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Sunday, May 5
5:00-6:00 pm Conference Pre-Registration
Monday, May 6
7:30-8:30 am Conference Registration and Morning Coffee
8:30-8:40 Welcome Remarks from Conference Director
Julia Boguslavsky, Executive Director, Conferences, Cambridge Healthtech Institute
8:40-8:45 Chairperson’s Opening Remarks
8:45-9:10 Translating Biological Data into Predictive Biomarker Development Strategies
Brett Hall, Ph.D., Scientific Director, Oncology Biomarkers; Biomarker Lead, Heme Disease Area Stronghold, Janssen R&D, Johnson & Johnson
A decade after completion of the human genome sequence, the translation of complex genomic data into widely used clinical tests has been slower than anticipated. Three complex tests (in vitro diagnostic multiplex index assays - IVDMIA) have been approved as prognostic tests, but there has still not been a single approval of an IVDMIA to predict response to therapy. Retrospective analyses of the development of predictive biomarkers for first-in-class oncology drugs over the last ten years shows that 1) insufficient patients have been exposed to an efficacious dose to support complex statistical analyses to correlate high-content data against clinical endpoints, and 2) biomarkers that correlate to response in Phase II studies are not always good predictors of overall survival in Phase III trials. We will need to modify the clinical development paradigm for first-in-class agents to support the efficient co-development of predictive markers.
9:10-9:35 Application of Next-Generation Sequencing in Phase III Oncology Trials
Shirin Khambata Ford, Ph.D., Executive Director and Global Head, Oncology Correlative Sciences, Novartis
Analysis of tumor samples by next-generation sequencing (NGS) has increased dramatically in the last 2 years. Most of the reported results are genetic landscapes generated on samples collected outside clinical trials or from early phase trials. Application of this technology in large global Phase III trials provides an excellent opportunity for treatment efficacy predictive biomarker explorations. Study design considerations and analysis strategies for the implementation of complex and resource demanding NGS analysis in Phase III trials will be discussed.
9:35-10:00 Can Biomarkers Recover Drug Development from the Ditch?
Abdel Halim, Pharm.D., Ph.D., DABCC-MDx, DABCC-TOX, DABCC-CC, FACB, Director, Clinical Biomarkers, Daiichi Sankyo Pharma Development
Despite all the potential benefits of using biomarkers to advance the pharmaceutical industry, discrepant results can pose a threat to development programs by triggering false decisions. This talk will highlight the following topics: biomarkers and their potential utility in drug development, limitations, major reasons behind discrepant results and possibility of its mitigation.
10:00-10:30 Networking Coffee Break
10:30-10:55 Advancing Biomarkers for Alzheimer’s Disease—From Target Engagement to Diagnostics
Johan Luthman, D.D.S., Ph.D., Senior Program Leader, Neuroscience & Ophthalmology Research & Development Franchise Integrator, Merck
Measuring pathophysiology associated factors, such as Aβ peptide and tau protein in cerebrospinal fluid, and imaging brain function with fluorodeoxyglucose PET or functional MRI, or pathology with amyloid PET or MRI, allows us to detect and follow the progression of very early, pre-dementia stages of AD. While the use of pathophysiology associated biomarkers allows pharmacodynamics monitoring of putative disease modifying therapeutics, further qualification efforts are paving the way for diagnostic and prognostic readouts.
10:55-11:25 Developing Biomarkers to Predict Response to Therapies in Oncology and Autoimmune Diseases through Molecular Disease Sub Typing
Renée Deehan Kenney, Ph.D., Vice President, Research, Selventa
Molecular drivers of disease are manifested across multitudes of interrelated biochemical pathways rather than genomic variations alone. We systematically interrogated thousands of these potential disease drivers with patient data to generate gene expression biomarkers to predict therapeutic response. Two case studies are presented: a blood biomarker to select rheumatoid arthritis patients likely to respond to anti-TNFs, and a tumor biopsy biomarker to select ER+ breast cancer patients prone to disease progression during tamoxifen treatment.
11:25-11:40 Highly Multiplexed SOMAmer Assays as a Flexible Platform for Biomarker Discovery Research
Nick Saccomano, Ph.D., CTO, SomaLogicSomaLogic presents a transformative proteomic biomarker discovery technology that measures > 1100 human proteins in just 50 uL of a biological sample with high-performance and high-throughput. Average LOD is ~40 fM, the overall dynamic range spans 8 logs, with ~5.1% coefficient of variation. This technology is enabled by a new class of reagents (termed “SOMAmers”) that contain novel chemically modified nucleotides which greatly expand their physicochemical diversity. Our assay has been used in dozens of clinical and preclinical studies; we have also demonstrated the progression of protein signatures to multi-analyte panel assays for later stage applications.
