<p><span style="text-decoration: underline;"><ac:link><ri:page ri:contenttitle="Security classification of information" /></ac:link></span><span
style="color: rgb(255,255,153);">:</span> <span style="color:
rgb(51,153,102);"><strong>Public</strong></span></p>
<ac:macro ac:name="expand"><ac:parameter ac:name="title">Access
rights</ac:parameter><ac:rich-text-body>
<p>no restrictions</p></ac:rich-text-body></ac:macro>
<p><br class="atl-forced-newline" /></p>
<hr />
<p><ac:macro ac:name="anchor"><ac:default-parameter>Top</ac:defaultparameter></ac:macro></p>
<ac:macro ac:name="note"><ac:rich-text-body>
<p>Please delete any dublets</p></ac:rich-text-body></ac:macro>
<ac:macro ac:name="unmigrated-inline-wiki-markup"><ac:plain-textbody><![CDATA[{glossary}
5-FU: 5-fluorouracil
AA: Anaplastic astrocytoma
AAALAC: Association for Assessment and Accreditation of Laboratory Animal
Care
ABP: Activity Based Planning
AC: Accounting & Controlling
ACO: Accountable Care Organization
AD: Alzheimer Disease
AD: Atopic Dermatitis
ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity
ADME: Absorption, Distribution, Metabolism, Excretion
AE: Adverse Event
AEMPS: Agencia Espanola de Medicamentos y Productos Sanitarios / Spanish
Agency for Medicines and Health Products
AHRQ: Agency for Healthcare Research and Quality (US)
AIA: Adjuvant Induced Arthritis
AIFA: Agenzia Italiana del Farmaco / Italian Medicines Agency (Drug and HTA
authority Italy)
AIID: AutoImmune and Inflammatory Disease
AIO: Arbeitsgemeinschaft Internistische Onkologie (German Cooperative Group)
ALK: Anaplastic Lymphoma Kinase (marker in NSCLC)
AMCP: American Managed Care Pharmacy (HTA research US)
AMES: Bacterial Reverse Mutation Assays
AMR: Alliance Management Research
ANOVA: Analysis of Variance
AO: Anaplastic oligodendroglioma
AOB: Any Other Business
AOFP: Absolute Open Flow Potential test (also referred as conventional
backpressure test)
AOTM: Agencja Oceny Technologii Medycznych / Agency for Health Technology
Assessment (HTA agency Poland)
APA: American Psychiatric Association
APC: Analytical and Pharmaceutical Chemistry
API: Active Pharmaceutical Ingredient
APP: Amyloid Precursor Protein
AS: Serono Compound Number
ASCO: American Society of Clinical Oncology
ATC: Anatomical Therapeutic Chemical
AtO: Answer to Objection
AUC: Area Under the Curve
AWSMG: All Wales Medicines Strategy Group (HTA body Wales)
BA: Business Analytics
BACE: Beta-site APP-Cleaving Enzyme
BBB: Blood Brain Barrier
BCCP: Breast & Cervical Cancer Program
BD: Business Development
BDP: Biomarker Development Plan
BEMC: primary Brain Microvascular Endothelial Cell
BH4: tetrahydrobiopterin
BI: Business Intelligence
BI: Budget Impact
BID: Twice daily
BIM: Budget Impact Model
BLA: Biologics Licensing Application
BOR: Best Overall Response
BOS: Boston Hub
BRAT: Benefit Risk Assessment Team
BRACE: Benefit Risk Assessment Center of Excellence
BrdU: BromodeoxyUridine
BSA: Body Surface Area
BSC: Best Supportive Care
BSC: Balanced Score Card
BTC: Biliary Tract Cancer
BU: Business Unit
CA: Corporate Auditing
CA: Chromosome Aberration assay
Caco-2: Human epithelial colorectal adenocarcinoma cell line
CADTH: Canadian Agency for Drugs and Technologies in Health (HTA authority
Canada)
CAPA: Corrective And Preventive Action
CAPOX: Capecitabine (Xeloda), oxaliplatin
CATS: Cross Application Time Sheet
CBA: Cost Benefit Analysis
CBF: Cerebral blood flow
CBS: Cost Breakdown
CBTC: Canadian Brain Tumor Consortium
CC: Corporate Communications
CCRT: Centralised Coding Review Team
CD: Crohns Disease
CDA: Confidentiality Agreement
CDC: Clinical Data Coordinator
CDC: Complement Dependent Cytotoxicity
CDD: Customer Defined Database
CDE: Center for Drug Evaluation Taiwan (HTA agency Taiwan)
CDER: Center for Drug Evaluation and Research
