THE DRug DEvElOPmENT PiPEliNE - CenterWatchstore.centerwatch.com/pdfs/samples/CLV112_index.pdf · THE DRug DEvElOPmENT PiPEliNE ... » Direct and Capitalized Cost of Developing a

C H A P T E R O N E

THE DRug DEvElOPmENT PiPEliNE

» Drugs in Worldwide Clinical Development » Distribution of global Drug Pipeline by Research Phase » Worldwide Active R&D Projects in Development » Distribution of Active Projects in Clinical Phases Only » Distribution of global Pipeline by molecule Type » Number of Companies with Active Clinical Projects Worldwide » Top Six largest Pharmaceutical Company Pipelines » most Active Clinical Pipelines » New Drug Approvals » Declining global Clinical Trial volume » Worldwide Clinical Trial initiations » Percent of Clinical Trials initiated Outside the uS » Worldwide Clinical Trials volume » Distribution of Active Clinical Trials » Active Phase i Clinical Trials Worldwide » Active Phase ii Clinical Trials Worldwide » Active Phase iii Clinical Trials Worldwide » Active Phase iv Clinical Trials Worldwide » global Compounds in R&D by Therapeutic Area » Distribution of global R&D Projects by Therapeutic Area » Drugs in Clinical Development by Therapeutic Area » Therapeutic Area growth

» most Active Therapeutic Areas » Worldwide R&D Pipeline by Therapeutic Area (Anabolics–Biopharmaceuticals)

» Worldwide R&D Pipeline by Therapeutic Area (Bone, Cartilage, Connective Tissue System Drugs–Digestive System Drugs)

» Worldwide R&D Pipeline by Therapeutic Area (Drug Addiction & Abuse Drugs–immunologics)

» Worldwide R&D Pipeline by Therapeutic Area (motor System Drugs–Wound & Burn Treatment)

» Projects in Development by Therapeutic Area (Anti-cancers–Formulations)

» Projects in Development by Therapeutic Area (musculoskeletal–Dermatologicals)

» Projects in Development by Therapeutic Area (Blood & clotting– miscellaneous)

CenterWatch Clinical Trials Data Library

C H A P T E R T W O

DRug DEvElOPmEnT PERfORmAnCE

Cycle Time

» Drug Development Duration: Cycle Time in Years from InD Approval to nDA Approval

» Clinical Approval Times for Drugs and Biopharmaceuticals

» Average Clinical Development Time: mean Total Development Time in months

» Clinical and Approval Times

» Cycle Time Acceleration Targets: Phases II-III

Success Rates

» Phase Transition Probabilities for All Drugs

» Success Rate variation by molecule Size

» nCE Approval Success Rates by Therapeutic Class

» Success Rates by Therapeutic Area and Phase

» Success Rates in Oncology

» Incidence of Project Cancellations

» Estimated value of Cancellations: grant Dollars lost due to Cancellations in millions

» Traditional Clinical Development Scope, Purpose, and Duration

» Traditional Development Duration


C H A P T E R T H R E E

DRug DEvEloPmEnT EConomiCs

» global R&D spending

» Annual growth in R&D spending

» Annual growth in R&D spending (cont’d)

» Benchmark R&D spend as a Percentage of sales

» R&D spending as a Percent of sales by sector

» Estimated Worldwide R&D spending as a Percent of sales

» Benchmark R&D spending and Annual growth

» Total Clinical spending by Phase

» global R&D spending by Phase

» Distribution of Total global R&D spending

» Direct and Capitalized Cost of Developing a single Drug

» Total global spending on Clinical Development

» growth in global Phase i-iii Clinical Trial grant spending

» Total spending on Clinical Trial grants

» Total Clinical Trial grant spending

» mean Cost Per Patient by Phase

» Annual growth in Per Patient Cost

» Clinical Trial grant sources for Academic Centers

» industry spending on Clinical Trial grants by Phase

» mean Cost Per Patient by Therapeutic Area Across Phases i-iii

» mean Patient Reimbursement Per visit

» mean Patient Reimbursement Per visit by Therapeutic Area Across Phases ii & iii


C H A P T E R F O U R

CLINICAL RESEARCH PARTNERS

Contract Clinical Outsourcing » Clinical Services Outsourcing » The Integral Role of CRO Partners: Worldwide R&D Capacity » Percentage of Budget Dollars Spent on Outsourcing » Global Market for Contract Preclinical and Clinical Services » Top CROs by Worldwide Employee Size » Incidence of Site Management Responsibilities Outsourced to CROs

» Site Responsibilities Outsourced by Company Size » Site Ratings of Sponsor and CRO Relationship Attributes » Site Ratings of Sponsor and CRO Study Conduct Support Attributes

