Precision Medicine – it’s not just for oncology anymore

In the past decades, precision medicine has revolutionized how cancer patients are diagnosed and treated. By tailoring treatment to a specific disease driver, and taking into account a person’s genes, environment and lifestyle, researchers can target the right patients with the right medicine at the right time. And when scientists find something that works, they think, what’s next? What if precision medicine could be leveraged to help fight diseases other than cancer?

This is the question AbbVie drug researchers and developers want to answer, said Ian McCaffery, Ph.D., Vice President of Precision Medicine.  

Precision medicine – or “PMed” as it’s called around AbbVie’s labs and hallways – is spearheaded by McCaffery who joined AbbVie in March 2020 and brought with him 20 years of precision medicine experience with most of that time in the biotech industry. At AbbVie, his team of almost 200 researchers spans from the west coast to the east coast to Europe. 

“I remember when patients were diagnosed with cancer – it was considered one disease,” McCaffery said. “Then, advancements like precision medicine helped researchers understand the complexity of the disease, and how a person’s genetics change the disease and change how to treat that disease. We're learning that like cancer, immune-related diseases are not uniform and have different drivers. We are working to identify and target those drivers.”

To find the right patients for a specific treatment, AbbVie researchers are using predictive biomarkers and ultimately the companion diagnostic assays which are tests used to help match a patient to a specific drug or therapy. But it all begins with developing a deep understanding of each disease driver, which are mutations that cause tumor growth. “Developing a deep, molecular understanding of disease is highly complex, requiring expertise from across the company,” McCaffery said.

“This means that precision medicine takes a village. It requires clinical and translational scientists working closely with colleagues from other groups in R&D to bring all the necessary expertise to generate and interpret molecular information. While this complexity can seem daunting, AbbVie has broad and deep expertise across the organization.”

This expertise comes from cutting-edge technologies used to identify predictive markers that build upon our understanding of molecular drivers. For some diseases, especially where phenotypic data are hard to quantify, AbbVie researchers are incorporating digital technologies including sensors, wearables, and other technologies to help identify which patients would benefit most from a treatment, McCaffrey said.

Researchers are also using sophisticated machine learning and artificial intelligence to illuminate predictive relationships from highly complex and multi-modal data, including clinical, molecular, and digital data. These analytical tools are giving teams a look at diseases at a digital pathology level.

Precision medicine, which already plays an important role in our work in R&D, will play an even bigger role in the coming years, said Neil Gallagher, M.D., Ph.D., Chief Medical Officer and Vice President of Development.

“We want to be aspirational and do something big that will help address a huge unmet need,” Gallagher said. “In the past two decades we have learned so much in oncology about the molecular biology of cancer and that has led to better treatments for patients. We want to do the same for immunology. We want to change the way we develop new immunology drugs and make them more effective and precise for each patient. If we can bring a new medicine that really makes a difference for, say 10% of ulcerative colitis patients, that would have a significant positive impact for those patients.”

Ulcerative colitis is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. It causes painful symptoms that can be severe and include diarrhea, abdominal pain and cramping, rectal pain and bleeding, fatigue, and urgent bowel movements. The cause of the disease is unknown, but research does point to a patient’s genes and environment as possible factors, which aligns to precision medicine.

Ulcerative colitis currently lacks a non-invasive disease monitoring tool to measure and predict treatment outcomes, so an AbbVie team is exploring opportunities to work with inflammatory bowel disease experts across the country to conduct a digital biomarker study and help address this unmet need.

“These digital analyses could indicate disease or mechanistic activity in patients or be associated with treatment response,” Gallagher said. “By using these approaches, we hope to not only accelerate medicine development but also someday put these tools in the hands of patients and doctors to help guide treatment decisions.”

Tom Hudson, M.D., AbbVie’s Senior Vice President of R&D and Chief Scientific Officer, envisions “precision medicine for every program.”

Even AbbVie’s Discovery group, which drives early science and early pipeline work, is looking at how precision medicine can help patients beyond oncology and immunology. For example, neuroscience teams are also using imaging and biomarkers to study the most promising areas of disease biology to help develop strategies that directly target disease pathology to potentially treat diseases like Alzheimer’s and Parkinson’s.

“When someone has a fever, doctors want to know the cause,” Hudson said. “They don’t stop at treating the fever. That is where medicine is headed in the next decade. There is not one drug for breast cancer or one drug for lupus. We want to know the cause and the pathology of that disease that is specific for each patient. In the future, we hope that understanding will lead to more targeted and effective medicines for patients.”