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Ph@rm@ > Module 1 > Flashcards

Module 1 Flashcards

1
Q

Pharmaceutical Industry Goals

A

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

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2
Q

New Agenda

A

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.
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3
Q

Pharmaceutical Industry Goals

A
  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.
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4
Q

Pharmaceutical companies are for-profit.

A
  • 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.
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5
Q

New product development is driven by

A
  1. PATIENT NEEDS
  2. BUSINESS NEEDS
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6
Q

A typical pharmaceutical company:

A
  1. Research and development
  2. Manufacturing
  3. Commercial and marketing
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7
Q

The pharmaceutical industry is high risk because

A
  • High investment cost for R&D
  • Very competitive market
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8
Q

The pharmaceutical industry is regulated by agencies

A
  • Food and Drug Administration (FDA)
  • World Health Organization (WHO)
  • Other regulatory agencies
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9
Q

The pharmaceutical industry collaborates

A
  • Partners with academic institutions
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10
Q

Leading Pharmaceutical Products By Sales Worldwide in 2011

A

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

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11
Q

Leading Pharmaceutical Products By Sales Worldwide in 2022

A

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

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12
Q

R&D Spending (2021)

A
  1. Pfizer
  2. Roche Pharmaceuticals
  3. Merck & Co.
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13
Q

Pharmaceutical Company Organization

A

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
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14
Q

Commercial and Marketing

A
  • 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
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15
Q

Manufacturing

A
  • 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
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16
Q

Research and Development

A
  • 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

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17
Q

The Dug Research and Development Process

A
  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)
18
Q

The Philippine Pharmaceutical Industry

A
  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
19
Q

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

Protected by patent (20 yrs)

A

ORIGINATOR/INNOVATOR
Ex. Bactrim (sulfamethaxozole + trimethoprime)

20
Q

Brands that have the same
molecule as the originator

Produced and distributed without
patent protection

A

BRANDED GENERICS
Ex. Cotrimoxazole (Combizole)

21
Q

Drugs carrying the name of the
molecule followed by its
manufacturer

A

UNBRANDED GENERICS
Ex. Cotrimoxazole only

22
Q

R&D in the Philippines

A
  • Generics development
  • Patent searching
  • Bioequivalence (BE) studies
23
Q

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

A

discovery

24
Q

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

A

2 (both)

25
Q

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

A

20

26
Q

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

A

10 to 12

27
Q

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

A

bioequivalence

28
Q

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

A

8

29
Q

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

A

Manufacturing and marketing

30
Q

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

A

Generic; private label

31
Q

Market Stage in the Philippines

A

Growth Phase

32
Q

Competition Stage in the Philippines

A

Highly Concentrated

33
Q

Basis of Competition in the Philippines

A

Pharmacy Retail Chains

34
Q

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

A

30,000; 6,900; 23,100

35
Q

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

A

9.6

36
Q

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

A

30 to 80

37
Q

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

A

16

38
Q

Competition Dashboard composes of

A

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

39
Q

Career opportunities

A
  • 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
40
Q

The future of the industry

A
  • Biotech and biologics
  • Small molecules
  • Expiring drug patents in the next decade
  • New findings from existing drugs
41
Q
A

Ph@rm@ (11 decks)

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