CDM: Clinical Data Manager
CDP: Clinical Development Plan
CDT: Clinical Development Team
CDTL: Clinical Development Team Leader
CDU: Clinical Development Unit
CE: Cost Effectiveness
CEA: Cost Effectiveness Analysis
CEAC: Cost Effectiveness Acceptability Curve
CECOG: Central European Cooperative Oncology Group
CED: Coverage with/for Evidence Development
CER: Comparative Effectiveness Research
CES: Corporate External Services
CF: Corporate Finance
CH: Consumer Healthcare
ChAT: Choline Acetyl Transferase
CHMP: Committee of Medicinal Products for Human use
CHO: Chinese Hamster Ovary
CI: Corporate Information Services
CI: Confidence Interval
CI: Competitive Intelligence
CIA: Collagen Induced Arthritis
CIDD: Commercial Image Decision Document
CIL: Clinical Information & Learning Management
CIR: Cartilage Injury Repair
CIS: Clinically Isolated Syndrome
CIS: Corporate Information Service
CL: Corporate Legal and Compliance
CL: (Total Body) Clearance
CLM: Confined Liver Metastases
CMA: Cost Minimization Analysis
Cmax: Maximum concentration
CMC: Chemistry, Manufacturing and Control
CMC: Cardiometabolic Care
CMC-D: Chemistry, Manufacturing and Controls - Development
CMG: Company of the Merck Group (legal entity)
CMGs: Companies of the Merck Group
CMH: Cochran-Mantel-Haenszel
CML: Clinical Monitoring Leader
CMO: Chief Medical Officer
CMO: Contract Manufacturing Organization
CMR: Carcinogenicity, Mutagenicity, Reprotoxicity
CMR: Central Medicine Research
CMS: Center for Medicare and Medicaid Services (US)
CNS: Central Nervous System - brain & spinal cord
CNTF: Ciliary NeuroTrophic Factor
COA: Clinical Outcome Assessment
CoA: Certificate of Analysis
CoE: Center of Excellence
CoG: Cost of Goods
COMET or SCGE: Single Cell Gel Electrophresis Assay
CONITEC: Comissao Nacional de Incorporaca de Technologias (HTA body Brazil)
COSTART: Coding Symbols for a Thesaurus of Adverse Reactions Terms
CP: Corporate Procurement Global
CP: Check Point
CPM: Critical Path Method
CPO: Clinical Portfolio Optimization
CPP: Capacity, Process and Performance
CPPK: Clinical Pharmacology and Pharmacokinetics
CR: Complete Response
CRA: Clinical Research Associate
CRC: ColoRectal Cancer
CRF: Case Report Form
CRO: Contract Research Organization
CRO: Clinical Research Organization
CRO: Clinical Research Officer
CRPC: Castration-Resistant Prostate Cancer
CRT: Chemo-Radiotherapy
CS: Corporate Strategy
CS: Concept Sheet
CSF: CerebroSpinal Fluid
CSRC: Concept Sheet Review Committee
CSV: Computerized Systems Validation
CT: Chemotherapy
CT: Computed Tomography
CT: Corporate Tax
CTA: Clinical Trial Authorization
CTCAE: Common Terminology Criteria for Adverse Events
CTD: Common Technical Document
CTL: Clinical Trial Leader
CTM: Clinical Trial Manager
CTMS: Clinical Trial Management System
CTR: Clinical Trial Report
CTS: Clinical Trial Supplies
CUA: Cost Utility Analysis
CV: Coefficient of variation
CVZ: Het College voor zorgverzekeringen / The Health Care Insurance Board
(HTA decision body Netherlands)
CYP: Cytochrome P450
DA: Darmstadt hub
DAF: Disease Activity-Free
DB: Database
DBD: Database Developer
DC: Development & Commercialization
DCP: Decentralised Procedure
DCR: Disease Control Rate
DD: Due Diligence
DDD: Defined Daily Dose
DDI: Drug-Drug Interaction study
DDPS: Detailed Description of Pharmacovigilance System
DE: Data Entry
DFS: Disease-free Survival
DIPG: Diffuse Intrinsic Pontine Glioma
DLS: Dynamic Light Scattering
DLT: Dose Limiting Toxicity
DM: Data Management
DMARDs: Disease-Modifying AntiRheumatic Drugs
DMC: Data Monitoring Committee
DMD: Disease Modifying Drug
DMD: Duchenne Muscular Dystrophy
DME: Drug-Metabolizing Enzymes
DMOADs: Disease-Modifying OsteoArthritis Drugs
DMP: Data Management Plan
DMPK: Drug Metabolism and PharmacoKinetics
