Avoca Quality Consortium 2014 Summit Bio Booklet

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Page 1: Avoca Quality Consortium 2014 Summit Bio Booklet

Avoca Quality Consortium 2013 Summit

Page 2: Avoca Quality Consortium 2014 Summit Bio Booklet

Sponsored by Eli Lilly and Company and Pfizer, Inc., The Avoca Quality Consortium brings together quality, outsourcing and operational

professionals from Member pharma, biotech and CRO organizations to accelerate the development of best practices and industry standards for

proactive quality management.


AVOCA QUALITY CONSORTIUM CORE TENETS: • 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 Quality Consortium’s future priorities on “out-of-the-box” approaches; leading the way for industry breakthroughs

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PATRICIA LEUCHTENPresident & CEO - The Avoca Group, Inc.


On behalf of The Avoca Group – as well as our Co-Chairs, John Hubbard and Jeffrey Kasher, and our Summit Sponsor, Stephen Cutler -- welcome to the 2014 Avoca Quality Consortium Summit!

I want to offer a special welcome to the new Sponsor and CRO Member companies who have chosen to join us this year, including: Baxter Healthcare, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Premier Research and TAKE Solutions. I thank you, as well as our many longstanding Members, for believing in the importance of collaboration through the Quality Consortium.

Since we founded the Quality Consortium in early 2012, we have experienced steady growth. I am especially pleased to see that many of the original initiatives have begun to take hold. Using the 2012 Quality Agreement template as a key component, we moved into a robust, eight component framework for effective oversight. Additionally, insights into Quality Metrics that began in 2012 resulted in a new taxonomy and framework for metrics.

As the Quality Consortium continues to grow and take on new initiatives in the advancement of quality in clinical trials, it is important that we remain committed to the Core Tenets established by our original Members in 2012.

The original vision of the Avoca Quality Consortium was to help individual companies optimize their approaches to proactive quality management, while focusing on a larger vision to move toward standards for quality management. While this remains the core of the Quality Consortium, we feel an obligation in 2014 and beyond to help transform clinical trial execution as a way to improve overall quality.

The theme and focus for this year’s Avoca Quality Consortium Summit reinforces that objective: Breaking Down Silos, Advancing Technology and Building Bridges to Patients. Our guest speakers and panel topics promise an exciting exchange centered around these themes. Our Quality Consortium gatherings -- and the Summit in particular – are all about creating an environment where new ideas can emerge from an open exchange of information.

In keeping with this, we have developed a program that addresses our industry’s need for transformation, particularly in the way companies work together, their ability to leverage information and technology, and through Sponsor and CRO relationships with sites and patients.

One important initiative the Quality Consortium launched this year was in fact borne out of a debate held at our very first Avoca Quality Consortium Summit. You’ll hear more over the coming two days about how we propose to transform the approach the industry takes to the prequalification of suppliers in order to reduce costs and increase efficiency for all stakeholders.

As always, this meeting would not be possible without the support of our Summit Sponsors. With special recognition to our leading sponsor ICON Clinical Research, I want to thank everyone who continues to believe in our work and this important industry movement including: Acurian, Inc., DrugDev, INC Research, and inVentiv Health Clinical.

I look forward to spending time with you at this third annual Avoca Quality Consortium Summit!

Warm regards,

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Eli Lilly and Company

Jeffrey S. Kasher, Ph.D., was named Vice President, Global Clinical Innovation and Implementation in September 2012. In his current role Jeff has the opportunity to lead significant, disruptive, Patient Centric Transformational efforts in the company and ensure delivery of the innovative molecules that are currently in Lilly’s clinical portfolio.

Dr. Kasher received a Bachelor of Science degree in chemistry from Franklin & Marshall College (Lancaster, Pa), 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.

