alliance management: Topics will include: Building the Competencies of Alliance Management within the Entire Organization. Creating Metrics and Survey Tools to Measure and Demonstrate Alliance Value & Success. Successful Partner Strategies and Integration Processes. Alliance Management Strategic Agenda for the Future. Managing and Structuring Resources as the Quantity of Alliances Increase. Leading Through Influence: Leveraging Knowledge and Executing Project Across Cross-Disciplinary Teams Exploring the Functional and Strategic Roles of Alliance Management and Project Management.   See  Alliances glossary

animal models: See disease models

baculovirus: The advantages for using the Baculovirus Expression Vector System (BEVS) were first revealed in 1982 by Gale Smith and Max Summers at Texas A&M University. Since then, baculovirus vectors have proven their importance as tools for recombinant protein expression and as biological control agents. 

Beyond Genome June  San Francisco, CA   

biodefense:  The multiple independent efforts in biodefense need to be developed into a response network that can be implemented rapidly and effectively. This will require a detailed investigation into how to best prepare for and respond to a national incident or disaster. The infrastructure for generating and sharing information that can identify biodefense exposure and minimize consequences will prove to be an invaluable asset. An integrated database connecting disease centers that gives clinical conditions and potential exposure to disease is critical to this mission, as are biosensors that can give sensitive, real-time information that provide defense against large-scale exposure. This infrastructure in turn also needs to support a decision- making hierarchy so that information can be shared appropriately and resources can be mobilized. The introduction of state- of- the- art devices and technologies to enable this task needs to be integrated into this framework for readiness and response. 

Biomarker World Congress  is dedicated to all areas of biomarker research spanning the pharmaceutical and diagnostic pipeline. Bringing together a mix of large and medium pharmaceutical, biotech and diagnostics companies, leading universities and clinical research institutions, government and national labs, CROs, emerging companies and tool providers, a place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies. Sessions include • Biomarkers in translational medicine, • Pharmacogenomics, • Pharmacodiagnostics, • Biomarker assay development and validation, • Biomarkers for molecular diagnostics, • Clinical validation of biomarkers, • Biomarkers for clinical pharmacology, • Biomarkers for patient selection, • Biomarkers to monitor response to therapy, • Expression signatures in biomarker discovery, • Biomarker data analysis, • Genomic, proteomic and matabolomic biomarkers, • Disease-specific biomarkers: cancer, CNS and inflammatory diseases, • Biomarkers for go/no-go decisions, • Impact of biomarkers on medicine, • Regulatory issues Biomarker World Congress  

biomarkers:  Anatomic, physiologic, biochemical, or molecular parameters associated with the presence and severity of specific disease states. Biomarkers are detectable and measurable by a variety of methods including physical examination, laboratory assays and medical imaging. Massachusetts General Hospital, Center for Biomarkers in Imaging, 2004 http://www.biomarkers.org/NewFiles/faqs/definition.html#Anchor-What-35882

A characteristic that is measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacological responses. M. Danhof, Meeting Report, Markers of pharmacological and toxocological action, BioMedCentral, 2001 http://www.biomedcentral.com/abstracts/CRP/1/023/

bioprocessing strategies: The rapidly developing biologics industry is faced with many complex areas of concern. There are multiple issues that need to be analyzed as we explore process standardization, and the financial and economic ramifications of new systems and methodologies. Bioprocessing glossary

blood safety: The quality and safety of blood and blood products is a major concern to the health community. The goal is to prevent, as completely as possible, the transmission of infectious or potentially dangerous particles. How can this goal be reached? What are the newest and most precise screening assays? Which agents need to be screened for? Which new pathogens are a potential threat to humans? How early can pathogens be detected? Which donors are being excluded/included? Which effect has pooled screening on the window-period? 

Bridging Clinical and IT may cover: Capturing, Managing and Measuring Clinical Data Quality to Ensure Accurate Statistical Analysis and Optimum Outcomes, Progress on Standards and Interoperability, Adapting Clinical Trial Operations in Tandem with EDC Technologies and Implementation , Using IT for Continuous Process Managing, Improvement, and Innovation to Increase Productivity and ROI, and Choosing Strategies for Global Trials. 

Bridging Discovery and IT: may include Developing Drug Discovery Strategies that Leverage New Technology, Integrating Biology, Chemistry, and Drug Safety, Extracting Maximum Value from Informatics , Identifying Strategic Shifts in Information Technology Investments, and Overcoming Cultural and "Language" Barriers.

bridging Development and IT:  may include In Silico Approaches for Predicting ADME Properties of Drugs, Validation of ADME Models, Integration of ADME Assays and IT Data, Early ADME System Requirements and Capabilities , and Improving the Interface Between IT Specialists and Assay Designers - Getting the Data Needed.

bridging Pharma and IT: This program will focus on tactics and processes that organizations can effectively and efficiently use to minimize communication gaps between scientists, researchers, and information technology professionals in building solutions and capabilities, utilizing data models and their validation, and integrating drug targets and compounds. Joint presentations from pairs of end users and IT and informatics partners will provide indispensable guidance for surmounting challenges and delivering results. 

business series Pharmaceutical Strategy

cancer genomics and proteomics: Sessions include Novel genomic markers for cancer, Protein markers for cancer, Targeted cancer therapy, Monitoring disease progression and response to therapy, Understanding cancer mechanism from expression data, and Cancer disease modeling. 

cancer immunotherapeutics: By targeting molecular and cellular changes specific to cancer, new therapeutic developments have a great potential of being more effective than current treatments. As research increases in this steadily growing field, important questions arise such as: What are the newest strategies in inhibiting cell growth? What is the current success rate? How to identify new targets? How to increase the effectiveness and specificity of new compounds? What is the future route of protein therapeutics? What is important when moving from bench to the market? What are the current intellectual property regulations? C

cancer vaccines:  While the common goal for cancer immunotherapeutics is to boost the immune system and thereby fight cancer in various stages, what is needed most for treating cancer successfully are more precisely-targeted therapies. The approaches vary widely and ideally it may be reached by using the patient’s own immune system or by inducing T-cells or “vaccines”, however, many obstacles and challenges still need to be overcome. 

