PDAConnecting

People,Science

and

Regulation?PDA

and

the

GlobalPharmaceutical

Market

Presented

at

the

2011

Parenteral

DrugIndustry

Congress,

Beijing,

ChinaSeptember

2011PDA

and

the

GlobalPharmaceutical

MarketAbout

PDAThe

Global

Pharmaceutical

MarketSummaryAgenda4About

PDAWho

are

we

?Our

Vision,

Mission

&

FocusOur

ActivitiesMember

Core

CompetenciesMember

BenefitsWe

are:5A

community

of9,500

individual

memberscientists

and

professionals

in

70countries

representing

large

and

smallpharmaceutical

and

biopharmaceuticalcompanies,

regulatory

agencies,suppliers

and

academia.Our

VisionTo

be

the

foremost

global

provider

of

science,technology,

and

regulatory

informationandeducation

for

the

pharmaceutical

andbiopharmaceutical

community.6Our

MissionTo

develop

scientifically

sound,practical

technical

information

andresources

to

advance

science

andregulation

for

the

pharmaceuticaland

biopharmaceutical

industrythroughthe

expertise

of

ourglobal

membership.7Strategic

Focus8Our

Activities

(Volunteers)99

Over

1,000PDA

volunteers

worldwide

activelycarry

out

its

mission.

PDA

is

an

influential

voice

and

a

leading

technicalorganization

in

the

field

of

pharmaceutical

science

and

technology.

Through

the

development

of

Technical

Reports

and

responses

to

regulatory

initiatives,

PDA

andits

members

influence

the

future

course

ofpharmaceutical/biopharmaceutical

productstechnology.In

the

areas

of

Science

andTechnology,

PDA

influences

industrydirection

Develops

positions

on

current

andproposed

applications

of

technologyRooted

in

scienceConsensus

drivenRepresent

industry

best

practicesIdentifies

and

monitors

newtechnologies10Our

Activities

(SciTech)Supports

the

application

of

technologyand

compliance

requirements

throughmembership

participationScienceAdvisory

Board

(SAB)Biotechnology

Advisory

Board

(BioAB)Regulatory

Affairs

and

Quality

AdvisoryBoard

(RAQAB)Interest

Groups

(IGs)Task

Forces

(TFs)11Our

Activities

(SciTech)

Cont.12PDA

Interest

Groups

are

aligned

toAdvisory

BoardsInterestGroupsBIOABSABRAQABBiotechnologyBlow

FillSealClinical

Trial

MaterialsCombination

ProductsFacilities

and

EngineeringInspection

TrendsLyophilizationFiltrationQuality

Risk

ManagementPharmaceutical

Cold

ChainMicrobiology/EMQuality

SystemsVaccinesPackaging

ScienceRegulatory

AffairsPharmaceutical

WaterSystemsPrefilledSyringesProcess

ValidationSterile

ProcessingSupply

Chain

ManagementTechnology

TransferVisual

Inspection1213Our

Activities

(TRs)Technical

ReportsMeant

as

recommendation,

andguidance,

but

are

non-prescriptiveHowever

:Most

read

and

used

documents

byregulators

and

industryTRs

have

influenced

regulatoryGuidances,

e.g.

FDA’s

2004

AsepticGuideline,

ISO

13408-2

and

PIC/SAsepticGuide.New

Technical

Reports

(2010and

2011

Year

to

Date)

TR

47

-

Preparation

of

Virus

Spikes

Used

for

Virus

ClearanceStudies

TR

48

-

Moist

Heat

Sterilizer

Systems:

Design,

Commissioning,Operation,

Qualification

and

Maintenance

TR

49

-

Points

to

Consider

for

Biotechnology

CleaningValidationTR

50

-

Alternative

MethodsforMycoplasma

Testing

TR

51

-

Biological

Indicators

for

Gas

and

Vapor-PhaseDecontamination

Processes:

Specification,

Manufacture,Control

and

Use

TR

52

-

Guidance

for

Good

Distribution

Practices

for

thePharmaceutical

Supply

Chain

TR

53

–

Guidance

for

Industry:

Stability

Testing

to

SupportDistribution

of

New

Drug

ProductsOur

Activities

(Regulations)15Monitor

Global

Regulatory

ActivityPrimary

Focus:

U.S.

and

European

RegulatoryAgencies-

Includes

ICH,

PIC/S,

USP,

EP

and

WHODeveloping

interest

inAsia

and

IndiaInfluence

Global

Regulatory

PolicyInteractions

with

global

regulatory

authoritiesCo-sponsor

meetings

with

Regulators(FDA,EMA,PIC/S,ICH)Comments

on

proposed

regulations

andguidancePromote

science-based

regulationsOur

Activities

(PCMOSM)ScopeUtilizing

PDA’s

membership

expertiseto

drive:the

establishment

of

“bestpractice”

documentstraining

events

andcoursesto

aid

the

pharmaceuticalmanufacturers’

to

implement

ICHQ8,

Q9

and

Q10IMP

and

commercial

productsSee

our

project

dossier

on

the

PDAwebsite

(/pcmo)

for

moreinformation16Our

Activities

(PCMOSM)Objectives

Enable

an

innovative

environment

for

continual

improvementof

products

and

systemsPut

science

into

practiceEnable

increase

of

process

robustness

and

knowledgeFoster

relief

from

regulatory

prescriptions17PCMO

ProjectsLife

cycleIMP

manufacture

and

distributionImplementation

of

QbD

in

ManufacturingTechnology

TransferSupply

Chain/Good

Distribution

PracticesQuality

SystemsCapturing

knowledge

management

during

commercialmanufacturingManagement

of

Suppliers

and

ContractorsEstablishing

a

Pharmaceutical

Quality

SystemConcepts

for

trainingAdditional

PCMO

ProjectsProcessFrom

Process

Validation

to

Process

VerificationConcepts

forCleaning

ValidationHow

to

improve

robustness

of

a

manufacturingprocessUtilization

of

statistical

methods

for

production

andbusiness

processesCorrective

and

preventive

actionsRisk

ManagementRisk

Based

ManufacturingSterile

APIsRisk-Based

scheduling

of

auditsOur

Activities

(Conferences)World-class

eventsDesigned

toEducatePromote

interaction

Advance

memberinterestsGlobal

venuesScience

andRegulatory

focus20Our

Activities

(TRI)PDA

Training

&

Research

InstituteState-of-the-art

training

facilityLearning

in

a

risk

free

environment21The

TRI

CurriculumValidationLyophilizationPre-filled

SyringesSterilization

TechnologyCold

ChainVisual

InspectionIncludes

courses

in:AsepticProcessingBiotechnologyEnvironmental

MonitoringFiltrationMicrobiologyQuality/Regulatory

Affairs22PDA’s

State

of

the

Art

Training

Facility

andRemote

Courses

Bring

Consistency

Worldwide23PDA

has

provided

Inspectorate

Training

to

anumber

of

countriesThe

most

recent

are:-Russia-Kazakhstan-EMA

and

many

of

the

EU

Inspectorate-Italy,

UK,

Ireland,

Sweden,

etc.-US

FDATraining

has

been

conducted

in

Russian

andChinese

languagesOur

Activities

(Membership)24Membership

competenciesMembership

benefits

New

membership

category

for

emergingeconomiesMembership

Core

CompetenciesApplied

SciencesAsepticProcessingManufacturing

ProcessEngineeringBiotechnologyMicrobiologyProcess

ValidationQuality

and

RegulatoryRegulatoryCompliance/GMPSupply

ChainQuality

Systems2525Membership

BenefitsProfessional

Resources

&

NetworkInterest

GroupsTask

ForcesChaptersCareer

Service

CenterStudent

Scientific

ProgramsSci-Tech

DiscussionGroupOnline

Membership

Directory26PublicationsPDA

Journal

of

Pharmaceutical

Science

&TechnologyPDA

LetterTechnical

ReportsBooks

and

Scientific

PublicationsMembership

Benefits

(Cont.)27PDA

Journal

WebsiteJournal

HighWire

websitelaunched

in

2009Easy

to

use

and

searchArchives

back

to

1998More

features

to

comeNew

Journal

Editorial

Staffon

boardRenewed

emphasis

on

corePDA

member

interestsBiotech,

Microbiology,Aseptic

Processing

andManufacturing

articlesdesired28New

Reduced

Cost

MembershipFor

emerging

economies

(including

China)Electronic

access

to:PDA

Journal

website,

current

and

prior

yearPDA

LetterPDA

membership

directoryNo

access

to:Electronic

Technical

ReportsPrint

version

of

PDA

Letter

Annual

Cost:

