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HIGHLIGHTS FROM EXL
PHARMA’S 4TH LATIN AMERICA
CLINICAL TRIALS February 25-26, 2010
Miami, Florida
UNIVERSITY/INDUSTRY COLLABORATIONS
US RESEARCH INSTITUTIONS AND INDUSTRY
Rhetoric
Political
Experts
History
Triple Helix and the Entrepreneurial University
Shared Goals and Complementary Strengths
IRB COLLABORATION AND ENHANCEMENT
Human Subjects Research Enhancement Program Sponsored by National Institutes of Health
John E. Fogarty International Center 12 months, $50,000
Objectives Develop sustainable electronic systems, procedures
and communication methods Increase administrative, scientific, socio-cultural and
ethical competencies of IRB members through joint workshops, short-term exchange and training activities
Create sustainable research ethics training courses for global health researchers
IRB COLLABORATION AND ENHANCEMENT
Projects Specific needs determined in partnership with
developing country ethics review committee IRB training, investigator training, best practices,
systems
Benefits of Participation Improve Ethical Review Committee competencies
Address critical barriers in review Reduce review time
Increase Investigator knowledge of research integrity requirements Improved protocols require less time to review and
approve
Develop knowledge leaders in research integrity
THREE UNLIKELY COLLABORATORS
EDICT Project
Clinical Trials
Microfinance
Industry
EDICT The Eliminating Disparities in Clinical
Trials Project2005-2009
Clinical Trials NavigationCommunity Health Worker/Promotora
Promotora de SaludHealth promoterBridge between communities and external
systemsSocial and cultural knowledgeProven modelTraining and certification
MICROFINANCE INDUSTRY Purpose
Give poor people access to credit, ultimately alleviating poverty
Types of MFIsCommercial banksMicrofinance banksMicrofinance NGOsRegulated and unregulated
Types of LendersGroups Individuals
CLINICAL TRIAL RECRUITMENT AND RETENTION UTILIZING PROMOTORAS WITHIN MFI INFRASTRUCTURE
MFI
Geographic Region
1
Loan Officer
Trust Group
Loan Officer
Trust Group
Geographic Region
2
Loan Officer
Trust Group
Loan Officer
Trust Group
Trust Group• Neighborhood level• Weekly meetings• Business training and support• Health education• Preventative health services
Promotora• Clinical Trial Education• Clinical Trial Recruitment• Clinical Trial Retention• Phase IV• Post Trial Management
GEOGRAPHICAL FOCUS
■ Oversaturation of Microfinance
■ Nearing Saturation
■ Strong Microfinance Presence, Medium Market Reach
■ Low Microfinance Presence, Huge Potential Market
■ Growing Microfinance Presence, Huge Potential Market
BENEFITS AND OBSTACLES Benefits
Microfinance is an expanding industry with an existing infrastructure
CHW/Promotora model Contributes to sustainability of community by job
creation leading to economic self-sufficiency Increased access to community improves
participant recruitment Follow-through enhances participant retention
BENEFITS AND OBSTACLES Obstacles
Communities of devastating povertyUnreliable social infrastructureRaises Significant Ethical questions
Vulnerable population Ability to comprehend consent Subject to undue influence or coercion? Weak ethical oversight
QUALITY IN CLINICAL RESEARCH
QUALITY IN TRIALS
Deviation in just a few centers can
invalidate/change the results of an entire
trial
Such events potentially have
widespread reputational and
credibility impact
The resource and time spent in remediation far out-weighs that
which would be expended in “getting it right the first time”
The integrity of all trial’s data is dependent on high quality, GCP/ICH compliant execution of trials at all sites and in all countries
POOR QUALITY COSTCorrect More Faults Earlier!
QA/QC Early in the Project $
QA/QC Late in the Project $
Find Here
Not Here!
Cost
to C
orr
ect
Local Management
Analyzing, objectives, indicators
Measurement
Improvement
Product
processing
Client
Needs
Activities that add valueInformation workflow
Input Output
Continuing Improvement toward Operational Excellence
4QY 4QNY
MYR
Client
Satisfaction
Client
Satisfaction
Quality Management Team
16 | 4th Latin America Clinical Trials Congress| US – Miami 25 -26 Feb 10 | Quality in Clinical Research | B. Funes | Business Use Only
QUALITY OVERSIGHT Quality Assurance (QA) is fault
prevention through process design and auditing and ensuring appropriate control steps are followed-Creating processes, procedures, tools, etc. to prevent faults from occurring
-Examples: Templates, checklists, guides, SOPs
Quality Control (QC) is fault/failure detection through static and/or routine testing
-Examining against pre-determined standards and criteria to measure conformance
-Examples: Periodic Self Assessments, Quality Plan, peer reviews, business walkthrough
WHAT IS A QUALITY PLAN Define your Quality Goals (Process & Metrics)
Selects appropriate detection and prevention methods
Analyze and be realistic about where defects come from
(Root/Cause)
Establish a formal in-process and inter-process review & checks
Establish a Training (Lessons Learned, sharing Best Practices,
Quality Management mindset and change culture)
Establish a Failure mode analysis (frequency of errors,
criticality)
