2. Formed in January of 2012 with 30 Members, The Avoca Quality
Consortium brings together quality, outsourcing, and operational
professionals from Member pharma, biotech, and clinical
research organizations (CROs) to accelerate the development
of best practices and industry standards for proactive quality
management.
THANK YOU TO OUR CONSORTIUM SPONSORS
3. WELCOME
On behalf of The Avoca Group, our Co-Chairs, Jeffrey Kasher and Christopher
Hilton, and our Summit Sponsor, Stephen Cutler, I am pleased to welcome you to
the 2013 Avoca Quality Consortium Summit.
This year, we have put together a program that promises to be both insightful
and thought-provoking. Reflecting on input from our Members, we have created
a series of sessions that explore how sponsor companies and CROs can find
the right balance between time, cost, and quality in this changing regulatory
environment. Through interactive discussions and workshops, thought leaders and
industry experts will tackle some of the top topics of the day, including effective
oversight, the best approaches to risk assessment and risk management, and
the role of culture in ensuring quality. We will close the day with an Industry “Call to Action” where industry
thought leaders will discuss key imperatives for 2013 and beyond.
You are also invited to be part of today’s discussions. I urge you to not only ask questions of our panelists, but
to also add to the dialog by providing your own perspectives, experiences, and insights. I hope each of you
will take full advantage of these unique opportunities to discuss together how we can help ensure quality in
outsourced clinical trials.
As you listen and participate in today’s sessions, you may want to keep in mind the Avoca Quality Consortium
Core Tenets that we established at our Executive Session last Fall:
PATRICIA LEUCHTEN
President & CEO - The Avoca Group, Inc.
Objective Research: Providing insights to individual companies and setting Quality Consortium priorities
Leading Practices: Optimizing approaches to proactive quality management
Collaboration: Pharma companies, biotech companies, and CROs working together to achieve common
goals
Engagement: Member involvement at the Executive as well as Functional level; engagement with Regulatory
Authorities to strive for mutual understanding and acknowledgement
Transparency: Sharing of information with other groups, organizations, and industry consortia to ensure no
duplication of efforts
Implementation: Operationalizing approaches to proactive quality management
Innovation: Focusing the Consortium’s future priorities on “out-of-the-box” approaches; leading the way for
industry breakthroughs
•
•
•
•
•
•
•
I would like to extend a special thank you to our Summit Sponsor, ICON, and our Supporting Sponsors, Sitrof
Technologies, Idis, Acurian, and LabCorp Clinical Trials. Today’s program would not be possible without their
support and sponsorship.
Thanks again for joining us for the second annual Avoca Quality Consortium Summit. We’re excited about
today, and we hope you will find the Summit both professionally and personally rewarding.
Warm Regards,
4. 4 Avoca Quality Consortium 2013 Summit
SUMMIT CO-CHAIRS
Eli Lilly and Company
Jeffrey S. Kasher, Ph.D., was named Vice President, Global Clinical Trial: Materials,
Implementation And Transformation in September 2012. In his current role, he is
responsible for the delivery of clinical studies and information in support of Lilly
molecules. The primary responsibility is to patients and healthcare professionals
who depend on Lilly’s products and services today and in the future. Kasher has
responsibility for Regional Clinical Operations, Global Clinical Pharmacology &
Diagnostics, Clinical Trial Manufacturing & Material Services, 6 Sigma/Business
Process Management/Critical Chain Project Management, and Clinical Development
Innovation.
Dr. Kasher received a Bachelor of Science degree from Franklin & Marshall College,
a Doctorate in Pharmacology from the State University of New York (Syracuse) and
a postdoctoral fellowship in physiology at Yale University School of Medicine.
Jeffrey S. Kasher, Ph.D.
Chris Hilton is Vice President of Development and Clinical Alliance Management
at Pfizer Inc. He leads an organization that oversees the clinical trial operational
support to Pfizer's late stage portfolio and business operations activities. Recently,
he has been leading the development and implementation of Pfizer's new Alliance
Partnership approach for clinical trial support with two leading CROs. Chris has
expertise in the areas of biometrics, study, and project management with a focus on
vendor oversight.
Pfizer, Inc.
