Precision Medicine: Shifting from One Drug for All Trials to Targeted Therapy Trials

With the advancements in clinical informatics and genomics over the last decade, there has been a paradigm shift from “one drug fits all” towards personalized medicine across therapeutic areas, known as precision medicine. Precision medicine finds better matches for existing drugs and identifies individuals with best responses, ensuring the right drug finds the right patient at the right time. Using genomic technologies during the preclinical oncology drug development phase facilitates identification of new biomarkers that can be leveraged clinically to optimize precision medicine in clinical trial designs. Precision medicine involves screening patients to identify individuals whose genetic makeup is likely aligned with the molecular mechanisms of a drug, increasing the probability that a patient responds to the therapy. The FDA considers this targeted approach of precision medicine to have manifold benefits, highlight data that provides more information on the safety, efficacy and genetic predispositions that contribute to varied patient outcomes. The FDA has developed guidance on review programs, including the Accelerated Approval Program, which is intended to expedite the approval of targeted therapeutics (based on surrogate endpoints/Biomarkers/Companion Diagnostics), thus ensuring that drugs with well understood response rates are fast-tracked.

The complexity of cancer continues to be appreciated, even as we gain a better understanding of cell signaling pathways and host immune responses. Genetic alterations play a pivotal role in the growth of all types of cancer, and researchers also have found that individual cancer tumors have a unique genetic profile. Analyzing these genetic profiles with NGS aids in understanding the relationship between biomarkers and patient responses. Genomic technologies facilitate the simultaneous measurement of a compendium of oncology markers that can be used in two ways: to match patients to specific drugs, but also to characterize new associations between biomarkers and therapeutics. Translational research is leveraging this knowledge to pave the way for new therapies and improved use of existing therapies.

Expression Analysis (EA), a Q² Solutions company, has developed a menu of genomic tests to supplement many endpoints for complex clinical trials, including a Comprehensive Cancer Panel (Q² Solutions CCP), HLA typing, exome sequencing and pan-cancer immune-profiling. These assays can be used singly, to match patient to drug—including therapeutic benefit as well as lack thereof—or in combination, to set the stage for more precise and individualized therapeutics, also known as precision medicine. BioPharma can improve the probability of clinical trial success with the Q² Solutions genomic panels to:

• Detect the most common actionable somatic alterations currently reported in cancer, including: point mutations, insertions, deletions and structural rearrangements
• Build comprehensive molecular information on genes of the most well understood pathways, creating a data source that can be used to influence new patient populations likely to benefit from targeted therapies
• Do more with less material, for reduction in testing turnaround time and overall cost

Speakers

Patrice Hugo, Ph.D., Chief Scientific Officer, Q2 Solutions, a Quintiles Quest Joint Venture

Dr. Hugo, currently leads global scientific strategy and implementation for Q2 Solutions, a Quintiles Quest joint venture. Dr. Hugo has more than 25 years of senior scientific leadership experience with extensive management expertise in laboratory operations applied to diagnostics, therapeutic targets and clinical trials. He obtained his Ph.D. at McGill University and completed 5 years of post- doctoral fellowship at the Walter Elisa Hall Institute in Australia, and Howard Hughes Medical Institute in Denver, Colorado.
Dr. Hugo was Associated Vice President Chief Scientist, Scientific Affairs, at Laboratory Corporation of America (LabCorp), and has held several other senior leadership positions at Clearstone Central Laboratories, Caprion and PROCREA BioSciences. A noted industry expert, Dr. Hugo has more than 75 scientific publications in internationally renowned journals. He also played an active role in a number of industry organizations, including being a member of the Board of Directors for the non-for-profit Personalized Medicine Partnership for Cancer in Quebec, and the Steering Committee for the Biomarker Factory.

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Victor Weigman, Ph.D., Associate Director, Translational Genomics, Q2 Solutions, a Quintiles Quest Joint Venture

Dr. Weigman has been doing biomarker discovery research with genomics for over 10 years, with 7 of those being with Expression Analysis (EA), a Q2 Solutions Company. He obtained his PhD at The University of North Carolina in Biology and Bioinformatics within the Lineberger Comprehensive Cancer Center. He has published 14 papers on biomarker identification and assay development over that time and has contributed to the development and launch of several genomic CLIA Assays.
Dr. Weigman currently directs the Translational Genomics Unit of Q2 Solutions, whose goal is the continued facilitation of preclinical drug development through biomarker identification. Ongoing research revolves around the genomic profiling of solid tumors from both DNA and RNA approaches including the development of robust assays that can be leveraged as laboratory developed tests.

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