Determine Costs of failure, rework, repair, waste, complaint
resolution, product return and replacement
Establish a Help line support
SUPERVISION OF THE CONDUCT OF CLINICAL INVESTIGATION
1. What is Appropriate Delegation of Study related Tasks?
2. What is adequate Training?3. What is adequate Supervision of the
Conduct of an Ongoing Clinical Trial?4. What are an Investigator’s
Responsibilities for Oversight of Other Parties involved in the Conduct of a Clinical Trial?
PROTECTING THE RIGHTS, SAFETY, AND WELFARE OF STUDY SUBJECT
1. Reasonable Medical Care Needed by Participation in a Clinical Trial
2. Reasonable Access to Medical Care3. Protocol Violations that Present
Unreasonable Risks
FUNCTION OF ESSENTIAL DOCUMENTS Demonstrate: compliance of the investigator, sponsor and
monitor Standards of GCPs all applicable regulatory requirements
GOOD DOCUMENTATION PRACTICES
ALCOA rule A:Accurate: The document must be error free. L:Legible: The document must be readable by
internal/external customers C:Concise: The document must tell the entire story and
be understood by internal/external customers. Contemporaneous
O: Organized: follows an standardized practice, easy to access and follow the story. Original
A: Attributable: Each aspect of the document must be traceable, such as, who recorded it, where and why.
OUTSOURCING IN CLINICAL RESEARCH
OUTSOURCING IN CLINICAL RESEARCH
R&D – Importance
For Country New treatments, new concepts, improve life expectancy,
investments, drive scientific development growth, technological development
For Patients Access to high technology and treatment, improve survival,
improve quality of life
For Professionals Scientific development, right use of drugs, international
exposure
For Sponsors Add and create value to the companies, drive the business
growth, introduce new drugs and concepts, adequate life cycle management of products
OUTSOURCING IN CLINICAL RESEARCH
• R&D drive business growth• R&D costs have increased and the new products approved reduced• Drug efficiency has declined• Increase R&D productivity reducing development times and costs• Succesful implementation of projects and high performance in R&D is essential
R&D – Importance x Implications
OUTSOURCING IN CLINICAL RESEARCH
• Strategic Alliances and Partnerships• Mergers and Acquisitions• In-licensing • Strong Scientific Rational and Study Design• Succesful implementation of CTs ( Expertise )• Metrics, KPIs• Working Model
R&D – Performance
OUTSOURCING IN CLINICAL RESEARCH
• Strategy to conduct multiple projects at same time • Share risks and flexibility for new conditions and needs• Reduce Operating costs• Focus in what is important (Business and Trials)• Improve Quality of Services• Access to expertise and tecnology• Resources available for other purposes• Reduce Headcount Source: IIR Clinical Develpment Outsourcing 101 Oct,2006 Debbie Kerr-Leathem and Bob Assenzo, [email protected], Sep,2007
R&D – Outsourcing - Objectives
OUTSOURCING IN CLINICAL RESEARCH
• Clear Objective and Time lines• Expertise needed• Evaluate capabilities• Resources needed and Weaknesses• Cost/Benefit
R&D – Outsourcing or not
OUTSOURCING IN CLINICAL RESEARCH
Full Service
• One vendor for all services• Increased efficiency, better communication• Vendor could not be good in all services
Source: IIR Clinical Develpment Outsourcing 101 Oct,2006 Debbie Kerr-Leathem
R&D – Types of Outsourcing
OUTSOURCING IN CLINICAL RESEARCH
Functional
• Different Vendors for different services• Dedicated resources, best performance, optimize expertise• Complex communication
Source: IIR Clinical Develpment Outsourcing 101 Oct,2006 Debbie Kerr-Leathem
R&D – Types of Outsourcing
OUTSOURCING IN CLINICAL RESEARCH
Project Specific x Program
• Specific vendor for a project or for one drug development• Expertise, save time, better communication, efficiency• Full program in charge of one vendor
Source: IIR Clinical Develpment Outsourcing 101 Oct,2006 Debbie Kerr-Leathem
R&D – Types of Outsourcing
OUTSOURCING IN CLINICAL RESEARCH
• Define clear objectives• Establish clear metrics• Determine KPIs to be evaluated periodically• Share processes and SOPs• Clear and free communication• Expectations and needs well understood• Commitment• Team work culture• Regular reports
R&D and Outsourcing Principles
STILL HAVE ANY QUESTIONS? FOR ADDITIONAL INFORMATION ON EXL PHARMA’S LATIN
AMERICA CLINICAL TRIALS, PLEASE VISIT WWW.EXLPHARMA.COM