Declining productivityIncreasing costsIncreasing complexityBigger and more difficult challengesDecreased willingness to pay by governments (society)Opportunities remainMuch more now about the quality of life as against the earlier focus on the length of a life.
In many ways this cartoon tells the story of the success of modern medicine and healthcare over the past 60 years.
Ireland 69.7 in 1960, to 71 in 1970 to ………..80.4 in 2010China 43 in 1960 to 73 in 2010.India 42 to 65.USA 70 in 1960 t0 71 in 1970 to 78 in 2010UK 71 IN 1960 TO 72 IN 1970 to 80.4 in 2010In the developed world the average increase in life expectancy has risen by around 10 yearsIn Asia it’s nearly 30 yearsIn Africa it’s between 15 and 20 years
Pharma spend around 8% of revenues on R&D every year.
57% of all are in North America ( 48% in the US, 7.5% in Canada)26% in EuropeIndia and China are growing fast with over 5000 studies combined. (3000 in China, 2000 in India)About 2,500 in Russia and the CIS countries
This is an industry that was virtually non existent 30 years ago.
So, let’s take a closer look as to how our services can be tailored to meet the needs of your program. You will benefit from our comprehensive menu of high-quality services, which you can use in combination to gain even greater value. Our clinical development services include the design and execution of trials, as well as support in finding new efficiencies within your existing clinical trial framework and in forging new models for clinical development. When trial services are purchased as an integrated whole, you receive a broad range of benefits due to the integration, including lower overall study costs, reduced timelines and simplified trial management. We also serve as a functional service provider of outsourced services development, working with you to find the model that will bring you the highest return on investment. Some of the decentralized functions and activities outsourced to us by customers in FSP models include clinical monitoring, data management, pharmacovigilance, biostatistics, medical writing, and IVR.Our late phase services provide you the support you need to determine what’s going on with your product once it enters the marketplace. They include observational studies/safety surveillance, Rx to OTC switch monitoring, claims and alternate indication studies, and outcomes studies.Importantly, in addition to actual clinical trial development, we also provide advisory services that focus on the operational elements that impact your product. These services include: consulting, capital investment, scientific advisory boards, CRA training.We also provide regulatory services, including regulatory submissions, regulatory consulting and IND preparation, to help ensure that your trial begins and ends in a way that is within full compliance.
John Kiernan, Vice President & Managing Director, Quintiles Ireland
Life Expectancy Between 10 and 30 years added in past 50 years. “New drugs are no small part of this medical miracle” – Mark McClellan, FDA**Source: CDC 7
New medicines contribute 40% to 60% ofgains in life expectancy: 1988-2000 2.5 Number of Years Increased Longevity Increase in Longevity Due to New Drug Launches Total Increase in Longevity 1.96 2.0 1.65 1.5 1.37 1.07 1.0 0.76 0.79 0.70 0.57 0.62 0.56 0.5 0.45 0.30 0.23 0.12 0.0 1988 1990 1992 1994 1996 1998 2000 8
The therapeutic revolution• 1,095 Novel Drug Therapies: 1963-2011 1960s Beta blockers 1970s Cancer drugs, ACE inhibitors 1980s Antipsychotics, Antidepressants, Antivirals (Herpes; HIV), First monoclonal antibody (OKT) 1990s Alzheimer’s drugs, Smoking cessation drugs, Asthma (corticosteroids), Statins (cholesterol reducers) 2000s First cancer vaccine (HPV), First gene therapy (neck cancer)Sources: FDA; Dorland Healthcare Information, 2004 9
Source: Lichtenberg, National Bureau of Economic Research 10
Global Research Based PharmaceuticalIndustry Global Sales $825bn Annual Global Spend on R&D $68bn Proportion outsourced to CROs 44% Global Revenues for CROs c.$28.2bn CRO Employees globally c.120,000 Bio Pharma R&D Employees Ireland c.2,000 11