carbohydrates: See glycomics 

cell culture: The in vitro propagation of animal of plant cells, in an artificial nutrient medium. IUPAC Biotech

As biopharmaceutical products steer closer to market, it is critical to improve cell culture processes both to increase yield and to decrease time spent on experiments and growing cells in order to reduce the bottom-line cost. Achieving greater productivity remains the paramount concern, and methods for analyzing titer, identifying components, and ensuring purity are essential elements of process improvement. 

chemical genomics: The targets of many drug candidates are unknown and are often difficult to tease out from among the thousands of gene products found in a typical organism. The “blindness” in the welter of potential cellular targets means that the process of designing therapeutic drugs is neither precise nor efficient. The exploration of chemical genomics will transform our understanding of how the human genome and proteome function. 

chemistry, drug discovery [lds 2006] See also fragment based drug design, library design and synthesis, natural products chemistry  CHI chemistry series

chemistry, medicinal SEE medicinal chemistry

clinical biomarkers: As the field matures, biomarkers are making their way into clinical trials. Faced with relative lack of experience in implementing biomarkers in clinical trials, many researchers and clinicians are facing similar challenges in modifying trial design and defining the right control population, validating biomarker assays from the biological and analytical perspective, and using biomarker data as a guideline for decision making. The Clinical Biomarkers Summit will address biomarker translation from pre-clinical to clinical studies and a variety of biomarker applications in clinical trials, including patient selection, monitoring clinical efficacy and safety, and clinical pharmacology. The Summit also addresses the bridging gap between the pharmaceutical and diagnostics industries and the potential of companion diagnostics. Specific case studies of leveraging biomarkers in accelerating and streamlining clinical trials will offer you a "state-of-the-field" status report, 

clinical pharmacology biomarkers: Clinical Validation of Biomarkers, Translational Research: Biomarker Translation from Animal to Man, Pharmacogenomics and Personalized Medicine, Strategies for Biomarker Development Prior to Clinical Trials, Expediting Clinical Proof-of-Concept Studies, Biomarkers in Clinical Pharmacology, Biomarkers to Surrogate Endpoints, Biomarkers to Predict Response to Treatment, Biomarkers for Patient Selection, Biomarkers for Compound Selection, Regulatory Implications  

clinical trial design: The escalating costs and length of today’s clinical trials are a major bottleneck for researchers attempting to get drugs to the market quickly.  However, a shift in the regulatory climate towards the use of biomarkers as surrogate endpoints and implementation of new and innovative approaches to the design and conduct of clinical trials offers the promise of increased productivity. At the same time there is a push for transparency in trials, which offers its own opportunities and raises sensitive IP issues for industry. Leveraging registries, results databases, and outcomes research and taking a new approach to data management will lead to improvements in the speed, safety and transparency of clinical trials. 

companion diagnostics:   See also molecular diagnostics 

companion diagnostics biomarkers: Pharmacodiagnostics: Prospects for Companion Diagnostics, Development of Biomarker-based Diagnostics, Expression Profiles for Disease Staging and Response Prediction, Pre-Symptomatic Disease Detection, Biomarker Assay Development and Validation, "Fit-for-purpose" Analytical Validation, Expression Profile Analysis and Interpretation, Novel Diagnostic Platforms, Potential of Microarrays in Molecular Diagnostics, Microarray Data Interpretation Biomarkers for Molecular Diagnostics, Pharmacodiagnostics: Prospects for Companion Diagnostics, Development of Biomarker-based Diagnostics, Expression Profiles for Disease Staging and Response Prediction, Pre-Symptomatic Disease Detection, Biomarker Assay Development and Validation, "Fit-for-purpose" Analytical Validation, Expression Profile Analysis and Interpretation, Novel Diagnostic Platforms, Potential of Microarrays in Molecular Diagnostics, Microarray Data Interpretation. 

comparative genomic hybridization CGH microarrays: Microarray-based comparative genomic hybridization (CGH microarray) is a technique by which variation in relative copy numbers between two genomes can be analyzed by competitive hybridization to DNA microarrays. In genomics, CGH arrays enable researchers to carry out genome-wide screening for regions of genetic alterations. This diagnostic tool takes advantage of the completed genome map to find new treatment pathways, as well as, finding applications in evolutionary science, medical genetics, and oncology.  

CHI diagnostics & safety series  

difficult to express proteins: GPCRs, kinases, ion channels, blood plasma proteins, vaccines, and antibodies are just some of the classes of proteins which have proven very difficult to express in quantities large enough to feed the pipeline of therapeutic proteins. Topics may include, but are not limited to: • Automation of expression and purification, • Novel expression systems or novel applications of existing systems, • Overcoming folding problems, • Improving yield, • Managing glycosylation, • Post translational processing, • Overcoming insolubility issues, • Finding the right expression system, • Case studies of success stories or failures 

digital health: The healthcare environment will be profoundly changed by the convergence of technology, and ready access to updated patient information. This meeting will delve into issues of how global connectivity and technology will drive a strategic vision of integrated healthcare delivery systems and cover the use of combinatorial device technology to integrate healthcare systems, and the novel connectivity of global electronic medical record efforts. Clinical management of disease will be addressed through the use of handheld and point-of-care devices. The value of real time patient information to the clinical management team and the pharmaceutical researcher will be leveraged while addressing the ethical and legal implications.  

Discovery on target  October  2007 - Boston, Massachusetts

disease models: Genetically modified mice have proven effective in the identification of new gene function and of novel drug targets and appropriate disease models are powerful tools for validation of such targets while facilitating disease and patient stratification studies at the same time. There is an marked increase in the use of mouse and other models for translational research purposes and a drive toward expediting the in vivo evaluation of in vitro selected molecules by developing animal models more predictive of therapeutic efficacy.   Related term: animal models

drug design: With the integration of virtual screening, advances in x-ray crystallography, design strategies, ligand- based, and other promising emerging technologies, structure-based drug design will continue to yield a number of potential leads, creating an enormous opportunity for the future of novel therapeutics to treat disease  

drug discovery: The early stages of discovery are the hardest to manage from a technical and operational standpoint. Expectantly plagued with failures, there is a constant need for resource shifts, technological enhancements and strategic changes. When all of these pieces are synthesized and balanced, success is probable. But juggling priorities, measuring strategies and managing budgets, makes synthesizing these an intimidating and difficult task.  This forum will focus on the strategic issues of managing discovery. From managing scientific initiatives to technological projects, the role of discovery executives is widespread. In order to be successful, one must be able to manage all of these processes in a period of strategic shifts within the industry. 

