Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 ·...

42
Global Technical Research & Development Dr. Begoña Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis Pharma, Basel, CH Recent advances in drug delivery and how they affect Life Cycle Management in Pharmaceutical Industry

Transcript of Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 ·...

Page 1: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Dr.

Beg

oña

Car

reño

Proj

ect L

eade

r Life

Cyc

le M

anag

emen

t &

Dru

g D

eliv

ery

Tech

nolo

gies

Nov

artis

Pha

rma,

Bas

el, C

H

Rec

ent a

dvan

ces

in d

rug

deliv

ery

and

how

th

ey a

ffect

Life

Cyc

le M

anag

emen

t in

Ph

arm

aceu

tical

Indu

stry

Page 2: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Age

nda

•B

rief i

ntro

duct

ion

to N

ovar

tis•

Pha

rmac

eutic

al in

dust

ry tr

ends

•Li

fe C

ycle

Man

agem

ent (

LCM

) and

Dru

g D

eliv

ery

Tech

nolo

gies

(D

DT)

: –

Def

initi

on–

LCM

& D

DT

at N

ovar

tis–

LCM

&D

DT:

wha

t do

drug

del

iver

y sy

stem

s of

fer?

Exa

mpl

es–

Sol

ubili

satio

n th

roug

h na

noni

satio

n: E

xam

ples

–By

pass

ing

Firs

t pas

s liv

er e

ffect

: Exa

mpl

es–

Con

veni

ance

and

com

plia

nce:

Exa

mpl

es–

Pat

ient

con

veni

ance

and

com

plia

nce

expr

esse

d in

sal

es•

Con

clus

ions

Page 3: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nov

artis

Org

anis

atio

n

•Car

diov

ascu

lar &

Met

abol

ism

•Onc

olog

y &

Hem

atol

ogy

•Neu

rosc

ienc

e•R

espi

rato

ry &

Der

mat

olog

y•I

nfec

tious

Dis

ease

s,

Tran

spla

ntat

ion

& Im

mun

olog

y (ID

TI)

•Oph

thal

mic

s•A

rthr

itis/

Bone

/Gas

troi

ntes

tinal

/U

rolo

gy (A

BGU

)N

OVA

D

•Gen

eric

s

•For

mer

Chi

ron

•Nov

el/c

onve

ntio

nal v

acci

nes

•Blo

od te

stin

g

Cons

umer

Hea

lth•O

TC•A

nim

al H

ealth

•Med

ical

Nut

ritio

n•G

erbe

r•C

IBA

Visi

onSand

ozPh

arm

aceu

tical

s

Page 4: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nov

artis

achi

evem

ents

–8

sign

ifica

nt a

ppro

vals

in 2

005,

incl

udin

g 2

high

prio

rity

revi

ews

–73

pro

ject

s in

dev

elop

men

t

–4

new

com

poun

ds to

be

filed

in 2

006

for a

ppro

val

–R

anke

d as

one

of t

he fa

stes

t and

mos

t pro

duct

ive

in

deve

lopm

ent

–Le

adin

g Pa

rtne

r of t

he F

DA

in C

ritic

al P

ath

Initi

ativ

e

Page 5: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Indu

stry

Tre

nds

: R&

D P

rodu

ctiv

ity is

Dec

linin

g

Glo

bal P

harm

aR

&D

exp

endi

ture

s (in

$ b

n)#

NM

Esap

prov

ed b

y FD

A

Sour

ce:

FDA

CD

ER

& C

BE

R; E

valu

ate

Page 6: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Safe

ty re

late

d w

ithdr

awal

s of

ora

l pro

duct

s in

the

US:

Num

ber o

fpa

tient

s ex

pose

d in

the

12 m

onth

s pr

ior t

o w

ithdr

awal

(‘00

0s)

Sour

ce:

IMS

Page 7: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

The

cost

to d

evel

op a

dru

g pr

oduc

t asc

ends

to $

900

Man

d 10

-15

year

s be

fore

laun

ch

Poss

ible

Sol

utio

ns

Res

earc

hD

evel

opm

ent

-A

ccel

erat

e de

velo

pmen

t tim

elin

es-

Lias

e w

ith re

gula

tory

aut

horit

ies

over

dev

elop

men

t pat

hs

-Life

Cyc

le M

anag

emen

t

Prot

eono

mic

sG

enom

ics

etc

Lice

nse-

in

Page 8: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Life

-Cyc

le M

anag

emen

t (LC

M)

Obv

ious

in s

ome

indu

strie

s....

