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Join us for the Immuno-Oncology Scientific Symposium on September 27, 2019.
Location: Nobu Hotel, 2-4 Avenida de Roma, Barcelona, ES, 08014, Barcelona, Spain
Time: 10:00 am -1:00 pm with lunch to follow

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Conference Agenda

Please note: Agenda times listed are approximate. Doors will open at 9:30 am for registration.

Time Speaker Topic
10:00-10:25 am Patrice Hugo Laboratory Considerations for Immuno-Oncology and
Drug Development
10:25- 10:50 am
Patrick Hurban Integrating Molecular Profiling into Biomarker Strategy
10:50-11:15 am John Cochran Anatomic Pathology for Developing Biomarkers
for Immuno-Oncology
11:15-11:30 am
Break
11:30-11:55 am Michael Brown Bioanalytical Quantitation and Immunogenicity Testing
in Immuno-Oncology Trials
11:55 am-12:20 pm Alistair Watt Next Generation Immuno-Oncology Flow Cytometry
12:20-12:45 pm Alan Wookey Companion Diagnostics for Immuno-Oncology
Clinical Development
12:45-1:00 pm Q&A Session

Topic Abstracts

Laboratory Considerations for Immuno-Oncology and Drug Development
Patrice Hugo, Ph.D., Immunology

The conceptual approach of targeting the immune system to either elicit or boost an immune response against cancer cells has been around for more than a century. However, it was the regulatory approval of ipilimumab, an anti-CTLA-4 antibody immune checkpoint inhibitor (ICI), in 2011 that prompted a paradigm shift in the field of cancer immunotherapy. There are now over 3,000 interventional active clinical trials evaluating cancer immuno-therapeutics. Half of those trials involve anti-PD-1 and/or anti-PD-L1 antibodies, with so far six of those being FDA approved. Other Immuno-Oncology (I-O) therapeutic modalities are also being developed, such as new T-cell targeted immunomodulators (ex: LAG-3), cancer vaccines, oncolytic viruses, cellular therapies (ex; Chimeric Antigen Receptor T-cell: CAR-T), anti-CD3-targeted bispecific antibodies and other immunomodulators (ex: Interferon-α approved in 1986). Together there are more than 25 I-O drugs approved in the USA.  Much effort has focused on the identification of biomarkers predictive of I-O drug response, particularly with ICIs. For instance, clinical findings have established that with pembrolizumab (anti-PD-1 ICI), patients with tumors expressing PD-L1 have higher drug response rate, hence leading to the concomitant approval of its anti-PD-L1 Companion Diagnostic (CDx). Last year, pembrolizumab and nivolumab were approved for the treatment of unresectable or metastatic solid tumors and Colorectal cancer (CRC) respectively, with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. Intense research activities are focusing not only on the development of more efficacious I-O drugs but also on the evaluation of predictive markers such as tumor infiltrating lymphocytes (TILs) and Tumor Mutation Burden (TMB). This presentation will provide an overview of the implications and challenges of incorporating such biomarkers in global clinical trials from a central laboratory perspective. The presentation will also set the stage for the rest of the sessions in this symposium including considerations around key I-O clinical trial laboratory disciplines including anatomic pathology, genomics/genetic testing, and flow cytometry, as well as Companion Diagnostics in support of I-O Clinical Development Programs.


Anatomic Pathology for Developing Biomarkers for Immuno-Oncology
Dr. John Cochran MD, FCAP, Pathology 

The approach to a complex and multifactorial disease like cancer is no easy challenge. A new landscape has emerged in the approach to cancer care with PD-L1 emerging as THE clinical immune biomarker leading the immune biomarker development efforts complimenting overall drug-development efforts. Data from both prospective and retrospective Phase I, II and III trials have demonstrated the association between tumor PD-L1 expression and response to anti-PD-1 agents.  Correlation between PD-L1 expression in the tumor microenvironment (TME) and clinical responsive to PD-1 blockade has also been reported.  In parallel, the dynamic nature of PDL1 as a biomarker has also been recognized due to change in expression and variable results, leading to re-evaluation of its role as a biomarker.

