NextGenerationDx.com

Fifth Annual 

Register by May 31 and Save up to $ 350! 

Moving Assays to the Clinic 

The Next Generation Dx Summit brings 

together all of the major players in the 

evolving areas of diagnostics 

Concurrent Programs 

August 20-21 

Enabling Point-of-Care Diagnostics 

Cancer Molecular Markers to Guide Therapy 

Companion Diagnostics: 

From Biomarker Validation to Regulatory Approval 

August 21-22 

Molecular Diagnostics for Infectious Disease 

Molecular Profiling of Circulating Tumor Cells 


Advancing Technologies and Winning Reimbursement 

Commercialization of Molecular Diagnostics 

Premier Sponsor 

August 20-22, 2013 

Hyatt Regency on Capitol Hill 

Washington, DC 

Plenary Keynote Discussion 

Perspectives on Evaluating Novel 

Diagnostics for Reimbursement 

Moderator: 

Andrew C. Fish 

Executive Director, AdvaMedDx 

Panelists: 

Elaine K. Jeter, M.D. 

J1 MolDx Medical Director, Palmetto GBA 

Lee H. Newcomer, M.D. 

Senior Vice President, Oncology, United Healthcare 

Dwight Denham, MBA 

Director, Clinical Research, Beckman Coulter, Inc. 

Aaron D. Bossler, M.D., Ph.D. 

Clinical Assoc. Prof., Dir., Mol. Pathology Lab and 

Mol. Genetic Pathology Fellowship Program, Univ. 

of Iowa Hospitals and Clinics and Co-Chair, AMP 

Economic Affairs Committee 

NextGenerationDx.com

Event-at-a-Glance 

Monday 

Tuesday AM 

Tuesday PM 

Wednesday AM 

Wednesday PM 

Thursday AM 

Thursday PM 

About the Summit 

Technological advances in next-generation diagnostics are driving growth and 

innovation in healthcare. Rapid and precise diagnosis is essential for personalized 

medicine and will change the way value is assessed and compensated in the 

healthcare system. This meeting offers a comprehensive view of the changing 

landscape of diagnostics and brings together the key players in the field. 

The Next Generation Dx Summit (Enabling Point-of-Care Diagnostics, Cancer 

Molecular Markers to Guide Therapy, Molecular Diagnostics for Infectious Disease, 

Companion Diagnostics, Commercialization of Molecular Diagnostics, Molecular 

Profiling of Circulating Tumor Cells) is designed to bring together all of the major 

players in the evolving areas of diagnostics. This year, we have assembled an 

impressive faculty of speakers from industry, government, and leading academic 

institutions. This meeting will showcase improvements in technology research and 

development with an emphasis on applications in the clinic and commercialization. 

Plan to hear what the industry leaders are saying about future market 

opportunities and network with your peers this August 20-22 in Washington, DC. 

Premier Sponsor 

Corporate Sponsors 

Enabling Point-of-Care 

Diagnostics 


Diagnostics 


Diagnostics 

Molecular Diagnostics for 

Infectious Disease 





2 | Next Generation Dx Summit 

Pre-Conference Short Courses* 

Cancer Molecular Markers 

to Guide Therapy 





Molecular Profiling of 

Circulating Tumor Cells 





Quanfying Healthcare 

Plenary Keynote Session 

Dinner Short Courses* 


Partnership Matters/ 

Regulatory Approval 








Technologies/ 

Reimbursement 


Technologies/ 

Reimbursement 


Technologies/ 

Reimbursement 







Commercialization of 

Molecular Diagnostics 





*Separate Registration Required 

“The meeting was excellent, one 

of the best I have attended, and the 

standard of talks matched to the 

schedule across the board.” 

Vice President, Diagnostics, GlaxoSmithKline 

“Great conference! Most up-to-date 

data. Perfect amalgamation between 

industry, labs, clinicians and regulatory 

bodies. Highly recommended!” 

Clinical Microbiology Fellow, NIH 

NextGenerationDx.com

Short Courses 

Monday, august 19 

MORNING SHORT COURSES 

9:00 am - 12:00 pm 

SC1 Overcoming Challenges of Working with FFPE Samples 

Moderator: P. Mickey Williams, Ph.D. (Contractor), Director of Molecular 

Characterization and Clinical Assay Development Laboratory (MoCha), Frederick 

National Laboratory for Cancer Research (tentative) 

Instructors: Helen M. Moore, Program Director, Biorepositories and 

Biospecimen Research Branch, NCI NIH 

Lynne Rainen, Ph.D., Principal Scientist, PreAnalytiX, BD 

Helen Y. Wu, Ph.D., Project Leader, Genomics and Oncology, Roche Molecular 

Systems 

Jason Lih, Ph.D. (Contractor), Principal Scientist, Molecular Characterization & 

Clinical Assay Development Laboratory, SAIC Frederick National Laboratory for 

Cancer Research, SAIC-Frederick 

• Non-formalin-based fixatives 

• Comparison of methods for preserving morphological, molecular, and protein 

biomarkers in tissue 

• Feasibility data from fine needle aspirates (FNA) 

• Assay development 

SC2 Latest Advances in 

TM 

Molecular Pathology 

Instructors: Jack H. Lichy, M.D., Ph.D., Chief, Pathology 

& Laboratory Medicine, VA Medical Center, Washington, D.C. 

Jennifer Morrissette, Ph.D., Director, Clinical Cancer Cytogenetics, University 

of Pennsylvania School of Medicine and The Children’s Hospital of Philadelphia 

Christopher D. Gocke, M.D., Associate Professor of Pathology and Oncology, 

Director of Hematology, Molecular Diagnostics, Johns Hopkins University 

School of Medicine 

• Introduction to molecular pathology methods 

• Molecular diagnostic cancer testing 

• Cytogenetic testing and microarray comparative genomic hybridization 

SC3 Clinical Studies for the Development of Evidence-Based 

Diagnostics 

Instructors: Catherine Schnabel, Ph.D., Vice President, Medical, Clinical & 

Regulatory Affairs, bioTheranostics, Inc. 

Brock Schroeder, Ph.D., Director, Medical & Scientific Affairs, bioTheranostics Inc. 

Development of a strong clinical program for diagnostic tests requires 

consideration and integration of key strategic drivers such as clinical adoption, 

reimbursement, & regulatory filing based on a proposed indication for use. 

In considering the appropriate use of new tests, clinicians and health care 

policymakers must consider the accuracy with which a test identifies a 

patient’s clinical status (clinical validity), the risks and benefits resulting from 

test use (clinical utility), and the medical value of the test (health economics/ 

outcomes). This workshop will provide a basic framework for establishing 

comprehensive clinical evidence based on analytical validity, clinical validity, 

clinical utility, and health economics and effectiveness, and utilize a case study 

of the 92-gene assay, CancerTYPE ID to build these points. 

• Clinical study designs for biomarker research/Levels of evidence 

• Formulating clinical endpoints 

• Framework for clinical evidence 

• Data requirements for various stakeholders 

• Case study 

SC4 Technology Trends in the Emerging Exosomes Field 

Instructors: Enal Razvi, Ph.D., Biotechnology Analyst 

Hannah Mamuszka, Vice President, Business Development, Exosome 

Diagnostics 

Leonora Balaj, Ph.D., Research Fellow, Massachusetts General Hospital, 

Harvard Medical School 

• Challenges and opportunities in exosome research: Where are 

the bottlenecks? 

• Technology development in exosomes and microvesicles (EMVs) 

• Classes of EMV researchers 

• EMVs as potential biomarkers: Prognostic vs. predictive 

SC5 Clinical Assay Development 

Instructors: Barbara A. Conley, M.D., Associate Director, Cancer Diagnosis 

Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute 

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

Diagnostics; Director, Molecular Diagnostics Laboratory, Department of 

Pathology, Virginia Commonwealth University 

Andrew Grupe, Ph.D., Senior Director, Pharmacogenomics, Celera/Quest 

Diagnostics 

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

Pharmacogenomics, ARUP Laboratories; Associate Professor, University of 

Utah 

Gene Pennello, Ph.D., Team Leader, Division of Biostatistics, U.S. Food and 

Drug Administration 

• Assessment of the analytical and clinical performance of biomarker assays 

• Translating NGS applications from a research environment to a standardized 

test offering in a clinical reference laboratory 

• Providing clinical value beyond existing tests on traditional platforms 

• Infrastructure to interpret and report results 

• Consequences of hardware, software and reagent updates 

• Validation of laboratory-developed tests 

• NCI Clinical Assay Development Program 

AFTERNOON SHORT COURSES 

2:00 - 5:00 pm 

SC6 Circulating Tumor Cells and Cancer Stem Cells from Research 

to Clinic 

Moderator: Marek Malecki, M.D., Ph.D., President, Phoenix Biomolecular 

Engineering Foundation; Visiting Professor, University of Wisconsin, Madison 

Instructors: Minetta C. Liu, M.D., Associate Professor, Department of Oncology 

and Department of Laboratory Medicine and Pathology, Mayo Clinic Cancer 

Center 

Avraham Rasooly, Ph.D., Chief, Disparities Research Branch, NCI NIH 

Abraham Tzou, Medical Officer, FDA CDRH 

Patrick Morris, Ph.D., Perkins Coie LLP 

• Isolation of living cells 

• Molecular profiling 

• Clonal expansion 

• IP aspects 

• Patient’s rights and ethical concerns 

• Cancer stem cells 

• Liquid biopsy 

SC7 Applications of Detection Theory in Diagnostics 

Instructor: John C. Carrano, Ph.D., President, Carrano Consulting, LLC 

• Applying basic principles of detection theory 

• ROC curve trends and interpretation 

• Application of cost-benefit analysis to product choice 

• Decision tree and systems level analysis 

NextGenerationDx.com Next Generation Dx Summit | 3

SC8 Next-Generation Sequencing as a Diagnostics Platform 

Instructors: Jamie Platt, Ph.D., CGMBS, MB (ASCP), Director, Advanced 

Sequencing, Quest Diagnostics, Nichols Institute 

Shashikant Kulkarni, M.S. (Medicine), Ph.D., FACMG, Head, Clinical Genomics; 

Medical Director, Cytogenomics and Molecular Pathology; Associate Professor 

of Pediatrics, Genetics, Pathology and Immunology, Washington University 

School of Medicine 

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

Office, College of American Pathologists 

• The landscape of next-generation sequencing and challenges for 

clinical applications 

• Advances in application of next-generation sequencing to cancer diagnostics 

• Development of laboratory standards for next-generation sequencing as a 

clinical tool 

SC9 Regulatory Compliance in Drug-Diagnostics Co-Development 

Instructors: Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott 

Molecular, Inc. 

