Quality Oversight of Clinical Vendors

Tuesday - October 12, 2010

Morning Workshop

8:00 Registration and Morning Coffee
8:30 Workshop Opens
10:00 30-Minute Break
12:00 Workshop Concludes; Luncheon for Morning Workshop Delegates

Oversight “101”: Developing a Vendor Quality Management Plan

The regulators are clear in their inspectional approach: Sponsors may transfer their responsibilities, specific duties and functions. However, sponsors are ultimately responsible and accountable for the quality of the work performed on their behalf.(ICH E-6 GCP 5.2; 21 CFR 312.52). Therefore, it is imperative that everyone involved in the management of a clinical trial understands what quality oversight is and how to effectively perform it in an environment of increased scrutiny and enforcement activity.

This pre-conference workshop discusses the key components of a Vendor Quality Plan, as well as methods for risk identification, focusing on the vendor’s infrastructure and personnel assigned to your study. Therefore, Sponsors can successfully manage vendor quality and compliance prospectively during a clinical trial in a uniform, consistent, quality-focused, efficient and effective manner. Impact on Sponsor clinical operations and clinical development budgets are discussed in order for sponsors to project and plan the cost and resources required to implement the Vendor Quality Plan.

Learning Objectives:

• Examine FDA inspectional findings of Sponsors/ CROs for outsourced clinical trial execution activities
• Describe contents of a Vendor Quality Plan
• Discuss key documents that should be maintained during study conduct
• Convey methods and tools sponsors can utilize for risk identification and risk mitigation for their outsourced duties and functions

Who Should Attend This Workshop

Professionals from pharmaceutical and biotech companies, CROs, AROs and other clinical vendors who work in the following departments:

• Clinical Quality Assurance
• Clinical Quality Control
• Clinical/GCP Compliance
• Clinical Standards and Training
• Vendor Management
• Quality Management
• Clinical Project Management
• Clinical Operations including:
  • Clinical Trial Directors and Other Senior Staff
  • Clinical Trial Managers
  • Clinical Trial Monitors
  • Project Managers
  • Clinical Site Managers
  • CRAs

This workshop is also beneficial to anyone training junior staff on how to manage and oversee clinical vendors. It is also valuable to former monitors without trial management experience as well as trial managers who have little or no monitoring experience.

Distinguished Workshop Leader:
Liz Wool, CCRA, CMT
President & CEO,
QD-QUALITY AND TRAINING SOLUTIONS, INC.
Member, Board of Trustees,
Association of Clinical
Research Professionals (ACRP)

Afternoon Workshop

1:00 Registration for Afternoon Workshop
1:30 Workshop Opens
3:00 30-Minute Break
5:00 Workshop Concludes

Conducting an Audit to Assess and Qualify a Vendor

The way you position yourself as a QA Auditor during a vendor qualification/assessment audit sets the pace as to how the Sponsor- Vendor relationship will develop once the vendor is selected. Vendors are in the market to secure your business and will compete effectively to win the bidding process. Therefore, during the qualification visit, the vendor’s Business Development and Project teams will provide you with the best overview of their services and product-related information. Typically, vendors have no intent to obscure or withhold any information from a potential client. However, like any other company, they are mindful of their strengths and weaknesses within their organization and will not volunteer information during an audit unless you ask the right question, drill down to peel the layers, and interview the right people.

The objective of this workshop is to present you with a realistic approach to conduct a well-scoped vendor audit by providing real audit scenarios and presenting helpful audit techniques and strategies followed by an interactive discussion.

By attending this workshop, attendees will learn how to determine if the vendor possesses:

• The proper knowledge-base and qualified staff
• Appropriate quality standards and quality management systems in place to manage your projects
• A system in place to identify non-conformance issues pro-actively
• The capability to quality issues for your projects and CAPAs

Attendees will also learn how to determine if the vendor:

• Is in compliance with the regulations and guidelines
• Can handle critical situations effectively
• Operates in a cost efficient manner
• Has an open line of communication with the Sponsor

Distinguished Workshop Leader:
Gayatri Girwarr (GG), MD
President/Owner and CEO
GG PHARMA CONSULTING, INC.

