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The Pharmaceutical Industry And Career Options. National University of Singapore Department of Pharmacy 21 Nov 2006 KPP Prasad, Ph.D. Quality Operations Director Pfizer Global Manufacturing. Presentation Topics Biomedical Sciences Global Pharmaceutical Industry

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The Pharmaceutical Industry

And Career Options

National University of Singapore

Department of Pharmacy

21 Nov 2006

KPP Prasad, Ph.D.

Quality Operations Director

Pfizer Global Manufacturing


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  • Presentation Topics

  • Biomedical Sciences

  • Global Pharmaceutical Industry

  • Biomedical Industry in Singapore

  • Skills required in Pharmaceutical Manufacturing

  • Job Scope for Graduates


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4th Pillar


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  • 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


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  • 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


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Product lifecycle

File Patent

Years

0

5

6

7

9

12

13

15

DEVELOPMENT

PRODUCTION

DISCOVERY

MARKETING

Candidate

Nomination

SALES

TOX

IDEA

I

II

PK &

Safety

III

Pilot Efficacy

Full development

Comparative

agents

Filing

Approval

Process

Registration

(Approval)

Preclinical

Clinical

Pharmaceutical R&D




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Pharmaceutical R&D

New Product Pipeline

OUTPUT

DEVELOPMENT

RESEARCH

20 in 5

20 major new drugapplications duringthe five years

225

projectsin development

(130 new molecules, 95 major product enhancements)

400

projectsin discovery research

THE FUTURE:

New approachesto improvehuman health

Ideas

MULTIPLE

PRODUCT

ENHANCEMENTS


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  • Pharma Sales (US $B) 2005

    • 1 Pfizer : 44.3

    • Sanofi-Aventis : 34.0

    • Glaxo SmithKline : 33.9

    • AstraZeneca : 24.0

    • Johnson & Johnson : 22.3

    • Merck : 21.9

    • 7 Novartis : 20.3

    • Roche : 16.6

    • Bristol-Myers Squibb : 15.3

    • Wyeth : 14.3

Source : Contract Pharma July 2006


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  • Pharma Sales (US $B) 2005

    • 11Eli Lilly : 13.8

    • Abbott : 13.3

    • Boehringer- Ingelheim : 9.0

    • Takeda : 9.0

    • Schering-Plough : 8.8

    • Astellas Pharma : 7.5

    • Daiichi-Sankyo : 6.9

    • Novo Nordisk : 5.6

    • Eisai : 5.1

    • Bayer AG : 5.1

Source : Contract Pharma July 2006


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  • BioPharma Sales (US $B) 2005

    • 1 Amgen : 12.0

    • 2Genentech : 5.5

    • Serono : 2.3

    • Biogen Idec : 2.3

    • Gilead Sciences : 1.8

    • Genzyme Corp : 1.8

    • Medimmune : 1.2

    • 8 Chiron Corp : 1.1

    • Millennium : 0.3

    • ImClone : 0.2

Source : Contract Pharma July 2006


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  • 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


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  • 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)



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Definition of Terms

Pharmaceutical Manufacturing

(Simplified)

Primary Manufacturing

Active Pharmaceutical Ingredients (Drug Substance)

Secondary Manufacturing

Drug Product

Chemical Synthesis

Biotechnology

Tableting

Encapsulation

Sterile Dosage Forms

Packaging

Fermentation

Blending

Granulation

Special unit operations i.e. laser drilling

Coating


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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


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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


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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


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  • 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



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