Maham Ansari, MS, RAC, Consultant, Strategic Regulatory Services 

OptumInsight (UnitedHealth Group) 

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

• U.S. requirements and processes 

• U.S. government oversight of diagnostics, diagnostic clearance and 

approval pathways 

• Co-development process & timelines 

• Integration of Rx and Dx development plans 

• Navigating the development process 

• Co-development examples and lessons learned 

• Approval path for devices ex-U.S. and more 

DINNER SHORT COURSE 

5:30 - 8:30 pm 

SC10 Regulatory and Reimbursement Issues with Multiplex 

Molecular Assays/Next-Generation Sequencing 

Instructors: Melina Cimler, Vice President, Quality & Regulatory Affairs, 

Illumina, Inc. 

Victoria Pratt, Ph.D., FACMG, Chief Director, Molecular Genetics, Quest 

Diagnostics Nichols Institute 

Wednesday, august 21 

DINNER SHORT COURSES 

6:30-8:30 pm 

SC11 Use of Matrix-Assisted Laser Desorption Ionization Time of 

Flight Mass Spectrometry in Clinical Microbiology 

Instructor: Robin Patel, M.D., Chair, Division of Clinical Microbiology, 

Consultant, Divisions of Clinical Microbiology and Infectious Diseases; 

Professor of Microbiology and Medicine, College of Medicine, Mayo Clinic 

• Adoption in the clinical laboratory 

• Comparison of available systems 

• Strengths and limitations 

SC12 New Dealmaking Strategies in Companion Diagnostics 

Instructors: Jorge Leon, Ph.D., President, Leomics Associates, Inc. 

Matthew J. Hawryluk, Ph.D., Director, Business Development , Foundation 

Medicine, Inc. 

SC13 The Future of Point-of-Care Diagnostics 

Instructors: Keith F. Batchelder, M.D., CEO, Genomic Healthcare Strategies 

Peter S. Miller, COO, Genomic Healthcare Strategies 

• Why pharma will have to find new POC approaches to make companion 

diagnostics succeed 

• Near-patient testing – What are the business and technology implications? 

• New partnering opportunities for POC companies 

• Why the old business models won’t work 

• The wild cards – Consumer product companies 


AUGUST 20-21 

Seventh Annual 

ENAbliNG PoiNt-of-CArE DiAGNoStiCS 

for Evidence-based Medicine 

Recommended Conference Short Courses* 

Applications of Detection Theory in Diagnostics 

The Future of Point-of-Care Diagnostics 

*Separate registration required, please see page 3 for details 

tuesday, august 20 

7:30 am Registration and Morning Coffee 

EMERGENCY MEDICINE 

8:30 Chairperson’s Opening Remarks 

Gerald J. Kost, M.D., Ph.D., MS, Professor, Pathology and Laboratory Medicine; 

Director, Clinical Chemistry and Point-of-Care Testing; Faculty, Biomedical 

Engineering and Comparative Pathology, University of California, Davis 

8:40 Emergency and Disaster Point-of-Care Testing: Cardiac 

Biomarkers, Complex Chaos, and Sustainable Resiliency 

Gerald J. Kost, M.D., Ph.D., MS, Professor, Pathology and Laboratory Medicine; 

Director, Clinical Chemistry and Point-of-Care Testing; Faculty, Biomedical 

Engineering and Comparative Pathology, University of California, Davis 

Point-of-care (POC) testing enables on-site decision-making where it counts 

most at points of need in ERs, complex emergencies/disasters, and smallworld 

networks. New national policies and guidelines are harmonizing 

heretofore chaotic change, morphing “POC culture” where patients take 

ownership of medical care and improve sustainability in low-resource 

settings. Now, the U.S. also can adopt guidelines and national policy that 

enhance resiliency! 

9:10 A New Open-Source Point-of-Care Test (POCT) System for 

Emergency Room and Physician’s Office Labs 

Chong H. Ahn, Ph.D., Mitchell P. Kartalia Chair and Professor, Microsystems 

and BioMEMS Laboratory, School of Electronics and Computing Systems, 

University of Cincinnati 

A new open-source POCT system for use in Emergency room labs and 

Physician’s office labs will be presented in this talk. The open-source and rapidly 

reconfigurable nature of the POCT system provides rapid assay conversion 

to POCT, “tunable” ultra-high sensitivity, and wide-dynamic range for cardiac 

Troponin-I as well as b-hCG. Thus, this POCT system allows the user of POCT 

have the quality of lab-based methods. 

9:40 Biomarkers and POCT in Patients with Heart Failure 

Adam J. Singer, M.D., Professor and Vice Chairman for Research, Department 

of Emergency Medicine, Stony Brook University 

Heart failure is one of the most costly and common reasons for hospital 

admission and readmissions within 30 days in the USA. This lecture will briefly 

review the pathophysiology of heart failure and the role of biomarkers in the 

diagnosis and management of heart failure. It will then discuss the specific role 

of point-of-care testing in ED patients with suspected heart failure and its role 

in improving care. 

10:10 Coffee Break 

APPLICATIONS IN GLOBAL HEALTH 

10:55 Chairperson’s Remarks 

Matthew Lorence, Ph.D., MBA., Senior Vice President, Marketing, Sales, and 

Business Development, TessArae, LLC 

11:00 The Changing Landscape in Point-of-Care Diagnostics: 

Advances in Developing World Applications and Their Potential 

Impact in Developed Markets 

Rich Thayer, Managing Partner, Halteres Associates, LLC; CEO, Catalysis 

Foundation for Health 

Understanding unmet needs and business model options prior to initiating 

development of POC systems for limited resource settings is essential 

for success. Learn how advancements in diagnostics technologies and 

communications, in addition to a better understanding of local market 

conditions and needs, are driving increased interest in delivering diagnostic 

solutions for these important markets. 

11:30 Improving Patient Access to HIV/AIDS Diagnostics in 

Developing Countries 

Randy Allen, Ph.D., Manager, Corporate Relations, Clinton Health Access 

Initiative (CHAI) 

Diagnostics products used in the developed world do not adequately serve 

resource-limited settings (RLS) with insufficient electricity, transportation, 

and trained healthcare workers. Scale-up of patient access to diagnostics will 

require more productive use of conventional technologies and implementation 

of Point-of-Care (POC) products specifically designed for RLS. Opportunities 

now exist for widespread scale-up of cost-effective diagnostics in 

developing countries. 

12:00 pm Enabling POC Diagnostics through Standard Setting 

Gene Walther, MBA, Deputy Director, Diagnostics, Discovery, Bill & Melinda 

Gates Foundation 

Accurate and timely medical diagnosis is a critical step in the successful 

treatment of disease. In the developing world, where illness due to malaria, 

TB, HIV and other infectious diseases is a daily reality for millions, appropriately 

designed diagnostic tests are often not available or affordable. Through the 

establishment of product, regulatory and business standards, the development 

of needed diagnostics can be developed and deployed more effectively. This 

session will discuss the efforts to establish these standards to improve POC 

diagnostics for the global health market. 

12:30 Sponsored Presentation (Opportunity Available) 

12:45 Luncheon Presentations (Sponsorship Opportunities Available) 

or Lunch on Your Own 

2:00 Session Break 

POINT-OF-CARE PATHOLOGY 


John T. McDevitt, Brown Wiess Professor, Bioengineering & Chemistry, Rice 

University 

2:20 Programmable Bio-Nano-Chip Systems for Serum CA125 

Quantification: Toward Ovarian Cancer Diagnostics at the 

Point-of-Care 

John T. McDevitt, Brown Wiess Professor, Bioengineering & Chemistry, Rice 

University 

We report the adaptation of the programmable bio-nano-chip (p-BNC), an 

integrated, microfluidic, and modular (programmable) platform for CA125 serum 

quantitation, a biomarker prominently implicated in multimodal and multimarker 

screening approaches. 

2:50 Presentation to be Announced 

3:20 Latest Advances in Molecular Amplification 

for Point-of-Care Applications 

Speaker to be Announced, Axxin 

Sponsored by 

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing 

5 | Next Generation Dx Summit NextGenerationDx.com

AUGUST 20-21 

Seventh Annual 

ENAbliNG PoiNt-of-CArE DiAGNoStiCS 

for Evidence-based Medicine 

4:10 Panel Discussion: What Stakeholders Want from POC 

Moderators: Keith F. Batchelder, M.D., CEO, Genomic Healthcare Strategies 

Peter S. Miller, COO, Genomic Healthcare Strategies 

• Patient empowerment 

• Help providers and payers measure outcomes 

• Prescription compliance 

• Drive to lower cost in healthcare system 

• Use in clinical trials and near patient testing in hospitals 

Panelists: Sally Okun, RN, MMHS, Vice President, Advocacy, Policy & Patient 

Safety, PatientsLikeMe 

Rob Havasy, Project Specialist and Operations Manager, Center for Connected 

Health, Partners HealthCare System, Inc. 

Robert Di Tullio, Vice President, Global Regulatory and Clinical Affairs, Alere 

Michael Nohaile, Ph.D., Vice President, Corporate Strategy, Amgen, Inc. 

Mark Alexandre Rogers, M.D., Head, Near Patient Testing Unit, Novartis 

5:10 Wine and Cheese Pairing Welcome Reception 

in the Exhibit Hall with Poster Viewing 

6:10 Close of Day 


Sponsored by 

7:30 am Problem Solving Breakout Discussions with Continental 

Breakfast 

Concurrent Problem Solving Breakout Sessions are interactive, topic-specific 

discussions hosted by a moderator. These sessions are open to all attendees, 

sponsors, exhibitors, and speakers and provide a forum for discussing key 

issues and meeting potential partners. See website for topics. 

MOBILE HEALTH 


Katherine Tynan, Ph.D., Business Development & Strategic Consulting for 

Diagnostics Companies, Tynan Consulting LLC 

» 8:30 Keynote PResentatIon: Mobile and Cloud: 

Rethinking Point-of-Care diagnostics 

Sailesh Chutani, Ph.D., CEO, Mobisante 

Point-of-care diagnostics devices coupled with the power of real-time 

data in the cloud, can revolutionize access to health care while reducing 

costs. Mobisante has used this model to create a smart-phone and cloudbased 

ultrasound imaging system, where the collected set of images can 

be archived in the cloud, processed for enhancements, and analyzed for 

providing guidance. 

9:00 Shine and iBGStar: Case Studies in Redesigning to Disrupt 

Existing Product Categories 

Sonny Vu, Ph.D., CEO, Misfit Wearables 

Stories from the development of Shine and iBGStar will be presented. The 

thought process behind both of these award-winning product designs as well 

as crowdfunding and how to use it to gather early user feedback will also 

be addressed. 

