EIP.G

- •

.

These are troubled times.....

€90bn Irish bailout ends in tunnoil.Now Europe fears crisis will spread

~. theguardian

Warning that VI< 'may neverrecover' ifGreece exits euro -.:

•

•••

•,

..(l. ,;

I .•:lA I

~ /1. "'t. :;o.a,,' - l

Greek austerity plans not ready, sayeurozone ministers Recession causes

doubts over Italy'sdeficit cut plans

1

....,

-EurOlone mlnls1.rs tUlve ~st doubt onGr••ce'. lIbility to push throughausterity menu re. n••ded to relene a130bn .uro (S170bn: [110bn) bailout.

AI it mtebng 01 finance 11\lOlS1ers In BrusselSGermany's WOlfoang SCnaeuDle saI<I a planagree<! Dy Gret<e'S fragile (oa~uonanerdays Of lalkS was -not at a Sl39t wMre It canDe slgned orrThe EU and IMF demaOde<l stoogent cuts In Gemlan FllIance Mlnls'« WoIfgq SChHII~

return IQ( the baIloUt mooey Ntgoc.IIII.ontlllYefll tome'lf tnOUgtI'

These are troubled times.....

•

.----- MOOCO

u.<--•

GERMAJff

FIWKE~" :tITAlY ~

CH'".-.--w'"

,-__ SOOTH

""'"

• SnlllN RECESSION(two or men quarten of negative~ lnck.u:fng the most rt<leflt quarter)

EMERGEO fROM RECESSION(two lJIIrteI'S (:If negative wowthbut most recent quarter was pos/tllOe)

• OCDGEO RECESSION (..., "'" ....Of morequarttrSof negative~

B1lA2ll

,-J---ARGENTlNA

'Ill- SOUTMAFRlCA

•

These are troubled times.....

·....and pharma ;s not ';mmune~Fewer New Drugs Gain ApprovalPharmaceutteal companies have spent more on research anadevelopment over time. but have discovered fewer novel drugs goodenough to gain EO.A. approval.

PHARMAC£unCAL R&OEXPENOIT\JRES

$ 70 "'Iben

NEW DRUGSAPPROVED·

60

'95 '00 '10'OS'00

20

o'95

10

40

30

50

'09'OSI i ,

PhrMa...........iiie'fiitJe;fS· .

1""",1

10

o

60

50

40

30

20

• Does not Include biologies, "'Pharrnaceu!tcal Research and Manufacturersof Amcnca. or PhRMa, Includes most or the maJOr U.$. pharmaccutlcalresearch and biotechnology companies.

Souroes: Food .-ld Drug Admlnl51ratlon;Phal'fNCeUtal R~rch aM t·l.Nlut'ectorp.1"l cA Amenca

.....and pharma is not 'immune~

$40

$50

$43.0

$311.11 $39.4

New DrugApprov.1s (NHE.)

PhRHA Hom....rRaD Spe.nding-

53

60

50

-~ 39 -z: 40 ,"9.8c.2z 3 30 -- -$26.0 .-.. so- 26 ~8 30,.

30 $2.2.7 ....> -0 25 $19.0 $21.0

~- 24.. 22 $16.9.. 21 $20 etc $15.2 18 .." 20 $12.7 $"1:3.4 17 ~, E~ $11.5 ~~ ..0 ~

~..,.

10$JO

z

o $0

1992 1993 1994 1995 J996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

SOUl( : B.,,,II 8[ Con'POny: US ~ood and 0'''9 A""'-lIaUon

Drug Development is a Costly Business

The cost of producing a successful marketable productwas approximately €980 million in 2006

• Figure includes both the cost of the successful candidateand those of the failures.

• Failures represented over 70% of the total cost in 1995.

• Only 34% of new drugs introduced between 1990 and1994 registered revenues that exceeded the averageresearch and development cost (blockbusters).

• In 2003 it was estimated that in order to maintain ahealthy revenue growth rate of 10%, the ten largestpharmaceutical companies would need to launch aboutthree new compounds per year. Less than two launchesper company were actually achieved in 2000.

