Biomarkers & Diagnostics, World Congress 2013, May 6-8, 2013 Loews Philadelphia Hotel, Philadelphia, PA

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Biomarkers & Diagnostics, World Congress 2013, May 6-8, 2013 Loews Philadelphia Hotel, Philadelphia, PA

February 19, 2013 by 2012pharmaceutical

Reporter: Aviva Lev-Ari, PhD, RN

http://www.biomarkerworldcongress.com/

DOWNLOADS

http://www.biomarkerworldcongress.com/bmc_content.aspx?id=95326

Conference Programs

May 6 – 7, 2013

Track 1: Translational Biomarkers in Drug Development

Track 2: Clinical Assay Development

Track 3: Cancer Tissue Diagnostics

May 6 – 8, 2013

Track 4: Executive Summit: Companion Diagnostics

May 7 – 8, 2013

Track 5: Biomarkers for Patient Selection

Track 6: Cancer Drug Resistance

Track 7: Exosomes and Microvesicles as Biomarkers

and Diagnostics

SPEAKERS

Jason M. Aliotta, M.D., Assistant Professor, Medicine, Warren Alpert Medical School, Brown University

John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON Development Solutions

Maria E. Arcila, M.D., Department of Pathology, Memorial Sloan-Kettering Cancer Center

Khusru Asadullah, M.D., Vice President and Head, Global Biomarkers, Bayer Pharma

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

M.J. Finley Austin, Ph.D., Personalized Healthcare & Biomarker Strategy Director, AstraZeneca

Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program Office, College of American Pathologists

Geoffrey Stuart Baird, M.D., Ph.D., Assistant Professor, Laboratory Medicine, University of Washington

Robert A. Beckman, M.D., External Faculty, Center for Evolution and Cancer, Helen Diller Family Cancer Center, UCSF; Executive Director, Clinical Development Oncology, Daiichi Sankyo Pharma Development

Darrell R. Borger, Ph.D., Co-Director, Translational Research Laboratory, Massachusetts General Hospital Cancer Center

Mark Broenstrup, Ph.D., Director, Biomarker and Diagnostics, R&D Diabetes Division, Sanofi

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

Claudio Carini, M.D., Global Clinical Immunology and Biomarkers Lead, Bioenhancement Development Unit, Pfizer

Luigi Catanzariti, Ph.D., Executive Director and Global Program Director, Diagnostics, Novartis

David Chen, Ph.D., Senior Director, Correlative Sciences, Oncology Clinical Development, Novartis Pharmaceuticals

Carol Cheung, M.D., Ph.D., Department of Pathology, University Health Network

Atish Choudhury, M.D., Instructor in Medicine, Medical Oncology, Dana-Farber Cancer Institute

Seth Crosby, M.D., Director, Partnerships & Alliances, Washington University School of Medicine

Mark E. Curran, Ph.D., Vice President, Immunology Biomarkers, Janssen Research & Development

Stephen P. Day, Ph.D., Director, Medical Affairs, Hologic

Viswanath Devanarayan, Ph.D., Global Head, Exploratory Statistics, AbbVie, Inc.

Luis Alberto Diaz, M.D., Associate Professor of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Max Diem, Ph.D., Professor, Chemistry and Chemical Biology, Northeastern University

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

Crislyn D’Souza-Schorey, Ph.D., Professor, Biological Sciences, University of Notre Dame

Dominik Duelli, Ph.D., Assistant Professor, Cellular and Molecular Pharmacology, Rosalind Franklin University of Medicine & Science, Chicago Medical School

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

Reyna Favis, Ph.D., Scientific Director, Clinical Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson

Andrea Ferreira-Gonzalez, Ph.D., Professor and Chair, Division of Molecular Diagnostics; Director, Molecular Diagnostics Laboratory, Department of Pathology, Virginia Commonwealth University

Andrew Fish, Executive Director, AdvaMedDx

Herbert A. Fritsche, Ph.D., Senior Vice President and CSO, Health Discovery Corporation

Felix Frueh, Entrepreneur-in-Residence, Third Rock Ventures

Steve Furlong, Ph.D., Safety Science Lead, AstraZeneca Clinical Development

George A. Green IV, Ph.D., Director, Pharmacodiagnostics, Bristol-Myers Squibb

Patrick Groody, Ph.D., Divisional Vice President, Research & Development, Abbott

Steven Gutman, M.D., MBA, Strategic Advisor, Myraqa

Abdel Halim, Pharm.D., Ph.D., DABCC-MDx, DABCC-TOX, DABCC-CC, FACB, Director, Clinical Biomarkers, Daiichi Sankyo Pharma Development

Sam Hanash, M.D., Ph.D., Director, McCombs Institute for Cancer Early Detection and Treatment, MD Anderson Cancer Center

Charles R. Handorf, M.D., Ph.D., Professor and Chair, Pathology and Laboratory Medicine, University of Tennessee

Amir Handzel, Ph.D., Associate Director, Translational and Clinical Sciences, OSI Pharma (Astellas)

Chunhai “Charlie” Hao, M.D., Ph.D., Associate Professor, Neuropathology Attending, Department of Pathology & Laboratory Medicine, Emory University School of Medicine

Madhuri Hegde, Ph.D., Executive Director, Emory Genetics Laboratory; Associate Professor, Human Genetics, Emory University School of Medicine

Philip Hewitt, Ph.D., Head, Early Non-Clinical Safety (Liver and Kidney), Merck Serono

