
Companion Diagnostics: From Biomarker Identification to Market Entry
Monday, April 28, 2014 - Tuesday, April 29, 2014
Presented By
The recent growth in complex biological data has enabled a major paradigm shift in healthcare away from "one-size-fits-all" approaches towards customized, patient-tailored therapies. Biomarker-based companion diagnostics (CDx), designed to identify responsive patient sub-populations or those likely to experience adverse drug effects, lie at the heart of this personalized, precision medicine movement.
This 2-day conference will provide a neutral forum for international scientists and clinicians from academia, industry, and government — as well as healthcare policy makers, regulatory experts, insurance sector representatives, and other stakeholders — to discuss research, financial, and regulatory strategies that will facilitate CDx development and integration into clinical care. Presentations will illustrate successes and failures based on case studies; evaluate emerging applications of technologies such as epigenetics, bioinformatics, and nanotechnology; analyze diverse therapeutic target areas beyond cancer including inflammatory, infectious, cardiovascular, metabolic, and neurodegenerative diseases; recognize regulatory hurdles; and formulate solutions to better improve public health with CDx and personalized medicine.
Call for Abstracts
Abstract submissions for the Poster Session will continue to be accepted until further notice.
The application deadline for "Hot Topic" presentations and travel fellowships has formally expired.
For complete abstract submission instructions, please send an email to CDx2014@nyas.org with "Abstract Information" in the subject line. There is no need to type a message; instructions will be forwarded automatically. Please call 212.298.8618 with any questions. Select additional abstracts will be accepted on a rolling basis.
Registration Pricing
By 04/04/2014 | After 04/04/2014 | Onsite | |
Member | $250 | $295 | $325 |
Student/Postdoc Member | $135 | $165 | $195 |
Nonmember (Academia) | $325 | $385 | $415 |
Nonmember (Corporate) | $395 | $465 | $495 |
Nonmember (Non-profit) | $325 | $385 | $415 |
Nonmember (Student / Postdoc / Fellow) | $170 | $200 | $230 |
Registration includes a complimentary, one-year membership to the New York Academy of Sciences. Complimentary memberships are provided to non-members only and cannot be used to renew or extend existing or expiring memberships. A welcome email will be sent upon registration which will include your membership credentials.
Presented by
Agenda
* Presentation titles and times are subject to change.
Day 1 — Monday, April 28, 2014 | |
7:15 AM | Registration and Continental Breakfast |
8:00 AM | Welcome Remarks |
8:05 AM | Keynote Panel |
8:05 AM | Towards Biomarker-based Personalized Healthcare: Current Status and Future Trends |
8:15 AM | Promoting Personalized Medicine through Policy Strategies |
8:25 AM | Regulatory Strategies to Safely Accelerate the Implementation of Companion Diagnostics |
8:35 AM | Integrating Companion Diagnostics in the Healthcare — the Insurance Sector Perspective |
8:45 AM | The Future of Academic Research towards Translation for Personalized Medicine |
8:55 AM | Interactive Panel Discussion |
9:40 AM | Audience Q&A |
10:00 AM | Coffee Break |
10:30 AM | Introduction & Opening Remarks |
Session I: Paving the Way to Personalized MedicineSession Chair: David A. Fryburg, MD, Selventa | |
10:55 AM | Genomics Medicine |
11:20 AM | Functional Proteomics, Companion Diagnostics and Precise Medicine |
11:45 AM | Insights for Personalized Medicine from the Gut Microbiome |
12:10 PM | Networking Lunch |
Session II: Case Studies — Lessons from the Past and Pioneers of the FutureSession Chair: Michael Corbo, PhD, Pfizer Inc | |
1:20 PM | Case Study: Xalkori Companion Diagnostic |
1:40 PM | Development of Selzentry (Maraviroc) and the Companion Diagnostic HIV Tropism Assay |
2:00 PM | Industry Spotlight — Development of Kalydeco as a Genotype Specific Drug for the Treatment of Cystic Fibrosis |
2:20 PM | Industry Spotlight — Pathways of Disease Progression in Heart Failure: What Can Galectin-3 Tell Us? |
2:40 PM | Panel Discussion |
3:10 PM | Coffee Break |
Session III: Concurrent Workshops — The Next Frontier(s) of Therapeutic Target Areas | |
Concurrent Workshop A: Infection, Inflammation, and Airway DiseaseWorkshop Leader: Tariq Sethi, BSc, MA, PhD, FRCP, King's College London | |
3:40 PM | Biomarkers for Precision Medicine in Airway Diseases |
