national university of singapore department of pharmacy 21 nov 2006 kpp prasad, ph.d. quality...
TRANSCRIPT
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