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Formed in January of 2012 with 30 Members, The Avoca QualityConsortium brings together quality, outsourcing, and operationalprofessionals from Member pharma, biotech, and clinicalresearch organizations (CROs) to accelerate the developmentof best practices and industry standards for proactive qualitymanagement.THANK YOU TO OUR CONSORTIUM SPONSORS
WELCOMEOn behalf of The Avoca Group, our Co-Chairs, Jeffrey Kasher and ChristopherHilton, and our Summit Sponsor, Stephen Cutler, I am pleased to welcome you tothe 2013 Avoca Quality Consortium Summit.This year, we have put together a program that promises to be both insightfuland thought-provoking. Reflecting on input from our Members, we have createda series of sessions that explore how sponsor companies and CROs can findthe right balance between time, cost, and quality in this changing regulatoryenvironment. Through interactive discussions and workshops, thought leaders andindustry experts will tackle some of the top topics of the day, including effectiveoversight, the best approaches to risk assessment and risk management, andthe role of culture in ensuring quality. We will close the day with an Industry “Call to Action” where industrythought 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, butto also add to the dialog by providing your own perspectives, experiences, and insights. I hope each of youwill take full advantage of these unique opportunities to discuss together how we can help ensure quality inoutsourced clinical trials.As you listen and participate in today’s sessions, you may want to keep in mind the Avoca Quality ConsortiumCore 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 commongoalsEngagement: Member involvement at the Executive as well as Functional level; engagement with RegulatoryAuthorities to strive for mutual understanding and acknowledgementTransparency: Sharing of information with other groups, organizations, and industry consortia to ensure noduplication of effortsImplementation: Operationalizing approaches to proactive quality managementInnovation: Focusing the Consortium’s future priorities on “out-of-the-box” approaches; leading the way forindustry breakthroughs• • • • •• • I would like to extend a special thank you to our Summit Sponsor, ICON, and our Supporting Sponsors, SitrofTechnologies, Idis, Acurian, and LabCorp Clinical Trials. Today’s program would not be possible without theirsupport and sponsorship.Thanks again for joining us for the second annual Avoca Quality Consortium Summit. We’re excited abouttoday, and we hope you will find the Summit both professionally and personally rewarding.Warm Regards,
4 Avoca Quality Consortium 2013 SummitMichael D. Jones, MBAEli Lilly and CompanySince joining Eli Lilly and Company in 1982 as a molecular geneticist, Mr. Joneshas held a variety of leadership positions throughout Lilly Research Laboratoriessupporting global clinical development of pharmaceutical products includingClinical Operations, Regulatory Affairs, Information Systems, Quality and ProductDevelopment team leadership. Presently, he is Senior Director of Global ClinicalOperations, responsible for planning and implementation of Lilly-sponsored clinicaltrials worldwide. Mr. Jones is engaged in a number of current industry initiativesincluding membership in the Clinical Trial Transformation Initiative SteeringCommittee, TransCelerate BioPharma, Inc. Risk-Based Monitoring team, and theSociety for Clinical Research Sites Leadership Council.Update: Jeffrey Kasher is unable to attend this year’s Avoca Quality Consortium Sum-mit. In his absence, we are pleased to welcome Co-Chair Michael D. Jones ofEli Lilly and Company.SUMMIT CO-CHAIR
5 Avoca Quality Consortium 2013 SummitSUMMIT CO-CHAIRSEli Lilly and CompanyJeffrey S. Kasher, Ph.D., was named Vice President, Global Clinical Trial: Materials,Implementation And Transformation in September 2012. In his current role, he isresponsible for the delivery of clinical studies and information in support of Lillymolecules. The primary responsibility is to patients and healthcare professionalswho depend on Lilly’s products and services today and in the future. Kasher hasresponsibility for Regional Clinical Operations, Global Clinical Pharmacology &Diagnostics, Clinical Trial Manufacturing & Material Services, 6 Sigma/BusinessProcess Management/Critical Chain Project Management, and Clinical DevelopmentInnovation.Dr. Kasher received a Bachelor of Science degree from Franklin & Marshall College,a Doctorate in Pharmacology from the State University of New York (Syracuse) anda 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 Managementat Pfizer Inc. He leads an organization that oversees the clinical trial operationalsupport to Pfizers late stage portfolio and business operations activities. Recently,he has been leading the development and implementation of Pfizers new AlliancePartnership approach for clinical trial support with two leading CROs. Chris hasexpertise in the areas of biometrics, study, and project management with a focus onvendor oversight.Pfizer, Inc.Christopher J. HiltonThe overall theme for the 2013 work of the Quality Consortium:Helping our Members achieve the right balance between meetingtimelines, ensuring cost containment, and achieving the highest levelof quality.
