Drug discovery & development term index

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Drug discovery, development & diagnostics term index
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions? Mary Chitty mchitty@healthtech.com
Last revised July 12, 2019

Not a comprehensive list of terms, but a quick and dirty finding aid while I'm working on getting these glossaries into a (long overdue) searchable database. Chemistry term index Healthcare Term Index Informatics term index Technologies term index Molecular Biology term index Ethics

CHI’s Drug Discovery and Development Map Drug discovery & development commentary

Biologics : adaptive T cell therapy, antibody... , antibody drug conjugates, antibody engineering, antigen, antisense therapy, biological pharmacokinetics, biological product, biologics, biopharmaceutical, bispecific…, biotechnology, biotransformation, CAR T, cell based therapies, cellular therapy, chimeric antigen receptors, developability biologics, DNA vaccines, domain antibodies, fusion protein therapeutics, gene therapy, humanized antibodies, immunotechnology, immunotherapy, immunotoxins, molecular therapeutics, monoclonal, multispecific antibodies, next generation antibodies, oligonucleotide therapeutics, PEGs, PepTalk, peptide therapeutics, polyclonal, protein therapeutics, recombinant…, reverse vaccinology, therapeutic antibodies, , vaccine , veterinary biologics   Biologics overview See also Pharmacogenomics

Bioprocessing analytical development, baculovirus, biomanufacturing, bioprocess, bioproduction, bioreactors,  cell culture, cell line, , cell strain, cell therapy CMC, cGMP current Good Manufacturing Practice, characterization methods, CHO Chinese Hamster Ovary cells, comparability, , continuous processing, cultured cells, disposables, downstream processing, dynamic light scattering, expression vector , fluidic systems, freeze drying, gene therapy CMC, Good Manufacturing Practice GMP, host cell proteins, host vector system, lyophilization, manufacturing 4.0, method development, microbial production, , microreactors, molecular farming, oligonucleotide CMC, pharming, Process Analytical Technology PAT , process characterization, process chemistry, protein expression, protein production, protein purification, recombinant protein expression, single use technologies, tissue culture, upstream processing, vector….

Business of biopharmaceuticals Adaptive Design, benchmarking, best practices, big pharma, biomedical companies, , biotechnology ..., blockbuster, brand name sector, business intelligence, business models R&D, business rules, Centers for Medicare and Medicaid Services CMS, , competitive ..., compound annual growth rate CAGR, corporate DNA, CXO Executive Summit, disintermediation, disruptive technologies, drug development costs, ebXML, elevator pitch, emerging growth companies, emerging technologies, EphMrA, fail fast, FIPCO Fully Integrated Pharmaceutical Company, , franchises, GICS Global Industry Classification Standard, health spending, high tech industry, hype, hypercompetitive, incubators, KOL Key Opinion Leaders, lead users, life cycle management, life sciences, market ..., marketing, megabrands, METI Ministry of Economy, Trade & Industry, milestones, multibusters, NAICs North American Product Classification System, niche busters, open source intelligence,, payers payors, pharmaceutical industry, pharmaceutical marketing, pharmaceutical spending, portfolio management, price trends – prescription drugs, process optimization, productivity, project portfolio management, proof of concept, proof of principle, reimbursement, risk, sexy technologies, Small & Medium sized Enterprises SMEs, specialty pharmaceuticals, spin-offs, stage gate criteria, start-ups…, strategic resource management, technology ..., time to market, unicorn companies, white space, XBRL

        Biopharmaceutical Alliances alliances, collaboration, competitive advantage, consortium, CORDIS Community Research and Development Information Services, Cooperative research and Development Agreements CRADA, discovery rights, expectations management, extension of agreement, joint venture, keiretsu, NCRPA, partnership, SBIR Small Business Innovation Research, STRR Small Business Technology Transfer,, strategic alliances, technology consortia, Technology Research Association TRA, technology service agreement

