avoca quality consortium summit 2013 bio booklet

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  1. 1. Avoca Quality Consortium 2013 SummitSUMMIT 2013
  2. 2. 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
  3. 3. 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 todays 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 todays 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 Consortiums future priorities on out-of-the-box approaches; leading the way forindustry breakthroughsI would like to extend a special thank you to our Summit Sponsor, ICON, and our Supporting Sponsors, SitrofTechnologies, Idis, Acurian, and LabCorp Clinical Trials. Todays program would not be possible without theirsupport and sponsorship.Thanks again for joining us for the second annual Avoca Quality Consortium Summit. Were excited abouttoday, and we hope you will find the Summit both professionally and personally rewarding.Warm Regards,
  4. 4. 4 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 Lillys 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.
  5. 5. 5 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERSMerry Chu, M.Sc.Hazel CollieEli Lilly Canada Inc.Grnenthal 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 Grnenthal 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.
  6. 6. 6 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERSGrace CrawfordICON Clinical ResearchMs. Crawford is a Senior Director of Quality Assurance at ICON Clinical Researchand has spent over 19 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, SQAs Clinical Specialty Section, MARSQA and MARSQAs 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
  7. 7. 7 Avoca Quality Consortium 2013 SummitEXECUTIVE ROUNDTABLE MEMBERS AND PRESENTERSStephen 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 PPDs senior leadership team. He is responsible foroverseeing strategy and execution of the companys global quality function, includingclinical and laboratory quality assurance, regulatory co