Stephen M. Hewitt, M.D., Ph.D., Clinical Investigator, Laboratory of Pathology, National Cancer Institute, NIH

Holly Hilton, Ph.D., Head, Disease and Translational Genomics, Hoffmann-La Roche; Adjunct Professor, University of Medicine and Dentistry New Jersey

Fred H. Hochberg, M.D., Associate Professor, Neurology, Massachusetts General Hospital

Shidong Jia, Ph.D., Scientist, Oncology Biomarker Development, Genentech

Chris Jowett, General Manager, Commercial Operations, Abbott Molecular

Jingfang Ju, Ph.D., Co-Director of Translational Research, Pathology, Stony Brook University

Peter M. Kazon, General Counsel, American Clinical Laboratory Association

Eric Lai, Ph.D., Senior Vice President and Head, Pharmacogenomics, Takeda Pharmaceuticals International

Ira M. Lubin, Ph.D., Team Lead, Genetics Laboratory Research and Evaluation Branch, CDC

Johan Luthman, D.D.S., Ph.D., Senior Program Leader, Neuroscience & Ophthalmology Research & Development Franchise Integrator, Merck

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP Laboratories

Ron Mazumder, Ph.D., MBA, Global Head, Research and Product Development, Janssen Diagnostics, Janssen Pharmaceutical Companies of Johnson & Johnson

Duncan McHale, Ph.D., Vice President, Global Exploratory Development at UCB Pharma

Alan Mertz, President, American Clinical Laboratory Association

Yoshi Oda, Ph.D., President, Biomarkers and Personalized Medicine Core Function Unit, Eisai

Lorraine O’Driscoll, Ph.D., Associate Professor, Pharmacology; Director, Research, School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin

Carol S. Palackdharry, M.D., MS, Medical Director, ActiveHealth Management; Clinical Lead, Oncology Condition Analysis, Aetna

Saumya Pant, Ph.D., Research Fellow, Merck

Liron Pantanowitz, M.D., Associate Professor, Pathology and Biomedical Informatics, University of Pittsburgh Medical Center

Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen

Sonia Pearson-White, Ph.D., Scientific Program Manager, Oncology, The Biomarkers Consortium, Foundation for the National Institutes of Health

Emanuel Petricoin III, Ph.D., Co-Director, The Center for Applied Proteomics and Molecular Medicine, George Mason University

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

Mark Priebe, MT(ASCP)SBB, Managing Director, QualityStar Quality Consortium

Debra Rasmussen, MBA, Senior Director, Regulatory Affairs, Johnson & Johnson

Hallgeir Rui, M.D., Ph.D., Professor, Cancer Biology, Medical Oncology, and Pathology, Thomas Jefferson University

Hakan Sakul, Ph.D., Executive Director and Head, Diagnostics, Worldwide R&D, Clinical Research and Precision Medicine, Pfizer

Kurt A. Schalper, M.D., Ph.D., Associate Research Scientist, Pathology, Yale School of Medicine

Stephen C. Schmechel, M.D., Ph.D., Associate Professor, Pathology, University of Washington School of Medicine

Robert Schupp, Ph.D., Executive Director, Diagnostics Hematology/Oncology, Celgene Corporation

Jason S. Simon, Ph.D., Director, Immuno-Oncology Biomarkers, Discovery Medicine and Clinical Pharmacology, Bristol-Myers Squibb

Sharon Sokolowski, Ph.D., Principal Scientist, Pfizer Global Research & Development

Gyongyi Szabo, M.D., Ph.D., Professor, Gastroenterology, University of Massachusetts Medical School

Douglas D. Taylor, Ph.D., Professor, Obstetrics and Gynecology, University of Louisville School of Medicine

Meghna Das Thakur, Ph.D., Presidential PostDoctoral Fellow, Novartis Institutes for BioMedical Research

Emina Torlakovic, M.D., Ph.D., Associate Professor, Laboratory Medicine and Pathobiology, University of Toronto

Jessie Villanueva, Ph.D., Assistant Professor, Molecular & Cellular Oncogenesis Program, The Wistar Institute

Glen J. Weiss, M.D., Co-Head, Lung Cancer Unit, The Translational Genomics Research Institute (TGen); Director, Clinical Research, Cancer Treatment Centers of America; CMO, CRAB-Clinical Trials Consortium

David Wholley, Director, Biomarkers Consortium, Foundation for the NIH

David T.W. Wong, D.M.D., D.M.Sc., Professor, Associate Dean of Research, UCLA School of Dentistry and Director of Dental Research Institute

Janghee Woo, M.D., Albert Einstein Medical Center

Wen Jin Wu, M.D., Ph.D., Principal Investigator, Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA

Brenda Yanak, Ph.D., Precision Medicine Leader, Clinical Innovation, Pfizer

Tammie Yeh, Ph.D., Molecular Biomarkers, Oncology Lead, Merck

Eunhee S. Yi, M.D., Consultant, Anatomic Pathology, Mayo Clinic; Professor, Pathology, Mayo Clinic College of Medicine

Malcolm York, MPhil, Director and Head, Clinical Pathology and Safety Assessment, GlaxoSmithKline R&D

Theresa Zhang, Ph.D., Associate Director, Exploratory and Translational Sciences, Merck

BIOMARKERS

& DIAGNOSTICS

world congress 2013

MAY 6 – 8, 2013 | LOEWS PHILADELPHIA HOTEL | PHILADELPHIA, PA

Cambridge Healthtech Institute’s Ninth Annual

BiomarkerWorldCongress.com

The Leading Annual Meeting Dedicated to Biomarkers

and Diagnostics Research and Implementation

Dinner Courses:

