2012年トピックアウトライン

• ADC's, Bispecifics & Empowered Antibodies
  -抗体薬物複合体、二重特異性抗体と強化抗体-

  次世代抗体薬物複合体
  Strategies for Optimizing Properties and Designing Better ADC's

  • 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

  強化抗体と二重特異性抗体
  Strategies to Differentiate Your Molecule and Make More Potent Antibody Therapeutics

  • 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

• Next-Gen Sequencing Applications & Translational Technologies
  -次世代シーケンシングの応用と翻訳のための技術-

  次世代シーケンシングの臨床および研究分野への応用
  Case Studies, 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

  トランスレーショナル生物学と翻訳技術
  Game-Changing Technologies to Characterize Disease Biology and 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?

• The Future of Rx/Dx Summit
  -Rx/Dxの将来像に関するサミット-

  Rx/Dx（治療薬とコンパニオン診断薬）の開発、商品化、提携のためのモデル
  Aligning Emerging Models for Rx and Dx with Regulatory and Reimbursement Policies to Improve Patient Care and Stimulate New Drug & Diagnostic Products and Partnerships

  • 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

  未来の臨床診断薬
  Optimizing Product Development and Commercialization through Clinical Applications of Next-Generation Sequencing and other Lifescience Platform Technologies

  • 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

• Clinical Biomarkers & New Frontiers in Cancer
  -がんの臨床バイオマーカーと新たな研究領域-

  臨床的に意義のあるバイオマーカー
  Discovery, Validation and Implementation of Biomarkers for Clinical Use and Drug & Diagnostic Applications

  • 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

  がんの新たな研究領域:臨床研究の新たな枠組み
  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