» Sponsor and CRO Payment Tardiness: Site Perceptions of Changes in Payment Timeliness

» Clinical Trial Laboratory Services Market Size

Investigative Site Landscape » Active Unique Investigators Filing Form 1572s World Wide » Proportion of Novice Investigators Conducting Clinical Trials » Global Distribution of 1572 Filings » Distribution of Industry-Funded Clinical Trials in the USGlobal Market Share of Active Clinical Trials by Investigative Site Setting

» Comparing Network Size » Geographic Focus and Scope » SMOs of Yesteryear » Number of Clinical Grants Awarded » Top Investigative Site Operating Concerns » Distribution of Annual Study Volume per Investigator » Rising Scope and Declining Size of Clinical Trials » Site Reported Cancellations » Site Reported Recovery of Start-Up Costs Associated with Cancellations

» Global Investigative Site Staffi ng » Total FTE Employees per Investigative Site » Mean Number of Employees by Staff Type (Full and Part Time) » Mean Number of Employees by Staff Type by Region (Full and Part Time)

» Global Investigative Site Mean Revenue and Profi tability » Investigative Site Expenses and Profi t » Type of Accounting Method Used by Investigative Sites » Wide Differences in Site Payable and Receivable Cycles » Percentage of Clinical Research Revenue Owed That is Written off as Bad Debt in 2011

»


C H A P T E R F O U R

CLINICAL RESEARCH PRACTICES

Patients / Study Volunteers » How Many Studies Have You Participated In? » Most Frequent Illness Addressed? » How Did You First Contact the Study Center? » How Much Time Did it Take Before the Study Staff First Contacted You?

» How Long Was The Study? » How Many Visits Were Required for the Study? » How Aware Were You About Clinical Trials as a Treatment Option Prior to Learning About this Study?

» Factors Impacting Study Participation » Factors Reducing Volunteer Willingness to Participate » Who Helped You Make the Decision to Participate? » Study Participation Concerns » How Knowledgeable was Your Physician About Where You Could Find More Information About Active Clinical Trials?

» Were You Compensated for Your Participation in the Study? » Did You Receive Any Support that Assisted You in Participating? » Type of Support Received? » Whom Did You Initially Meet With On Your First Visit?

» Did You Receive an Informed Consent Form Before Beginning the Study?

» Did You Read the Informed Consent Form? » Who Reviewed the Informed Consent Form with You? » How Well Did You Understand the Informed Consent Form? » “I Understood That I May Receive a Placebo (Sugar Pill) Instead of the Investigational Medicine”

» Understanding Study Expectations: Physician Visits and Medication Treatment

» Understanding Study Expectations: Understanding the Risks » Understanding Study Expectations: Information Received Matched Actual Experience

» Was Medical Care Helpful During the Trial? » Dropping Out of the Study » Reasons for Dropping Out » How Would You Rate the Overall Quality of Care Received During the Study?

» Would You Participate in a Clinical Trial Again? » Would You Recommend that a Member of Your Family or Friend Participate in a Clinical Study?


C H A P T E R F I V E


Protocol Design » Rising Protocol Complexity and Burden » Complexity and Work Burden by Phase » Impact on Clinical Trial Performance » Protocol Complexity Impact on Cycle Time » Growth in Protocol Complexity and Work Burden by Phase: 2002-2007 CAGR

» How Important is Protocol Design to Your Decision to Participate in a Clinical Trial?

Relationship Management and Effectiveness » Average 2011 Rating of Relationship Quality for a Typical Sponsor

» Sponsor Rating of Overall Relationship Quality » Regional Comparison - Average Sponsor Ratings » Average Sponsor Ratings by Site Type » Average Sponsor Ratings by Years of Experience » Company Ratings of Relationship Quality » Company Ratings of Relationship Quality (cont’d) » Frequency of Attributes in Top 3: “Good / Excellent” Ratings » Essential Attributes to Study Success » The Top Sponsors by Essential Attributes

» Evaluating Sponsor Performance: “Better” and “Much Better” Rating

» Evaluating Sponsor Performance: “Worse” and “Much Worse” Rating

» Comparing Performance Quality to Category Importance » Comparing Attribute Importance to Sponsor Performance - Gaps

» Quality of Staff Professionalism: Sponsor » Quality of Workstyle: Sponsor » Quality of General Project Management: Sponsor » Quality of Study Initiation Process: Sponsor » Quality of Ongoing Study Conduct: Sponsor » Quality of Grant Payment Process: Sponsor » Average 2011 Relationship Quality Rating for the Typical CRO » Benchmark Proportion of Sites Rating CRO Relationship Quality » Regional Comparison of Average CRO Ratings » Average CRO Ratings by Site Type » Average CRO Ratings by Years of Experience » The Top Rated CROs » Site Ratings by Experience and Setting » Comparing Performance Quality to Category Importance » Comparing Attribute Importance to CRO Performance - Gaps


