highlights from exl pharma's 4th latin america clinical trials

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HIGHLIGHTS FROM EXL PHARMA’S 4 TH LATIN AMERICA CLINICAL TRIALS February 25-26, 2010 Miami, Florida

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Page 1: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

HIGHLIGHTS FROM EXL

PHARMA’S 4TH LATIN AMERICA

CLINICAL TRIALS February 25-26, 2010

Miami, Florida

Page 2: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

UNIVERSITY/INDUSTRY COLLABORATIONS

Page 3: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

US RESEARCH INSTITUTIONS AND INDUSTRY

Rhetoric

Political

Experts

History

Triple Helix and the Entrepreneurial University

Shared Goals and Complementary Strengths

Page 4: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 5: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 6: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

THREE UNLIKELY COLLABORATORS

EDICT Project

Clinical Trials

Microfinance

Industry

Page 7: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 8: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

MICROFINANCE INDUSTRY Purpose

Give poor people access to credit, ultimately alleviating poverty

Types of MFIsCommercial banksMicrofinance banksMicrofinance NGOsRegulated and unregulated

Types of LendersGroups Individuals

Page 9: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 10: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 11: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 12: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 13: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

QUALITY IN CLINICAL RESEARCH

Page 14: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 15: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 16: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 17: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 18: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 19: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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?

Page 20: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 21: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

FUNCTION OF ESSENTIAL DOCUMENTS Demonstrate: compliance of the investigator, sponsor and

monitor Standards of GCPs all applicable regulatory requirements

Page 22: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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.

Page 23: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

OUTSOURCING IN CLINICAL RESEARCH

Page 24: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 25: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 26: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 27: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 28: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

OUTSOURCING IN CLINICAL RESEARCH

• Clear Objective and Time lines• Expertise needed• Evaluate capabilities• Resources needed and Weaknesses• Cost/Benefit

R&D – Outsourcing or not

Page 29: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 30: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 31: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 32: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

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

Page 33: Highlights from  ExL Pharma's 4th Latin America Clinical Trials

STILL HAVE ANY QUESTIONS? FOR ADDITIONAL INFORMATION ON EXL PHARMA’S LATIN

AMERICA CLINICAL TRIALS, PLEASE VISIT WWW.EXLPHARMA.COM