DMR: Data Management Report
DOC: Development Operating Committee (previously Product Development
Committee)
DOR: Duration of Response
DP: Discovery Program
DP: Drug Product
DP: Decision Point
DP0: Decision Point to initiate the first Good Laboratory Practices animal
tox study
DP1: Decision Point phase I: decision to initiate the first trial in humans
DP2: Decision Point phase II: decision to initiate the first patient trial
(PoC or Phase II)
DP3: Decision Point phase III: decision to initiate the first pivotal trial
DP4: Decision Point phase IV: decision to submit the dossier in first
core/key country(s)
DP5: Decision Point phase V: decision to launch the product in first core/key
country(s)
DPED: Decision Point Exploratory Development
DPHD: Discovery Point Hit Discovery
DPHO: Decision Point Hit Optimisation
DPLO: Decision Point Lead Optimisation
DPM: Discovery Project Management (a department in Project Management, under
Product Leadership)
DPP: Discovery Project Proposal
DPPR: Development Project Process Reports (from KITE)
DPT: Discovery Project Team
DPTL: Discovery Project Team Leader
DQP: Department Quality Policy
DQS: Department Quality Standard
DQSP: Data Quality Surveillance Plan
DR: Disaster Recovery
DS: Drug Substance
DSC: Differential Scanning Calorimetry
DSMB: Data Safety Monitoring Board
DSO: Data Structure Output
DSO: Drug Safety Officer
DST: Data Standards
DUS: Drug Utilization Study
DVP: Data Validation Plan
EAE: Experimental Autoimmune Encephalomyelitis
EBM: Evidence Based Medicine
EC: European Commission
EC: Ethics Committee
ECM: Extracellular Matrix
ECOG: Eastern Cooperative Oncology Group
eCRF: Electronic Case Report Form
ECTD: Electronic Common Technical Document
ECTRIMS: European Committee for Treatment and Research in Multiple Sclerosis
ED: Exploratory Development
EDC: Electronic Data Capture
EDMS: Electronic Document Management System
EDSS: Enhanced Disability Status Scale
EES: Employee Engagement Survey
EFPIA: European Federation of Pharmaceutical Industries and Associations
EGF: Epidermal Growth Factor
EGFR: Epidermal Growth Factor Receptor
EHD: Extrahepatic Disease
EHS: Environmental, Health, Safety
EJP: Economically Justifiable Pricing
ELISA: Enzyme Linked ImmunoSorbent Assay
ELISpot: Enzyme-Linked Immunosorbent Spot
EM: Exploratory Medicine
EMA: European Medicines Agency
EMD: Merck Compound Number
EMEA: European Medicines Evaluation Agency
EMR: Electronic Medical Record
eNPV: expanded Net Present Value
ENS: European Neurological Society
EORTC: European Organisation for the Research and Treatment of Cancer
EPAR: European Public Assessment Report
EPFL: Ecole Polytechnique Federal de Lausanne (famous university in Lausanne,
Switzerland)
EQ: Environment, Health, Safety, Security, Quality
ErbB: Epidermal growth factor receptor family of transmembrane receptor
tyrosine kinases comprising ErbB1-4
ERDT: Effective Research and Development Teams
ERO: External Research Organisation
ESL: Early Stage Licensing
ESMO: European Society for Medical Oncology
ETH: Eidgenössische Technische Hochschule (famous university in Zurich,
Switzerland)
ETS: Early Tumor Shrinkage
EU: European Union
EUnetHTA: European network for Health Technology Assessment
EU QPPV: Qualified Person responsible for Pharmacovigilance in the European
Union
EVC: Ethical Validation Committee
EVD: Evidence & Value Development (former HSR)
F: Bioavailability
FA: Folinic Acid
FAC: Focal Adhesion Complex
FACS: Fluorescent Activated Cell Sorting
FAK: Focal Adhesion Kinase
Fc: Fragment Crystallizable Region
FCF: Free Cash Flows
FCGR: Fc-gamma receptor
FCS: First Commercial Sale
FDA: Food and Drug Administration
FDC: Full Development Committee
FDG-PET: 18Fluorodeoxyglucose-Positron emission tomography
FFS: Failure-free survival
FGF: Fibroblast Growth Factor
