School of Pharmacy

Early-Phase Clinical Development encompasses research from preclinical studies through phase 1 and 2 trials of the drug development process. These trials are the first time an exploratory compound is studied in a human population and are commonly known as “first in human” trials. As a clinical research scientist, pharmacists assume lead roles in:

• Designing and managing clinical trials
• Study protocol development
• Selecting primary investigator and trial sites
• Ensuring proper data collection and interpretation
• Determining the best dose of the medication for later studies
• Reporting serious adverse events
• Publishing clinical study reports and manuscripts

Late-Phase Clinical Development encompasses research from phase 2 and 3 human trials of the drug development process.

In addition to the activities in Early-Phase Clinical Development, pharmacists in Late-Phase Development also have the opportunity to participate in:

• Planning investigator meetings
• Chairing international clinical trial team meetings
• Overseeing deliverables from various external contractors
• Study protocol development

The marketing department is responsible for strategic implementation of the advertising and promotion supporting a company’s products. A pharmacist in Market Research/Business Analytics generally helps to:

• Analyze past and present market data to monitor current and future trends
• Forecast market trends
• Create patient population evaluation models
• Identify unmet medical and pharmaceutical care needs

In this role, pharmacists:

• Critically analyze and evaluate evidence-based medicine
• Plan and implement continuing education programs and materials
• Collaborate and network with key opinion leaders from industry, managed care, and academia to create promotional and educational programs
• Act as a key member in the development of publication plans

MSLs are therapeutic specialists who coordinate the communication of clinical information between pharmaceutical companies and medical experts.

The MSL is a field-based associate who collaborates with and communicates information to:

• The sales force
• Practitioners in the field
• Clinical trial investigators
• Internal stakeholders

A pharmacist in Medical and Scientific Affairs:

• Provides expertise on global life cycle management
• Collaborates with Global Brand Medical Directors and their teams
• Integrates data from internal and external sources into actionable information for clients
• Reviews and approves promotion and advertising from a medical perspective in compliance with FDA regulations

Pharmacists have found a niche in this department by:

• Evaluating a product’s safety profile throughout its development and into its postmarketing stage
• Participating in clinical development team discussions relating to adverse events
• Integrating information from preclinical safety trials to ongoing trials
• Contributing to ongoing safety documents submitted to health authorities

The Health Economics and Outcomes Research (HEOR) group helps to identify, measure, and compare the costs and consequences of health-related courses of action to assign a “perceived” value to pharmaceutical intervention.

A pharmacist in HEOR can:

• Compare the economic effect of 2 or more drug products
• Assist in the development of drug formularies
• Develop national or international clinical practice guidelines