6 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS Merry Chu, M.Sc.Hazel CollieEli Lilly Canada Inc.Grünenthal GmbHMerry Chu has over 16 years of pharmaceutical industry experience and currentlyholds the position of Director of Global Medical Quality, Regional and Third PartyManagement for Eli Lilly and Company. In this role, she has Quality responsibility forglobal clinical operations and medical affairs in all regions in addition to oversight ofthe associated external partnerships.Merry received her Bachelor of Science degree in Toxicology and Human Biologyand her Masters in Science in Clinical Pharmacology and Toxicology, both from theUniversity of Toronto. She joined Lilly in 2004 and during her career at Lilly, has heldtechnical 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 andhas worked for over 20 years in the pharmaceutical industry in the areas ofBiostatistics, Clinical Data Management, Project Management and Quality. She hasbeen at Grünenthal now for over 9 years during which she has held many differentmanagement positions within clinical development. In her current position she isresponsible for all quality activities within clinical development including internalquality initiatives, SOP management, quality aspects of vendor relationshipand inspection preparation.
7 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS Grace CrawfordICON Clinical ResearchMs. Crawford is a Senior Director of Quality Assurance at ICON Clinical Researchand has spent over 19 ½ years in the pharmaceutical industry in the areas of clinicalresearch and quality assurance. Her main responsibilities include implementing andmaintaining an effective GCP Quality Assurance program and leading the global QAfunction 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. Inaddition to her laboratory responsibilities, she was a member of the Total QualityManagement Team and assisted in the Total Quality Improvement efforts of thelaboratory that she worked in. Ms. Crawford has received a M.Sc. in ClinicalMicrobiology from the Medical College of Pennsylvania and has been an activemember of organizations such as ASQ, Local Clinical Quality Assurance DiscussionGroups, SQA, SQA’s Clinical Specialty Section, MARSQA and MARSQA’s ComputerValidation Committee, and DIA.Alexion PharmaceuticalsMike was born in London, UK and graduated from the University of Sheffield with adegree in Genetics in 1979. He then went to the University of Birmingham to do anMSc in Applied Genetics and completed his doctorate in the Department ofPsychology 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 providingstatistical consultancy to a wide variety of healthcare professionals. In 1988 hemoved back to London to join Hoechst as Head of Biometrics.In 1995, Mike joined Pfizer in the UK leading the global biometrics activities for twomajor drug programs. In 2002, Mike moved to the US to take up a position as theDevelopment Operations site head for Groton/New London. In 2006, Mike movedto New York as the Head of Phase 3b/4 and New York site head for DevelopmentOperations. In this role he was accountable for operational delivery of phase 3b/4trials across the Pfizer portfolio. In 2009, Mike was appointed Head of Clinical StudyOperations. In 2012, Mike joined Alexion Pharmaceuticals as Head of Global ClinicalOperations focusing on the development of drugs for ultra-rare diseases.Mike Collins
8 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS Stephen Cutler, Ph.D.ICON Clinical Research ServicesSteve has 24 years of experience within the pharmaceutical and CRO industry andjoined ICON from Kendle where he held the position of Chief Executive Officer,having previously served as Kendles Chief Operating Officer. Prior to Kendle, Stevespent 14 years with Quintiles where he served as Senior Vice President, GlobalProject Management; Senior Vice President, Clinical, Medical and Regulatory; SeniorVice President, Project Management - Europe; and Vice President, Oncology -Europe as well as regional leadership positions in South Africa and Australia. Priorto joining Quintiles, Steve held positions with Sandoz (now Novartis) in Australiaand Europe. He holds a B.Sc. and a PhD from the University of Sydney and aMasters of Business Administration from the University of Birmingham (UK).PPDJames Dixon joined PPD in February 2013 as Senior Vice President of Global Qualityand Compliance and member of PPD’s senior leadership team. He is responsible foroverseeing strategy and execution of the company’s global quality function, includingclinical 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, pharmaceuticaland biotechnology industries. He joined PPD from PRACS Institute, where he servedas Chief Operating Officer and was responsible for providing strategic direction andleadership to the company’s service lines, quality infrastructure, management andbusiness development activities. Prior to that role, he served as Senior Vice Presidentof 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 MedImmuneand 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. Dixon2013 Consortium Research: Managing risk in outsourced clinical trialsthrough risk assessment, risk sharing, and risk-based management:an assessment of whether these are effective ways of achieving theright balance of time, cost, and quality.