.

Wha

t doe

s it

mea

n in

Nov

artis

?

All

mea

sure

s/ p

roje

cts

initi

ated

-i

n ad

ditio

n to

mai

nstre

am d

evel

opm

ent –

that

are

inte

nded

to e

nhan

ce th

e va

lue

of a

bra

ndth

roug

hout

its

life

cycl

e to

the

bene

fit o

f the

pat

ient

s an

d N

ovar

tis.

Page 9: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nov

artis

LC

M&

DD

T or

gani

satio

n

11 p

harm

acis

ts /c

hem

ists

with

At l

east

sev

eral

yea

rs o

f exp

erie

nce

in

drug

pro

duct

dev

elop

men

t

appl

icat

ion

of D

DT

to p

roje

cts

LCM

str

ateg

ies

Indi

vidu

al a

reas

of e

xper

tise

(ora

l/

pare

nter

al/tr

ansm

ucos

al)

Expe

rienc

e in

pat

ent s

trat

egie

s an

d

pate

nt li

fe e

xten

sion

s

Expe

rts

in c

ompe

titiv

e en

viro

nmen

t

Page 10: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Eas

t Han

over

Orle

ans

Tsuk

uba

Bas

el

Mum

bai Si

ngap

ore

Trul

y G

loba

l Pha

rmac

eutic

al &

Ana

lytic

al D

evel

opm

ent

Page 11: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nov

artis

LC

M&

DD

T Ta

sks

Cont

ribut

ion

to

late

-pha

se L

CMIn

itiat

ion

of

proa

ctiv

e LC

M

Lead

feas

ibili

ty

stud

ies

both

inte

rnal

ly

and

with

ex

tern

al p

artn

ers

Info

rmat

ion

onco

mpe

titor

s

Asse

ssm

ent o

f ex

tern

alte

chno

logi

es

Page 12: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

–w

hy is

it s

o im

port

ant

?•

Mai

nstre

am d

evel

opm

ent f

ocus

es o

n br

ingi

ng th

erap

eutic

ben

efits

to

pat

ient

s as

rapi

dly

as p

ossi

ble

(Gliv

ec: d

evel

opm

ent <

100

0 da

ys)

•LC

M fo

cuse

s on

tailo

ring

drug

pro

duct

to p

atie

nt‘s

nee

ds a

nd

pref

eren

ces

and

on o

ptim

isin

g th

e th

erap

eutic

val

ueof

dru

g pr

oduc

ts

Idea

lly L

CM

lead

s to

a h

ighe

r mar

ket s

hare

for t

he b

rand

in

crea

sed

sale

s

Page 13: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

–ho

w is

it a

chie

ved

in g

ener

al ?

Thro

ugh…

•New

indi

catio

ns•A

ltern

ativ

e dr

ug d

eliv

ery

syst

ems,

pack

agin

g an

d de

vice

s•A

ltern

ativ

e dr

ug s

ubst

ance

pro

pert

ies

•Im

prov

ed m

anuf

actu

ring

proc

esse

s

Page 14: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nov

artis

LC

M&

DD

T: T

he D

DT

Part

–Se

arch

for i

nnov

ativ

e D

rug

Del

iver

y Te

chno

logi

es

–A

sses

smen

t of e

xter

nal t

echn

olog

Fit t

o N

ovar

tis d

evel

opm

ent p

ortfo

lio?

»Fi

t to

Nov

artis

tech

nolo

gypo

rtfo

lio?

–Ev

alua

tion

of (t

echn

ical

) fea

sibi

lity

»Pa

per a

sses

smen

Feas

ibili

ty tr

ial u

p to

(and

incl

udin

g) c

linic

al tr

ial (

step

wis

eap

proa

ch, f

inal

pro

of o

f fea

sibi

lity)

–C

oord

inat

e ev

alua

tion

of e

xter

nal D

DT

allia

nce

prop

osal

s

Page 15: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

–w

hat d

o D

DTs

offe

r ?