Fit-for-Purpose Biomarker Assay

Development and Validation

Next-Generation Sequencing as

a Clinical Test

Laboratory-Developed Tests

Conference Programs:

May 6 – 7, 2013

Track 1: Translational

Biomarkers in Drug Development

Track 2: Clinical Assay

Development

Track 3: Cancer Tissue

Diagnostics

May 6 – 8, 2013

Track 4: Executive Summit:

Companion Diagnostics

May 7 – 8, 2013

Track 5: Biomarkers for

Patient Selection

Track 6: Cancer Drug Resistance

Track 7: Exosomes and

Microvesicles as Biomarkers

and Diagnostics

Premier Sponsor

Featured Speakers

Hakan Sakul

Head, Diagnostics

Pfizer

Yoshi Oda

President, Biomarkers & Personalized Medicine

Eisai

David Wholley

Director

Biomarkers Consortium

Khusru Asadullah

VP, Head, Global Biomarkers

Bayer

Nicholas C. Dracopoli

VP, Janssen R&D

Johnson & Johnson

Eric Lai

SVP, Head, Pharmacogenomics

Takeda

2 | Biomarkers & Diagnostics World Congress BiomarkerWorldCongress.com

BIOMARKERS & DIAGNOSTICS

world congress 2013

Track 1: Translational Biomarkers

in Drug Development

Track 2: Clinical

Assay Development

Track 3: Cancer Tissue Diagnostics Track 4: Executive Summit:

Companion Diagnostics*

Sunday, May 5

5:00-6:00 Conference Pre-Registration

Monday, May 6

8:30-10:00 Biomarkers in Translational Medicine From Research Biomarkers to

Clinical Assays

Whole-Slide Imaging and

Digital Pathology

Commercialization of

Companion Diagnostics

10:00-10:30 Networking Coffee Break

10:30-11:50 Biomarkers in Translational Medicine From Research Biomarkers to

Clinical Assays

Whole-Slide Imaging and

Digital Pathology

Commercialization of

Companion Diagnostics

11:50-1:20 Luncheon Presentation

Sponsors

4 | Biomarkers & Diagnostics World Congress BiomarkerWorldCongress.com

Monday, May 6, 6:00-9:00 pm

Fit-for-Purpose Biomarker Assay Development

and Validation

Instructors:

John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON

Development Solutions

Viswanath Devanarayan, Ph.D., Global Head, Exploratory Statistics, AbbVie, Inc

This tutorial will provide recommendations on the “fit-for-purpose” best

practices in the development and validation of biomarker assays for

exploratory or advanced biomarker applications. Strategies for different

applications at various phases of biomarker development will be described.

Key elements in the method of development and validation will be illustrated

with examples, including reference to standard material, sample stability and

collection integrity, validation and QC samples, validity of reference standards,

calibration curve fitting methods, method optimization and feasibility studies.

Special challenges in protein biomarker assays will be discussed, including

strategies for moving from biomarker panels in the exploratory phase to the

few markers chosen to support clinical trials, cross-validation of biomarker

assays, etc.

Outline:

1. Introduction: Nomenclature, types of biomarker methods/assays, method

development and validation road-map, fundamental validity, similarity and

differences from PK assays and diagnostic applications

2. Pre-analytical and bioanalytical elements: Target range, standards,

validation and QC samples, stability, matrix effect, specificity and

relative selectivity

3. Calibration curve model selection, evaluation and weighting

4. Method feasibility and optimization with precision profiles

5. Evaluation of some pre-study validation characteristics such as precision,

bias, sensitivity and quantification limits

6. Use of sample controls for in-study performance monitoring and

conformance testing among laboratories

7. Special considerations for multiplex assays, cross-validation of assays, etc.

8. Method comparisons

Next-Generation Sequencing as a Clinical Test:

It Takes a Community

Instructors:

Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program

Office, College of American Pathologists

Madhuri Hegde, Ph.D., Associate Professor, Human Genetics; Senior Director,

Emory Genetics Laboratory, Emory University

Next-Generation Sequencing (NGS) is used widely in clinical research for

the discovery of disease-associated genes and the clinical community

is beginning to embrace this technology for diagnostic testing. The rapid

evolution of NGS technologies presents significant opportunities and

challenges for researchers and clinicians for improving health outcomes,

particularly with respect to an increased emphasis on personalized and

preventive medicine. Adoption of NGS in the clinical laboratory setting

requires the adoption of many processes and procedures, such as

the analytic and clinical validation of the test, CLIA certification/CAP

accreditation, standards for reference materials, availability for proficiency

testing, and questions regarding reimbursement and informed consent.

The success of NGS as a viable diagnostic modality depends on many

branches of the health care community working together. This session will

be informative and practical for the researcher and laboratorians who are

considering launching NGS as a clinical test.

Tuesday, May 7, 6:00-9:00 pm

Laboratory-Developed Tests

Regulatory Issues Facing Laboratory-Developed Tests

Peter M. Kazon, General Counsel, American Clinical Laboratory Association

The development of molecular diagnostics has been accompanied by a host

of regulatory issues, including coding, billing and FDA issues. This session will

review recent changes affecting these codes as well as the position of Medicare

on how to pay for these tests and tests including an algorithm, also referred

to as MAAAs. It will review the latest developments from the FDA concerning

whether such tests will require FDA pre-market approval or clearance, and what

action FDA is likely to take in the future. It will also review other actions that affect

these tests, such as the new MolDx program being overseen by Palmetto GBA, a

Medicare contractor.

