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Cambridge Healthtech biopharmaceutical glossary & taxonomy
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions?  Mary Chitty 
mchitty@healthtech.com
Last revised May 02, 2012

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 Bio-IT World  Conference & Expo  


BioIT World Conference & Expo Europe October 9-11, 2012 • Vienna Austria Program | Register | Download Brochure BioIT World Conference & Expo Europe


Biomarker conference series   includes all areas of biomarker research spanning the pharmaceutical and diagnostic pipeline, including safety and efficacy assessment in drug discovery, biomarker translation from preclinical to clinical studies, and biomarker applications in clinical trials, including patient selection, monitoring clinical efficacy and safety, and clinical pharmacology. 

Biomarker World Congress  May 21-23, 2012 • Philadelphia, PA Program | Register | Download Brochure   
Biomarker World Congress  

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 Informatics
Bioinformatics & Cancerinformatics
  February 21-23, 2012 • San Francisco, CA Program | Register | Download Brochure

cancer molecular markers: Emerging Molecular Markers of Cancer  August 21-22, 2012 • Washington, DC Program | Register | Download Brochure  

Chemistry conference series

Clinical trials conference series 

Diagnostics conference series

Discovery on Target October 1-3, 2012 • Boston, MA Program | Register | Download Brochure Discovery on Target

 

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 Discovery Chemistry

Drug safety Conference  series

GLP Good Laboratory Practice:   Good Laboratory Practices: Guide to Compliance, provides clear recommendations for performing preclinical laboratory studies according to 21CFR58 and the OECD Principles of Good Laboratory Practice. The Guide includes templates for SOPs and other forms that can be copied and used directly in the laboratory, including a full set of GLP inspection sheets.  http://www. barnettinternational.com/ EducationalServices_ Publication.aspx?p=7802&id= 97212 

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 
Broader term: GxP

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 


High-Content Analysis
  January 10-13, 2012 • San Francisco, CA Program | Register | Download Brochure

High-Content Analysis  See also Live Cell Imaging

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: ImVacS  August 13-16, 2012 • Cambridge, MA Program | Register | Download Brochure ImVacS

informatics:  Glossaries & Taxonomies   Bioinformatics,   CheminformaticsClinical & Medical informatics   Drug discovery informatics   IT Infrastructure  
Informatics conference series

Live-Cell Imaging  January 12-13, 2012 • San Francisco, CA Program | Register | Download Brochure
Live-Cell Imaging See also high content analysis

medicinal chemistry: Mastering Medicinal Chemistry  February 21-23, 2012 • San Francisco, CA Program | Register | Download Brochure

Mastering Medicinal Chemistry

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
microRNA in Human Disease and Development

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 Med TRI-CON
Molecular Med TRI-CON  February 21-23, 2012 • San Francisco, CA  Program | Register | Download Brochure
  Compelling talks from industry, academia, government, and healthcare organizations.

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

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:  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
Next Generation Diagnostics Summit

PEGS: the essential protein engineering summit  April 30 - May 4, 2012 • Boston, MA Program | Register | Download Brochure
PEGS: the essential protein engineering summit

PepTalk  January 9-13, 2012 • Coronado, CA Program | Register | Download Brochure
PepTalk


personalized medicine: Executive Summit: Implementing Personalized Medicine  September 19-21, 2012 • Washington, DC Program | Register | Download Brochure

phage display: Phage and Yeast Display April 30 - May 1, 2012 • 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  Related terms:  bacteriophage, biopanning, phage;  Labels, signaling & detection; Proteomics directed protein evolution  
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:  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
Managing Post-marketing Studies (Phase IIIb-IV) and Registries

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

protein therapeutics: By 2020, the current renaissance of biotechnology will have resulted in a broad range of products that will, almost without exception, involve a degree of protein engineering. This report discusses new developments in therapeutic protein engineering and developments that are likely to occur through 2020. Engineering Next-Generation Therapeutic Proteins July 2011 Table of Contents | Tables and Figures

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  February 3-5, 2010 • San Francisco, CA Program | Register | Order CD    

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


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:  Strategic Resource Management  November 5-6, 2012 • Philadelphia, PA Program | Register | Download Brochure
. Strategic Resource Management

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 Structure-Based Drug Design

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 Translational Science

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

 
World Pharmaceutical Congress


XGen Congress & Expo  March 5-8, 2012 • San Diego, CA  Program | Register | Download Brochure 
XGen Congress & Expo


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

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