RAPID TESTING AND DIRECT-TO-CONSUMER 

PRODUCTS 

9:30 Health Management on Your iPhone 

Jason Oberfest, Co-Founder and CEO, Mango Health 

This talk will discuss how Mango Health has used game design principles to 

improve rates of medication adherence and how they plan to use the platform 

to migrate consumers from reactive to proactive health behavior over time. 

9:45 The Last Mile - Quantified Self Platform for Caregivers 

Chiara Bell, Founder and CEO, CareTicker 

Caregivers are the most critical, yet most overlooked, component of our 

healthcare system. We will address a radically new approach to understanding 

the care delivered by the 65 million caregivers annually and its impact on 

patient outcomes. 


10:30 Coffee Break in Exhibit Hall with Poster Viewing 

11:00 PLENARY KEYNOTE DISCUSSION 

Perspectives on Evaluating Novel Diagnostics for Reimbursement 

Moderator: Andrew C. Fish, Executive Director, AdvaMedDx 

• Levels of evidence needed to 

support novel diagnostics 

• Health economics 

• Analytical issues 

• CMS policy 

• Rate schedule 

Panelists: 

Aaron D. Bossler, M.D., Ph.D., Clinical Associate Professor, Director 

Molecular Pathology Laboratory and Molecular Genetic Pathology 

Fellowship Program, University of Iowa Hospitals and Clinics and Co-Chair, 

AMP Economic Affairs Committee 

Dwight Denham, MBA, Director, Clinical Research, Beckman Coulter, Inc. 

Elaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA 

Lee H. Newcomer, M.D., Senior Vice President, Oncology, United Healthcare 

12:30 pm Close of Conference 

Additional Sponsored Presentation by 


AUGUST 20-21 

Sixth Annual 

CANCEr MolECulAr MArKErS to GuiDE thErAPy 

Evaluating for Clinical use 

Recommended Pre-Conference Short Courses* 

Overcoming Challenges of Working with FFPE Samples 

Circulating Tumor Cells and Cancer Stem Cells from Research 

to Clinic 




BIOMARKER DISCOVERY 


Joe Gray, Ph.D., Associate Director, Translational Research for the Knight 

Cancer Institute, Oregon Health & Science University (OHSU); Director, OHSU 

Center for Spatial Systems Biomedicine (OCSSB) and Gordon Moore Chair of 

Biomedical Engineering, OHSU School of Medicine 

» 8:40 Keynote PResentatIon: total Cancer Care: 

developing a Molecular Markers approach for targeted 

therapies 

William S. Dalton, M.D., Ph.D., CEO, M2Gen; Director, Personalized Medicine 

Institute, H. Lee Moffitt Cancer Center & Research Institute 

Critical to using molecular markers to match patients to the best therapies 

is the development of a biorepository in parallel with the development of a 

data warehouse and an information system containing patient’s clinical and 

molecular data. The Total Cancer CareTM Protocol, now with >95K consented 

patients, >33K tumors and >16K genetic profiles, provides a foundation to 

accomplish the goal of targeted therapies. 

9:10 Multiplex Mutation Screening and other Assay Technologies 

in Support of a Personalized Cancer Medicine Registry 

Christopher L. Corless, M.D., Ph.D., Professor, Pathology and Medical Director, 

Knight Cancer Institute, Oregon Health & Science University 

Making personalized cancer care a reality requires novel approaches to finding 

treatment targets in cancers, because current single-gene assays are not 

adequate for the growing spectrum of actionable mutations. This presentation 

will focus on the opportunities and challenges of introducing new multiplexed 

and next-gen sequencing technologies into clinical laboratories. 

9:40 Paradigm’s Prospective Clinical Trial on 

Sponsored by 

mRNA and Protein Expression for Selecting 

Targeted Oncology Therapy 

Robert J. Penny, M.D., Ph.D., CEO, Paradigm 

Paradigm will review its founder’s previous prospective clinical trial results 

in which clinical outcomes of standard of care treatment were compared to 

targeted therapy based on molecular pathway findings . Validation of paraffin 

and frozen tissue mRNA findings will also be presented. 



11:00 Next-Generation Sequencing and Target-Based Approach in 

Early-Phase Clinical Trials in Cancer 

Filip Janku, M.D., Ph.D., Assistant Professor, Investigational Cancer Therapeutics, 

(Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center 

This presentation will outline the role of novel comprehensive genomic technologies in 

early-phase clinical trials in cancer. In addition, this presentation will suggest how earlyphase 

clinical trials can be expanded from dose finding to proof-of-concept studies. 

11:30 Innovations in Next-Generation Sequencing: Enhancing 

Understanding of Tumor Biology 

Steve Shak, M.D., CMO, Genomic Health 

12:00 pm The Role of Clinical Grade Next-Generation Sequencing 

in Cancer Diagnostics: Foundation Medicine’s Clinical Experience 

Gary Palmer, M.D., J.D., MBA, MPH, Senior Vice President, Medical Affairs and 

Commercial Development, Foundation Medicine 

Our experience with targeted next-generation sequencing in the clinic: the 

pitfalls and the promises. What we have learned from our first 2,000+ cases 

that will optimize the value of targeted next-generation sequencing to the 

clinician, the patient, and the payor. 





BIOMARKER ANALYSIS 


Christopher L. Corless, M.D., Ph.D., Professor, Pathology and Medical Director, 

Knight Cancer Institute, Oregon Health & Science University 

» 2:20 Keynote PResentatIon: Identifying tumor 

Intrinsic and extrinsic Predictive Markers 

Joe Gray, Ph.D., Associate Director, Translational Research for the Knight 

Cancer Institute, Oregon Health & Science University (OHSU); Director, OHSU 

Center for Spatial Systems Biomedicine (OCSSB) and Gordon Moore Chair of 

Biomedical Engineering, OHSU School of Medicine 

This talk will focus on new approaches to identification of molecular features 

intrinsic to tumors and from the extrinsic tumor micro environments that interact 

to determine responses to pathway targeted therapies. The talk will link results 

from analysis of well characterized in vitro models to clinical performance. 

2:50 Functionalizing the Cancer Genome: A Mutation-Driven View 

Gordon Mills, M.D., Ph.D., Chairman, Department of Systems Biology, Chief, 

Section of Molecular Therapeutics; Professor of Medicine and Immunology; and 

Anne Rife Cox Chair in Gynecology, MD Anderson Cancer Center 

Genomic aberrations have proven to be amongst the strongest and most 

robust biomarkers. However, emerging data suggests that we need to evaluate 

the consequences and effects of each aberration independently. For example, 

both activating and inactivating mutations in BRAF can alter patient outcome 

and require different therapies. I will describe a high-throughput platform to 

assess the consequences of specific point mutations and a method to identify 

therapeutic liabilities. 



4:10 Use of Whole Genome Outlier Analysis to Identify Occult 

Biomarkers of Drug Response 

David B. Solit, M.D., Elizabeth & Felix Rohatyn Chair, Memorial Sloan Kettering 

Cancer Center 

The use of next-generation sequencing methods including whole genome 

sequencing to identify the molecular basis of drug sensitivity and resistance 

will be discussed. 

4:40 Use of the Microenvironment to Develop Diagnostic and 

Prognostic Multigene Profiles for Prostate Cancer 

Dan Mercola, M.D., Ph.D., Professor, Pathology and Laboratory Medicine; 

Director, Translational Cancer Biology University of California at Irvine 

The gene activity changes in the microenvironment of prostate cancer can be used 

to form multigene profiles for diagnosis and for prognosis. Diagnosis based on 

gene expression in stroma by detection of “presence of tumor” and indicates the 

need for rapid re-biopsy. Prognosis is classification as early or no relapse following 

radical prostatectomy. The methods of profile development will be discussed. 


AUGUST 20-21 

Sixth Annual 

CANCEr MolECulAr MArKErS to GuiDE thErAPy 

Evaluating for Clinical use 





Sponsored by 


Breakfast 





UTILIZING CANCER BIOMARKERS IN 

CLINICAL TRIALS 


8:30 Molecular Markers for Clinical Decision-Making 

Scott Cameron, M.D., Ph.D., Oncology Director, Clinical Research Physician, 

Novartis Institutes for BioMedical Research, Inc. 

Personalized or precision medicine in clinical trials provides significant benefits 

by identifying populations of patients more likely to benefit, by reducing risk to 

those less likely to benefit, and potentially by allowing earlier decisions about 

the promise of new therapies. I will discuss examples where biomarkers 

have been employed in Novartis studies and how we are using them in 

discovery efforts. 

9:00 Translating Biological Data into Predictive Biomarker 

Development Strategies 

Nicholas Dracopoli, Ph.D., Vice President & Head, Oncology Biomarkers, 

Janssen R&D LLC 

This presentation will describe requirements for the development of successful 

predictive models in oncology, provide overview of predictive and prognostic 

models used in oncology today, and discuss how to improve discovery 

and validation of predictive models during development of first-in-class 

oncology drugs. 

9:30 NGS Biomarkers in Prospective Trials 

Seth D. Crosby, M.D., Director, Alliances and Partnerships, Department of 

Genetics, Washington University School of Medicine 

NGS data intended for treatment decisions must be generated in a clinically 

certified lab. The challenges of validating and reporting a clinical NSG panel are 

quite distinct from that of translational research. I will describe our CAP/CLIA 

validated oncology panel and the Clinical Genomicist Workstation, a tool we 

have created for converting NGS data to a clinical report. 

10:00 Panel Discussion: Overcoming Bottlenecks 

Moderator to be Announced 

• Discussion of I-SPY Breast Cancer Clinical trial 

• How do we link diagnostics and therapeutics early in development? 

• How do pharma companies use biomarkers in development? Why is it a 

challenge? What obstacles are there? How are they overcome? 

• Cost - How do you pay for cancer biomarkers in drug development? 

• Are we looking at the right cells? Biomarkers are a surrogate for treatment. 

What are the driver mutations that biomarkers correspond to? 

• Is genetics the end-game? 











Panelists: 









Present a Poster & save! 

