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Tuesday, April 29

 

5:00-6:00 pm Conference Pre-Registration

 

6:00-9:00 Dinner Course*

Exosomes and Microvesicles as Cancer Biomarkers

(*Separate registration required)

 

Wednesday, April 30

 

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

 

Translation from Biomarker Assay to Companion Diagnostic 

 

8:40-8:45 Chairperson’s Opening Remarks

Michael Burczynski, Ph.D., Executive Director, Biomarker Technologies, Discovery Medicine and Clinical Pharmacology, Bristol-Myers Squibb

 

8:45-9:10 Transforming a Research Assay to a Companion Diagnostic

Ron Mazumder, Ph.D., MBA, Global Head, R&D and Operations, Janssen Diagnostics, Janssen Pharmaceutical Companies of Johnson & Johnson

Developing a predictive biomarker on a diagnostic platform often involves converting an assay which uses research-grade reagents and a research platform onto a diagnostic instrument which can be commercialized globally with GMP-manufactured and validated reagents. Furthermore, design verification under Quality Systems Regulations, clinical validation and clinical reproducibility must be completed during the drug development process. I will highlight considerations from case studies to explore each of these topics. 

9:10-9:35 Tracking Value Creation across Diverse Biomarker Studies and Platforms in Pharmaceutical Development

MichaelBurczynskiMichael Burczynski, Ph.D., Executive Director, Biomarker Technologies, Discovery Medicine and Clinical Pharmacology, Bristol-Myers Squibb

An ever-growing list of biomarkers (and diagnostic assays) is frequently analyzed across many stages of drug development. One of the more vexing challenges facing pharmaceutical companies today is determining how to ensure that biomarkers are both judiciously implemented, yet also maximally utilized, to answer questions in translational research. For various reasons (cost, limited resources, shortened cycle times) it is no longer possible or acceptable to simply run multiple biomarker assays in clinical studies for exploratory purposes or to inform future therapeutic strategies. Biomarker assays (irrespective of platform) need to answer extremely well defined questions in drug development, and should employ associated metrics that can be objectively evaluated after study conclusion to determine whether the biomarker studies generated sufficient value to the program or therapeutic area in question. The present talk will focus on these principles and describe a general approach to 1) defining the potential value of biomarker assays prior to clinical study execution; 2) tracking biomarker assays and programs in clinical trials at a large pharma company via a specifically designed database strategy; and 3) objectively assessing the impact of biomarker assays following clinical study conclusion.

9:35-10:00 Successful Implementation of Global Biomarker Strategies Requires Laser Focus on Preanalytical Processes

Marisa Dolled-Filhart, Ph.D., Associate Director, Pathology and Companion Diagnostics, Merck

Generation of quality biomarker data begins with the development of an accurate and precise method. However, this is simply not sufficient. Studies show that the activities preceding sample analysis, the preanalytical activities, are as important, if not more important than method performance. Many reports cite significant assay variability being attributed to what happens prior to the sample arriving at the bioanalytical lab. Paying close attention to how the sample is collected, processed and shipped will ultimately determine your success.

 

10:00-10:30 Networking Coffee Break

 

10:30-10:55 Talk Title to be Announced

AndrewSchadeAndrew Schade, M.D., Ph.D., Senior Director, Diagnostics and Experimental Pathology, Tailored Therapeutics, Eli Lilly and Company





10:55-11:20 Companion Diagnostics: How Personal Does It Have to Get?

Daniel Edelman, Ph.D., Core Manager, Clinical Molecular Profiling Core, National Cancer Institute, NIH

Companion diagnostics are becoming an important and critical tool for clinicians in the treatment of patients suffering from diseases for which individualized targeted therapy is available. The FDA has approved 19 laboratory tests (as of December 2013) to aid in this improved treatment of patients. Yet, their impact on public health could depend on how personal they have to get. Also, laboratory-developed tests may provide a greater benefit in some circumstances. In this talk I will compare and contrast these and other relevant issues.



