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 lifecycleDISCOVERY TOX I II III PreclinicalClinical Registration (Approval) Years File Patent Candidate Nomination PK & Safety Pilot Efficacy Full development Comparative agents Filing Approval Process IDEA DEVELOPMENTPRODUCTION MARKETING SALES

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 OUTPUT DEVELOPMENT RESEARCH Pharmaceutical R&D Pharmaceutical R&D New Product Pipeline

Pharma Sales (US $B) Pfizer : Sanofi-Aventis : Glaxo SmithKline : AstraZeneca : Johnson & Johnson : Merck :21.9 7Novartis : Roche : Bristol-Myers Squibb : Wyeth :14.3 Source : Contract Pharma July 2006

Pharma Sales (US $B) Eli Lilly : Abbott : Boehringer- Ingelheim : Takeda : Schering-Plough : Astellas Pharma: Daiichi-Sankyo: Novo Nordisk : Eisai: Bayer AG: 5.1 Source : Contract Pharma July 2006

BioPharma Sales (US $B) Amgen : Genentech : Serono : Biogen Idec : Gilead Sciences : Genzyme Corp: Medimmune:1.2 8 Chiron Corp : Millennium: 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 BiotechnologyTableting Encapsulation Sterile Dosage Forms Packaging BlendingGranulation 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