Innovation and the Pharmaceutical Research and Development Industry

1
Innovation and the Pharmaceutical Research and
Development Industry

• January 2002
• MSD South Africa

2
(No Transcript)
3
(No Transcript)
4
(No Transcript)
5
DISCOVERY
Enzymes, receptors, genetics, proteomics
DEVELOPMENT
Safety, quality and efficacy tests
PRODUCTION
Quality assurance
REGISTRATION
Medical and marketing approval
MONITORING
Physician and patient satisfaction
6

7

8
FROM DISCOVERY TO PATIENT
9
RD SCIENTIFIC RISK
DISCOVERY AND DEVELOPMENT OF A SUCCESSFUL MEDICINE
YEARS
PHASES
15
INTRODUCTION/ REGISTRATION
14
IV
POST-MARKETING SURVEILLANCE
1
13
12
III
11
2
10
2 - 5
CLINICAL TEST (HUMANS)
II
DEVELOPMENT
9
8
I
5 - 10
7
6
PRECLINICAL TEST (ANIMALS)
10 - 20
5
4
3
3,000 - 10,000
2
1
0
QUANTITY OF SUBSTANCES
Source Based on PhRMA analysis, updated for data
per Tufts Center for the Study of Drug
Development (CSDD) database.
10
LENGTH OF DRUG DEVELOPMENT
Source Tufts CSDD, NCE Database, 1995.
11
COST OF DRUG DEVELOPMENT
U of Rochester
Tufts
Tufts
OTA
Myers Howe
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 Delfator.
12
COSTS 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 Introductions in the 1980s. Journal of
Health Economics. Vol. 13, (November 1994)
383-406.
13
INNOVATION OF THE PHARMACEUTICAL INDUSTRY
SOURCES OF 100 MOST PRESCRIBED DRUGS IN THE US IN
1992
PATENTED BY
Source PhRMA Survey Center for the Study of
Drug Development, Tufts University (1991)
14

15
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 500 million

16
Benefits of Pharmaceutical RD

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

17
Benefits of Pharmaceutical RD

• 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

18

• Worldwide 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