Main Conference, Day One - Wednesday, October 13, 2010

7:45 Registration and Morning Coffee
8:20 Chairperson’s Welcome

SETTING THE STAGE

8:30
FDA UPDATE
Oversight of Outsourced Work: A Review of Transfer of Obligations, Sponsor Responsibility and the FDA’s Risk-Management Approach to Inspections

With one-third of inspections having observations being linked to outsourcing, increased scrutiny around vendor oversight has sponsors and providers alike examining their oversight practices. Our speaker covers:

• A summary of findings around CRO oversight
• The oversight responsibilities of the sponsor versus the vendor
• A review of ICH Section 5: Sponsor Obligations: What findings might lead an inspector from a CRO back to the sponsor (or vice versa)?
• How responsibility should be documented: FDA requirement for transfer of responsibilities per 21 CFR 312
• Oversight vs. micromanaging: How much oversight is enough while retaining outsourcing efficiencies?
• FDA stance on oversight of what can be multiple levels of subcontractors
• An update on the FDA’s risk-management tool and how it compares with other industry tools
• Update on collaboration between FDA and EMA

Speaker:
Constance Cullity (formerly Lewin), MD, MPH
Branch Chief, Good Clinical Practice Branch 1
Division of Scientific Investigations, Office of Compliance
FDA/CDER


9:45
PANEL DISCUSSION
Industry Response to Increased Focus on Vendor Oversight during Inspections

Our panelists discuss recent inspection experience, particularly when part or all of a trial was outsourced to one or more clinical vendors.

Specifically, they comment on:

• The types of approaches sponsors and providers taking with oversight: Are there collaborative approaches that have worked?
• Examples of sponsor/provider partnerships and oversight that led to successful quality outcomes
• Findings found by different world regulatory agencies and how these compare
• Whether specific outsourcing models (i.e., preferred partnership agreements) can lead to better quality

Moderator:
Angela Berns
Associate Director and Head of Vendor Program, Clinical Quality Assurance
SCHWARZ BIOSCIENCES, A Member of the UCB Group

Panelists:
Katie Driscoll Alberta
Sr. Director, Worldwide QA, Good Clinical & Pharmacovigilance Practices (GCP & GPvP)
CEPHALON, INC.

Sam Tong
Head, Vendor QA
PFIZER, INC.

Maryann Livolsi, BSN, MSN, RN, RQAP-GCP
Associate Director, Global R&D Quality Assurance
SHIRE PHARMACEUTICALS

Joanne S. Malia
Associate Director, Medical Research Process Management
PURDUE PHARMA, LP

10:00
30-Minute Networking and Refreshment Break

10:30
Recent Sponsor and CRO Warning Letters: What Happened and What We Can Learn

There is heightened pressure on industry to ensure the integrity of its clinical research data and to proactively prepare to quickly respond to inspectional observations and enforcement actions rather than riskproducts being prevented from entering or staying on the market. Our speaker discusses what can be learned by the recent Sponsor/CRO warning letters regarding clinical practices that have invalidated major trials.

She covers:

• Why are some of the largest pharmaceutical companies receiving serious Warning Letters from the FDA?
• Was there fraud and/or misconduct activity detected by the FDA at one of the clinical sites?
• What lessons can be learned by recent FDA actions?
• What should you be doing now to safeguard the integrity of your clinical trials and data?

Speaker
Carol Bognar
Senior Director, GCP Services
THE WEINBERG GROUP INC.

VENDOR QUALIFICATION AND CONTRACTING

11:30
Selection and Ongoing Evaluation of High Quality Clinical Vendors

All vendors are assessed for quality prior to use. However, the who, what, when, why and how are all major questions that can differ depending on the type of sponsor, type of project and type of vendor. Also, qualifying a vendor can be a very different experience than auditing once a vendor is actually doing your project work and collecting data.

This session addresses:

• What is the selection process and criteria for vendors they are “prequalified,” and where does quality rank in the time-cost-quality pyramid?
• If you have used the vendor previously or are currently using their services, how do verify ongoing compliance and when do you assess them again? What is the decision process for re-assessing the vendor?
• When do you go back to do a full audit?
• Specialty vendors: There might be multiple “pre-qualified” vendors who are capable of handling a piece of outsourced work. If each has some risk associated, how do you choose?