Christopher J. Hilton
The overall theme for the 2013 work of the Quality Consortium:
Helping our Members achieve the right balance between meeting
timelines, ensuring cost containment, and achieving the highest level
of quality.
5. 5 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
Merry Chu, M.Sc.
Hazel Collie
Eli Lilly Canada Inc.
Grünenthal GmbH
Merry Chu has over 16 years of pharmaceutical industry experience and currently
holds the position of Director of Global Medical Quality, Regional and Third Party
Management for Eli Lilly and Company. In this role, she has Quality responsibility for
global clinical operations and medical affairs in all regions in addition to oversight of
the associated external partnerships.
Merry received her Bachelor of Science degree in Toxicology and Human Biology
and her Masters in Science in Clinical Pharmacology and Toxicology, both from the
University of Toronto. She joined Lilly in 2004 and during her career at Lilly, has held
technical and leadership positions in Analytical Laboratory Operations, Six Sigma,
Clinical Research, and Regional Medical Quality for North America.
Hazel has a BSc(hons) in Statistics from the University of Aberdeen in Scotland and
has worked for over 20 years in the pharmaceutical industry in the areas of
Biostatistics, Clinical Data Management, Project Management and Quality. She has
been at Grünenthal now for over 9 years during which she has held many different
management positions within clinical development. In her current position she is
responsible for all quality activities within clinical development including internal
quality initiatives, SOP management, quality aspects of vendor relationship
and inspection preparation.
6. 6 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
Grace Crawford
ICON Clinical Research
Ms. Crawford is a Senior Director of Quality Assurance at ICON Clinical Research
and has spent over 19 ½ years in the pharmaceutical industry in the areas of clinical
research and quality assurance. Her main responsibilities include implementing and
maintaining an effective GCP Quality Assurance program and leading the global QA
function for the Clinical Research division of ICON. Prior to joining ICON, Ms.
Crawford was a Medical Technologist at the Bryn Mawr Hospital for 7 years. In
addition to her laboratory responsibilities, she was a member of the Total Quality
Management Team and assisted in the Total Quality Improvement efforts of the
laboratory that she worked in. Ms. Crawford has received a M.Sc. in Clinical
Microbiology from the Medical College of Pennsylvania and has been an active
member of organizations such as ASQ, Local Clinical Quality Assurance Discussion
Groups, SQA, SQA’s Clinical Specialty Section, MARSQA and MARSQA’s Computer
Validation Committee, and DIA.
Alexion Pharmaceuticals
Mike was born in London, UK and graduated from the University of Sheffield with a
degree in Genetics in 1979. He then went to the University of Birmingham to do an
MSc in Applied Genetics and completed his doctorate in the Department of
Psychology at Birmingham in 1982 on the quantitative genetics of behavior
in fruit flies.
He then worked as a statistician at the Hospital Centre in Stoke-on-Trent providing
statistical consultancy to a wide variety of healthcare professionals. In 1988 he
moved back to London to join Hoechst as Head of Biometrics.
In 1995, Mike joined Pfizer in the UK leading the global biometrics activities for two
major drug programs. In 2002, Mike moved to the US to take up a position as the
Development Operations site head for Groton/New London. In 2006, Mike moved
to New York as the Head of Phase 3b/4 and New York site head for Development
Operations. In this role he was accountable for operational delivery of phase 3b/4
trials across the Pfizer portfolio. In 2009, Mike was appointed Head of Clinical Study
Operations. In 2012, Mike joined Alexion Pharmaceuticals as Head of Global Clinical
Operations focusing on the development of drugs for ultra-rare diseases.
Mike Collins
7. 7 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
Stephen Cutler, Ph.D.
ICON Clinical Research Services
Steve has 24 years of experience within the pharmaceutical and CRO industry and
joined ICON from Kendle where he held the position of Chief Executive Officer,
having previously served as Kendle's Chief Operating Officer. Prior to Kendle, Steve
spent 14 years with Quintiles where he served as Senior Vice President, Global
Project Management; Senior Vice President, Clinical, Medical and Regulatory; Senior
Vice President, Project Management - Europe; and Vice President, Oncology -
Europe as well as regional leadership positions in South Africa and Australia. Prior
to joining Quintiles, Steve held positions with Sandoz (now Novartis) in Australia
and Europe. He holds a B.Sc. and a PhD from the University of Sydney and a
Masters of Business Administration from the University of Birmingham (UK).