Drug Development is a Costly Business

Number of Compounds to Produce a New Drug

FDA Review

Phase 1111,000-5,000 Volunteers

PhUt 11100-500 Volunteers

5-10 Compounds

Phase I20-100 Vo:unteers

Clinical Trials

250 Compounds

Preclinical

• 3-6 Years • • 6-7Years • +- 0.5 - 2 Years --+

Source: PhRMA and FN estimates

Drug Development is a Costly Business

Number of Compounds to Produce a New Drug

Phase laPhase Ib Phase Ha

40-60 healthy 30-50 healthy 50 - 200

subjects patientssubjects

$300,000$300,000 $750 ,000

6 months6 months-l 9 months -2

year years

•6·1 Years

•

;p.==~~----- ,I' ' l...

•

Clinical Trials

•

Preclinical

3·6Vears•

Source: PhRMA and FN estimates

Drug Development is Time-Consuming

Number of Compounds to Produce a New Drug

FDA Review

Phase 1111,000-5,000 Volunteers

Phase 11

100-500 Volunteers

5-10 Compounds

Phase I20-100 Vo:unteers

Clinical Trials

250 Compounds

Preclinical

• 3-6 Years • • 6-7 Years • +- O.5-2Yean --+

Source: PhRMA and FN estimates

10-'5 years from start to launch

Growing Regulatory Conservatism

- - •

"The Committee's decided to ban further researchuntil it can be proven your 'wheel' poses no

threat to the environment, societ or public health"

Technology Stagnation

Technology Stagnation

Technology Stagnation

Technology Stagnation

• 2004: Waters introduces the first of its ultra-high performanceliquid chromatography instruments (Acquity UPLC®), capable ofwithstanding the high pressures associated sub-2 flm particlecolumn technology.

• 2006: Waters launches Acquity UPLC® H-Class for researchers"who have been attracted by the promise of UPLC but remainreluctant to change largely because of their comfort levels withexisting HPLC systems and techniques" (Rohit Kanna, WatersVP ofworldwide marketing).

• 2012: Legacy methods are still running under HPLC quaternarymethodology. Companies try to obtain advantages of sub-2 flmparticle columns on regular HPLC instruments, or change tocore-shell columns, but few, if any, migrate to ultra-highperformance liquid chromatography.

Just to put things in perspective...

-_.. _...--- -- ----_.. -...-_.. - ---_... ------

------ ----

•

- -------- -----~-- _-..-- --

----_._-

Consequences of Technology Stagnation

• Production and quality control are not state-of-theart compared to other industries.

• Products are of good quality, but this comes atgreat effort and cost compared to other industries.

• High manufacturing costs are compounded by theuse of technologies that are inefficient by modernstandards.

• Technology stagnation in manufacturing andanalysis acts as a bottleneck in the development ofinvestigational medicinal products, particularlybiotechnological products.

Drug Development is Time-Consuming

Number of Compounds to Produce a New Drug

FDA Review

Phase 1111,000-5,000 Volunteers

Phase 11

100-500 Volunteers

5-10 Compounds

Phase I20-100 Vo:unteers

Clinical Trials

250 Compounds

Preclinical

• 3-6 Years • • 6-7 Years • +- O.5-2Yean --+

Source: PhRMA and FN estimates

10-'5 years from start to launch

Drug Development: A Race Against Time

20Blockbuster US Patent Expiries

18

20s(,1I16

BlaxinPrlnlv1l~ Intron Zlthromax<Il 14c: Imigran0 Novolin- Augmentin.- 12 Noupog(lnto

'" Rocephln Oxycontin~ Glucophagc 2010ft<Il 10.. Levaquln

'" M.lavotinCl) 8 Coton- Claritln Ditlucan

Provacld0 Advair Pravachol0

6NFla....nt

Lovenox

PaxllElfexor

4 Plavtx Epogon

Louc ZocorFosamaxNeurontln

2Procrlt Norvasc

Clpro Rlsperdal0

2002 2003 2004 2005 2006 2007

o~

'D[]J@

Drug Development: A Race Against Time

Annual Sales Volume in the EUbecoming available for competition

2,2682,115

1,024 1,018

2,059

°

2,000 1,1'74

1,000

€ million 2,On

2004 2005 2006 2007 2008 2009 2010

Drug Development: A Race Against Time

Developed Markets Generic Share

11.9% .

~Canada

olulV

24.2%

15.3%

16.2%

5.0% : 8-9%

13-14%

21-22%

21-22%

27-28%

.2010 Generic Share

.2015 Share Increase

'.'~5 Kore.

