BioIT World   Sharing information and discussing enabling technologies that are driving biomedical research and the drug development process.

Biomarker World Congress  Includes:  Clinical applications of biomarkers, Personalized medicine, Biomarkers in translational medicine, Drug-diagnostic co-development, Biomarker assay development and validation, Clinical validation of biomarkers, Novel clinical trial designs to include biomarkers, Cancer biomarkers, Biomarkers for safety assessment and clinical pharmacology, Biomarkers for patient selection and monitoring response to therapy, Biomarkers for go/no-go decisions, Biomarker consortia   

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 Summit

business  Pharmaceutical Strategy conferences

chemistry:  Chemistry conference series

Discovery on target   

Drug discovery & development Cambridge Healthtech Institute conference series

Good Manufacturing Practice:  http://www.fda.gov/cdrh/comp/gmp.html  
Q&A on cGMP Current GMP for Drugs http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124740.htm 
Wikipedia  http://en.wikipedia.org/wiki/Good_Manufacturing_Practice  Broader term: GxP

G-protein-coupled receptors: GPCRs: Though G protein-coupled receptors (GPCRs) represent the most common target of drugs on the market, many of those drugs were developed before we knew much about GPCRs. In the past decade scores of GPCRs have been discovered and now we even have crystal structures of a few of these hard-to-express membrane proteins. The new GPCR frontier has opened exciting possibilities for drug development along with a whole set of challenges.  GPCR Based Drug Discovery, Discovery on Target Nov 2010 Boston MA  

GxP:  a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries.   http://en.wikipedia.org/wiki/GxP accessed  Jan 11, 2011  Narrower terms: GCP, GLP, GMP

hepatotoxicity: Hepatotoxicity is the number one cause for drug recalls and new drug refusals based on adverse drug reactions. According to FDA and industry sources hepatotoxicity accounts for ~27% of the drugs withdrawn from the market since 1960 and is responsible for greater than 40% of the clinical phase drug candidate terminations.  
New Assays and Tools for Predicting Hepatotoxicity 06 June 8-9, 2011 • Philadelphia, PA Program | Register | Download Brochure   

High-Content Analysis January 11-14, 2011 • San Francisco, CA Program | Register | Download Brochure  INCLUDES: HCA for Drug Screening and Toxicology, HCA for Pathway Analysis, Image Analysis and Data Management, Novel Probes and Biosensors, Novel Biological Models for HCA, Live-Cell Imaging, Neuronal Screening, Flow Cytometry  

idiosyncratic toxicity: The primary role of Phase IV post marketing surveillance is to detect rare or idiosyncratic adverse events that do not manifest in the population sizes common to clinical trials ... While clinical forecasting is aimed at predicting safety and efficacy early in the drug development process, rare or idiosyncratic toxicities can only be detected in Phase IV.  There, Phase IV serves as a very important safety net, to catch problems that could not be predicted.  Insight Pharma Reports, Bayesian Forecasting of Phase III Outcomes: The Next Wave in Predictive Tools, June 2007   

Few drug development surprises can be as devastating as toxicity problems that only show up under a combination of conditions as idiosyncratic toxicity. Because of the role of variations in human drug metabolizing enzymes there may only be subtle (or no) evidence of such problems during pre-clinical safety studies. Such problems are also unlikely to show up in all but the largest clinical trials, but if the side effects are serious, it can result in product withdrawal.   

informatics:  Glossaries & Taxonomies   Bioinformatics,   Cheminformatics,  Clinical & Medical informatics   Drug discovery informatics   IT Infrastructure  

ion channels:   Ion Channels are now established as an important target group for developing pharmaceutical therapeutics. To successfully move forward in this area, many challenges had to be overcome and several strategies are now in place to validate new targets and to improve and generate new leads. New techniques such as high-throughput screening, new patch-clamp methods, new imaging and updated cell based assays are providing information on new structural leads, on selectivity and on mechanism of action, as well as on emerging new therapeutic areas.  Ion channels as therapeutic targets, Discovery on Target Nov 2010 Boston MA   