Drug discovery & development CHI series

drug repositioning: Involves determining novel uses for existing drugs and rescuing failed compounds. Major benefits of this approach include shorter development cycles, faster drug approval, and the ability to capitalize on the repertoire of drug candidates. Different approaches will be presented for identifying additional indications for compounds, screening against new targets, evaluating patent life, and identifying medical need. Lessons learned will include how to harness creativity to invent new niche markets or diseases.  Related term: drug repurposing

Related terms: idiosyncratic toxicity, pharmacovigilance, post-marketing surveillance    See also Drug approvals glossary Drug safety & pharmacovigilance glossary

emerging markets:  Leveraging Asia’s Drug Development Resources to Improve Productivity of Western Companies, Current and Future Trends in Partnering with Local Companies in Asia, Overcoming Challenges Unique to Partnerships between Chinese and Western Biopharmaceutical Companies, Building a Lead Optimization Capability in Singapore and India, Strategic Planning for Clinical Development Operations in Asia, Planning Development Activities and Overcoming Logistical Challenges in Emerging Markets, The Regulatory Landscape in Asia and Opportunities for Multi-National Companies.  

emerging technologies -- cells, stem cells, tissues:  Stem cells glossary

executives on target: From managing scientific initiatives to technological projects, the role of discovery executives is widespread. In order to be successful, one must be able to manage all of these processes in a period of strategic shifts within the industry.

fluorescent proteins: The recent dramatic increase in the number of fluorescent proteins available for drug discovery - over 100 GFP-like proteins have been cloned by now – provides the biotech/pharma sector with the unique opportunity to expand their screening and tagging technologies over the whole visible color spectrum. Depending on the needs in the molecular pharmacology research, these biological fluorophores offer a wide variety of applicability ranging from tagging a gene, protein or drug target as a marker to providing receptor and metabolic dynamics data in real time and in living systems. This turns fluorescence into one of the premier technologies for drug discovery.

fragment based drug design: The fragment-based approach to drug design has potential for efficient progression into clinically successful compounds. Library design and computational ligand modeling to identify potential fragments, initial screening techniques, molecular optimization based on ligand-target characterization, linking, biological screens, and scaffold morphing/template hopping will be explored to identify advances to meet the challenges in the process. Topic List may include • Designing Improved Fragment Libraries, • Generic vs. Directed Libraries, • Library Application, • Advances to Improve Initial Screen Technology, • Novel Approaches to Characterization and Optimization of Leads, • Biological Assay Screens, • Clinical Case Studies.  

genomic biomarkers: Coverage Includes: Pathway Modeling and Biomarker Identification from Expression Data, Genomic Biomarkers For Molecular Diagnostics, Monitoring Disease Progression and Response to Therapy, Biomarkers to Assess Clinical Activity of Compounds, Genome- Wide Association Studies, and Novel Genomics Markers for Cancer 

GLP Good Laboratory Practice: It is extremely important to understand and draft good audit reports as well as Standard Operating Procedures (SOP’s). Topics include: Drafting Standard Operating Procedures (SOPs), Instrument Qualification: IQ, OQ, PQ, change control, Documentation, and Philosophy, Building a Lab vs. Maintaining a Lab, 21 CFR 11, Software Qualification: IQ, OQ, PQ, change control, Documentation, and Philosophy, Digital Archiving, Laboratory Information Management Systems (LIMS), Documentation Process: Drafting Document Templates that Facilitate Reconstructability, Compliance, and Archive , Report Writing Process: Templates, Reports, Manual vs. Automated Systems, Quality Control , Validation Assays , Designing a QC Process , Planning and Conducting Audits: How to audit effectively, FDA 483/ Warning Letters , Clinical Sample Analysis and Testing and pre-conference tutorial on "writing SOP’s 101". 

glycomics: Glycans are complex, making it hard to exploit their therapeutic possibilities. However, promising new tools and methodologies are available to tackle the most pressing questions, such as: How to purify the glycoproteins? How to analyze the "sticky" substance? What is necessary to get more information on the compound, its structure and binding specificities? After deciding on a target compound - what are the next steps? What are the weaknesses and strengths of analytical tools used? How can you compare various methods? And finally, how do you turn your investment in glycoproteins and carbohydrates into a success story  

GMP Good Manufacturing Practice: May include Process Controls, Equipment, Current GMP Requirements, Electronic Records and Electronic Signature, Dispute Resolution Process, Validation of Analytical Methods, Packaging and Labeling Controls, LIMS, quality and integrity of data, Testing and Release, Quality Control (incl. raw materials), NIST – Accredited Standards in the US and other countries, 21CFR 210 / 211, Stability Testing, GMP and FDA Compliance, and Analytical Data Interpretation 

See also Comparative Genomic Hybridization CGH Microarrays,  Labels & stains, Laser capture microscopy, Microarrays, Sample prep, Tissue microarrays,  Tissue technologies

G-protein-coupled receptors: GPCRs: More than 70% of the drugs on the market today are targeted to GPCRs, with sales of more than $30 billion. These targets will continue to be key in the search for effective therapeutics.  

