Sr. Manager – Techn.Training & External Affairs Catania Site Pharmaceutical Industry & Public Research Institutions : The bridge from Science to Drugs University of Catania Faculty of Political Science International Workshop 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 is Approved as a New Medicine ExploratoryDiscoveryPhase 0Phase 1Phase 2Phase 3Registration Identify Target Characterize Drug Prove Product Profile Commercialize Product Identify Development Candidate

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 :107-42, and Tufts Center for the Study of Drug Development 2001.

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

Effective Patent Life: Rx Drugs vs. Other Products Rx Drugs Including Hatch-Waxman Partial Patent Restoration Products Other Than Rx Drugs Average Effective Patent Life (Years) 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 Genomics Combinatorial Chemistry/ Highthroughput Screening

Genetic new biological target in 2010 Cancer new weapons in the fight against cancer Heart Diseases and Stroke new medicines in developmentHIV/Infectivology drugs and vaccines currently in development Neurological diseases 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 Discovery Preclinical Phase I Phase II Phase III Approval & Production Foundamental research Financing (e.g.subsidies) Patenting Financing (e.g. VC) Financing Regulation Incubators Government Support Cooperation with Universities Science Park Cooperation with Hospital Years Source: Ernst&Young

Competitiveness use Market Innovation 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 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 WYETH Catania