Patrice Hugo, Ph.D.
Dr. Patrice Hugo is the Q2 Solutions Chief Scientific Officer where he currently leads the global scientific strategy and is responsible for the medical affairs and scientific activities of the Central Laboratories, and the Specialty Testing Centers of Excellence worldwide including Expression Analysis Genomics, Vaccine, Biomarkers and BioAnalytical/ADME laboratories. He was a Principal Investigator leading the T-lymphocyte Unit at the Montreal Clinical Research Institute with academic appointments at McGill University and Montreal University. He then worked at PROCREA BioSciences and Caprion as Chief Scientific Officer and Executive Vice President R&D, respectively. Prior to joining Q2 Solutions, Dr. Hugo was assigned as Chief Scientific Officer at Clearstone Central Laboratories, later acquired by LabCorp, and became Associate Vice President and Chief Scientist at LabCorp/Covance Central Laboratories Division.
Dr. Hugo has more than 75 peer-reviewed scientific publications. He has played an active role in a number of industry organizations, including being a member of the Board of Directors for Personalized Medicine Partnership for Cancer in Quebec, and the Steering Committee for the Biomarker Factory. He is a member of the American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC).
Dr. Hugo obtained his Ph.D. in Experimental Medicine/Immunology at McGill University and completed post-doctoral fellowships in Immunology at the Walter Elisa Hall Institute in Australia, and at the Howard Hughes Medical Institute in Denver, Colorado. Throughout his academic work, Dr. Hugo focused on T-lymphocyte differentiation, self-tolerance induction, and leukemogenesis.
Bob Bailer, Ph.D
Dr. Bailer is the senior director of Vaccines at Q2 Solutions. In this role he oversees all aspects of the immunogenicity testing of vaccine products inclusive of the full assay life cycle from R&D through clinical testing. The range of assays in our Vaccine franchise spans PCR, antibody binding, and functional assays such as viral neutralization. Dr. Bailer has over 25 years of experience in the areas of viral immunology and vaccines. Most recently he served as as the Director of the Immunogenicity Testing Laboratory at the NIH/NIAID/Vaccine Research Center for over 17 years. In this role he oversaw the immunogenicity testing for all VRC clinical trials of vaccine and broadly neutralizing antibodies. Dr. Bailer has in excess of 120 peer-reviewed publications.
Dr. Bailer received a bachelor’s degree in Microbiology from Colorado State University and a Ph.D. in viral immunology from Ohio State University.
Michael Brown, Ph.D.
Immunogenicity/Anti-Drug Antibody, Large Molecule PK
Dr. Brown is the immunoanalytical scientific director and site lead for Q2 Solutions. He is responsible for a broad range of oversight of immunoanalytical laboratory operations in Marietta, Georgia, as well as helping to lead and guide our innovation, technology and scientific execution of work in the field of large molecule bioanalysis.
Most recently, Dr. Brown served as managing director and site head of ICON Bioanalytical Laboratories, where he was responsible for the implementation of scientific and organizational quality for regulated bioanalysis. He brings more than 20 years of experience in the contract research organization and life science sector, with the last 10 years holding positions of increasing responsibility in bioanalytical and immunoassay operations at ICON.
Dr. Brown earned a Ph.D. in microbiology and immunology from the State University of New York (SUNY) Health Science Center at Syracuse.
John Cochran, MD, FCAP
Dr. John Cochran is the Chief Pathologist at Q2 Solutions, where he leads an experienced international team of Pathologists and is responsible for global quality and harmony of Anatomic Pathology (AP) testing and reporting across all laboratory facilities, as well as oversight of training and certification of Pathologists. As the scientific advisor for AP services such as immunohistochemistry (IHC), In-Situ Hybridization (ISH), molecular pathology and cytology, he provides recommendations for new tests, instruments and technologies. Dr. Cochran has more than 20 years of pathology experience as founder, CEO, and Senior Medical Director of Chestatee Pathology Associates, PC, a pathology private practice overseeing 28 labs and actively involved in clinical trials. Prior to joining Q2 Solutions, Dr. Cochran was CLIA Lab Director of several labs in metro-Atlanta, GA and served as administrator for the private practice arm of the Department of Pathology and Laboratory Medicine at Emory University School of Medicine.