9 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS James D. Esinhart, Ph.D.Chiltern InternationalDr. Jim Esinhart joined Chiltern in 2006 and prior to his role as CEO, Jim was theSenior EVP, Global Scientific Services where he was responsible for managingglobal biometrics, medical and regulatory affairs, and information technology.Jim has held senior posts with several international biopharmaceutical researchorganizations and previously held a professorship at East Carolina University Schoolof Medicine. Jim was a founding employee for PharmaResearch Corporation,which through acquisition by Inveresk Research, later became part of Charles RiverLaboratories Clinical Services. At Charles River, Jim was Vice President of GlobalMedical 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 DwyerCerexa, Inc.Deborah Bisio Dwyer is currently at Cerexa, Inc. in Oakland, California. She started her industry experience atGenentech, Inc. in 1993 where she entered the business in data management. She made a successful transition toClinical Operations and contributed to and led development trials from Phase II through IV (and post marketingcommitments). After leaving Genentech in 2004, she joined Chiron Corporation as a Global Clinical ProgramManager, 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.
10 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS Pfizer, Inc.Dr. Hubbard is Senior Vice President and Worldwide Head of DevelopmentOperations for Pfizer Inc. In this position, he is responsible for global clinical trialexecution from Phase I to IV, which includes more than 700 clinical projects acrossspecialty 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 ExperimentalPsychology from the University of Santa Clara, a Doctorate from the Universityof Tennessee, and was a National Institute of Health Postdoctoral Fellow inCardiovascular and Clinical Pharmacology at the University of Texas HealthSciences Center.John Hubbard, Ph.D., FCPF. Hoffmann-La Roche Ltd and Genentech, Inc.Heather Jorajuria is a Senior Director and Global Head of Product DevelopmentQuality Assurance at Roche/Genentech. Mrs. Jorajuria manages a global teamof Quality Assurance professionals who are responsible for the quality oversightand conduct of risk-based compliance audits for all regulated non-clinical, clinicaltrial and pharmacovigilance activities at Roche/Genentech. Mrs. Jorajuria hasbeen in the Pharmaceutical Industry for over 17 years with the majority of timeresponsible for providing quality assurance for regulated activities supporting R&D.Mrs. Jorajuria obtained her Bachelor of Arts in Kinesiology from the University ofColorado, Boulder. Mrs. Jorajuria currently resides in the San Francisco Bay Area.Heather Jorajuria
11 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS QuintilesMargaret Keegan joined Quintiles in 2007 and is currently SVP, Global Head ofIntegrated Processes and Technologies. In this role her remit spans ClinicalDevelopment and currently includes oversight of strategic clinical alliances (3rdparty vendors); the Quintiles Contact Center; all major cross-functional new systems(including CTMS, portfolio planning and resource management); as well as QuintilesInfosario™ and the development of transformative integrated operational modelsfor Clinical Development. In addition, Margaret’s team now has oversight of qualityand productivity operationally across Clinical Development. Margaret has over 20years of pharmaceutical industry experience and has held senior leadership rolesin statistics, programming, data management, late phase and clinical functions.Margaret holds a Bachelor of Science degree in Pure and Applied Mathematics andis a Chartered Statistician.Margaret KeeganMitchell Katz, Ph.D.Purdue Pharma L.P.Dr. Mitchell Katz is Executive Director of Medical Research Operations at PurduePharma L.P. In this position he is responsible for leading all operational activitiesacross Purdue’s multinational clinical programs.Dr. Katz has 27 years of experience in the pharmaceutical and biotechnologyindustries, including preclinical research, pharmaceutical operations, and regulatoryaffairs. Prior to joining Purdue, he served as Vice President of Global ClinicalOperations & Data Management at Eisai Medical Research. Dr. Katz has experienceworking in start-up biotechnology companies, including Acorda Therapeutics,InterMune, Connetics, and NABI. He also held management positions at OrthoBiotech and Schering-Plough and participated in six successful NDA applications inhis professional career.Dr. Katz holds a B.A. in Biology a Ph.D. in Microbiology, and served as a postdoctoralresearch fellow at Downstate Medical Center in NY.The work of the Avoca Quality Consortium is in helping companiesoptimize their approaches to proactive quality managementwith an emphasis on bringing sponsors and CROs into greateralignment.