         Biopharmaceutical Finance A rounds, accredited investors, angel investor, annual reports, anti-dilution, behavioral finance, BioIT Investing and partnering, biopharmaceutical R&D financing, burn rate, clawback, convertible, dilution, down rounds, drug costs, early stage…, equity investments, exit strategies, financing, full ratchet, funding of genomic research, health economics, Immuno-Oncology Investing, Initial Public Offering IPO, liquidity event, mergers & acquisitions M&D, mezzanine financing, Net Present Value NPV< Neurotech Investing,   opportunity costs, partial acquisition, pharmaceutical fees, pharmacoeconomics, Private Investments in Public Equity PIPEs, prescription fees, pricing of drugs, private equity, profit hunts, quids, ratchets, real option valuation, risk…, ROI return on investment, risk, seed …, serial entrepreneurs, strategic investors, technology growth, tender offer, term sheet, tranche, valuation, venture capital, venture debt, venture leasing, venture philanthropy, warrant, washout round, white space 

         Biopharmaceutical Law & Intellectual property anti-trust, Bayh- Dole, Bilski vs. Kappos, biological patent, blocking patents, Cohen- Boyer, cross-licensing, Diamond vs. Chakrabarty, disease gene patents, DNA patents, electronic lab notebooks, European Patent Office EPO, EST patents, exclusivity, gene patents, genomic patents, human life patenting, Intellectual Property IP, international patents, Japanese Patent Office JPO, license, licensing, Material Transfer Agreement MTA, Myriad gene patents, non-obvious, novelty, patent ..., Patent & Trademark Office PTO, patent cliff, patent pools, patent stacking, patent thicket, patent trolls, prior art, reach through provisions, research exemptions, royalty stacking, safe harbor, SNP patents, software partnerships, stealth patents, submarine patents, technology transfer, trade secret, university industry partnerships, and IP, utility guidelines, utility patents W3C patent policy, World Intellectual Property Office WIPO 

Drug delivery & formulation active transport, adjuvant…, bioavailability, bioequivalence, biological availability, biologics formulation , biopharmaceutics, blood brain barrier, carrier mediated drug transport, cosolvent, crystalline, dosage form, drug delivery…, drug eluting stent, drug targeting, formulation, insulin infusion systems, liposome, micelle, microfiltration, microsphere, molecular pharmaceutics, nanodelivery, nanoencapsulation, nanoparticles, nucleotide delivery, oligonucleotide delivery, ophthalmological delivery, parenteral, pharmaceutics, pharmacodelivery, polymorph, polymorphic, polymorphism, preformulation, prodrug, protein delivery, targeted drug delivery, therapeutic equivalence 

Drug discovery & development Adaptive Design, benchmarking, best practices, big pharma, biomedical companies, , biotechnology ..., blockbuster, brand name sector, business intelligence, business models R&D, business rules, Centers for Medicare and Medicaid Services CMS, , competitive ..., compound annual growth rate CAGR, corporate DNA, CXO Executive Summit, disintermediation, disruptive technologies, drug development costs, ebXML, elevator pitch, emerging growth companies, emerging technologies, EphMrA, fail fast, FIPCO Fully Integrated Pharmaceutical Company, , franchises, GICS Global Industry Classification Standard, health spending, high tech industry, hype, hypercompetitive, incubators, KOL Key Opinion Leaders, lead users, life cycle management, market ..., marketing, megabrands, METI Ministry of Economy, Trade & Industry, milestones, multibusters, NAICs North American Product Classification System, niche busters, open source intelligence,, payers payors, pharmaceutical industry, pharmaceutical marketing, pharmaceutical spending, portfolio management, price trends – prescription drugs, process optimization, productivity, project portfolio management, proof of concept, proof of principle, reimbursement, reverse pharmacology, risk, sexy technologies, Small & Medium sized Enterprises SMEs, specialty pharmaceuticals, spin-offs, stage gate criteria, start-ups…, strategic resource management, technology ..., time to market, unicorn companies, white space, XBRL See also Biologics, Cancer, Pharmacogenomics Drug discovery & development Overview