FH: Function's Head
FIA: First in Animal
FIC: First in Class
FIH: First In Human
FIM: First in Man
FIP: First in Patient
FISH: Fluorescence In Situ Hybridization
FLAIR: Fluid-Attenuated Inversion Recovery
FOLFIRI: Folinic acid, 5-Fluorouracil, Irinotecan
FOLFOX: Folinic acid, 5-Fluorouracil, Oxaliplatin
FOP: Functional Operating Procedure
FOS: Functional Operating Standard
FPFV: First Patient First Visit
FPI: First Patient Infused
FRT: Functional Related Tool
FSH: Follicle Stimulating Hormone
FTE: Full Time Employee / Equivalent
FTO: Freedom To Operate
FY: Fiscal Year
FY: Full Year
G-BA: Gemeinsamer Bundesausschuss / Federal Joint Committee (HTA decision
body Germany)
Gad: Gadolinium
GBD&S: Global Business Development & Strategy (previously Portfolio
Development)
GBI: Global business intelligence
GBM: Glioblastoma (A malignant tumor of the central nervous system, usually
occurring in the cerebrum of adults)
GBS: Global Biostatistics
GC: Gastric Cancer
GCDU: Global Clinical Development Unit
GCLP: Good Clinical Laboratory Practice
GCO: Global Clinical Operations
GCP: Good Clinical Practice
GCPM: Global Clinical Program Manager
GCT: G-Classification Team
Gd-MRI: Gadolinium-enhanced Magnetic Resonance Imaging
GDM: Global Development and Medical (previously Development)
GDM: Global Data Management
GDP: Global Development Plan
GDP: Guanosine Diphosphate
GDP: Gross Domestic Product
GDS: Global Drug Safety
GDU: Global Development Unit
GEC: Global Executive Conference
GEDU: Global Early Development Unit
GERONIMO: Global ElectRONIc Medical affairs Operating system
GH: Growth Hormone
GHD: Growth Hormone Deficiency
GI: GastroIntestinal
GIA: G6P1 Induced Arthritis
GL: Geschäftsleitung
GL: Gold line
GLL: Global Line Leader Meeting
GLP: Good Laboratory Practice
GMA: Global Medical Affairs
GMADB: Global Medical Affairs Decision Board
GMG: Gesellschaft der Merck Gruppe
GMP: Good Manufacturing Practice
GMVD: Global Master Value Dossier
GPIC: Global Product Information Committee
GPM: Global Project Management
GPMS: Global Price Management System (Merck Serono)
GPT: Global Product Team
GPTL: Global Product Team Leader
GPU: Global Product Unit
GRA: Global Regulatory Affairs
GRAPT: Global Regulatory Affairs Product Team
GRC: Geneva Research Center
GRED: Global Research and Early Development (previously Research)
GRPI: Global Regulatory Product Information
GSEC: Global Safety & Ethics Committee
GSH: Glutathione
GSM: Gamma-secretase modulator
GSP: General Safety and Pharmacology
GSP: Global Strategic Plan
GTI: Genotox Impurities
GTP: Guanosine Triphosphate
GVA: Geneva hub
Gy: Gray
H2L: Heat to Lead
HA: Health Authorities
HAS: Haute Autorité de Santé / French National Authority for Health (HTA
decision body France)
HB-EGF: Heparin Binding EGF
HCC: Hepatocellular carcinoma
hCG: Human chorionic gonadotropin
HCP: High Corrective Priority
HD: Hit Discovery
HD: High Dose
HepO: Hepatocytes
hERG: human Ether à go-go Related Gene
HEOR: Health Economics & Outcomes Research
HER: Human Epidermal growth factor Receptor
HET: Hit Evaluation Team
hFSH: human Follicle Stimulating Hormone
HGG: High Grade Glioma
HIRA: Health Insurance Review & Assessment Service (HTA decision body South
Korea)
HLA: Human Leukocyte Antigen
HO: Hit Optimisation
HP: High Priority
HPA: Hyperphenylalaninemia
HPLC: High Performance Liquid Chromatography
HPRT: Hypoxanthine PhosphoRibo Transferase
HR: Corporate Human Resources
HR: Hazard Ratio
HRAS: v-Ha-ras Harvey Rat Sarcoma viral oncogene homolog
HRGs: Health Resource Groups
HRU: Health Resource Utilisation
HSR: Health Services Research
HTA: Health Technology Assessment
HTAi: Health Technology Assessment international (international society for
HTA)
HTRF: Homogeneous Time - Resolved Fluorescence
HTS: High Throughput Screening