High Content Analysis HCA: Over the three years of organizing the HCA meeting we have observed the technology mature and its adoption spread into many areas of compound screening/evaluation and functional analysis. HCA Europe will focus on the next steps of technology development, including new assays, reagents, and data analysis. It will also cover case studies and applications in primary and secondary compound screening, cytotoxicity evaluation, functional analysis, and more…

Human Proteome: See Plasma Proteome

India, drug development: The rise of India as a global economy presents great opportunities for the international pharmaceutical industry and it has, thus, become the partner of choice for industry collaborations. In order to minimize the expenses, time and risk involved in R&D, companies have found an effective solution and worthy partner in this low-cost region populated by a highly-skilled drug discovery and development talent pool. In addition, due to its growing population and expanding middle class, India presents valuable consumer market opportunities for pharmaceutical companies.

informatics: The study of the application of computer and statistical techniques to the management of information. In genome projects, informatics includes the development of methods to search databases quickly, to analyse DNA sequence information, and to predict protein sequence and structure from DNA sequence data. ORD Office of Rare Diseases, NIH glossary http://ord.aspensys.com/asp/resources/glossary_f-m.asp#I     Related: Bridging Pharma and IT: bridging development, discovery, clinical and IT

ion channels: Ion channels regulate multiple key physiological processes. Despite their disease relevance, ion channels remain largely unexploited as drug targets. The potential to utilize ion channels as molecular targets for cardiovascular disease; cancer; central nervous system diseases: Parkinson’s disease, epilepsy, and pain; immune disorders; inflammatory diseases; psychiatric disorders; diabetes; and other “channelopathies” is widely recognized. I

kinase targets: See protein kinase targets

labels: Optimal ways for targeting your tissues and cells, according to your diagnostic needs.   

laser capture microscopy: The laser capture microscope is a relatively new tool that allows procurement of DNA, RNA, and proteins of small and pure populations of cells. Traditionally used for separation of tumor cells, many additional applications of this technology, e.g. for developmental biology, or in vitro fertilization, have evolved. In addition, the combination of laser capture microscopy with other high sensitivity, high-throughput technologies such as microarrays offer exciting new possibilities for scientists in research and clinic. 

library design and synthesis: Despite numerous advances in high throughput synthesis methods, a more focused approach in screening is emerging. To better meet the need of enhancing biological relevance, drug likeness and diversity, we will refine, stabilize and better position compound libraries.  Combining the expertise of scientists in organic chemistry, medicinal chemistry, combinatorial chemistry, computational science, cheminformatics, biology, and pharmacology from academia, biotechnology and the pharmaceutical industry topics may include • Breakthroughs in approaches to library design, • Novel synthetic strategies, • New Templates for development, • The function of small and large libraries, • Enhancements in combined synthesis initiatives, • Refinements to improve activity for better lead optimization, • Tightened quality control, • Repositioning implementation (pre-screening), • Emerging techniques to enhance purification, analysis, stability, storage and profiling, • The science behind the new tools, • Improved strategies for delivery of compounds, • Harnessing the power of synthetic chemistry, • Case Presentations 

mammalian cell culture: As stem cell research, tissue modeling and other cell-based technologies evolve,  adding a mammalian cell culture program is necessary to learn how to better stabilize, sustain and cultivate these areas. Sessions will address the specific deficiencies in formulation, supplements, and contamination, to maximize cell growth and stabilize cell lines. 

medicinal chemistry: The role of a medicinal chemist is changing in industry today. There has never been more pressure to produce potent and safe compounds for advancement faster and more efficiently. Some of the challenges in this field stem from chemistry, supply and technology issues but also increasingly from working with, and interpreting knowledge coming from groups outside of chemistry including biology, computer- aided design, metabolism and pharmacokinetics, legal and regulatory affairs, and at times process research. Meeting the challenges of creating compounds that are both potent and safe in parallel with higher speed and lower budgets, working with outside vendors, while communicating with internal groups will be the focus of this event. 

microarray data analysis: Microarray experiments are costly – both in time and resources, making the careful design of experiments to generate useful gene expression data for diagnostics, target identification, screening, genotyping and other applications critical. The goal – designing microarray experiments that yield statistically defensible results. The generation of such useful data requires effective communication between those designing and running the experiments, with those analyzing the data, to those database developers who facilitate the data handling.  

microarrays: Tool for studying how large numbers of genes interact with each other and how a cell’s regulatory networks control vast batteries of genes simultaneously. Uses a robot to precisely apply tiny droplets containing functional DNA to glass slides. Researchers then attach fluorescent labels to DNA from the cell they are studying. The labeled probes are allowed to bind to cDNA strands on the slides. The slides are put into a scanning microscope to measure … how much of a specific DNA fragment is present. NHGRI glossary http://www.nhgri.nih.gov/DIR/VIP/Glossary/pub_glossary.cgi  

Microarrays build bridges on which biologists and clinicians can meet to understand, diagnose, and treat diseases. Microarray based technologies allow for rapid access to molecular pathways, more precise diagnosis and prognosis of disease, better understanding of drug action, and the ability to better define therapeutic strategies. That, coupled with the FDA's growing interest in the use of microarrays as diagnostic devices, holds a bright future for both researchers developing pharmaceuticals and clinicians improving diagnostics. Optimizing "arrays" depends on carefully assessing your specific purposes. Cambridge Healthtech Institute's Microarrays in Medicine: Arrays of Possibilities, will provide practical information and results about new technical developments and specific applications to help determine which arrays are best for your specific application or research need. 

molecular diagnostics: Scientific advances from the human genome and proteome projects have lead to a new generation of diagnostic products. The vast spectrum of innovative tools has defined a new generation of healthcare tools that will enable more effective prediction, diagnosis, characterization, monitoring, and treatment of diseases. The molecular diagnostics arena is rapidly changing how compounds are developed and marketed. Business issues around discovering, choosing, validating, and introducing biomarker products will be explored.   