Drug discovery informatics Biosemantics Group, CADD Computer Assisted Drug Design, computational drug design..., de novo design, drug design, eScience Lab, immunoinformatics, in silico ... , LIMS Laboratory Information Management Systems, molecular informatics, molecular mimicry, NeuroCommons, pharmacometrics, rational drug design, receptor mapping, simulations, soft drug design, structure based drug design, synthetic biology, virtual screening  See also Cheminformatics,

Drug safety & pharmacovigilance Adaptive Design, benchmarking, best practices, big pharma, biomedical companies, , biotechnology ..., blockbuster, brand name sector, business intelligence, business models R&D, business rules, Centers for Medicare and Medicaid Services CMS, , competitive ..., compound annual growth rate CAGR, corporate DNA, CXO Executive Summit, disintermediation, disruptive technologies, drug development costs, ebXML, elevator pitch, emerging growth companies, emerging technologies, EphMrA, fail fast, FIPCO Fully Integrated Pharmaceutical Company, , franchises, GICS Global Industry Classification Standard, health spending, high tech industry, hype, hypercompetitive, incubators, KOL Key Opinion Leaders, lead users, life cycle management, market ..., marketing, megabrands, METI Ministry of Economy, Trade & Industry, milestones, multibusters, NAICs North American Product Classification System, niche busters, open source intelligence,, payers payors, pharmaceutical industry, pharmaceutical marketing, pharmaceutical spending, portfolio management, price trends – prescription drugs, process optimization, productivity, project portfolio management, proof of concept, proof of principle, reimbursement, risk, sexy technologies, Small & Medium sized Enterprises SMEs, specialty pharmaceuticals, spin-offs, stage gate criteria, start-ups…, strategic resource management, technology ..., time to market, unicorn companies, white space, XBRL

Drug Targets agonist immunotherapy targets, allosteric modulators, autophagy, biological target, cancer cell metabolism, channel blocker, Chimeric Antigen Receptors CAR, constrained peptides, cytokine based therapeutics, cystoplasmic and nuclear receptors, Discovery on Target, disease targets, drug targets…drug transporters, DrugBank, druggable targets, efficacy targets, epigenetic targets, gene target, gene targeting, GPCRs G protein coupled receptors, histone demethylases, histone deacetylase Inhibitors HDAC, inflammation & autoimmune inhibitors, ion channels, kinases, macrocyclics, membrane proteins, membrane proteomics, microbiome, molecular drug targets, Molecular Pharmacopeia, molecular targeted therapy, molecular targets, multi-targeted therapies, Nf-Kappa B, nuclear hormone receptors, nuclear receptors, orphan G-protein coupled receptors, orphan nuclear receptors, phosphoinositide 3Kinase PI3K, protease inhibitors, protein families, protein kinases, protein protein interactions, retargeting, target , target characterization, target engagement, target families, target hopping, target identification, target labelling, target prioritization, target proteins, target qualification, target selection, , target validation, targeted gene repair, targeted therapy, Therapeutic targets Database, tractable targets, ubiquitin [as a drug target], virtual target screening

Pharmaceutical biology active center, agonist, analog, antagonist, antisense…aptamer, , binding…,deorphanize, drug leads, drug receptors, , efficacy, enzymes … epitope, homologue, hormone, ,inhibitors, intrinsic activity, ligand, paratope, permeability, pharmacophores, prodrug, promiscuous drugs, promiscuous inhibitors, receptors, recognition site, selectivity, solubility, specificity, substrate

Regulatory 21 CFR Part 11, accelerated approval, Advanced Therapy Medicinal Products ATMPS, analyte specific reagents, biogenerics, biosimilars, borderline products, brand name drugs, CBER, CDER, children in research, CLIA, Clinical Research Policy Analysis and Coordination CRPAC, combination products, Committee on Human Medicines, common technical document, compassionate use, cosmeceuticals, drug, effective, EMEA, expanded access, exploratory IND, fast track, FDA…, FDAMA, follow ons, GCP Good Clinical practice, generic drugs, GLP Good Laboratory Practice, guidance documents FDA, GxP, harmonization, HIPAA, home brew, ICH International Conference on Harmonisation, IND, informed consent, IRB, me too, MedWatch, Medicines & Healthcare Regulatory Authority MHRA, NCE, NDA, NME, non-prescription drugs, off label, openFDA, orphan …., PDUFA, predicate rules, prescription drugs, priority review, proprietary drug, , regulatory agencies, safe harbor, specified biotechnology products, third party review, well characterized biotechnology products, women and minorities