Speakers
Mark E. Lloyd
Expert Clinical Trial Head, Respiratory, Clinical Development & Medical Affairs
NOVARTIS PHARMACEUTICALS CORPORATION

Joanne Spallone
Global Head, Audit, Clinical Quality Assurance, USEH
NOVARTIS PHARMACEUTICALS CORPORATION

12:30
Luncheon

1:45
Defining and Managing Quality: Building Quality Expectations into the Relationship

Setting expectations for quality must be carefully established, agreed to, and managed for those expectations to be met. How do companies define these quality expectations? Are there best practices in defining quality indicators when outsourcing clinical research? The second part of this session discusses the implementation of quality agreements into the GCP setting. Quality agreements have been around for decades, but can they work effectively in the clinical arena? Can having a formal quality agreement or quality addendum alongside an outsourcing agreement help to establish expectations and form a solid working relationship? In this session, our speakers cover:

Part I: Setting Expectations for Quality

• Best practices for establishing quality attributes when outsourcing various pieces of a trial
• Spelling out expectations and ensuring all regulations are met
• Can quality indicators be identified and tracked to gauge research quality?
• Whose SOPs do you use: pros/cons?
• Using payment measures to ensure vendors meet certain standards or milestones (milestone payments)
• Do you include penalties or rewards for missed or exceeded quality milestones?

Part II: Operationalizing the Quality Agreement

• The role of a quality agreement in the GCP setting.
• Using the quality agreement to enhance the sponsor/service provider relationship.
• Practical considerations for quality agreement content.
• Legal touch points: standalone document vs. addendum to agreement

Speakers
Stan Szpindor, MS, Pharm
Associate Director, Global R&D Quality Assurance
SHIRE PHARMACEUTICALS

Peggy McHugh, RN
Director, Medical Operations
IRX THERAPEUTICS

3:00
30-Minute Networking and Refreshment Break

SETTING UP THE STUDY

BREAKOUT SESSIONS: CHOOSE A OR B

- A -

3:30
Protocol Complexity as a Factor in Service Provider Risk Management

This session reviews how protocol complexity adds to operational and compliance risk in clinical trials. Strategies to minimize complexity are discussed and the need for proactive risk management explored. Elements of complexity our speaker covers include:

• Size of the clinical trial
• Multiple primary/secondary endpoints
• Protocol requirements that deviate from institutional standard(s) of care
• Confirmation of eligibility by central review
• Progression free survival as a primary endpoint
• Dose adjustment/titration requirements

Speaker
Marta Fields
Director, Clinical Quality Assurance
SEATTLE GENETICS

- B -

3:30
Revolutionizing Monitoring: Redesigning Monitoring Plans, Trip Reports and Trending Reports to Optimize Evaluation of Critical Issues

Recent warning letters and compliance trends suggest that monitoring activities and monitoring reports are failing to detect and identify critical issues that impact the protection of human subjects and the quality and integrity of clinical trial data. This trend suggests there needs to be a new approach to monitoring activities and how those activities are documented in trip reports. This session offers the following learning points:

• Refresher on critical monitoring activities
• Suggestions for a risk-based approach to monitoring activities
• Recommendations for redesigning clinical monitoring plans, trip reports and trending reports
• Potential solutions for trends identified from monitoring activities

Speaker
Sharon S. Reinhard, MS
Associate Director, Clinical Quality Control
ENDO PHARMACEUTICALS3:30

- A -
Clinical Operations

4:30
Establishing Quality Expectations at the Project Kick-Off Meeting

Optimal oversight can be gained when sponsors clearly define roles and responsibilities, create a communication/issue escalation plan, and set mutual expectations around milestones and deliverables. An in-person kick-off meeting helps to avoid misinterpretation of the protocol and relays expectations beyond the contract, and ultimately promotes the building of a collaborative relationship. Our speakers cover:

• Establishing quality expectations at different phases of the project
• Defining a partnership culture
• Developing a Communication Plan (both internally and externally)
• Establishing a trip report review process

Speaker
Lisa J. Zimmerman
Vice President, Clinical Operations
POZEN, INC.