Cambridge Healthtech Institute encourages attendees to gain further 

exposure by presenting their work in the poster sessions. To secure a 

poster board and inclusion in the conference materials, your abstract must 

be submitted, approved and your registration paid in full by July 19, 2013 

• Your research will be seen by leaders from top pharmaceutical, biotech, 

academic and government institutes 

• Your poster abstract will be published in the conference materials 

• Receive $50 off your registration fee 


AUGUST 20-21 

Fourth Annual 

CoMPANioN DiAGNoStiCS: 


Regulatory Compliance in Drug-Diagnostics Co-Development 

Regulatory and Reimbursement Issues with Multiplex 


New Dealmaking Strategies in Companion Diagnostics 




BIOMARKER VALIDATION AND PROMOTION TO 

COMPANION DIAGNOSTICS 


8:40 Challenges in Developing Companion Diagnostics with the 

Complexity of Cancer 

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

AstraZeneca 

9:10 Validating Biomarkers in an Era of Regulatory and 

Reimbursement Uncertainty 

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

9:40 Sponsored Presentation 

Speaker to be Announced 



PARTNERSHIPS AT WORK 

Sponsored by 

11:00 Seeking Companionship for Personalized Healthcare: 

Companion Diagnostics Partnership between AstraZeneca and 

Roche Diagnostics 

Cecilia Schott, Executive Business Development Director, Personalized 

Healthcare, AstraZeneca 

Sushma Selvarajan, Head, Business Development & Strategy, Roche Molecular 

Systems 

This presentation will cover the road traveled by AstraZeneca and Roche 

Diagnostics to create an innovative partnership in the area of Companion 

Diagnostics. The aim was to create a framework for seamless collaborations 

between the companies by facilitating open dialogue and knowledge sharing. 

The speakers will share the key considerations on each side and share their 

experience in reaching common ground. 

11:40 Strategies to Align Drug and Diagnostic Development 

John F. Beeler, Ph.D., Director, Theranostics & Business Development, 

bioMerieux 

Jonathan Pan, Ph.D., Director, Oncology Companion Diagnostic and Disease 

Strategy, GlaxoSmithKline 

Precision medicine is a unique marriage between a targeted therapeutic and 

its companion diagnostic assay. The partnership to create these precision 

medicines requires a well-orchestrated relationship from development 

through commercialization. Here we address some of the key considerations 

in the Rx-Dx partnership to achieve successful commercialization of a 

precision medicine. 

from biomarker Validation 

to regulatory Approval 

12:20 pm Co-Development of Therapeutics and IVDs: Three 

Partners, Two Products, One Goal 

Andrea Lauber, Ph.D., Global Head, Transactions for Clinical Biomarkers and 

Pharmacodiagnostics, Bristol-Myers Squibb 

Kevin M. Harter, President and CEO, Saladax Biomedical 

Alignment is key to building successful partnerships. This is ever more the 

case when two or more companies join together to develop and commercialize 

separate but interrelated products that have different financial considerations, 

regulatory paths and markets. Mutually shared goals and open communication 

are the glue for building alignment, especially as the process of codevelopment 

of companion products takes on a life of its own. We will discuss 

the importance of these elements with examples of how it is possible to build 

productive collaborations that can withstand continually changing landscapes. 

1:00 Luncheon Presentation I 

Speaker to be Announced, PrimeraDx 

1:30 Luncheon Presentation II 

(Sponsorship Opportunity Available) 



Sponsored by 

2:20 Clinical Development of a Drug with a Companion 

Diagnostic: It’s Not Just about the Drug! 

Kenneth Emancipator, M.D., Director, Companion Diagnostics, Merck 

When a companion diagnostic is co-developed with a therapeutic (drug or 

biologic), the clinic development program must support the registration 

requirements for both products. This presentation discusses the regulatory 

concepts, the key elements for planning successful clinical trials, various 

options for clinical trial design, and, most importantly, the common pitfalls 

encountered during the course of co-development programs. 

2:50 Use of NGS as a Biomarker Tool for Oncology Drug 

Development 

Premal Shah, Ph.D., Director, Business Development, Genomic Health, Inc. 

Oncology therapeutic development will become increasingly challenging with 

rising costs and an even lower percentage of development projects being 

approved. The evolving reimbursement and healthcare landscapes will also 

put cost pressures on drugs. Biomarkers will be necessary to alleviate these 

pressures and companies—given the emergence of successful diagnostics 

companies—should look to outsource and partner to incorporate biomarkers 

into clinical development. 




AUGUST 20-21 

Fourth Annual 


4:10 Panel Discussion: Incorporating Companion Diagnostics 

Considerations Early in Product Development 

Moderator: Maureen Cronin, Ph.D., Executive Director, Strategic Information 

Management, Celgene 

Panelists: Session Speakers 

• Understanding the routine clinical management of the targeted disease and 

what biospecimens are generally available 

• Ascertaining that there are realistic diagnostic biomarkers in the available 

patient specimens 

• Selecting the most informative modality for the diagnostic test (is it protein, 

DNA or RNA markers) 

• Understand the population ranges and prevalence for the selected diagnostic 

marker and its precision for testing the appropriate clinical endpoints 

• Beginning the pharmacodynamic testing of the diagnostic biomarkers at the 

earliest stages of the drug development process 





Sponsored by 

7:30 am Problem-Solving Breakout Discussions with Continental 

Breakfast 





REGULATORY COMPLIANCE IN DRUG-DIAGNOSTICS 

CO-DEVELOMENT 


8:30 Regulatory Strategy in Drug-Diagnostics Co-Development 

William Pignato, Global Head, Regulatory Affairs, Novartis Oncology 

Companion Diagnostics 

We have moved deliberately towards the advancement of targeted molecular 

therapies and associated companion diagnostics. Selecting patients most 

likely to benefit from these agents has given rise to significant interest in 

the development of new companion diagnostic technologies to enhance 

a therapeutics safety or efficacy. However significant development and 

regulatory hurdles still remain. These challenges and practical considerations 

in the co-development of drugs and diagnostics from a diagnostic regulatory 

perspective will be discussed. 

from biomarker Validation 

to regulatory Approval 

9:00 Regulatory Considerations for Cancer Genomic Analysis 

Melina Cimler, Vice President, Quality & Regulatory Affairs, Illumina, Inc. 

Next-generation sequencing (NGS) enables deep sequencing of tumor biopsies 

to allow detailed profiling, identification of hundreds of mutations, guiding 

therapeutic decisions. As data are accumulated in conjunction with functional 

studies and patient outcomes, new biomarkers can be identified. Low input, 

short turnaround time, and low cost of targeted NGS provide huge potential 

of clinical utility, including diagnostic and therapeutic applications. This offers 

unique clinical development and regulatory challenges. 


10:00 Global Regulatory Environment in Drug and Diagnostic 

Co-Development: What is Now and What is Next? 

Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc. 

The global regulatory environment for companion diagnostics continues 

to evolve since the time of the contemporaneous approval of the Abbott 

Molecular Vysis ALK Break Apart FISH IVD test and Pfizer drug XALKORI in 

2011. How will the future state of the global regulatory environment and 

regulations shape the shape the future of personalized medicine? 











Panelists: 









Additional Sponsored Presentations by 


AUGUST 21-22 

Fifth Annual 

MolECulAr DiAGNoStiCS for iNfECtiouS DiSEASE 

the Challenge of bringing New technologies into routine Clinical Practice 


11:00 am Registration 










Panelists: 

Aaron D. Bossler, M.D., Ph.D., Clinical Assoc. Prof., Dir., Mol. Pathology Lab 

and Molecular Genetic Pathology Fellowship Program, University of Iowa 

Hospitals and Clinics and Co-Chair, AMP Economic Affairs Committee 




12:30 pm Enjoy Lunch on Your Own 

BRINGING NEW TECHNOLOGIES INTO 

ROUTINE CLINICAL PRACTICE 


Franklin R. Cockerill, III, M.D., Ann and Leo Markin Professor of Microbiology 

and Medicine, Chair, Department of Laboratory Medicine and Pathology, Mayo 

Clinic 

» 2:00 FeatuRed PResentatIon: Integrating Rapid 

Pathogen Identification, susceptibility testing, and 

antimicrobial stewardship significantly decreases 

Hospital Costs 

James M. Musser, M.D., Ph.D., Fondren Distinguished Endowed Chair; 

Pathology and Genomic Medicine, The Methodist Hospital System; Dir., Ctr for 

Mol. and Translational, Human Infectious Diseases Research, The Methodist 

Hospital Research Institute 

We used bloodstream infections to test the hypothesis that integrating rapid 

pathogen identification by mass spectrometry, susceptibility testing, and 

antimicrobial stewardship significantly decreases hospital costs. In our 1,000bed 

quaternary hospital, the altered work flow resulted in substantial annual 

cost savings. We recently added targeted full-genome sequencing of infecting 

organisms to this re-engineered platform. 

» 2:25 FeatuRed PResentatIon: use of outcome data 

to Justify the Implementation of new technology into 

the Clinical Laboratory 

Susan M. Novak-Weekley, Ph.D., D(ABMM) Director, Microbiology, Southern 

California Permanente Medical Group Regional Reference Laboratories 

The challenge in the health care today, more so than ever before, is to provide 

affordable, quality care to patients. The use of outcome data to drive decisions 

in the laboratory is extremely important to help administration understand why 

new technology should be incorporated into the laboratory setting and how that 

technology impacts the patient. 

2:50 Assays for the Detection of Bacteremia and Their Impact on 

Patient Care 

Karen C. Carroll, M.D., Professor of Pathology and Medicine; Director, Division 

of Medical Microbiology, The Johns Hopkins University School of Medicine 

A variety of assays are available to speed the identification of pathogens in 

positive blood cultures. These assays may have an impact on patient outcomes 

and reduce healthcare costs. 

3:15 Infectious Disease Testing with the Verigene Sponsored by 

System: Multiplex Assays for Blood Cultures and 

Enteric Pathogens 


Nanosphere’s FDA-cleared Verigene System enables rapid molecular testing for 

infectious diseases in a near-patient setting. Cartridge-based multiplexed tests 

for bloodstream infections, GI infections, and respiratory tract infections provide 

physicians with comprehensive, time-critical results that allow for real-time 

optimization of patient treatment. 

3:30 Impact of a Multiplex Molecular Diagnostic Sponsored by 

Panel for Rapid Identification of the Causes of 

Infectious Gastroenteritis 

Jeff Hester, Ph.D., Vice President, Research & Development, Viracor-IBT Laboratories 

Infectious gastroenteritis is a common illness that is challenging for both 

appropriate patient management and contributes to significant health economic 

costs—particularly within the hospital system. A novel multiplexed molecular 

diagnostic assay to detect the most frequent bacterial, viral and parasitic 

causes of the illness in less than a day will be presented and discussed and 

compared to traditional microbiological methods. 


MULTIPLEX DEVICES 

4:30 Highly Multiplexed Microbiology Devices – Performance 

Validation Challenges and Solutions 

Uwe Scherf, M.Sc., Ph.D., Deputy Director, Division of Microbiology Devices, 

Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices 

and Radiological Health, U.S. Food and Drug Administration 

Highly multiplexed microbiology in vitro diagnostic devices present several 

advantages. However, establishing and validating the performance of these 

devices to make informed clinical and public health decisions pose significant 

scientific challenges. The talk will present recommendations for studies 

to establish the analytical and clinical performance of highly multiplexed 

microbiology in vitro nucleic acid based diagnostic devices. 