12 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS Research Pharmaceutical Services, Inc.Dr. Harris Koffer is President of Research Pharmaceutical Services (RPS), a clinicalresearch organization providing services to the Pharmaceutical and Biotechnologyindustries in support of clinical drug development.Prior to joining RPS, Dr. Koffer served as Vice President, Clinical Trials andPharmaceutical Business Development for Quest Diagnostics; Vice Presidentand General Manager of Covance Clinical Services and President of CovancePeriapproval Services. In these roles, he was responsible for global centrallaboratory services as well as full service clinical research and developmentcapabilities for Phases I through IV of drug development.He earned both a BS in Pharmacy and a Doctor of Pharmacy degree from thePhiladelphia College of Pharmacy and Science and completed a Fellowship inClinical Pharmacology at Thomas Jefferson University Hospital in Philadelphia.Harris Koffer, Pharm.D.Jeffrey A. Kueffer is the Senior Vice President for Global Operations Managementat INC Research, Inc. Jeff is the principal architect of the TrustedProcess™ whichis 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 PublicAdministration in 1977. In 1987, Jeff completed his MBA, with a concentration inSystems Analysis, from the University of New Mexico. With over twenty five yearsof Project Management experience, Jeff has worked in both the public and privatesector with primary emphasis in Operations Management, Software development,and Business Process Re-engineering. For the last fourteen years, Jeff has workedin a variety of senior operational leadership positions in support of PharmaceuticalClinical Drug Development.INC Research®Jeffrey A. Kueffer, MBA, PMP
13 Avoca Quality Consortium 2013 SummitEXECUTIVE 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 growthstrategy. Prior to joining Theorem, John was COO of INC Research, a company forwhom he achieved a compound annual growth rate of 40 percent year after yearfor multiple years. John was also the founder and president of Tanistry Inc., a CROspecializing in CNS indications, before it was acquired by INC Research in 2001.Before founding Tanistry, he was an executive of PPD Development. John earnedhis Bachelor’s, Master’s, and Doctoral degrees in Psychology from the University ofTexas, 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 thePresident 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 morethan 35 years of drug development experience on a global basis. His career includes13 years with major drug development services companies with responsibilities inoperations and executive management and 9 years with Sterling Drug (now a partof Sanofi-Aventis) in the clinical, regulatory, and drug metabolism areas.inVentiv Health, Inc.Jeffrey P. McMullenOver the long term, The Avoca Quality Consortium willdevelop a new paradigm in the industry’s approach to qualitymanagement and partnering to ensure high quality and riskmitigation.
14 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERS Theorem Clinical ResearchAngelika Tillmann has over 30 years of professional experience in clinical researchin various roles in academia, Pharma and CRO industry. Angelika currently isemployed as Vice President and Head of the Global Clinical Quality AssuranceGroup and Compliance Framework at Theorem Clinical Research.In this role, Angelika establishes best practice standards for the global CQAoperation, managing and overseeing all CQA related activities around the globe,including oversight of the conduct of the entire range of audits for clinical trials, aswell as internal process and systems audits. As Head of the Compliance Framework,she is responsible for the oversight of SOP development, advice on compliance torelevant regulatory requirements, preparation of clients and investigational sites forinspections, the implementation and oversight of corrective and preventive actionplans (CAPAs), the performance of risk assessments, the oversight of operationalmetrics, 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’sGCP Committee since 2004. Angelika is also a member of the DGGF in Germanysince 1995 and a member of the DGGF’s Working Group on Risk Management since2012.Angelika Tillmann
15 Avoca Quality Consortium 2013 SummitGUEST SPEAKERS AND FACULTYBregman Partners, Inc.Peter Bregman is the CEO of Bregman Partners, Inc., a global management consultingfirm which advises CEOs and their leadership teams. He speaks, writes, and consultsabout how to lead and how to live.He is the author, most recently, of 18 Minutes: Find Your Focus, Master Distraction, andGet the Right Things Done, winner of the Gold medal from the Axiom Business Bookawards, named the best business book of the year on NPR, and selected by Publisher’sWeekly and the New York Post as a top 10 business book. He is also the author ofPoint 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 BusinessReview, Fast Company, Forbes, National Public Radio (NPR), Psychology Today, andCNN, 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 fortalent. By unleashing that talent, focusing it on business results, and aligning it with acompelling vision, both the individual and the organization thrive. Since 1989, Peterhas trained and coached all levels of management and individuals to recognize theirleadership, exhibit leadership behaviors, model and stimulate change, and foster theirown 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, CEOMargaret DavisMargaret Davis is the Founder and President of Margaret Davis Consulting, a culturechange and coaching firm based in Princeton, New Jersey. Margaret specializes inculture assessment and analysis, coaching, and services that support these efforts.Margaret Davis received her B. A. from Princeton University in Cultural Anthropology, hasbeen trained in Family Systems Theory at the Georgetown Family Center, and pursuesongoing graduate studies in Psychology and Organizational Development.Margaret Davis Consulting
