Cambridge Healthtech Institute's 10th Annual

Clinical and Translational Biomarkers

Precision Medicine, Liquid Biopsy, and Clinical Trials

September 17 - 18, 2020 ALL TIMES EDT

The promise of precision medicine has been driven by the need to accurately predict patient response to therapy while ensuring drug efficacy and safety. Reducing costs and the time required for drug development is also a driving force in the use of biomarkers. Cambridge Healthtech Institute’s 10th Annual Clinical and Translational Biomarkers meeting will cover novel biomarker discovery, clinical and analytical biomarker validation, and the role of biomarkers in clinical decision making.

Thursday, September 17

PLENARY KEYNOTE PROGRAM

12:20 pm

PLENARY KEYNOTE: Tackling Undruggable Oncoproteins: Lessons from the VHL Tumor Suppressor Protein

William G. Kaelin, Jr., MD, 2019 Nobel Laureate; Professor, Medical Oncology, Dana-Farber Cancer Institute; Investigator, Howard Hughes Medical Institute; Co-Founder, Cedilla and Tango Therapeutics

VHL tumor suppressor protein (pVHL) inactivation is common in kidney cancer and upregulates the HIF2 transcription factor. PT2977/MK-6482 is an allosteric HIF2 inhibitor now in Phase 3 testing. Thalidomide-like drugs (IMiDs) bind to cereblon which, like pVHL, is the substrate-binding unit of a ubiquitin ligase. IMiDs redirect cereblon to destroy the myeloma oncoproteins, IKZF1 and IKZF3. We have developed new assays for identifying drugs that can destabilize oncoproteins of interest.

12:45 pm LIVE Q&A:

Plenary Keynote Discussion

Panel Moderator:
Stewart Fisher, PhD, CSO, C4 Therapeutics, Inc.
Panelist:
William G. Kaelin, Jr., MD, 2019 Nobel Laureate; Professor, Medical Oncology, Dana-Farber Cancer Institute; Investigator, Howard Hughes Medical Institute; Co-Founder, Cedilla and Tango Therapeutics
12:55 pm LIVE PANEL AND Q&A:

Plenary Keynote Discussion: De-Risking Early Drug Discovery

Panel Moderator:
Nadeem Sarwar, PhD, Founder & President, Eisai Center for Genetics Guided Dementia Discovery, Eisai, Inc.
  • Data Sciences
  • ​Novel Chemical Modalities
  • Investment and Partnering Models
  • COVID-19 Progress as Examples of Successful Partnerships
Panelists:
Anthony A. Philippakis, PhD, Chief Data Officer, Data Sciences & Data Engineering, Broad Institute; Venture Partner, GV
Stephen A. Hitchcock, PhD, Head, Research, Takeda Pharmaceuticals, Inc.
1:35 pm Lunch Break - View Our Virtual Exhibit Hall

IMMUNE PROFILING AND TUMOR MICROENVIRONMENT CHARACTERIZATION

2:05 pm

Molecular Signatures of Tumor Immune Evasion

Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center

A wide world of mechanisms leading to tumor immune evasion have emerged. Assessment of these mechanisms has relevance to immunotherapy applications.

2:25 pm

Immune Profiling in an Evolving Immune Oncology Landscape

Darrell R. Borger, PhD, Associate Director, Translational Sciences & ODDU, Takeda Oncology

Emerging cancer immunotherapy strategies are increasingly more sophisticated in promoting an anti-tumor immune response in patients. This presentation addresses developments in tissue-based cell profiling technologies that can reveal complex changes in tumor-immune infiltration and shifts in immune cell activity/polarity as it relates to preclinical development. In addition to providing insight into mechanisms of action, emerging signatures may provide direction for translational biomarkers that may improve clinical outcomes in early-phase trials.

2:45 pm

Integrative Analyses of Environment, Microbiome, Immunity, and Tumor for Precision Oncology

Shuji Ogino, PhD, Chief Molecular Pathological Epidemiology & Professor, Pathology, Brigham & Womens Hospital

The integrative field of immunology-MPE (molecular pathological epidemiology) is an emerging paradigm, and can investigate influences of the exposome (dietary, lifestyle, environmental, microbial, pharmacological, and other exposures) on tumor-immune interactions, thereby informing immunotherapy research. Using over 1500 colorectal cancer cases with rich data on immune response, whole exome sequencing, RNA-sequencing, tumor neoantigens, and clinical outcomes, proof-of-principle immunology-MPE studies have shown great promise for precision prevention and immuno-oncology.