Laboratory-Developed Tests in the Genomic Medicine Era: Validation, Regulation

and Challenges Faced by New Technologies and Clinical Applications

Andrea Ferreira-Gonzalez, Ph.D., Professor and Chair, Division of Molecular

Diagnostics; Director, Molecular Diagnostics Laboratory, Department of

Pathology, Virginia Commonwealth University

Laboratory-developed tests are those tests developed, validated and

performed by clinical laboratories. There are standards and regulations in

place for the validation of these tests before they are introduced into clinical

practice. This presentation will discuss the process of validation under the

current regulatory framework, and regulatory challenges posed by new

technologies such as NGS and its clinical applications.

LDTs in the Context of CLIA: An NIH Experience

Daniel Edelman, Ph.D., Facility Head, Clinical Molecular Profiling Core, National

Cancer Institute, NIH

The mission of the Clinical Molecular Profiling Core (CMPC) of the National

Cancer Institute (NCI) is to provide state of the art genomic testing for specimens

obtained from NCI clinical trials. The greatest impact is effected where test results

have immediate clinical application for personalized cancer care for individual

patients enrolled in these trials. To that end, the CMPC is CLIA certified and

provides a growing set of clinical test modalities. In this talk we’ll discuss the

challenges of meeting CLIA regulations in this new age of genomics at NIH for

high-complexity assays that did not exist as diagnostic tests when the federal

guidelines were written.

LDT Regulation Guidance from the FDA: Where Does It Stand after Three Years?

Stephen P. Day, Ph.D., Director, Medical Affairs, Hologic

The FDA’s announced intent to further regulate laboratory developed tests

(LDTs) enters its third year without the issuance of the anticipated guidance.

This presentation will summarize what the FDA has made publicly available

on the subject up to this time, the positions and recommendations put

forward by medical and industry professional societies, and how it will

potentially affect clinical laboratories offering LDTs and the delivery of quality

medical care.

Next-Generation Sequencing Assays as Laboratory-Developed Tests

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics; Co-Medical Director,

Pharmacogenomics, ARUP Laboratories; Associate Professor, University of Utah

As next-generation sequencing (NGS) technologies improve in accuracy

and cost effectiveness, they will become standard in clinical laboratories.

Multi-gene panels, exome or genome analysis are alternative approaches.

With the complexity of genomic scale sequencing, implementing NGS

assays into clinical laboratories requires expertise in laboratory techniques,

informatics and interpretation. CLIA-certified clinical laboratories are

developing NGS assays as laboratory-developed tests (LDTs). The

presentation will discuss how NGS assays are “procedures” involving input

from health care professionals, and how they fit under the category of high

complexity LDTs.

*Separate registration required

Dinner Courses*

BiomarkerWorldCongress.com Biomarkers & Diagnostics World Congress | 5

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

Biomarkers in Translational Medicine

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

8:45-9:10 Translating Biological Data into Predictive Biomarker

Development Strategies

Nicholas C. Dracopoli, Ph.D., Vice President, 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

David Chen, Ph.D., Senior Director, 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.

10:55-11:20 Perspectives of Target and Marker Discovery in Multiple Myeloma

Robert Schupp, Ph.D., Executive Director, Diagnostics Hematology/Oncology,

Celgene Corporation

While major advances in therapeutic treatments have almost quadrupled the

overall survival of patients with multiple myeloma (MM) within the last decade,

the clinical challenges are now to optimize clinical utility of drugs and their

therapeutic sequence. The immunomodulatory drugs (IMiDs) thalidomide,

lenalidomide, and pomalidomide comprise an essential treatment modality in

MM and have shown to needfully bind to a newly identified protein in order

to exert their antimyeloma activity. Since this potential new target protein

may qualify as a biomarker predicting clinical response and the emergence of

resistance, significant challenges remain with regards to validating a robust

assay. This talk will highlight key challenges in the methodology and further

development of measurements leading to establishing a new biomarker in MM.

11:20-11:35 Measure for Measure: Assaying the Sponsored by

Rise and Fall of Protein Biomarkers across the Proteome

Steve Williams, M.D., Ph.D., CMO, SomaLogic

Shakespeare’s proteome: “Oh what may man within him hide, though angel on

the outward side!” – Early disease markers. “Our doubts are traitors and make

us lose the good we oft might win, by fearing to attempt” – Now is proteomics’

time. “Truth is truth to the end of reckoning” – Truth standards and biomarkers.

“The miserable have no other medicine but only hope” – Proteomics applied.

“What’s mine is yours, and what is yours is mine.” – Working with us.

11:35-11:50 Sponsored Presentation

(Opportunity available. Contact Ilana Quigley at 781-972-5457

or iquigley@healthtech.com)

11:50-1:20 pm Luncheon Presentation Sponsored by

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.

Biomarker Utility in Clinical Development

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.

Track 1: Translational Biomarkers in Drug Development

6 | Biomarkers & Diagnostics World Congress BiomarkerWorldCongress.com

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 Metabolomic Profiling for NMR Based Clinical Sponsored by

Assay Development

Thomas 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 Networking 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. See Page 4 for additional information.)