Pharmaceutical Healthcare Facts and FiguresLife Cycle of an Innovative 2012Medicine Estimated cost of development $1.3bn to $1.8bn. 12
Rising costs threatenhealthcare advances… Clinical Drug Development: • Time: 7 to 10 years • Cost: $1.3 billion per approval • Success Rate: 8% for candidates entering Phase I U.S. Health Expenditure: • 13.6% of GDP in 2000 • 18.2% of GDP in 2011 Ireland Health Expenditure: IPHA , 3rd Oct • 13,317m 2012 • 9.5% GDP (2009) 13
Changing New Health Landscape Divergent Challenging economic biopharma conditions environment Promise of Rise of technological new markets (r)evolution Socio- Strained demographic healthcare shifts environment 14
The Current Environment for BioPharma Regulatory Pressures: Complexity of technology/innovation Development Pressures: Approval Times Stakeholders Scrutiny Intense FDA/EMA Scrutiny Patient Access Demands Ethical Concerns & Patients needed Commercialization Stakeholders Numerous Regulatory Agencies R&D Timelines Health Technology Assessment Productivity Real World evaluation Patent Cliff Financial Pressures: Product Pipelines Costs Capital Constraints Demand for Value Payer Pressure ROI 16
Other factors impacting BioPharma Population changes New technologies and Screening procedures Escalating health care costs Public expectations and patient empowerment Information sources…internet, TV… Disease areas Personalisation of medicine Global economic environment Market Access Real world analysis and value determination. 17
Map of All Studies in ClinicalTrials.gov25th October 2012 18
Clinical Trials - Globally Currently 134,668 Total Open United States 64766 19339 Canada 10128 3213 Germany 9462 2842 France 8251 3118 UK 7119 2271 Italy 5386 1758 Total Open Spain 4808 1743 Denmark 3403 1061 Netherlands 4308 1324 Sweden 2816 740 Belgium 4057 1141 Norway 1899 536 Total Open Ireland 691 209Source: www.clinicaltrials.gov 20
Clinical Trials - USA • Currently 64,766 Total Open California Texas 17765 14759 4306 3445 Ireland 691 / 209 / 4.6m New York 14733 3667 Florida 11726 2436 Maryland 10957 2905 Ohio 10564 2376 Total Open Population Rhode Island 2282 491 1m New Hampshire 1392 338 1.3m Vermont 1298 248 0.6m Hawaii 1283 253 1.4mSource: www.clinicaltrials.gov 21
• More than half the clinical trials being conducted worldwide are happening in North America >United States / Canada 56% 26% in Ireland Europe is 1.9% European total 22
Greater Stakeholder CooperationCulture of innovation & collaboration• Academia• Industry• Government• Health Service > Clinical research is an integral part of medical education.• Patient > Patient advocacy > AwarenessBourne out of a greater level of trust, confidence and abelief that all stake-holders have a shared goal ofdelivering improved health outcomes for patients 23
What is a Clinical Research Organization?• A contract research organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of research & development services outsourced on a contract basis.• A CRO can provide such services as biopharmaceutical development, preclinical research, clinical research, and clinical trials management. Many CROs (but not all CROs) specifically provide clinical- study and clinical-trial support for drugs and/or medical devices. CROs range from large, international full-service organizations to small, niche specialty groups. CROs that specialize clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval, without the drug sponsor having to maintain a staff for these services. 25
Medicinal Product Continuum Phase I and Labs Clinical Global Consulting Commercial Development Data Strategic Services Management Research Services New Clinical Central Clinical DM SRS Sales & Chemical Phase I Laboratories Phases II - III Marketing Entity Outcomes /Real World data Healthy Bio-sample Clinical Trialdiscovery discovery Volunteers AnalysisGlobal Product Development Data Patients Patients Prescribers commercial services Confidence in drug & disease Uncertainty indication. 26
