Cambridge Healthtech Institute’s Inaugural 

Technology-Driven Oncology Clinical Development 

Biomarkers and Strategies for Combination Therapy and Immunotherapy

February 16-18, 2015 | Moscone North Convention Center | San Francisco, CA
Part of the 22nd Annual Molecular Medicine Tri-Conference

 

The series of failures of cancer therapies in late stages of clinical development forced us to look for new and innovative strategies of cancer therapy in general and cancer clinical development in particular. Clinical development scientists are working hard to keep up with the recent discoveries in cancer biology as well as with the genomic technologies available to advance clinical development strategies. The Technology-Driven Oncology Clinical Development conference, part of the 22nd International Molecular Medicine Tri-Conference, is designed to discuss the latest advances in combination therapy and cancer immunotherapy research, and to search for solutions and strategies that allow to match clinical development with these advances.


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Monday, February 16

10:30 am Conference Program Registration


NGS-DRIVEN STRATIFIED CANCER TRIALS

11:50 Chairperson’s Opening Remarks

Steffan N. Ho, M.D., Ph.D., Senior Director, Early Development and Translational Oncology, Pfizer Oncology

 12:00 pm LungMAP/S1400: A Unique Public-Private Master Protocol for Drug-Biomarker Registration

David Gandara, M.D., Professor of Medicine, Division of Hematology/Oncology, University of California, Davis School of Medicine; Director, Thoracic Oncology Program, Senior Advisor to the Director, UC Davis Comprehensive Cancer Center; Chair, Lung Committee, Southwest Oncology Group (SWOG)

Despite rapid advances in deciphering the complex genomics of non-small cell lung cancer (NSCLC), clinical translation into approvable biomarker-drug combinations has been problematic, due in part to the relative rarity of genomically-defined subsets. Lung-MAP (S1400) is a one-of-a-kind public-private partnership designed to speed up development of targeted therapies for NSCLC of squamous cell histology (SCCA). Here we describe development of this registration-compliant biomarker-driven Phase II/III multi-arm “master” protocol, employing next generation sequencing to identify actionable molecular abnormalities, followed by patient randomization to biomarker-driven targeted therapy versus standard of care.

12:30 The Evolving Genotype-to-Phenotype Paradigm in Oncology Drug Development

Steffan N. Ho, M.D., Ph.D., Senior Director, Early Development and Translational Oncology, Pfizer Oncology

The clinical application of multiplexed molecular profiling technologies offers unprecedented opportunities to enhance the drug development process by directing treatment to patients who are more likely to benefit. However, molecular profiling technologies are in the early stages of clinical application as companion diagnostic tests. Future success will require close integration between not only biology and technology, but also between clinical and diagnostic development strategies.

1:00 Session Break

1:15 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

2:15 Session Break

2:30 Chairperson’s Remarks

2:40 Clinical Trials for Predictive Biomarker Discovery and Validation in Oncology Drug Development

Shirin Khambata Ford, Ph.D., Executive Director, US Hematology and Oncology Medical Affairs, Celgene Corporation

In the last decade, development of various targeted therapies in oncology requires testing in targeted populations matched to a drug’s mechanism of action. This presentation will focus on retrospective and prospective trial designs incorporating biomarkers, using real world examples from completed and ongoing studies. The genomic and molecular technologies used for biomarker assessment and associated challenges in marker development and validation will also be discussed.

 3:10 Universal Testing for Actionable Genomic Variants in Cancer: a Paradigm Shift in Precision OncologyDaniel S. Grosu, M.D., M.B.A. Vice President, Clinical Development & Medical Affairs, Illumina, Inc.Rapid technological progress allowing for broad interrogation of genomic variation in cancer, and a parallel expansion in knowledge regarding the actionability of an ever-growing number of germline and somatic variants, are revolutionizing the management of the disease. A paradigm shift is currently under way from drug-centered to patient-centered precision oncology, enabled by the advent of high-throughput, widely accessible NGS-based “universal” cancer genomic testing and featuring the emergence of “companion therapeutics”.