THE FUTURE OF POINT-OF-CARE TESTING 

5:00 The Future of Point of Care Testing: Moving Diagnostics to 

“Point-of-Impact” 

Christine C. Ginocchio, Ph.D., MT (ASCP), Senior Medical Director and Chief, 

Division of Infectious Disease Diagnostics, Department of Pathology and 

Laboratory Medicine and Department of Molecular Medicine, Feinstein 

Institute for Medical Research, North Shore-LIJ Health System, Professor, 

Hofstra North Shore-LIJ School of Medicine, NY 

The current economics of healthcare has led to many laboratory consolidations 

and centralization of testing, affording financial savings and expanded testing 

services. However, appropriate clinical care remains imperative. Results must 

be provided within a time frame that impacts patient care and outcome. 

To meet this goal, laboratories must now also consider a reversal from 

centralization to decentralization of critical testing to the appropriate “point of 

impact”. New rapid simple technologies that meet this goal and the potential 

financial and clinical benefits of point of impact testing will be discussed. 

Sponsored by 



5:45 Bringing an OTC Home Use Rapid HIV Test Kit to Market 


This talk will describe the role of risk assessment, in addition to sensitivity and 

specificity, in the determination of safety and efficacy for the first approved 

over-the-counter home use rapid HIV test kit. This approach takes into account 

both the public and individual health impacts. 

6:00 Dinner Short Course Registration 


AUGUST 21-22 

Fifth Annual 



6:30-8:30 Recommended Dinner Short Course* 

Use of Matrix Assisted Laser Desorption Ionization Time of 

Flight Mass Spectrometry in Clinical Microbiology 


tHuRsday, august 22 


Breakfast 

EMERGING TECHNOLOGIES & THE IMPACT ON 

HEALTHCARE OUTCOME 


Robin Patel, M.D., Chair, Clinical Microbiology; Consultant, Clinical Microbiology 

and Infectious Diseases; Professor, Microbiology and Medicine, College of 

Medicine, Mayo Clinic 

8:30 The Impact of Emerging Diagnostic Laboratory Techniques 

and the Effects on Healthcare Outcome 

Franklin R. Cockerill, III, M.D., Deptartment of Laboratory Medicine and 

Pathology, Mayo Clinic 

The diagnosis and treatment of infectious diseases has been significantly 

facilitated by new testing methods, providing considerably faster and more 

accurate means for diagnosis of pathogens; and in some cases, have provided 

the first means for identification and quantification of pathogens, particularly 

viruses. This lecture will include a historical and a high level technical review 

of newer diagnostic methods, and the impact these methods have had on the 

diagnosis and treatment of infectious disease. 

8:55 Validation of Next-Generation Sequencing Assays for 

Pathogen Diagnosis in a CLIA Laboratory 

Charles Chiu, M.D., Ph.D., Assistant Professor, Departments of Laboratory 

Medicine and Medicine (Infectious Diseases), UCSF School of Medicine 

Here we will discuss validation of an NGS-based assay for viral detection 

in the CLIA laboratory with a high degree of sensitivity and specificity; 

implementation of a flexible, automated, and cloud-compatible pipeline 

for pathogen detection in metagenomic NGS data; and applications of this 

system for microbial diagnosis and outbreak investigation in clinical and public 

health settings. 

9:20 Next-Generation Sequencing in a Public Health Laboratory 

Patrick Tang, M.D., Ph.D., FRCPC, Program Head, Molecular Microbiology and 

Genomics, BC Centre for Disease Control - Public Health Microbiology and 

Reference Laboratory 

Clinical microbiology laboratories are now exploring the use of next-generation 

sequencing technology to replace or complement traditional methods for 

infectious disease diagnosis and epidemiology. Recent successes include the 

use of whole genome sequencing for communicable disease epidemiology. 

9:45 Multiplex Respiratory Pathogen Detection: Sponsored by 

Combining Speed with Accuracy to Enhance 

Clinical Decision Making 

Scott McKeown, Ph.D., Molecular Diagnostics Business Manager, Randox 

Laboratories Ltd. 


Speaker to be Announced, Evogen 

10:15 Coffee Break in the Exhibit Hall with Poster Viewing 

TRANSITIONING NGS TO THE CLINICAL SETTING 

10:45 Automated, Cloud-Enabled Bioinformatics Pipeline for 

Whole-Genome Sequencing-Based Pathogen Diagnostics 

W. Florian Fricke, Assistant Professor, Microbiology & Immunology, Institute for 

Genome Sciences, University of Maryland School of Medicine 

WGS-based diagnostic tools promise to provide increased resolution for 

isolate typing, phenotype prediction, and epidemiological analyses. In order to 

facilitate the transition of WGS-based diagnostics into the clinic, standardized, 

bioinformatic analysis protocols are needed. We demonstrate the feasibility 

of building an automated, cloud computing-enabled diagnostic pipeline to 

support reproducible WGS analysis for microbial isolate typing, virulence, and 

antimicrobial resistance profiling. 

11:15 The Next Generation of Outbreak Investigation: 

Identification of Known Viruses in New Places and an Unknown 

Virus in the US 

Laura McMullan, Ph.D., Molecular Pathogenesis and Antiviral Section, Virus 

Special Pathogens Branch, Centers for Disease Control 

Outbreaks require diagnostic assays that rapidly identify the pathogen. We 

have developed a metagenomics approach of pathogen discovery that has 

identified a new arenavirus in Zambia, Yellow Fever virus in Uganda, and a novel 

phlebovirus in the USA. 

LAB AUTOMATION AND SPECIMEN PROCESS 

11:45 A Tsunami of Change, Automation in Clinical Microbiology 

Nathan A. Ledeboer, Ph.D., Assistant Professor of Pathology, Medical College 

of Wisconsin 

Since inception, clinical microbiology has required a highly technical and 

skilled workforce with limited automation. Clinical staff have complained of 

poor turnaround, while the laboratory awaits microbial growth. However, with 

increasing specimen volumes and fewer available skilled workers, laboratories 

are increasingly seeking automated solutions. 

12:15 pm Sponsored Presentation (Opportunity Available) 

12:45 Luncheon Presentation I: Immunoassay Sponsored by 

Technology with Sensitivity of Nucleic Acid Testing: 

p24 Case Study 

David Duffy, Ph.D., Vice President, Research, R&D, Quanterix 

This presentation will describe the application of an ultra-sensitive singlemolecule 

digital immunoassay to HIV detection, using a single molecule array 

(Simoa) to count individual molecules of p24 capsid protein in the blood, which 

indicates the presence of HIV virus. Results showed 3,000 times greater 

analytical sensitivity than conventional immunoassays, and comparable to the 

gold standard of nucleic acid testing. 

1:15 Luncheon Presentation II (Sponsorship Opportunity Available) 


RAPID DETECTION OF BLOOD STREAM INFECTION 


Pietro Scalfaro, M.D., EMBA, CEO, Spinomix SA 

2:05 Rapid Detection of Bloodstream Infections 

Donna M. Wolk, MHA, Ph.D., D(ABMM), System Director, Clinical Microbiology, 

Geisinger Health System, Department of Laboratory Medicine 

This program will describe and review existing and future technologies that can 

improve the microbiology laboratory’s ability to rapidly identify bloodstream 

pathogens and provide pivotal results for escalation or de-escalation of 

antimicrobials. Current and potential applications of technologies in diagnostic 

clinical microbiology laboratories will be discussed. 


AUGUST 21-22 

Fifth Annual 



2:35 Panel Discussion: Improving Pathogen Detection 

& Monitoring the Host Response in Sepsis Detection & 

Management 

Moderator: Pietro Scalfaro, M.D., EMBA, CEO Spinomix SA 

Panelists: Steven Michael Opal, M.D., Professor of Medicine, Infectious 

Disease Division, Brown Medical School 

Roslyn A. Brandon, Ph.D., Co-Founder, President & CEO Immunexpress 

Bert K. Lopansri, M.D. Division of Infectious Diseases and Clinical Epidemiology 

Intermountain Medical Center and LDS Hospital, Medical Director, UCR Clinical 

Microbiology Laboratory 

John P. Burke, M.D., Chief, Division of Clinical Epidemiology & Infectious 

Diseases, Intermountain Medical Center and LDS Hospital, & Professor of 

Internal Medicine at the University of Utah 

3:35 Spotlight Presentation: Application of Digital PCR to Clinical 

Viral Load Testing 

Randall T. Hayden, M.D., Director, Clinical and Molecular Microbiology, Member, 

Department of Pathology, St. Jude Children’s Research Hospital 

Viral load testing has become integral to clinical care, but is often limited 

by poor standardization and precision. Digital PCR offers a means of direct 

quantitative measurement that may improve both accuracy and precision 

over current methods. This session will describe the theory behind digital 

PCR, as well as some initial studies evaluating its use for viral load testing in 

clinical samples. 

4:05 A Novel, 2nd Generation Device for Ambient Storage and 

Transportation for Downstream Infectious Disease Testing: 

ViveSTTM 

Anita M. McClernon, MSc, Director of Laboratory Services, bioMONTR® Labs 

Infectious disease monitoring often requires collection sites to ship patient 

samples to reference laboratories, requiring careful temperature control 

and special packaging. Here we report data evaluating the stability and 

reproducibility of infectious plasma specimens stored on ViveST analyzed with 

RT-PCR and Sequencing Technolgies. ViveST can offer a global solution and 

enhance access to healthcare and significantly reduce the burden associated 

with shipping frozen samples. 

Sponsoring Organizations 

Vital Insights Transforming Care 

Lead Sponsoring Publications Sponsoring Publications 

Web Partners 

FierceBiotech 

THE BIOTECH INDUSTRY’S DAILY MONITOR 


AUGUST 21-22 

Fourth Annual 

MolECulAr ProfiliNG of CirCulAtiNG tuMor CEllS NEW 

This Year 


Circulating Tumor Cells and Cancer Stem Cells from Research 

to Clinic 

Next-Generation Sequencing as a Diagnostics Platform 













Panelists: 









MOLECULAR CHARACTERIZATION OF CTCs 


2:00 Advancing Personalized Medicine: Next-Generation 

Sequencing on Circulating Tumor Cells 

Jeffrey S. Ross, M.D., Medical Director, Foundation Medicine; Cyrus Strong Merrill 

Professor and Chair, Pathology and Laboratory Medicine, Albany Medical College 

In patients with metastatic cancer, biopsy to identify genomic alterations that 

predict sensitivity to targeted therapeutics is not always possible. In such 

patients, CTCs represent a potential source of material for genomic profiling, 

but assaying large numbers of cancer-related genes in CTCs is challenging. We 

have optimized our comprehensive genomic profiling assay to robustly profile 

CTCs to identify actionable genomic alterations and guide therapy. 