16 Avoca Quality Consortium 2013 SummitAnn Meeker-OConnellMs. Meeker-OConnell is the Acting Division Director for Good Clinical PracticeCompliance in the Office of Scientific Investigations (OSI), Office of Compliance, Centerfor Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration(FDA). In this capacity, Ann oversees two branches, one responsible for overseeingmarketing application related inspections and providing recommendations on dataintegrity and subject protections to CDERs review divisions and the other responsiblefor complaint evaluation, for-cause inspections and development of appropriateadministrative and regulatory actions post-inspection. Previously, Ann served as OSIsActing Associate Director for Risk Science, Intelligence, and Prioritization, leading a teamdeveloping risk-based analytic tools for pre- and post-marketing compliance activities.Ann is actively involved in a range of initiatives evaluating innovative models for clinicaltrial design, conduct, and oversight. Ann is currently serving as a co-lead for a ClinicalTrials Transformation Initiative (CTTI) project seeking to develop models for buildingquality into the scientific and operational design of trials.Before joining FDA, Ann spent over 9 years working in clinical and compliance rolesin industry and academia, where she was responsible for designing and implementinga global clinical internal process audit program; serving as the compliance lead fordevelopment programs in oncology, immunology, and diabetes; conducting both routineand for-cause audits; drafting and reviewing submissions to the FDA; and developingclinical trial and healthcare compliance policies and procedures.US FDAThe 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 managementconsulting firm, Bregman Partners. Dr. Jacobson’s other areas of expertise includerelationship building, teamwork, organizational development, and communicationstrategies. At Avoca, Dr. Jacobson develops and delivers learning modules, workingdirectly with client teams on relationship management strategies and tools.Dr. Jacobson has a BA from Princeton University and an MPH and PhD from TempleUniversity. He is currently based in the Research Triangle Park area of North Carolina.Howard Jacobson, Ph.D.GUEST SPEAKERS AND FACULTY
17SUMMIT MODERATORS AND FACILITATORSAvoca Quality Consortium 2013 SummitThe Avoca Group, Inc.Dr. Denise Calaprice-Whitty has extensive experience in directing clinical researchprograms in a variety of settings including academia, a CRO, a large globalpharmaceutical company, and a small biotechnology company. After receiving herBachelor’s Degree in Biology from Harvard University and her M.S. and Ph.D. fromPrinceton, Dr. Calaprice-Whitty entered the world of clinical research as an NIH fellowat Columbia University’s College of Physicians and Surgeons. She subsequently joinedQuintiles as a Clinical Research Project and Program Director, where she directed full-service international research programs including studies in Phases I through IV, andincluding NDA and IND preparation, submission, and support. As Senior Director ofClinical Research at Altana Pharma, Dr. Calaprice-Whitty developed the infrastructureof the U.S. clinical research department and contributed to infrastructure developmentinternationally, including training of personnel, SOP and guideline development, and KOLrelationship development, while simultaneously overseeing the performance of bothoutsourced and sponsor-performed international clinical trials. As Director of ClinicalSciences 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 DeGrawSidney DeGraw is an independent consultant with 27 years of leadership positions in thepharmaceutical, biotech, and CRO industries. She has expertise in development strategy,and the planning and execution of global clinical programs using varied operationalmodels. Ms. DeGraw’s experience building and leading successful Clinical Operationsorganizations in both the Sponsor and CRO sectors provides a unique perspective thatbrings value to industry decision-makers.Ms. DeGraw retired from the position of Vice President of Clinical Operations atMedImmune in May 2012, with accountability for leadership and delivery of all globalPhase I through III clinical programs. Prior to this, Ms. DeGraw held executive levelpositions at PRA International, where she was responsible for the harmonization of NorthAmerican clinical operations, and at Sepracor (now Sunovion), where she played a leadrole in advancing the companies first two products to NDA submission.