- B -
Quality Assurance

4:30
When Things Go Wrong: Importance of an Issue Escalation Plan

When planning to conduct clinical trials, an issue escalation plan must be created to avoid potential compliance implications. The Issue Escalation Plan may be a standalone document or something built into a communication, monitoring or quality plan. Our presenter addresses:

• Potential issues/risks in clincial research
• Clarifying roles and responsibilities for issue identification, escalation, tracking and resolution
• How to use metrics and other ways to identify issues
• When is it appropriate to escalate?
• Tracking and documenting issues through to resolution
• When things go right: Learning opportunities and process improvement initiatives

Speaker
Christine Sahagian
Associate Director, Clinical Compliance
BIOGEN IDEC

5:30
Day One Concludes

5:30-6:30
Interactive Wine & Cheese Round Table Discussions, Hosted By Compliance Implementation Services (CIS)

Choose your preferred topic and discuss in an intimate setting. Attendance per table is limited. You will be asked for your selection when you register onsite.

1. Breaking Down Quality Roles and Responsibilities between Clinical Operations and QA
   MODERATOR: Kenneth G. Olovich, RPh, MBA, Chief Operations Officer, Chorus Resonance, a division of Lilly Research Laboratories
   
2. Quality Oversight of Academic Research Organizations (AROs)
   MODERATOR: S. Michael Sharp, PhD, FRAPS, VP, Regulatory, Quality and Clinical Affairs, AngioDynamics®
   
3. Managing Critical, Clinical Documents
   MODERATOR: Catherine Arthey, Strategy & Operations / Life Science, Deloitte Consulting LLP
   
4. Improving Clinical Trial Oversight through Quality Monitoring
   MODERATOR: Toni Barsh, Co-Founder and VP, Account Management, Compliance Implementation Services (CIS)
   
5. Maintaining High Quality when Working with Highly Technical Vendors and their Output
   MODERATOR: Mark E. Lloyd, Expert Clinical Trial Head, Respiratory, Clinical Development & Medical Affairs, Novartis Pharmaceuticals Corporation
   
6. Leveraging CRO QA Support: Interface with Sponsor QA
   MODERATOR: Martie Griffin, VP Corporate QA and Compliance, Celtic Therapeutics Corporation

Day Two - Thursday, October 14, 2010

7:30
Morning Coffee

8:00
Chairperson’s Recap of Day One

8:15
Panel Discussion
The Vendor Role in Quality Oversight of Clinical Trials

With the inspectional spotlight on CROs as well as sponsors, our panel of varying types of clinical vendors discusses their role in ensuring that quality work is being performed on the sponsor’s behalf. They address:

• What makes for a successful study with a sponsor: What do vendors need from sponsors for optimal quality?
• What can sponsors do to help vendors do their jobs most effectively and efficiently?
• What are vendors doing to ensure quality management of their work?
• How to share internal audit results without a negative business impact

Moderator:
David K. Marks, RQAP-GCP
Senior Director and Global Head, Quality Management
RESEARCH PHARMACEUTICAL SERVICES, INC. (RPS)

Panelists:
Rod Thorell
Director of Quality Management and Compliance
PHT CORPORATION

Liz Wool, CCRA, CMT
President and CEO
QD-QUALITY AND TRAINING SOLUTIONS, INC.

Robert McCormick
Office of Special Investigations and Government Liaison
PPD


If you are a vendor and are interested in participating in this panel discussion, please contact Program Director, Pam Sobotka at psobotka@exlpharma.com.

9:00
Achieving Quality when Overseeing Vendors in Emerging Regions

Global pharmaceutical companies and CROs are rapidly expanding in emerging regions in order to cost-effectively recruit for clinical trials that continue to grow in size and complexity. Whether you use a local CRO in one of the emerging regions or a Global player with presence in that region, there is an added level of oversight and management to ensure compliance and avoid lapses in meeting international quality standards. You might qualify a vendor at a US location, only to find out that their affiliate offices outside of the US might not measure up. Do you assume the company’s staff in emerging regions understand and adhere to their global SOPs? Are the levels of documentation accurate? How do you assess differences in qualifications and experience? Our speaker covers:

• FDA, ICH and International standards vs country specific regulations, guidances and practices
• Comparison of quality issues between the US and emerging regions
• Complexities of vendor selection when working across the globe and with different cultures
• Key factors to consider when overseeing teams at global or local CROs in emerging countries