Healthcare term index
Cancer & Immuno-Oncology IO adoptive cell based cancer immunotherapy, adoptive T cell therapy, animal models cancer, antibodies cancer therapy, antimetabolites, Antineoplastic Agents, Immunological, autoantibodies, biological tumor markers, bispecific antibodies for oncology, cancer biomarkers, cancer genomics, cancer Immunome Atlas, cancer immunotherapies, cancer informatics, cancer proteomics, cancer resources for patients, cancer vaccines, CAR T cell therapy, , cellular oncogene (proto-oncogene), chemoprediction, circulating cell free DNA, circulating tumor cells, Comparative Oncology Program, driver mutations, early detection of cancer, familial cancer, FDA Office of Hematology and Oncology Products, galectinomics, Gleevec, hematological cancer therapies, Herceptin, hereditary cancer, Immuno-Oncology IO…,immunomodulatory, immunotherapy, imprecision medicine, Interagency Council on BioMedical Imaging in Oncology, liquid biopsy, mathematical oncology, molecular profiling, molecular targets, neoadjuvant therapy, myeloid cells, neoantigen …, NK Natural Killer Cells…., oncogene…, oncolytic virotherapy, oncosomes, p53, passive immunotherapies, patient navigation, precancerous, preclinical oncology, predictive oncology, preventive oncology, proto-oncogene…, solid tumors, sporadic cancer, targeted therapy, therapy ladders, tumor antigen, tumor markers, tumor microenvironment, tumor models, tumor myeloid, tumor suppressor genes, tumoroid, tumour…

Clinical trials adaptive clinical trials, adaptive licensing, Artificial Intelligence in clinical trials, attrition, basket trials, big data , clinical..., clinical trials, computable phenotypes, CONSORT, CRO Clinical Research Organization, developmental site agreements, efficacy trials, enrichment strategies, enrollment planning, expansion cohort, explanatory trials, forecasting budgeting & contracting, intervention, large simple trials, late stage research & observational trials, lure of initial value, measurements, NIH Collaboratory, outsourced outsourcing, patient, patient-centric, patient engagement, patient recruitment, Patient Reported Outcomes, Phase I, II, III, IV, phase zero, pivotal clinical trials, placebo non and placebo responders, pragmatic clinical trials, protection of human subjects, protocol…, Randomized Clinical Trials RCTs, real world data, resource management, risk based monitoring, sensors wearables & digital biomarkers, site…, stratification, subject, umbrella trials

Clinical & Medical informatics : adaptive clinical trials, AI and healthcare, Bayesian clinical trials, Bayesian networks, biomathematics, biomedical informatics, case definitions, CDISC, clinical data repositories, clinical forecasting, clinical informatics, clinical research, clinomics, cohort studies, communications standards, comparative effectiveness research, complex diseases, computational phenotypes, computational physiology, computational therapeutics, consumer health informatics, digital health digital therapeutics, drug utilization, e-health, electronic data capture, electronic medical records, electronic prescribing, electronic records FDA, evidence based medicine, genomic epidemiology, health informatics, health IT tools, health record, healthcare informatics, HL7 Health Level 7, human factors, immunoinformatics, in silico clinical trial, in silico pharmacology, laboratory informatics, LOINC Logical Observation Identifiers Names and Codes, meaningful use, medical bioinformatics, medical informatics, MEDRA, meta-analysis, meta-regression mHealth mobile health, National Center for Integrative Biomedical Informatics, National Electronic clinical Trials and Research NECTAR, neuroimaging, neuroinformatics, Office of the National Coordinator for Health Information Technology (ONC), outcomes research, pathology informatics, patient engagement, patient reported outcomes, Personal Health Record PHR, pharmacoepidemiology, population health, predictive genomics, predictive pharmacogenomics, prognosis, public health informatics, Real World Data RWD, Real World Evidence RWE, systems medicine, syndromics, telehealth, telemedicine,  SNOMED, UMLS, uncertainty, universal trial number