Dr. Hubbard is Senior Vice President and Worldwide Head of Development Operations for Pfizer Inc. In this position, he is responsible for clinical trial operations and management of more than 450 clinical projects from Phase I to IV. Dr. Hubbard serves as Co-Chair of Pfizer’s early Development Committee and Clinical and Medical Excellence Innovation Board and is a member of the Portfolio Strategy and Investment Committee and Worldwide Research & Development Leadership Team. Dr. Hubbard received a Bachelor of Science degree in Biopsychology from the University of Santa Clara and a Doctorate from the University of Tennessee, with a research focus on the genetic basis of hypertension and autonomic dysfunction. He was a National Institute of Health Postdoctoral Fellow in Cardiovascular and Clinical Pharmacology at the University of Texas Health Sciences Center.

Pfizer, Inc. John W. Hubbard, Ph.D., FCP

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Jamie Heywood

An MIT-trained mechanical engineer, Jamie entered the field of translational medicine when his 29 year old brother Stephen was diagnosed with ALS, or Lou Gehrig’s Disease. Today, Heywood is the chairman of PatientsLikeMe, where he provides the scientific vision and architecture for its patient-centered medical platform. He co-founded the company in 2004 with his youngest brother, Benjamin, and friend, Jeff Cole.

Named one of “15 companies that will change the world” by CNN Money, PatientsLikeMe is a personalized research and peer care platform that allows patients to share in-depth information on treatments, symptoms and outcomes. This novel open model allows clinicians, providers and the pharmaceutical industry to better understand diseases and the patient experience. Patients improve their care while actively partnering with industry to accelerate and influence the development of new treatments and biomarkers.

Jamie is also the founder and past CEO of the ALS Therapy Development Institute (ALS TDI), the world’s first non-profit biotechnology company. During his tenure at ALS TDI Jamie helped pioneer an open research model and industrialized therapeutic validation process that made ALS TDI the world’s largest and most comprehensive ALS research program.

Heywood’s work has been profiled in the The New Yorker, The New York Times Magazine, Businessweek, 60 Minutes, CBS Evening News, NPR, Science, and Nature. In 2009, he was chosen for WIRED magazine’s “Smart List” and Fast Company’s “10 Most Creative People in Healthcare.” Heywood and his brother Stephen were the subjects of Pulitzer Prize winner Jonathan Wiener’s biography, His Brother’s Keeper, and the Sundance award-winning documentary, “So Much So Fast.”

Co-Founder, ChairmanPatientsLikeMe

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Peter Aurup, M.D.Merck Research Laboratories

Peter Aurup, M.D., is Vice President and Head of Global Clinical Trial Operations (GCTO) at Merck Research Laboratories. In this role, he is responsible for all aspects of clinical trial execution including data management for all global, regional and local studies in all of Merck’s therapeutic areas. Dr. Aurup leads a function of approximately 3,800 people, with locations in the U.S. and abroad. Currently, there are approximately 275,000 patients participating in Merck/MSD sponsored clinical trial programs worldwide.

Dr. Aurup received his medical degree from the Medical School at University of Copenhagen, Denmark, in 1983 and worked in internal medicine and cardiology before joining the pharmaceutical industry in 1988.

Dr. Cutler has 24 years of experience within the pharmaceutical and CRO industry and joined ICON plc 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).

ICON plcStephen Cutler, Ph.D.

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Coleen GlessnerPfizer, Inc.

As Vice President, Head of Clinical Trial Process and Quality (CTPQ), Coleen leads Pfizer’s GCP quality management system to ensure that the portfolio of clinical trials meets the highest standards of quality, compliance, and process excellence. CTPQ is also accountable for processes and controls that include SOPs, training, metrics and quality assessments. Most recently, she has been focused on building quality into Pfizer’s partnerships and driving a culture of quality.