3:40 PANEL DISCUSSION: Challenges in Developing Oncology Therapy with the Complexity of Cancer Heterogeneity

Panel Moderator: Steffan N. Ho, M.D., Ph.D., Senior Director, Early Development and Translational Oncology, Pfizer Oncology

Panelists: David Gandara, M.D., Professor of Medicine, Division of Hematology/Oncology, University of California, Davis School of Medicine; Director, Thoracic Oncology Program, Senior Advisor to the Director, UC Davis Comprehensive Cancer Center; Chair, Lung Committee, Southwest Oncology Group (SWOG)

Shirin Khambata Ford, Ph.D., Executive Director, US Hematology and Oncology Medical Affairs, Celgene Corporation

Daniel S. Grosu, M.D., M.B.A. Vice President, Clinical Development & Medical Affairs, Illumina, Inc. 

4:10 Sponsored Presentation

Speaker to be Announced, SpeeDx Pty Ltd.

4:25 Sponsored Presentation (Opportunity Available)

4:40 Break and Transition to Plenary Session

5:00 Plenary Session

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:30 Close of Day


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Tuesday, February 17

7:00 am Registration and Morning Coffee

8:00 Plenary Session

9:00 Refreshment Break in the Exhibit Hall with Poster Viewing


TRANSLATIONAL APPROACHES IN CANCER IMMUNOTHERAPY DEVELOPMENT

10:05 Chairperson’s Remarks

10:15 Biomarkers in Cancer Immunotherapy

Ira Mellman, M.D., Vice President, Cancer Immunology, Genentech

Recent advances in cancer immunotherapy differ from other developments in oncology therapeutics in several respects. Not only have immunotherapies proved remarkably promising, but also the underlying science promises to be largely driven by findings in the clinic. Thus, both patient selection and the discovery of new therapeutic opportunities will be dependent on the ability to identify, collect, and understand biomarkers and immunobiology of patient response and lack of response.

10:45 Strategies for Clinical Development of Cancer Immunotherapy

Roy Baynes, M.D., Senior Vice President Global Clinical Development, Merck

It has been established that autoimmunity against a number of malignancies can be revealed by pharmacologic modulation of checkpoint inhibitors and co-stimulatory molecules. A strategic imperative is comprehensive definition of the efficacy and safety of monotherapy across tumor types. This has required understanding the limitations of standard response evaluations and the need to identify and appropriately manage immune mediated adverse events. Patient selection and study enrichment approaches are emerging. Informative biology will be required to evaluate the array of potential therapeutic combinations.

11:15 Translational Approaches for the Development of Intratumoral Immunotherapies

Robert Pierce, M.D., CMO, OncoSec Medical, Inc.

Intratumoral therapies are capable of reversing local immunosuppressive mechanisms and driving systemic anti-tumor immune responses. Given the safety and potential systemic efficacy of this approach, Intratumoral therapies will likely play a growing role in future combination immunotherapy regimens. The pros and cons of current syngeneic mouse models will be addressed with particular emphasis on unique aspects of intratumoral therapies.

11:45 Preclinical Validation of Immunotherapies and Combination Strategies for Cancer

James Smothers, Ph.D., Senior Director, Head, Discovery, Immuno-Oncology & Combinations DPU, Oncology R&D, GlaxoSmithKline

Recent clinical strategies to modulate T cell checkpoint pathways have demonstrated significant patient benefit in melanoma, renal cell carcinoma and non-small cell lung cancer indications. Clinical successes with immuno-oncology medicines greatly depend upon animal disease model studies and other preclinical rationale for their development. Translational data coupled with preclinical results can further bridge understanding of what patient populations might gain the most benefit from an immuno-oncology experimental medicine alone or in combination with another agent.