HUVEC: Human primary Umbilical Vein Endothelial Cell
i.c.v.: intracerebroventricular
i.d.: intra-dermal
i.p.: intraperitoneal
i.v.: intravenous
IACUC: Institutional Animal Care and Use Committee
IB: Investigator's Brochure
IBD: Inflammatory Bowel Disease
IC: In-house Consulting
IC50: Half maximal inhibitory concentration
ICER: Incremental Cost Effectiveness Ratio
ICF: IntraCellular Fluid
ICF: Informed Consent Form
ICh: Intermittent chemotherapy
ICH: International Conference on Harmonization of technical requirements for
registration of pharmaceuticals for human use
ICS: Intracellular Cytokine Staining
ICSC: Integrated Clinical Study Committee
IDMC: Independent Data Monitoring Committee
IFL: Irinotecan, bolus fluorouracil, leucovorin
IFN: Interferon
IFNß: beta interferons
iGDP: integrated Global Development Plan
IgG: Immunoglobulin G
IgG1: Immunoglobulin G1
IHC: ImmunoHistoChemistry
IIT: Investigator Initiated Trial
IL: Interleukin
IL-2: Interleukin-2
ILD: Interstitial Lung Disease
IMI: Innovative Medicine Initiative
IMP: Investigational Medicinal Product
IMP: Investigational Medicinal Program
IMPD: Investigational Medical Product Dossier
IN: Corporate Insurance
IND: Investigational New Drug
INAHTA: International Network of Agencies for Health Technology Assessment
INN: International Non-proprietary Name
IP: Intellectual Properties
IPF: Idiopathic Pulmonary Fibrosis
IPMA: International Project Management Association
IQWiG: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (HTA
body Germany)
IRB: Institutional Review board
IRC: Independent Review Committee
IRMA: Integrated Risk Management Activities
IRR: Infusion-Related Reactions
ISE: Integrated Summary of Effectiveness (US-specific)
ISPOR: International Society for Pharmacoeconomics and Outcomes Research
ISS: Integrated Safety Summary
ISS: Internal Sales Service
IST: Investigator Sponsored Trial
ITC: Indirect Treatment Comparison
ITC: Isothermal Titration Calorimetry
ITT: Intention To Treat
IVRS: Interactive Voice Response Systems
iv: intravenous
JGPT: Joint Global Project Team
JSC: Joint Steering Committee
KAM: Key Account Manager
Kd: Dissociation constant
KHSA: Binding constant to Human Serum Albumin
Ki: Inhibitory constant
KI: Key Initiative
KOL: Key Opinion Leader
KPI: Key Performance Indicators
KPS: Karnofsky Performance Status
KRAS: Kirsten Rat Sarcoma
KRAS: Kirsten-RAS-oncogene-associated gene
KTL: Key Thought Leader
L2: Merck acronym: level 2 leadership, those people reporting to the PEC
LA: Locally Advanced
LAP: Last Approved Plan
LBA: Biologics Licensing Application
LBE: Last Best Estimate
LCM: Life Cycle Management
LCMS: Liquid Chromatography coupled to Mass Spectroscopy
LCP: Low Corrective Priority
LD50: Dose leading to 50 % of dead subjects
LD: Low Dose
LDC: Lead Discovery Committee
LDH: Lactate Dehydrogenase
LDP: Lead Discovery Plan
LDSO: Local Drug Safety Officer
LFC: Lead Finding Chemist
LID: Levodopa Induced Diskynesia
LIL: Local Investigator Liaison
LIMS: Laboratory Information Management System
LLD: Liver Limited Disease
LMIC: Low- and Middle-Income Country
LN: Lupus Nephritis
LO: Lead Optimisation
LOT: Line Of Therapy
LPI: Last Patient Infused
LPS: Lipopolysaccharide
LRF: Legal Request Form (legal reference number given to each R&D agreement
in order to archive them properly)
LSF: Legal Service Form
LTFU: Long Term Follow Up (refers to studies)
LTM: Leadership Team Meeting
LV: Leucovorin
LY: Life-Year
M&S: Marketing & Selling
MAA: Marketing Authorization Application (submitted to EMA)
MAb: Monoclonal Antibody
MAH: Marketing authorization holder
ManGo: Management of GxP Documents (MerckSerono Global R&D)
MAP: Medical Affairs Plan
MAPI: Merck Award Plan for Inventions
MAPK: Mitogen Activated Protein Kinase
MARC: Medical Affairs Review Committee