Current assays for the determination of PDL1 status in tumors are based on immunohistochemistry and demonstrate some differences in assay characteristics. Each companion diagnostic assay supports specific registered therapy creating complexity for patients in the use of PD1- and PDL1-blocking agents if they move from one PD1- or PDL1-targeted therapy to another. Recognizing this challenge early on, the oncology community has initiated efforts to harmonize led by FDA and non-profit organizations.  The characterization of immune infiltrate in the tumor using the immunoscore has been recognized as a possible prognostic and predictive factor.  Technological advances like multi-color immunohistochemistry, provide new opportunities to better characterize the underlying biology of PDL1 expression. Ideally, anatomic pathology biomarker development would utilize existing tissue biopsy samples, reducing patient burden and streamlining the research process. Tests would be straightforward in creation and interpretation, methods standardized across trial sites, and biomarker assays developed for research would lead to beneficial, commercially available tests.  In reality, the process of creating and implementing a biomarker using new or archival tissue faces several key challenges, which will be reviewed during the presentation.


Integrating Molecular Profiling into Biomarker Strategy
Patrick Hurban, Ph.D., Genomics

The success of checkpoint inhibitors has led to unmatched excitement about immuno-oncology approaches. Development of immuno-therapeutics has resulted in significantly improved clinical outcomes for some patients suffering from serious cancers. Despite these successes, very little is known about prognostic or therapeutic biomarkers to help identify people who could receive these benefits. Genomics can empower the success of these therapies by identifying biomarkers to pinpoint patients likely to experience the greatest benefit, while potentially reducing toxicities and adverse events. Identifying biomarkers associated with these benefits can be accelerated by using high-throughput sequencing (HTS) technology, which has already demonstrated great promise in targeted therapy approaches. Beyond discrete biomarkers associated with specific genes or tissues of origin, there is increased excitement surrounding biomarkers describing broad-based genomic features—such as microsatellite instability or tumor mutational burden—which have proven utility regardless of tissue of origin. Molecular profiling of the tumor genome and transcriptome thus provides insight into general and specific molecular lesions important in the progression of the tumor, as well as insight into the degree and character of immune system activation. Other genomic assessments, such as T Cell Receptor sequencing and clonality can further characterize the tumor microenvironment, while methods such as metagenomic analysis using 16S sequencing can identify systemic features that may correlate with efficacy. Here we summarize the clinical relevance of these and other methods that facilitate comprehensive genomic profiling, as well as when and how to use these methods for biomarker discovery for immunotherapy trials.

Bioanalytical Quantitation and Immunogenicity Testing in Immuno-Oncology Trials 
Michael Brown, Ph.D., Immunogenicity/Anti-Drug Antibody, Large Molecule PK

Essential to any drug development program is pharmacokinetic (PK) and immunogenicity data sufficient to demonstrate safety and efficacy in appropriate conditions of use. Regulatory guidelines exist for quantitative (PK) bioanalytical methods and for the identification, characterization and quantification of antibodies to those drugs. Many factors may influence the PK and the development of an immune response against therapeutic proteins used in I-O trials. Among these are treatment associated factors (mode of action, route of administration, frequency of administration, duration of therapy) and patient and disease related factors (disease type and status, immune system function, genetic factors, concomitant disease, prior exposure, pre-existing antibodies). Combination therapies such as biologic dual checkpoint blockade, large molecule blockers with co-stimulatory agonistic antibodies, bifunctionals/bispecifics, biologic and small molecule inhibitors increase the complexity of the design and validation of sensitive and specific methods. To be discussed are key considerations in planning and resourcing that will insure the availability of materials and the proper design essential to validating bioanalytical methods that provide the characteristics that meet the needs of the program and those of regulatory agencies.