label free: Label-free detection of biomolecules is currently receiving intense attention due to the clear advantages it offers over fluorescent methods. These researchers are pursuing a label-free protein detection method based upon field-effect detection-a technique that has been used for DNA, but not yet for proteins. If they are successful, they will develop arrays of sensors for the purpose of high-throughput parallel detection, and examine the generality of their findings for various diverse proteins. Label Free Electrical Detection of Proteins, Deshpande Center for Technological Innovation, MIT http://web.mit.edu/deshpandecenter/proj_manalis.html 

mammalian cell lines: Gene expression in mammalian cells is the foundation for protein production.  As more protein-based products head into development, the need to refine processes for optimizing cell line development increases.  Reducing the time needed to identify high-expressing clones and develop cell lines is essential for trimming a project’s overall costs. http://www.bioprocessingsummit.com/bpd/mex/ 

medicinal chemistry: Medicinal chemistry strategy technology and innovation, hot topics in medicinal chemistry: fragment based discovery and biophysical techniques, Targets in hot pursuit: protein protein and allosteric modulators, pain and anemia, oncology   Mastering Medicinal Chemistry February 23-25, 2011 • San Francisco, CA Program | Register | Download Brochure  .  

A chemistry based discipline, also involving aspects of biological, medical and pharmaceutical sciences. It is concerned with the invention, discovery, design, identification and preparation of biologically active compounds, the study of their metabolism, the interpretation of their mode of action at the molecular level and the construction of structure- activity relationships IUPAC Medicinal Chemistry

micro-RNA miRNA: Coverage includes: microRNA in Biomarker and Diagnostic Development, microRNA in Therapeutic Development, microRNA in Human Development and Disease , microRNA and Cancer Mechanism, microRNA and Cancer Stem Cells microRNA in Human Disease & Development March 28-30, 2011 • Cambridge, MA Program | Register | Download Brochure | 

With the first diagnostics set to debut within a year, the new research and development field of microRNAs is beginning to reveal its potential. This new report establishes a baseline for observing microRNAs’ maturation, including assessments of: The science and analysis of first-generation microRNA commercial applications, The early adaptors and where they are heading with this emerging technology, Clinical applications, which will begin in oncology, followed by infectious diseases, neurology, metabolic disorders, and cardiovascular diseases, The youthfulness of the field of microRNA and more.  Insight Pharma Reports, microRNAs: Commercial Products on the horizon, 2008

molecular diagnostics: Translating next generation sequencing into the clinical lab, reimbursement, new analytes in unconventional places, regulation of molecular diagnostics, highly multiplexed carrier screening tests, multiplexed clinical assays Molecular Diagnostics February 23-25, 2011 • San Francisco, CA Program | Register | Download Brochure 

Molecular diagnostic applications in the areas of oncology, personalized medicine, inherited disorders, prediction of genetic disease risk, and many others are rapidly increasing in number as this burgeoning field expands beyond infectious disease testing. ... The molecular diagnostics market is exploding. New genes and biomarkers are continually being identified and clinically validated, increasing the number of different tests available. The requisite technology and instruments are advancing in tandem. While many companies offer tests that detect only one or a few genetic changes, some companies have now developed tests capable of detecting large numbers of these changes. Many companies are taking their tests through the traditional diagnostics market strategy of gaining FDA clearance, while others have chosen a different strategy and are offering tests through their own CLIA-certified laboratories. Insight Pharma Reports, Molecular Diagnostics: A dynamic and rapidly broadening market, 2009 

Molecular diagnostics & biomarkers  conference series  

molecular imaging: An essential tool in drug discovery and development, translational approaches in in vivo molecular imaging research, utilization in therapeutic areas  Vivo Molecular Imaging June 8-9, 2011 • Philadelphia, PA Program | Register | Download Brochure