.

31.7% I 34-35%

12.8% 15-16%

.:l::.W

u,

- .'

21.3% : •. 27-28%

13.4% 21-22%

SourcE': IMS Market Prognoiis. Apr 2011

Drug Development: A Race Against Time"

.2010 Gel'!.'rk Sl'are

2015 Sh~re I"crea~e

27-28

8-9%

""=;-J 13-14%

,~.

........

lo...

P"",." SOLUTION.~-

::CoUlpanie's offer a mixed portfolio ofnt;~.- .".",," '::),ne:dici'hes"and generio m=-=ec1icines; 22

PI.... E_ p~ Ell '''' 21-22%

.........cRIop«d.1

HOWEVER2,268 34-35%

€. The' gene'rics market is a differenlngl1 game.2,000 1,774 ..~

•

•,

....

-~ .

~ l~

ID 12­~

i 10

•~ .-

MiWY originatotOcompanies do not possess the e~perience

and/or know-how to play in the generic space, and musta,cquire or form joint ventures with existing players.

2004 2005 2006 2007 2008 2009 2010

Is Europe prepared to pay?In Europe, generics make up almost one halfofvolume

sales, but merely a fraction ofvalue sales100%

90%79%

70% 70%g Volume - generic market shareIIValue - generic market share

57% 60%50% 52% 53% 53%

48%

37% 38% 42% 4

13% 4

13% 43% 4~% 4~

32% 33% 34% iiI f"7% 28% i IiI I 28% I 28% 28% 30%

11 I!§ 18% 18% 17%16% 13% 13% 13% 13% 16%20%

0%

30%

60%

70%

40%

50%

80%

10%

Is Europe prepared to pay?

The European Union constantly considers cost­containment policies in public pharmaceuticalspending.

• External reference pricing as a tool to controlprices and set a parameter of expenditures.

• Rebates, clawback and payback policies.• Internal reference pricing.

The inclusion of the most recent medicinalproducts in reimbursement lists or governmentformularies is sometimes inexplicably delayed.

Is Europe prepared to pay?

"Europe has unfortunately slipped in termsofits willingness to pay for innovation. ...We're now at a point where we have to takethe view and I thinkface the reality thatreally it's about the us. and, excitinglyanew, it's about Japan in terms ofwhereinnovation should be driven."

(Sir Andrew Witty, CEO GlaxoSmithKline)

Where have we heard this before?R&D INVESTMENT

Pharmaceutical R&D ExpenditureNME LAUNCHES

New Molecular Entities (NMEs)by Region of First Launch

0+--.-.--,...,--,-.---.---.-.-..,9293949596979899000102

- -----

- ••/

-

Europe

U.5.

$30

IIIZ 20o-......-III'"

us

CAGR92-02

11%

8%

100%

80

60

40

20

o

203

1993-1997

170

1998-2002

It's not quite deja vu.Enter the Pharmaemerging Markets

Spending by Geography

$l,175-1,20SBn

2006

Soulte: IMS Hafht Progrosis., H,y 2012

2011

• United States

• EU5• Japan• Pharmerglng

• Canada• Rest of Europe• South Korea• Rest of Wond

It's not quite deja vu.Enter the Pharmaemerging Markets

RANk 2006 INDEX RANK 2011 INDEX RANk 2016 INDEX

1 United States 100 1 United States 100 1 United States 100

2 Japan 35 2 Japan 36 2 A China 3'3 A France 13 3 A China 21 3 V Japan 364 V Gennany 13 4 Germany 14 4 A Brazil 15

5 .6. China , 5 V France 12 5 V Germany 13

6 V Italy 8 6 .6. Brazil , 6 V France 11

7 A Spain 6 7 V Italy , 7 Italy 8

8 V UK 6 8 V Spain 7 8 A India 7, V Canada 6 , Canada 7 , A Russia 7

10 Brazil 5 10 V UK 7 10 V Canada 6

11 Australia 3 11 A Russia 5 11 V UK 6

12 Mexico 3 12 V Australia 4 12 V Spain 5

13 South Korea 3 13 A India 4 13 V Australia 4

14 Russia 3 14 V South Korea 4 14 A Argentina 4

15 V India 2 15 V Mexico 3 15 V South Korea 416 A Turkey 2 16 Turkey 3 16 V Mexico 3

17 V Netherlands 2 17 A Poland 2 17 A Venezuela 318 V Belgium 2 18 A Venezuela 2 18 V Turkey 319 A Greece 2 19 V Netherlands 2 19 A Indonesia 220 V Poland 2 20 V Belgium 2 20 V Poland 2

...... Change in ranking over prior 5 yearsAppendix notuR~nking in all years based on spending in constant US! at 04 2011 ellthange riltes.

