Sr. Manager – Techn.Training & External Affairs Catania Site

Pharmaceutical Industry & Public Research Institutions : Pharmaceutical Industry & Public Research Institutions :

The bridge from Science to DrugsThe bridge from Science to Drugs

University of Catania Faculty of Political Science International Workshop

19-20 March 2004

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.

Drug Development Process

Product Flow: Goals

Only 1 Out of 5,000-10,000 Screened Compounds Only 1 Out of 5,000-10,000 Screened Compounds is Approved as a New Medicine is Approved as a New Medicine

Exploratory Discovery Phase 0 Phase 1 Phase 2 Phase 3 Registration

Identify Target

Characterize Drug

Prove Product Profile

Commercialize Product

Identify Development

Candidate

0 4 8 12 16

0

5

10

15

20

25

30

35

4019

80

1981

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1999

2000

2001

2002

E

R&

D E

xp

en

dit

ure

s (

US

$ B

illi

on

s)

0

10

20

30

40

50

60

New

Molecular E

ntities Approved

Since 1980, R&D Spending Increased ~7x, While New Drug Approval Rate Remained the Same

Source:PhRMA Annual Survey ,2001.US-FDAGlobal Market Research &Analysis

Cost of Developing New Drugs Skyrocketing

Sources: DiMasi et al., J. Health Econ 1991 10:107-42, and Tufts Center for the Study of Drug Development 2001.

0

2

4

6

8

10

12

14

16

1960s 1970s 1980s 1990s

Pre-IND Phase IND Phase NDA Phase

Drug Development Times

Source: Joseph A. DiMasi, “New Drug Development; Cost, Risk and Complexity”, Drug Information Journal, May 1995. (From R&D Directions, 1996)

Yea

rs

3.2

2.5

2.4

5.1

4.1

2.1

5.9

5.5

2.8

6.1

6.1

2.6

8.1

11.6

14.2 14.8

Effective Patent Life: Rx Drugs vs. Other Products

11-12

18.5

0

4

8

12

16

20

1 2Rx Drugs Including Hatch-Waxman Partial

Patent Restoration

Products Other Than Rx Drugs

Ave

rag

e E

f fe

ctiv

e P

ate

nt

Li f

e (Y

ear

s)

Source:PhRMA USA

Future scenarios & challenges in healthcare

Increasing of : Ageing population. Chronic-degenerative and

environment related pathologies Quality of life for patients Diseases/needs related to less development countries.

Changing of : Demographic index Environment Social behaviors Global markets

Rational Drug Design

The Power of new technologies in R&D life science

Proteomics

Bioinformatics

Biotechnology

GenomicsCombinatorial Chemistry/Highthroughput Screening

GeneticGenetic

18.00018.000 new biological target in 2010

CancerCancer

402402 new weapons in the fight against cancer

Heart Diseases and StrokeHeart Diseases and Stroke123123 new medicines in development

HIV/InfectivologyHIV/Infectivology8383 drugs and vaccines currently in development

Neurological diseasesNeurological diseases 176176 new medicines to change/improve (patient’s life)

Towards the future: The right target for the right disease

Source:PhRMA USA

From Thought to Finish Life Science: A cross-fertilization process

Qualified labor & education

0 2 4 6 8 10 12 14 16

Discovery Preclinical Phase I Phase II Phase IIIApproval

& Production

Foundamental research

Financing (e.g.subsidies)

Patenting

Financing (e.g. VC) Financing Financing

Regulation

Incubators

Government Support

Cooperation with Universities

Science Park

Cooperation with Hospital

YearsSource: Ernst&Young

Competitivenessuse

MarketInnovation

Plus - value

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..)

Foster the loop: innovation competitiveness-market

Some Prerequisite

Critical Location Factors

Valuable supporting Policy 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

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

“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”

Future directions

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 at glance

PHARMACEUTICAL SITEPHARMACEUTICAL 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 EUROPEAN DRUG SAFETY & METABOLISM CENTER”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

WYETH Catania