Transcript PAPPL Quality Operations

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
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&D
Product lifecycle
File Patent
0
5
Years
6
7
9
12
DEVELOPMENT
DISCOVERY
13
15
PRODUCTION
MARKETING
SALES
Candidate
Nomination
TOX
IDEA
I
PK &
Safety
Preclinical
II
Pilot
Efficacy
III
Full development
Comparative
Filing
agents
Clinical
Approval
Process
Registration
(Approval)
Pharmaceutical R&D
Pharmaceutical R&D
Pharmaceutical R&D
New Product Pipeline
Ideas
400
projects
in discovery
research
225
projects
in development
(130 new molecules,
95 major product
enhancements)
20 in 5
20 major new drug
applications during
the five years
MULTIPLE
PRODUCT
ENHANCEMENTS
THE FUTURE:
New approaches
to improve
human health
Pharma Sales (US $B) 2005
1
2
3
4
5
6
7
8
9
10
Pfizer
Sanofi-Aventis
Glaxo SmithKline
AstraZeneca
Johnson & Johnson
Merck
Novartis
Roche
Bristol-Myers Squibb
Wyeth
Source : Contract Pharma July 2006
:
:
:
:
:
:
:
:
:
:
44.3
34.0
33.9
24.0
22.3
21.9
20.3
16.6
15.3
14.3
Pharma Sales (US $B) 2005
11
12
13
14
15
16
17
18
19
20
Eli Lilly
Abbott
Boehringer- Ingelheim
Takeda
Schering-Plough
Astellas Pharma
Daiichi-Sankyo
Novo Nordisk
Eisai
Bayer AG
Source : Contract Pharma July 2006
:
:
:
:
:
:
:
:
:
:
13.8
13.3
9.0
9.0
8.8
7.5
6.9
5.6
5.1
5.1
BioPharma Sales (US $B) 2005
1
2
3
4
5
6
7
8
9
10
Amgen
Genentech
Serono
Biogen Idec
Gilead Sciences
Genzyme Corp
Medimmune
Chiron Corp
Millennium
ImClone
Source : Contract Pharma July 2006
:
:
:
:
:
:
:
:
:
:
12.0
5.5
2.3
2.3
1.8
1.8
1.2
1.1
0.3
0.2
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,
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)
Govt
Pharmaceutical/Medical Device
Manufacturers in Singapore
Definition of Terms
Pharmaceutical Manufacturing
(Simplified)
Primary Manufacturing
Secondary Manufacturing
Active Pharmaceutical
Ingredients (Drug Substance)
Drug Product
Fermentation
Chemical
Synthesis
Biotechnology
Blending
Tableting
Granulation
Encapsulation
Coating
Sterile Dosage
Forms
Special unit
operations i.e. laser
drilling
Packaging
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