2:30 Genome-Wide Analysis of CTCs from Breast and Prostate Cancer 

James Hicks, Ph.D., Research Professor, Genetics, Cold Spring Harbor Laboratory 

Single nucleus sequencing (SNS) enables genomic profiling of individual 

cancer cells, providing information on tumor initiation, evolution and genetic 

heterogeneity. The method also permits the analysis of rare cancer cells 

isolated from the bloodstream and other fluids. We will describe progress in 

using ‘fluid biopsies’ to monitor cancer treatment and direct therapy in prostate 

and other cancers. 

3:00 Profiling Melanoma CTCs to Therapeutically Target Those 

Forming Metastases 

Gavin P. Robertson, Ph.D., Professor, Pharmacology, Pathology, Dermatology 

and Surgery, Penn State University; Director, Penn State Melanoma Center, 

Penn State Melanoma Therapeutics Program, and Foreman Foundation 

Melanoma Research Laboratory 

Molecular profiling of CTCs can be accomplished, but identifying those genes 

functionally relevant to CTC behavior is a challenge. This talk describes the 

isolation of melanoma CTC followed by expression profiling to identify key 

targets regulating metastatic behavior. Finally, the role of a protein in the 

metastatic process is demonstrated through use of novel animal and cell 

culture-based systems. 

3:30 Molecular Profiling of Circulating Tumor 

Cells for Oncology Diagnostics Using the IsoFlux 

System 

Cristian Ionescu-Zanetti, Ph.D., CTO, Fluxion Biosciences 


Sponsored by 


4:30 Molecular Characterization of CTCs: A Road to Improved 

Understanding of Metastatic Process 

Denis Smirnov, Ph.D., Associate Scientific Director, Oncology Biomarkers, 

Janssen Pharmaceuticals 

Molecular characterization of circulating tumor cells offers an opportunity to 

elucidate metastatic process. That opportunity is often limited by technical 

challenges associated with analysis of rare cells. Insights gained by CellSearch 

research team will be shared during this presentation. 

5:00 Molecular Characterization Including DNA and RNA FISH of 

CTCs and Cancer Associated Cells 

Jeffrey Chalmers, Ph.D., Professor, Chemical and Biomolecular Engineering, 

Ohio State University 

Using a negative enrichment methodology, which removes RBCs and high 

expressing CD45 cells, we have demonstrated a significant heterogeneity in 

the type of cells present in blood of cancer patients. In addition to antibodies 

bound to flouroprobes, we are also using DNA FISH and RNA FISH technology 

to demonstrate this heterogeneity. We will summarize some these findings 

from squamous cell carcinoma of the head and neck, breast cancer and 

colorectal cancer. 

5:30 The Identification and Characterization of Breast Cancer CTCs 

Competent for Brain Metastasis 

Dario Marchetti, Ph.D., Professor, Pathology & Immunology and Molecular & 

Cellular Biology; Director, CTC Core Facility, Baylor College of Medicine 

Mechanisms implicating circulating tumor cells (CTCs) in fatal breast cancer 

brain metastasis remain elusive. We characterized CTCs isolated from blood 

mononuclear cells of breast cancer patients, and developed CTC lines. EpCAMnegative 

CTCs express markers needed to promote brain metastasis. Firsttime 

evidence characterizing breast cancer CTCs, leading to the description 

of a protein signature suggestive of metastatic competency to the brain will 

be presented. 


6:30-8:30 pm Dinner Short Courses* 




Breakfast 



sponsors, exhibitors, and speakers and provide a forum for discussing key issues 

and meeting potential partners. See website for topics. 

CTC UTILITY IN CLINICAL TRIALS 


8:30 Circulating Tumor Cells in Prostate Cancer Drug 

Development: One Cell at a Time 


AUGUST 21-22 

Fourth Annual 

MolECulAr ProfiliNG of CirCulAtiNG tuMor CEllS NEW 

This Year 

Howard I. Scher, M.D., Chief, Genitourinary Oncology Service, Sidney Kimmel 

Center for Urologic and Prostate Cancers, Memorial Sloan-Kettering Cancer Center 

9:00 Practical Considerations for the Incorporation of CTC 

Analyses in Clinical Trials 

Minetta C. Liu, M.D., Associate Professor, Oncology, Laboratory Medicine and 

Pathology, Mayo Clinic 

9:30 Enumeration and Molecular Analysis of CTCs from Clinical 

Trials 

Edith Szafer-Glusman, Ph.D., Senior Research Associate, Oncology Biomarker 

Development, Genentech 

In this talk I will give an overview of our efforts in the analysis of CTCs in 

clinical trials, and the utility of CTC analysis associated with different trial 

phases with respect to enumeration and biomarker characterization. 



10:45 Strategies for Analysis of CTC-Based Pharmacodynamic 

Biomarkers in Clinical Development of Targeted Anti-Cancer 

Therapeutics 

Lihua Wang, Ph.D., Senior Scientist, PADIS, LHTP, Applied Developmental 

Directorate, SAIC-Frederick, National Cancer Institute 

This presentation describes assay strategies for assessing pharmacodynamic 

biomarkers in CTCs in patients undergoing clinical trials of targeted anticancer 

therapeutics. Given the limitations of surface molecule-based CTC 

methods, we are developing and evaluating an antibody-independent CTC 

capture technology to analyze biomarkers in patients with a variety of advanced 

cancers. Our studies indicate that assessment of CTC-based pharmacodynamic 

biomarkers has value for rapidly assessing drug activity in clinical development 

of molecularly targeted anticancer therapeutics. 

11:15 Multiplexed Molecular Profiling and Quantification of 

Circulating Tumor Cells as Predictive Biomarkers of Cancer 

Prognosis 

Ximei Qian, Ph.D., Assistant Professor, Biomedical Engineering, Emory 

University 

We report a new method using surface-enhanced Raman spectroscopy 

(SERS) to characterize circulating tumor cell (CTC) biomarker expression in a 

multiplexed fashion. The three-marker one-tube assay increases the detection 

sensitivity and provides an efficient, quantitative, cross-referenced and 

inexpensive platform, and can be rapidly translated into clinical testing for 

molecular profiling of CTCs. 

11:45 Microfluidic Isolation and Molecular Characterization of 


David Miyamoto, M.D., Ph.D., Instructor, Radiation Oncology, Massachusetts 

General Hospital 

Our group has recently developed a series of microfluidic devices to capture, 

image, and molecularly characterize rare circulating tumor cells (CTCs) shed 

into the blood from otherwise poorly accessible metastatic tumor deposits. 

Here, we describe our recent efforts to dissect the molecular and cell biology 

of CTCs, and the potential of this analysis to non-invasively monitor and predict 

treatment responses. 

12:15 pm Sponsored Presentation (Opportunity Available) 




CTC ISOLATION AND CHARACTERIZATION 

TECHNOLOGIES 


2:05 Pre-Analytical Variables Impacting High-Content 

Methodologies for CTC Detection 

Emily J. Greenspan, Ph.D., Program Manager, Office of the Director, Center for 

Strategic Scientific Initiatives (CSSI), National Cancer Institute 

Pre-analytical variables involved in the collection, handling and processing 

of blood for circulating tumor cell (CTC) assays can potentially impact CTC 

enumeration and characterization. This talk will highlight the study design and 

preliminary results from a project led by CSSI, NCI to determine if two preanalytical 

variables, namely time-to-assay and blood collection tube-type impact 

a high definition (HD)-CTC assay. 

2:35 Capture and Analysis of CTCs in Prostate Cancer: Exploring 

Biomarkers of Taxane Sensitivity 

David M. Nanus, M.D., Chief, Division of Hematology and Medical Oncology, 

Weill Cornell Medical College - New York Presbyterian Hospital 

Dr. Nanus, in collaboration with his colleagues at Weill Cornell and Cornell 

University in Ithaca, has developed a microfluidic device that isolates circulating 

prostate cancer circulating tumor cells (CTCs). This device, known as the GEDI 

device, will be used in a prospective randomized clinical trial in patients with 

castrate resistant prostate cancer treated with taxane chemotherapy to assess 

drug response and determine the mechanisms of sensitivity and resistance to 

chemotherapy at the cellular level. 

3:05 Development of a Novel CTC Assay Based on Mesenchymal 

Biomarker Capture 

Andrew J. Armstrong, M.D., Associate Professor, Medicine and Surgery, Duke 

Cancer Institute, Divisions of Medical Oncology and Urology, Duke University 

Current evidence suggests the importance of epithelial plasticity in mediating 

cancer metastasis across a range of epithelial cancers, and this plasticity 

may lead to the transient loss of the epithelial phenotype during invasion 

and hematogenous dissemination. Such cells (CTCs) may be missed by the 

current epithelial-based Cellsearch assay. Here I detail our approach to the 

development of a novel assay based on this plasticity biology. 

3:35 Presentation to be Announced 

4:05 Close of Conference 


AUGUST 21-22 

Second Annual 


















Panelists: 









MOVING TOWARDS MULTIPLEX COMPANION 

DIAGNOSTICS 


2:00 The Challenges of Clinical Assay Development and 

Implementation in the Era of Targeted Cancer Treatments 

P. Mickey Williams, Ph.D., Director, Molecular Characterization Laboratory, 

Frederick National Laboratory for Cancer Research 

This talk will discuss some of the challenges that lie ahead in developing 

effective and efficient multi-analyte clinical assays to accompany the growing 

number of targeted cancer therapies with a focus on next-generation 

sequencing technologies. 

2:30 Strategic and Computational Considerations in the 

Development of Multiplexed Companion Diagnostics 

Amir Handzel, Ph.D., Associate Director, Translational and Clinical Sciences, OSI 

Pharma (Astellas) 

The diverse challenges in developing validated complex diagnostic biomarkers 

have been highlighted by several failures in the last decade. The universe of 

molecular entities for biomarkers is rich and their extremely large numbers 

present difficult problems of selection and validation in a statistically robust 

way. In addressing them, an array of technical, operational and organizational 

approaches must be employed. I will discuss these strategic and technical 

elements while pointing to pitfalls and how to avoid them. 

3:00 The Future of Companion Diagnostics 

Jeremy Bridge-Cook, Ph.D., Senior Vice President, Research & 

Development, Luminex 

Sponsored by 

Advancing technologies and 

Winning reimbursement 

3:30 Microfluidics: Deriving Big Benefits from 

Sponsored by 

Small Structures 

Richard A. Montagna, Ph.D., Senior Vice President, Scientific 

Affairs, Rheonix, Inc. 

