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– and help us bring laboratory science into the next
generation.

Working alongside smart and driven colleagues, you can
make a lasting impact on our customers, the industry,
patient health around the world, and your career.  

Tumor Mutational Burden
          (TMB) Assay



Immune Landscape Signatures



Microsatellite Instability
          Assay (MSI)





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Related Services:
  • Genomics
  • Central
  • Bioanalytical
  • Flow Cytometry
  • Vaccines


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Insight:
  • Through Q2 Solutions' Oncology Center of Excellence, our experts in biomarker discovery are providing a better understanding of therapeutic targets, molecular signaling, drug biology and patient response
  • EA Genomic Services, a Q2 Solutions Company, bioinformatics experts and scientists have published over 150 peer-reviewed articles in leading scientific journals since 2001 and have taken  major roles in the FDA-led MAQC and SEQC projects
Innovation:
  • Adopt innovative new strategies for patient selection. We've developed dramatically more efficient means of enrolling rare, biomarker-defined patients - leveraging next-generation sequencing and our established site relationships
Results:
  • Q2 Solutions helped develop diagnostics for many of the biomarkers used today, including BCR-Abl, ALK, BRAF, C-KIT, EGFR, KRAS and HER2--AFTER THIS!!!!!!!!!!!!!!

 

 




Industry Trends Our Testing Solutions
Less Invasive Sampling
  • Liquid biopsy: cell free nucleic acids and circulating tumor cells (CTCs)
  • Mutation detection including Next Generation Sequencing
  • Flow cytometry, immunoassays, proteomics
Shift toward molecular methods
  • Next generation sequencing (NGS) replacing FISH panels
  • Gene expression panels replacing multiple IHCs
Ultra-high sensitivity
  • Mutation detection at < 0.01%≤/li>
  • Single-cell analysis by flow cytometry/molecular platforms
  • Detection of disease and early resistance
Companion Diagnostics
  • Already established for many methods
  • Expanding to genomics/NGS platforms
HELLOOOOO
LNS offers:
Contracts, Legal and Procurement: As one of the industry's largest and most trusted lab service providers, we can establish contract directly with global cendors and take responsibility for all devliery and governance.
Quality Assurance: We employ a rigorous vendor qualification process and uphold monitoring efforts that include on-site audits by trained quality assurance auditors, monitoring of established KPIs and tracking of Corrective and Preventative Actions (CAPA) plans.
Project Services: Your dedicated laboratory network manager ensures integration of external laboratories in your study and manages the vendor relationship, governance, and initial point of escalation.
Data management: We utilize Quintiles Infosario® to provide customers harmonized, consolidated data from multiple sources.




Meet the Authors:

Mark Edinger, Scientific Advisor, Flow Cytometry, Q2 Solutions

Mark Edinger Mark Edinger is the scientific advisor for Flow Cytometry at Q2 Solutions. As the scientific advisor, Mark is responsible for flow cytometry assay design and implementation. He works with both the Translational Biomarkers Laboratory to develop assays and the Global Cytometry Group to produce assays, and is the architect of the systems and workflows used in Q2 Solutions’ flow cytometry assay development and production laboratories.

Mark began his career at the Cleveland Clinic Foundation, a preeminent medical institution, where he pioneered flow cytometry in the late 1970s, building both clinical and research core flow cytometry laboratories. During his 21 years at the Cleveland Clinic, Mark developed many of the techniques and assays employed today for clinical practice and academic research. During this time, Mark also was a consultant for Becton Dickinson (BD) Immunocytometry Systems and participated in clinical trials of new BD products. In 1998, Mark formally joined BD where he founded the Technical Applications Group, and later the R&D Systems Validation Laboratory. While at BD, Mark, working with scientists at Amgen, developed the whole blood phosphoprotein lysing buffer that is now used daily in laboratories throughout the world. Mark joined Quintiles in 2012 and has been part of a collaboration which introduced the quantitative standardization of flow cytometers, along with other state of the art practices, making Quintiles flow laboratories the first to offer this level of instrument standardization anywhere in the world. Mark became part of the Q2 Solutions team when the company was officially launched in June 2015 as a result of a Quintiles and Quest Diagnostics joint venture.

Mark graduated from Case Western Reserve University with a Bachelor of Science degree in Biology.

Victor Weigman, Ph.D., Director, Translational Genomics, Q2 Solutions

Victor Weigman Dr. Victor Weigman, Ph.D. is Director, Translational Genomics at Q2 Solutions, a Quintiles Quest Joint Venture, leading the group with a goal of continued facilitation of pre-clinical 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.

Dr. Weigman brings more than 10 years of biomarker discovery research with genomics, with a majority of them dedicated to Expression Analysis (EA), a Q2 Solutions Company. He has published 14 papers on biomarker identification and assay development and has contributed to the development and launch of several genomic CLIA Assays.  Additionally, Dr. Weigman is involved in pharma partnerships for clinical trial development using genomic profiling technologies.