Rick Sax, M.D.Quintiles

Dr. Sax is a >20-year veteran of the pharmaceutical industry, having held senior positions in Clinical Development at Merck & Co. and AstraZeneca. His career has included leading cardiovascular drug development at Merck, and leadership roles in the U.S. Business, Global Medical Sciences, and New Opportunities at AstraZeneca. Prior to joining Quintiles in 2011, he helped lead an effort at AstraZeneca to transform Clinical Development, focusing on improving program and protocol design. In his current role at Quintiles, he oversees the Biostatistics/Medical Writing/Global Regulatory Affairs (Clinical Analysis & Reporting Services), Safety Knowledge & Reporting, and the Center for Integrated Drug Development – Quintiles home for clinical program and trial design and its enabling technology platform, Infosario Design®.


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Judy Swilley, Ph.D.INC Research®

Judy Swilley, Ph.D. is an Executive Vice President and General Manager at INC Research, where she has accountability for the company’s Strategic Alliance team as well as the Global Clinical Operations Management group. Dr. Swilley has more than 26 years of experience in the global CRO and pharmaceutical industry. She has spent the past 21 years within global CROs including executive-level positions in Strategic Partnership Development, Global Clinical Operations, Project Operations, Clinical Monitoring and Staff Training and Development. Judy also spent over 5 years with Rhone-Poulenc Rorer (now Sanofi-Aventis) as a CRA and Clinical Research Manager.

Judy graduated with a bachelor’s degree in Pharmacology from the University of Liverpool in the United Kingdom, and completed a Ph.D. in Pharmacology at Liverpool jointly with the Liverpool School of Tropical Medicine.

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Founder and Chief Commercial Officer, Melissa Easy is responsible for leading DrugDev’s commercial strategy and development. Over the years, Melissa has worked as a consultant for CROs both large and small and more pharmaceutical companies than she dares count. The insight she accumulated in these roles, and the inefficiencies and resulting frustrations she witnessed, laid the concept for DrugDev. From its humble birth in 2009, Melissa is very proud of how her ‘first child’ has blossomed and DrugDev’s success to date in carrying out its mission of helping sponsors and CROs identify, pay and engage investigators.

Melissa Easy


Jennifer ByrnePMG Research

Jennifer Byrne, CEO of PMG Research, leads one of the largest Integrated Site Networks in the U.S, which provides a comprehensive research infrastructure to large multi-specialty physician, practices, healthcare institutions, academic centers, and community based private practice physicians. Jennifer and her team of 150 Clinical Research Coordinators and support staff and 130 Principal Investigators have conducted over 7,000 pharma and device trials with the inclusion of well over 100,000 trial participants. She is the founder of The Greater Gift Initiative, a non-profit organization dedicated to honoring clinical research volunteers through the gifting of lifesaving vaccines to children in developing countries. Jennifer serves on the Advisory Board for CISCRP and the Wake Forest Institute for Regenerative Medicine, and has served as Mentorship Committee Chair for the Society of Clinical Research Sites. Jennifer was named to the CenterWatch Top 20 Industry Innovators in 2013.

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Jeremy GilbertPatientsLikeMe

Jeff James is the CEO of Wilmington Health in Wilmington, NC. He is responsible for the strategic vision and its deployment as well as all financial and operational aspects of the practice.

Jeff is a frequent national speaker on a diverse range of subjects including: Lean/Process Improvement in Healthcare, Cultural Transformation, Aligning Incentives and Physician Leadership. He is a physician advocate and healthcare executive with over 18 years of strategic and operational experiences.

He has participated as an active Board Member on several community and healthcare related organizations including: The American Medical Group Association, Coastal Connect Health Information Exchange, the Economic Development Corporation, Wilmington Chamber of Commerce and the North Carolina State Medical Society’s ACO Steering Committee.

Jeff holds a Master of Business Administration Degree and is a Certified Public Accountant.

