-Doctoral Fellow will pursue activities in either
Regulatory Affairs or Clinical Development at the Forest Research
Institute.
Regulatory Affairs
The Regulatory Affairs department serves as a
liaison between the FDA (Food and Drug Administration) and Forest
Research Institute and is responsible for maintaining a positive
and productive relationship. The Fellow will acquire, through
firsthand experience, a general knowledge of the regulatory
requirements for developing and marketing a new drug. This includes
the filing and maintenance of INDs and NDAs according to federal
regulations and guidances. The Fellow will develop skills in
providing the Project Team with strategic regulatory guidance for
drug development. Additionally, the Fellow’s experience will
include review of product-related promotional material for
regulatory compliance.
Clinical Development
Clinical Development is responsible for development
and implementation of protocols and clinical trials for the CNS and
Internal Medicine Therapeutic Areas from Phase II to Phase IV;
current indications include depression and anxiety disorders,
Alzheimer’s disease, neuropathic pain, hypertension and pulmonary
disorders.
The Fellow will join a CNS clinical team, working with other
departments, including Biostatistics and Data Management, to
conceptualize studies, and with Field Operations and research sites
to implement clinical trials of various scope and size. The Fellow
will assist in the development of protocols and trial materials,
training of investigator sites, maintenance of ongoing trials and
will participate in the analysis, interpretation and reporting of
clinical trial data.
Second Year
The Fellow will have an opportunity to pursue areas of interest
in various other departments at Forest Research Institute through
rotations of 3 to 6 months in duration. These departments may
include:
- Clinical Pharmacology
- Project Management
- Drug Safety Surveillance
- Regulatory Affairs
- Clinical Development
- Medical Affairs
- Medical Science Liaisons