Lartigau Oriane Polin Nicolas 5th year of Pharmacy-Industrial course 2014, February

 Support to the pharmaceutical, biotechnology and medical device industries in the form of research services outsourced. biopharmaceutical development, biologic assay, preclinical research, clinical trials management, pharmacovigilance, commercialization.  Top 5 therapeutic areas : Oncology, CNS, Infectious disease, Metabolic disorders and Cardiovascular disease. Vaccin development growing up  Market share : 2013 : 37,4 billion $ 2012 : 33,6 billion $ 2009 : 19,1 billion $ Contract Research Organisation (CRO)

CRO companies market

 Optimizing development time (30% faster)  Ever higher and complex requirements of regulatory authorities  Emergence of Biotech companies  Lower fixed costs, flexibility  Professionalism, expertise specific  Find patients, investigators  Policy of reduction of human resources in all major labs Interests of subcontracting

 Is one of the world’s largest and most comprehensive drug development services companies.  Large public CRO by revenue (2,2 billion of $ in 2012)  > 12, 000 employees  Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today COVANCE PROFILE

COVANCE in the world Covance, with headquarters in Princeton, New Jersey, has employees in more than 60 countries

Covance’s Activities

Covance’s activities Non Clinical development Early Development

Non Clinical Development:  TOXICOLOGY These services are designed to help you:  Characterize adverse effects  Identify target organ toxicity  Define mechanisms of action  Establish a dose response relationship  Assist in dose selection for clinical trials  Assist in the overall assessment of risk to humans, animals and the environment Early Development

Non Clinical Development:  TOXICOLOGY  In vivo toxicology studies = studies of the effects of drugs in animals.  Genetic toxicology studies = studies of the effects of drugs on chromosomes, as well as on genetically modified mice.  Immunotoxicology services = evaluation of the impact of drugs or chemicals on the structure and function of the immune system.  To be compliant with Good Laboratory Practices. Early Development

Non Clinical Development: Early Development Pharmaceutical Chemistry - Determination the metabolic profile and bioavailability of drug candidates. Research Products - Monoclonal antibody services (research of cancer, and infectious and other diseases) - Rigorous quality control requirements concerning preclinical animals Bioanalytical Services Determine the appropriate dose and frequency of drug application

Covance’s activities Non Clinical developmentPreclinical development Early Development Toxicology Pharmaceutical Chemistry Research Products Bioanalytical Services

Preclinical  The introduction of a drug into the human body for the first time.  The "go/no-go" decisions for further development.  Standardized Clinical Pharmacology studies. Early Development Preliminary evaluation of drug safety Pharmacokinetics Tolerance

Covance’s activities Clinical development Late Stage Development

Clinical Development:  Phase II & III  To manage the complex clinical development experience simply, efficiently, comprehensively and successfully.  Optimize performance  Comprehensive planning through Covance’s P3 PredictiveProactivePreventative Late Stage Development

Covance’s activities Clinical development Late Stage Development Central Laboratory

Central Laboratories:  Services  Genomics (3 sections)  Immunology (enzyme-immunoassay)  Hematology (Urinalysis, Flow Cytometry, diabetes mellitus)  Others… Late Stage Development

Central Laboratories:  Central laboratory testing is Covance's core competency.  Objective: The data provided are combinable and results in global clinical trial reference ranges because they use consistent laboratory methods, identical reagents and calibrators, and similar equipment globally Late Stage Development

Central Laboratories: Covance: The world’s largest provider of central laboratory services. Late Stage Development

Covance’s activities Clinical development Late Stage Development Central Laboratory Market Acces Services

 Provider Services  Industry-leading consultative insight to help you maximize your product value.  Health Economics & Outcomes Research  Examples: Pricing studies, competition in therapeutic area…  Risk Management (REMS = Risk Evaluation and Mitigation Strategies )  Manage a customized risk management program.  Managed Market Services  Covance Managed Markets Services (MMS) makes the labor-intensive, time-consuming, and costly contract management process far simpler and more efficient. Late Stage Development