11:20-11:50 Sponsored Presentation  

JermeyBridgeCookJeremy Bridge-Cook, Senior Vice President, Research and Development, Luminex Corporation

The development of biomarkers from discovery to clinical implementation as a Companion Diagnostics is a process which is inherently unpredictable; no two development pathways are alike. Given this unpredictability, it is desirable to develop biomarkers using a platform which provides flexibility, but which also reduces complexity as much as possible. The xMAP ® platform has been used extensively at all stages of biomarker development. The speaker will highlight some examples of discovery, validation and clinical implementation of biomarkers on xMAP ®

11:50-12:15 pm Sponsored Presentation

Rajiv Pande, Ph.D., Vice President, Scientific Affairs, CyVek Inc.

CyPlex Systems is a novel quantitative immunoassay platform that integrates a disposable microfluidic cartridge with a fully automated desktop analyzer. Multiple samples can be loaded onto a single CyPlex cartridge, and multiple analytes per sample can be quantified simultaneously, within an hour. CyPlex cartridges combine a unique solid phase approach (glass nanoreactors)with microfluidics toprovide high quality multi-analyte results without the typical multiplexing compromises. CyPlex assays showexcellent robustness and are extremely easy to perform.


12:15-12:50 Luncheon Presentation:  Validated Multiplexed Cytokine Assays: A New Standard for Immunoassays

Pankaj Oberoi, Ph.D., Vice President, Commercial Assays, Meso Scale Discovery

Inconsistencies between biomarker studies can be attributed to variability between assay kit lots. Even CE‐marked kits may lack reproducibility because the CE mark is self‐regulated. With the use of well‐characterized, purified reagents and highly optimized assays, MSD’s V‐PLEX™ product portfolio demonstrates consistent and robust immunoassays. MSD has developed a 30‐plex human biomarker assay that is analytically validated and shows excellent lot‐to‐lot reproducibility and superior sensitivity, precision, and accuracy.  

 

Biomarkers in Translational Medicine 

 

1:25-1:30 Chairperson’s Opening Remarks

Suso Platero, Ph.D., Director, Oncology Biomarkers, Janssen Pharmaceuticals

 

1:30-1:55 Biomarkers in Translational Medicine: From Bench to the Clinic and Back

Suso Platero, Ph.D., Director, Oncology Biomarkers, Janssen Pharmaceuticals

Translational medicine could be defined as the application of biomarkers from preclinical models to clinical trials. But also, once we start dosing patients, the generation of hypothesis using clinical samples is a key feature of translational medicine for our understanding of the interaction of the drug with the specific disease. By looking at patients’ samples and correlating their status to drug responses we can identify biomarkers that are important for mechanism of action of the drug and sensitivity of the patient’s disease to the drug. Uniting both approaches will yield better biomarkers that can later on be used in subsequent phases of drug development.

 

1:55-2:20 Translation of Emerging Biomarkers from Preclinical Species to Human Populations

Jiri Aubrecht, Pharm.D., Ph.D., Senior Director and Safety Biomarker Group Lead, Drug Safety Research & Development, Pfizer

Biomarkers provide essential tools for refining of therapeutic index in drug development, monitoring disease progression and/or examining effects of environmental exposure to chemicals. Despite the success of routine markers used in preclinical and clinical settings a new cohort of safety biomarkers with better sensitivity and specificity is being evaluated. This includes tissue-specific proteins, metabolites and/or circulating miRNAs. Since drug development relies on preclinical evaluation of lead compounds, the biomarker translation across animal species to humans is essential. To study the performance of emerging biomarkers we employ a variety of approaches including animal models and clinical studies. The presentation will introduce recent progress in applying state-of-the-art technologies such as next-generation sequencing in biomarker development as well as several case studies documenting advances in cross species translation for biomarkers of hepatotoxicity and nephrotoxicity. 