PPD
James Dixon joined PPD in February 2013 as Senior Vice President of Global Quality
and Compliance and member of PPD’s senior leadership team. He is responsible for
overseeing strategy and execution of the company’s global quality function, including
clinical and laboratory quality assurance, regulatory compliance, risk management,
policy and procedure management, and quality management systems.
Jay is a seasoned executive with 27 years of experience in the CRO, pharmaceutical
and biotechnology industries. He joined PPD from PRACS Institute, where he served
as Chief Operating Officer and was responsible for providing strategic direction and
leadership to the company’s service lines, quality infrastructure, management and
business development activities. Prior to that role, he served as Senior Vice President
of Regulatory Affairs and Quality and Compliance as well as chief compliance officer.
Jay also held the role of Vice President of Quality and Compliance at both MedImmune
and Covance.
He is a member of the Drug Information Association and the Society of Quality
Assurance and possesses a Bachelor’s Degree in Biology from Campbell University.
James R. Dixon
2013 Consortium Research: Managing risk in outsourced clinical trials
through risk assessment, risk sharing, and risk-based management:
an assessment of whether these are effective ways of achieving the
right balance of time, cost, and quality.
8. 8 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
James D. Esinhart, Ph.D.
Chiltern International
Dr. Jim Esinhart joined Chiltern in 2006 and prior to his role as CEO, Jim was the
Senior EVP, Global Scientific Services where he was responsible for managing
global biometrics, medical and regulatory affairs, and information technology.
Jim has held senior posts with several international biopharmaceutical research
organizations and previously held a professorship at East Carolina University School
of Medicine. Jim was a founding employee for PharmaResearch Corporation,
which through acquisition by Inveresk Research, later became part of Charles River
Laboratories Clinical Services. At Charles River, Jim was Vice President of Global
Medical Data Sciences. Jim graduated BS in Statistics from Radford University,
Virginia and gained a PhD in Biostatistics from The Medical College of Virginia,
Virginia Commonwealth University and is based in Wilmington, North Carolina, US.
Deborah Bisio Dwyer
Cerexa, Inc.
Deborah Bisio Dwyer is currently at Cerexa, Inc. in Oakland, California. She started her industry experience at
Genentech, Inc. in 1993 where she entered the business in data management. She made a successful transition to
Clinical Operations and contributed to and led development trials from Phase II through IV (and post marketing
commitments). After leaving Genentech in 2004, she joined Chiron Corporation as a Global Clinical Program
Manager, having oversight on Clinical Operations and Outsourcing aspects for Global Phase III Critical Care Trials.
She has been with Cerexa for the past 6 years and now leads the Outsourcing group.
9. 9 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
Pfizer, Inc.
Dr. Hubbard is Senior Vice President and Worldwide Head of Development
Operations for Pfizer Inc. In this position, he is responsible for global clinical trial
execution from Phase I to IV, which includes more than 700 clinical projects across
specialty care, primary care, oncology, established products, emerging markets,
vaccines business units and pharma- and bio-therapeutic research units.
Dr. Hubbard received a Bachelor of Science degree in Biological and Experimental
Psychology from the University of Santa Clara, a Doctorate from the University
of Tennessee, and was a National Institute of Health Postdoctoral Fellow in
Cardiovascular and Clinical Pharmacology at the University of Texas Health
Sciences Center.
John Hubbard, Ph.D., FCP
F. Hoffmann-La Roche Ltd and Genentech, Inc.
Heather Jorajuria is a Senior Director and Global Head of Product Development
Quality Assurance at Roche/Genentech. Mrs. Jorajuria manages a global team
of Quality Assurance professionals who are responsible for the quality oversight
and conduct of risk-based compliance audits for all regulated non-clinical, clinical
trial and pharmacovigilance activities at Roche/Genentech. Mrs. Jorajuria has
been in the Pharmaceutical Industry for over 17 years with the majority of time
responsible for providing quality assurance for regulated activities supporting R&D.
Mrs. Jorajuria obtained her Bachelor of Arts in Kinesiology from the University of
Colorado, Boulder. Mrs. Jorajuria currently resides in the San Francisco Bay Area.
