Module 1

Question 1

Pharmaceutical Industry Goals

Answer 1

“Devoted to inventing medicines that allow patients to live longer, healthier and more productive lives.”

Question 2

New Agenda

Answer 2

Promote physical and mental health and well-being, and to extend life
expectancy for all by achieving universal health coverage and access to
quality health care.

• Sexual and reproductive health
• Family planning, information and education
• Accelerating progress made in fighting communicable diseases and epidemics.
• Accelerating progress made in fighting non-communicable diseases, including behavioral, developmental and neurological disorders.

Question 3

Pharmaceutical Industry Goals

Answer 3

1. Ending epidemics.
2. Reduce mortality from non-communicable
   diseases through prevention and treatment.
3. Achieve universal health coverage (i.e., medicines and vaccines for all).
4. Support R&D of vaccines and medicines for diseases that heavily affect developing countries.
5. Support economic development and human well-being, with a focus on affordable and equitable access for all.
6. Enhance scientific research.
7. Upgrade technological capabilities of industrial sectors, particularly for developing countries.
8. Support domestic technology development,research and innovation.

Question 4

Pharmaceutical companies are for-profit.

Answer 4

• Companies race to develop and launch products to maximize market share
  and sales.
• The industry is highly-competitive. Geographically concentrated in the U.S.
  (Northeast and West Coast) and Europe.

Question 5

New product development is driven by

Answer 5

1. PATIENT NEEDS
2. BUSINESS NEEDS

Question 6

A typical pharmaceutical company:

Answer 6

1. Research and development
2. Manufacturing
3. Commercial and marketing

Question 7

The pharmaceutical industry is high risk because

Answer 7

• High investment cost for R&D
• Very competitive market

Question 8

The pharmaceutical industry is regulated by agencies

Answer 8

• Food and Drug Administration (FDA)
• World Health Organization (WHO)
• Other regulatory agencies

Question 9

The pharmaceutical industry collaborates

Answer 9

• Partners with academic institutions

Question 10

Leading Pharmaceutical Products By Sales Worldwide in 2011

Answer 10

LIPITOR (PFIZER)
PLAVIX (SANOFI-AVENTIS/BMS)
SERENTIDE/ADVAIR (GSK)

Question 11

Leading Pharmaceutical Products By Sales Worldwide in 2022

Answer 11

COMIRNATY (BIONTECH/PFIZER)
HUMIRA (ABBVIE)
SPIKEVAX (MODERNA)

Question 12

R&D Spending (2021)

Answer 12

1. Pfizer
2. Roche Pharmaceuticals
3. Merck & Co.

Question 13

Pharmaceutical Company Organization

Answer 13

A typical pharmaceutical company will have these three functions:

1. Research and Development
   Drug discovery
   Drug development
   Formulations
   Animal studies
   Clinical studies
   Regulatory interactions
2. Manufacturing
   Manufacture for clinical studies
   Manufacture for sales
   Package and shipment of drugs
   Regulatory interactions
3. Commercial and Marketing
   Launch drugs
   Market and sell drugs
   Phase 4 studies
   Science liaisons
   Regulatory interactions

Question 14

Commercial and Marketing

Answer 14

• Product launching and marketing
• Provides customer-focused approach to drug development
  Key questions:
  1. What are some unmet medical needs?
  2. Who are our target audience?
  3. Differentiation vs competition

Question 15

Manufacturing

Answer 15

• Synthesis of small molecules and active ingredients
• Drug manufacturing – for clinical studies and sales
• Vaccine and biopharma product manufacturing
• Optimization of drug manufacturing processes
• Demonstrate readiness for registration

Question 16

Research and Development

Answer 16

• Drug discovery and development
  Lead discovery (5 to 6 years)

8 to 10 years:
Preclinical testing
IND Application
Phase I
Phase II
Phase III
NDA Review and Approval

Phase IV

Question 17

The Dug Research and Development Process

Answer 17

1. Basic research (2-3 years)
2. Non-clinical research (3-5 years)
3. Clinical studies (3-7 years)
4. New drug application and review Approx. (1 year)
5. Approval and launch
6. Post-marketing surveillance and clinical studies (Phase IV)

Question 18

The Philippine Pharmaceutical Industry

Answer 18

1. 3rd largest market in the ASEAN region
2. Top global pharmaceutical companies
   have manufacturing bases in the country
3. High volume of vulnerable individuals
4. Dominated by the generic sector

Question 19

Drugs that are first to launch
within a single or combined
molecule

Protected by patent (20 yrs)

Answer 19

ORIGINATOR/INNOVATOR
Ex. Bactrim (sulfamethaxozole + trimethoprime)

Question 20

Brands that have the same
molecule as the originator

Produced and distributed without
patent protection

Answer 20

BRANDED GENERICS
Ex. Cotrimoxazole (Combizole)

Question 21

Drugs carrying the name of the
molecule followed by its
manufacturer

Answer 21

UNBRANDED GENERICS
Ex. Cotrimoxazole only

Question 22

R&D in the Philippines

Answer 22

• Generics development
• Patent searching
• Bioequivalence (BE) studies

Question 23

For a patented drug, companies apply for the patent during _____ phase

Answer 23

discovery

Question 24

For a generic drug, it takes about ______ years to develop the drug and _____ years for regulatory approval

Answer 24

2 (both)

Question 25

For a patented drug, patents are granted for _____ years.

Answer 25

20

Question 26

For a patented drug, it takes ________ years to bring the drug to the market

Answer 26

10 to 12

Question 27

For a generic drug, company does not have to conduct clinical trials, they only have to prove ________

Answer 27

bioequivalence

Question 28

For a patented drug, companies are left with _______ years to market the drug and recoup R&D costs

Answer 28

8

Question 29

For a generic drug, company has to only recoup __________ and __________ costs

Answer 29

Manufacturing and marketing

Question 30

Philippines Pharmacy Retail Market is Drive by the High Sale of _________ Medicines coupled with Growth in the ___________ Medicines: Ken Research

Answer 30

Generic; private label

Question 31

Market Stage in the Philippines

Answer 31

Growth Phase

Question 32

Competition Stage in the Philippines

Answer 32

Highly Concentrated

Question 33

Basis of Competition in the Philippines

Answer 33

Pharmacy Retail Chains

Question 34

As of 2018, there are __________ drugstores operating in the Philippines out of which ______________ stores are organized chain stores and ___________ are unorganized chain stores.

Answer 34

30,000; 6,900; 23,100

Question 35

Pharmacy chains are expected to grow at a five year CAGR of ______% during the forecast period 2019-2013

Answer 35

9.6

Question 36

The cost of branded drugs were observed to be _____ to _____ % more in comparison to their generic counterparts of the same category

Answer 36

30 to 80

Question 37

Out of the top 20 pharmaceutical companies present in the Philippines, ____ are foreign companies.

Answer 37

16

Question 38

Competition Dashboard composes of

Answer 38

Mercury Drug Watsons Rose Pharmacy Generika drugstore The Generics Pharmacy Southstar Drug

Question 39

Career opportunities

Answer 39

* Drug discovery * Pharmaceutical development and formulations * Manufacturing: supervision and quality control * Clinical research: clinical studies, statistician, data analysis, writing * Project management * Regulatory affairs * Sales and marketing

Question 40

The future of the industry

Answer 40

* Biotech and biologics * Small molecules * Expiring drug patents in the next decade * New findings from existing drugs