 

2:20-2:45 Translational Biomarkers: Need, Progress and Challenges

Donna L. Mendrick, Ph.D., Associate Director, Regulatory Affairs, NCTR, FDA

Biomarkers used in animal testing and in the clinic to identify adverse drug events are inadequate to identify population-based safety risks and individual susceptibilities. System biological approaches offer new discovery modalities to improve the identification and mechanistic understanding of new biomarkers. Published literature is filled with reports of potentially novel and useful biomarkers; however, academic labs do not receive funding to work toward regulatory qualification of such biomarkers so they tend to remain the subject of single publications. To effect change, new biomarkers need to be accepted by the community at large.

 

2:45-3:45 Refreshment Break in the Exhibit Hall with Poster Viewing

 

Technology Showcase: Biomarkers in Drug Development 

 

3:45-4:15 Sponsored Presentation  

Denis_Smirnov_JanssenDiagnosticsDenis Smirnov, Ph.D., Associate Scientific Director, US Biomarker Oncology, Janssen R&D US

Molecular characterization of circulating tumor cells (CTCs) offers a unique opportunity  to dynamically monitor metastatic process so optimal therapy regimens can be developed and applied in clinic.  Potential and challenges of molecular characterization of CTCs will be discussed.

4:15-4:30 A Simple Blood Test to Assess Insulin Resistance (IR) in Clinical Trials: Quantose IRTM 

Nelson Rhodes, Ph.D., Associate Study Director, Metabolon, Inc.

Identify insulin resistance status and track improvements of subjects in any clinical trials where subjects experience a change in glycemic status or anytime a change in weight occurs. The new, clinically-validated Quantose IR™ blood test is an accurate and effective tool for determining drug treatment effects in CV/MD/other trial populations

Molecular Response4:30-5:00  Validation of Patient Selection Biomarkers using Patient Derived Xenograft (PDX)Models in Preclinical Trials of Oncology Therapeutics

Thomas B. Broudy, Ph.D., CSO, Molecular Response LLC

We have established a broad platform of genomically-defined patient derived xenograft (PDX) models enabling preclinical trials to validate patient selection biomarkers in targeted cancer populations.  We will share how these clinically relevant models have been used to identify and validate KIT and RAS selection markers for targeted oncology therapeutics.  By approximating clinical trials in the preclinical setting, we help our partners establish more confident clinical development strategies—responsive populations, effective combinations, predictive tests, and resistance strategies.

 

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
  • Non-Coding RNAs as Biomarkers and Diagnostics

(*Separate registration required)

 

Thursday, May 1

 

7:30-8:15 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

 

"Big Data" and Biomarker Development 

 

8:25-8:30 Chairperson’s Opening Remarks

Nicholas C. Dracopoli, Ph.D., Vice President, Janssen R&D, Johnson & Johnson

 

8:30-8:55 Big Data and Small Trials: Translating Biological Data into Clinical Biomarkers

Nicholas C. Dracopoli, Ph.D., Vice President, Janssen R&D, Johnson & Johnson

All of the companion diagnostic tests approved by the FDA for use in oncology are for “driver mutations” in genes involved in signal transduction pathways. These tests are for single analytes predicting the functional status of the drug target or pathway. There are no approved companion diagnostics for drugs that work through alternative mechanisms such as chemotherapy or immunomodulation. This presentation will discuss why so few biomarkers have been developed, and why we have mostly failed to develop molecular profiles that predict drug response. 

 

8:55-9:20 Talk Title to be Announced

Emmanuelle Di Tomaso, Ph.D., Global Correlative Science Lead, Novartis Institutes for BioMedical Research

 

9:20-9:45 Clinical Trial Biomarkers in a World of Big Data and Predictive Analytics

Michael Hale, Ph.D., Executive Director, Medical Sciences Biostatistics, Amgen

Predictive analytics are being increasingly used to optimize marketing for many non-medical products and companies by looking at the behavior and/or characteristics of an individual, predicting the needs of that individual, and then addressing those needs. We frequently encounter this when web-browsing, or when participating in retail store loyalty programs, with advertising and coupons targeted to the specific individual based on predictive models employed by advertisers and retailers. This makes the traditional drug development program appear antiquated, where a drug may be intended for all patients with a given indication. This talk contrasts those methods and practices for addressing individual needs with the way medicines are typically prescribed, and considers a way to integrate big data, product label, and predictive analytics to improve and enable personalized medicine. Some important questions are posed (but unresolved), such as who could do this? and what are the implications if we were to predict outcomes for individual patients?

