Innovation

1
Innovation the Pharmaceutical Research
Development Industry
2
Inventions
3
Research Development (RD)in Pharmaceuticals
DISCOVERY Enzymes, receptors, genetics,
DEVELOPMENT Safety, quality and efficacy
tests PRODUCTION Quality assurance REGISTRATION Me
dical and marketing approval MONITORING Physician
and patient satisfaction
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Chronology of Drug Innovation
SOURCES/INNOVATIONS
cell pharmacology/ molecular biology
natural products derivatives
serendipity
receptors
enzymes
genetic engineering
chronic de- generative disease associated with
aging, inflammation cancer
biotech drugs
lipid lowerers ACE inhibitors
H2-antagonists beta blockers
NSAIDS
psychotropics
penicillins sulphonamides aspirin
NEW THERAPEUTIC CYCLES
1900 1950 1960 1970 1980 1990 2000 2010 2020 2030
Source Lehman Brother Pharmaceutical Research
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R D in Pharma
From discovery to patient
Patent application
Acute toxicity
Pharmacology
Phase I clinical trials
Chronic toxicity
Registration and transparency
Phase II
Phase III
Reimbursement
Pharmacovigilance
Price
1 medicinal product
0 5 years 10 years 15 years 20 years
Patent expiry
Supplementary Protection SOUTH AFRICA?
10 years of research
2 to 3 years of administrative procedures
Source Recherche Vie, LIM (AGIM)
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RD Scientific Risk
Discovery development of a successful medicine
YEARS
PHASES IV III II I
15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 0
INTRODUCTION /REGISTRATION
POST-MARKETING SURVEILLANCE
1
CLINICAL TEST (HUMANS)
DEVELOPMENT
2
2 - 5
PRECLINICAL TEST (ANIMALS)
5 - 10
BASIC RESEARCH
SYNTHESIS, EXAMINATION
SCREENING
3,000 10,000
QUANTITY OF SUBSTANCES
Source Based on PhRMA analysis, updated for
data per Tufts Center for the Study of Drug
Development (CSDD) database
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Length of Drug Development
Total time from synthesis to approval
15.3
14.2
11.6
8.1
Source Tufts CSDD, NCE Database, 1995
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Cost of Drug Development
U of Rochester Tufts OTA Myers Howe Tufts
Source R Hansen, PhD, University of Rochester
J.A. DiMasi, Tufts University Office of
Technology Assessment, Myers Howe, 1997 Tufts
Center for the Study of Drug Development 2001.
All figures except 2001 reflect impact of
inflation as measured by the GDP Deflator.
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Drug DevelopmentCosts vs Returns 1980s Study
AVERAGE PV OF RETURNS 224 MM
AVERAGE RD COSTS 202 MM
Source Grabowski and Vernon, Returns to RD on
New Drug Introduction in the 1980s. Journal of
Health Economics Vol. 13, (November 1994)
383-406
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Innovation of the Pharmaceutical Industry
PATENTED BY
Source PhRMA Survey Center for the Study of
Drug Development, Tufts University (1991)
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Pharmaceutical Research and Development Process

• 1 in 5,000 compounds make it to market
• Takes 12 to 15 years from discovery to launch
• Average cost of nearly 800 million

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Benefits of Pharmaceutical Research and
Development

• Prevent and treat disease
• Reduce costly hospitalization, nursing home stays
  and surgeries
• Return patients to productive lives

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Benefits of Pharmaceutical Research and
Development

• Antibiotics and vaccines have virtually wiped out
  diptheria, syphilis, whooping cough, measles and
  polio in many parts of the world
• 8 out of 10 children can now survive leukemia
• Over the past 30 years, medicines have helped
  reduce heart disease and stroke by half for many
  populations

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Worldwide Drug Research Continues

• 96 new drugs for heart disease and stroke
• 316 anti-cancer medicines
• 122 drugs to treat AIDS
• 146 drugs and vaccines for children
• 17 new treatments for Alzheimers disease
• 29 medicines for arthritis