Market size and Growth CRO Market Share of global R&D Value CRO market by drug phase ($bn), 2010 50.00 66% 70% 45 42.6 45.00 58% 43.87 60% 40 38.3 40.00 39.88 34.6 50% 35 50% Billions of dollars 35.00 31.2 44% 34.68 30 28.2 30.00 38% 30.15 25.5 40% 25 23.2 $bn 25.00 33% 26.22 22.80 30% 20 20.00 15 15.00 20% 10 10.00 5 10% 5.00 0 0.00 0% 2010 2011 2012 2013 2014 2015 2016 2010 2011 2012 2013 2014 2015 Source: Business Insights US Western Europe Eastern Europe China India Other Asia Latin America OtherRef: ACRO – Association of Clinical Research Ref: CRO Market Outlook to 2016 / Business InsightsOrganizations 27
Market size and Growth • A significant portion of R&D budgets are used for outsourcing services offered by the CRO industry, approximately $20 billion in 2010. • This figure is expected to grow at 15% p.a. over the next 4 years and will increase further with the broadening of the spectrum of services outsourced to cover the entire value chain. • Currently the bio-pharmaceutical industry outsources approximately 33% of it’s R&D* spend globally and this is anticipated to grow by 15% annually over the next 5 years.* It is estimated that in 2010 over 60% of all biopharmaceutical product development spend was outsourced. 28
CRO Global Employment Numbers Employees 180000 161051 160000 146410 140000 121000 133100 120000 110000 100000 100000 80000 66000 60000 40000 20000 0 2008 2010 2011 2012 2013 2014 2015Ref: ACRO – Association of Clinical Research Organizations 29
End-to-end Development SolutionsFull Service CRO / PSC (Pharmaceutical Services Company) • Portfolio Planning > Life Cycle Safety • Biomarker Development > Medical Device Services • Global Regulatory Strategy > Post-Marketing Surveillance • Central Laboratory Services > Rx to OTC Switch • Cardiac Safety Services > Finance Policy Consulting • Data Management > Outcomes Research • Biostatistics > Health Economics Clinical Go-to- Integrated Coachin Disease Modeling Trial Regulatory Market Market Full Suite of g Translational Management and Management Agency Phase IV Research, Comme Post Clinical Research & Rx to OTC Simulation Phase I, II & Submission rcialisation & Approval Services Switch III Global Market Services Access Fully Integrated Biopharma Services Provider 30
The Challenge: Reinvent HealthcareModels Clinical Drug Development • Time: up to 10 years • Cost: >$1.3 billion per approval • Success Rates: as low as 8% Healthcare Delivery • Lacks population level safety evaluation • Lacks population level treatment outcomes 2010 Health Expenditure: US 17.6% of GDP EU 9.6% of GDP 31
Evidence-based medicineTwo Frontiers Going DEEPER: Going BROADER: Understanding Understanding Disease Causality Real-world Outcomes • Genetics • Proteomics • Large Population Databases • Cellular lineages and • Data Analytics environments 32
Data, Data EverywhereNew data resources and tools to use them will be themeans to improve health outcomes and reduce costs EXPANDING SOPHISTICATED MODELING & DATABASES ANALYTICS SIMULATION Genetics Databases to ask “What If” to test treatment questions and cost options Observational & EHR Databases 33
Emerging Model:Research-Care ConvergenceLeveraging data across all sectors to improve decision-making…• Evidence-based drug design• Evidence-based therapeutic evaluation• Evidence-based policy and economicsHealthcare must measure standards of care andcost—and then exceed them—or pay more andmore for sub-optimal solutions. 34
Convergence in Three ArenasTherapeutic Innovation• Targeted therapeutics• Personalized medicinePatient Care• Outcomes evaluation in real-world populations• Comparative effectiveness/ optimal interventionsHealth Management• Cost-effectiveness / value-based pricing• Improved resource allocation• Prevention / positive health behavior programs 35
Future Focus Cultural Change in Medical Education Better Greater Patient Stakeholder Engageme Cooperation nt Real Evidence world / Value research based outcome medicine s 36
Thank You email@example.comQuintiles Ireland Limited, Registration No. 162942 VAT Registration No. IE 6562942T Directors: John G Kiernan (Managing) Alasdair MacDonald UK Michael Wilson UK 37