CHI diagnostics & safety series  

molecular imaging: The ability to detect biological changes at the level of cells and molecules in vivo plays a key role for future progress in molecular medicine. This leads to a demand for new probes and technologies which target specific metabolic events on a molecular level. In addition, current technologies are still battling the challenge to find a clinically suitable imaging modality, which allows to predict efficacy of drugs in the clinic. I

Molecular Medicine Tri-conference, Feb. San Francisco CA  

monoclonal antibodies MAbs:  A single species of immunoglobulin molecules produced by culturing a single clone of a hybridoma cell. MAbs recognize only one chemical structure, i.e., they are directed against a single epitope of the antigenic substance used to raise the antibody. IUPAC Biotechnology

Antibodies produced by clones of cells such as those isolated after hybridization of activated B lymphocytes with neoplastic cells. These hybrids are often referred to as hybridomas. MeSH, 1982

Monoclonal antibodies are quickly becoming key resources in the therapeutic, diagnostic and drug discovery fields. With the phenomenal growth in the market for monoclonal antibodies, it becomes even more critical to explore diverse methods of design, production and application of technologies to provide the antibodies needed. Topics may include, but are not limited to: • Pharmaceutical/drug discovery applications, • Successful therapeutic case studies, • Target characterization and validation, • Novel expression methods, • Improving safety of therapeutics, • Improving mAb characteristics • Optimizing yields, • Novel immunization methods (like cDNA), • Use of different species for fusion/new, fusion partner cell lines, • Antibodies to signaling proteins/ Phospho-specific antibodies 

nanodelivery: Targeted therapy offers the promise of creating drugs that by the specificity of their design and delivery make them both more effective and less toxic. Multifunctional devices offer novel capabilities, including the possibility of delivering a detection, imaging agent, and drug in one vehicle. This creates the unique advantage of being able to give distribution data and traceability through the use of one agent, that can in tandem detect, address, and monitor disease. This functionality can be leveraged to deliver multiple combinations of drugs by extended release. Nanotechnology promises to create a break-through class of imaging agents that offer distinct advantages and can be used for the early detection and diagnosis of disease. Diagnostic molecules have the potential to act as biomarkers in drug development and diagnostics, and can be used in the imaging of cancer in living subjects. 

natural products chemistry:  Nature remains one of the most valuable sources of information, yet the biggest challenge to drug discovery is the multi-disciplinary journey. Topics may include • Natural Product inspired compound design & synthesis, • Improved growth options for natural sources that are otherwise in short supply, • Productive and promising resources, • Use of natural products in quality control throughout the process, • Manipulation of various pathways to produce better yields, • Specialized natural products libraries, • Rapid isolation of genes for natural product biosynthesis, • Productive identification of individual natural products components, • Improved high- throughput purification of natural products from crude mixtures, • Generating structurally diverse natural product analogs by genetic manipulation, • Novel screening methods for natural products, • The systems biology to better utilize natural products 

nucleic acid based technologies: Demand for genomic and gene expression analysis continues. However, nucleic acid isolation and purification is one of the most technically challenging and labor-intensive procedures performed in any laboratory, whether for biodefense, drug discovery, or diagnostics. Whatever technology is selected, success depends on a balanced combination of good experimental design, sample preparation, primer/probe design, amplification, detection, and analysis, as well as the selection of equipment and reagents.     See also PCR polymerase chain reaction glossary

pathway & disease modeling: Coverage includes expression profiling data analysis, biomarker identification from expression data, modeling signaling pathways, modeling pathway modulation by drugs, understanding cancer mechanism from expression data, and cancer disease modeling. Beyond Genome: Systems Biology Pathway & Disease Modeling, June 2006, San Francisco CA

pathway analysis, RNAi for:  This "end-users" meeting tackles the challenges of integrating RNAi technology into your functional genomics and target validation studies.  

pathways: The term biochemical pathways has principally referred to metabolic pathways, which are the pathways by which a cell converts compounds that enter it into cellular components (e.g., small molecules and macromolecules including proteins, nucleic acids, storage carbohydrates, and fatty acids) and by which the cell derives energy. Signaling pathways are biochemical pathways that regulate cellular characteristics and processes such as physiology, proliferation, changes in shape and motility, differentiation, adhesion, and intercellular interactions. High- content screening approaches can be used to help elucidate pathways. 

PCR Polymerase Chain Reaction: A laboratory technique to rapidly amplify pre- determined regions of double- stranded DNA. Generally involves the use of a heat stranded DNA polymerase. IUPAC Bioinorganic

While PCR is the backbone of molecular biological research, it has not achieved the same throughput as more recent technologies such as microarrays and parallel whole genome sequencing. Whatever technology is selected, success depends on a balanced combination of good experimental design, sample preparation, probe design, amplification, detection, and analysis as well as selection of equipment and reagents. 

PEGS: Protein Engineering Summit, a weeklong series of meetings dedicated to protein research. The event covers diverse topics ranging from the use of phage display to design proteins and peptides with desired properties, to offering effective solutions for producing proteins that are difficult to express. It also highlights the design, development and optimization of recombinant and conventional monoclonal antibodies for research tools and therapeutics.   See also difficult to express proteins, monoclonal antibodies, phage display, protein engineering, protein therapeutics delivery, recombinant antibodies  

personalized medicine: Session topics include Biomarkers to assess clinical activity of compounds, Genome wide association studies, novel markers for cancer, targeted cancer therapies, and monitoring disease progression and response to therapy. 
See also pharmacogenomics glossary

phage display: Selection systems of biologically- active molecules are essential to pipeline of novel protein therapeutics which can be directed against targets that are intractable to small molecules. Phage display and related techniques such as mRNA, bacteria, yeast, antibody, ribosome display offer the ability to generate and select ligands against biologic mechanisms, and engineer drug- like properties into candidates that show high affinity and specificity. Novel scaffolds will be considered for many reasons, including the ease of synthesis and the ability to address new drug targets. This meeting will focus on the technologies used to optimize protein and peptide entities against targets, and the refinement of these methods for clinical application against cancer, AIDS, autoimmune, infection, and other diseases. Topics may include, but are not limited to: Recombination- Based Cloning, Antibody Alternatives, Novel Scaffolds for Designing Biologically Active Molecules, Optimization of Ligands, Protein Medicinal Chemistry - Addressing Immunogenicity, Stability and Half- Life, Synthetic Amino Acids and Peptides, Mapping Functional Sites on Target Proteins, Improved Methods of Screening Epitope Libraries, Bridging Technologies With Applications, Production of Humanized, Complex Therapeutic Proteins 