Wilmington Health, PLLCJeff James

A seasoned business development and innovation professional with deep experience navigating the healthcare value chain, Jeremy Gilbert leads product strategy and development efforts at PatientsLikeMe. He is also responsible for the company’s commercial products, which help pharmaceuticals, providers and others in the healthcare industry better understand unmet patient needs. Prior to joining PatientsLikeMe, Jeremy was an Engagement Manager at McKinsey & Company’s healthcare practice, where he led strategy and execution projects for Fortune 500 clients. Jeremy has co-founded four technology startups and has invented and launched notable products in e-commerce, mobile and discovery bioinformatics. He is the creator of the Sapphire Biobanking Solution, a state-of-the-art informatics platform that tracks biological materials and their genotypic and phenotypic data. A true technologist, Jeremy has developed software since the age of seven and spent more than 14,000 career hours in software design and construction. The recipient of Boston Business Journal’s “MBA All Star Award,” Brandeis University’s Michtom Prize for Excellence in Computer Science, and MIT’s Seley Scholar award, Jeremy earned his bachelor’s degree in computer science and anthropology from Brandeis University. He also holds a master’s degree in business administration from MIT’s Sloan School of Management.


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Princeton Consultants, Inc.

Steve Sashihara is the co-founder and CEO of Princeton Consultants Inc., which blends information technology and management consulting. Steve leads the firm’s Custom Optimization practice—transforming businesses by designing and installing software that makes tangible recommendations for action.

Steve is the author of “The Optimization Edge: Reinventing Decision Making to Maximize All Your Company’s Assets” (McGraw Hill), the first non-technical book to explain optimization to the busy business executive (www.optimizationedge.com). It has been reviewed by publications such as Forbes, Investor’s Business Daily and Consulting Magazine. In April 2012 Steve contributed the article, “From Big Data to Big Optimization: What Every Executive Needs to Know,” to The European Financial Review.

Steve graduated in 1980 from Princeton University. He serves on the advisory council for the university’s department of Operations Research and Financial Engineering (ORFE).

Steve Sashihara


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The Avoca Group, Inc.

The Avoca Group, Inc.

Debbie Briffa is Senior Project Manager of The Avoca Group. In this key role, Debbie manages and oversees a variety of relationship programs for both our pharma and CRO clients. In addition, Debbie is an active member of the Avoca Quality Consortium leadership team working on a variety of projects including our recently launched Pre Qualification initiative as well as managing our Quality Oversight Portal, and overseeing the logistics for the Summit and other Consortium meetings.

Prior to joining Avoca, Debbie had over 16 years of executive and management experience. She was former Vice President, Corporate Services and Marketing at Morgan Stanley managing all of the Firm’s Corporate Service functions including Procurement, Contingent Labor, Global Media Production, Business Services and Marketing, and the Global Events Planning group.

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.

As a consultant for the last 10 years, Dr. Calaprice-Whitty has provided support to pharmaceutical companies, clinical service providers, university investigators, and government agencies engaged in clinical research, with a focus on the areas of partnering strategies, relationship management, metric development, and business data analysis. She also oversees the annual Avoca Industry Survey and Avoca Quality Consortium Survey research programs.

Debbie Briffa

Denise Calaprice-Whitty, Ph.D.

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The Avoca Group, Inc.

Caryn Laermer is Associate Director of The Avoca Quality Consortium. In this key role, Caryn manages and oversees all Consortium strategies and initiatives, member engagement, member recruitment, member and industry communications and Summit and other Consortium meetings. Prior to joining Avoca, Caryn had several years of executive and management experience. She was former Vice President, Derivatives Group at Donaldson, Lufkin & Jenrette (now Credit Suisse) specializing in the sales and trading of stock options, foreign currency derivatives and futures. Ms. Laermer graduated from Tufts University with a B.A. in Economics. She is a member of Omicron Delta Epsilon, Economics Honor Society and holds an MBA in Finance from New York University.

Caryn Laermer, MBA

Janis L. Hall, MBA, COP

Janis Hall has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) she was responsible for R&D sourcing, contracting and supplier alliance management. As the primary point of contact to health authorities for inspection readiness for strategic sourcing, she developed and successfully implemented an end-to-end process for inspection readiness of the sourcing organization. Janis is a Certified Outsourcing Professional and has been a chair, invited speaker and panelist at numerous conferences. She holds a MBA from the University of Delaware and a BS in Chemistry from Towson University.

