Our passion for precision or personalized medicine dates back to my early research career in clinical pharmacology. I started to investigate the impact of genetic polymorphisms and changes in gene expression of cytochrome P450s (CYPs) in the late 80’s and early 90’s in the laboratory of Prof. Urs A. Meyer, who discovered and described the CYP2D6 polymorphisms and their impact on debrisoquine. From there, my interest in pharmacogenetics moved from the lab to applied research and the clinic, developing new genotyping tools based on microarray and other high-throughput technologies before capillary and next-generation sequencing became abundant.
In the early 2000’s the FDA started to publish on pharmacogenetics and the impact on genetic variations on PK and PD. I was fortunate to meet Drs. Larry Lesko and Janet Woodcock who trusted me to help draft the first guidance document that introduced genetics and genomics into the regulatory process, the FDA guidance for industry: pharmacogenetic data submissions. I became the Agency’s first Associate Director for Genomics and, together with Federico Goodsaid formed the Genomics Group as part of Clinical Pharmacology in CDER, as well as a new FDA-wide, inter-Center, interdisciplinary pharmacogenomics review team. We started to update drug labels with pharmacogenetic information, published the first version of the FDA’s biomarker table website, created an entirely data submission process, authored the first policies on companion diagnostics (it later became a draft guidance), and designed and implemented a new biomarker qualification process (now known as the Biomarker Qualification Program), which was also the first demonstration project of the Critical Path Initiative.
Our tenure at the FDA led to many successes, most of all invoking a change in the industry not only integrating genetics, genomics, and other biomarker research in pharmaceutical and diagnostic development, but sharing this information with the Agency and using it for regulatory decision making. The challenge for precision medicine to reach patients now was less of a regulatory issue and more of a market access/ commercialization question. The pharmacy benefit management industry, sitting in between manufacturers, payers and providers creates an ideal hub for introducing new technologies into the health care market. I joined Medco in 2008, at the time the largest pharmacy benefit management company, to build a personalized medicine research team. Here I met Julia McEachern and Gabriela Lavezzari who helped me build the Medco Research Institute, a large health economic and outcome research (HEOR) organization. Several of our clinical research efforts translated into commercial programs deployed through Medco’s pharmacy infrastructure.
In 2012, after the acquisition of Medco by Express-Scripts, I founded Opus Three. Since inception, we advised 50+ clients for, among other efforts, the regulatory approval of several diagnostic and pharmaceutical products and helped starting and expanding companies, evaluated market opportunities, performed due-diligence, designed clinical trials, and facilitated small and large corporate initiatives, including change management efforts.
One of the bottle-necks in precision medicine is the analysis of complex, heterogeneous data. Traditional statistical methods are not suitable for the competent analysis and interpretation of large, multivariate data. New analytical approaches, such as e.g. formal concept analysis are needed to identify meaningful signals with confidence. Opus Three recently formed a strategic alignment with Ariana Pharma, an artificial intelligence and advanced analytics company under the leadership of Mohammad Afshar. This new capability allows us to seamlessly integrate biomarker and other (clinical) data with regulatory and commercial strategies that depend on advanced statistics and the integration of biological and clinical knowledge.
Regulatory consulting remains the main focus of Opus Three and I am excited about the expansion of competencies and services that complement this core competency. We work closely with our clients, believe in a hands-on, results-oriented approach, and take pride in building lasting, long-term relationships. Together with our clients we are excited to look back on hundreds of successfully completed assignments, creative solutions and the launch of new products – and we look forward to working with you to make a difference in patients lives.