A microfluidic platform has been developed that permits the performance of 

sophisticated molecular diagnostic testing in a fully automated and unattended 

manner. Once a raw clinical specimen is introduced, the system, consisting 

of a robotic workstation and a disposable microfluidic cartridge and reagent 

packs, automatically performs all sample preparation, analysis and readout 

under the control of software. A variety of diverse assays will be described 

with applications in personalized medicine and companion diagnostics. In all 

cases, highly complex assays can easily be performed by individuals of varying 

skill level. 


BRINGING A NOVEL COMPANION DIAGNOSTIC 

TO THE GLOBAL MARKETPLACE 

4:30 Expert Panel Discussion: Bringing A Novel Companion 

Diagnostic to the Global Marketplace- What are the Issues to 

Think About? 

Moderator: Jonathan Roy, Senior Director, Head,Commercial Diagnostics, 

GlaxoSmithKline 

• Timeline for reimbursement: What happens during waiting time 

for reimbursement 

• Who pays for testing? 

• LDTs in Global markets vs. FDA approved tests 

• Aligning goals and timelines 

• How do you see the environment evolving? 

• Maintaining quality across markets 

Panelists: 

Richard Ding, CEO, bioTheranostics 

Kenneth J. Bloom, M.D., CMO, Clarient, Inc. 

Keith Miller, CSO, UCL Cancer Institute, School of Life and Medical Sciences, 

University College London 


6:30-8:30 pm Dinner Short Courses* 

New Dealmaking Strategies in Companion Diagnostics 




Breakfast 





COMPANION DIAGNOSTICS IN CLINICAL SETTINGS 


8:30 Clinical Molecular Testing for Secondary Drug Resistance in 

Cancer 

Karen E. Weck, M.D., Professor & Director, Molecular Genetics Laboratory, 

University of North Carolina School of Medicine 

One of the biggest advances in cancer treatment has been the development 

of molecularly targeted therapies, and molecular testing to identify somatic 

mutations predictive of drug response has become increasingly important to 


AUGUST 21-22 

Second Annual 


guide cancer therapy. However, secondary resistance to targeted therapies 

often develops. This presentation will highlight clinical molecular testing to 

detect secondary drug resistance in cancer and how cancer genome profiling is 

changing the practice of pathology. 

9:00 Companion Diagnostics in the VA Healthcare System 

Jack H. Lichy, M.D., Ph.D., Chief, Pathology & Laboratory Medicine, VA Medical 

Center, Washington, D.C. 

This presentation will describe challenges presented by the rapidly increasing 

demand for companion diagnostics in the VA Healthcare system from the 

viewpoint of a VA laboratory director. The relative merits of various strategies 

for meeting this demand will be considered, including establishing an internal 

VA reference laboratory service, the use of commercial laboratories, and 

distribution of testing throughout this 100+ hospital system. 

9:30 Use of Targeted, Ultra-Deep Next-Generation Sequencing- 

Based Diagnostic Testing of Cancer Genes in a CAP/CLIA 

Environment 

Shashikant Kulkarni, Ph.D., Head, Clinical Genomics, Washington University 

School of Medicine at St. Louis 

Next-generation sequencing-based diagnostic testing for cancer mutations 

to provide information about diagnosis, prognosis and treatment is being 

successfully incorporated into clinical laboratories. We will discuss the 

challenges and issues related to the clinical application of NGS. Data generated 

from NGS testing performed in CAP/CLIAregulated clinical environments 

demonstrates that next-generation-based clinical cancer genomic profiling 

to aid clinical diagnoses, predicting outcomes, and directing therapeutic 

interventions is an efficient alternative to established methods for detecting 

somatic mutations, particularly when testing multiple genes is indicated. 

10:00 Ultra Specific Antibodies Against Cancer Sponsored by 

Biomarkers, Ideal for Companion Diagnosis 

Donghui Ma, Ph.D., Vice President, Tissue Sciences, OriGene 

Technologies Inc. 

Antibody with cross-reactivity creates unexpected side effects or false 

diagnosis when used clinically. Using an novel high density protein microarray 

chip technology, we discovered that multiple well known diagnostic mAbs 

lacks the desired specificity. OriGene has created UltraMABs with validated 

specificity. HER2 & ERCC1 will be discussed. 


10:45 Detection and Monitoring of Chromosomal Alterations 

in the Circulation of Cancer Patients with Whole-Genome 

Sequencing 

Mark Sausen, Ph.D., Associate Scientist , Personal Genome Diagnostics 

To identify incipient, residual, and recurrent tumors, we developed a noninvasive 

approach that identified structural alterations in cancer patients that 

were not present in healthy individuals. Subsets of these rearrangements 

were associated with clinically actionable genes. Given that chromosomal 

abnormalities are present in nearly all tumors, this approach represents a noninvasive 

method for tumor detection and monitoring. 

11:15 Challenges in Comprehensive Genotyping of Tumors for 

Actionable Alterations: The Lung Cancer Paradigm 

Marc Ladanyi, M.D., William Ruane Chair in Molecular Oncology, Attending 

Pathologist, Molecular Diagnostics Service; Member, Human Oncology and 

Pathogenesis Program, Memorial Sloan-Kettering Cancer Center 

Many of the actionable genetic alterations initially identified in lung cancer 

were mutated oncogenes (EGFR, KRAS, BRAF) well-suited to detection by 

point mutation genotyping methods, but such methods are not applicable to 

more recently nominated actionable genetic alterations in lung cancer such 

as gene fusions (involving ALK, RET, ROS), amplifications (MET, FGFR1), and 

tumor suppressor genes (STK11, NF1). These developments have been driving 

a search for ever-more comprehensive genotyping platforms, prominently 

including next-generation sequencing-based approaches. 

Advancing technologies and 

Winning reimbursement 

11:45 Panel Discussion: The Future of Companion Diagnostics 

Moderator: Karen E. Weck, M.D., Professor & Director, Molecular Genetics 

Laboratory, University of North Carolina School of Medicine 

Panelists: Session Speakers 

12:15 pm Multimarker Tests as Companion 

Diagnostics 

Carol E. Berry, MBA, Senior Vice President & General 

Manager, Pharmacogenomic Services Division, Asuragen Inc. 

Sponsored by 



REIMBURSEMENT OF COMPLEX GENOMIC TESTS 

AND COMPANION DIAGNOSTICS 



Speaker to be Announced, Quorum Consulting 

2:15 New Novitas Biomarker LCDs: How Will They Affect Both 

Cancer and Non-Cancer Molecular Testing? 

Mitchell I. Burken, M.D., Medicare Medical Director, Novitas Solutions, Inc. 

The emergence of personalized laboratory medicine has been characterized by 

a multitude of testing options which can more precisely pinpoint management 

needs of individual patients. As a result, the growing compendium of socalled 

biomarkers requires a more careful evaluation by both clinicians and 

laboratorians as to what testing configurations can more optimally realize the 

promises of personalized medicine. 

2:45 Reimbursement of Cancer Genomic Analysis 

Victoria Pratt, Ph.D., FACMG, Chief Director, Molecular Genetics, Quest 

Diagnostics Nichols Institute 

This session will provide an overview of the CPT coding process and the Gapfill 

and Crosswalk processes. 

3:15 Companion Diagnostics and the Path to Market – Do All 

Roads Lead to Rome? 

Steven Gutman, M.D., Strategic Advisor, NA, Myraqa, Inc. 

This session will provide an overview of the scientific approaches most 

commonly considered for use in product co-development and will consider the 

trade-offs to be addressed in selecting the optimal design. 

3:45 Panel Discussion: Reimbursement for New Molecular 

Diagnostics Codes: More Questions Than Answers 



AUGUST 21-22 

Third Annual 

CoMMErCiAlizAtioN of MolECulAr DiAGNoStiCS 

roadmap for Success 

















Panelists: 









COMMERCIALIZATION PATH FOR SEQUENCING 


Harry Glorikian, Founder & Managing Partner, Scientia Advisors LLC 

1:50 Commercializing Diagnostic Services on Sponsored by 

a Global Platform 

Michael Fannon, President, BioIT Solutions, Former CIO, 

Human Genome Sciences 

Dx markets require sophisticated workflow management, outcome 

interpretation, and secure report preparation. Add regulatory, reagent supplychain, 

and reimbursement issues and many diagnostics pioneers face critical 

business needs for real-time controls. Mike discusses practical guidelines for 

fast and cost-effective platform deployment to manage modern Dx services. 

2:05 Genomic Testing for All Cancer Patients at Dana-Farber 

Cancer Institute, Brigham & Women’s Hospital, and Boston 

Childrens Hospital 

Barrett J. Rollins, M.D., Ph.D., Linde Family Professor of Medicine, Harvard 

Medical School; CSO, Dana-Farber Cancer Institute 

The landscape of genomic abnormalities in cancer is often unknown at the level 

of the individual patient, and the influence of specific genotypes on clinical 

behavior is often unclear. These are impediments to the development of a 

commercially viable clinical test. To address these deficiencies, we developed 

PROFILE, a project that obtains genomic and linked clinical information on all 

patients who come to our hospitals for cancer-related care. 

2:35 Disruption of the Diagnostics Market by NGS Technologies 

Dietrich Stephan, Ph.D., Founder & CEO, Silicon Valley Biosystems (SVBio) 

The cost of next-generation sequencing and the changing reimbursement 

schema is forcing adoption of NGS by purveyors of DNA Diagnostic tests. 

The continued success of these organizations will rely on reducing COGs 

and streamlining internal workflows, thus optimizing margins. The successful 

transition to cheaper technologies will define the winners and losers in the new 

ecosystem of diagnostics. 

3:05 Non-Invasive Prenatal Testing Using Circulating Cell-Free 

Fetal DNA: An Innovative High-Throughput Clinical Application of 

Next-Generation Sequencing 

Dirk van den Boom, Executive Vice President, R&D & CTO, Sequenom, Inc. 

The utility of cell-free fetal DNA present in maternal plasma of pregnant women 

has revolutionized the approach to non-invasive prenatal testing (NIPT) for fetal 

aneuploidies. This presentation will provide an overview of the development, 

implementation,and commercialization of MaterniT21 PLUS - a next-generation 

sequencing based laboratory developed test for detection of fetal trisomies 

21,18,13 and sex aneuploidies; in addition, there will be a summary of almost 

two years of clinical testing. 

3:35 Rapid IVD Instrument Development 

Sponsored by 

Walter Gilde, Business Development Manager, 

KMC Systems, Inc. 

Rapid IVD product development focuses on accelerated 

time to market and lower development cost. Understanding 

user requirements, selecting and optimizing the hardware and software 

architecture, and leveraging off-the-shelf technologies are essential elements 

for success. The timely application of these three strategies can minimize 

design change, speedtime to market, and allow OEMs to meet user needs at a 

reasonable cost. 