Molecular Diagnostics including Genetic & genomic testing $1,000 genome,  analyte specific reagents, analytical selectivity, analytical sensitivity, analytical specificity, capsule endoscopy, carrier testing, clinical chemistry, clinical Next Generation Sequencing diagnostics, clinical sensitivity, clinical specificity, combination drug diagnostics, combination products, companion diagnostics, Computer Aided Detection CAD, Computer Aided Diagnosis CADx, “designer” babies, diagnosis, diagnostics, diagnostics automation, digital health, digital pathology, family history, general purpose reagent, GeneReviews, genetic counseling, genetic discrimination, genetic enhancement, genetic predisposition, genetic privacy, genetic screening, genetic susceptibility, genetic test, germ cells, germline mutation, "good genes bad genes”, in vitro diagnostic multivariate index assays IVDMIAs, in vitro diagnostics IVDs, Laboratory Developed Tests LDTs, medical genetics, medical genomics, molecular biopsy, molecular diagnostics, molecular pathology, multiplex assays, newborn screening, patient stratification, point of care diagnostics,  preconception testing, predictive testing, predisposition, preimplantation diagnosis, prenatal diagnosis, presymptomatic test, research diagnostics, risk communication, SACGT Secretary’s Advisory Committee on Genetic Testing, sample prep, screening, sensitivity, sex selection, single cell analysis, somatic cells, susceptibility, theranostics 

Biomarkers biological markers, biomarkers, biosignatures, clinical endpoints, digital biomarkers, disease markers, efficacy biomarkers, genetic biomarkers, “ideal” biomarkers, markers, protein biomarkers, safety biomarkers, surrogate ... , type 0, type I, type II biomarkers, valid biomarkers

Molecular Medicine All of US Research program, behavior …, chronome, chronotherapy, clinical proteomics, cogneceutials, cryomedicine, cryosurgery, cryotherapy, determinism [genetic] , disease... , drug utilization review, environmental factors, epidemiology, experimental medicine, functional foods, genetics, genotypic prevention, global health, glycogerontology, health disparities, human gene transfer, human microbiome, Medbiquitous Consortium, medical errors, molecular  ..., morbidity compressing, mortality reducing, nanomedicine, NIGMS, normal, nutriceuticals, nutrigenomics, nutritional genomics, phenotypic prevention, public health, quantified self, rare diseases, regenerative medicine, translational medicine, translational science, uncertainty, women’s health, , world health Patient resources

Pharmacogenomics ADME ..., ADME/Tox, chronopharmaokinetics, chronopharmacology, clinical pharmacology, computational pharmacology, CRISPR for precision medicine, cytochrome p450 enzymes, disease resistant individuals DMPK, drug metabolism, Drug Metabolizing Enzymes DME, drug response, expression pharmacogenomics, FDA guidelines pharmacogenomics, flip flop pharmacokinetics, genomic data, genotype-to phenotype, immunophenotyping, in silico pharmacology, individualized medicine, integrative and organ systems pharmacology, kinetic outliers, mechanism of action MOA, median effective dose, metabonomics/metabolomics, microbiome based precision medicine, mode of action MoA, molecular mechanisms of action, molecular pharmacology, molecular phenotyping, network pharmacology, personalized medicine, pharmacodynamics, pharmacoepigenomics, pharmacogenetics, pharmacogenomics, pharmacokinetics, pharmacometabonomics, pharmacophylogenomics, pharmacoproteomics, phenotype…., Polypharmacology, precision diagnostics, precision medicine,   predictive ..., quantitative pharmacology, quantitative systems pharmacology, systems pharmacology, therapeutic equivalency, therapeutic index, translational pharmacodynamics, Voluntary Genomic Data Submissions VGDS    