Pharmaceutical Strategies Series

plasma proteome: The plasma proteome is both the most useful and the most difficult version of the human proteome. It is certainly the most sampled proteome; proteins in plasma were studied even before we knew genes existed. However, this abundance can be viewed as a two- edged sword. The most abundant source of proteins in the human body, plasma is also one of the easiest to collect, leading to its broad use in proteomics and the identification of hundreds of biological markers. Yet, newly discovered markers are obscured by the presence of these ubiquitous proteins - the ten most abundant proteins in plasma account for about 90% of the total proteome. 

pharmacogenomics: Comprises the study of variations in targets or target pathways, variation in metabolizing enzymes (pharmacogenetics) or, in the case of infectious organisms, genetic variations in the pathogen. CHI Drug Discovery Map http://www.healthtech.com/drugdiscoverymap.asp    

portfolio management: Key issues to be addressed include: New Approaches to Prioritizing and Rank-Ordering Portfolio Projects, Achieving More Effective and Real-Time Portfolio Management and Resource Allocation, Effectively Measuring and Managing a Diversified Portfolio, Using Decision Analysis Methods to Efficiently Evaluate the Risk vs. the Value of Portfolio Projects, Optimizing Resource Allocation to Efficiently Drive the Most Promising Projects.  

post-approval drug safety: Improving products’ effective clinical safety will increase the industry’s fundamental value proposition to patients, healthcare providers, payors and regulators. Pharmacovigilance program implementation and specific strategies and approaches to creating true value from a post- approval drug safety program will be the focus, tackling many of the pressing issues that executives are facing today. Topics include: Implementing programs that yield the greatest possible ROI in terms of both increasing the probability of timely approval and mitigating safety risks, Aligning resources to design and execute a proactive risk management plan, Integrating drug safety knowledge longitudinally across a compound’s lifecycle, Optimizing the allocation of an organization’s scarce and increasingly costly drug safety assessment resources, Understanding regulatory authorities’ evolving drug safety risk management expectations and how they should be applied in practice, Differentiating the value and rigor of assessment methods and tools — including Phase IV trials, observational studies, patient and drug registries, and database mining,  Utilizing quantitative approaches for surveillance and signal detection in pharmacovigilance, Driving your business for the best benefit-risk ratio. An intensive pre- conference tutorial on strategies for meeting the regulatory agency’s expectations and avoiding approval delays or narrowed labeling will be offered. 

preclinical drug development: The ability to accurately predict safety earlier the drug development process depends largely on the model that is chosen. Animal models of disease and knowledge of specific pathways provide a means of evaluating and progressing drug candidates. The pressure to accelerate drug discovery and development has increased, driven by technology advancement and strong competitive forces. Numerous opportunities exist to implement innovative paradigms to optimize candidate progression from discovery to early clinical evaluation. Successful development of new translational biomarkers will enable the progression of candidates from preclinical to clinical, and provide a means of predicting success in humans. 

project management: Covers Communicating Project Management Value within a Global Organization , Project Templates that Facilitate Portfolio Analysis, Research Program Planning: How Research Innovation Coordinates with Project, Portfolio and Resource Management, Implementation of a Global Cross-Functional Project and Resource Planning Tool, Cutting Product Development Time, and Reallocating a Successful Project Team. 

protein arrays: Protein arrays are poised to become a central proteomics technology. Important academically for both basic research as well as commercially for biotechnical, clinical, and pharmaceutical enterprises these different research, diagnostic, and therapeutic applications also drive the demand for more than one protein array technology. The objective behind any protein array development is to achieve efficient and sensitive high- throughput protein analysis, carrying out large numbers of determinations in parallel by automated means. Protein arrays make possible the parallel multiplex screening of thousands of interactions, encompassing protein- antibody, protein- protein, protein- ligand and protein- drug, enzyme- substrate screening and multianalyte diagnostic assays. 

protein biomarkers: The Protein Biomarkers 2006 meeting will review the strategies and case studies of deriving value from biomarker research, including developing new diagnostic products, accelerating clinical trials, and enhancing the drug safety profiles by assessing the toxicity and efficacy earlier. The meeting will also address the biomarker lifecycle, starting from discovery and validation, through assay development and clinical implementation. Finally, it will review the latest proteomics technologies for biomarker discovery and diagnostic assay development. 

See also biomarkers. Biomarkers can be protein or proteomic, but need not be. 

protein drug delivery: See protein therapeutics delivery

protein expression: As the amounts of proteins required for appropriate characterization and testing increase due to the demands of the drug discovery/development pipeline, the responsibility for providing these larger quantities of purified, stable proteins falls upon the protein expression scientist. In order to improve the yield and purity of these proteins for both therapeutics and diagnostics, researchers must turn to the newest technologies and methods. 

protein folding disorders: Alzheimers, Parkinson's Disease, one of the inherited forms of emphysema, CJD, Cystic Fibrosis, Type 2 Diabetes, and even some cancers are all related to the abnormal folding of proteins within the body. These devastating diseases cause untold misery, extracting both monetary and human tolls. This highly focused conference will discuss strategies for elucidating protein misfolding mechanisms, methods for improved study of these events and applications to the development of effective drug discovery and development for the treatment of these disorders.

protein kinases: Protein kinases play a critical role in signaling pathways that control fundamental cellular processes. To date, more than 500 human protein kinase genes have been identified. These offer a multitude of potential kinase targets and an exciting opportunity for the pharmaceutical industry, especially in the area of cancer, immune diseases and diabetes. New developments in inhibiting the catalytic function of kinases, as well as promising technologies in the proteomic field, expand the possibilities of kinases for drug development. Enabling rational drug design, furthering target identification, developing selective inhibitors of various kinase targets, utilization of kinase structures and inhibitors to enable increasingly selective drug targeting and providing new insights into conformational variability between kinases 

protein process development: The science of protein expression has utilized high-throughput methodologies to provide small quantities of many proteins for characterization and analysis. Once specific proteins are selected for development there are numerous issues to be addressed related to production scale-up and optimization. Some of the tools used for protein expression have been slow to filter downstream to the process development/scale-up portion of the pipeline. If drug development groups are to continue to supply the amounts of protein necessary for animal and human trials, these issues need to be resolved. 

