Sr. Manager

1
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
2
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.

3
Product Flow Goals
Only 1 Out of 5,000-10,000 Screened Compounds is
Approved as a New Medicine
4
Since 1980, RD Spending Increased 7x, While
New Drug Approval Rate Remained the Same
SourcePhRMA Annual Survey ,2001.US-FDAGlobal
Market Research Analysis
5
Cost of Developing New Drugs Skyrocketing
Sources DiMasi et al., J. Health Econ 1991
10107-42, and Tufts Center for the Study of Drug
Development 2001.
6
Drug Development Times
14.8
14.2
2.6
2.8
11.6
2.1
6.1
8.1
Years
5.5
4.1
2.4
2.5
6.1
5.9
5.1
3.2
Source Joseph A. DiMasi, New Drug Development
Cost, Risk and Complexity, Drug Information
Journal, May 1995. (From RD Directions, 1996)
7
Effective Patent Life
Rx Drugs vs. Other
Products
Average Effective Patent Life (Years)
Rx Drugs Including Hatch-Waxman
Partial Patent Restoration
Products Other Than Rx Drugs
SourcePhRMA USA
8
Future scenarios challenges in healthcare
Increase of Healthcare Expenditures
9
The Power of new technologies in RD life science
Rational Drug Design
Proteomics
Biotechnology
Combinatorial Chemistry/ Highthroughput Screening
Genomics
Bioinformatics
10
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 (patients life)
SourcePhRMA USA
11
From Thought to Finish Life Science
A cross-fertilization process
12
Foster the loop
innovation competitiveness-market
Competitiveness
Market
Innovation
13
Critical Location Factors
Some Prerequisite
Valuable supporting Policy

• Local city/national incentive programs, e.g.
  grants, subsidies
• Access to transport and communications
  infrastructure
• Positive promotion of seed or early stage capital
  to minimize risk
• Subsidized incubation facilities
• Relevant business training for scientist
• Positive investment business climate

• Proximity to academic excellence and skilled
  workforce
• Technical support and service facilities
• Pool of well managed IP/licensing opportunities
• Connections with and co-location of larger life
  sciences businesses
• Patenting licensing, commercialization expertise
  and related professional services
• Quality living and life style opportunities

14
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
15
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 Companys major divisions include
• Wyeth Pharmaceuticals
• Wyeth Consumer Healthcare
• Fort Dodge Animal Health

16
(No Transcript)
17
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

18
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

19
Many Thanks and Arrivederci