Research and Innovation > Research & Development

AbbVie's Approach to Research & Development

ADAPTIVE CLINICAL TRIALS

In oncology and neuroscience, AbbVie is designing adaptive clinical trials, which may help us to more quickly establish proof of concept and determine the appropriate dose of an investigational medicine.

MOLECULAR MODELING

Our scientists use molecular modeling technology to better understand the structure of a particular molecular target. Armed with more knowledge of its structure, we can refine and improve the design of our compounds.

PROJECT TEAMS

Working in project teams, our scientists across different disciplines work in a collaborative way, which generates diverse insights and perspectives that help focus our work.

R & D Process

THE DISCOVERY PHASE

We identify diseases and conditions that lack effective treatments or have treatments with unwanted side effects. After that, the process for targeting compounds looks like this:

Target Identification

We look for a chemical, protein, or gene that plays an important role in a particular disease.

Tool Generation/Characterization

Then our scientists assemble lead compounds—chemicals that may interact with that target—by screening thousands of existing compounds to find suitable candidates, or by studying the structure of the target to develop a hypothesis about what a medicine for that target should look like.

Lead Optimization

Next, we custom-build small molecules (or manipulate existing ones in the case of biotechnology solutions) to meet those criteria. Most often, the resulting group of molecules will have desirable features but will need modification to increase their activity or to minimize side effects. This process, called lead optimization, results in hundreds of potential candidates for new medicines. To select compounds for further testing, researchers ask: Will this compound be more effective than current ones? Will it be possible to manufacture? Based on the answers to these questions, we choose a few candidates for preclinical testing.

THE DEVELOPMENT PHASE

Once the discovery phase of a molecule has been completed, it's time to test its safety and efficacy. This is where the development phase begins.

Preclinical Evaluation

The main goal of preclinical work is to conduct a variety of tests to evaluate safety and ensure the compound reaches its intended target—before human tests begin.

Clinical Trials

If preclinical testing of a compound proves successful, it moves into clinical trials where teams of physicians conduct studies to determine if the medicine is safe in people and effective for the disease in question. There are generally three phases of clinical trials:

Phase I

This phase involves the first human tests in a small number of healthy volunteers to assess tolerability and potential dosing.

Phase II

In this phase, a small group of volunteer patients who have the disease being studied are monitored in placebo-controlled trials. The goal is to establish the "proof of concept" (POC) or how the medicine effectively treats the disease. Researchers continue to evaluate the drug's safety and determine optimal dose strength and schedule.

Phase III

The medicine is tested in large, randomized, placebo-controlled trials with larger numbers of patient volunteers to generate statistically significant data. Researchers further evaluate safety and efficacy and identify side effects.

The clinical trials from all of the development phases provide the data required to prepare submissions for regulatory approval to agencies around the world. The requirements for securing regulatory approval vary across different countries and geographic regions.