From 2014-2016, Dr. Cochran was Clinical Director of the Lab Accreditation Program at The Joint Commission where he also served as a Pathology Specialist Surveyor from 2009-2017. He is also a trained laboratory inspector for the College of American Pathologists, of which he is also a Fellow. Dr Cochran has chaired hospital Institutional Research and Review Boards and participated in multiple clinical trials, both in the clinical setting and for regional CROs and legacy Quintiles (2014-2017). He has developed 77 labs across the US for both his own practice and that of other clinical groups (POLs), predominantly in the areas of Toxicology (Drug Testing and Pharmacogenomics) and AP.
After receiving his undergraduate degrees in Biology and Philosophy from Emory University, Dr. Cochran graduated from the Emory University School of Medicine. He completed his residency at Emory University School of Medicine’s Affiliated Hospitals. Dr. Cochran is Board-certified by the American Board of Pathology.
Mark Edinger is the scientific advisor for flow cytometry at Q2 Solutions, and 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 he is the architect of the systems and workflows used in Q2 Solutions’ flow cytometry assay development and production laboratories. Mark joined Quintiles in 2012 and was 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. Previously, he worked at Becton Dickinson (BD) where he founded the Technical Applications Group, and later the R&D Systems Validation Laboratory. While at BD, Mark worked with scientists at Amgen to develop the whole blood phosphoprotein lysing buffer that is now used daily in laboratories throughout the world. 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. While there, he developed many of the techniques and assays employed today for clinical practice and academic research. During this time, Mark also was a consultant for BD Immunocytometry Systems and participated in clinical trials of new BD products.
Mark graduated from Case Western Reserve University with a Bachelor of Science degree in biology.
Marc Edwards, MD, MBA, FCAP, FASCP
Dr. Edwards is the senior medical director, North America, for the Q2 Solutions Laboratory located in Valencia, CA, and a medical advisor to the medical and scientific affairs teams of Q2 Solutions. He has 25 years of experience in the pathology and clinical laboratory, having supported the global pharmaceutical drug development industry from central laboratories providing laboratory, pathology, and biomarker testing services.
He received a BA in Chemistry from Austin College, a Medical Degree from Baylor College of Medicine, and an MBA at the University of Dallas. He did his residency training at The University of Texas Southwestern Medical Center in Dallas, Texas in an accredited AP/CP 5-year Pathology Residency. He is a Board Certified Clinical and Anatomic Pathologist.
Jill Haizlip, BSc, MBA
Director of Regulatory Affairs, CDx, IVD
Jill Haizlip is the director of Regulatory Affairs for Companion Diagnostics (CDx) and In Vitro Diagnostics (IVD), where she supports regulatory strategy and submissions (US and Ex-US), providing regulatory guidance for internal stakeholders for assay development and clinical studies activities, and support for client engagements. Jill has regulatory and product development experience in IVD device, biologics, and combination drug/medical devices. Jill has assumed leadership of Q2 Solutions’ Companion Diagnostics (CDx) Single Site PMA program. She has a Master of Business Administration from the Bryan School of Business, University of North Carolina, Greensboro, and a Bachelor of Science in Biology from the University of North Carolina, Chapel Hill.
Patrick Hurban, Ph.D.
Dr. Hurban 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.
J. Matthew Hutzler, Ph.D.
Dr. Hutzler is the director of In Vitro Metabolism at Q2 Solutions. Previously, he was a DMPK project lead in drug discovery for five years at Boehringer-Ingelheim Pharmaceuticals, where he worked on several project teams supporting inflammation and atherosclerosis therapeutic areas. Dr. Hutzler also held a similar position at Pfizer Inc. for over five years, initially helping build an in vitro core lab. With over 15 years of experience in the drug metabolism field, his ADME research has focused on characterizing atypical enzyme kinetics for cytochrome P450 enzymes, structure-activity relationships for inhibition of CYP2D6, mechanistic understanding of inhibition of cytochrome P450 enzymes, extrapolation of in vitro metabolism data for human clearance and pharmacokinetic predictions, understanding species differences and variability of aldehyde oxidase activity using hepatocytes, and most recently, investigating novel in vitro models to address slowly metabolized drug molecules. He has published over 30 peer-reviewed articles in high impact journals and three book chapters.