4:00 PM | Stratified Medicine in Autoimmune Diseases: Rheumatoid Arthritis Examples |
4:20 PM | mTOR Signaling: a Central Pathway to the Pathogenesis of Multiple Inflammatory and Immune System Disorders — Implications for Personalized Medicine |
4:40 PM | Companion Diagnostics in Autoimmune Disorders: Improving Outcomes in RA and IBD |
5:00 PM | Panel Discussion |
Concurrent Workshop B: Metabolic and Cardiovascular DiseasesWorkshop Leader: Mark J. Caulfield, MD, FRCP, William Harvey Research Institute, Queen Mary University of London | |
3:40 PM | Implications for Personalized Medicine |
4:00 PM | Advances in Blood Pressure Genomics |
4:20 PM | Personalized Diabetes Medicine |
4:40 PM | A Novel Fasting Blood Test for Insulin Resistance: Application of Metabolomics to Diagnostic Development |
5:00 PM | Panel Discussion |
Concurrent Workshop C: Neurodegenerative DiseaseWorkshop Leader: Eugene O. Major, PhD, National Institute of Neurological Disorders and Stroke, NIH | |
3:40 PM | The Genetics of Multiple Sclerosis — Implications for Personalized Medicine |
4:00 PM | Biomarkers for Parkinson's Disease — Imaging Onset, Progression, and Effect of Treatment |
4:20 PM | Identification of Biomarkers for the Diagnosis, Prediction, and Progression of Alzheimer's Disease |
4:40 PM | Increased Plasma C-reactive Protein (CRP) as a Peripheral Biomarker for anti-TNF Treatment with XPro1595 in Patients with Treatment Resistant Depression |
5:00 PM | Panel Discussion |
5:30 PM | Poster Session and Networking Reception |
7:00 PM | Day 1 Concludes |
Day 2 — Tuesday, April 29, 2014 | |
8:00 AM | Continental Breakfast |
Session IV: Highlights from the Therapeutic Target Areas Workshop | |
8:45 AM | Highlights —Therapeutic Target Areas beyond Cancer: Infection and Immunology, Metabolic and Cardiovascular Diseases, and Neurodegenerative Disease Workshop Leaders will present 10-minute summaries of the therapeutic target area workshops held the previous day. A total of combined 25 minutes will be available for audience Q&A. |
Session V: Emerging Technologies in the Companion Diagnostics ArenaSession Chair: to be announced | |
9:40 AM | Sequencing Approaches for Personalized Cancer Therapy Selection |
10:00 AM | The Impact of Epigenetics on the Future of Personalized Medicine |
10:20 AM | Innovation in Metabolomics to Improve Personalized Healthcare |
10:40 AM | Coffee Break |
11:10 AM | Rapid and High Sensitivity Whole Blood Companion Diagnostics with T2MR |
11:30 AM | Harnessing Complex Biological Data for Personalized Medicine |
11:50 AM | Panel Discussion |
12:10 PM | Networking Lunch |
Session VI: The Road Ahead — Identification of Hurdles and Solutions to the Implementation of Personalized Medicine into HealthcareSession Chair: Claudio Carini, MD, PhD, Pfizer Inc | |
1:20 PM | Biomarker Validation |
1:40 PM | Beyond Oncology – Future Outlook for Companion Diagnostics – Challenges and Opportunities |
2:00 PM | Informatics Solutions for Biomarker Research and Personalized Medicine in Clinical Care |
2:20 PM | Regulatory Approaches to Accelerate Predictive Biomarker Development and Companion Diagnostic Approval in the United States |
2:40 PM | Coffee Break |
3:10 PM | The European Union Regulatory Framework for Companion Diagnostics and Personalized Medicines in Comparison to US Legislation |
3:30 PM | Making Personalized Medicine more Affordable |
3:50 PM | Speaker to be announced |
4:10 PM | Panel Discussion |
4:55 PM | Closing Remarks |
5:00 PM | Adjourn |
Speakers
Chair, Organizing Committee
Claudio Carini, MD, PhD
Pfizer Inc
Keynote Panelists
Elaine Collier, MD
National Center for Advancing Translational Sciences / NIH
Mikael Dolsten, MD, PhD
Pfizer Inc
website
Michael Kolodziej, FACP, MD
Aetna
Reena Philip, PhD
US Food & Drug Administration
Charles L. Sawyers, MD
Memorial Sloan-Kettering Cancer Center
website
Organizers
Melanie Brickman Stynes, PhD, MSc
The New York Academy of Sciences
David A. Fryburg, MD
Selventa
Brooke Grindlinger, PhD
The New York Academy of Sciences
Kerstin Hofmeyer, PhD
The New York Academy of Sciences
Raju Kucherlapati, PhD
Harvard Medical School
website
Iain McInnes, FRCP, PhD, FRSE
University of Glasgow
website
Michael A. Pacanowski, PharmD, MPH
US Food and Drug Administration
Peter Parker, MD
King's College London
website
Andras Perl, MD, PhD
Upstate Medical University, SUNY
website
Tariq Sethi, BSc, MA, PhD, FRCP
King's College School of Medicine
website
Speakers
Aram Adourian, PhD
BG Medicine, Inc.