Pat

ient

ben

efits

suc

h as

:

–Im

prov

emen

t of t

hera

peut

ic in

dex

(effi

cacy

/ saf

ety)

–Im

prov

emen

t of c

onve

nien

cefo

r pat

ient

–Im

prov

emen

t of p

atie

nt c

ompl

ianc

e

Page 16: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

–w

hat d

o D

DTs

offe

r ?

Impr

ovem

ent o

f effi

cacy

/ saf

ety

Red

uced

sid

e ef

fect

sIn

crea

sed

bioa

vaila

bilit

y &

redu

ced

varia

bilit

yO

ptim

ized

bas

ed o

n PK

-PD

cor

rela

tion

Page 17: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

–w

hat d

o D

DTs

offe

r ?

Impr

ovem

ent o

f pat

ient

con

veni

ence

•Red

uced

dos

ing

freq

uenc

y•R

educ

ed in

ject

ion

volu

me

•Pre

ferr

ed a

dmin

istr

atio

n ro

ute

•Im

prov

emen

t of s

wal

low

-abi

lity

•Com

bina

tion

prod

ucts

Page 18: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

–w

hat d

o D

DTs

offe

r ?

Impr

ovem

ent o

f pat

ient

com

plia

nce

•Adm

inis

trat

ion

with

out w

ater

•Opt

imal

dos

age

form

s fo

r pat

ient

pop

ulat

ions

(chi

ldre

n /

elde

rly)

•Opt

imiz

ed d

osag

e fo

rm fo

r dis

ease

(e.g

. acu

te tr

eatm

ent)

Page 19: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

–th

e fir

st e

xam

ple

1898

2 ye

ars

afte

r the

foun

datio

n o

f Hof

fman

n-La

Roc

he

•A

coug

h sy

rup

cont

aini

ng R

oche

's T

hioc

ol

•Th

e sy

rup'

s or

ange

flav

ourm

akes

it a

suc

cess

The

3rd

laun

ched

pro

duct

is a

LC

M p

rodu

ct:

Page 20: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

List

of s

ome

of th

e D

DTs

that

add

ress

diff

eren

t iss

ues

Solu

bilit

y/pe

rmea

bilit

yN

ano/

mic

roni

satio

nC

yclo

dext

rins

Hot

mel

t ext

rusi

onLi

pid

form

ulat

ions

1st p

ass

met

abol

ism

Tran

smuc

osal

deliv

ery,

e.g.

buc

cal,

nasa

l del

iver

ytr

ansd

erm

al, p

aren

tera

lde

liver

y

Con

trol

led

rele

ase

(sus

tain

ed)

Mat

rix ta

blet

s, c

oate

dm

ultip

artic

ulat

eO

smot

icsy

stem

s, G

astr

ic re

tent

ion

syst

ems,

dep

ofo

rmul

atio

ns

Patie

nt c

onve

nien

ce/c

ompl

ianc

eO

DT,

thin

film

s, p

atch

es e

tcA

ltern

ativ

e de

liver

y ro

ute

Page 21: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

& D

DT

exam

ples

on

how

to a

ddre

ss s

olub

ility

pro

blem

s

Page 22: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Solu

bilit

y pr

oble

ms

•40%

of t

he s

elec

ted

drug

mol

ecul

es fo

r dev

elop

men

t are

lipo

phili

c

•Fro

m th

e N

CEs

app

rove

d in

200

2, >

50

% w

ere

poor

lyso

lubl

e in

w

ater

Page 23: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nan

osis

ing

: Why

do

we

need

nan

opar

ticle

s in

dru

g de

liver

y ?