Heather Jorajuria
10. 10 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
Quintiles
Margaret Keegan joined Quintiles in 2007 and is currently SVP, Global Head of
Integrated Processes and Technologies. In this role her remit spans Clinical
Development and currently includes oversight of strategic clinical alliances (3rd
party vendors); the Quintiles Contact Center; all major cross-functional new systems
(including CTMS, portfolio planning and resource management); as well as Quintiles
Infosario™ and the development of transformative integrated operational models
for Clinical Development. In addition, Margaret’s team now has oversight of quality
and productivity operationally across Clinical Development. Margaret has over 20
years of pharmaceutical industry experience and has held senior leadership roles
in statistics, programming, data management, late phase and clinical functions.
Margaret holds a Bachelor of Science degree in Pure and Applied Mathematics and
is a Chartered Statistician.
Margaret Keegan
Mitchell Katz, Ph.D.
Purdue Pharma L.P.
Dr. Mitchell Katz is Executive Director of Medical Research Operations at Purdue
Pharma L.P. In this position he is responsible for leading all operational activities
across Purdue’s multinational clinical programs.
Dr. Katz has 27 years of experience in the pharmaceutical and biotechnology
industries, including preclinical research, pharmaceutical operations, and regulatory
affairs. Prior to joining Purdue, he served as Vice President of Global Clinical
Operations & Data Management at Eisai Medical Research. Dr. Katz has experience
working in start-up biotechnology companies, including Acorda Therapeutics,
InterMune, Connetics, and NABI. He also held management positions at Ortho
Biotech and Schering-Plough and participated in six successful NDA applications in
his professional career.
Dr. Katz holds a B.A. in Biology a Ph.D. in Microbiology, and served as a postdoctoral
research fellow at Downstate Medical Center in NY.
The work of the Avoca Quality Consortium is in helping companies
optimize their approaches to proactive quality management
with an emphasis on bringing sponsors and CROs into greater
alignment.
11. 11 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
Research Pharmaceutical Services, Inc.
Dr. Harris Koffer is President of Research Pharmaceutical Services (RPS), a clinical
research organization providing services to the Pharmaceutical and Biotechnology
industries in support of clinical drug development.
Prior to joining RPS, Dr. Koffer served as Vice President, Clinical Trials and
Pharmaceutical Business Development for Quest Diagnostics; Vice President
and General Manager of Covance Clinical Services and President of Covance
Periapproval Services. In these roles, he was responsible for global central
laboratory services as well as full service clinical research and development
capabilities for Phases I through IV of drug development.
He earned both a BS in Pharmacy and a Doctor of Pharmacy degree from the
Philadelphia College of Pharmacy and Science and completed a Fellowship in
Clinical Pharmacology at Thomas Jefferson University Hospital in Philadelphia.
Harris Koffer, Pharm.D.
Jeffrey A. Kueffer is the Senior Vice President for Global Operations Management
at INC Research, Inc. Jeff is the principal architect of the TrustedProcess™ which
is the metrics driven methodology INC Research employs to consistently deliver
“actionable” information to their Customers – on time and on budget. As such,
Jeff oversees the development, deployment and use of the TrustedProcess™
methodology by all INC project teams.
Jeff attended the University of Arizona and completed his BS in Public
Administration in 1977. In 1987, Jeff completed his MBA, with a concentration in
Systems Analysis, from the University of New Mexico. With over twenty five years
of Project Management experience, Jeff has worked in both the public and private
sector with primary emphasis in Operations Management, Software development,
and Business Process Re-engineering. For the last fourteen years, Jeff has worked
in a variety of senior operational leadership positions in support of Pharmaceutical
Clinical Drug Development.
INC Research®
Jeffrey A. Kueffer, MBA, PMP
12. 12 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
A respected industry leader with more than 20 years of focused experience,
Dr. John Potthoff oversees Theorem’s global operations and long-term growth
strategy. Prior to joining Theorem, John was COO of INC Research, a company for
whom he achieved a compound annual growth rate of 40 percent year after year
for multiple years. John was also the founder and president of Tanistry Inc., a CRO
specializing in CNS indications, before it was acquired by INC Research in 2001.