The Avoca Group, Inc.

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Taft and PartnersPete Taft

In his 30-year career as a writer and communications executive, Pete Taft has coached hundreds of business leaders, scientists, politicians, and public officials in the art and science of persuasive communications. He is the Founder and CEO of ClearPoint as well as two other successful communications firms: PharmApprove, a regulatory communications consultancy to the pharmaceutical industry, and Taft and Partners, an award-winning branding, marketing and public relations firm. Pete began his career as a newspaper and magazine journalist in New York before becoming the Communications Director for the New Jersey Department of Labor and Industry, where he transformed the way that agency and its leaders spoke to the public. As a result of that work, Pete was asked to serve as a communications adviser to both the governor’s senior staff as well as his campaign communications committee. He continues to coach political candidates, Congressional representatives, and other elected officials as well as leaders in both the public and private sector. Pete has delivered scores of workshops on communications throughout the US and Europe and is much sought after as both a coach as well as keynote speaker.

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 35 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


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The Avoca Group, Inc.Steven B. Whittaker

Steven B. Whittaker is Executive Director, for The Avoca Quality Consortium and Senior Consultant for the Avoca Group, where he conducts Quality Workshops, Executive Level Consulting for Pharmaceutical Quality, Clinical Development, Project Management, Sourcing, Alliance and Relationship Management.

Steve’s 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.


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ICON plc is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 76 locations in 37 countries and has approximately 10,300 employees. Further information is available at www.iconplc.com.

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Acurian is a leading full-service provider of clinical trialpatient enrollment and retention solutions for the life sciences industry. The company increases the enrollment performance of investigator sites worldwide by identifying, contacting, prescreening, and referring people who live in the local community but are unknown to a research site. As a result, trial sponsors complete enrollment without incurring the unexpected expense of adding sites, time, or CRO change orders.

INC Research is a therapeutically focused contract research organization with an unrivaled reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase 1 - Phase 4 programs in therapeutic areas of specialty, and in innovative pediatric trials. Our “Trusted Process™” methodology and therapeutic foresight leads our customers to more confident, better-informed drug and device development decisions. . For more information, please visit our website at www.incresearch.com.

DrugDev streamlines engagement among sponsors, CROs and doctors to advance the common goal of doing more trials. Through the creation of global, standardized processes, the use of smart technology, and the cultivation of unique relationships DrugDev is consistently and efficiently transforming the way drug developers identify, engage and pay investigators.

inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I–IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. www.inventivhealthclinical.com

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2014 marks the 15th year The Avoca Group has been successfully helping pharmaceutical, biotech and clinical research organizations build,

measure and manage critical business relationships.

As part of Avoca's 15th anniversary, we are donating $10,000 to support the Pancreatic Cancer Action Network. This is in honor of friends and family members who have been impacted by this devastating disease.

The Pancreatic Cancer Action Network is a nationwide network of

people dedicated to working together to advance research, support patients and create hope for those affected by pancreatic cancer. Go to

www.pancan.org for more information.

“Being part of a clinical trial has shown me the difference between thinking ‘outside of the box’ in terms of patient care and treatment, and accepting what was essentially a hopeless diagnosis. My trial gave me the hope I needed to

face my fears.” –Pancreatic cancer trial participant

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ABOUT THE AVOCA GROUPFounded in 1999, The Avoca Group is a consulting and survey research firm

based in Princeton, New Jersey. The Avoca Group develops and implements

global relationship and alliance management and quality oversight programs

for pharmaceutical companies, biotech companies, and pharmaceutical ser-

vice providers. Avoca works solely in the healthcare industry.

The Avoca Group179 Nassau St. Suite 3aPrinceton, NJ 08542 Phone (609) 252-9020Fax (609) 252-9022 For information regarding new Membership for Avoca’s Quality Consortium, please contact Danya Burakoff [email protected] or (619) 994-8677.

Existing Members, please contact Caryn Laermer at [email protected] or (609) 799-0511.

© 2014 The Avoca Group