protein therapeutics: As a major class of therapeutics, protein therapeutics poses great challenges in its development, production, delivery, safety, and stability. This conference will address issues facing the current generation of protein therapeutics, including vaccines, antibodies, recombinant proteins, and other varieties of protein therapeutics. Topics will include: better discovery and development strategies, overcoming production challenges, product stability, quality control and safety, and case studies of successful therapeutics. PepTalk Current Challenges in Protein Therapeutics, Jan. 11-12, 2006, San Diego CA Future success rates of new bio- therapeutic products depends on:novel molecular engineering, intellectual property protection, and efficient manufacturing.  Protein engineering can be defined as the use of genetic and chemical techniques to change the structure and function of a protein, thus producing a novel product with specific, desired, properties. Why go through the effort? The worldwide demand for innovative protein therapeutics is growing 30 % each year. 

protein therapeutics delivery: New therapeutic approaches are needed to target the biologic mechanisms that give rise to a variety of diseases. Increasing the success rate of novel therapeutic entities involves employing drug delivery solutions earlier in discovery. The pharmaceutical industry can employ novel delivery techniques to extend patent lives and meet the growing demand for hard- to- deliver drugs. Engineering protein therapeutics with delivery in mind will mean that more drugs will enter the pipeline and move from bench to clinic. This meeting will delve into topics related to the routes of delivery which affect the activity of protein therapeutics in terms of uptake and distribution within the body, and present a more effective approach to engineering protein therapeutics. Topics may include, but are not limited to: • Novel Delivery Systems, • Safety, • Efficacy, • Routes of Delivery, • Pharmacokinetics, • Immunogenicity, • Advanced PEGylation Techniques, • Stability, • Post -Translational Modifications, • Novel Constructs and Conjugates, • Fusion Proteins, • Protein Optimization, • Case Studies of Biotherapeutics in the Clinic, • Regulatory Considerations and Guidance 

proteomics: Sessions include Array Technologies for Protein Biomarker Applications, Mass Spectrometry for Protein Biomarker Discovery, MS Data Analysis for Biomarker Identification, Integrating Genomic and Proteomic Data for Biomarker Discovery, Proteomics for Target Validation, Proteome Profiling Approaches to Study Signaling Pathways, 

Industrial scale analysis of many proteins and their interactions, over time, ultimately tying this into physiological processes and biological pathways and networks.    

quantitative PCR:  Gene expression profiling continues as the predominant tool to identify markers associated with disease or therapy targets. Gene expression data is prone to variance from experiment to experiment, lab to lab, platform to platform. Gene expression data must be validated with independent quantitative analysis tools. Biological research is costly – both in time and resources - making the careful design and validation of gene expression experiments to generate useful data for diagnostics, target identification, screening, and genotyping applications critical. All researchers are still confronted with difficult questions after completing any expression profiling experiment - how to validate and standardize the data that has been generated. 

R & D strategy: Ensure long- term viability, Protect yourself from a failed collaboration, Improve R&D performance, realize the promise of personalized medicine.

recombinant antibodies: The pipeline of therapeutic antibodies has been growing steadily, building on successful clinical trials, particularly in cancer. This growth will certainly accelerate, as genomic companies with many novel targets seek to employ antibodies to modulate these targets. In addition, studies employing antibodies, or antibody mimics, are being ramped up as part of the explosive growth of proteomics. All of these trends place a tremendous emphasis on the development of new approaches for faster antibody development, improved methods of selection and optimization, alternatives for production, and evaluation for novel applications. Topics may include, but are not limited to: • Improving selection of antibody targets, • Antibody modification to improve safety and efficacy, • Case studies of clinical development, • Novel therapeutic applications, • Clinical trial status of antibodies • Synthetic antibody libraries, • Novel display systems and arrays, • Advances in antibody production, including transgenics, • Engineering and optimization, • Development of intracellular antibodies, • Protein function and localization studies

regulomics: The regulation of specific molecular interactions that determine gene expression. This conference will explore genetic regulation of pathways related to disease processes. Of significant interest are: analysis of gene expression profiles and data- and knowledge-driven analysis to unveil biological mechanisms; identifying “key mediators” that govern complex biological processes.  

repositioning, repurposing: See drug repositioning

RNA quality: 

RNAi RNA interference: RNAi gene silencing phenomenon whereby specific dsRNAs ( RNA, DOUBLE- STRANDED) trigger the degradation of homologous mRNA ( RNA, MESSENGER). The specific dsRNAs are processed into SMALL INTERFERING RNA (siRNA) which serves as a guide for cleavage of the homologous mRNA in the RNA- INDUCED SILENCING COMPLEX (RISC). DNA METHYLATION may also be triggered during this process. MeSH 2003

Special coverage of high-throughput library screening using either chemically synthesized or expressed RNAi reagents, a look at the automation required, and an in-depth discussion around cell line and primary cell transfection will be key features of this years event. Time will be dedicated to an analysis of how to interpret the data generated from RNAi experiments and the latest advances in RNAi in vivo experiments will be featured extensively   Topics include RNAi screening for target discovery & validation, RNAi screening of kinases, RNAi in animal models, and RNAi therapeutics   RNAi for target validation, Genome Wide siRNA for High Content Screening, Technology Showcase, Cellular Assays for Pathway analysis, Standards for High Content Cellular Assays ThinkTank RoundTable Discussions   

RNA glossary

sample preparation:  Biobanking of tissues, standardization in proteomics, the quality of RNA all these issues need to be addressed, to ensure the production of reliable and high quality data. Can RNA quality be predicted? How does the quality of the RNA change the outcome of the expression profiles? What are the newest developments in gene expression profiling when applied to microarray technologies? How can reproducibility be improved? Can there be a consensus on “standardization"?   

small molecule backup strategies: The emphasis being placed on early recognition of “proof of principal” or “fail fast” strategies means that it becomes even more important than before that companies put in place optimal strategies for small molecule back-up compounds. How much effort should be invested in evaluation and optimization of back-ups that are not lead compounds, and what factors need to be considered for the timing of such investments? To what extent does the competitive situation, the strategic fit of the project, the level of validation of the target or the compound class, affect the choice between a more aggressive or less aggressive back-up strategy? And what strategies are being employed for back-ups that have been parked where the lead goes on to be successful? Do these assets remain unutilized or is there an effort to monetize them via out-licensing? What factors prevent more effort along these lines? Does every company developing small molecule therapeutics face these questions for every project under development? Are there ways beyond just standard policy (the same answer for every case) or gut feel (a different answer for every project) to address these issues? 

stem cells The initial excitement generated by identification of novel stem cell populations must give way to more focused efforts on methods to manipulate their differentiation and self-renewal capabilities. While we know a great deal of what stem cells can do, we don’t understand the molecular processes that afford them such unique attributes. 