3:05 pm

The Immune Microenvironment of Neoplastic Precursor Lesions in the Pancreas

Elizabeth Thompson, MD, PhD, Assistant Professor, Pathology and Oncology, The Johns Hopkins Hospital

While much work has focused on the tumor immune microenvironment of established cancers, little is known about the immune response to the earliest stages of tumor development. This talk will explore the immune microenvironment of neoplastic precursor lesions in the pancreas, focusing on pancreatic intraepithelial neoplasia and intraductal papillary mucinous neoplasms (IPMN) with emphasis on features predicting grade of dysplastic change and recurrence/progression to malignancy.

3:25 pm LIVE Q&A:

Session Wrap-Up Panel Discussion

Panel Moderator:
Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center
Panelists:
Darrell R. Borger, PhD, Associate Director, Translational Sciences & ODDU, Takeda Oncology
Shuji Ogino, PhD, Chief Molecular Pathological Epidemiology & Professor, Pathology, Brigham & Womens Hospital
Elizabeth Thompson, MD, PhD, Assistant Professor, Pathology and Oncology, The Johns Hopkins Hospital
3:45 pm Happy Hour - View Our Virtual Exhibit Hall
4:15 pm Close of Day

Friday, September 18

PRECISION MEDICINE IN ONCOLOGY

10:00 am

Oncology Biomarker Development Strategies in Precision Therapies

Yan Li, PhD, Senior Director, Oncology Precision Medicine, Bayer U.S.

This presentation will discuss combining tissue and liquid biopsy to follow the patient’s tumor evolution and adding RNA gene expression profiling to DNA to expand clinical options for patients.

10:20 am

Liquid Biopsies Enabling Precision Medicine


Jonathan Beer, Director, FPM Lead of Disruptive Technologies, Novartis Precision Medicine

There are currently four precision medicine drugs which can be prescribed from two US FDA-approved CDx tests using ctDNA, and with many CDx submissions for plasma assays under the breakthrough designation indicates that plasma is increasing its impact in the clinical practice of precision medicine. The Japanese PMDA has approved the first NGS CDx plasma assay and many companies have announced PMA submissions of an NGS plasma assay for approval in the US which will be game changing for cancer patients.

10:40 am

How to Catch Them All: Genomic Panels Big and Small

Jennifer Morrissette, PhD, Director, Clinical CytoGenomics Laboratory; Associate Professor, Pathology, University of Pennsylvania

High volume clinical laboratories need to accommodate a variety of specimen types, qualities, and quantities. This typically cannot be accomplished using a single method; we have validated a large hybrid-capture based panel and a small amplicon-based companion panel for low-input and/or low-quality DNA. This talk will discuss the decision-making process for panel design, both inter- and intra-laboratory. The large panel includes content shared across multiple institutions which have decided to utilize similar methodologies allowing for cross-validation.

Lauren Martens, Director of Biology and scientific co-founder, Tiaki Therapeutics

Tiaki has created a discovery platform for identification, validation and development of therapeutic strategies. Implementation of the FirePlex assay in early target discovery has enabled identification of putative neuroinflammation program-enabling biomarkers. Zeev Gechtman, Abcam's technical product manager will present the Q&A session. 

11:20 am LIVE Q&A:

Session Wrap-Up Panel Discussion

Panel Moderator:
Jennifer Morrissette, PhD, Director, Clinical CytoGenomics Laboratory; Associate Professor, Pathology, University of Pennsylvania
Panelists:
Yan Li, PhD, Senior Director, Oncology Precision Medicine, Bayer U.S.
Jonathan Beer, Director, FPM Lead of Disruptive Technologies, Novartis Precision Medicine
Lauren Martens, Director of Biology and scientific co-founder, Tiaki Therapeutics
11:40 am Coffee Break - View Our Virtual Exhibit Hall

BIOMARKER DISCOVERY AND TRANSLATION

11:55 am

Translational Biomarkers – From Discovery to the Clinic

Katherine M. Call, PhD, Senior Director & Head, Proteogenomics, Sanofi Genzyme R&D Center

Biomarkers are a critical component to advance therapeutic programs and to make informed decisions along the value chain. In Sanofi Translational Sciences, we utilize genomics, genetics, proteomics, molecular histology and informatics approaches to identify candidate biomarkers. This presentation will illustrate multi-pronged and integrated approaches to discover and qualify biomarkers for hand-off for use in development and in the clinic. Several biomarker case studies will be presented, illustrating different approaches and utilities of biomarkers, as well as key factors for success.

