National University of Singapore Department of Pharmacy 21 Nov 2006 KPP Prasad, Ph.D. Quality Operations Director Pfizer Global Manufacturing The Pharmaceutical.

National University of SingaporeDepartment of Pharmacy

21 Nov 2006

KPP Prasad, Ph.D.Quality Operations DirectorPfizer Global Manufacturing

The Pharmaceutical IndustryAnd 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

4th 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&DPharmaceutical R&D

Product lifecycle

DISCOVERYDISCOVERY

TOXTOXII

IIIIIIIIII

Preclinical Clinical Registration(Approval)

YearsYearsFile Patent

CandidateNomination

PK &Safety Pilot

Efficacy Full developmentComparative

agentsFiling

ApprovalProcess

IDEAIDEA

0 5 6 7 9 12 13 15

DEVELOPMENTDEVELOPMENT PRODUCTIONPRODUCTIONMARKETINGMARKETING

SALESSALES

Pharmaceutical R&DPharmaceutical R&D

Pharmaceutical R&DPharmaceutical R&D

400projects

in discovery research

20 in 520 major new drugapplications during

the five years225

projectsin development(130 new molecules,

95 major product enhancements)

THE FUTURE:New approachesto improvehuman health

IdeasMULTIPLE

PRODUCT

ENHANCEMENTS

OUTPUTDEVELOPMENT

RESEARCH

Pharmaceutical R&DPharmaceutical R&D

New Product Pipeline

Pharma Sales (US $B) 2005

1 Pfizer : 44.32 Sanofi-Aventis : 34.0 3 Glaxo SmithKline : 33.94 AstraZeneca : 24.05 Johnson & Johnson : 22.36 Merck : 21.9 7 Novartis : 20.38 Roche : 16.69 Bristol-Myers Squibb : 15.310 Wyeth : 14.3

Source : Contract Pharma July 2006Source : Contract Pharma July 2006

Pharma Sales (US $B) 2005

11 Eli Lilly : 13.8 12 Abbott : 13.313 Boehringer- Ingelheim : 9.0 14 Takeda : 9.015 Schering-Plough : 8.816 Astellas Pharma : 7.517 Daiichi-Sankyo : 6.918 Novo Nordisk : 5.619 Eisai : 5.1 20 Bayer AG : 5.1

Source : Contract Pharma July 2006Source : Contract Pharma July 2006

BioPharma Sales (US $B) 2005

1 Amgen : 12.02 Genentech : 5.53 Serono : 2.34 Biogen Idec : 2.35 Gilead Sciences : 1.8 6 Genzyme Corp : 1.87 Medimmune : 1.28 Chiron Corp : 1.19 Millennium : 0.310 ImClone : 0.2

Source : Contract Pharma July 2006Source : Contract Pharma July 2006

Drug Discovery to CommercialManufacturing

•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 TermsDefinition of Terms

Pharmaceutical Manufacturing

(Simplified)

Primary Manufacturing

Active Pharmaceutical Ingredients (Drug Substance)

Secondary Manufacturing

Drug Product

FermentationChemical 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/ AnalystsQuality 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 YouThank YouThank YouThank You