mBC: metastatic Breast Cancer
MBP: Myelin Basic Protein
MCB: Master Cell Bank
MCC: Merkel Cell Carcinoma
mCRC: metastatic ColoRectal Cancer
MCDA: Multi Criteria Decision Analysis
mCRPC: metastatic Castration-Resistant Prostate Cancer
MDACC: MD Anderson Cancer Center (Houston, Texas, USA)
MDD: Major Depressive Disorder
MDR: Multi Drug Resistance
MedDRA: Medical Dictionary for Regulatory Activities
MEK: Mitogen activated Extracellular signal regulated protein Kinase
MERLIN: Merck Serono Research and Development Information Network
MFISH: Multiplex Fluorescence In-Situ Hybridization
MGMT: O6-Methylguanine-DNA Methyltransferase
MHC: Major Histocompatibility Complex
MHLW: Ministry of Health Labour and Welfare (HTA decision body Japan)
MHRA: Medicines and Healthcare products Regulatory Agency (UK based)
MIA: Monosodium Iodoacetate
MIR: Medical Indication Review
MIST: Metabolites In Safety Testing
ML: Molecule Leader
MLA: Mouse Lymphoma Assay
MM: Merck Millipore
MNT: MicroNucleus Test
MoA: Mode of Action
MOG: Myelin Oligodendrocyte Glycoprotein
mOS: Median Overall Survival
mPFS: Median Progression-Free Survival
MPD: Manufacturing Product Development
MPPE: Merck (Serono) Preclinical Proposal Evaluation
MR: Medical Responsible
MR: Market Research
MRA: Magnetic Resonance Angiography
MRI: Magnetic Resonance Imaging
mRNA: messenger RiboNucleic Acid
MRP: Multidrug Resistance Protein
MRP: Mutual Recognition Procedure
MS: Multiple Sclerosis
MS: Mass Spectrometry
MS: Milestone
MSA: Master Services Agreement
MSA: Merck Serono Aubonne, one of the manufacturing sites
MSB: Merck Serono Biological compound number
MSC: Merck Serono Chemical compound number
MSFC: Multiple Sclerosis Functional Composite
MSI: Medical Science and Innovation
MSR: Merck Serono Research
MSSA: Merck Serono S.A.
MSSE: Merck Shared Services Europe
mt: mutant
MTC: Mixed Treatment Comparison
MTD: Mean therapeutic dose
MTD: Maximum Tolerated Dose
MVVG: Versicherungsvermittlung
NA: Not Available
NABTC: North American Brain Tumor Consortium
NABTT: New Approaches to Brain Tumor Therapy
NBE: New Biological Entity
NCD: Non Clinical Development
NCE: New Chemical Entity
NCI: National Cancer Institute (USA)
NCIC: National Cancer Institute of Canada
NCS: Non Clinical Safety
NDA: New Drug Application
NDA: Non-Disclosure Agreement
NDD: Neurodegenerative Diseases
NHS: National Health Service
NICE: National Institute of Health & Clinical Excellence (HTA body UK)
NIM: Non Clinical Issue Meeting
NIS: Non-interventional studies
NK: Natural Killer (cells)
NMA: Network Meta-Analysis
NMDa: N-Methyl-D-aspartic acid
NME: New Molecular Entities
NOAEL: No Observable Adverse Effect Level
NOEL: No Observed Effect Level
NPV: Net Present Value
NR: Not Reported
NRAS: Neuroblastoma RAS viral (v-ras) oncogene homolog
NS: Not Significant
NSAID: Non Steroidal Anti Inflammatory Drug
NSCLC: Non-Small Cell Lung Cancer
OA: OsteoArthritis
OE R&D: Operational Excellence Research and Development
OECD: Organisation for Economic Cooperation and Development
OHDA: Hydroxy-Dopamine
ONC: Oncology
OOO: Out Of Office
OP: Operative Planning
OPM: Operational Project Management
OR: Overall Response
ORR: Overall/Objective Response Rate
OS: Overall Survival
OSM: Option Space Mapping
PHE: Pricing & Health Economics - OBSOLETE
p.o.: per os (oral administration)
PA: Psoriatic Arthritis
PAES: Post-Authorization Efficacy Study
PAMPA: Parallel Artificial Membrane Permeability Assay
Papp: Apparent Permeability
PAS: Patient Access Scheme
PASS: Post-Authorization Safety Study
PBAC: Pharmaceutical Benefits Advisory Committee (HTA decision body AU)
PBL: Peripheral Blood Leukocyte
PBMC: Peripheral Blood Mononuclear Cell
PBS: Phosphate Buffer Solution
PC: Project Coordinator
PCD: Pre-Clinical Development
PCI: Process and Capability Improvement