website
Naomi Aronson, PhD
Blue Cross and Blue Shield Association
website
Christopher J. Barnum, PhD
Emory University School of Medicine
Erwin P. Böttinger, MD
Icahn School of Medicine at Mount Sinai
website
Angela Brand, MD, PhD, MPH
Maastricht University, Institute for Public Health Genomics
website
Mark J. Caulfield, MD, FRCP
William Harvey Research Institute, Queen Mary University of London
website
Jeff E. Cobb, PhD
Metabolon, Inc.
Michael Corbo, PhD
Pfizer Inc
Mark E. Curran, PhD
Janssen Research & Development, LLC
Philip Lawrence De Jager, MD, PhD
Harvard Medical School
website
S. Dusko Ehrlich, PhD
Institut National de la Recherche Agronomique (INRA)
website
Federico Goodsaid, PhD
Vertex Pharmaceuticals
Abdel-Baset Halim, PharmD, MSc, PhD, DABCC, FACB
DrugScan, Inc
Julie A. Johnson, PharmD, FCCP, BCPS
University of Florida
website
Bruce W. M. Jordan, PhD
Roche Diagnostics
Charles Knirsch, MD, MPH
Pfizer Inc
Massimo Loda, MD
Harvard Medical School / Dana Farber Cancer Institute
website
Tom Lowery, PhD
T2 Biosystems
Eugene O. Major, PhD
National Institute of Neurological Disorders and Stroke, NIH
Kenneth Marek, MD
Institute for Neurodegenerative Disorders
website
Jane Mellor, PhD
University of Oxford
website
Michelle M. Mielke, PhD
Mayo Clinic
website
Robert M. Plenge, MD, PhD
Merck Research Laboratories
Toni I. Pollin, PhD
University of Maryland School of Medicine
website
Hakan Sakul, PhD
Pfizer Inc
Daniela Starcevic, PhD
Icahn School of Medicine at Mount Sinai
Additional speakers to be announced.
Sponsors
Silver Sponsor
Bronze Sponsor
Academy Friend
Grant Support
Supported by a grant from AbbVie
Supported by an educational grant from Celgene Corporation
Exhibitor
Siemens Healthcare Diagnostics, Inc
Promotional Partners
American Society of Clinical Oncology
American Society of Human Genetics
Elsevier's Global Events List: Science & Medicine
NYSSPATH - New York State Society of Pathologists
Precision Medicine & Big-DATA in Life Sciences @LinkedIn
The Royal College of Pathologists
The Royal Society of Chemistry
The Society to Improve Diagnosis in Medicine
United States & Canadian Academy of Pathology (USCAP)
Presented by
Abstracts
Day 1 — Monday, April 28, 2014
Session I: Paving the Way to Personalized Medicine
Genomics Medicine
Raju Kucherlapati, PhD, Departments of Genetics and Medicine, Harvard Medical School, Boston, Massachusetts, United States
Functional Proteomics, Companion Diagnostics, and Precision Medicine
Peter J. Parker, PhD, King’s College London and London Research Institute of Cancer Research UK, London, United Kingdom
Insights for Personalized Medicine from the Gut Microbiome
S. Dusko Ehrlich, PhD1,2
1INRA, Metagenopolis, Jouy en Josas, France
2Human Microbiome Centre, King’s College, London, United Kingdom
Session II: Case Studies — Lessons from the Past and Pioneers of the Future
Case Study: Xalkori Companion Diagnostic
Hakan Sakul, PhD, Pfizer Inc
Industry Spotlight — Development of Selzentry (Maraviroc) and the Companion Diagnostic HIV Tropism Assay
Charles Knirsch, MD, MPH, Pfizer Inc
Development of Selzentry (Maraviroc) and the Companion Diagnostic HIV Tropism Assay
Jayvant Heera, MD and Charles Knirsch, MD, MPH, Pfizer Inc, Pearl River, New York, United States
Development of Kalydeco as a Genotype Specific Drug for the Treatment of Cystic Fibrosis
Federico Goodsaid, PhD, Vertex Pharmaceuticals, Washington, District of Columbia, United States
Pathways of Disease Progression in Heart Failure: What Can Galectin-3 Tell Us?