Dr. Hutzler earned his Ph.D. in pharmaceutical sciences from West Virginia University under the direction of Dr. Timothy S. Tracy and completed a post-doctoral fellowship at Pharmacia with Dr. Larry Wienkers.
Wendell Jones, Ph.D.
Dr. Jones is currently principal bioinformaticist and scientific advisor at Q2 Solutions-EA Genomics, where he conducts collaborative scientific research with clients in multiple areas, especially in oncology and immuno-oncology. He has over 15 years of experience in advanced genomic technologies and 20 years of experience in scientific leadership, including serving as vice president of statistics and bioinformatics at Expression Analysis, Inc and chief scientific officer at Reliametrics, a Nortel business unit. Dr. Jones has led the analysis, development and validation of the bioinformatic and computational systems that process complex genomic assays, including next generation sequencing assays, evaluating new and emerging genomic technologies, and developing bioinformatic implementation strategies. He has authored over 45 peer-reviewed publications, serves on the Board of Directors as vice president of the new MAQC Society, and has held leadership roles in the MAQC, MAQC-II, SEQC, SEQC2 consortiums.
Dr. Jones obtained a BS in mathematics at Furman University, earned an MS in math sciences, and a Ph.D in math sciences (statistics emphasis) at Clemson University.
Steven Lobel, PhD, D-ABMLI, MBA, FACB
Clinical Immunology, Pediatric/Endocrinology
Dr. Lobel is the senior director of Q2 Solutions Medical Laboratories. In this role, he leads medical and scientific aspects of clinical laboratory testing for chemistry, urinalysis, hematology, coagulation, flow cytometry, PBMC processing, microbiology, molecular pathology, automated immunoassays, biomarker testing and anatomic pathology. In addition, he is the scientific lead for pediatric and endocrinology studies.
Dr. Lobel has more than 35 years of experience in the medical and scientific realm within academia, hospital, and central and reference laboratories. He is board certified by the American Board of Medical Laboratory Immunology (D-ABMLI) and as such is approved to direct a CLIA certified laboratory. Dr. Lobel also is board certified by the American Academy of Microbiology and is an elected fellow of the National Academy of Clinical Biochemistry (FACB). He has authored more than 50 peer-reviewed publications, is on the editorial board for clinical and vaccine immunology, and is the recipient of several research grants and awards.
Dr. Lobel earned a Bachelor’s degree in microbiology from University of Texas at Austin and a Masters and Ph.D. in immunology at the School of Medicine at State University of New York at Buffalo. In 1977, he earned a Lady Davis Fellowship to perform post-doctoral research at the Hubert H. Humphrey Center for Experimental Medicine at Hadassah Medical Center in Jerusalem, Israel.
Stephen Lowes, Ph.D.
Small Molecule PK
Dr. Lowes is a senior scientific director for small molecule and pharmacokinetics, where he leads the scientific disciplines around LC/MS bioanalysis for both small molecule and biomolecule applications including biomarker assays. Previously, he was an executive management scientific leader of Advion BioServices, where he worked since 1995 in regulated bioanalysis with particular emphasis on LC/MS. Dr. Lowes is a founding member of the Global Bioanalysis Consortium (GBC), and an active contributor to the Global CRO Council (GCC). He is a steering committee member of the bioanalytical microsampling working group, and a past-chair of the AAPS Bioanalytical Focus Group. Dr. Lowes started his industrial career at VG Biotech in the UK that became the LC/MS instrument entity of Waters Corporation. He has more than 40 peer reviewed publications on bioanalysis and is a frequent speaker at national and international conferences. Dr. Lowes is co-editor of the recent text “Regulated Bioanalysis: Fundamentals and Practice.”
Dr. Lowes received his Bachelor’s degree in Analytical Chemistry at Sheffield Hallam University and earned his Ph.D. in Analytical Chemistry from the Open University, United Kingdom.
Vlada Melnikova, M.D., Ph.D.
