By Eric Smalley
August 31, 2011
Personalized medicine — the concept of targeting drugs to address an individual’s biomolecular makeup — is reshaping drug development at pharmaceutical companies around the world. A key aspect of personalized medicine is the creation of diagnostic tests which can determine whether patients will respond to certain drugs, including how much to take and if the drug is effectively working as intended. The process of developing a new drug and designing its companion diagnostic test is a complicated process in which systems engineering has an opportunity to become standard practice in the pharmaceutical industry.
In 2008, pharmaceutical giant Novartis set up a diagnostics development unit, Molecular Diagnostics (MDx), within the company’s pharmaceutical division demonstrating a systems thinking approach to the parallel development processes. Leading the unit’s systems engineering efforts are Michael C. Little, global head of diagnostics development, and Devon C. Campbell, director of engineering and systems.
This October, Little and Campbell will present their approach to designing pharmaceutical diagnostic tests: "Systems Thinking in Personalized Medicine" at the 2011 MIT SDM Conference on Systems Thinking for Contemporary Challenges.
The more we know about an individual’s genetic, protein, and metabolic profile, the easier it is for a physician to select the right drugs and dosages to meet the patient’s targeted needs. A diagnostic test can inform a physician’s determination as to whether a patient is a candidate for a particular drug and what dosage may be appropriate. So the design and development of companion diagnostic tests is becoming a crucial part of developing the drug. "The way the FDA defines this, if your test isn’t very good, your drug is sunk," said Little.
Patients, physicians, testing laboratories, drug makers, insurance companies, and government regulators are all stakeholders in the outcome. So it makes sense that pharmaceutical companies would embrace systems thinking, said Little. "It’s really the focus today of most diagnostic development," he said.
Incorporating diagnostic development within the pharmaceutical division makes it easier for researchers to share information. Developing a drug and a companion diagnostic test in parallel is inherently complicated because drug development and test development involve very different sets of challenges, said Campbell. "That crafts your whole vision for how you’re going about your business from a diagnostics perspective," he said. The challenge is looking at the big picture and being able to optimize it as a system, he said.
Little and Campbell’s talk will explore diagnostic development from macro and microscopic perspectives, including the use of system dynamics, with tools like causal loop diagrams and stock and flow diagrams, to paint the big picture. Nothing we do happens in a silo, said Campbell. "Everything is really a feedback system."
If you can map out the feedback system, you can better identify how the impact of one decision can affect other areas, said Campbell. Repeatedly seeing this in action with in vitro diagnostic development "really demonstrated to me the power of holistic and systems thinking," he said.
At stake is the ability to produce new drugs that deliver on the promise of personalized medicine. "I think we’re at the forefront of a new era in medicine, and I think the companies that execute well on systems thinking are the ones that are going to win this battle," said Little.
Devon C. Campbell
Michael C. Little, PhD