Module 1 Flashcards
Pharmaceutical Industry Goals
“Devoted to inventing medicines that allow patients to live longer, healthier and more productive lives.”
New Agenda
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.
Pharmaceutical Industry Goals
- Ending epidemics.
- Reduce mortality from non-communicable
diseases through prevention and treatment. - Achieve universal health coverage (i.e., medicines and vaccines for all).
- Support R&D of vaccines and medicines for diseases that heavily affect developing countries.
- Support economic development and human well-being, with a focus on affordable and equitable access for all.
- Enhance scientific research.
- Upgrade technological capabilities of industrial sectors, particularly for developing countries.
- Support domestic technology development,research and innovation.
Pharmaceutical companies are for-profit.
- 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.
New product development is driven by
- PATIENT NEEDS
- BUSINESS NEEDS
A typical pharmaceutical company:
- Research and development
- Manufacturing
- Commercial and marketing
The pharmaceutical industry is high risk because
- High investment cost for R&D
- Very competitive market
The pharmaceutical industry is regulated by agencies
- Food and Drug Administration (FDA)
- World Health Organization (WHO)
- Other regulatory agencies
The pharmaceutical industry collaborates
- Partners with academic institutions
Leading Pharmaceutical Products By Sales Worldwide in 2011
LIPITOR (PFIZER)
PLAVIX (SANOFI-AVENTIS/BMS)
SERENTIDE/ADVAIR (GSK)
Leading Pharmaceutical Products By Sales Worldwide in 2022
COMIRNATY (BIONTECH/PFIZER)
HUMIRA (ABBVIE)
SPIKEVAX (MODERNA)
R&D Spending (2021)
- Pfizer
- Roche Pharmaceuticals
- Merck & Co.
Pharmaceutical Company Organization
A typical pharmaceutical company will have these three functions:
- Research and Development
Drug discovery
Drug development
Formulations
Animal studies
Clinical studies
Regulatory interactions - Manufacturing
Manufacture for clinical studies
Manufacture for sales
Package and shipment of drugs
Regulatory interactions - Commercial and Marketing
Launch drugs
Market and sell drugs
Phase 4 studies
Science liaisons
Regulatory interactions
Commercial and Marketing
- 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
Manufacturing
- 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
Research and Development
- 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
The Dug Research and Development Process
- Basic research (2-3 years)
- Non-clinical research (3-5 years)
- Clinical studies (3-7 years)
- New drug application and review Approx. (1 year)
- Approval and launch
- Post-marketing surveillance and clinical studies (Phase IV)
The Philippine Pharmaceutical Industry
- 3rd largest market in the ASEAN region
- Top global pharmaceutical companies
have manufacturing bases in the country - High volume of vulnerable individuals
- Dominated by the generic sector
Drugs that are first to launch
within a single or combined
molecule
Protected by patent (20 yrs)
ORIGINATOR/INNOVATOR
Ex. Bactrim (sulfamethaxozole + trimethoprime)
Brands that have the same
molecule as the originator
Produced and distributed without
patent protection
BRANDED GENERICS
Ex. Cotrimoxazole (Combizole)
Drugs carrying the name of the
molecule followed by its
manufacturer
UNBRANDED GENERICS
Ex. Cotrimoxazole only
R&D in the Philippines
- Generics development
- Patent searching
- Bioequivalence (BE) studies
For a patented drug, companies apply for the patent during _____ phase
discovery
For a generic drug, it takes about ______ years to develop the drug and _____ years for regulatory approval
2 (both)
For a patented drug, patents are granted for _____ years.
20
For a patented drug, it takes ________ years to bring the drug to the market
10 to 12
For a generic drug, company does not have to conduct clinical trials, they only have to prove ________
bioequivalence
For a patented drug, companies are left with _______ years to market the drug and recoup R&D costs
8
For a generic drug, company has to only recoup __________ and __________ costs
Manufacturing and marketing
Philippines Pharmacy Retail Market is Drive by the High Sale of _________ Medicines coupled with Growth in the ___________ Medicines: Ken Research
Generic; private label
Market Stage in the Philippines
Growth Phase
Competition Stage in the Philippines
Highly Concentrated
Basis of Competition in the Philippines
Pharmacy Retail Chains
As of 2018, there are __________ drugstores operating in the Philippines out of which ______________ stores are organized chain stores and ___________ are unorganized chain stores.
30,000; 6,900; 23,100
Pharmacy chains are expected to grow at a five year CAGR of ______% during the forecast period 2019-2013
9.6
The cost of branded drugs were observed to be _____ to _____ % more in comparison to their generic counterparts of the same category
30 to 80
Out of the top 20 pharmaceutical companies present in the Philippines, ____ are foreign companies.
16
Competition Dashboard composes of
Mercury Drug
Watsons
Rose Pharmacy
Generika drugstore
The Generics Pharmacy
Southstar Drug
Career opportunities
- 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
The future of the industry
- Biotech and biologics
- Small molecules
- Expiring drug patents in the next decade
- New findings from existing drugs