Next Generation Immuno-Oncology Flow Cytometry
Alistair Watt, PhD., Translational Science

A next generation of flow cytometry practice has evolved in recent years. This evolution is based, in part, on more complete instrument characterization and standardization, refinement of panel construction, optimized processing protocols, new polymer fluorochromes, advancements in detector technology, and new acquisition and analysis algorithms. Together these developments provide the basis for an exquisite, new, and expanded set of tools for dissecting the immune response to malignant cells and the overall tumor microenvironment. These practical and technological advances in flow cytometry practice serendipitously arrived concomitantly with our burgeoning understanding of the role of the immune response in the progression or eradication of tumor. These advances now provide a significant discovery driver on how best to monitor and manipulate the immune response to produce more efficacious treatment outcomes. Highly complex flow cytometry assays (30 plus biomarkers in a single tube with greater than 500 reportable populations) are now routinely used to monitor immune response checkpoint inhibitors, cellular proliferation, activation or exhaustion, tumor infiltrating T Cells, circulating levels of chimeric antigen receptor T Cells, multi-specific antibody construct performance, drug receptor occupancy, and post treatment levels of disease. In addition, the large-scale implementation of next generation flow cytometry in the clinical trials has now become practical with the availability of affordable novel high-performance instrumentation, expanded software analytical capabilities, and cloud-based analysis tools and reporting capability.

Companion Diagnostics for Immuno-Oncology Clinical Development
Alan Wookey, Companion Diagnostics and Oncology 

Companion Diagnostics have been approved for several Immuno-Oncology (I-O) agents. The Central Laboratory involvement in generating the data to support such submissions is key but not without its challenges. This presentation will discuss the experience of a large Central Laboratory of delivering global PD-L1 data to support such submissions, as well as the other technologies and biomarkers that hold promise in validating predictive biomarkers for I-O.
 

Speakers:

Patrice Hugo, Ph.D.
Immunology

Dr. Hugo, chief scientific officer at Q2 Solutions, 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 LabCorp/Covance. He has held several other senior leadership positions at companies including 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 a 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.

Patrick Hurban, Ph.D.
Genomics

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. 

John Cochran, MD, FCAP
Pathology

Dr. John Cochran is the Chief Pathologist at Q2 Solutions, where he leads an experienced global team of Pathologists and provides strategic vision to the company. He has over 20 years of pathology experience and vast knowledge of the clinical trial industry. Previously, Dr. Cochran was CEO and founder of Chestatee Pathology Associates, a pathology private practice with contractual relationships for professional laboratory management. Prior to that, he was Medical Director at Pathology Lab in Georgia. Dr. Cochran has served as a managing consultant to Emory Specialty Associates, Division of Pathology, the private practice arm of the Department of Pathology at Emory University. In addition, he was a consultant to numerous wealth management firms worldwide on healthcare investments, as well as to internet-based medical content providers on subjects involving the pathologic basis of disease.

After receiving his undergraduate degree from Emory University, Dr. Cochran graduated from the Emory University School of Medicine. He also completed his residency at Emory University School of Medicine. Dr. Cochran is board certified by the American Board of Pathologists.

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.

Alistair Watt, Ph.D.
Translational Science

Alistair Watt, Ph.D. is the Director of the Translational Science Laboratory (ADL) in Europe and is based in Edinburgh, Scotland. He has significant experience in the development of flow cytometry, ELISA and Molecular Biology assays for clinical trials. Before joining Q2 Solutions, Dr. Watt was a Senior Post-Doctoral Fellow at the University of Edinburgh working on a European Union Framework 6 project to define the conditions necessary for controlled embryonic cell differentiation to multiple cell types. In this role, he mentored Ph.D. students and produced coursework and taught undergraduates. From 2000-2003, Dr. Watt worked at the Medical College of Wisconsin, Milwaukee. He was awarded an American Heart Association Post-Doctoral fellowship to study the transcriptional control of heart development leading to a number of high profile publications. Dr. Watt received his Ph.D. from the University of Edinburgh in 1999 for work on liver development as a model for tissue formation and differentiation.

Alan Wookey
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.