2012 Conference Topics Outline

August 06-08, 2012 · The Westin San Francisco Market Street · San Francisco, CA

Antibody Drug Development

Antibody-Drug Conjugates
Discovery, Development and Manufacturing
- 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
Strategies for Targeting and Optimizing Properties of Next-Generation Antibody Molecules
- 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
»Submit an Abstract to Present
Translating Biology to the Clinic

Targeted Next-Gen Sequencing
Concrete Applications and Strategies for Finding "Hot Spots" of Biological and Clinical Relevance
- 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
Translating Biology and Technology
Characterizing Disease Biology to Transform Clinical Medicine, Drug and Diagnostic Development
- 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?
»Submit an Abstract to Present
Diagnostic Development

Rx/Dx Collaboration Models
Aligning Business Models of Drug, Diagnostic and Technology Companies with Regulatory and Reimbursement Policies to Transform Medicine and Stimulate New Product Development
- 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
Enabling Technologies and Scientific Strategies
- 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
»Submit an Abstract to Present
Clinical Biomarkers and Cancer

Clinically-Relevant Biomarkers
Discovery and Validation for Clinical Use and Drug/Diagnostic Development
- 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
Translating an Understanding of Cancer Biology into Tailored Therapies and Novel Diagnostics
- 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
»Submit an Abstract to Present

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2012 Conference Topics Outline

2012 Conference Topics Outline

Antibody Drug Development

Translating Biology to the Clinic

Diagnostic Development

Clinical Biomarkers and Cancer