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You are here > Biopharmaceutical Glossary homepage/Search Cambridge Healthtech Biopharmaceutical glossary ADAPT Accelerating
Development and Advancing Personalized therapies September 19-21, 2012 • Washington, DC Program | Register | Download Brochure BioIT World Sharing information and discussing enabling technologies that are driving biomedical research and the drug development process. Bio-IT
World Conference & Expo
April
24-26, 2012 • Boston, MA Program | Register | Download
Brochure
Biomarker
World Congress
May
21-23, 2012 • Philadelphia, PA Program | Register | Download
Brochure Bioprocessing conference series 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 cancer informatics: Cancer
Informatics April
25-26, 2012 • Boston, MA Program
| Register | Download
Brochure cancer molecular
markers: Emerging
Molecular Markers of Cancer
August 21-22, 2012 • Washington, DC Program | Register | Download
Brochure Clinical trials conference series Discovery
on Target October
1-3, 2012 • Boston, MA Program | Register | Download
Brochure
Drug & disease targets conference series Drug discovery & development conference series Drug
Discovery Chemistry
April
17-19, 2012 • San Diego, CA Program | Register | Download
Brochure
Drug
safety Conference series
Good Manufacturing Practice: http://www.fda.gov/cdrh/comp/gmp.html
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 High-Content
Analysis
HCA
:Applications,
technology and market aspects of high-content analysis (HCA)—a field that
originated when automated microscopic imaging technology joined with the
high-throughput screening paradigm that signified the birth of “industrialized
drug discovery.” High-Content Analysis Report
December 2011 Table of Contents | Tables and Figures 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. immunotherapeutics:
informatics:
Glossaries & Taxonomies Bioinformatics,
Cheminformatics,
Clinical
& Medical informatics Drug
discovery informatics IT
Infrastructure Live-Cell
Imaging
January
12-13, 2012 • San Francisco, CA Program | Register | Download
Brochure medicinal chemistry:
Mastering
Medicinal Chemistry
February
21-23, 2012 • 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: micro-RNA miRNA: Track 1: microRNA in Diagnostic
and Therapeutic Development, Track 2: microRNA Pathways in Disease and
Development microRNA
in Human Disease and Development
March
12-13, 2012 • 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 & biomarkers conference series molecular medicine: molecular imaging: 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 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: Assay technologies have been evolving since scientists first discovered they could measure glucose, insulin, and several hormones in the blood to help them diagnose disease. Early instruments such as the Ames Reflectance Meter, used for detecting glucose levels, have morphed into such sophisticated systems as flow cytometers. The Human Genome Project provided the basics for researchers to launch into the field of human genomics and they needed the tools to accomplish this. DNA microarrays allowed for massively parallel gene expression analyses. Scientists soon discovered that while the genomewide assays were extremely valuable, there were genes of interest that they had difficulty measuring when they got hundreds of data points from a microarray. Low- to mid-density assays have allowed scientists to pinpoint the genetic code for a variety of uses, from genetic heredity studies to drug metabolism and patient stratification. Insight Pharma Reports, Multiplex assays in Translational Medicine: Technologies, Applications, and Future Directions, 2008 next
generation diagnostics: Technological advances in next
generation diagnostics are driving growth and innovation in healthcare. Rapid
and precise diagnosis is essential for personalized medicine and will change the
way value is assessed and compensated in the healthcare system. Next
Generation Diagnostics Summit
August 21-23, 2012 • Washington, DC Program | Register | Download
Brochure PEGS:
the essential protein engineering summit April
30 - May 4, 2012 • Boston, MA Program | Register | Download
Brochure PepTalk
January 9-13, 2012 • Coronado, CA 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
Related terms: bacteriophage, biopanning, phage; Labels,
signaling & detection; Proteomics
directed protein evolution 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: Portfolio
Management
November 6-7, 2012 • Philadelphia, PA Program
| Register | Download
Brochure post-marketing surveillance: Managing
Post-marketing Studies (Phase IIIb-IV) and Registries February 7-8,
2012 • Miami, FL Program
| Register
| Download Brochure Topics
to be discussed include: Managing
post-marketing studies (Phase IIIb-IV): Understanding the key challenges with
registries, quality of life studies, and post-marketing study regulatory
commitments
… pricing: Comparative case studies of market launch, market access, and product pricing strategies for a variety of cancer drugs and companion diagnostics. Effective and sustainable commercialization strategies will be discussed. Pricing, Reimbursement and Market Access for Targeted Cancer Therapies November 6-7, 2012 • Philadelphia, PA Program | Register | Download Brochure protein engineering: PEGS: the essential protein engineering summit April 30 - May 4, 2012 • Boston, MA Program | Register | Download Brochure 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 proteomics: Industrial scale analysis of many proteins and their interactions, over time, ultimately tying this into physiological processes and biological pathways and networks. reimbursement: Evidence
required for post-marketing pricing and reimbursement decisions differs
significantly from evidence needed for regulatory approval. Therefore, it is
important to formulate goals for generating, collecting, and analyzing such
reimbursement evidence early in product development in order to ensure
commercial success of a therapeutic, diagnostic, or device. We are witnessing
the emergence of a new integrated strategy as the biopharmaceutical industry
is partnering up with payers to develop evidence around a product’s validity
and utility, and comparative clinical and cost effectiveness. Pricing,
Reimbursement and Market Access for Targeted Cancer Therapies
November 6-7, 2012 • Philadelphia, PA Program
| Register
| Download Brochure RNAi RNA interference:
A 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 RNA interference (RNAi)
is being commonly used as a screening tool for identifying and validating
potential drug targets, exploring unknown cellular pathways, and for performing
whole-genome functional screens. The screens developed, using both small
interfering RNA (siRNA) and short hairpin RNA (shRNA), are now fairly robust and
sensitive and can be performed in a reliable and high-throughput fashion RNAi
for Functional Screening November 3-4, 2011 • Boston, MA Program
| Register
| Download Brochure stem cells: In
addition to enabling regenerative medicine, stem cell research promises to
enhance drug discovery and development efforts by providing new tools to improve
efficacy and toxicity testing, drug screening, novel target discovery, and
understanding of disease mechanisms and pathways.
Stem
Cells in Drug Discovery and Development November 2-3, 2011 • La
Jolla, CA Program
| Register
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structure- based drug design:
Structure-based drug design took nearly two decades of multiple, parallel
technological improvements to arrive at its current mainstream position in
medicinal chemistry. Developments in computer graphics, high-power radiation
sources, computational processing power, refinement protocols, virtual screening
and crystallography were all necessary to create the environment for rapid,
iterative structure-based drug discovery. Given the crisis facing the
pharmaceutical industry in the translation of early stage drug discovery
results, a different set of tools, concerned with algorithms and methods for
predicting the biological profiles, will need to be refined. Structure-Based
Drug Design June 6-8, 2012 • 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/ Technologies conference series Therapeutic
indications conference series 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
21-23, 2012 • San Francisco, CA Program | Register | Download
Brochure vaccines:
An
analytical snapshot of the current state of the vaccine industry, its
development efforts, and an outlook to 2020. New
Trends in Preventive and Therapeutic Vaccines October
2011 Table
of Contents | Tables
and Figures |Executive
Summary Novel Vaccines August 13-15, 2012 • Cambridge, MA Program | Register | Download Brochure World Pharmaceutical
Congress June 5-7,
2012 • Philadelphia, PA Program | Register | Download Brochure
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