PAPPL Quality Operations - National University of Singapore ...

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National University of Singapore

Department of Pharmacy


21 Nov 2006



KPP Prasad, Ph.D.

Quality Operations Director

Pfizer Global Manufacturing

The Pharmaceutical Industry

And Career Options

Presentation Topics



Biomedical Sciences


Global Pharmaceutical Industry


Biomedical Industry in Singapore


Skills required in Pharmaceutical Manufacturing


Job Scope for Graduates

Biomedical Sciences Industry


Pharmaceuticals


Biotechnology


Medical Devices


Healthcare Services

4
th

Pillar

Biomedical Sciences Industry


Highly knowledge
-
intensive industry


Biomedical Sciences is the 4th pillar of the


manufacturing sector according to EDB Industry 21

Plan


Manufacturing output in 2005 increased by 9.8 % to

S$

18 billion


Employment in 2005 increased by 8.6 % to 10, 000 jobs


Target to hit by 2015, manufacturing output of

S$ 25 billion and 15, 000 jobs

Global Pharmaceutical Industry


Research based industry with R & D spend of 20% of

sales


Each drug discovery costs US $500 million


Worldwide market of US $ 280 billion


USA accounts for 35 % sales, Asia < 15 % sales


Consolidation through mergers & acquisitions



Pharmaceutical R&D

Product lifecycle

DISCOVERY

TOX

I

II

III

Preclinical

Clinical

Registration

(Approval)

Years

File Patent

Candidate

Nomination

PK &

Safety

Pilot
Efficacy

Full development

Comparative

agents

Filing

Approval

Process

IDEA

0

5

6

7

9

12

13

15

DEVELOPMENT

PRODUCTION

MARKETING

SALES

Pharmaceutical R&D

Pharmaceutical R&D

400

projects

in discovery
research

20 in 5

20 major new drug

applications during

the five years

225

projects

in development

(130 new molecules,
95 major product
enhancements)

THE FUTURE:

New approaches

to improve

human health

Ideas

MULTIPLE

PRODUCT

ENHANCEMENTS


Pharmaceutical R&D


New Product Pipeline

Pharma Sales (US $B) 2005


1

Pfizer



:

44.3

2
Sanofi
-
Aventis


:

34.0

3
Glaxo SmithKline


:

33.9

4
AstraZeneca


:

24.0

5
Johnson & Johnson

:

22.3

6
Merck



:

21.9


7

Novartis



:

20.3

8
Roche



:

16.6

9
Bristol
-
Myers Squibb

:

15.3

10
Wyeth




:

14.3



Source : Contract Pharma July 2006

Pharma Sales (US $B) 2005


11


Eli Lilly




:

13.8


12
Abbott



:

13.3

13
Boehringer
-

Ingelheim

:


9.0

14
Takeda



:


9.0

15
Schering
-
Plough


:


8.8

16
Astellas Pharma


:

7.5

17
Daiichi
-
Sankyo


:


6.9

18
Novo Nordisk



:


5.6

19
Eisai




:

5.1

20
Bayer AG



:


5.1

Source : Contract Pharma July 2006

BioPharma Sales (US $B) 2005


1


Amgen



:

12.0

2


Genentech




:

5.5

3

Serono




:

2.3

4

Biogen Idec




:

2.3

5
Gilead Sciences


:

1.8

6
Genzyme Corp


:

1.8

7
Medimmune


:

1.2

8


Chiron Corp



:

1.1

9
Millennium



:

0.3

10

ImClone




:

0.2

Source : Contract Pharma July 2006

Drug Discovery to Commercial




Manufacturing


Screening of older compounds and testing of newly


synthesized compounds


Evaluation of compounds in multiple animal tests models



Toxicological and pre
-
clinical studies


Clinical Trials
-

Phases I, II & III


Regulatory submission


Marketing of new medicine


Phase IV post
-
marketing surveillance


Development of line extensions


Pharmaceutical Industry in Singapore



1960’s : “Large Scale” hospital based manufacturing,

Govt

pharmaceutical lab, local pharmaceutical



manufacturers


1970’s : Multinational pharmaceutical manufacturers


1986 : Closure of the Govt pharmaceutical lab


1987 : Licensing of pharmaceutical manufacturers


2000 : Singapore joins PIC/S


2001 : Formation of Health Sciences Authority (HSA)

Pharmaceutical/Medical Device
Manufacturers in Singapore


Definition of Terms


Pharmaceutical Manufacturing


(Simplified)

Primary Manufacturing

Active Pharmaceutical
Ingredients (Drug Substance)

Secondary Manufacturing

Drug Product

Fermentation

Chemical
Synthesis

Biotechnology

Tableting

Encapsulation

Sterile Dosage
Forms

Packaging

Blending

Granulation

Coating

Special unit
operations i.e. laser
drilling

Job Scope


Manufacturing Operations

-


Production Chemists/Pharmacists



Process Engineers

Technical Development

-


Process development chemists




Formulation Scientists





Validation Engineers

QA/QC


-


Chemists/ Analysts





Quality compliance officers




Quality Assurance Specialists




Regulatory compliance officers

Materials Management

-

Warehousing and Supply Chain



Specialists


Job Attractions


Big Budgets

-


Multi
-
million dollar projects



Strategic global sites in
Singapore

Technology

-


Generally State
-
of
-
the
-
art



EDB attracts capital intensive
projects

Training

-


cGMPs require adequate
training


Technical training


Typically training costs are 3
-
5
% of


wage bill







Job Attractions


Travel

-


Overseas attachments during


Technology Transfer




Most functions have corporate


reporting line

Career

-


Career prospects are limitless for
those

with the necessary education, skills

and ability


Job Satisfaction

-


Security and Social Status

What do recruiters look for ?


Good spoken and written communication skills


Team players


Leadership qualities


Able to explain clearly projects carried out


All rounders


beyond academic achievements


Consistency in performance


Organizational skills


Clear career objectives


Enthusiasm and passion


Willing to learn and teach

Thank You