Nomen Omen - Informa Connect...Verba volant scripta manent "By assigning a single international name...
Transcript of Nomen Omen - Informa Connect...Verba volant scripta manent "By assigning a single international name...
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Nomen OmenThe INN Programme: scope and policies
Dr Raffaella Balocco Mattavelli, WHO INN Programme
Antibody Engineering & Therapeutics
December 11-15, 2017, San Diego, CA
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
What's in a name?
Safety
Quality
Information
RegulationRational use use
Procurement
Efficacy
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Verba volant scripta manent
"By assigning a single international name to drugs, WHO helps ensure that a prescription filled abroad is what doctor ordered back home."
Dr Margaret Chan,
Former WHO Director General
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
WHO some basic facts
194 Member States
Two governing bodies: - World Health Assembly - Executive Board
WHO Secretariat: - HQ- six Regional Offices- WHO Expert Panels
(e.g... on the International Pharmacopoeia and Pharmaceutical Preparations etc.)
Constitution 1946, in force since 7 April 1948(World Health Day)
Article 2 (u) International standards
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
WHO's constitution
Inter alia:
to act as the directing and coordinating authority on international health work
to develop, establish and promote international standards for food, biological, pharmaceutical and similar products
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
The WHO International Nonproprietary Name (INN) Programme
To provide one single name worldwide for active pharmaceutical substances
Initiated in 1950 by resolution WHA3.11
Operational since 1953
Based on WHO Constitution
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
INN Programme
To devise a single name for a substance
INNs are recognized in almost all Member States
INNs can be used freely and cannot be registered as trade names
Not concerned with formulations
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Interested parties outside WHO
USAN Program
Pharmacopoeias
(BP, FP, USP, JP….)
European Commission,
WCO, WIPO, …
Research based
industry
National trade-mark
authorities
DRAs(EMA, US-FDA….)
INN Programme
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Various trade names ® for one substance, ex. paracetamol
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Various generic names for one substance, ex. paracetamol
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
One International Nonproprietary Name for one substance, ex. paracetamol
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
INNs…
Unique name
Distinctive in sound and spelling
Not liable to confusion with other names in common use
Formally placed by WHO in the public domain
Can be used without any restriction to identify pharmaceutical substances
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
The INN System
WHO Secretariat
INN Expert Group
INN Advisory Groups on Biologicals, publications etc.
Publications
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
The Business Process Model
Broad consultation
Lot of correspondence
2 INN meetings/year
"Ad hoc" meetings……
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
INN selection process
➢ Secretariat receives INN applications
➢ Consultation / INN Expert Group
➢ Secretariat informs applicants
➢ Validation of Information
➢ Published in a List of proposed INN
➢ 4-month period for objections and comments
➢ Published in a List of recommended INN
Clinical Phase I
Use code pending
r.INN assignment
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
General Principles in devising INN
INN should not be too long
Isolated letters, numbers to be avoided
Anatomical, physiological, therapeuticalconnotations, trademarks conflicts to be avoided (cardioprofen, superprofen, cancerprofen, panadolprofen)
Transliteration issues"f" instead of "ph" "t" instead of "th"
"i" instead of "y" avoid "h" and "k"
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Use of stems
To indicate chemical and /or pharmacological group relationship
Published for 'established series of related compounds'▪ Fantasy prefix + -stem as a suffix: tazobactam (63)(29)
▪ Fantasy prefix + -stem- as an infix: misoprostol (47)(22)
▪ Stem- as a prefix +fantasy suffix: cefuroxime (34)(16)
INN and stems have protection within trade mark arena
WHO publication "The use of stems in the selection of INN " Stem book 2013+ Addendum (when necessary)
➢ Names of
"pharmacologically/chemically -related"
substances
have a common stem
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Biologicals are more complex