Speaker
Munish Mehra, PhD
Managing Director
GLOBAL DRUG DEVELOPMENT EXPERTS

10:00
30-Minute Networking and Refreshment Break

QUALITY MANAGEMENT

10:30
Utilizing Audits Effectively to Measure Vendor Performance

Now you’re using a vendor, when is the right time to conduct an inprocess audit? And, how will you audit? Will you utilize sponsor auditors, independent auditors or vendors’ internal auditors? Our speaker address these questions as well as:

• Developing Trust: Overcoming conflicts of interest when the CRO has their own QA Group
  • Do CROs audit to SOPs the same way the sponsor would?
  • Do/should CROs perform audits of their internal systems, independent of their contract with the sponsor?
  • How much will the internal QA group at the CRO share with the sponsor?
• Identifying systemic problems and sharing solutions
• Teamwork: Sharing audit metrics and CAPAs
• Helping your vendors be inspection ready through audits
• Comparing audit findings across similar and different vendor types

Speaker
Richard Reeve
Head of GCP-QA
CEREXA

11:30
Building a Quality-to-Quality Partnership at the Outset of a Project

A successful quality plan can be built from the very beginning with all parties taking responsibility when there are issues to address with the goal of preventing failure from ever occurring. QA personnel at the sponsor and vendor can have a mutual way of evaluating quality and addressing issues, and our presenter discusses Cephalon’s recent experience with:

• Developing a joint QA program and a sponsor/CRO governance board
• The importance of face-to-face meetings between sponsor and provider QA teams
• How to maximize efforts
• Sharing audit findings
• Pros and cons of this approach
• Establishing a good QA to QA interaction between sponsor and vendor

Speaker
Katie Driscoll Alberta
Sr. Director, Worldwide QA, Good Clinical & Pharmacovigilance Practices (GCP & GPvP)
CEPHALON, INC.

Robert McCormick
Office of Special Investigations and Government Liaison
PPD


12:30
Luncheon

CASE STUDY!

1:30
Providing Quality Governance via a Single Point of Contact within an External Provider Management Team Model at AstraZeneca

AstraZeneca utilizes an External Provider Management Team (EPMT) model to manage studies placed with CROs. The CROs are selected for their expertise in specific clinical therapy and disease areas and are given a high level of accountability in delivering the studies. Since the model’s inception, AstraZeneca has experienced significant productivity improvements of internal resources deployed to deliver outsourced studies. Quality has improved as well, through the naming of a Single Point of Contact (SPoC) who provides a consolidated view of vendor performance. Our presenter addresses:

• Objectives of AstraZeneca’s governance model
• Operationalizing the model
• Use of quality management relationship (QMR) document
• What is the single point of contact (SPoC) and what are the SPoC’s responsibilities?
• Linking the governance model to the external provider management team
• Boundary issues between QA and the clinical team regarding third party relationship management

Speaker
Erik Williamsen, MS
Lead Advisor, Compliance Advice and Assurance
ASTRAZENECA

CASE STUDY!

2:30
Sponsor-CRO Quality Management Plans: An Integrated Approach to Building Relationships, Increasing Transparency, and Ensuring Quality

This session presents an approach to development and implementation of Quality Management Plans (QMP) for clinical programs that identify key indicators, metrics, reports, and tools for in-process assessment of quality that standardize evaluative activities, feedback mechanisms, and escalation pathways for quality-related issues. The QMP is developed by, and is a shared responsibility of the Sponsor and CRO, and the Operational and Quality Assurance functions of each organization. After this session attendees should be able to:

• Describe a model for developing a Sponsor-CRO Quality Management Plan (QMP) for a clinical development project or program
• List several key indicators and tools that can be used to evaluate inprocess project quality
• Discuss the roles of Clinical Operations and Quality Assurance in both the Sponsor and CRO in development and implementation of a QMP
• Describe potential benefits to the Sponsor-CRO relationship and overall program quality through the implementation of QMPs

Speakers
Donna Edgerton
Senior Director, Clinical Quality Standards QA.
MILLENNIUM: THE TAKEDA ONCOLOGY COMPANY

Karen Brennan
Senior Director, Clinical Operations
MILLENNIUM: THE TAKEDA ONCOLOGY COMPANY

3:30
Conference Concludes