Transcript TOPS Drug Development Training

Pharmaceutical Industry & Public Research Institutions :
The bridge from Science to Drugs
Sr. Manager – Techn.Training & External Affairs Catania Site
University of Catania
Faculty of Political Science
International Workshop
19-20 March 2004
Drug Development Process
The Drug Research and
Development Process is
a very complex integrated
and cohesive
set
of
activities, tactical milestones
and strategic decisions that
are conducted during the development
cycle of drugs from the beginning of a
scientific idea or serendipity observation
to the laboratory bench and the
commercial market.
Product Flow: Goals
0
4
Exploratory Discovery
Identify
Target
8
Phase 0
Identify
Development
Candidate
Phase 1
Characterize
Drug
12
Phase 2
Prove
Product
Profile
Phase 3
16
Registration
Commercialize
Product
Only 1 Out of 5,000-10,000 Screened Compounds
is Approved as a New Medicine
Since 1980, R&D Spending Increased ~7x, While
New Drug Approval Rate Remained the Same
60
35
50
30
40
25
20
30
15
20
10
10
Source:PhRMA Annual Survey ,2001.US-FDAGlobal Market Research &Analysis
2002E
2001
2000
1999
1997
1996
1995
1994
1993
1992
1991
1990
1989
1988
1987
1986
1985
1984
1983
1982
1981
0
1980
5
0
New Molecular Entities Approved
R&D Expenditures (US$ Billions)
40
Cost of Developing New Drugs Skyrocketing
Cost of Development ($MM)
$1,000
$802
$800
$600
$400
$231
$200
$54
$0
1976
1987
2000
Sources: DiMasi et al., J. Health Econ 1991 10:107-42, and Tufts Center for the Study of Drug Development 2001.
Drug Development Times
16
14.8
14.2
14
2.6
Years
12
10
2.8
11.6
2.1
6.1
8.1
8
2.4
5.5
4.1
6
4
2.5
5.1
2
6.1
5.9
3.2
0
1960s
1970s
Pre-IND Phase
1980s
IND Phase
1990s
NDA Phase
Source: Joseph A. DiMasi, “New Drug Development; Cost, Risk and Complexity”, Drug Information Journal, May 1995.
(From R&D Directions, 1996)
Effective Patent Life:
Rx Drugs vs. Other Products
20
18.5
16
12
11-12
8
4
0
Source:PhRMA USA
Rx Drugs
1 Including
Hatch-Waxman Partial
Patent Restoration
2 Other
Products
Than Rx Drugs
Future scenarios & challenges in healthcare
Changing of :

Demographic index
Increasing of :

Ageing population.


Environment

Social behaviors


Global markets

Chronic-degenerative and
environment related pathologies
Quality of life for patients
Diseases/needs related to less
development countries.
The Power of new technologies in R&D life science
Proteomics
Rational Drug Design
Biotechnology
Combinatorial Chemistry/
Highthroughput Screening
Genomics
Bioinformatics
Towards the future:
The right target for the right disease
Genetic
18.000 new biological target in 2010
Cancer
402 new weapons in the fight against cancer
Heart Diseases and Stroke
123 new medicines in development
HIV/Infectivology
83 drugs and vaccines currently in development
Neurological diseases
176 new medicines to change/improve (patient’s life)
Source:PhRMA USA
From Thought to Finish Life Science:
A cross-fertilization process
Foundamental research
Financing (e.g.subsidies)
Financing (e.g. VC)
Financing
Financing
Patenting
Regulation
Qualified labor & education
Incubators
Science Park
Government Support
Cooperation with
Universities
Discovery
0
Years
Preclinical
2
Source: Ernst&Young
4
Cooperation with
Hospital
Phase I
6
Phase II
8
10
Approval
&
Production
Phase III
12
14
16
Foster the loop:
innovation competitiveness-market
Competitiveness
Plus - value
Innovation
use
Market
Remuneration and ploughback of profits
•Attractive financial conditions and availability of funds/grants
(incentives, loans, fiscality, venture capitals, industrial presence, etc.)
•Strong normative conditions
(patent protection, market rules, smoothing of bureaucratic procedures, etc.)
•High educational conditions
(high university specializations, cross fertilization Universities-Industries, spin-off, start-up,
etc..)
Critical Location Factors
Some Prerequisite
Valuable supporting Policy

Proximity to academic excellence and
skilled workforce

Local city/national incentive
programs, e.g. grants, subsidies

Technical support and service
facilities

Access to transport and
communications infrastructure

Pool of well managed IP/licensing
opportunities

Positive promotion of seed or early
stage capital to minimize risk

Connections with and co-location of
larger life sciences businesses

Subsidized incubation facilities

Relevant business training for
scientist

Positive investment & business
climate


Patenting licensing,
commercialization expertise and
related professional services
Quality living and life style
opportunities
Future directions
“Strategic alliances with the scientific
community are the basis for the
foundamental knowledge building of
researchers, and in turn may provide the
basis for new start-ups in the region”
“By supplying the life sciences industry
with new talent and establishing strategic
alliances with both life sciences firms
and other knoledge institutions, we are
actively creating room for innovation”
WYETH at glance
Wyeth is one of the largest research-driven
pharmaceutical and health care products companies. It
is a leader in the discovery, development,
manufacturing, and marketing of pharmaceuticals,
vaccines, biotechnology products and non-prescription
medicines that improve the quality of life for people
worldwide.
The Company’s major divisions include:
• Wyeth Pharmaceuticals
• Wyeth Consumer Healthcare
• Fort Dodge Animal Health
WYETH Catania
PHARMACEUTICAL SITE
 SET UP IN 1959 AS THE ITALIAN SUBSIDIARY OF
AMERICAN CYANAMID-LEDERLE COMPANY
 SPECIALIZED IN MANUFACTURING : ANTIBIOTICS,
PARENTERAL DRUGS, LYOFILIZED VIALS AND
PRE-FILLED SYRINGES
 MARKETS: ITALY, EUROPE, USA, JAPAN
 OVER 700 EMPLOYEES
WYETH Catania
“EUROPEAN DRUG SAFETY & METABOLISM CENTER”
 A PRESTIGIOUS WYETH RESEARCH CENTER
SET UP IN 2001
 AN OUTSTANDING TEAM OF RESEARCHERS CLOSELY
FOLLOWING FDA GUIDELINES
 THE ONLY PHARMACOLOGICAL RESEARCH CENTER IN THE
SOUTH OF EUROPE SPECIALIZED IN SAFETY & METABOLISM
STUDIES OF INNOVATIVE ANTICANCER COMPOUNDS