Call for Papers - Submit Your Abstract Today with the Form Below

Deadline to Submit: Friday, January 20, 2012

This year, we are accepting abstracts in each of the following 8 categories. Please see the form below for a more detailed listing of the topics areas under each category:

• Rx/Dx Collaboration Models
• Future Clinical Diagnostics
• Clinically-Relevant Biomarkers
• New Frontiers in Cancer
• Targeted Next-Gen Sequencing
• Translational Biology and Technology
• Antibody-Drug Conjugates
• Empowered Antibodies & Bispecifics

Rx/Dx Collaboration Models

• Strategies for building diagnostic capabilities to accelerate new product development
• Emerging business/economic models for Rx/Dx collaboration or co-development
• How to optimize a platform technology for clinical diagnostic use and/or reimbursement potential?
• Success factors in Rx/Dx partnering to support commercial launch of a drug
• Are current regulatory guidelines appropriate for co-development of therapeutics and diagnostics?
• The case for and against Companion Dx test regulation: FDA-Approved vs. lab-developed tests
• Reimbursement policies/strategies in the new era of Rx/Dx collaboration: Is there a workable model?
• Aligning strategies for drug and diagnostic co-development in early planning and R&D
• Where do the opportunities lie for future drug/diagnostic development?
• Opportunities and challenges for drug developers
• Opportunities and challenges for diagnostic companies and technology platform providers
• Opportunities and challenges for payers and healthcare organizations
• Opportunities and challenges for physician-scientists and their patients
• Case studies of companion diagnostics in development or approved

Future Clinical Diagnostics

• New developments in infectious disease diagnostics
• New developments in cancer diagnostics
• Sequencing applications for clinical diagnostics
• Diagnostics for personalizing medicine/clinical treatment at the bedside
• Strategies to inform biology-based clinical treatment decisions in patients
• New technologies for finding diagnostic biomarkers
• Impact of technology changes on clinical diagnostics and hospital practices
• Evolving diagnostic technologies: from mass spec , microarrays and PCR to sequencing, hybrid selection techniques and exomes

Clinically-Relevant Biomarkers

• Exploiting biomarkers as clinical management tools or for drug or diagnostic development
• What level of scientific evidence is required to prove clinical utility of a companion diagnostic biomarker for guiding therapy decisions or clinical trial strategy?
• Positive-predictive biomarker discovery for finding responder patients
• Exploiting blood-based biomarkers (CTC's, free DNA/RNA, exosome) for drug and diagnostic development
• Biomarker assay development and translation to the clinic
• Pharmacogenomic biomarkers for stratifying patient sub-groups
• Technologies for enabling biomarkers for personalized medicine
• The emerging role of non-coding RNA's in disease
• Tumor and tissue-based biomarker panels
• Epigenomics and methylation analysis: Finding biomarkers for predictive and diagnostic use

New Frontiers in Cancer

• Strategies to predict and improve patient response to cancer drugs
• Monitoring/anticipating drug resistance in cancer: new clinical strategies for disease therapy
• Alternative strategies for tumor characterization/noninvasive approaches for accessing tumor cells
• Tumor profiling strategies for precision medicine to characterize disease subtypes and patient populations
• Disease heterogeneity: clinical implications of tumor heterogeneity
• Deep sequencing strategies to characterize disease heterogeneity and to separate driver mutations from passenger mutations
• Blood as a source of cancer biomarkers (CTC's, free DNA/RNA, exosome)
• Epigenomics and methylation analysis: Finding biomarkers for predictive and diagnostic use
• Combinations of multiple targeted agents for cancer
• The emerging role of non-coding RNA's in disease
• Functionalizing the cancer genome

Targeted Next-Gen Sequencing

• Applications of personal sequencers: PGM, MiSeq, GS Junior
• Epigenomics and methylation analysis: Finding biomarkers for predictive and diagnostic use
• Metagenomics: Sequencing of viral and bacterial populations
• RNA-Seq/Transcriptome sequencing studies and applications
• Expanding the exome: new sequencing approaches
• Targeted sequencing/re-sequencing
• Target enrichment strategies and genome partitioning
• HLA and immune receptor repertoire sequencing
• The emerging role of non-coding RNA's in disease
• Clinical applications of next-generation sequencing
• Sequencing data analysis, statistics and bioinformatics
• Sequencing vs. arrays vs. other genomic technologies - which is better for routine projects?
• New simplified sample preparation solutions

Translational Biology and Technology

• What level of biological understanding is necessary to inform the best therapeutic approach or to predict treatment outcomes?
• Which technologies are best to reveal the biology for different diseases?
• Elucidating the biological mechanism of the target/pathway for your drug
• Novel technologies for characterizing disease to match biological targets with patient subgroups
• How can next-generation sequencing technologies enable your drug discovery efforts?
• Single cell and rare cell analysis technologies
• Exploiting ips cells and stem cells for understanding disease biology and new drug screening
• Assay development using human cells, tissues and tumors
• Novel technologies for characterizing DNA, RNA and proteins
• What is the FDA doing to accommodate the fast-paced evolution of technological advances from genomics to the clinic?

Antibody-Drug Conjugates

• Optimizing ADC's in preclinical and clinical development
• Novel ADC engineering and design
• Target selection strategies and disease-associated targets for ADCs
• Novel ADC payloads and creative payload delivery - toxins, cytokines, enzymes
• Exploring novel chemistries, linkers and linker chemistry-stability
• New ADC technologies beyond current approaches
• Tumor antigen expression and the efficacy window of opportunity
• ADC process development, scale-up and characterization
• Purification of ADCs and "sticky" antibodies
• Manufacturing technologies and challenges

Empowered Antibodies & Bispecifics

• Target discovery: which targets will benefit from empowered antibodies?
• Empowering the immune system and T-cell recruitment
• Rationally-designed antibodies for specific targets and functions
• Optimization strategies for bispecifics and multifunctional antibodies
• Bispecific targeting and BiTE-like molecules
• Clinical data on and performance of bispecifics - do they really work?
• Biophysical stabilization and characterization approaches
• Co-development of companion diagnostics for antibody products
• Combination strategies for ADCs, bispecifics and other biotherapeutics
• FDA guidance on combination of investigational agents
• Whole antibody versus antibody fragment based bispecifics