9:45-10:45 Coffee Break in the Exhibit Hall with Poster Viewing

 

10:45-11:10 IBM Watson and the Valley of Death

Mark S. Boguski, M.D., Ph.D., Associate Professor, Pathology, Center for Biomedical Informatics, Harvard Medical School

There is a large and widening gap created by our ability to generate data much faster than we can ever ascribe meaning to it via traditional approaches. This gap has been evident in biomedicine since the late 1990s and has now become a "Valley of Death" in the application of new technologies for biomarker discovery and clinical diagnostics. These technologies produce more data than we can ever hope to interpret by consulting the literature, for two reasons. First, there is no literature pertaining to most of the findings and perhaps never will be because the traditional model for follow-up and validation does not scale. Second, even when literature is available, most of it may represent non-reproducible results. For example, it has been estimated that the majority of "breakthrough" research in oncology, women's health and cardiovascular disease cannot be replicated or confirmed. Systems like IBM Watson that heavily leverage a literature corpus to find connections and make inferences suffer from obvious limitations in this context. There is a way out of the Valley of Death but it will require both researchers and technology developers to approach the problem differently.

 

11:10-11:35 Big Data and Reliability of Biomarker Identification

Andreas Schuppert, Ph.D., Vice President, Technology Development, Bayer Technology Services GmbH; Professor, AICES, RWTH Aachen University

“Big Data” offers great promise both to industry and clinics. Systematic analysis of very large, multivariate data sets is expected to be a powerful technology to improve the overall efficiency in the pharma pipeline as well as to enable the expected benefits of personalized medicine. However, the reality suffers from an apparent lack of reproducibility of the data resulting in a lack of reliability in the biomarkers for complex diseases. We demonstrate on a heterogeneous set of gene expression data from cancer studies that a systematic utilization of the intrinsic correlations in highly multivariate data can be used to extract scores enabling the quantitative characterization of tumor status with a high degree of stability. 

 

11:35-12:00 Leveraging Big Data Analytics to Power Drug Discovery and Development

Iya Khalil, Ph.D., Executive Vice President and Co-Founder, GNS Healthcare

We are living in the era of big data in healthcare, with unprecedented ability to collect data at multiple levels (molecular/'omic', phenotypic, and real world data from EMRs, mobile devices, patient reported outcomes, etc.) and at scale. This has the potential to transform our fundamental understanding of disease and our ability to match the right interventions to the right patients. Key to leveraging this data are advances in mathematics and computation that unlock the knowledge within complex data enabling personalized, actionable predictions and precision targeting of interventions.

 

12:00-12:30 Panel Discussion

Moderator: Nicholas C. Dracopoli, Ph.D., Vice President, Janssen R&D, Johnson & Johnson


 

BioScale12:30-1:00pm Luncheon Presentation: An Acoustic Assay Platform for Developing and Performing Biomarker Analysis 

Martin_Latterich_BioScale Martin Latterich, BioScale Inc. 

Biomarkers play a pivotal role in translational research. BioScale has developed an Acoustic Assay technology that enables the user to rapidly and cost-effectively develop novel, reproducible biomarker assays for both circulating biomarkers and intracellular markers. Acoustic assays enable exceptional precision, consume <10% Ab vs ELISA and are hands-free – allowing a sensitive automated immunoassay.  We showcase several collaborative studies from key opinion leaders in the cancer community that demonstrate the benefits of Acoustic Assays.