AVOCA’S FALL QUALITY CONSORTIUM MEMBER MEETING
“Progress through Collaboration”
October 10th, 2013
Princeton, New Jersey
A group of 55 Consortium Members gathered at the fourth Avoca Quality Consortium Member’s
Meeting in Princeton, New Jersey on October 10th to discuss the acceleration of best practices and
industry standards in order to achieve proactive quality management. The following companies were
represented at the session:
Alexion Pharmaceuticals Inc. * Amgen *Astellas Pharma Global Development, Inc.
*AstraZeneca * Biogen Idec, Inc. * Cerexa, Inc. * Chiltern * Covance, Inc.
* Cubist Pharmaceuticals, Inc. * Daiichi Sankyo Pharma Development * Eli Lilly and Company
* Endocyte, Inc. * F. Hoffmann-‐‑La Roche Ltd. * Genentech, a member of the Roche Group
* Grünenthal GmbH * Grünenthal USA, Inc. * ICON Clinical Research * INC Research
* inVentiv Health Clinical, LLC * inVentiv Health Clinical Labs, Inc.
* Janssen Research & Development LLC * Pfizer, Inc. * PPD * PRA International
* Purdue Pharma L.P. * Quintiles * RPS, Inc. * Sanofi * Seattle Genetics, Inc.
* SynteractHCR, Inc. * Theorem Clinical Research
The core themes for this meeting included:
• The implementation and socialization of Consortium guidelines, tools, and metrics within
Member organizations and among sourcing partners
• Sharing of Member information, challenges, and the desired future state of proactive quality
management and closer collaborations between Sponsors and CROs
• The focus for the Consortium in 2014
Patricia Leuchten, Avoca’s CEO and Founder of the Consortium, welcomed Members to the meeting with
a reminder that patients and our pursuit to accelerate the development of life saving medicines is at the
center of the work of the Quality Consortium. She framed the Consortium Companies’ common goals for
improving quality, increasing efficiency, and lowering costs and the industry’s common challenges,
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2. which include the need to do more with less. “As an industry, we can make great progress through
collaboration,” she stated.
The Consortium’s Executive Director, Steve Whittaker, introduced Avoca team members who have been
working on authoring the guidelines and tools for effective oversight and proactive quality management
that will be hosted on the Avoca Quality Consortium Web portal. Janis Hall, an Avoca Consultant,
outlined the process for developing the guidelines and leading practices based on the documentation that
was provided to Avoca from Member organizations. Many Member companies contributed information
and tools. Avoca then aggregated and assimilated information from Member companies and drew upon
external resources as well to develop the best practices.
A Quintiles executive asked if there were any notable industries beyond the pharmaceutical industry
from where we could borrow key elements and learnings. Janis Hall noted that the idea of “Quality by
Design” is relatively new in the clinical space, as it was borrowed from heavy manufacturing industries,
such as the auto industry. Avoca is currently authoring best practice Quality By Design guidelines and
tools that will be hosted under the Process swim lane.
At the core of the October Member meeting was a demonstration of the web portal and search engine that
Avoca is developing that will host all the tools and guidelines under the eight “swim lanes” that
comprise proactive quality management:
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3. The web portal also includes other Consortium documents such as the modularized Quality Agreement
This technology platform is easy to navigate and permits Members to actively use the different swim
lanes to identify, locate, and then download specific guidelines and tools. The portal enables Members to
extract the components and sections of documents that they need for their respective organizations.
Members were given a roadmap and exercise to practice with the tool to ensure they felt comfortable
navigating and accessing different documents. A Purdue Pharma Executive said, “I like the idea of
having many opportunities to select the right tools. One size doesn’t fit all. But we do need to know how
to consistently do things and this type of standardization is exciting and important.”
The portal has embedded a “Social Center” that functions similarly to LinkedIn, Salesforce Chatter, and
Facebook, where Members can upload profile information and interact with other Consortium Members.
“Nothing we are doing in this space is static. Regulations change. Pressures on the industry, knowledge,
experiences change. Is there a mechanism in place to make sure best practices are updated?” an
AstraZeneca executive asked.
Avoca is constantly updating its documents, and none of the tools are static. For example, one of the 2012
deliverables was a Quality Agreement template, which has since been revised and updated based on
ongoing feedback. Members have the ability to set alerts through the portal so that they are notified
when content has been added, changed, or updated.
