Pengantar

Teknologi
Desain
Obat Deni Iskandar, S.Si., Apt., MPH.
@deniiskandar
Pengantar
Teknologi
Desain • Introduction to Pharmaceutical Industry
Obat
• Pharmaceutical Product Life Cycle
• Innovation: The Process of Drug Discovery
• Portfolio Management in New Drug
Development
• Regulatory
• Pharmaceutical Care
• Future of Pharmaceutical Industry
Introduction to Pharmaceutical Industry

• What is pharmaceutical industry?

• Innovation and marketing in pharmaceutical
industry
• Pharmaceutical industry outlook
• Challenges in pharmaceutical industry
Introduction to Pharmaceutical Industry

Secara luas
Meliputi semua org yg terlibat/dibutuhkan, mulai dr obat
itu msh “diangankan” oleh seorg ahli sampai mjd produk
jadi dan dikonsumsi o/pasien/penderita

Secara sempit
Riset obat-obatan dan manufakturnya/ perusahaan
farmasi yg menyediakan obat u/diracik dlm bentuk obat
atau sediaan siap pakai o/ para ahli farmasi di ruang
lingkup praktiknya

What is pharmaceutical industry?

Introduction to Pharmaceutical Industry

Pharmaceutical industry:
Companies engaged in researching, developing,
manufacturing, and marketing drugs and biologicals for
human or veterinary use
http://www.trade.gov/td/health/PharmaceuticalIndustryProfile2010.pdf

- Linked to science
- More regulated: impact people’s quality of life

What is pharmaceutical industry?

Introduction to Pharmaceutical Industry

What is pharmaceutical industry?

Introduction to Pharmaceutical Industry

What is pharmaceutical industry?

Introduction to Pharmaceutical Industry

What is pharmaceutical industry?

Introduction to Pharmaceutical Industry

What is pharmaceutical industry?

Introduction to Pharmaceutical Industry

https://www.firstwordpharma.com/node/1408804

What is pharmaceutical industry?

Introduction to Pharmaceutical Industry

subpar innovation for an extended

period: differentiation potential
decrease > deteriorating margins
Innovation
price competition with generic drug
firms and may, ultimately,
Marketing
be forced to merge with or be
acquired by another company

Innovation and marketing in pharmaceutical industry

Introduction to Pharmaceutical Industry

In Ding, M., In Eliashberg, J., & In Stremersch, S. (2014). Innovation and marketing in the pharmaceutical industry: Emerging practices, research, and policies.

Innovation and marketing in pharmaceutical industry

Introduction to Pharmaceutical Industry

Innovation

Marketing

http://www.firstwordpharma.com/node/1211072#axzz3xz4tAZ7x

Innovation and marketing in pharmaceutical industry

Introduction to Pharmaceutical Industry

without strong marketing

capabilities > will not fully unlock
the value of innovation
Innovation
thus it stands to miss out on billions
of dollars for its stakeholders and
Marketing
on the resources needed to sustain
continued innovation

Innovation and marketing in pharmaceutical industry

Introduction to Pharmaceutical Industry
Characteristics
drugs as having
Live or die “double personalities”
Large in size
Finite lifespan 1. Conventional
Innovation
product
2. As a public goods
Marketing

Cost, uncertainty, return, time

Innovation and marketing in pharmaceutical industry

Introduction to Pharmaceutical Industry
Indonesia

Pharmaceutical industry outlook

Introduction to Pharmaceutical Industry

o The market is among the least developed

o Significant market growth potential
o Lack of formal price
o Well-established local industry
o Low purchasing power
o Sizeable and strong generic drug market
o Regulatory system biased
o Introduction of Good Manufacturing Practice
o Reliance on imports
(GMP) standards.
o Pharmaceutical sales through illegal channels
STRENGTH WEAKNESSES o Reliance on imported active pharmaceutical
ingredients

o Demand for low-cost drugs o Poor efficacy of counterfeit drugs

OPPORTUNITY THREAT
o
o
Trade liberalization within ASEAN
Halal drug manufacturing.
o
o
Compulsory licensing for antiretroviral
Uncertainty new health insurance
o Exports likely to increase o Widespread corruption
o Privatization of the local manufacturing o Reduction of tariffs on drugs
Clinical trials base o Halal certification for pharmaceutical products.
o Taxes on raw materials lowered o Weakness in the currency
o Inadequate healthcare coverage and lack of
disease monitoring leading to epidemics.