18 Avoca Quality Consortium 2013 SummitThe Avoca Group, Inc.Patricia Leuchten is a leading authority on global clinical outsourcing and strategicalliances between pharmaceutical sponsors and clinical research organizations(CROs). Ms. Leuchten has more than 25 years of industry experience and foundedThe Avoca Group in 1999. As the industry’s premier consulting and survey researchfirm, The Avoca Group offers specific expertise in clinical outsourcing and alliancemanagement. In 2011, Ms. Leuchten founded the Avoca Quality Consortium, amember-driven organization of nearly 30 pharmaceutical and CRO companies,bringing together Executives, Quality Management, Outsourcing and operationalprofessionals in the collaborative effort to accelerate the development of a bestpractice approach to proactive quality management and CRO oversight.Ms. Leuchten is a frequent speaker and writer on topics addressing clinicaloutsourcing, strategic alliances, quality management, and relationship managementin the pharmaceutical industry.Patricia LeuchtenThe Avoca Group, Inc.In addition to her role overseeing Avoca project teams, Janice Hutt consults withsenior teams within pharmaceutical companies to develop effective strategiesfocused on strengthening relationships with their service providers. Janice alsoworks in-depth with service providers focusing on effective partnering practicesto optimize outsourced relationships. Janice’s expertise enables her clients, bothsponsors and service providers, to foster an environment of mutual understanding,enhanced collaboration, and increased commitment, resulting in improved programoutcomes.Janice brings over 30 years experience in the pharmaceutical and pharmaceuticalservices industries. Prior to joining Avoca, Janice worked in clinical research atMerck for 10 years before working for 8 years with several CROs, as Director ofBusiness Development. Janice holds a Masters Degree in Education from AcadiaUniversity and a BS degree in Biology and Chemistry from Rider University.Janice HuttAvoca Research and the development of Leading Practices are the two pillarsof the Avoca Quality Consortium that provide the foundation for our work.SUMMIT MODERATORS AND FACILITATORS
19 Avoca Quality Consortium 2013 SummitSUMMIT MODERATORS AND FACILITATORSMint Collective, LLCMarc Monseau has spent almost 20 years devising new ways to reach, engage, andinfluence people through digital channels. Marc’s varied career includes serving asan analyst for a London-based market research group, reporting for theInternational news organization, Bloomberg Business News, and workingwithin the corporate communications team at Johnson & Johnson.Recently, Marc co-founded Mint Collective, an independent consultancy focusedon helping organizations develop strategic communications programs that deliverbusiness results.Through his consulting work, Marc works closely with a wide range of clients toidentify credible approaches to reach and engage key online audiences. In additionto strategic counsel, Marc provides educational seminars to raise the culturalreadiness of his clients and develops policies and processes to ensure the long-termviability of innovative communications initiatives.Marc studied English Literature at Kenyon College in Ohio, and has a MastersDegree in Anglo-American Literary Relations from University College London.Marc MonseauThe Avoca Group, Inc.Steven B. Whittaker is an independent consultant for the pharmaceutical, biotech,and CRO industries, providing expertise in project management, pharmaceuticaldevelopment, clinical development, outsourcing strategies and execution plans. Hiswealth of experience through years of drug development leadership roles and hisestablished network with professionals across these industries provide a uniqueand valuable combination of insights for organizational leaders. Whittaker hasserved for 12 consecutive years on the Advisory Board for the annual Partnershipsin Clinical Trial program, chairing the board for 2 years. In addition, Whittaker hasmoderated numerous quarterly Clinical Research Consortium forums, developingstrategic agendas and facilitating the exchange of leadership concepts betweenclinical development executives across several top-tier pharmaceutical and biotechorganizations.Whittaker retired from Eli Lilly and Company in December 2009 where he servedas Chief Operating Officer/Sr. Director of Operations and Project Managementfor the Cardiovascular/Acute Care Platform. As the leader of the Global ClinicalResearch Sourcing Office, Whittaker established Lilly’s first corporate strategy andoperational design for outsourcing global clinical development to CRO preferredpartners. This included the selection and initial implementation of the preferredpartner approach for global, full-service CRO capabilities. Whittaker also led Lilly’sProject Management Center of Excellence, establishing standards for leaders ofproject development.Steven B. Whittaker
20 Avoca Quality Consortium 2013 SummitTHANK YOU TO OUR 2013 SUMMIT SPONSORS