IVD Alliance Management
Dr. Vlada Melnikova is a scientific advisor responsible for IVD alliance management. Prior to joining Q2 Solutions, Dr. Melnikova held R&D leadership positions at several biotech companies including Trovagene, Transgenomics and ApoCell, where she led the development of liquid biopsy assays and device platforms. She brings over 20 years of experience in oncology biomarker development and basic and translational cancer research, and has authored over 46 peer reviewed manuscripts, journal reviews and book chapters.
Dr. Melnikova earned her medical degree from Russian State Medical University in Moscow, Russia. She received her Ph.D. in Biological Engineering from Université Henri Poincaré, Nancy 1 in France, and completed a postdoctoral fellowship in the Department of Immunology, MD Anderson Cancer Center, Houston, Texas.
Ayaskant Pany, MD
Dr. Pany is the sr. medical laboratory director for the Q2 Solutions Laboratories located at Edinburgh, UK and at Centurion, South Africa. He also serves as the scientific advisor for microbiology/tropical diseases as part of the medical and scientific affairs teams of Q2 Solutions. His primary responsibilities include scientific and technical management of the laboratories and its employees, and overseeing developmental activities for TB and microbiology at Q2 Solutions. Previously, Dr. Pany worked at Quintiles Clinical Trials Laboratory, Mumbai, and was in charge of the setting up and operation of bacteriology/molecular biology and mycobacteriology laboratories at Mumbai and Centurion facilities, respectively. He was a research scientist and coordinator for R&D services at the R&D Division (advanced genomics, proteomics and molecular biology) of Super Religare Laboratories Ltd., Mumbai, and as lecturer, Mycobacteriology Section, Department of Microbiology, at St. John’s National Academy of Health Sciences, Bangalore. Dr. Pany has more than 17 years of experience in the medical field in various capacities – scientist, academician, clinician and surgeon - with 7 years within the clinical trial diagnostic industry. His areas of special interest are infectious diseases clinical trials especially tuberculosis, laboratory management, biosafety, assay development and diagnostics. He has presented and published original research and reviews in reputed conferences and journals. He also served as a College of American Pathologists (CAP) Inspector in the fields of microbiology, immunology and molecular biology.
Dr. Pany has an MD in microbiology from Bangalore Medical College and Research Institute and an MBBS from MKCG Medical College, Berhampur, Odisha. He holds a life membership of Indian Association of Medical Microbiologists (IAMM) and is also registered as a Professional Natural Scientist with the South African Council for Natural Scientific Professions (SACNASP).
Joseph Sebastian, Ph.D.
Dr. Sebastian is the scientific advisor for infectious diseases at Q2 Solutions. Most recently, he was associate vice president and national discipline director for molecular infectious diseases at LabCorp. Dr. Sebastian has more than 18 years of scientific leadership experience with extensive management expertise in laboratory operations, report approvals and validation applied to diagnostics and clinical trials, especially in infectious diseases area. He has more than 30 scientific publications in internationally renowned journals and more than 35 scientific presentations at major national meetings. He is also a Fellow of the National Academy of Clinical Chemists.
Dr. Sebastian obtained his Ph.D. in biochemistry at Washington State University and completed post-doctoral fellowships in DNA repair and hormonal carcinogenesis at the University of North Carolina at Chapel Hill and NIEHS/NIH at RTP, NC.
Precision Medicine Software and Technologies
Dr. Wang is the CEO of BioFortis, the precision medicine and technology solutions offering, and a Q2 Solutions company. For more than 20 years, Dr. Wang developed several software products with pharmaceutical customers, government agencies, and academia. He has deep knowledge in the rapidly evolving field of precision medicine and its associated biomarker-driven clinical trials, and strives to bring precision medicine technology solutions to researchers to help solve real-world health problems.
Dr. Jian Wang received his Ph.D. in bioengineering from the University of Washington.
Companion Diagnostics, Oncology
Alan Wookey is the global science lead for companion diagnostics, and the scientific advisor for oncology. 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. Prior to joining Q2 Solutions, he 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 its clinical biomarkers group. During his 20+year career, Alan also served as associate vice president, global head of companion diagnostics, of LabCorp Clinical Trials (now Covance).
Alan earned Bachelor of Science degrees in life sciences and microbiology from the University of Liverpool, and a Post Graduate Diploma in management studies from Manchester Metropolitan University.