Q&A: Steven Watkins, CSO, Lipomics

Founded in 2000 and headquartered in West Sacramento, Calif., Lipomics Technologies specializes in analyzing and interpreting lipid metabolism with an eye toward a better understanding of disease progression and drug discovery. Recently, Executive Editor Randall C Willis talked to Dr. Steven Watkins about the company’s perspective on lipidomics and the pharmaceutical industry.

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Founded in 2000 and headquartered in West Sacramento, Calif., Lipomics Technologies specializes in analyzing and interpreting lipid metabolism with an eye toward a better understanding of disease progression and drug discovery. Recently, Executive Editor Randall C Willis talked to Dr. Steven Watkins about the company's perspective on lipidomics and the pharmaceutical industry.
What is lipidomics and its role in drug discovery?
Lipidomics and the technologies that spin out of lipidomics should have a large role to play in the drug development process. Lipids are central to metabolism and the dysregulation of lipid metabolism is primary to diabetes, obesity, cardiovascular disease, inflammation, and a host of other diseases of importance to public health. It is very surprising to me that more isn't known about lipids already. We really are ten years behind proteins, genes, and transcripts in terms of our technology and understanding. What we do have going for us is the fact that most of the qualitative pathways for lipid synthesis and metabolism are known, so we have a roadmap to work with.
What we need to understand better is the regulation of these pathways and their involvement in disease processes. This is why we have developed our technology to be quantitative and comprehensive for lipid metabolites. We can measure the absolute amounts of each product, substrate and intermediate of the pathways simultaneously and we can use these data to assemble an understanding of the biological underpinnings of disease and treatment response.
We are currently using the analytical data and our interpretive capabilities to help characterize preclinical model systems and drug responses, to identify markers of healthy versus disease conditions, translate results from preclinical models to humans, to select drug candidates with greatest impact on disease markers and hence efficacy, and to help manage clinical trials by providing dose-response and efficacy information linked to the metabolic basis for a physiological change.
In the near future, we intend to provide companion diagnostics for commercialization with drugs to help provide each patient with the most effective drug therapy. This in turn increases physician loyalty, improves patient compliance, enhances market viability, and enables premium pricing and increased profitability
Can you offer examples of using lipidomics to understand drug targets or disease?
The bulk of the work at Lipomics is clinical, and we are involved in two general areas of clinical research. The first centers around finding pathways and markers of disease that will be informative in developing diagnostics and new drugs. For example, we are involved in building an understanding of the role of lipid metabolism in insulin resistance, obesity, and weight gain and loss. The second area of research is therapy focused, and we are typically looking for markers of efficacy and dose response that can be linked to biochemical pathways.
Where do you see this technology most benefiting the bottom line of drug discovery?
New and innovative therapies and a better understanding of targets and drug effects. A good example of an application for our technology would be in finding PPARs agonists that provided both improved insulin sensitivity and no increased body weight. Because outcomes such as these are apparent from their biochemical signatures on our platform, we can quickly vet new compounds for their effect on these processes.
Likewise, we can provide translational capabilities including confidence that the effects will be observed in humans, and validation of effective dosing and response in clinical trials. The speed and confidence with which drugs can move through the pipeline will be significantly increased by using the robust biochemical markers of metabolism so apparent in lipid metabolite profiles.
How do you see the marketspace for metabolic disorders such as diabetes and obesity developing?
I think everyone agrees that the market for obesity therapies and products will experience significant growth because of the obviously growing population base. It is interestingly a space with both a huge need and an almost utter lack of current, viable solutions. The best-selling obesity drug today generates only about $100 million in revenue, despite the widely recognized obesity epidemic—highlighting the need for better obesity therapy.
Although there is debate over whether obesity is best treated as a metabolic or behavioral issue, there seems a common underlying belief that an effective obesity drug will quickly achieve blockbuster status. We believe that because any mechanism of weight loss that leads to decreased fat must by definition have a metabolic effect, our technology is well positioned to take advantage of the marketplace.
 What other disease areas might benefit from lipidomics analysis?
Lipids might not be the first thought to come to mind when you think about the causes of autism, Alzheimer's, or cancer, but they are critically important to these diseases and virtually all others. Lipids are central to metabolism and integrated into virtually all metabolic processes at some level. Even in those diseases where lipids are not primary causative agents, maintaining proper lipid metabolism is very important to the success of treatment and for maintaining quality of life.
 What is the next challenge for lipidomics?
We have made substantial inroads in the industry to demonstrate the utility of measuring lipid metabolites to facilitate drug discovery, development, and commercialization. We have worked with 11 of the 12 largest pharmaceutical companies, among many other companies and institutions. However, it seems the industry is still grappling with several issues to fully accept metabolism-based approaches. For example, there is the issue of data reduction and analysis. We're addressing this by having assembled what we believe is the world's leading bioinformatics–biology group, where our focus is to guide all assays and analysis by an understanding of the underlying biochemistry. Fundamentally, we seek to leverage the 100 years of accumulated biochemical knowledge to focus our analysis on biologically meaningful interpretations.  
There is also the issue of coordinating efforts of pharmaceutical and diagnostics companies to ensure that the promise of "companion diagnostics" is attained. This is a non-trivial challenge, but one that is surmountable. When you consider that a $30-billion cholesterol-lowering drug market exists solely because we can measure LDL cholesterol accurately, it is easy to see the benefit of companion diagnostics. As a small company among established pharmaceutical and diagnostics companies, we are pursuing creative ways to align these parties and ensure that reliable biomarkers are available and validated on a worldwide basis upon commercial introduction of new drugs, with supporting physician education and training.
Finally, there is always the regulatory component. Fortunately, the FDA has taken a proactive stance and is progressively advancing an agenda that will enable numerous 'omics based approaches to commercialize metabolic diagnostics.

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