The potential of stem cells has captured the attention of the public and the politicians. However, as with all new basic scientific and technical knowledge, careful and rigorous examination of the SCIENCE of stem cell biology is required before unwise applications of stem cell therapy is used. 

strategic resource management: Key issues to be addressed include: Aligning Portfolio & Productivity with Corporate Strategy to Drive Strategic Resource Allocation, Designing Strategic Resource Management Systems Specifically for Pharma R&D, Applying Weights to Quantitative and Qualitative Criteria for Improved Decision-Making, Managing and Integrating Outsourced Resources into Planning and Execution, Creating a Process to Successfully Transfer FTEs Among Projects, Building Partnerships Between Project Management, Resource Management, Functional Management, and Finance. 

structure based drug design: Advances in Structure- Based Drug Design continue to enhance the efficiency and overall success rate in the process of discovering novel therapeutic agents. With the integration of virtual screening, advances in x-ray crystallography, design strategies, ligand-based, and other promising emerging technologies, structure-based drug design will continue to yield a number of potential leads, creating an enormous opportunity for the future of novel therapeutics to treat disease. 

systems biology: Systems biology is the study of an organism, viewed as an integrated and interacting network of genes, proteins and biochemical reactions which give rise to life. Instead of analyzing individual components or aspects of the organism, such as sugar metabolism or a cell nucleus, systems biologists focus on all the components and the interactions among them, all as part of one system. These interactions are ultimately responsible for an organism´s form and functions. Systems Biology, the 21st century science, Institute for Systems Biology, Seattle, 2005 http://www.systemsbiology.org/Intro_to_ISB_and_Systems_Biology/Systems_Biology_--_the_21st_Century_Science

target validation: Sessions Include: RNAi Screening for Target Discovery/ Validation, RNAi Screening of Kinases, RNAi in Animal Models, Modeling Pathway Modulation by Drugs, Proteomics for Target Validation, and Genome-Wide Association Studies.  

targeted therapeutics: Key issues to be addressed include this year include The paradigm shift in the pharmaceutical model – Internal impact on R&D strategies, Competing/ profiting with the new strategic model , The role of diagnostic companies in the new model, The impact on CRO’s and clinical trials, Impact for marketing – new strategies and thought processes, and How payors and providers factor-in to the equation – evaluating the economics of companion diagnostics  

text mining: Competition in the pharmaceutical industry has increasingly become based upon better recognition and analysis of information, much of which is available as published text. The days of specialists being able to read all of the relevant literature coming out is long past, particularly as more system biology approaches are used. New text-mining tools are providing advantages for faster recognition and correlation of pieces of information useful for creating a new hypothesis or asking new questions. 

tissue microarrays: Tissue microarrays (TMAs) have rapidly become an essential tool to increase throughput for validation. Utilization of TMAs different detection methods, including in situ hybridization and immunohistochemistry,can now be used in a high-throughput manner to confirm the results of gene expression microarrays and proteomic discovery platforms. Additionally, TMAs built from archival pathology material have become a powerful tool in reducing new biomarkers from the research bench to clinical utility. TMAs have also become the platform to survey the expression profile of human tissues and tumors in a statistically relevant fashion. Research combining TMAs with new interpretative tools and analysis result not only in more samples being evaluated, but being evaluated in greater detail. 

tissue models:  Cells, tissues, and organs function in a 3-D environment. Utilization of 3-D in vitro tissue models can help validate functionally new targets and pre- selected hits more efficiently then immediate in vivo testing.  

tissue technologies:  The goal of reducing failure rates in discovery research is optimally achieved when using human tissues. However, clinically relevant genomic and proteomic test development using human tissue requires a specialized collection, handling, and banking methods to generate reliable analyses. Protocols for proper tissue procurement, specimen handling, and cryopreservation, as well as non-destructive collection of pure cell populations  

translational medicine: Key issues to be addressed include: • clinical models to bridge discovery and development, • leveraging discovery tools to save projects in early clinical development, • determining which technologies to use and where they make the largest impact, • developing new assays and identifying novel biomarkers through discovery and preclinical collaboration, • managing and allocating a finite amount of resources.  

translational research: Sessions include translation from animal to human, targeted therapies, monitoring disease progression and response to therapy, biomarkers to assess clinical activity of compounds, and genome wide association studies: 

TSE Transmissible Spongiform Encephalopathies: We bring together for the first time all of the laboratories developing diagnostic blood tests for a head-to-head comparison of their methodologies and achievements. Other important topics include an expanded discussion about protein misfolding, reviews of BSE, vCJD, and CWD, updated tissue infectivity data, new methods of decontamination in hospitals and industry, filter technology for removing infectivity from blood, strategies being explored for therapeutic intervention, and a concluding panel on issues of FDA and USDA regulation.   

vaccines - novel: The topic of vaccines has entered the forefront of the public’s thoughts and emotions as new diseases threaten the global population. Nevertheless, the potential for shortfalls looms large as vaccine developers and producers wrestle with scarcity of funds and regulatory hurdles. Large numbers of vaccines are needed, yet burdensome production methods require facilities that do not exist. Innovations are required to bring vaccines into a new age of design, production, and delivery. Developing novel vaccines involves myriad challenges as manufacturers hustle to meet growing demands in preparation for a potential H5N1 pandemic and defeat the scourge of raging diseases such as HIV. The traditional method for growing vaccine in chicken eggs is undergoing renovation, and the promises of new technologies offer increased opportunities to provide ample and effective vaccines for the future. 

IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry.

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