Avoca Quality Consortium Summit 2013 Bio Booklet

Avoca Quality Consortium 2013 Summit

SUMMIT 2013

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

WELCOMEOn 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 LEUCHTENPresident & CEO - The Avoca Group, Inc.

Objective Research: Providing insights to individual companies and setting Quality Consortium prioritiesLeading Practices: Optimizing approaches to proactive quality managementCollaboration: Pharma companies, biotech companies, and CROs working together to achieve common goalsEngagement: Member involvement at the Executive as well as Functional level; engagement with Regulatory Authorities to strive for mutual understanding and acknowledgementTransparency: Sharing of information with other groups, organizations, and industry consortia to ensure no duplication of effortsImplementation: Operationalizing approaches to proactive quality managementInnovation: Focusing the Consortium’s future priorities on “out-of-the-box” approaches; leading the way for industry breakthroughs

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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 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.


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.



Grace CrawfordICON 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 behaviorin 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



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 QualityAssurance 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.



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.



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



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.



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



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 ResearchJohn 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.



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


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


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.

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SUMMIT MODERATORS AND FACILITATORS



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.




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


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.

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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


THANK YOU TO OUR 2013 SUMMIT SPONSORS


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 programs for pharmaceutical

companies, biotech companies, and pharmaceutical service 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 at [email protected] or (619) 994-8677.

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

© 2013 The Avoca Group

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Avoca Quality Consortium Summit 2013 Bio Booklet

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