The rapidly emerging field of molecular imaging is poised to open new vistas for basic researchers, scientists working in drug discovery and development, and physicians. Little more than 5 years old, the postgenomic field of molecular imaging is undergoing rapid research and commercial development, driven largely by big pharma’s burgeoning interest in biomarkers as crucial for decision support in preclinical and early clinical development. Insight Pharma Reports, Molecular Imaging in Drug R&D and Medical Practice: Techno9logies, Applications, Markets,  http://www.insightpharmareports.com/reports/2008/92_Molecular_Imaging/overview.asp  2008

monoclonal antibodies MAbs:  In the nearly 35 years since the first process for creating mAbs was introduced, they have remained a centerpiece of the growing biotechnology industry.  Thirty therapeutic mAbs have been approved around the world, including 23 in the United States.  A number of these drugs have attained blockbuster status, with sales reaching the coveted billion-dollar mark and well beyond.  Rituxan, Remicade, Avastin, Herceptin, and Humira alone generated sales of over $4 billion each in 2008, and global sales for this entire sector surpassed $30 billion last year. The biotech industry devoted years to reducing the immunogenicity of mAbs, developing the technologies—detailed in this report—to progress from chimeric, to humanized, to fully human antibodies. These succeeding generations of mAbs have demonstrated incremental improvements in safety and activity, and the industry is currently in the middle of a major shift toward humanized and human products. Insight Pharma Reports, Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment 2009

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

multiplex assays:  Multiplex assays for simultaneously detecting several biomarkers in a single sample, traditionally used in discovery proteomics, are becoming popular in clinical diagnostics research. The range of clinical applications for these assays is broad and includes autoimmune disease, infectious disease, oncology, cardiology, and endocrinology testing, as well as metabolomics and toxicology screening. The anticipated advantage of multiplex assays in clinical diagnostics is the fact that a panel of several biomarkers has better diagnostic value than a single analyte. However, some substantial obstacles are in the way of clinical utility of identified sets of biomarkers. In its inaugural year, this conference will present solutions and case studies for an array of topics related to clinical laboratory implementation of non-genomic multiplex assays such as regulatory challenges, commercialization issues, and technological barriers and advances. A comprehensive account of the clinical proteomics and metabolomics technologies will be introduced throughout the conference including bead-based immunoassay platforms, mass spectrometry-based multiplexed protein assay platforms, custom microplates, nanotechnology solutions, etc. Special emphasis will be placed on the regulatory issues related to the approval process of multiplex platforms and assays. Translating Proteomics & Metabolomics into the Clinical Laboratory  August 23-24, 2011 Washington DC  

The increased emphasis on personalized therapy has affected the entire process of drug discovery, development and marketing. Pharmaceutical companies must adjust their strategies, starting from target identification to validation, clinical trials, approval processes, and marketing in order to fit into the new concept. Successful collaboration with diagnostics partners has become a cornerstone in the efforts to bring to the market tailored and targeted therapies, with companion tests helping to match the right drug to the right patient. The process of acceptance of the personalized medicine concept is being fueled by strong FDA endorsement, as well as an increasing demand from insurance companies for evidence of efficacy to support reimbursement decisions. 
Personalized Medicine  September 7-8, 2011 • Philadelphia, PA Program | Register | Download Brochure

phage display: Phage and Yeast Display of Antibodies and Proteins  May 9-10, 2011 • Boston, MA  Program | Register | Download Brochure


Use of genetically engineered phage to present peptides as segments of their native surface proteins. Peptide libraries may be produced by populations of phage with different gene sequences. IUPAC Combinatorial Chemistry  Broader term: display technologies 

Pharmaceutical Strategies conference series

pharmacogenomics:  Despite their slightly different definitions, as with other "-genetics" and "-genomics" terms, pharmacogenomics (PGt) and pharmacogenomics (PGx) are often used interchangeably.  This is not surprising since both terms refer to the study or use of genetic variation in drug responses. PGx is also often used as the more all-encompassing, or default, term when referring to the general study or use of genetic variation in drug response. ... There really isn't clear consensus (yet) on the best definitions for each term. Insight Pharma Reports, Pharmacogenomics: Delivering on the promise, 2009 