Tuesday, May 7

7:30-8:15 am Breakfast Presentation Sponsored by

Identifying Non-Invasive Biomarkers of Smoking-

Related Parenchymal Lung Disease (i.e. COPD and

IPF) to Detect Subclinical Lung Disease

Ivan O. Rosas, M.D., Assistant Professor, Medicine Division, Pulmonary &

Critical Care Medicine, Brigham & Women’s Hospital, Harvard Medical School

Biomarkers for Safety Assessment

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

8:30-8:55 Pre-Clinical Safety Biomarkers and Translation to Clinical

Testing: Current Perspectives

Malcolm York, MPhil, Director and Head, Clinical Pathology and Safety

Assessment, GlaxoSmithKline R&D

Significant efforts have been conducted into the analytical validation,

characterization and qualification of safety biomarkers, notably for the

assessment and prediction of cardiac, kidney and liver safety. However,

significant challenges are still evident in the interpretation of toxicity

biomarker signals above defined thresholds, which report apparent injury

(but in the absence of the histopathology) and their relevance for clinical

safety testing. Current perspectives on the measurement and use of toxicity

biomarkers/multiple biomarkers, along with integration with other measures

of biological response, to improve definition of safety margins and riskbenefit

characterization of exploratory new medicines will be discussed.

8:55-9:20 Biomarkers of Acute Kidney Injury: From Pre-Clinical Species

to Human Patients

Jiri Aubrecht, Pharm.D., Ph.D., Senior Director, Safety Biomarker Group Lead,

Drug Safety Research & Development, Pfizer

Acute kidney injury provides a significant challenge to drug development.

Recently, new biomarkers of acute kidney injury have been developed. In this

presentation we will review the recent progress in applying emerging biomarkers

of acute kidney injury across pre-clinical species and human subjects.

9:20-9:45 Preparing for Safety Biomarkers to Support Clinical Trials

Stephen T. Furlong, Ph.D., Safety Science Lead, AstraZeneca Patient Safety

Many new biomarkers are being considered for use in clinical trials to

monitor drug-induced organ toxicity. However, deciding which biomarkers

to use, selecting a vendor to perform the assays, establishing sample

handling protocols, preparing for statistical analysis of the data and

deciding how to use the data all represent significant challenges. This talk

will review these topics, provide examples from specific biomarkers and

provide suggestions for overcoming some of these challenges.

9:45-10:10 Identifying Biomarkers of Kidney and Liver Toxicity by

Integrating Toxicogenomics Datasets with Biological Networks

Philip Hewitt, Ph.D., Head, Early Non-Clinical Safety (Liver and Kidney), Merck Serono

Candidate nephrotoxicity biomarkers were identified by interrogating

profiles from hundreds of publicly available toxicogenomics datasets,

including datasets from the EU PredTox and Japanese TG-GATEs

projects. Application of multiple bioinformatics approaches identified

43 significant candidates. These findings were corroborated by testing

model nephrotoxic compounds using whole genome expression profile

experiments both in vivo and in vitro. This in silico approach greatly

enriched candidates for those likely to be true biomarkers.

10:10-11:00 Coffee Break in the Exhibit Hall with Poster Viewing

Biomarker Collaborations and Consortia

11:00-11:25 From Promise to Progress: An Update on the Biomarkers

Consortium

David Wholley, Director, Biomarkers Consortium, Foundation for the NIH

11:25-11:50 Open Innovation in Biomarker Discovery: Experiences

from Our Grants for Targets and Biomarkers Initiative

Khusru Asadullah, M.D., Vice President and Head, Global Biomarkers, Bayer

HealthCare

To combine expertise Bayer Healthcare has set up a novel open innovation

approach called Grants4Targets. After a review process, grants are

provided to perform focused experiments to further validate the proposed

targets/biomarkers. In addition to financial support, specific know-how on

target validation and drug discovery is provided. Experienced scientists

are nominated as project partners and, depending on the project, tools

or specific models are provided. More than 600 applications have been

received and 77 projects granted so far.

11:50-12:15 pm Biomarker Discovery—The Power of Collaborative

Networks

Duncan McHale, Ph.D., Vice President, Global Exploratory Development, UCB

Pharma

Clinically useful, predictive biomarkers have been very elusive despite

the growth of Big Biology. Individual technology solutions are commonly

touted as being able to identify drug response biomarkers but are rarely

successful. It is likely that to be successful a network of collaborators will

be needed bringing together technology discipline experts with disease

biology experts. A case example is given in rheumatoid arthritis.

12:15-1:45 Enjoy Lunch on Your Own

Track 1: Translational Biomarkers in Drug Development

BiomarkerWorldCongress.com Biomarkers & Diagnostics World Congress | 7

Track 2: Clinical Assay Development

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

From Research Biomarkers to Clinical Assays

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

8:45-9:10 Biomarkers and the Quest for Clinical Utility—Obstacles,

Challenges and Opportunities

Steven Gutman, M.D., MBA, Strategic Advisor, Myraqa

Over the past ten years there has been an explosive increase in the number

of biomarker assays available for the study and evaluation of human

disease. To ensure stakeholders are able to use this growing menu of tests

responsibly, there is a compelling need to understand the clinical utility of

these assays. Unfortunately a surprising number of tests are plagued by

inadequate information on clinical utility. This talk will focus on obstacles,

challenges and opportunities for addressing this problem.

9:10-9:35 Clinical Assay Development—The Process and Considerations

Herbert A. Fritsche, Ph.D., Senior Vice President and CSO, Health Discovery Corporation

The process for successful development of a clinical laboratory test begins

with a strict definition of the test concept and its clinical utility; design of an

accurate and robust assay for the analyte; analytical validation followed by

clinical validation; and lastly, translation of the new test from the research

lab to routine clinical use, which includes validation of the new test outside

of the research setting. Success of development is defined as acceptance of

the new test by the medical community as the “standard-of-care.”