200

nmpr

otec

tive

stab

ilize

r

40 µ

m

To d

ecre

ase

the

part

icle

siz

e an

din

crea

se d

rug

part

icle

su

rfac

e ar

ea, w

hich

lead

s to

: Par

ente

ral r

oute

:

•i.v

. inj

ecta

bilit

y of

nan

osus

pens

ions

w

ithou

t ris

k of

thro

mbo

sis

•S

olub

iliza

tion

of p

oorly

sol

uble

drug

s w

ithou

t a ri

sk o

f pre

cipi

tatio

n

•E

ntra

pmen

t of i

rrita

ting

drug

s

prev

entio

n of

phl

ebiti

s at

inje

ctio

n si

te

Ora

l rou

te:

•E

nhan

ced

in-v

ivo

diss

olut

ion

•E

nhan

ced

abso

rptio

n

•R

educ

ed v

aria

bilit

y

Page 24: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Com

mer

cial

ly a

vaila

ble

“nan

o-sc

ale”

ther

apeu

tics

•Li

poso

mes

(Dox

il, D

auno

Xom

e,M

ycoc

et, A

mB

iom

e, V

isud

yne)

•Al

bum

in-b

ound

nan

opar

ticle

s(A

brax

ane,

AP

P

•G

adol

iniu

m c

hela

tefo

r MR

I im

agin

g (M

agne

vist

, Gd-

DTP

A D

imeg

lum

ine,

B

erle

x)

•Iro

n ox

ide

parti

cles

for M

RI i

mag

ing

(Fer

idex

, Ber

lex)

•M

icro

emul

sion

s(N

eora

l®C

yclo

spor

ine,

Nov

artis

)

•P

rodu

cts

usin

g É

lan’

s N

anoC

ryst

alte

chno

logy

(Rap

amun

e®,W

yeth

, E

men

d®, M

erck

)

Page 25: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nov

artis

Impr

oved

Bio

avai

labi

lity

and

redu

ced

Varia

bilit

y th

roug

h N

eora

l mic

roem

ulsi

on fo

rmul

atio

n 0

200

400

600

800

1000

1200

1400

1600

0.0

2.0

4.0

6.0

8.0

Tim

e (h

)

Concentration (ng/ml)

0

200

400

600

800

1000

1200

1400

1600

02

46

8Ti

me

(h)

Concentration (ng/ml)

Page 26: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Mic

ro/n

anon

isat

ion

alte

rnat

ives

: > 1

0 D

Dco

mpa

nies

Top-

dow

n te

chno

logi

es:

•N

ano-

Mill

ing

•H

omog

eniz

atio

n

Bot

tom

-Up

tech

nolo

gies

:

•P

reci

pita

tion

•S

CF

combinatio

ns

Ela

nB

axte

r

Sky

epha

rma

Pha

rmas

ol

Bax

ter

Sol

iqs

Dow

Sol

uBes

t

Nek

tar

Eiff

el

Ferr

oA

ctiv

ery

Page 27: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

How

do

the

nano

sizi

ngte

chno

logi

es d

iffer

?

•Te

chno

logy

prin

cipl

e (b

otto

m u

p vs

. top

dow

n)

•Es

tabl

ishe

d sc

ale

and

mat

urity

(GM

P, d

ev. s

tage

)

•C

reat

ion

of a

mor

phou

s or

cry

stal

line

nano

part

icle

s

•C

hoic

e of

sta

biliz

ers:

pol

ymer

s an

d/or

sur

fact

ants

•C

oatin

g ef

ficie

ncy

•U

se o

r om

ittan

ce o

f a s

olve

nt

•IP

pro

tect

ion

Page 28: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nan

onis

atio

n: N

anoC

ryst

alte

ch. i

n 4

mar

kete

d dr

ugs

•Wye

th’s

imm

unos

uppr

essa

ntR

apam

une®

(siro

limus

)

•For

mul

ated

in a

tabl

et

•Pre

viou

sly

avai

labl

e on

ly a

s an

ora

l sol

utio

n in

bot

tles

or s

ache

ts w

hich

re

quire

d: Ref

riger

atio

n st

orag

eM

ust b

e m

ixed

with

wat

er o

r ora

nge

juic

e pr

ior t

o ad

min

istra

tion

•Mer

ck’s

Em

end®

(Apr

epita

nt) f

orm

ulat

ed in

a c

apsu

le

Con

veni

ance

&

Com

plia

nce

Bio

avai

labi

lity

impr

ovem

ent

Em

end

was

dev

elop

ed a

s an

NC

E

Page 29: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nan

onis

atio

n: N

anoC

ryst

alte

chno

logy

in 4

mar

kete

d dr

ug p

rodu

cts

(Con

t)