Interferon beta
MW 19'000D
Aspirin
MW 180D
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
An expanding area within pharmacy
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Current INN position for biological products
26 biological groups with stems
3 groups with an INN nomenclature scheme
Generals policies developed for 12 groups of biological products
'INN for biological and biotechnological substances a review' http://www.who.int/entity/medicines/services/inn/BioReview2016.pdf?ua=1
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Biological groups with INN stemsStemName of the groupStemName of the group
-parinHeparin derivatives including low molecular mass heparins
-ganan(pre-stem)
Antimicrobial, bactericidal permeability increasing polypeptides
-irudinHirudin derivatives-rsenAntisense oligonucleotides
-imodImmunomodulators, both stimulant/suppressive and stimulant
-apt-Aptamers, classical and mirror ones
-kinraInterleukin receptor antagonists-coginBlood coagulation cascade inhibitors
-kinInterleukin type substances-cogBlood coagulation factors
-mabMonoclonal antibodies-celCell therapies
-tocinOxytocin derivatives -stimColony stimulating factors
-tidePeptides and glycopeptides-aseEnzymes
-relinPituitary hormone-release stimulating peptides-poetinErythropoietin type blood factors-fuspFusion proteins
-ceptReceptor molecules, native or modified-geneGene therapies
-siran-Small interfering RNA-relixGonadotropin-releasing hormone (GnRH) inhibiting peptides
-actideSynthetic polypeptides with a corticotropin-like action
-erminGrowth factors and Tumour necrosis factors (TNF)
-ressinVasoconstrictors, vasopressin derivativessom-Growth hormone (GH) derivatives
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Former Nomenclature scheme for monoclonal antibodies
PrefixSubstem A:Target Class
Substem B:Species
Stem:
random -am(i)- serum amyloid protein (SAP)/amyloidosis (pre-substem)
-mab
-b(a)- bacterial
-c(i)- cardiovascular
-f(u)- fungal
-gr(o)- skeletal muscle mass related growth factors and receptors (pre-substem)
-k(i)- interleukin
-l(i)- immunomodulating
-n(e)- neural
-t(u)- tumour
-v(i)- viral
-a- rat
-axo- rat-mouse (pre-sub-stem)
-e- hamster
-i- primate
-o- mouse
-u- human
-vet- veterinary use (pre-sub-stem)
-xi- chimeric
-xizu- chimeric-human(ized)
-zu- humanized
Ex. drozitumab (103)(65) ; olokizumab (103)(65)
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Current Nomenclature scheme for monoclonal antibodies
Prefix: Infix:target class
Stem:
random -ba- bacterial -mab-ami- serum amyloid protein (SAP)/amyloidosis (pre-substem)
-ci- cardiovascular
-fung- fungal
-gros- skeletal muscle mass related growth factors and receptors (pre-substem)
-ki- interleukin
-li- immunomodulating
-ne- neural
-os- bone
-toxa- toxin
-ta- tumour
-vet- veterinary use (pre-stem)
-vi- viral
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
General policies for glycosylatedproteins/peptides
• Identify the group with a stem (ex. -poetin)
• Indicate differences in the amino acid sequence with a random prefix (ex. darbepoetin)
• Indicate differences in the glycosylation pattern with a Greek letter spelt in full as second word(ex. darbepoetin alfa)
Greek letters assigned in the alphabetical sequence as applications received !
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Reaching the world
➢ INNs Lists are published in WHO Drug Information
➢ All INNs are published in a Cumulative List
➢ On-line INN information: Mednet - INN Extranet
➢ Global Data Hub
➢ School of International Nonproprietary Names - SoINN
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
INN Links
• http://www.who.int/medicines/services/inn/en/index.html
• http://mednet.who.int/
• https://extranet.who.int/tools/inn_global_data_hub/
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
School of INN
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
School of INN ….more
• Virtual School
• Teaches the INN and Science of Nomenclature for Pharmaceutical Substances
• Develops innovative strategies to promote INN as a central theme for teaching all health professionals
• Publishes book, articles, leaflet for purpose of raising awareness of INN in the scientific community and the educational community
• Develops e-learning platforms for the continuing education of students and health professionals
• Offers e-learning courses
• Identifies Pilot sites for INN education: Friends of INN Universities
• Opens to partners and collaborations
• and…….
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
SoINN Platform(under development)
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
School of INN
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Thank you
Nomen est omen