12:15 pm

Maximizing the Return on Clinical Samples: Considerations for IO Discovery Biomarker Analysis

Amber C. Donahue, PhD, Senior Manager, Biomarker Clinical Assay Lead, Oncology Clinical Assay Group, Pfizer Inc.

Clinical samples are precious and generally limited. There are ways to stretch specimens further, such as aliquoting, or provision of extracted nucleic acid or even data rather than FFPE sections to analyzing laboratories. However, there are considerations necessary to this approach, including careful specimen tracking, freeze/thaw stability, fit-for-purpose cross-validation, and assay limitations.

12:35 pm

Utility of Biomarker Post-Translational Modifications Enabling Patient Stratification

Michael Baratta, BA/MCAHPM, Scientific Director and Chief of Staff, Clinical Biomarker Development Innovation, Takeda

Advances in analytical instrumentation and reagents have afforded researchers the opportunity to interrogate post-translational modifications (PTMs) of protein biomarkers. Analysis of Tau and p181 Tau levels in CSF has been utilized in clinical trials to gain insight as a diagnostic compliment to PET scans, monitoring disease progression and response to therapeutic intervention. Incorporation of expanded Tau PTM analysis as part of a translational research strategy will be presented.

12:55 pm LIVE Q&A:

Session Wrap-Up Panel Discussion

Panel Moderator:
Katherine M. Call, PhD, Senior Director & Head, Proteogenomics, Sanofi Genzyme R&D Center
Panelists:
Amber C. Donahue, PhD, Senior Manager, Biomarker Clinical Assay Lead, Oncology Clinical Assay Group, Pfizer Inc.
Michael Baratta, BA/MCAHPM, Scientific Director and Chief of Staff, Clinical Biomarker Development Innovation, Takeda
1:15 pm Refresh Break - View Our Virtual Exhibit Hall
1:25 pm Brown Bag Lunch and Interactive Breakout Discussions - View Our Virtual Exhibit Hall

Grab your own lunch and join a breakout discussion group. These are informal, moderated discussions with brainstorming and interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic. Discussion topics and moderators will be listed on the website.


BREAKOUT: Integrated Biomarker Approaches

Katherine M. Call, PhD, Senior Director & Head, Proteogenomics, Sanofi Genzyme R&D Center
  • Integrating genomics, genetics, proteomics, post-translational modifications, molecular histology, and other data for biomarker discovery
  • Informatics tools and data requirements for biomarker identification
  • Translational approaches for biomarker discovery, qualification, and clinical development
  • High-throughput biomarker analysis and data generation
  • Integrated biomarker approaches for disease progression monitoring and predicting response to therapy

PREDICTIVE BIOMARKERS

2:00 pm

Predictive Molecular Marker for C. Difficile Infection Recurrence

Xuemei Zhao, PhD, Senior Principal Scientist, Merck

This presentation will discuss endogenous serum IgG antibodies to Clostridium difficile toxin B which are associated with protection against C. difficile infection recurrence.

2:20 pm

PD-L1 Immunohistochemistry (IHC) as a Predictive Marker for the PD-1/PD-L1 Axis Blockade from the Pathologist Perspective

Mari Mino-Kenudson, MD, Professor, Pathology, Massachusetts General Hospital

PD-L1 immunohistochemistry (IHC) is a globally accepted predictive biomarker for the PD-1/PD-L1 axis blockade and is now deployed in most pathology laboratories. Although its appropriate implementation and interpretation are critical, it can be challenging due to the multiple antibody clones/platforms available and given the typically small samples provided. Thus, I will discuss important considerations on pre-analytical, analytical and post-analytical aspects of PD-L1 IHC mainly for lung cancer. These issues are not specific for PD-L1 IHC and need to be considered when co-developing a predictive IHC marker for an agent in clinical trials in general. I will also briefly touch upon other predictive biomarkers for immunotherapy.


2:40 pm Close of Conference





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