National University of Singapore Department of Pharmacy 21 Nov 2006 KPP Prasad, Ph.D.

1. 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

2. Presentation Topics • Biomedical Sciences • Global Pharmaceutical Industry • Biomedical Industry in Singapore • Skills required in Pharmaceutical Manufacturing • Job Scope for Graduates

3. Biomedical Sciences Industry • Pharmaceuticals • Biotechnology • Medical Devices • Healthcare Services 4th Pillar

4. 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

5. 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

6. 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

7. Pharmaceutical R&D

8. Pharmaceutical R&D

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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)

15. Pharmaceutical/Medical Device Manufacturers in Singapore

16. 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

17. 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

18. 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

19. 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

20. 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

31. Thank You