11:40-11:55 Taking the Fight Against Cancer Personally
Rami Kakonen, Vice President, Business Development, MediSapiens Ltd.
Current cancer care is a diagnostic nightmare and new ways to enable more accurate and personalized treatments are needed. MediSapiens has developed system that allows the storage and powerful analysis of large genomics datasets to turn the oncology Big Data into knowledge that can be used in development of more personalized cancer therapies.
11:55-12:25 pm Luncheon Presentation
Obtaining NAT Sensitivity with ELISA: Results from Application of Simoa to Blood Screening
David Wilson, Ph.D., Vice President, Product Development, Quanterix
Until recently, nucleic acid testing (NAT) represented the most sensitive method for early acute HIV infection, when individuals are most contagious. Using Single Molecule Arrays (Simoa), a digital ELISA technique, researchers were able to demonstrate a 3000x sensitivity improvement over conventional ELISA and equivalence with the NAT gold standard but at a fraction of the cost. This ground-breaking research has significant implications for blood banking, HIV detection and beyond.
1:20-1:25 Chairperson’s Remarks
1:25-1:50 Implementing Biomarkers in Clinical Trials
Suso Platero, Ph.D., Director, Oncology Biomarkers, Janssen Pharmaceuticals
Finding biomarkers is relatively easy nowadays. One has only to open any journal and find dozens of articles showing the discovery of new biomarkers. The bottleneck in the development of biomarkers is in the correlation of the appropriate biomarkers to each specific drug. This is done in the context of clinical trials. Several strategies will be presented of how to better accomplish this task in an efficient and time sensitive manner.
1:50-2:15 Clinical Innovation in Precision Medicine
Brenda Yanak, Precision Medicine Leader, Clinical Innovation, Pfizer
This presentation will give examples of how Pfizer is innovating in the clinical development space to aid in the advancement of precision medicine.
2:15-2:40 Discovering Oncology Biomarkers and Translating into Clinical Trials
Theresa Zhang, Ph.D., Associate Director, Exploratory and Translational Sciences, Merck
This talk will present a platform for discovering oncology response biomarkers using a large panel of tumor cell lines, validating them in selected in vivo models, and refining and estimating biomarker prevalence in a large human tumor reference dataset. The predictive signature will then be converted into an analytically validated assay that will be performed in a CLIA- or CAP-certified laboratory in order to enroll patients for clinical trials. The process will be illustrated by examples.
2:40-3:40 Refreshment Break in the Exhibit Hall with Poster Viewing
3:40-4:05 Biomarker Discovery for Immuno-Oncology Agents
Jason S. Simon, Ph.D., Director, Immuno-Oncology Biomarkers, Discovery Medicine and Clinical Pharmacology, Bristol-Myers Squibb
Tumor cells can use escape mechanisms to avoid or suppress the natural immune response, ultimately resulting in tumor growth; in fact, avoiding immune destruction is one of the emerging hallmarks of cancer. Therefore, understanding and dismantling key immune escape mechanisms (“checkpoints”) is a key focus of immuno-oncology research. In concert with identifying agents to regulate the immune checkpoint is working to understand which tumor types and patient characteristics will respond best to this treatment approach. This talk will review our strategy to identify biomarkers which help support clinical development and commercialization strategies.
4:05-4:30 Accelerating and Personalizing Clinical Trials with Biomarkers and Adaptive Design, the I-SPY 2 Example
Sonia Pearson-White, Ph.D., Scientific Program Manager, Oncology, The Biomarkers Consortium, Foundation for the National Institutes of Health
I-SPY 2 is a unique clinical trial managed as a public/private partnership by the Foundation for the NIH (FNIH) Biomarkers Consortium. I-SPY 2 employs an innovative adaptive trial design testing multiple drugs in high-risk breast cancers in the neoadjuvant setting, and will advance the understanding of which drugs work best with tumor types with different biomarker profiles, and the drive toward personalized medicine.
4:30-5:00 Metabolomic Profiling for NMR Based Clinical Assay DevelopmentThomas O’Connell, Ph.D., Senior Director, Assay Research & Development, LipoScience, Inc.Metabolomic profiling yields a unique picture of the downstream phenotype taking into account genetic influences as well as environmental factors such as diet, lifestyle and the microbiome. In this presentation it will be shown how NMR technology is used in both the discovery and translation of biomarkers into the clinical laboratory. Applications include the prediction, diagnosis and prognosis of disease as well as the guidance of pharmaceutical interventions.
5:00-6:00 Welcome Reception in the Exhibit Hall with Poster Viewing
6:00-9:00 Dinner Courses
Fit-for-Purpose Biomarker Assay Development and Validation
Next-Generation Sequencing as a Clinical Test
(Separate registration required)
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