9:35-10:00 Bridging Research and “Clinical” Assays in Pharmaceutical

Research & Development

John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON

Development Solutions

Many biomarker assays used in drug development are research assays

(i.e., not accredited diagnostic devices). This presentation will look at the

following: basic validation experiments across assays in research and

diagnostics; differences and assay evolution as methods progress through

different uses of results data; the requirements for accreditation of assays to

be used in diagnostics; and a brief look at the development of a companion

diagnostic and its implications from the laboratory perspective.

10:00-10:30 Networking Coffee Break

10:30-10:55 Key Considerations for Choosing and Transitioning a

Research Grade Assay to the Clinical Setting

Tammie C. Yeh, Ph.D., Molecular Biomarkers, Oncology Lead, Merck

Developing a biomarker assay with the clinical perspective in mind is critical to

the success of the biomarker. Identifying/choosing a robust biomarker readout

is as important as developing a robust analytical assay to ensure clinical utility.

It is important to understand the inherent biological variability as well as the

clinical feasibility of a biomarker readout, both of which will depend on tissue

type, tissue processing and the specific clinical setting. Both patient selection

and pharmacodynamic biomarkers will be addressed in this presentation.

10:55-11:20 Clinical Assay Development for Cancer Protein Biomarkers:

What Works and What Does Not Work

Samir Hanash, Ph.D., Program Head, Molecular Diagnostics, Fred Hutchinson

Cancer Research Center

The breadth and depth of proteomics technologies for the discovery of

biomarkers has increased substantially over the past decade, covering

a dynamic range of more than 7 logs in protein abundance. As a result,

numerous cancer biomarker candidates have emerged from discovery

studies. There remains a need for the development of high-throughput

technologies that allow testing the utility of these biomarkers for their

intended clinical application to meet regulatory requirements. Current

opportunities and challenges will be presented.

11:20-11:45 Will Regulation of Laboratory-Developed Tests Stifle Innovation?

Alan Mertz, President, American Clinical Laboratory Association

Laboratory developed tests (LDTs) are regulated by Federal law (CLIA),

state law, and industry standards established by the College of American

Pathologists. For many years, FDA has maintained that LDTs are medical

devices. FDA’s legal authority has been questioned, however, and Congress,

in July 2011, considered legislation that would enhance the CLIA framework

for regulating LDTs. FDA’s work plan for 2013 does not mention new

guidance on LDTs, but remains a possibility. Closing the LDT pathway would

have substantial effects on clinical laboratories, health care providers, and

patients. This presentation will examine the role of LDTs in creating new

tests, diagnosing rare diseases, and including the most up-to-date clinical

information in diagnostic tests.

11:45-1:20 pm Enjoy Lunch on Your Own

NGS in Clinical Use

1:20-1:25 Chairperson’s Remarks

1:25-1:50 College of American Pathologists’ Standards and Proficiency

Testing for Next-Generation Sequencing for the Clinical Laboratory

Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program

Office, College of American Pathologists

The rapid and ongoing advances in the genetic test market, spurred by the

opportunities of Next-Generation Sequencing (NGS), necessitate many facets

of the health care industry to work cohesively. Adoption of NGS as a clinical test

requires the adoption of many processes and procedures, such as the analytic

and clinical validation of the test, CLIA certification/CAP accreditation, standards

for reference materials, availability for proficiency testing, genetic counseling,

and questions regarding reimbursement, informed consent and incidental

findings. This talk will focus on the laboratory requirements developed at CAP

for CLIA/CAP accreditation and the plans for proficiency testing for NGS.

1:50-2:15 Assuring the Quality of Next-Generation Sequencing in

Clinical Laboratory Practice

Ira M. Lubin, Ph.D., Team Lead, Genetics Laboratory Research and Evaluation

Branch, Division of Laboratory Science and Standards, Laboratory Science,

Policy, and Practice Program Office, Office of Surveillance, Epidemiology, and

Laboratory Services, Centers for Disease Control and Prevention

Integration of next-generation sequencing (NGS) into the clinical laboratory

requires test validation, establishment of quality control procedures, and

the independent assessment of test performance by proficiency testing

or alternate approaches. Existing regulatory requirements and professional

guidance do not adequately address these quality issues for clinical NGS

testing. This talk will describe the outcomes of a national workgroup

organized by the Centers for Disease Control and Prevention tasked to

identify principles and develop guidance to promote good clinical laboratory

practices for NGS and meet regulatory and professional standards.

2:15-2:40 Clinical NGS: Validation, Reporting and Economics

Seth Crosby, M.D., Director, Partnerships & Alliances, Washington University

School of Medicine

As NGS enters the clinic, matters of analytic and clinical validation are just

the start of the medical director’s worries. How should results be quickly

generated and communicated to a physician in a meaningful and actionable

manner? What are the new rules for billing and reimbursement?

2:40-3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

3:40-4:05 Exome Sequencing in a Clinical Setting to Guide Patient Care

Madhuri Hegde, Ph.D., Associate Professor, Human Genetics; Senior Director,

Emory Genetics Laboratory, Emory University

8 | Biomarkers & Diagnostics World Congress BiomarkerWorldCongress.com

Track 2: Clinical Assay Development

Advances in genomic medicine have made it necessary for clinical laboratories

to rapidly implement new technologies to guide patient care. Exome

sequencing is rapidly being implemented across different specialties such as

inherited diseases, cancer and infectious diseases. This talk will focus on the

clinical utility of exome sequencing in patient care with real case examples.