C H A P T E R F I V E


» Quality of Staff Professionalism: CRO » Quality of Workstyle: CRO » Quality of General Project Management: CRO » Quality of Study Initiation Process: CRO » Quality of Ongoing Study Conduct: CRO » Quality of Grant Payment Process: CRO

Patient Recruitment » Distribution of Global Development Spending, Trial Volume, and Patient Enrollment

» Probability of Successful Investigative Site Performance » A Typical Multi-Site Recruitment Pattern » Preferred Patient Recruitment Methods » Aggregate Patient Recruitment Success Rates » Reasons Patients Seek Online Clinical Trials Information » Individuals Who Would Most Infl uence Your Decision to Participate

» Top Site Perceived Factors Contributing to Faster Cycle Times » Factors Contributing Most to Delays in Enrolling the First Patient » Factors That Most Often Cause Delays » Factors That Could Best Prevent Future Delays » Enrollment Delays » Enrollment Delays by Region » Percent of Sites Extending Patient Enrollment Period

Section Cover Slide: Development Technology Solutions » EDC Solutions » Estimated EHR Market Growth » Hospital System Adoption of EHRs » Practicing Physician Adoption of EHR Systems » Barriers to Hospital System Adoption of EHRs » Top Barriers to Practicing Physician Adoption of EHRs


C H A P T E R S I X

THE GlobAl PHARmACEuTICAl mARkET

» Global Pharmaceutical Sales

» Year-by-Year Growth in Global Pharmaceutical Sales

» 2010 Global Pharmaceutical Sales by Region

» largest Therapeutic Areas by Global Pharmaceutical Sales

» largest Therapeutic Areas by Global Pharmaceutical Sales (cont’d)

» u.S. Generic market Share of Prescription Sales

» Growth in Worldwide Prescription and oTC Sales by Therapeutic Area: 2008 - 2016

» Growth in Worldwide Prescription and oTC Sales by Therapeutic Area: 2008 - 2016 (cont’d)

» Global Sales Contribution by Age of Drug

» Annual Growth Rate of u.S. Prescription Pharmaceutical market

» 2010 u.S. Prescription Sales for the Top 10 Therapeutic Classes

» 2010 u.S. Prescription Sales for the Next Top 10 Therapeutic Classes

» Top 12 u.S. Prescription Products by u.S. Sales, 2010

» Next 13 u.S. Prescription Products by u.S. Sales, 2010

» Worldwide Prescription Drugs Sales: Top 10 Companies

» Worldwide Prescription Drugs Sales: Next 10 Companies

» Worldwide market Share of Prescription Drugs Sales: Top 10 Companies

» Worldwide market Share of Prescription Drugs Sales: Next 10 Companies

» Worldwide medical Device market: Projected Sales

» u.S. medical Device market: Projected Sales

» Select medical Device manufacturers

» Generic Pharmaceutical market

» Top 10 Generic Companies


C H A P T E R S E V E N

DRUG DEVELOPMENT REGULATION

IND and NDA Submissions and Approvals » Number of IND Submissions » Number of INDs Submitted Each Quarter » Total NDA Submissions and Approvals » Original NDA / BLA Submissions » NDA Submissions by Filing Status » BLA Submissions by Filing Status » NME Submissions by Filing Status » Number of NDAs and NMEs Approved » Approved NDAs and NMEs Receiving Priority Designations

» NMEs Approved with Postmarketing Requirements and/or REMs

» NME / BLA Approvals » NDA Approvals » New Biologic Approvals » FDA Orphan Drug Approvals » FDA Orphan Drug Designations

Regulatory Review and Approval Cycle Time » Cycle Time in Years from IND Approval to NDA Approval » Mean NME Approval Times » Median Approval Times for Biotech Drugs and Biologics » Mean EMA Processing Time for Human Medicinal Products

FDA Inspection Results » FDA, CDER Inspections of Sponsors and CROs » Complaints Filed Against Investigators » Complaints Filed Against Investigative Sites as Percentage of Active INDs

» CDER Inspections of Clinical Investigators » Investigator Deficiencies: Final Classification of OAI » Bioresearch Monitoring Inspections Overseen by FDAs CDER

» Site Audit Preparedness » Warning Letters Issued to Principal Investigators » FDA Inspection Results » Investigator Disqualifications


Documents

THE DRug DEvElOPmENT PiPEliNE - CenterWatchstore.centerwatch.com/pdfs/samples/CLV112_index.pdf · THE DRug DEvElOPmENT PiPEliNE ... » Direct and Capitalized Cost of Developing a