pCODR: pan-Canadian Oncology Drug Review (oncology HTA body Canada)
PCR: Polymerase Chain Reaction
PCS: Protein and Cell Sciences
PCT: Pragmatic Clinical Trial
PD: Progressive Disease
PD: Parkinson Disease
PD: PharmacoDynamics
PD: Portfolio Development
PDC: Product Development Committee
PDGF: Platelet-Derived Growth Factor
PDs: Pharmacodynamics
PEAT: Protein Engineering & Antibody Technologies
PEC: Pharmaceutical Executive Committee (previously Executive Management
Board)
PERT: Project Evaluation and Review Technique
PfD: Portfolio Development
PfM: Portfolio Manager / Portfolio Management
PFS: Progression free Survival
PGP: P-GlycoProtein
PGx: Pharmacogenomics
PI: Prediction Interval
PIA: Pristane Induced Arthritis
PIMS: Project Information and Management System
PIP: Pediatric Investigational Plan
PK: Pharmacokinetics
PK / PD: PharmacoKinetics / PharmacoDynamics
PKs: Pharmacokinetics
PKU: Phenylketonuria
PLP: Pyridoxal Phosphate
PLT: Project Leadership Training
PM: Performance Materials
PM: Project Manager
PM CoE: Project Management Centre of Expertise
PMA: Phorbol 12-Myristate 13-acetate
PMBOK: Project Management Body Of Knowledge®
PMC: Preclinical Medicine Committee
PMCoE: Project Management Center of Excellence - former name of PfD's Global
Project Management department, renamed in April 2010
PMO: Program Management Office
PNS: Peripheral Nervous System (nerves coming from central nervous system
(brain & spine) and the autonomic nervous system (vital organs)
PoC: Proof of Concept
PoP: Proof of Principle
PoS: Probability of Success
po: Per os, per oral
PPB: Plasma Protein Binding
PPMS: Primary Progressive Multiple Sclerosis (primary activity in the spinal
cord)
PPRS: Prescription & Price Regulatory Services (UK)
PR: Partial response
PS: Performance Status
PS: Patents & Scientific Information
PSO: Psoriasis
PSUR: Periodic Safety Update Report
PTP: Pharma Transparency Portal (CIS countries)
pts: Patients
q2w: every two weeks/biweekly
QA: Quality Assurance
QALY: Quality Adjusted Life Year
QC: Quality Control
QD: Quality Document
Qde: Quality Delegate
QDeSC: Quality Delegate Site Coordinator
QMS: Quality Management System
QOL: Quality Of Life
QPPV: Qualified Person for PharmacoVigilance
QRM: Quality Risk Management
QSAR: Quantitative Structure Activity Relationship
R: Randomization
R&D LT: Research and Development Leadership Team
R&R: Roles and Responsibilities
R/M: Recurrent/Metastatic
RA: Regulatory Affairs
RA: Rheumatoid Arthritis
RA: Risk Assessment
RACI: Responsible, Accountable, Consulted, Informed
RAF1: v-raf1 murine leukemia viral oncogene homolog 1
RAMP: Research Alliance Management Program
RBS: Resource Breakdown Structure
RCK: Rockland
RCM: Ring-Closing Metathesis
RCM: Regulatory Compliance Management
RCM: Restrictive CardioMyopathy
RCT: Randomized Controlled Trial
RD: Recurrent Disease
RDI: Relative Dose Intensity
RDMM: Research and Development Management Meeting
RDMT: Research and Development Management Team
REA: Relative Effectiveness Assessment
RECIST: [Response Evaluation Criteria In Solid Tumors|HSR:RECIST Criteria]
REG: Regulatory
rhFGF18: Recombinant Human Fibroblast Growth Factor 18 (in our pipeline - for
Osteoarthritis)
RGD: Arginine-Glycine-aspartic acid
r-hGH: recombinant human Growth Hormone (our Saizen product)
RIMPFT: Relatively Ineffective Medical Procedure for Treatment (e.g. of
children)
RI-KM: Research Information and Knowledge Management
RLCM: Rebif Life Cycle Management
RNF: Rebif New Formulation
RNG-1: Rebif Next Generation
ROC: Research Operating Committee (prev. Discovery Review Committee)
ROP: Rules of Procedures
ROW: Rest of World
RR: Response Rate
RPRS: Research Portfolio Review System
RRMS: Relapsing/Remitting Multiple Sclerosis (primary activity in the brain)
RSA: Risk-Sharing Agreement
