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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



What's in a name?

Safety

Quality

Information

RegulationRational use use

Procurement

Efficacy



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



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



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



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



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



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



Various trade names ® for one substance, ex. paracetamol



Various generic names for one substance, ex. paracetamol



One International Nonproprietary Name for one substance, ex. paracetamol



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



The INN System

WHO Secretariat

INN Expert Group

INN Advisory Groups on Biologicals, publications etc.

Publications



The Business Process Model

Broad consultation

Lot of correspondence

2 INN meetings/year

"Ad hoc" meetings……



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



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"



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

http://www.who.int/medicines/services/inn/stembook/en/index.html



Biologicals are more complex

Interferon beta

MW 19'000D

Aspirin

MW 180D



An expanding area within pharmacy



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

http://www.who.int/entity/medicines/services/inn/BioReview2016.pdf?ua=1



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



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)



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



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 !



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

http://mednet.who.int/



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/

• [email protected]

http://www.who.int/medicines/services/inn/en/index.html

http://mednet.who.int/

https://extranet.who.int/tools/inn_global_data_hub/

mailto:[email protected]



School of INN



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…….



SoINN Platform(under development)



School of INN

https://www.youtube.com/embed/efjbk5o_xBk?rel=0&autoplay=1



Thank you

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nomen omen - informa connect...verba volant scripta manent "by assigning a single international...

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