Therapeutic areas: Cardiovascular CNS & Neurology Immunology Infectious Diseases Inflammation Alzheimer's, antibacterial, antibiotic, antivirals, autistic disorder, autoimmune & inflammation, biodefense, blood substitutes, BSE, CJD, cardiac…, cardiovascular, cosmetic psychopharmacology, diabetes, emerging infectious, hepatitis, HIV, immunogenetics, immunogenomics, immunological, infectious, inflammation, lipoproteomics microbial proteomics, NASH & Fibrosis, neuroceuticals, NeuroCommons, neurodegenerative, neuropharmaceuticals, neuroproteomics, Neurotech investing, obesity, ophthalmology, prion, psychogenomics, psychoneuroimmunology, systems immunotechnology

Drug safety Conferences http://www.healthtech.com/Conferences/Search.aspx?k=&r=&s=DSF
World Pharmaceutical Congress WPC http://www.worldpharmacongress.com/
Drug safety CDs, DVDs http://www.healthtech.com/Conferences/CompactDiscSearch.aspx?k=&r=&s=DSF
Drug safety Short courses http://www.healthtech.com/Conferences_Upcoming_ShortCourses.aspx?s=DSF

Drug safety Barnett Web Seminars http://www.barnettinternational.com/EducationalServices/Search.aspx?k=&t=&j=Drug%20Safety&s=&e=&r=

Drug targets Conferences http://www.healthtech.com/Conferences/Upcoming.aspx?s=TRGS
Discovery on Target http://www.discoveryontarget.com/
Drug targets CDs, DVDs http://www.healthtech.com/Conferences/CompactDiscs.aspx?s=TRGS
Drug targets Short courses http://www.healthtech.com/Conferences_Upcoming_ShortCourses.aspx?s=TRGS

Clinical trials Conferences http://www.healthtech.com/conferences/upcoming.aspx?s=CTL
BioIT World Expo http://www.bio-itworldexpo.com/
SCOPE Summit for Clinical Operations Executives http://www.scopesummit.com/
Clinical Trials Short courses http://www.healthtech.com/Conferences_Upcoming_ShortCourses.aspx?s=CTL

Clinical Trials Barnett books http://www.barnettinternational.com/EducationalServices/Publications.aspx
Clinical Trials Barnett Core Curriculum http://www.barnettinternational.com/EducationalServices/Seminars.aspx
Clinical Trials Barnett Web Seminars http://www.barnettinternational.com/EducationalServices/Webinars.aspx

Diagnostics Conferences http://www.healthtech.com/Conferences/Search.aspx?k=&r=&s=BMK
Molecular Medicine Tri Conference http://www.triconference.com/
Diagnostics Short courses http://www.healthtech.com/Conferences_Upcoming_ShortCourses.aspx?s=BMK

Insight Pharma Reports Biomarkers and Diagnostics http://www.insightpharmareports.com/Biomarker-Diagnostics-Reports/

Healthcare Conferences http://www.healthtech.com/Conferences/Search.aspx?k=&r=&s=HLTS
BioIT World Expo http://www.bio-itworldexpo.com/
Molecular Medicine TriConference http://www.triconference.com/
Healthcare CDs, DVDs http://www.healthtech.com/medialibrary/?s=HLTS

Therapeutic indications Conferences: http://www.healthtech.com/Conferences/Search.aspx?k=&r=&s=RXXS
Therapeutic indications CDs, DVDs http://www.healthtech.com/Conferences/CompactDiscSearch.aspx?k=&r=&s=RXXS
Therapeutic indications Short courses http://www.healthtech.com/Conferences_Upcoming_ShortCourses.aspx?s=RXXS

Molecular Med Monthly subscriptions http://www.healthtech.com/newsletter_reg.asp

How to look for other unfamiliar terms

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