Source: IMS Market Prognosis. May 2012 Index in each ~ar based on rat;o of country spending to U.S. spending (in constant USl) in the y~ar.

Outsourc;ng ;5 not new

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in CNStJI Cities..

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AWORLD~r OF

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.,...", oIltlKom cOlld spHd 6t'tt1oplnHt.r- otlltf c.aII cfllttrS.rt 091.19"'.

Mawitius.

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, INOIIJT stmces. dlIp~ uII ctnItrs,IlllIIlI&sint'U ,*,-otfiu W'lIflIlrNdy9fftfl'1tt $10bib Iaflpom Md cNdIlit S57 ... by 2008.1rd1n prtMOtnlu 1Itl, Iltosys,1Ad 'I'trv -Hlt11119IobiI1t1llltrs.1lld us. IT StRict f.1IlS1ft piI:IllQ 1ft.

Outsourcing is not newSOIII. mICA

IHIII

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EJS1lIII EIIIIIl

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,....-. Gtmin IIIIlItIMtlcNlt.

t!..1Jut this is differe

AWORLDOF

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Outsourcing is not newSOUIH IflICA

S-1OO lDc.II.ofhroan sttYIct , •.portfn tmploy up to 10,000fG9I~sllfdlllllllJ In QNll9lrx ...ojKl:s. blllq)lGrtf Motllftlla, lid IIlt,1 Un SUIRiD (film. Stilll.llM 'llOflDClUS"tCllltd PIli of ..sttl"s II'ld doctorllft'n KItf'C:n. IT. MId IUtII.

lUll

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of ftlKCItI COlIllI sptH cif tllop'1'ofnt.Otatr aGlm ft O\ii : , lIP •.-

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AWORLDOF

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S«0IllIq' f.-..o!1tt nMd ,tQiattfUlllOllIsourtlllCJ ",,"!'of us. (:OlII£IIIIH

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IS bKomrtICI. Uy (IJtldIct*__IIlU! tM:tl' tor GtwII OKltIt, IIItrl.PIlitips.. McrosafL _lIttIIf NI;1...cs.lIb. SU'tftlIIM Il'. ""dwlft .....aIId ICllIlirddtd 1On..",_ e- cnltrsfer ....1Id 50uUI~ .rt .,.130III cNStJII atJft.::m

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spu~ 119 COIlSUlMl1ln tilt U,$.....Ewopt.

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Outsourcing is not newSOUIH IflICA

S-1OO lDc.II.ofhoarl sttYIct , •.portfn tmploy up to 10,000fG9I~sllfdlllllllJ In CM9ltJ ...ojKl:s. blllqIklrt' Motllftlla,lIld Iatel Un SUIRiD cflltn. S MiM 'llOfblUS"l'llPtd IlDOt of ..sttl"s II'Id doctorllft'n KltN:n. IT. MId /UtI\.

Inll

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..... .and A.'lItI1c:iD rT wr .,prof.n

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Wlhducltlld~ of fflllCll, [a­flU, lad GfnIoIII". III OWl' A'/bsutl'''....1lIlI aI ctIItftJ Yl:rllll9"., to brooNn~Dtfll~.lJDft

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AWORLDOF

OUTSOURCING

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Are emerging markets the solution?

( Global New Molecular EntitiesCountry Availability

Global Launches of New Molecular Entities

..... -- -.tlWlovatar• Orphan• fellowet'

o+-L-LJ--L.....LJL.....JL.I......--,O....................'"