History of Covance Corning manufacter of glass, ceramics and related materials acquired best-in-class drug development companies Besselaar Conducted clinical trials Hazleton Microtest (molecular toxicology) Philadelphia association of clinical trials -> Quest diagnostics -> Covance Corning Pharmaceuticals Services :

COVANCE ‘ Strategy of Growth Extern Technologies Acquisition Intern Technologies Acquisition Restructuration Parternship

COVANCE ‘ Strategy of Growth Extern Technologies Acquisition Intern Technologies Acquisition Restructuration Parternship

 1999 : emerging field of personalized medicine wishes of expand pharmacogenomics program initialy : solid experience for DNA, RNA extraction  2000 : alliance with Variagenomics  Integrate pharmacogenomics to central laboratory testing services  2009 : strategic acquisition of Merck’s genomics laboratory in Seattle  Bring world-class talent and technologies 1st in geonomics, biomarkers and discovery services Technology Acquisition To Perform

COVANCE ‘ Strategy of Growth Extern Technologies Acquisition Intern Technologies Acquisition Restructuration Parternship

 Study tracker® provides clients around the world with access to their toxicology, bioanalytical, and metabolism study data in near-real time. =>used by every top20 pharmaceutical company  Lablink® central lab results on-line in near real time  TrialTracker® study data in near real time : -Investigative site information -Project team list, enrollment information -study reports -SAE tracking 2001 : Secure Data Access

Clinical Trial Optimisation 2012 : A proprietary methodology designed to optimize clinical trial performance : -improving quality -reducing costs -decreasing trial timelines Recommendations on site, investigator and geographic selection

COVANCE ‘ Strategy of Growth Extern Technologies Acquisition Intern Technologies Acquisition Restructuration Parternship

 CRG (client relations group) : led by senior executives Focused on identifying opportunities to apply Covance’s ressources and expertise in all area of drug development.  6 sigma procedures Intern Restructuration

COVANCE ‘ Strategy of Growth Extern Technologies Acquisition Intern Technologies Acquisition Restructuration Parternship

Covance partenaria Lilly Sanofi Aventis Kellogg Company Bayer Healthcare Takeda

 Eli Lilly sold his Greenfield campus to Covance : 50 millions $  Eli Lilly makes Covance his partner for R&D : 10 years Paiement around 1,6 billion $ : strategic R&D collaboration Covance assumed control of the Greenfield campus and 264 Lilly employees Covance and Eli Lilly relationship

 Covance’s gain : -Site of toxicology testing -Market of Lilly’s preclinical and clinical trials during 10 years  Lilly’s gain : -Get rid of a site in lack of activities -Get a lower drug development -Speed the flow of new medicines Covance and Eli Lilly relationship

Covance partenaria Lilly Sanofi Aventis Kellogg Company Bayer Healthcare Takeda 7 years: $42 million strategic service contracts => Analytical chemistry, microbiology, stability testing

 Sanofi Aventis sold his site of : Porcheville Alnwick 25 millions $ Covance saved employees for 5 years  Sanofi makes Covance his partner for R&D for 10 years 1,2 Billion $ < paiement < 2,2 billion $ Covance and Sanofi Aventis relationship

 Covance’s gain : -CMC (chemistry, manufacturing and controls) service -Preformulation, formulation, API fabrication (activ pharmaceutical ingredient)  Sanofi Aventis ‘gain : -R&D portfolio, toxicology technology, clinical trials, labo central, market access => Transform his R&D model to discover drugs using performant technologies ans doing innovant partenariaship Covance and Sanofi Aventis relationship

Covance partenaria Lilly Sanofi Aventis Kellogg Company Bayer Healthcare Takeda

Vision of Mr. Joseph Herring Joseph Herring Chairman of the Board and Chief Executive Officer « People, Process and Clients » People attract right people with right skills investments to develop highest potential Promotions, career development opportunities Process Broad range buisness processes Technologies acquisition Clients Collaborating closely Understanding what they need deliver right solutions

Strenghts Broad portfolio of services People, Process and Clients Weakness Deacrising of Early Development’s benefits Opportunities International expansion Strategic alliance Threats Association of animals protection Competition between other CROs Complex regulatory authorities SWOT

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