•Abb

ott‘

s Tr

iCor

®(fe

nofib

rate

)

•For

mul

ated

in a

tabl

et•C

an b

e ad

min

iste

red

with

or w

ithou

t foo

dIn

the

orig

inal

form

ulat

ion

adm

inis

tratio

n w

itha

mea

l was

nee

ded

•Meg

ace®

ES

(meg

estro

l)fo

rmul

ated

as

oral

sol

utio

n

•Im

prov

ed d

isso

lutio

n ra

te a

nd b

ioav

aila

bilit

y P

atie

nts

are

able

to ta

ke o

ne-fo

urth

of t

he v

olum

e of

the

orig

inal

pro

duct

Con

veni

ance

&

Com

plia

nce

Bio

avai

labi

lity

impr

ovem

ent

Page 30: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nan

onis

atio

n-Sk

yeph

arm

a: ID

D-P

: one

mar

kete

d pr

oduc

t

Firs

t Hor

izon

Trig

lide™

(Fen

ofib

rate

):

•For

mul

ated

in a

tabl

et

•Can

be

adm

inis

tere

d w

ith o

r with

out f

ood

In th

e or

igin

al fo

rmul

atio

n ad

min

istra

tion

with

a

mea

l was

nee

ded

Con

veni

ance

&

Com

plia

nce

Page 31: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Nan

otec

hnol

ogy

Dev

elop

men

t: a

few

con

clud

ing

rem

arks

•Th

e na

no-b

ased

bio

med

ical

tech

nolo

gy c

andi

date

s ar

e ex

pand

ing*

•68

% in

crea

se in

the

clin

ical

pip

elin

e fr

om 2

005

•13

0 na

note

ch-b

ased

dru

gs a

nd d

eliv

ery

syst

ems

•12

5 de

vice

s or

dia

gnos

tic te

sts

•D

eman

d fo

r nan

otec

hnol

ogy

heal

th c

are

prod

ucts

in th

e U

S is

pro

ject

ed to

incr

ease

nea

rly 5

0 pe

rcen

t per

yea

r to

$6.5

bill

ion

in 2

009.

* So

urce

: 200

6 N

anom

edic

ine,

Dev

ice

& Di

agno

stic

Rep

ort,

Nat

iona

l Hea

lth In

form

atio

n, L

LC.

Page 32: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

& D

DT

exam

ples

on

how

to a

ddre

ss 1

st p

ass

met

abol

ism

Page 33: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Exam

ple

of a

Dos

age

Form

with

Incr

ease

d B

ioav

aila

bilit

y an

d R

educ

ed F

irst-P

ass

Met

abol

ism

024681012

02

46

810

12T

ime

(h)

Plasma concentration (ng/ml)

Zydi

s 10

mg

Eld

epry

l 10m

gZy

dis

1.25

mg

10 m

g Zy

dis

tabl

et d

eliv

ers

near

ly e

ight

tim

esth

e co

ncen

trat

ion

of s

eleg

iline

than

an

ord

inar

y 10

mg

tabl

et

Sour

ce:

http

://w

ww

.car

dina

l.com

/pts

/con

tent

/abo

utus

/who

wea

re/b

roch

/CH

-PTS

-DLV

-Zyd

is.p

df

Page 34: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

LCM

& D

DT-

Exam

ples

of p

atie

nt c

onve

nien

ce

and

com

plia

nce

impr

ovem

ent

Page 35: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Exam

ple

of In

hala

tion

repl

acin

g In

ject

able

dosa

ge fo

rm

Exub

era:

Pul

mon

ary

INSU

LIN

App

rove

d by

the

FDA

in J

anua

ry 2

006

1st n

ew a

dmin

istr

atio

n ro

ute

sinc

e it

was

dis

cove

red

in 1

921!

!