4:05-4:30 Interpreting Clinical Next-Generation Sequencing Data:

Current Challenges and Hope for the Future

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics; Co-Medical Director,

Pharmacogenomics, ARUP Laboratories; Associate Professor, University of Utah

With the complexity of genomic scale sequencing (next-generation

sequencing or NGS) and the massive amounts of data obtained, informatics

is essential. Two challenges in evaluating a variant are 1) is it real and 2)

is it clinically significant. Informatics allow alignment and variant calling

(differences from a reference sequence), and sifting of probable clinically

insignificant variants. More challenging is prioritizing variants that are likely

to be associated with the clinical symptoms. In addition to the symptomguided

analysis approach, NGS data can reveal variants in genes related to

drug metabolism that may affect efficacy or response. This presentation will

discuss approaches to prioritize symptom-related variants as well as the

potential of NGS data for companion diagnostics or therapeutics.

4:30-5:00 Sponsored Presentations

(Opportunities available. Contact Ilana Quigley at 781-972-5457

or iquigley@healthtech.com)

5:00-6:00 Networking 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. See Page 4 for additional information.)

Tuesday, May 7

7:30-8:15 am Breakfast Presentation Sponsored by

Identifying Non-Invasive Biomarkers of Smoking-

Related Parenchymal Lung Disease (i.e. COPD and

IPF) to Detect Subclinical Lung Disease

Ivan O. Rosas, M.D., Assistant Professor, Medicine Division, Pulmonary &

Critical Care Medicine, Brigham & Women’s Hospital, Harvard Medical School

Choosing a Platform for Companion Diagnostics

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

8:30-8:55 Validating Biomarker Assays as a Prelude to Companion

Diagnostic Development: Emerging Platform-Specific Considerations

Michael Burczynski, Ph.D., Executive Director, Biomarker Technologies, Discovery

Medicine and Clinical Pharmacology, Bristol-Myers Squibb

Timely implementation of companion diagnostics alongside therapeutic

products has amplified the need to validate predictive biomarkers in earlier

phases of drug development. Today, biomarker strategies are more complex

and require more diverse platforms than ever before. Ensuring that analytical

validation strategies for these exploratory predictive biomarker assays

are aligned with the downstream requirements for full-blown companion

diagnostic development is a critical activity that ultimately helps determine

the efficiency with which targeted medicines can be brought to market.

8:55-9:20 Choosing a Platform for Companion Diagnostic Development

Ron Mazumder, Ph.D., MBA, Global Head, Research and Product Development,

Janssen Diagnostics, Janssen Pharmaceutical Companies of Johnson & Johnson

One of the early considerations in developing a companion diagnostic is

choice of platform. Several factors, such as technical performance, regulatory

and reimbursement path, and commercial access will be discussed in this

context. Examples from the literature and case studies will be presented.

9:20-9:45 Thoughts and Considerations for Choosing a Companion

Diagnostic Technology and Platform Delivery System

Patrick Groody, Ph.D., Divisional Vice President, Research & Development, Abbott

Choosing a diagnostic technology and testing platform for the

development of a companion diagnostic test can be a significant challenge.

A wide variety of factors including the development time, capabilities of

potential partners and the ability of laboratories and physicians to access

and perform the test routinely in a clinical setting are key factors in

developing a companion diagnostic program. This talk will focus on variety

of strategies for developing commercial companion diagnostic tests.

9:45-10:00 Sponsored Presentation

(Opportunity available. Contact Ilana Quigley at 781-972-5457

or iquigley@healthtech.com)

10:00-11:00 Coffee Break in the Exhibit Hall with Poster Viewing

Multiplexed Assays

11:00-11:25 Measurement of Telomere Repeats in Human Cancer Cell Lines

and Tissues Using a Monochrome Multiplex Quantitative PCR Assay

Daniel Edelman, Ph.D., Facility Head, Clinical Molecular Profiling Core, National

Cancer Institute, NIH

This talk will describe our efforts for the development and validation of a

QPCR multiplex assay to enable the quantitation of overall telomere length

(TL) in cancerous cell lines and tissues. A TL pattern between cancers

might provide valuable diagnostic or prognostic information to promote

a better understanding of the molecular or pathogenic characteristics of

specific cancer types.

11:25-11:50 Multiplexed Immunoassays on Formalin-Fixed, Paraffin-

Embedded Tissue Homogenates as Cancer Diagnostics

Geoffrey Stuart Baird, M.D., Ph.D., Assistant Professor, Laboratory Medicine,

University of Washington

Multiplex immunoassays (MIs) performed on formalin-fixed, paraffinembedded

(FFPE) tissue homogenates offer several advantages

over immunohistochemistry as cancer diagnostics. In contrast to

immunohistochemistry, MIs offer absolute quantitation and improved

sensitivity and specificity through the use of sandwich assay geometries.

Moreover, MI instrumentation has already been adopted in the clinical

laboratory, and is much less expensive than a mass spectrometer. MIs have

been validated as a clinical diagnostic for pituitary adenoma classification in

FFPE tissue, with current work focused on breast carcinoma.

11:50-12:05 pm Diagnostic Classifiers for the Detection Sponsored by

of Bladder Cancer

Mark Ruddock, Ph.D., Team Leader, Molecular Biology, Randox

Pharma Services

Patients presenting with hematuria require investigations, including

cystoscopy and imaging of their upper urinary tracts, to identify the source

of bleeding. This is a significant health burden, which is set to increase

because of our aging population. Using biochip array technology, we have

identified diagnostic classifiers for detecting bladder cancer.