RT: Radiotherapy
RT: Related Tool
RWE: Real World Evidence
Rx: Radiological
S&E: Search & Evaluation
s.c.: subcutaneous
S.D.: Standard Deviation
SAE: Serious Adverse Event
SAP: Statistical Analysis Plan
SAR: Structure Activity Relationship
sc: Subcutaneous
SC: Site Coordinator
SCC: Squamous Cell Carcinoma
SCCHN: Small Cell Cancer of the Head and Neck
SCE: Small Chemical Entities
SCGE or COMET: Single Cell Gel Electrophoresis Assay
SCLC: Small Cell Lung Cancer
SD: Stable Disease
SDD: SAS Drug Development
SDM: Safety Data manager
SDM: Streamline Decision Making
SEED: Shaping European Early Dialogues (HTA collaboration Europe)
SIRPM: Strategic Innovation and Research Portfolio Management
SLA: Service Level Agreement
SLE: Systemic Lupus Erythematosus
SLS: Static Light Scattering
SM: Stratified Medicine
SME: Site Molecule Expert
SMEDDS: Self MicroEmulsifying Drug Delivery System
SMC: Scottish Medicines Consortium (HTA body Scotland)
SmPC: Summary of Product Characteristics
SMQ: Standardized MedDRA Queries
SOBP: Society of Biological Psychiatry
SoC: Standard of Care
SOP: Standard Operating Procedure
SOPD: Sum of the Product of Diameters
SOW: Statement Of Work
SP: Study Plan
SPA: Special Protocol Assessment
SPC: Summary of Product Characteristics
SPE: Special Purpose Entity (financial term)
SPR: Surface Plasmon Resonance
SR: Sustained Release (Rebif / Medusa)
SRE: Serious Reportable Event
SRE: Systematic Review of Evidence
SSc: Systemic Sclerosis, Systemic Scleroderma
STEPP: Subpopulation Treatment Effect Pattern Plots
STS: Soft Tissue Sarcoma
SUSAR: Suspected Unexpected Serious Adverse Reaction
SWAN: System We All Need (Clinical Trial Management System)
SWOG: Southwest Oncology Group
SWOT: Strengths, Weaknesses, Opportunities & Threats
T&SC: Technologies and Site Coordination
t1/2: Half Life
TA: Therapeutic Area
TALT: Therapeutic Area Leadership Team
TBFA: Target Binding Filtration Assay
TC: Target Chemist
TC: TeleConference
TCD: Therapeutic Concept Discovery
TCM: Therapeutic Concept Discovery Meeting
TCM: Traditional Chinese Medicine
TCP: Target Compound Profile
TCT: Therapeutic Concept Team
TDM: Trial Data Manager
TDP: Transforming Development Program
TDROC: Time-Dependent Receiver Operating Characteristics
TEAE: Treatment-Emergent Adverse Event
TEER: Transepithelial / Endothelial Electrical Resistance
THLD: Threshold Pharmaceuticals, Inc.
TK: Toxicokinetics
TLP: Target Lead Profile
TLV: Tandvards och Läkemedelsvörmansverket / Dental and Pharmaceutical
Benefits Agency (HTA body Sweden)
TGF: Transforming Growth Factor
tmax: Time to maximum concentration
TMF: Trial Master File
TMZ: Temozolomide
TNF: Tumor Necrosis Factor
TNM: Tumor-Node-Metastasis staging system
TOX: Toxicology
TPC: Target Product Claim
TPP: Target Product Profile
TSMP: Talent and Succession Management Program
TT: Trial Team
TTC: Threshold of Toxicological Concern
TTF: Time to Treatment Failure
TTP: Time To Progression
UAT: User Acceptance TEST
UC: Ulcerative Colitis
UDS: induction of Unscheduled DNA Synthesis
UGT: Uridine diphosphate GlycosylTransferase
UHC: Universal Health Coverage
UMN: Unmet Medical Need
UMT: User Management Tool
USP: Upstream Process
USP: Unique Selling Point
VBP: Value-Based Pricing
VCAM: Vascular Cell Adhesion Molecule
VCL: Virtual Central Laboratory
Vd: Volume of Distribution
VEGF: Vascular Endothelial Growth Factor
VEGFR: Vascular Endothelial Growth Factor Receptor
Vss: Volume of distribution at steady state
WBS: Work Breakdown Structure
WCB: Working Cell Bank
WHO: World Health Organization
WI: Work Instructions
WL: Werksleitung
WPG: Working Practice Guideline
WS: Work Stream
wt: wild type
WTP: Willingness To Pay
XELOX: Xeloda (capecitabine), oxaliplatin
XRD: X-Ray Diffraction
{glossary}]]></ac:plain-text-body></ac:macro>