Page 36: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Exam

ple

of In

hala

tion

repl

acin

g In

ject

able

dosa

ge fo

rmH

epat

ic s

inus

oida

l pla

sma

insu

lin le

vels

for E

xube

rain

hala

tion

and

Hum

ulin

IVC

-infu

sed

insu

linH

epat

ic g

luco

se lo

ad fo

r Exu

bera

inha

latio

n an

d H

umul

inIV

C-in

fuse

d in

sulin

Lung

s pr

ovid

e an

attr

activ

e ta

rget

for b

oth

syst

emic

and

loca

l dru

g de

liver

ySo

urce

: ht

tp://

diab

etes

.dia

bete

sjou

rnal

s.or

g/cg

i/con

tent

/full/

54/4

/116

4

Page 37: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Exam

ple

of O

ral r

epla

cing

Inje

ctab

ledo

sage

form

012345678

030

6090

120

150

180

210

240

270

300

Brita

ject

(2.5

mg

sc)

Zydi

s Fo

rmul

atio

n A

Zydi

s Fo

rmul

atio

n B

Caps

ule

form

ulat

ion

Zydi

sap

omor

phin

eta

blet

del

iver

s co

mpa

rabl

e bi

oava

ilabi

lity

to in

ject

able

apom

orph

ine

Sour

ce:

http

://w

ww

.car

dina

l.com

/pts

/con

tent

/abo

utus

/who

wea

re/b

roch

/CH

-PTS

-DLV

-Zyd

is.p

df

Page 38: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Exam

ple

of c

onve

nien

ce a

nd c

ompl

ianc

e im

prov

emen

t

Zolm

itrip

tan

–a

mig

rain

e dr

ug

Fast

mel

t tab

lets

:

Can

be

take

n w

ithou

t wat

eran

y tim

e an

d an

ywhe

re,

even

whe

n pa

tient

feel

s na

useo

us

Nas

al s

pray

:

Shor

ter t

max

Earli

er s

ympt

om re

lief

Page 39: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Patie

nt c

onve

nian

ce a

nd c

ompl

ianc

e ex

pres

sed

in s

ales

Sour

ce: S

. Milo

jevi

c, D

rug

deliv

ery

Part

ners

hip

Con

fere

nce,

Eur

ope,

200

4

Page 40: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Life

-Cyc

le M

anag

emen

t –va

lue

of p

aten

t pro

tect

ion

It’s

com

mer

cial

rew

ard

for i

nnov

atio

n!

time

Inno

vatio

nPa

tent

(R

&D

)fil

ing

Laun

chB

asic

Pate

ntEx

piry

LCM

Pate

ntFi

ling

(„2n

d in

nova

tion“

,se

cond

ary

pate

nts)

Seco

ndar

yPa

tent

Expi

ry

Page 41: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Con

clus

ions

LCM

thro

ugh

tech

nica

l lin

e ex

tens

ions

pro

vide

s th

e fo

llow

ing

bene

fits:

»Im

prov

emen

t of t

hera

peut

ic v

alue

of d

rug

prod

ucts

thro

ugh

impr

oved

ther

apeu

tic in

dex

(effi

cacy

/ saf

ety)

»Im

prov

emen

t of c

onve

nien

cefo

r pat

ient

»Im

prov

emen

t of p

atie

nt c

ompl

ianc

e

»E

nric

hes

Nov

artis

por

tfolio

»In

crea

ses

the

busi

ness

val

ue o

f a b

rand

»P

rolo

ngs

the

life

cycl

e of

a b

rand

Page 42: Carreño Project Leader Life Cycle Management & Drug Delivery Technologies … · 2016-12-01 · Carreño Project Leader Life Cycle Management & Drug Delivery Technologies Novartis

Glo

bal T

echn

ical

Res

earc

h &

Deve

lopm

ent

Ack

now

ledg

emen

ts

•La

Soc

ieda

d E

spañ

ola

de Q

uím

ica

Tera

péut

ica

•N

ovar

tis P

harm

a, s

peci

ally

to:

–C

hris

tine

Boh

man

n an

d Jo

erg

Ogo

rka

for r

evie

win

g th

ese

slid

es–

Bar

bara

Lue

ckel

, Nic

olet

ta L

oggi

a, M

icha

el A

mbu

ehl a

nd

Joer

n-S

tefa

n Lu

cks

for l

endi

ng m

e so

me

of th

eir s

lides

.....

and

of c

ours

e to

all

of y

ou fo

r you

r tim

e to

day!

Con

tact

det

ails

: beg

ona.

carr

eno-

gom

ez@

nova

rtis

.com