12:15 pm Session Break

12:25 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

1:25 Refreshment Break in the Exhibit Hall with Poster Viewing


PANEL DISCUSSION: PRACTICAL ASPECTS OF IMPLEMENTING THE MASTER PROTOCOl

2:00 Moderator’s Remarks

Glenn A. Miller, Ph.D., CTO & Executive Vice President, MolecularMD

  • Predictive biomarkers and translational medicine in the S1400 lung-mAP trial
  • Implementing the MATCH protocol
  • Opportunities and challenges in designing and conducting basket

Panelists:

Philip C. Mack, Ph.D., Associate Adjunct Professor, Internal Medicine, Hematology and Oncology, University of California Davis Medical Center

Jason Lih, Ph.D., Principal Scientist, Molecular Characterization Group, Leidos Biomedical Research, Inc./Frederick National Laboratory for Cancer Research

J. Carl Barrett, Ph.D., Vice President, Translational Sciences, Onc iMed, AstraZeneca

3:40 Enabling Advances in Cancer Genomics with NGS

Frank S. Ong, M.D., Associate Director, Medical Affairs, Illumina, Inc.

 

4:10 Mardi Gras Celebration in the Exhibit Hall with Poster Viewing

5:00 Breakout Discussions in the Exhibit Hall (see website for details)

6:00 Close of Day


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Wednesday, February 18

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:00 Plenary Session PANEL

9:45 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall


PDX MODELS TO INFORM CLINICAL TRIALS

10:35 Chairperson’s Remarks

Neal Goodwin, Ph.D., Vice President, Corporate Research and Development, Champions Oncology

10:45 Towards Personalized Medicine: Companion Therapeutics in the I-SPY 2 TRIAL

Laura J. van ‘t Veer, Ph.D., Professor of Laboratory Medicine, University of California San Francisco; Leader, Breast Oncology Program; Associate Director, Applied Genomics, UCSF Helen Diller Family Comprehensive Cancer Center; Principal Investigator, Bay Area Breast Cancer SPORE; Angela and Shu Kai Chan Endowed Chair in Cancer Research

Cancer therapeutics are nowadays targeted to inhibit the activated networks. The multitude of choices is effectively evaluated in the neo-adjuvant therapeutic setting where drugs are given before surgery and direct tumor response can be monitored by imaging. Accompaniment by comprehensive molecular diagnostics allows one to find the right drug for the right patient. The I-SPY 2 breast cancer trial maximizes the neoadjuvant approach by adaptively assigning patients to the treatment arm where their tumors biology is showing the most effective response.

11:15 Optimizing Clinical Trial Designs by PDX Integration

Philip C. Mack, Ph.D., Associate Adjunct Professor, Internal Medicine, Hematology and Oncology, University of California Davis Medical Center

Compared to cell lines and GEMMs, Patient-Derived Xenografts (PDXs) are a superior representation of the molecular complexity and natural evolution of patient tumors. In collaboration with The Jackson Laboratory (JAX), we have developed an extensive, well-characterized resource of over 60 NSCLC PDX models. Models retain the mutational characteristics, heterogeneity and histology of the donor tumor. Integration of PDX modeling into clinical trials provides an opportunity to optimize personalized therapeutic strategies that has not been previously available.

11:45 Patient Derived Xenograf Clinical Trial Program

Neal Goodwin, Ph.D., Vice President, Corporate Research and Development, Champions Oncology

A PDX clinical program to guide patient treat menthas engrafted >750 patient specimens with a 70% patient tumor take rate and a >80% correlative treatment accuracy in completed clinical tests. This program has been expanded to support predictive clinical trials for breast, sarcoma, and lung cancers in partnership with clinical trial centers and cooperative trial groups. Ultimately, this program will include matched patient translational studies across numerous patient models for Phase II trial patient stratification.

12:15 pm Session Break

12:25 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:00 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing


TRANSLATIONAL APPROACHES
TO CHILDHOOD CANCER

1:40 Chairperson’s Remarks

1:50 Translational Genomics of Pediatric Cancers to Identify Novel Biomarkers, Drivers and Therapeutic Targets

Javed Khan, M.D., Genetics BranchHead, Oncogenomics SectionDeputy Branch Chief, Center for Cancer Research, National Cancer Institute

Recently here has been an explosion of information related to the cancer genome. I will describe the use of high-throughput technologies such as next-generation sequencing, siRNA and compound screening to identify novel biomarkers, drivers and therapeutic targets. I will summarize some of the key discoveries made, focusing my comments on neuroblastoma, rhabdomyosarcoma and Ewing’s sarcoma. Finally I will describe the use of genomics for precision therapy trials for children with refractory or relapsed cancers.