Following the demo and practice of the IT solution, which will “go live” with three of its swim lanes on
November 15th, Members discussed the concept of “socialization”, a term that refers to a company’s
ability to successfully ensure best practices become incorporated into the cultural norm of Member
organizations and their partnerships. It includes the ability to address major barriers that prevent
successful implementation of change initiatives and its impact on best practices.
Steve Jacobs, President of Global BioPharm Solutions LLC, spoke about influencing organizational
change for large and complex organizations using socialization. He spoke about the tangible skills in
change management as well as human skills that can be applied. Jacobs recommended starting with the
“why”. Companies and people need to be able to clearly articulate why they do what they do. Why
should anyone care? What is the purpose, cause, or belief?
“If you can’t get your folks to understand the why, you need to modify and adapt your change plan or
adjust it or it will fail,” he said.
Jacobs also highlighted the 5 C’s as the core of being able to build and maintain trust: Consistency,
Commitment, Competency, Communication, and Character. He mentioned the importance of identifying
and expressing appreciation to people for the important contributions they make to the company’s
challenges. He stressed the value of employee engagement and lessons learned meetings; where you can
instill mental discipline by using after-‐‑action reviews to promote learning, frank discussion of
performance, and a continuous improvement mindset. “It is important for lessons learned to be posted
and shared with the larger group or company. They also help when there is turnover.”
A panel with executives from Cerexa, Amgen, and Quintiles shared their respective experiences with
socialization of the quality agreement and quality best practices.
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4. Sarah Carter, Executive Director, Planning and Platform Services, Amgen, stated that it requires, “a shift
in the employee’s mentality -‐‑ shifting away from something else requiring their attention during the busy
day job and role. You have to get them to understand the reason behind the change and make it easier
compared to what they currently do. They have to know, ‘What’s in it for me?’ If you can’t explain this,
then you won’t get buy-‐‑in. Management is at the strategy level and often does not take the time to
explain ‘the why’ and ‘what is in it for me’ to everybody. Getting them to understand the importance of
an initiative and why it is important is essential.”
Tony Owen, Vice President Clinical Quality Assurance, Quintiles, supported that notion, stating, “A lot
of quality initiatives are driven from the top, and often there is a gap between management and
operations on what they need.”
“Ownership is a key motivator. One of the tactics in our group is helping staff understand how the
quality initiatives will help them do what they need to do,” said Denise Sharp, Associate Director,
Pediatric Program, Cerexa. “People need to understand how quality management would impact their
work and how it is explained to CRO partners. They need to understand how it will help Cerexa as a
company and how it will help the end product.”
One Consortium Member made the suggestion for Avoca to tie the documents and tools in the web portal
to actual success measures or have people comment on whether a document or tool has led to success.
Avoca and Pfizer presented a joint session on a Quality Metrics Case Study. David Nickerson, Senior
Director, Quality and Risk Management Lead, Clinical Quality Management, Pfizer, and Dr. Denise
Calaprice-‐‑Whitty, Senior Consultant, The Avoca Group, co-‐‑presented.
“There were so many metrics, so little time,” Nickerson stated. “There are many different roles related to
reviewing the data such as the process owners, operational partners/CROs, study teams, governance
committees, etc., so we felt we needed to reach out to Avoca to do an external review of our metrics,
metric processes, and approach.”
Denise Calaprice-‐‑Whitty provided background information on how Avoca’s Quality Metrics were
derived, including perspectives based on additional research. She and Dave Nickerson introduced a
Quality Metrics framework for consideration by the Consortium Members and engaged the attendees in a
discussion regarding best practice approaches to developing robust metrics programs. Key concepts
include a proposed taxonomy that is tied to outcomes and an approach for grouping metrics for the correct
audience and intended goal for the use of the metric.
Patty Leuchten then closed the meeting with a review of the Pulse Survey Results that focused on 2014
initiatives. This survey was sent to staff at all Consortium Member companies prior to the October
meeting. The polling tool was used to obtain on-‐‑site interest from Consortium Members on potential
Recommendations that were made by attendees at both the May 2013 Quality Summit and at this October
Working Session will be incorporated into the 2014 plans that will be presented on November 15, 2014 at
an Executive Meeting for Consortium Members.
Members will be notified of our 2014 Quality Consortium Initiatives after the November Executive
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