12:05-12:30 Development of Multiplexed Protein Pathway Activation

Mapping Clinical Assays for Personalized Cancer Therapy

Emanuel Petricoin III, Ph.D., Co-Director, The Center for Applied Proteomics and

Molecular Medicine, George Mason University

Cellular signaling pathways are a protein-based network, and the intended

drug effect is to disrupt aberrant protein phosphorylation-based enzymatic

activity, and epigenetic phenomena. The reverse-phase protein microarray

platform provides detailed information about the state of the cellular

“circuitry” from small samples. Measurements of dozens to hundreds of

specific phosphorylated proteins that represent most of the targets for

targeted therapeutics can be obtained at once from only a few thousand

cells. This information helps select specific therapy(ies) tailored to the

patient’s tumor activated protein “circuitry.”

12:30-1:45 Enjoy Lunch on Your Own

BiomarkerWorldCongress.com Biomarkers & Diagnostics World Congress | 9

Track 3: Cancer Tissue Diagnostics

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

Whole-Slide Imaging and Digital Pathology

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

8:45-9:10 Validation of Whole Slide Imaging in Pathology

Liron Pantanowitz, M.D., Associate Professor, Pathology and Biomedical

Informatics, University of Pittsburgh Medical Center

Validation of whole slide imaging (WSI) is important to ensure that digitized

slides are at least equivalent to that of glass slides. The College of American

Pathologists (CAP) Pathology and Laboratory Quality Center convened a

panel to recommend validation requirements for WSI systems to be used

for clinical diagnostic purposes employing a combination of evidence-based

evaluation of the literature, expert consensus and public commentary. The

recommendations are comprehensive and address technical, interpretation

components and administrative issues related to WSI in pathology providing

practical guidance for all types of laboratories who are using or plan to

utilize WSI systems for diagnostic clinical work. This session will educate

participants about WSI in pathology, the regulatory issues surrounding digital

pathology, and review the validation guidelines developed by the CAP.

9:10-9:35 New Applications Utilizing Whole Slide Digital Imaging

for Anatomic Pathology Inter- and Intra-Lab Peer Review and

Benchmarking Quality Assurance

Mark Priebe, MT(ASCP)SBB, Managing Director, QualityStar Quality Consortium

Although application of Whole Slide Digital Imagining (WSI) for primary

diagnosis is limited by the FDA at this time, WSI is a significant enabling

technology for anatomic pathology (AP) quality assurance (QA) initiatives

both inter- and intra-laboratory. This presentation will review current AP/

QA programs and the application of WSI to a novel approach of gaining

longitudinal benchmarking data for quality review. The presentation

will focus on understanding design requirements for development and

implementation, investment requirements, confidentiality considerations

and methods to encourage pathologist participation and acceptance.

9:35-10:00 Label-Free Infrared Spectral Histopathology: Diagnostics and

Prognostics

Max Diem, Ph.D., Professor, Chemistry and Chemical Biology, Northeastern University

Infrared spectral histopathology is a method in which the biochemical

composition of a histopathological sample is used, rather than

morphometric criteria, to diagnose disease. To this end, thousands of

infrared spectra are collected from pixels about 10 μm on edge, and

analyzed to produce spectral images that detect abnormality based on

variations in composition. The accuracy of this method is comparable to

multi-panel immunohistochemistry.

10:00-10:30 Networking Coffee Break

10:30-10:55 Tumor Heterogeneity Assessed by Immunohistochemistry

of Multiplexed Protein Biomarkers

Steve Schmechel, M.D., Ph.D., Associate Professor, Pathology, University of

Washington School of Medicine

Intratumoral heterogeneity of protein expression may be linked to the

biological aggressiveness of tumors and selection of therapies. Analytical

and statistical methods to quantify heterogeneity are needed, particularly

for multiplexed assays. This presentation will discuss novel methods to

measure tumor heterogeneity.

10:55-11:20 Application of WSI in Consensus Review for Clinical Trials

Stephen M. Hewitt, M.D., Ph.D., Clinical Investigator, Laboratory of Pathology,

National Cancer Institute, NIH

Whole Slide Imaging is an enabling technology within pathology, altering all

aspects of current practice. Consensus review processes for clinical trials have

previously been expensive, slow, and complicated by issues of reproducibility.

Whole Slide Imaging and distributed review overcome many of these issues,

and provide new opportunities that have previously not been feasible.

11:20-11:50 Sponsored Presentations

(Opportunities available. Contact Ilana Quigley at 781-972-5457

or iquigley@healthtech.com)

11:50-1:20 pm Enjoy Lunch on Your Own

NGS in Clinical Use

1:20-1:25 Chairperson’s Remarks

1:25-1:50 College of American Pathologists’ Standards and Proficiency

Testing for Next-Generation Sequencing for the Clinical Laboratory

Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program

Office, College of American Pathologists

The rapid and ongoing advances in the genetic test market, spurred by the

opportunities of Next-Generation Sequencing (NGS), necessitate many

facets of the health care industry to work cohesively. Adoption of NGS as

a clinical test requires the adoption of many processes and procedures,

such as the analytic and clinical validation of the test, CLIA certification/CAP

accreditation, standards for reference materials, availability for proficiency

testing, genetic counseling, and questions regarding reimbursement,

informed consent and incidental findings. This talk will focus on the

laboratory requirements developed at CAP for CLIA/CAP accreditation and

the plans for proficiency testing for NGS.