Before founding Tanistry, he was an executive of PPD Development. John earned
his Bachelor’s, Master’s, and Doctoral degrees in Psychology from the University of
Texas, where he is also an adjunct professor in the Department of Psychology.
Theorem Clinical Research
John G. Potthoff, Ph.D.
Jeffrey McMullen is Vice Chairman of inVentiv Health. He previously served as the
President and Chief Executive Officer of PharmaNet, which he co-founded in 1996.
PharmaNet is now part of inVentiv Health’s clinical division. Mr. McMullen has more
than 35 years of drug development experience on a global basis. His career includes
13 years with major drug development services companies with responsibilities in
operations and executive management and 9 years with Sterling Drug (now a part
of Sanofi-Aventis) in the clinical, regulatory, and drug metabolism areas.
inVentiv Health, Inc.
Jeffrey P. McMullen
Over the long term, The Avoca Quality Consortium will
develop a new paradigm in the industry’s approach to quality
management and partnering to ensure high quality and risk
mitigation.
13. 13 Avoca Quality Consortium 2013 Summit
EXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS
Theorem Clinical Research
Angelika Tillmann has over 30 years of professional experience in clinical research
in various roles in academia, Pharma and CRO industry. Angelika currently is
employed as Vice President and Head of the Global Clinical Quality Assurance
Group and Compliance Framework at Theorem Clinical Research.
In this role, Angelika establishes best practice standards for the global CQA
operation, managing and overseeing all CQA related activities around the globe,
including oversight of the conduct of the entire range of audits for clinical trials, as
well as internal process and systems audits. As Head of the Compliance Framework,
she is responsible for the oversight of SOP development, advice on compliance to
relevant regulatory requirements, preparation of clients and investigational sites for
inspections, the implementation and oversight of corrective and preventive action
plans (CAPAs), the performance of risk assessments, the oversight of operational
metrics, and she is heading Theorem’s Quality Council. Outside her company,
Angelika is presenting at local and international training seminars and conferences.
Angelika is a member and Fellow of RQA in UK since 1995 and a member of RQA’s
GCP Committee since 2004. Angelika is also a member of the DGGF in Germany
since 1995 and a member of the DGGF’s Working Group on Risk Management since
2012.
Angelika Tillmann
14. 14 Avoca Quality Consortium 2013 Summit
GUEST SPEAKERS AND FACULTY
Bregman Partners, Inc.
Peter Bregman is the CEO of Bregman Partners, Inc., a global management consulting
firm which advises CEOs and their leadership teams. He speaks, writes, and consults
about how to lead and how to live.
He is the author, most recently, of 18 Minutes: Find Your Focus, Master Distraction, and
Get the Right Things Done, winner of the Gold medal from the Axiom Business Book
awards, named the best business book of the year on NPR, and selected by Publisher’s
Weekly and the New York Post as a top 10 business book. He is also the author of
Point B: A Short Guide to Leading a Big Change and co-author of five other books.
Featured on PBS, ABC, and CNN, Peter is a regular contributor to Harvard Business
Review, Fast Company, Forbes, National Public Radio (NPR), Psychology Today, and
CNN, as well as a weekly commentator on Fox Business News.
Peter bases his work on the notion that an organization, at its core, is a platform for
talent. By unleashing that talent, focusing it on business results, and aligning it with a
compelling vision, both the individual and the organization thrive. Since 1989, Peter
has trained and coached all levels of management and individuals to recognize their
leadership, exhibit leadership behaviors, model and stimulate change, and foster their
own development and growth as well as that of their teams and colleagues.
Peter earned his B.A. from Princeton University and his M.B.A. from Columbia University.
Peter Bregman, CEO
Margaret Davis
Margaret Davis is the Founder and President of Margaret Davis Consulting, a culture
change and coaching firm based in Princeton, New Jersey. Margaret specializes in
culture assessment and analysis, coaching, and services that support these efforts.
Margaret Davis received her B. A. from Princeton University in Cultural Anthropology, has
been trained in Family Systems Theory at the Georgetown Family Center, and pursues
ongoing graduate studies in Psychology and Organizational Development.