... ,

3S ,~ "',wis 2S ~z

~ ,.,w,z

IS

~9 10 <~

5 1

w,ao"z

~ "'''~

5 ..""> SO"<> ...""B "'''" ,."~

~

""0w• '"<,~

#

• Add1tIon~1 2006·2010 NME available In 2016

• 2006-2010 NME available In 2011

2005 2006 2007 2008 2009 2010 2011 IAverage1Per Ye"r12012 •l~l~ _

Are emerging markets the solution?

rE t e

",oltor

to 2011 IAver.I Per Yeilr12012 •

12016

Pharmerglng

• Additional 2006·2010 NME available In 2016

.2006-2010 NME available In 2011

Developed

Global New Molecular EntitiesCountry AvailabilityG b.

ew>: SO%~ z< "'..z "'"-"" ~ 70%

~ "'.. ..5 "'.. :5 60%-" '"~ """ :c SO%~ """ >- 40%~ ::l"'..0 UI 30%~ 20..~ 0• 10.. ~ 20%0 Cl~ ...« ... 10%<

~C. ~~~0

< w~ .. ! ~ ::l :! l;

I E~ - . '" O'lb8

,'"rVI

"#AdehU

• 2006-

SoY'''': IMS IMtltuto for KNItha,. In

Sourm: IMS Instituto for HNlthcalll Inbtn/ltic\ May 2012

Are emerging markets the solution?

GLobaL Launches of New MoLecuLar Entities

no 2011! AverageI Per Yeilr12012 •

12016

rE t e

OVdtor.- - --looovator• Orphan• Follower

2005 2006 2007 2008 2009 2010 2011 1AverageI Per Year 112012 - 1l2016 _I

15

10

40,

5

35

o

VI 30w

o 2Sz

~ 20w>:z

~9"

""'..G b,

20..

10.....

"'..

Sou'''': IMS IMtltuto for KNltha..

Source: INS Instituto for HoaLthcart lnblNtics. May 2012

So let~s access emerging markets

This is not as straightforward as it seems.

• Diverse healthcare systems

• Fragmented markets

• Complex regulatory systems

• Cultural and language barriers

• Increased competition (local and global)

• Varied infrastructure

• Highly dynamic situation

India: A case study

In 2005:

• Sector ranked 4th worldwide in volumeterms, 13th in value.

• Market worth €3.6 billion (1% of worldmarket in value, 8% in volume).

• Growth rate of 5.1%, projected to reach€18.8 billion by 2010.

• Total exports around €2.25 billion, to over65 countries.

India: A case study

Why this success?

Jugaad: Literally, anarrangement or aworkaround, which has tobe used because of lack ofresources. Practically, acreative idea, a quick,alternate way of solving orfixing problems.

India: A case study

Today:

• Plans to widen scope of price controls to348 medicines from the current 74. "Mostcountries follow some form ofprice control.We need to ensure that expensive drugs areavailable at affordable rates to the poor."

(D.S. Kalba, Secretary, Pharmaceutical Department)

India: A case study

Figure 2: The Wealth Pyramid across the emerging markets (adapted from Prahalad andL1eberthal, 1998').

Purchasing power parity

In U.S. dollars

Population in millionsChina India 8razil

hi\ Greater than $20,000 2 7 9

a lot

Have \ $10,000 to $20,000 60 63 15

Have less \ $5,000 to $1 0,000 330 125 27

Have not \ Less than $5,000 800 700 105

India: A case study

Today:

• Plans to widen scope of price controls to348 medicines from the current 74. "Mostcountries follow some form ofprice control.We need to ensure that expensive drugs areavailable at affordable rates to the poor."

(D.S. Kalba, Secretary, Pharmaceutical Department)

• Big Pharma is having a hard timeprotecting the intellectual property of itsanticancer drugs.

India: A case study

"The danger ofpushing the pricesofprescription drugs down, down,down is that at some point thebusiness model of developingthese drugs will lose itsattractiveness. India isbecoming very reluctant torespect IP for Western companiesand that is becoming a challenge

fi "or us.

(Marijn Dekkers, CEO Bayer)

Is the writing on the wall?

If it seems too good to be true,

It probably is.

Is the writing on the wall?

Romania

100%

Brazil16Mn

PolandMexkoe·

Turke

South Africa •

Russia

Argentina. •

20% 40% 60% 80%% OF POPULATION WITH 2016 INCOME >55,000

•k1stan

• Indonesia

lodaIOOMn

Vietnam

Volume Growth and PopulationsWith >$5,000/year Income by Country in 2016

80%

~ 70%~,N '0%~

~, SO%

~ 40%05 30%w,0 20%"0> 10%#

0%

-10%

0%27.$

$9580

Tier 3Ph"rmel'1ll l "O

~... 1,

4.'