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: Effectively determining, measuring and managing a diversified portfolio, New approaches to prioritizing and rank-ordering portfolio projects, Achieving more effective and real-time portfolio management and resource allocation, Use of Multi-Objective Analysis in portfolio management of early stage projects, Balancing internal R&D investments and resources with external collaborations, Understanding the impact of partnerships and co-development deals on resource and portfolio management, Overcoming organizational challenges to maximizing value and balancing risks, Tested methods to improve pharma’s agility and flexibility in order to attain higher levels of innovation and speed, How can you learn from the gaps/differences between your projected portfolio and the reality/outcomes, Creating a governance body and corporate structure to enable agile decision making, How can pharma translate lessons learned from other industries? Training project teams to provide appropriate information (strategic alternatives, risk, assumptions, etc.) for executives to evaluate in decision making Portfolio Management November 9-10, 2011 • Philadelphia, PA   

post-approval drug safety: How leading companies are defining and implementing a formal framework of corporate risk management    ATTAIN strategies to place risk management more in connection with benefits  EXAMINE the use of quantitative and qualitative methods to better balance benefit-risk  MASTER global regulatory authorities’ evolving expectations  UNDERSTAND how to improve clinical trial safety and surveillance 
Post-Approval Drug Safety Strategies  November 8-9, 2010 • Philadelphia, PA Program | Register | Download Brochure

 

protein engineering: A technique used to produce proteins with altered or novel amino acid sequences. The methods used are: 1. Transcription and translation systems from synthesized lengths of DNA or RNA with novel sequences. 2. Chemical modification of  'normal' proteins. 3. Solid-  state polypeptide synthesis to form proteins.  IUPAC Compendium

Procedures by which protein structure and function are changed or created in vitro by altering existing or synthesizing new structural genes that direct the synthesis of proteins with sought-after properties. Such procedures may include the design of MOLECULAR MODELS of proteins using COMPUTER GRAPHICS or other molecular modeling techniques; site-specific mutagenesis (MUTAGENESIS, SITE-SPECIFIC) of existing genes; and DIRECTED MOLECULAR EVOLUTION techniques to create new genes. MeSH 2003

PEGS: the essential protein engineering summit  May 9-13, 2011 • Boston, MA  Program | Register | Download Brochure  

protein expression: Despite decades of research and advances, some areas of protein science remain extremely challenging and complex.  Antibodies, vaccines, human proteins, and other difficult-to-express proteins have fueled new research and expression methodologies and technologies.  High throughput purification and tags promise great rewards, but still pose important questions for researchers.  Cell free expression methods hold great potential, but pose new challenges. 
Overcoming Protein Expression Challenges with Solutions January 13-14, 2011 • Coronado, CA Program | Register | Download Brochure 

protein therapeutics:  Recombinant Protein Therapeutics  January 10-11, 2011 • Coronado, CA Program | Register | Download Brochure 
This meeting addresses the innovative strategies and supporting technologies that spur progress, including engineering the Fc regions.  Persistent challenges will be discussed, along with case studies of recombinant protein therapeutic products.  
Part of PEP Talk January 10-14, 2011 • Coronado, CA Program | Register | Download Brochure 

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

RNAi RNA interference: RNA Interference  February 3-5, 2010 • San Francisco, CA Program | Register |    

stem cells: The new generation of stem cell research offers viable insights and resources of replacement cells to treat and reverse diseases, leading to regenerative medicine and ultimately personalized therapies. The primary objectives of Cambridge Healthtech Institute’s Stem Cells are the basics of regenerative medicine, including stem cell sources (embryonic, adult, cord blood or iPS) and technologies to harness their potential, pathways to deliver the new therapies, and translation of basic stem cell research into clinical applications. Stem Cells  February 23-25, 2011 • San Francisco, CA Program | Register | Download Brochure