Pharmaceutical industry outlook

Introduction to Pharmaceutical Industry

• Declining new drug approval

• Competition of generics
• Pricing of patented drug
• Corporate image deterioration
• Rethink its policies towards
sales representatives
• Changing media landscape
• Empowered consumer

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

• Declining new drug approval

• Competition of generics
• Pricing of patented drug
• Corporate image deterioration
• Rethink its policies towards
sales representatives
• Changing media landscape
• Empowered consumer

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

• Declining new drug approval

• Competition of generics
• Pricing of patented drug
• Corporate image deterioration
• Rethink its policies towards
sales representatives
• Changing media landscape
• Empowered consumer

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

• Declining new drug approval

• Competition of generics
• Pricing of patented drug
• Corporate image deterioration
• Rethink its policies towards
sales representatives
• Changing media landscape
• Empowered consumer

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

• Empowered consumer

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

Challenges in pharmaceutical industry

Introduction to Pharmaceutical Industry

Challenges in pharmaceutical industry

Pharmaceutical Product Life Cycle

• What is product life cycle

• Product life cycle approach in pharmaceutical
industry
Pharmaceutical Product Life Cycle

What is product life cycle?

Pharmaceutical Product Life Cycle

Product lifecycle management (PLM) is a systematic,

controlled concept for managing and developing products
and product related information

• Physical and/or functional properties of the product

• Technological research, design and to the production,
use, maintenance, recycling, and destruction of the
product, and possibly to the official regulations
connected with the product
• The Meta data – is information about information

What is product life cycle?

Pharmaceutical Product Life Cycle

What is product life cycle?

Pharmaceutical Product Life Cycle

Product life cycle approach in pharmaceutical industry

Pharmaceutical Product Life Cycle

Product life cycle approach in pharmaceutical industry

Pharmaceutical Product Life Cycle

Product life cycle approach in pharmaceutical industry

Innovation: The Process of Drug Discovery

• Overview of innovation in the pharmaceutical

industry
• Economics
• History
• Genesis of a drug
• Intellectual property
• Business model in drug discovery and
development
Innovation: The Process of Drug Discovery

Overview of innovation in the pharmaceutical industry

Innovation: The Process of Drug Discovery
Nature of the pharmaceutical industry compared
to others:
• Focus on people
• Innovation is a must
• High uncertainty on R&D
• Technology-push model

• High impact of success

• Powerful engine of economic progress

Overview of innovation in the pharmaceutical industry

Innovation: The Process of Drug Discovery
Drug discovery:
• Odds of creating a marketable drug: 1 in every
5000 – 10000 potential compound
• Chances of a promising drug candidate to make
it through the sequential stages of the drug
development process: 1 in 5
• 30% failure associated with toxicity, 30% lack of
efficacy, others related to rate of action,
duration of effect, absorption, distribution,
metabolism, excretion

Economics
Innovation: The Process of Drug Discovery
Drug discovery:
• 2000: total cost of new drug was $803 mil
• 2005: total cost of new drug was $1.3 bil
• Approximately 50% for R&D

Economics
Innovation: The Process of Drug Discovery
Before WWII:
• pharmaceutical industry and life science was
relatively tenuous
• Derived from/based on natural sources (herb)
• Little formal testing on safety and efficacy
• War instigated needs of antibiotics

History
Innovation: The Process of Drug Discovery
After the war:
• Faced a vast set of diseases and disorders
with no known cures
• Random screening
• Mid-1970, advancement in science propelled
the understanding of the biochemical and
molecular mechanism of diseases and action
pathway of existing drug
• Most of drugs derived from nature, organic
synthesis, fermentation
• Early 1980, biotechnology, genetic
engineering
History