WORKING FOR A HEALTHIER WORLD

We advance leading-edge science through dynamic and collaborative approaches to bring meaningful solutions to some of the most serious health challenges. Research and innovation are the cornerstones of AbbVie’s business. They are the power behind our passion to help patients.


2.3_A_bluegloves

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.


2.3_C_whiteboard

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

AbbVieWebsiteChart_16541_v11

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.

Candidate Generation

Next, we custom-build small molecules (or biologics) 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 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 have a favorable safety/tolerability profile? 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 before human tests begin.

Clinical Trials

If preclinical testing of a compound proves successful, it moves into clinical trials where teams of physicians and other clinical scientists 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 or whether the medicine has the potential to positively impact 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 confirm the efficacy and safety profile by generating 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.

Following regulatory approval, clinical studies are conducted to support additional indications or new formulations as well as for post-marketing monitoring and research.

YOU ARE ABOUT TO LEAVE FOR A 3RD PARTY WEBSITE

Notice

The "Yes" link below will take you out of the AbbVie family of websites.

Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie.

The Internet site that you have requested may not be optimized to your screen size.

Do you wish to leave this site?

EXIT ABBVIE.COM

The product-specific site Internet site that you have requested is intended for the residents of a particular country or countries, as noted on that site.

As a result, the site may contain information on pharmaceuticals that are not approved in other countries or region. If you are a resident of a country other than those to which the site is directed, please return to AbbVie.com or contact your local AbbVie affiliate to obtain the appropriate product information for your country of residence.

The Internet site that you have requested may not be optimized to your screen size.

Do you wish to continue to this product-specific site?

YOU ARE ABOUT TO LEAVE FOR A 3RD PARTY WEBSITE

Notice

The "Yes" link below will take you out of the AbbVie family of websites.

Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie.

The Internet site that you have requested may not be optimized to your screen size.

Do you wish to leave this site?