$2780•

• Brand spending

3.3 7.1

$2980

S150 - 16SBn

519480

1.9 2.6

$4780

• Total spending

11.2 7.9

Pharmerging Spending and Growth

516180

2011

SpendingIn 2016

Growth to2016

SoUJal: IMS InstitutQ for HoNlthcare Inknnaticl" IMS M«1'lIIt Proonosi$, IUV 2012 Sourct: lnstitutll fof HoNlthcn lofol1lllltics. I"S ~(bt Prognosis,. May 2<112; ((onollist IrttlliQtOtll Urnt, Jan 2012

Is the writing on the wall?

Pharmerging Spending and Growth

SpendingIn 2016 S161.n

r

SpendingIn 2016 51618" $478" $29B" •$278n

Tier 3Phannerglng

$9S8n

ton y n 0 6

Jtn AtnGll •

•Roman..

JSSIol •

PolandMexICO••

_-,"'!!!r~

SO,*, 100%

>$5,000

nO

'Mo

$150 - 1658"

Growth to2016

10.4

Growttl to2016

10.4 1.. 2." 4." 7.7

$194Bn2011

11.2 2011

eT""Sourw: LIIS 11lSt1t\I'- fof IiNlthCl'" In"" 11.2 7•• J.J 7.1 27.5

• Total spending • ","od spending

Source: JMS InstitutQ for ttwLthcarv lnformatics,. INS Hafkot Prognosis,. Hay 10lZ

Is the writing on the wall?

....,16'"

South AfnGll •

•

RUSSia •

a. Romanta

ulot ononyn06

Ol~ fcotlOPlSllnt....9"'IO' lImL Jln 2012

PolandMexICO••

,----""''''''''--BO,*, 100%

)ME :>$5,000

•Romania

100%

BraZil16Mn

South Africa •

Russia •Argentina.

• Thailand

IndialooMn

• Indonesia

20% 40% 60% 80%

% OF POPULATION WITH 2016 INCOME >55/000

Vietnam

•akist:an

Volume Growth and PopulationsWith >$5,OOO!year Income by Country in 2016

PolandMexico••

-10% +- "!.!u!!:.!!rk

0%

80%

'" 70%-•N 60%-:<l:I: 50%

~ 40%0

"Cl 30%w:E=> 20%....0> 10%I-

0%

SpendingIn 2016 $161.n

11.2

2011

10.4

Growth to2016

•~"~ "" ,_••, ... 'oh•• , I

Source: Institute for tWalthc:.w Infonnatics. IHS Milrblt Proonosis, May 2012; ECOllOlllst Intilij~ Unit,..lan 2012

Challenges in Emerging Markets• Many companies struggle with regulatory standards in

different global regions; companies from certain regionsmay work to higher standards than FDA or EU GMP.

• Pricing products is problematic. Different systems existand reference pricing lists change regularly. The wrongdecision in one market can backfire in an another region.NICE-like systems are being established in emergingmarkets.

• Products from certain countries are not easily registered inother countries due to historical and cultural issues.

• Wealth Pyramid is unlikely to change and generatesdifferent attitudes towards intellectual property protection:counterfeiting activities follow pharma in emergingmarkets.

Challenges in Emerging Markets

2016 Pharmaceutical Spend Per Capita2005$ and Population

900..III 800::>0z 700~III

" 600

ii!0 500

~~ 400u

'" 300~

;;J. 200::>zz" 100

0

Developed Ph.-merglng

US. $892 Pop. 326Mn

Japan $644 Pop. 124Mn

Canada $420 Pop. 36Mn

EUS $375 Pop. 320Mni -

South Korea $323 Pop. SOHn

Rest of Europe $321 Pop. lOSMn

Brazil $180 Pop. 201Hn

Russia $179 Pop. 14QMn

China $121 Pop. l,349Mn::---7-=:-::'--.,....,..,-:::-:-"'

Pharmerylng l1er 3 $96 Pop. i,OUMn

India $33 Pop. l,292Mn

POPULATION

50011:.: IKS Mol/ut Progf1OSl\, ~...Jy 2012: EconolA;st ht.llig,nc. Unit. Join 2012