Dr. Weigman obtained his Ph.D. at the University of North Carolina in Biology and Bioinformatics within the Lineberger Comprehensive Cancer Center.

Patrick Hurban, Ph.D. Senior Director and Global Head, Translational Genomics, Q2 Solutions

Patrick Hurban Patrick Hurban, Ph.D. is senior director and global head of Translational Genomics at Q2 Solutions. In this role, he is responsible for the identification and implementation of new genomic capabilities, encompassing bioinformatics and wet-laboratory methods, as well as the development and validation of genomic assays to support research and clinical programs. These include broad-based screening assays, such as exome and RNA sequencing, to highly focused expression, genotyping and sequencing assay panels that target a smaller number of genes. 

Dr. Hurban has more than 25 years of experience in molecular genetics, including more than 18 years in positions of increasing responsibility in high-profile genomics-focused organizations. His research interests have focused on the genetic control of gene expression and have spanned diverse fields such as toxicology, developmental, and cancer biology. 

Following a Bachelor’s degree in Biology from the University of North Carolina at Chapel Hill, he earned his Ph.D. in Human Genetics from the University of Utah in Salt Lake City before serving as a postdoctoral research fellow of the American Cancer Society in the Department of Developmental Biology at Stanford University.

Alan Wookey, Scientific Advisor, Oncology and Companion Diagnostics, Q2 Solutions

Prior to joining Q2 Solutions, Alan Wookey served as Director and Head of the Oncology Biomarker Group at AstraZeneca where he initiated the company’s personalized medicine and pharmacogenetics efforts, as well as their Clinical Biomarkers Group. During his more than 20-year career, Wookey also served as Associate Vice President, Global Head of Companion Diagnostics, of LabCorp Clinical Trials (now Covance). 

At Q2 Solutions, he leads business development and scientific strategy for the companion diagnostics and oncology service offerings. He also provides expert consultation in a number of areas including science and technologies, regulatory and management.  Alan Wookey earned Bachelor of Science (B.Sc.) degrees in life sciences and microbiology from the University of Liverpool and his Post Graduate Diploma in Management Studies from Manchester Metropolitan University.

Franklin Sederat, M.D. MSc, Director of Hematopathology, Q2 Solutions

Franklin Sedarat Dr. Franklin Sedarat is board certified in anatomic pathology, clinical pathology, and hematology. Dr. Sedarat has more than 10 years of experience in hematopathology and oncological pathology, with a long track record as consultative diagnostician in hematopathology. Prior to coming to Q2 Solutions, he served in multiple national reference labs including Integrated Oncology/LabCorp, Genzyme Genetics, and Genoptix. Dr. Sedarat has published in multiple peer reviewed journals and has presented in various national and international conferences. 

As director of hematopathology at Q2 Solutions, Dr. Sedarat Oversees anatomic pathology and hematopathology clinical operations and testing in Valencia, ensures laboratory operations meet or exceed all applicable regulatory requirements, and that the highest standards of customer service, quality and safety standards are maintained. As a principal investigator, he supports multiple clinical trials and companion diagnostics studies.

Patrice Hugo, Ph.D., Chief Scientific Officer, Q2 Solutions

Patrice HugoPatrice Hugo, Ph.D. is chief scientific officer of Q2 Solutions, a Quintiles Quest Joint Venture. Dr. Hugo leads the organization’s global scientific strategy and implementation, developing and accelerating strategies to help improve human health through innovation that transforms science and data into actionable medical insights.

Dr. Hugo brings more than 25 years of senior scientific leadership experience with extensive management expertise in laboratory operations applied to diagnostics, therapeutic targets and clinical trials. Most recently, Dr. Hugo was Associate Vice President and Chief Scientist at Laboratory Corporation of America (LabCorp). He has held several other senior leadership positions at companies including LabCorp, 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 is active in a number of industry organizations, including his role on the Board of Directors for the non-for-profit Personalized Medicine Partnership for Cancer in Quebec, Warnex offering analytical and bioanalytical services and his role as a Steering Committee Member for the Biomarker Factory.

Dr. Hugo obtained his Ph.D. at McGill University and completed five years of post- doctoral fellowship at the Walter Elisa Hall Institute in Australia, and Howard Hughes Medical Institute in Denver, Colorado.
Time Speaker Topic
1:30-1:50 pm Patrice Hugo, Ph.D., Immunology description
1:50- 2:15 pm
Radha Krishnan, MD, Anatomic Pathology description
2:15-2:40 pm Patrick Hurban, Ph.D., Genomics description
2:40-2:55 pm
Break
2:55-3:15 pm Michael Brown, Ph.D.,
Immunogenicity/Anti-Drug Antibody, Large Molecule PK
Break
3:15-3:45 pm Mark Edinger, Flow Cytometry Break
3:45-4:30 pm Andrew Crenshaw, Global CDx Discipline Director
Alan Wookey (Panelist), Companion Diagnostics, Oncology
Break