Global Citizenship

A Balanced R&D Portfolio

Today, only about 1 in 10,000 pharmaceutical compounds progresses from the laboratory into the marketplace, and only 1 in 12 of the compounds entering clinical trials ultimately will reach patients. Development cycles for medical devices are similarly complex.

We take a broad-based approach to our product pipeline, balancing higher-risk breakthrough research with refining innovation in all of our businesses. Such diversity helps offset some of the challenges and changes that can occur in any one segment of our business, and it enables us to better manage our pipeline development timelines and product life cycles.

At the same time, we continually look for opportunities to increase the efficiency of our R&D program. As early as possible in the R&D process, we try to determine which therapies and technologies are the most promising and merit accelerated development, while also determining which projects are less promising and ought to be abandoned.

Robust Innovation Process

Innovation and discovery are central to all of Abbott’s businesses. Throughout the company we try to focus our R&D resources where they will have the greatest impact on patients and consumers. Each Abbott business has its own processes and mechanisms for assessing and acting upon ideas. Many of these ideas are then shared across functions and disciplines.

The Abbott Scientific Governing Board, composed of the research heads from each Abbott business, meets regularly to review research and exchange ideas. Through collaborative meetings and internal communications systems, Abbott scientists focusing on different diseases and issues frequently share insights and knowledge.

As an example, in our diagnostics business, ideas for new tests to detect or monitor diseases come not only from our own scientists, but also from outside companies and research institutions. To more efficiently evaluate these ideas and decide which ones to pursue, Abbott Diagnostics in 2011 established a Novel Biomarker Committee.

The goal of this committee is to identify and prioritize potential biomarkers that can help doctors make decisions at an earlier point in the progression of disease than existing tests. Broadly defined, a biomarker is anything that can be measured relating to a disease state, such as a test of blood or urine, an X-ray or another physical finding. Abbott conducts substantial research to map the progression of various disease states – and to identify decision points where doctors could benefit from additional factual data to support potential changes in treatment.

Based on this mapping, our Novel Biomarker Committee studies ideas for proposed biomarkers – to determine which proposals hold the greatest potential for improving health care on a sufficiently broad basis to justify the necessary investment. The committee also explores whether the proposed test can most efficiently be performed using an automated or manual method – and which approach is most likely to meet the needs of our customers.

After only a year of operation, Abbott Diagnostics’ Novel Biomarker Committee has already identified several promising areas of exploration, including hepatitis C, arteriosclerotic and chronic heart disease, diabetes, sepsis, traumatic brain injury and oncology. Additionally, the committee has helped to achieve substantial savings in time and resources that might otherwise have been spent on futile projects. By focusing our R&D efforts on areas of greatest need and potential, we increase our chances of making a real difference for patients and health care providers.

Similarly, Abbott Vascular has a steering committee that solicits ideas and input and creates target topics in clearly triaged scope areas. This committee holds quarterly meetings and hosts technical exchanges for scientists, technologists and marketers to highlight ongoing innovation.

Meantime, Abbott Nutrition generates innovative nutrition ideas by consulting experts around the world – in part through the Abbott Nutrition Health Institute, a global knowledge center focused on advancing nutrition education. To better focus on improving innovation, Abbott Nutrition recently formed an internal Global Innovation Office and launched an interactive online employee ideation tool.

Targeting Compounds

Innovation in our pharmaceutical division starts with identifying diseases and conditions that lack effective treatments or have treatments with unwanted side effects. We look for a chemical or protein (“target”) that plays an important role in a particular disease. 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. We then custom-build molecules 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.

To complement these internal processes, our advance technology team scours the globe in search of potential new partnerships with researchers in academia, government, biotechnology and other industries. Resulting arrangements include classic licensing and merger and acquisition activities, as well as novel risk-sharing arrangements with academia, nonprofits and other biopharmaceutical companies. Our internal integrated discovery project teams – composed of chemists, biologists and pharmacologists – work together across disciplines to further advance scientific understanding.

Increasing R&D Efficiency

In response to the growing demand for health care services among developing nations and the growing length of time required to research and develop new products, Abbott is working to make the R&D process as efficient as possible. Major initiatives include efforts to:

• More quickly identify which research projects are most promising and which are less promising, so that we can focus our resources for maximum impact
• Expand clinical trials in emerging markets to achieve faster registration of products in countries where needs are increasing. For example, Abbott is currently conducting a first-ever trial of its innovative bioresorbable vascular scaffold in India, and we are conducting Phase 3 studies for a promising cancer compound in China. Additionally, we are conducting global clinical trials – involving more than 20 sites around the world – for new medicines targeting multiple sclerosis and Alzheimer’s disease
• Create more synergy in our R&D project teams by enabling scientists from a wide range of disciplines – including chemistry, biology and pharmacology – to work together on common challenges

Abbott is emerging as a leader in devising ways to make the development of new medicines faster and more efficient, particularly in oncology and neuroscience. One way we are doing this is through truly innovative adaptive trial designs – on our own and in collaboration with others. Adaptive clinical trials are designed to make clinical trials smarter, faster and more efficient, greatly increasing the chance that each patient will receive appropriate doses of medicine.

In 2009, for example, Abbott conducted the first adaptive Phase 2 clinical trial in Alzheimer's disease. The trial was designed to establish proof of concept and to determine the most effective dose. We are now employing similar trial designs in our Phase 2 studies for other investigational medicines for Alzheimer’s disease and other central nervous system disorders

In addition, Abbott has instituted numerous ways for scientific and technical employees to collaborate on ideas of common interest. For example, at the Abbott Bioresearch Center in Worcester, Massachusetts, we have established a roundtable process enabling bench scientists to share day-to-day observations in their laboratories with our R&D leadership and suggest avenues for additional exploration. Similarly, scientists at our site in Redwood City, California, host a weekly collaborative review meeting to share best practices and to brainstorm new ideas about how to advance the multiple compounds under development at the site. We also have established a global online community enabling Abbott scientists around the world to exchange ideas and best practices.

Sharing R&D Results

In November 2011, Abbott hosted its second annual Abbott Day of Science and Technology for R&D employees across all Abbott business units and geographies. Intended to foster cross-functional knowledge sharing and collaboration, the 2011 event included a symposium on opportunities and challenges in personalized medicine and cancer therapy, plus a poster session with 200 entries. Attracting more than 800 local participants, the event also was available to thousands more employees around the world through our online Science and Engineering Collaboration Portal. This enabled R&D teams from across the company to discuss their accomplishments and share knowledge across multiple focus areas.

In 2011, we also celebrated the 26th anniversary of the Volwiler Society, our company’s highest scientific honor. Named after Dr. Ernest Volwiler, a distinguished scientist who became President of Abbott in 1950 and went on to become Chairman of the Board in 1958, the Society recognizes the top 3 percent of our company’s scientists and researchers. The 198 Volwiler Society members exchange ideas about novel research opportunities, share best practices and serve as mentors to more junior scientists.

Members of the Volwiler Society are elected by the Scientific Governing Board, a group of research and development leaders across Abbott’s diverse range of business divisions. Nominees are evaluated based on their ingenuity, scientific excellence, consistent productivity and performance at Abbott. In 2011, the Volwiler Society sponsored a series of six educational seminars. These seminars are available via Web cast and open to all employees in R&D roles across the company. In 2011, the Volwiler Society seminar series included thoughtful presentations on Abbott’s role in fighting cancer, neglected tropical diseases and eye ailments, along with discussions of our work on companion diagnostics and our idea management process.