   
Commercialization of stem cells can potentially help to treat an astounding variety of medical conditions. After a slow start, the stem cell age is finally poised to begin, as numerous factors converge to catapult stem cell technology into the medical mainstream. This report considers: the current state of stem cell science and technology  Supplies and services, Major applications of stem cell science, Sources of funding, regulatory hurdles, and the commercial outlook, IP challenges, public perception, bioethical concerns, and diversity in policies. Stem cell science is on the precipice of becoming big business. These enigmatic cells lie at the heart of a fledgling technology with great clinical promise. Insight Pharma Reports, Stem cells come of age, 2008

strategic resource management:  Key issues to be addressed include: Aligning portfolio & productivity with corporate strategy to drive strategic resource allocation, Designing  and tailoring strategic and flexible resource management systems specifically for pharma R&D, Applying weights to quantitative and qualitative criteria for improved decision making, Incorporating a globalized workforce and other resourcing options (off-shoring, in-sourcing, in-out licensing and risk-sharing) into capacity management, Building partnerships between project management, resource management, functional management, and finance to drive productivity, Understanding the impact of partnerships and co-development deals on resource and portfolio management, Pursuing operational excellence: Competitive advantages, new operating models, a new lean industry, and learning from resource process development beyond just clinical, Implications for resource and portfolio management of different development paradigms: Research, early and late stage development, Supporting agile development and agile adaptation of data into planning: How to manage uncertainty, react to outcomes efficiently, and create an agile and efficient organization . Strategic Resource Management November 8-9, 2011 • Philadelphia, PA

structure based drug design: The latest development in computational technology for drug discovery, and puts structure-based molecular approaches into the perspective of targeted therapeutics. Highlights include Protein Flexibility, Complex Drug-Ligand Interactions Observed From Nanoseconds-Level Molecular Dynamic Simulation , Novel Modality Drug Targeting Combination of Chemical and Biologic Properties, Computational Fragment Mapping for Protein-Protein Interaction Target Identification , Computational Approaches to Finding and Optimizing GPCR Modulators .  Structure-Based Drug Design June 9-10, 2011 • Cambridge, MA Program | Register | Download Brochure

systems biology: This report focuses on the current and future applications of Systems Biology in drug discovery, specifically in pinpointing optimal individual targets, and combinations of targets, to overcome metabolic pathway redundancies, leading to efficacious and safe products. Insight Pharma Reports, Systems biology: A disruptive technology, 2008

The label “systems biology” is pretty awful, except, of course, for the many even worse labels that have been tried. More important is what SB seeks to do: transform biology and health care into a rigorous, predictive science offering a richer understanding of biology and a vastly improved approach to drug development and medicine. SB would build on the molecular biology revolution and elucidate the wiring diagrams (and their rules) buried in the data.   John Russell, BioIT World, Sept  2007 http://www.bio-itworld.com/issues/2007/sept/cover-story/ 

translational research: To improve human health, scientific discoveries must be translated into practical applications. Such discoveries typically begin at “the bench” with basic research  in which scientists study disease at a molecular or cellular level then progress to the clinical level, or the patient's “bedside.” Scientists are increasingly aware that this bench-to-bedside approach to translational research is really a two-way street. Basic scientists provide clinicians with new tools for use in patients and for assessment of their impact, and clinical researchers make novel observations about the nature and progression of disease that often stimulate basic investigations. Translational research has proven to be a powerful process that drives the clinical research engine. However, a stronger research infrastructure could strengthen and accelerate this critical part of the clinical research enterprise. NIH Common Fund, Translational Research Overview, 2011 http://commonfund.nih.gov/clinicalresearch/overview-translational.aspx 

translational science: translating preclinical and clinical knowledge  Translational Science February 23-25, 2011 • San Francisco, CA Program | Register | Download Brochure

vaccine development clinical: The Clinical Development of Therapeutic Vaccines conference will address the clinical challenges facing therapeutic vaccine developers, including patient selection, international outsourcing for trial completion, and navigating regulatory approval. The landmark approval of Provenge (sipuleucel-T) in 2010 brought therapeutic vaccines and immunotherapeutics into the media’s spotlight, yet therapeutic vaccines extend beyond cancer. Clinical development of these products includes the use of novel clinical trial designs, identification of patient populations as well as addressing regulatory concerns. http://www.healthtech.com/imt/clv 

vaccines - novel: Vaccine leaders from around the world will come together to discuss critical issues surrounding the development of effective – and affordable – vaccines … This meeting examines the most successful vaccines that respond to the most pernicious diseases threatening humankind. Novel Vaccines: Design & Development August 16-17, 2011 • Cambridge, MA Program | . 

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

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