Falsified Medicinal Products

2008 2009 2010 2011

Number of cases 3,207 3>368 1,812 2,494

Number of articles 8,891,056 11,462,533 3,200,492 27,460,538

India UAE India China(51.6%) (73-7%) (93.2%) (68.2%)

Provenance Top 3Syria India China India

(36.4%) (22.6%) (4·7%) (28.2%)

UAE China Hong Kong Hong Kong(8.7%) (l.4%) (04/0) (1.5%)

European Commission Taxation and Customs Union

Quality and safety are non-negotiable

• Manufacturer will remain responsible for ensuringEU GMP compliance of the API manufacturers heuses. Applicant for MA must confirm in writingthat manufacturer of finished product has verifiedcompliance with EU GMP of API manufacturerthrough audits.

• Finished product manufacturer must ensure thatAPIs it uses have been manufactured in line withEU GMP & distributed in line with EU GDP byconducting audits.

• Onus is on Qualified Persons.

Quality and safety are non-negotiable

• Medicinal products to bear safety features enablingwhole distributors and persons authorised orentitled to supply medicinal products to the publicto verify the authenticity of the medicinal productand identify individual packs, as well as a deviceallowing verification of whether the outerpackaging has been tampered with.

• Qualified Person has to ensure that the safetyfeatures have been affixed on the packaging.

Changes in the industry: globalisation

• Local knowledge is thekey to working locally, buthow is this knowledgeintegrated with the rest ofthe corporation?

• Change agents whosefocus is emerging marketsare needed throughoutthe organisation toprovide the missing link.

SCOTTISII IIIGIII~NI)S--

NOHTIII;HN V'.;1"N"M--Never underestimate Ihe importance of local knowledge.---_..__....._-_._.....-­

"'...:.......-. .._-­_....._-_.-......­......._.",_..--_..._.._­...-....--_.._-__ 4. -- ... _

-..._-_ _.._-- "' ..--_...__ .,..: ......01==-01"-'-_"'_ HSBC ID_...,...;.. ..... _ '"'" workI'Iloc&1 blnIc

Changes in the industry: biologicals

60 -,----------------------------

"'0~ 50Qi...'"....~40

""'"~ 30::l<.IQi-0 2 0

El~ 10

Z

• Small molecules

• Biopharmaceuticals

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003

Year

Changes in the industry: biologicalsBiosimilar penetration in Europe embryonic;potential in USA post 2014For R&D based companies is going to be an established market play

0/0 share of global biosimilars

lSO,GOO

300,000

~ 250,000..'"W lOO,OOO~

'"'" 1SO,000

100,000

so,ooo

o

Medica...Stada

5%

2001 '008 '00' 2010

The industrial pharmacist of the future

Seven Skill Sets Necessary to Operate in the PharmaceuticalIndustry of the Future

1) Ability to Manage Decentralized Intellectual Capital Resources

2) Ability to Work in Joint Ventures and Across Divisions. Cultures and Countries

3) Ability to Integrate an Understanding of Intellectual Property Laws,Scientific Expertise and Business Strategy

4) Ability to Spur Creativity While Managing Commercially

5) Knowledge and Insight on the Decision-Making Dynamics of Payers

6) Expertise in the Functioning and Decision-Making of Regulatory Agencies

7) Human Resource Skills to Help Transform Pharmaceutical Companies

The industrial pharmacist of the future• A changing workplace:

• drug discovery in Europe with drug developmentconducted in India and registration executed in Europeor North America

• drug discovery occurring in China, developed in China,commercialised in China and then registered andcommercialised in Europe

• drug discovery conducted in China, developmentconducted in India and commercialised in Europe

• Basic Formulation Development for smallmolecules will be outsourced to low cost countrieswhereas large molecules will be developed in theEU and USA.

«:European Industrial Pharmacists Group

• The main objective of El PG is to promote and upholdthe importance and role of the industrial pharmacistwithin the pharmaceutical industry.

• Promote the modern pharmaceutical industry toobservers and more importantly to young pharmacists

• Ensure that educational standards meet the needs of theindustrial pharmacist in the industry of 2020

• Provide mentoring and coaching to young pharmacistswho need career advice

:::European Industrial Pharmacists Group

• However, the industrial pharmacist of the future needsto evolve with the industry in which he/she operates.

• The industrial pharmacist of the future needs to thinkdifferently.

• The industrial pharmacist of the future needs

Jugaad