3:50 Next Generation Sequencing vs. Individual 

Assays – Implications for Demonstrating Clinical 

Utility in the Context of Reimbursement Decisions 


Sponsored by 


BRINGING A NOVEL COMPANION DIAGNOSTIC TO 

THE GLOBAL MARKETPLACE 

4:30 Expert Panel Discussion: BRINGING A NOVEL COMPANION 

DIAGNOSTIC TO THE GLOBAL MARKETPLACE: What are the 

Issues to Think About? 

Moderator: Jonathan Roy, Senior Director, Head Commercial Diagnostics, 

GlaxoSmithKline 

• Timeline for reimbursement: what happens during waiting time 

for reimbursement 

• Who pays for testing? 

• LDTs in Global markets vs. FDA approved tests 

• Aligning goals and timelines 

• How do you see the environment evolving? 

• Maintaining quality across markets 

Panelists: 

Richard Ding, CEO, bioTheranostics 

Kenneth J. Bloom, M.D., CMO, Clarient, Inc. 

Keith Miller, CSO, UCL Cancer Institute, School of Life and Medical Sciences, 

University College London 


6:30- 8:30 pm Dinner Short Courses* 

Dealmaking in Companion Diagnostics 



AUGUST 21-22 

Third Annual 

CoMMErCiAlizAtioN of MolECulAr DiAGNoStiCS 

roadmap for Success 



Breakfast 





STRATEGIC ASSESSMENT: 

Analytic Frameworks and Evidence Levels to Support Market 

Authorization & Market Access 


8:30 Stakeholders Needs in Market Authorization and Market 

Access Decisions 


Building evidence strategies for the multiple stakeholders within the market 

authorization and access process is essential to support their decisions. 

Manufacturers of diagnostics products also have their internal stakeholders 

to align to a common strategy for market authorization and access. This 

presentation will discuss stakeholder analysis considerations and possible 

analytic frameworks and evidence levels that can be developed by 

manufacturers to impact commercialization timelines of novel diagnostics. 

INTERNATIONAL DEPLOYMENT 

9:30 Novel Model for Funding Stratified Medicine in UK 

Penny Wilson, Ph.D., Lead Specialist, Detection and Identification of Infectious 

Agents, Technology Strategy Board 


10:30 Has Your Assay Patent Lost Its Value? 

Sponsored by 

Edward Gamson, Partner, Healthcare Life Sciences & 

Pharmaceutical of Husch Blackwell Sanders, LLP 

The Supreme Court changed the division of profits from diagnostic assays in 

Mayo v. Prometheus, and may change more in deciding Myriad this summer. 

Drs. Edward Gamson and Robert Gould, scientist lawyers, will discuss the 

impact of recent changes in the case law on the creation and enforcement of 

rights in diagnostic patents. 

10:45 Expert Panel Discussion: GENE PATENTS: AMP vs. Myriad, 

What Are the Commercial Implications? 

Moderator: Roger Klein, M.D., J.D., Department of Molecular Pathology, 

Cleveland Clinic Foundation 

Panelists: 

Lori Pressman, Independent Consultant 

Debra G.B. Leonard, M.D., Ph.D., Professor and Chair, Department of 

Pathology, UVM College of Medicine, Physician Leader, Pathology and 

Laboratory Medicine, Fletcher Allen Health Care, UVM College of Medicine 

Hans Sauer, Ph.D., J.D., Deputy General Counsel for Intellectual Property, 

Biotechnology Industry Organization 

12:15 pm Using Virtual Population Simulation Sponsored by 

to Generate Evidence for Reimbursement 

Quanfying Healthcare 

Discussions 

Badri Rengarajan, M.D., Medical Director, Archimedes 

Negotiating a high reimbursement price in the absence of complete data (longterm 

outcomes, real-world usage) is challenging. Simulation modeling with 

virtual patients proceeding through a virtual healthcare system can generate 

longitudinal data in real-world settings within hours, thereby changing the tone 

of the negotiation and potentially supporting a higher reimbursement. 



REIMBURSEMENT OF COMPLEX GENOMIC TESTS 

AND COMPANION DIAGNOSTICS 


Chairperson to be Announced, Quorum Consulting 


Speaker to be Announced, Quorum Consulting 

2:15 New Novitas Biomarker LCDs: How Will They Affect Both 

Cancer and Non-Cancer Molecular Testing? 

Mitchell I. Burken, M.D., Medicare Medical Director, Novitas Solutions, Inc. 

The emergence of personalized laboratory medicine has been characterized by 

a multitude of testing options which can more precisely pinpoint management 

needs of individual patients. As a result, the growing compendium of socalled 

biomarkers requires a more careful evaluation by both clinicians and 

laboratorians as to what testing configurations can more optimally realize the 

promises of personalized medicine. 

2:45 Reimbursement of Cancer Genomic Analysis 

Gary Martucci, Senior Director, Strategic & National Payer Accounts, 

Foundation Medicine 

3:15 Companion Diagnostics and the Path to Market – Do All 

Roads Lead to Rome? 

Steven Gutman, M.D., Strategic Advisor, NA, Myraqa, Inc. 

This session will provide an overview of the scientific approaches most 

commonly considered for use in product co-development and will consider the 

trade-offs to be addressed in selecting the optimal design. 

3:45 Panel Discussion: Reimbursement for New Molecular 

Diagnostics Codes: More Questions Than Answers 



Sponsor & Exhibitor opportunities 

CHI offers comprehensive sponsorship packages which include presentation 

opportunities, exhibit space and branding, as well as the use of the pre and post 

show delegate lists. Sponsorship allows you to achieve your objectives before, 

during, and long after the event. Any sponsorship can be customized to meet 

your company's needs and budget. Signing on earlier will allow you to maximize 

exposure to hard-to-reach decision makers. 

AgendA PresentAtions 

Showcase your solutions to a guaranteed, highly-targeted audience. Package 

includes a 15 or 30 minute podium presentation within the scientific agenda, exhibit 

space, on-site branding and access to cooperative marketing efforts by CHI. 

BreAkfAst & Luncheon PresentAtions 

Opportunity includes a 30 minute podium presentation. Boxed lunches are 

delivered into the main session room, which guarantees audience attendance and 

participation. A limited number of presentations are available for sponsorship and 

they will sell out quickly. Sign on early to secure your talk! 

invitAtion-onLy viP dinner/hosPitALity suite 

Sponsors will hand-pick their top prospects from the conference pre-registration 

list for an evening of networking at the hotel or at a choice local venue. CHI will 

extend invitations and deliver prospects. Evening will be customized according 

to sponsor’s objectives (i.e. purely social, focus group, reception style or plated 

dinner, plated dinner with specific conversation focus). 

exhiBit informAtion 

Exhibitors will enjoy facilitated networking opportunities with qualified decision 

makers at the Next Generation Diagnostics Summit, making it the perfect platform 

to launch a new product, collect feedback and generate new leads. Exhibit space 

sells out quickly, so reserve yours today! 

2012 sponsors & exhibitors 

20/20 GeneSystems 

Advanced Cell Diagnostics 

Ambry Genetics 

ArcticZymes 

Asuragen 

Aushon BioSystems 

Biodesix 

Biofortuna 

BioMedomics 

bioMerieux, Inc. 

Biosearch Technologies, Inc. 

Boston Healthcare Associates 

Bridgehead Intl GFK 

Cureline 

D-Target 

Diagnostic Consulting Network 

EdgeBio 

Enplas 

Folio Biosciences 

GenePOC 

HTG Molecular Diagnostics 

KMC Systems 

Luminex 

McKesson 

MolecularMD 

Myriad RBM 

OriGene 

Predictive Biosciences 

Looking for AdditionAL wAys to drive LeAds to your sALes teAm? chi 

cAn heLP! 

We offer clients numerous options for custom lead generation programs to 

address their marketing and sales needs, including: 

custom LeAd generAtion ProgrAms: 

• Targeted campaign promotion to unparalleled database of 800,000+ individuals in 

the life sciences 

• Experienced marketing team promotes campaign, increasing awareness and leads 

Live weBinArs: 

• Assistance in procuring speakers 

• Experienced moderators 

• Dedicated operations team to coordinate all efforts 

whitePAPers: 

• Industry recognized authors, with vast editorial experience, available to help 

write your white paper 

*chi ALso offers mArket surveys, PodcAsts, And more! 

Reserve your exhibit space by may 10 & sAve $300! 

For additional information, please contact: 

Joseph Vacca 

Manager, Business Development 

781-972-5431 | jvacca@healthtech.com 

PrimeraDx 

Promega 

Quanterix 

Randox Laboratories 

ResearchDx 

RHEONIX 

Scienion, Inc. 

Slone Partners 

Sony DADC 

ThinXXS Microtechnology AG 

Trillium Diagnostics 

uFluidix Inc. 


hotel & travel information 

Conference Hotel: 

The Hyatt Regency on Capitol Hill, Washington, DC 

400 New Jersey Avenue 

Washington, DC 20001 

Tel: 202-737-1234 

Discounted Room Rate: $195 s/d 

Discounted Room Cut-off Rate: July 24, 2013 

Please visit NexGenerationDx.com to make your reservation 

online or call the Hotel directly to reserve your sleeping room 

accommodations. You will need to identify yourself as a 

Cambridge Healthtech Institute conference attendee to receive 

the discounted room rate. Reservations made after the cut-off 

date or after the group room block has been filled (whichever 

comes first) will be accepted on a space- and rate-availability 

basis. Rooms are limited, so please book early. 

Top Reasons to Stay at the Hyatt Regency on Capitol Hill 

• Complimentary wireless internet in your guest room 

• Walking Distance to Smithsonian Museums, the National Mall and local attractions 

• Steps away from the U.S. Capitol Building 

• Restaurants and Shops are just minutes from the Hotel 

Flight Discounts: 

American Airlines 

Special discounts have been established with American Airlines for this conference: 

• Call 1-800-433-1790 and use Conference Code 8283BJ 

• Go online at www.aa/group.com enter Conference code 8283BJ in promotion 

discount box 

• Contact our designated travel agent, Rona Meizler at 1-617-559-3735 or 

rona.meizler@protravelinc.com 

Car Rental Discounts: 

Special discount rentals have been established with Hertz for this conference. 

• Call Hertz, 1-800-654-3131 use our Hertz Convention Number (CV): 04KL0004 

• Go online www.hertz.com use our Hertz Convention Number (CV): 04KL0004 

“The Next-Generation 

Diagnostics Summit was a 

great meeting with many 

relevant, timely topics and 

excellent speakers.” 

CSO, Metamark Genetics

NextGenerationDx.com

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