Margaret Davis Consulting
15. 15 Avoca Quality Consortium 2013 Summit
GUEST SPEAKERS AND FACULTY
Ann Meeker-O'Connell
Ms. Meeker-O'Connell is the Acting Division Director for Good Clinical Practice
for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration
(FDA). In this capacity, Ann oversees two branches, one responsible for overseeing
marketing application related inspections and providing recommendations on data
integrity and subject protections to CDER's review divisions and the other responsible
for complaint evaluation, for-cause inspections and development of appropriate
administrative and regulatory actions post-inspection. Previously, Ann served as OSI's
Acting Associate Director for Risk Science, Intelligence, and Prioritization, leading a team
developing risk-based analytic tools for pre- and post-marketing compliance activities.
Ann is actively involved in a range of initiatives evaluating innovative models for clinical
trial design, conduct, and oversight. Ann is currently serving as a co-lead for a Clinical
Trials Transformation Initiative (CTTI) project seeking to develop models for building
quality into the scientific and operational design of trials.
Before joining FDA, Ann spent over 9 years working in clinical and compliance roles
in industry and academia, where she was responsible for designing and implementing
a global clinical internal process audit program; serving as the compliance lead for
development programs in oncology, immunology, and diabetes; conducting both routine
and for-cause audits; drafting and reviewing submissions to the FDA; and developing
clinical trial and healthcare compliance policies and procedures.
US FDA
The Avoca Group, Inc.
Dr. Howard Jacobson is a manager and consultant in the area of change management.
He has been a consultant and Director of Marketing for global change management
consulting firm, Bregman Partners. Dr. Jacobson’s other areas of expertise include
relationship building, teamwork, organizational development, and communication
strategies. At Avoca, Dr. Jacobson develops and delivers learning modules, working
directly with client teams on relationship management strategies and tools.
Dr. Jacobson has a BA from Princeton University and an MPH and PhD from Temple
University. He is currently based in the Research Triangle Park area of North Carolina.
Howard Jacobson, Ph.D.
16. 16
SUMMIT MODERATORS AND FACILITATORS
Avoca Quality Consortium 2013 Summit
The Avoca Group, Inc.
Dr. Denise Calaprice-Whitty has extensive experience in directing clinical research
programs in a variety of settings including academia, a CRO, a large global
pharmaceutical company, and a small biotechnology company. After receiving her
Bachelor’s Degree in Biology from Harvard University and her M.S. and Ph.D. from
Princeton, Dr. Calaprice-Whitty entered the world of clinical research as an NIH fellow
at Columbia University’s College of Physicians and Surgeons. She subsequently joined
Quintiles as a Clinical Research Project and Program Director, where she directed full-
service international research programs including studies in Phases I through IV, and
including NDA and IND preparation, submission, and support. As Senior Director of
Clinical Research at Altana Pharma, Dr. Calaprice-Whitty developed the infrastructure
of the U.S. clinical research department and contributed to infrastructure development
internationally, including training of personnel, SOP and guideline development, and KOL
relationship development, while simultaneously overseeing the performance of both
outsourced and sponsor-performed international clinical trials. As Director of Clinical
Sciences at Regeneron Pharmaceuticals, Dr. Calaprice-Whitty played a similar role,
overseeing programs in Phases I through III.
Denise Calaprice-Whitty, Ph.D.
The Avoca Group, Inc.
Sidney DeGraw
Sidney DeGraw is an independent consultant with 27 years of leadership positions in the
pharmaceutical, biotech, and CRO industries. She has expertise in development strategy,
and the planning and execution of global clinical programs using varied operational
models. Ms. DeGraw’s experience building and leading successful Clinical Operations
organizations in both the Sponsor and CRO sectors provides a unique perspective that
brings value to industry decision-makers.
Ms. DeGraw retired from the position of Vice President of Clinical Operations at
MedImmune in May 2012, with accountability for leadership and delivery of all global
Phase I through III clinical programs. Prior to this, Ms. DeGraw held executive level
positions at PRA International, where she was responsible for the harmonization of North
American clinical operations, and at Sepracor (now Sunovion), where she played a lead
role in advancing the companies first two products to NDA submission.
17. 17 Avoca Quality Consortium 2013 Summit
SUMMIT MODERATORS AND FACILITATORS
The Avoca Group, Inc.