Aram S. Adourian, PhD, BG Medicine Inc., Waltham, Massachusetts, United States
This presentation will include discussion of unlabeled uses of approved/cleared products.
Session III: Concurrent Workshops — The Next Frontier(s) of Therapeutic Target Areas
Concurrent Workshop A: Infection, Inflammation, and Airway Disease
Biomarkers for Precision Medicine in Airway Diseases
Tariq Sethi, BSc, MA, PhD, FRCP, King’s College London, London, United Kingdom
Stratification of Rheumatoid Arthritis
Iain McInnes, FRCP, PhD, FRSE, University of Glasgow, United Kingdom
mTOR Signaling: a Central Pathway to the Pathogenesis of Multiple Inflammatory and Immune System Disorders — Implications for Personalized Medicine
Andras Perl, MD, PhD, State University of New York, Division of Rheumatology, Departments of Medicine and Microbiology and Immunology, Biochemistry and Molecular Biology, State University of New York, Upstate Medical University, College of Medicine, Syracuse, New York, United States
Companion Diagnostics in Autoimmune Disorders: Improving Outcomes in RA and IBD
Mark E. Curran PhD, Janssen Research and Development, LLC, Springhouse, PA USA
Concurrent Workshop B: Metabolic and Cardiovascular Diseases
Implications for Personalized Medicine
Julie A. Johnson, PharmD, FCCP, BCPS, University of Florida, United States
Advances in Blood Pressure Genomics
Mark J. Caulfield, MD, FRCP, William Harvey Research Institute, Barts National Institute for Health Research Biomedical Research Unit, Queen Mary University of London, United Kingdom
Personalized Diabetes Medicine
Toni I. Pollin, MS, PhD, University of Maryland School of Medicine, Baltimore, MD, USA
In contrast, there is clear clinical utility to genetic testing for monogenic diabetes, which accounts for at least 1% of diabetes and results from mutations in several genes including HNF1A, GCK, HNF4A, KCNJ11. Diagnosing monogenic diabetes enables personalized treatment, resulting in improved glucose control, better prediction of prognosis, and an enhanced familial risk assessment. However, a recently population-based study revealed that 94% of children with monogenic diabetes were misdiagnosed, mostly with T1DM or T2DM, and accordingly usually receiving the wrong treatment. To address this gap, we are implementing, evaluating and disseminating a multi-pronged approach which includes provider eduction, efficient screening all diabetic individuals for “red flags” suggestive of monogenic diabetes, molecular diagnosis using targeted next-generation DNA sequencing, and personalized treatment (e.g., sulfonylureas rather than insulin for individuals who have HNF1A mutations) and genetic counseling for affected individuals and their families.
A Novel Fasting Blood Test for Insulin Resistance: Application of Metabolomics to Diagnostic Development
Jeff E. Cobb, PhD, Metabolon, Inc.,Durham, NC, US
Concurrent Workshop C: Neurodegenerative Disease
The Genetics of Multiple Sclerosis — Implications for Personalized Medicine
Philip Lawrence De Jager, MD, Harvard Medical School
Biomarkers for Parkinson's Disease—Imaging Onset, Progression, and Effect of Treatment
Kenneth Marek, MD, Institute for Neurodegenerative Disorders (IND)
Both advances in imaging technology and an explosion in the availability of imaging probes have enabled Positron Emission Tomography (PET) and Single-Photon Emission Computerized Tomography (SPECT) to inform PD drug development decisions. Several imaging ligands target the loss of nigrostriatal dopaminergic function in PD. Studies have demonstrated that imaging outcomes may predict disease progression and suggest that a growing toolbox of ligands probing striatal function may identify sub-groups likely to develop PD clinical milestones such as dyskinesia or cognitive impairment and those subjects likely to respond to specific PD therapies. Imaging tracers targeting the underlying pathology of PD such as alpha-synuclein will ultimately provide further insight into disease onset and progression. Several studies are further exploring PD biomarkers including the Parkinson Progression Marker Initiative (PPMI), an international, multi-center, observational longitudinal study designed to identify and validate PD markers and PD subsets for further therapeutic studies.
Identification of Biomarkers for the Diagnosis, Prediction, and Progression of Alzheimer's Disease
Michelle M. Mielke, PhD, Departments of Epidemiology and Neurology, Mayo Clinic, Rochester, Minnesota, United States
Hot Topic
Speaker selected from submitted abstracts
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