$100.00[canupgrade

to

fullmembership

for

additional

$149.00

(total

$249)]The

Global

PharmaceuticalMarketAgendaBusiness

EnvironmentPharma

Manufacturing

EnvironmentRegulatory

EnvironmentClosing

ThoughtsBusiness

Changes

in

Pharma32Dependence

onBlockbustersEmerging

MarketsLoss

of

Patent

ProtectionConsolidation/

Mergers

&

AcquisitionsDependenceon

Blockbusters33Diversification

via

Geographic

ExpansionEmerging

markets

–

share

of

global

pharma

growth:34Source;

IMS

HealthPatent

“Cliff”35Recent

Pharma

Mergers

and

Acquisitions36Processes

have

been

evolving…

From

mortar

and

pestle

to

highly

complexbioreactors.

From

manually

intensive

aseptic

processesto

highly

automated

equipment

withadvanced

environmental

controls.From

test

tubes

to

Raman

spectroscopy.

From

Pen

and

Paper

to

Gigabytesof

electronic

data.37The

Pharmaceutical

Supply

Chain

hasbecome

more

complex38Globalization

of

Supply

ChainMore

off-shore

sourcing

and

distribution

Increased

percentage

of

“cold

chain”products

Increase

in

diversion,

counterfeiting

and“economically

motivated

adulteration”O(jiān)ur

concept

of

quality

has

changed…

From

test

and

release

to

QualityAssurance

to

Quality

by

Design.

From

‘craftmanship’

to

validatedprocesses.

From

R&D

/

Manufacturing/

Quality

silosto

Quality

System

Approach

that

reachesfrom

beginning

of

new

productsthroughout

the

lifecycle.39Our

regulatory

framework

has

alsochanged…4030

years

ago:Highly

fragmented,

lack

of

consistency,20

years

ago:Beginnings

of

EU

integration

and

internationalharmonization.TodayAdvances

in

International

HarmonizationTomorrowGreater

cooperation

and

exchange

of

informationamong

global

regulatorsChallenges

for

thePharmaceuticalIndustry

in

the

21st

CenturyGlobalizationRationalizationIntegrationCostReductionSupply

Chain

IntegrityAll

add

up

to

increased

Complexity41Globalization42

Rationalization

of

Manufacturing

capacityis

occurring

at

the

same

time

that

globaldemand

for

pharmaceuticals

is

rising.

Growth

rate

is

most

noticeable

in“pharmerging”markets–

China,

Brazil,

Mexico,

South

Korea,

India,

Turkey

andRussia

vs.

US/EU/Japan

Cost

pressures

are

driving

moremanufacturing

to

“pharmerging”

countriesRationalizationPharma

manufacturing

has

over-capacityReduction

of

facilities

is

ongoingImpact

is

greatest

in

US

and

Europe

Product

rationalization

is

ongoing

at

majorpharma43Integration44Integrating

merger

partnersIntegrating

CROs

and

CMOsIntegrating

SuppliersAPIsExcipientsPackaging

ComponentsKey

Manufacturing

materialsCost

Reduction45

Decline

in

top-line

revenue

adds

pressureon

Pharma

companies

to

reduce

expensesto

maintain

bottom

line

revenueRationalization

of

overcapacityPricing

pressure

on

materials

and

Cost

ofGoods

Government

pricing

pressure

is

increasingworldwideSupply

Chain

Integrity46Enhancing

Supplier

Quality

Managementsupplier

selection

and

qualification

processes,on-going

monitoring

and

management.Increasing

Supply

Chain

Controls

forincoming

materials

and

components,supply

route

security

and

verification,verification

of

incom