Patricia Leuchten is a leading authority on global clinical outsourcing and strategic
alliances between pharmaceutical sponsors and clinical research organizations
(CROs). Ms. Leuchten has more than 25 years of industry experience and founded
The Avoca Group in 1999. As the industry’s premier consulting and survey research
firm, The Avoca Group offers specific expertise in clinical outsourcing and alliance
management. In 2011, Ms. Leuchten founded the Avoca Quality Consortium, a
member-driven organization of nearly 30 pharmaceutical and CRO companies,
bringing together Executives, Quality Management, Outsourcing and operational
professionals in the collaborative effort to accelerate the development of a best
practice approach to proactive quality management and CRO oversight.
Ms. Leuchten is a frequent speaker and writer on topics addressing clinical
outsourcing, strategic alliances, quality management, and relationship management
in the pharmaceutical industry.
Patricia Leuchten
The Avoca Group, Inc.
In addition to her role overseeing Avoca project teams, Janice Hutt consults with
senior teams within pharmaceutical companies to develop effective strategies
focused on strengthening relationships with their service providers. Janice also
works in-depth with service providers focusing on effective partnering practices
to optimize outsourced relationships. Janice’s expertise enables her clients, both
sponsors and service providers, to foster an environment of mutual understanding,
enhanced collaboration, and increased commitment, resulting in improved program
outcomes.
Janice brings over 30 years experience in the pharmaceutical and pharmaceutical
services industries. Prior to joining Avoca, Janice worked in clinical research at
Merck for 10 years before working for 8 years with several CROs, as Director of
Business Development. Janice holds a Masters Degree in Education from Acadia
University and a BS degree in Biology and Chemistry from Rider University.
Janice Hutt
Avoca Research and the development of Leading Practices are the two pillars
of the Avoca Quality Consortium that provide the foundation for our work.
18. 18
SUMMIT MODERATORS AND FACILITATORS
Avoca Quality Consortium 2013 Summit
Mint Collective, LLC
Marc Monseau has spent almost 20 years devising new ways to reach, engage, and
influence people through digital channels. Marc’s varied career includes serving as
an analyst for a London-based market research group, reporting for the
International news organization, Bloomberg Business News, and working
within the corporate communications team at Johnson & Johnson.
Recently, Marc co-founded Mint Collective, an independent consultancy focused
on helping organizations develop strategic communications programs that deliver
business results.
Through his consulting work, Marc works closely with a wide range of clients to
identify credible approaches to reach and engage key online audiences. In addition
to strategic counsel, Marc provides educational seminars to raise the cultural
readiness of his clients and develops policies and processes to ensure the long-term
viability of innovative communications initiatives.
Marc studied English Literature at Kenyon College in Ohio, and has a Masters
Degree in Anglo-American Literary Relations from University College London.
Marc Monseau
The Avoca Group, Inc.
Steven B. Whittaker is an independent consultant for the pharmaceutical, biotech,
and CRO industries, providing expertise in project management, pharmaceutical
development, clinical development, outsourcing strategies and execution plans. His
wealth of experience through years of drug development leadership roles and his
established network with professionals across these industries provide a unique
and valuable combination of insights for organizational leaders. Whittaker has
served for 12 consecutive years on the Advisory Board for the annual Partnerships
in Clinical Trial program, chairing the board for 2 years. In addition, Whittaker has
moderated numerous quarterly Clinical Research Consortium forums, developing
strategic agendas and facilitating the exchange of leadership concepts between
clinical development executives across several top-tier pharmaceutical and biotech
organizations.
Whittaker retired from Eli Lilly and Company in December 2009 where he served
as Chief Operating Officer/Sr. Director of Operations and Project Management
for the Cardiovascular/Acute Care Platform. As the leader of the Global Clinical
Research Sourcing Office, Whittaker established Lilly’s first corporate strategy and
operational design for outsourcing global clinical development to CRO preferred
partners. This included the selection and initial implementation of the preferred
partner approach for global, full-service CRO capabilities. Whittaker also led Lilly’s
Project Management Center of Excellence, establishing standards for leaders of
project development.
Steven B. Whittaker
19. 19 Avoca Quality Consortium 2013 Summit
THANK YOU TO OUR 2013 SUMMIT SPONSORS