2:20 Preclinical Childhood Cancer Models for Developing Molecularly Targeted Therapies

Peter Houghton, Ph.D., Director, Center for Childhood Cancer, The Research Institute, Nationwide Children’s Hospital

The Pediatric Preclinical Testing Program (PPTP) supported through the National Cancer Institute, has developed in excess of 150 patient derived tumor xenograft models (PDX). These models have been characterized by expression profiling, SNP analysis and exome sequencing. The primary screen utilizes 49 xenograft models to identify agents that have broad-spectrum or tumor-type selective activity. Examples of the predictive value of expression profiles or sequence data for identification of active agents will be discussed.

2:50 The Institutes for Molecular Medicine at Phoenix Children’s Hospital to Address the Unmet Need: Slow Progress in Pediatric Drug Development

Nazneen Aziz, Ph.D., Senior Vice President & Chief Research Officer, Phoenix Children’s Hospital

More effective therapies are unavailable in pediatric cancer, in stark contrast to the rapid introduction of targeted therapies in adult cancer that are revolutionizing the treatment of adults with cancer. PCH’s Molecular Medicine Program will focus on utilizing genomic methodologies to better understand mechanisms of disease and to stratify patient populations, with the ultimate goal of improving clinical care and outcomes. The program will support a dynamic interplay between the clinic, the laboratory, and pharmaceutical companies focusing on real-time translation of scientific knowledge and patient data to identify the best possible treatment for patients.

3:20 Panel Discussion: Childhood Cancer Research: Specific Features and Advances

Moderator: Peter Houghton, Ph.D., Director, Center for Childhood Cancer, The Research Institute, Nationwide Children’s Hospital

Panelists: Speakers of the Session

3:50 Refreshment Break


ENABLING CANCER RESEARCH
AND DEVELOPMENT

4:00 Chairperson’s Remarks

4:10 Isolation of DNA/RNA Biomarkers and the Quest for Liquid Biopsy Cancer Diagnostics

Michael J. Heller, Ph.D., Professor, Nanoengineering & Bioengineering, University of California San Diego

The isolation of circulating cell free (ccf) DNA and ccf-RNA directly from blood and/or plasma remains a complex and time consuming procedure, which is impeding process toward liquid biopsy and point of care (POC) cancer diagnostics. We have now demonstrated the rapid isolation and detection of ccf-DNA/RNA from a number of different hematological and solid tumor samples.

4:40 Antibody Validation to Prevent Error

David L. Rimm, M.D., Ph.D., Professor, Pathology; Executive Director, Translational Pathology; Director, Yale Pathology Tissue Services, Yale University

Antibodies are an extremely broadly used and valuable tool, both in discovery research, translational research and in the clinic. However, some of the data produced and published in the literature is flawed, or misleading due to non-specificity or cross-reactivity. Here we will look at the use of antibodies, both in the research and clinical setting and show how lack of rigorous validation can produce flawed data. We will also provide guidelines for antibody validation that can be used to avoid flawed, but publishable results.

5:10 Managing Quality in Biorepository Operations to Support Translational Research- Experiences of the OHSU Knight BioLibrary

Devon Kelly, Director, OHSU Knight BioLibrary, Knight Cancer Institute, Oregon Health and Science University

Methods by which human research specimens are consented, collected, stored and distributed varies greatly from repository to repository. This variation is a large contributing factor in the ability of researchers to generate high-quality data from specimens acquired from multiple repositories into a single research project. Therefore, it is important to manage the quality of biobanking activities to maximize the utility of banked specimens collected for future research projects. Experiences in assessing and standardizing practices across a large cancer repository network will be discussed.

5:40 Close of Conference Program



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2015 MMTC Final Agenda 

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Leica Biosystems 
 

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Silicon Biosystems 

 

Singulex 

Thomson Reuters-Large 






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