Avoca Quality Consortium 2014 Summit Bio Booklet

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<ul><li> 1. Avoca Quality Consortium 2013 Summit </li></ul><p> 2. 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. THANK YOU TO OUR CONSORTIUM SPONSORS 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 Consortiums future priorities on out-of-the-box approaches; leading the way for industry breakthroughs 3. PATRICIA LEUCHTEN President &amp; CEO - The Avoca Group, Inc. WELCOME 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 &amp; 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 years 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 industrys 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. Youll 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, 4. 4 Avoca Quality Consortium 2014 Summit SUMMIT CO-CHAIRS 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 Lillys clinical portfolio. Dr. Kasher received a Bachelor of Science degree in chemistry from Franklin &amp; 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 Pfizers early Development Committee and Clinical and Medical Excellence Innovation Board and is a member of the Portfolio Strategy and Investment Committee and Worldwide Research &amp; 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 5. 5Avoca Quality Consortium 2014 Summit KEYNOTE SPEAKER 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 Gehrigs 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 worlds 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 worlds largest and most comprehensive ALS research program. Heywoods 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 magazines Smart List and Fast Companys 10 Most Creative People in Healthcare. Heywood and his brother Stephen were the subjects of Pulitzer Prize winner Jonathan Wieners biography, His Brothers Keeper, and the Sundance award-winning documentary, So Much So Fast. Co-Founder, Chairman PatientsLikeMe 6. EXECUTIVE ROUNDTABLE PANELISTS AND PRESENTERS 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 Mercks 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 Kendles 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 plc Stephen Cutler, Ph.D. 6 Avoca Quality Consortium 2014 Summit 7. 7Avoca Quality Consortium 2014 Summit Coleen Glessner Pfizer, Inc. As Vice President, Head of Clinical Trial Process and Quality (CTPQ), Coleen leads Pfizers 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 Pfizers partnerships and driving a culture of quality. Rick Sax, M.D. Quintiles Dr. Sax is a &gt;20-year veteran of the pharmaceutical industry, having held senior positions in Clinical Development at Merck &amp; 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 &amp; Reporting Services), Safety Knowledge &amp; Reporting, and the Center for Integrated Drug Development Quintiles home for clinical program and trial design and its enabling technology platform, Infosario Design. EXECUTIVE ROUNDTABLE PANELISTS AND PRESENTERS 8. EXECUTIVE ROUNDTABLE PANELISTS AND PRESENTERS 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 companys 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 bachelors 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. 8 Avoca Quality Consortium 2014 Summit 9. SUMMIT MODERATORS, FACILITATORS AND FACULTY 9Avoca Quality Consortium 2014 Summit DrugDev Founder and Chief Commercial Officer, Melissa Easy is responsible for leading DrugDevs 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 DrugDevs success to date in carrying out its mission of helping sponsors and CROs identify, pay and engage investigators. Melissa Easy GUEST SPEAKERS Jennifer Byrne PMG 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. 10. Jeremy Gilbert PatientsLikeMe 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 Societys ACO Steering Committee. Jeff holds a Master of Business Administration Degree and is a Certified Public Accountant. Wilmington Health, PLLC Jeff James A seasoned business development and innovation professional with deep experience navigating the healthcare value chain, Jeremy Gilbert leads product strategy a...</p>