6th CROWN Congress -

6th CROWN Congress
March 7 - 9, 2017
Philadelphia, PA

An Elite Gathering of Clinical Decision-Makers Ready to Learn, Network and Engage on Topics Critical to the Effective Development, Execution and Management of Clinical Trials

Faculty – 6th CROWN Congress


Gail Adinamis
Founder and CEO, GLOBALCARE CLINICAL TRIALS, LLC

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Gail Adinamis, Founder and CEO, GLOBALCARE CLINICAL TRIALS, LTD.

Gail Adinamis provides vision, leadership, strategic planning and oversight for GlobalCare Clinical Trials. Ms. Adinamis is an accomplished executive with more than 35 years of comprehensive phase I-IV clinical trials experience, including more than 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. Ms. Adinamis founded the business model for centrally managed in-home and alternate site services for clinical trials in 1992.

Ms. Adinamis is an industry thought leader and has spoken at more than 30 industry conferences. She is an entrepreneur with strong business development and operational expertise along with a proven track record for success. She established and headed clinical trials divisions for three national home infusion companies. She was also the Founder and CEO for a niche clinical trials service organization providing a mobile network of clinicians to speed patient recruitment and increase compliance and retention for sponsored clinical trials.

Ms. Adinamis was recognized for two consecutive years by INC 500/5,000 as being among the leaders of the top 5,000 fastest-growing private companies in the United States and received merit-based awards for CEO of the Year and International Game Changer of the Year.


Dimitris Agrafiotis, Ph.D., FRSC
Chief Data Officer and Head of Technology Products, COVANCE

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Dimitris Agrafiotis, Ph.D., FRSC, is Chief Data Officer and Head of Technology Products at Covance, the drug development division of LabCorp. Prior to joining Covance in 2013, he spent 10 years at Johnson & Johnson where he served as Vice President of Informatics and Research IT. Dr. Agrafiotis received his Ph.D. in theoretical chemistry from Imperial College London in 1988, and held postdoctoral fellowships at the UC Berkeley and Harvard, where he worked with Nobel laureate EJ Corey. In 1991, he joined Parke-Davis as a Senior Scientist in the computational drug design group, and in 1994 he moved to three-dimensional pharmaceuticals as a founding member of its scientific staff, responsible for building the company’s informatics and computational drug design capabilities. Following a successful IPO and the acquisition of the company by Johnson & Johnson in 2003, he was appointed Senior Research Fellow and Team Leader of Molecular Design and Informatics, a position he held until 2006 when he was appointed Global Head of Informatics and Research IT. His work is documented in more than 90 peer-reviewed publications and book chapters and 18 issued US patents. He is a member of the Covance Global Operating Committee and the Covance Science Council, and holds two adjunct faculty appointments. In 2012 he was elected Fellow of the Royal Society of Chemistry for his contributions to chemical and pharmaceutical research, and in 2016 he was named in Computerworld’s Premier 100 Technology Leaders for his technology leadership and innovative approaches to business challenges.


Moe Alsumidaie, MBA, MSF
Industry Expert and Content Contributor, APPLIED CLINICAL TRIALS

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Moe Alsumidaie is a business strategist who specializes in data analysis and predictive modeling to drive decision-making in clinical project management. Moe holds extensive experience in Phase I-IV, IDE and 510(K) clinical research and healthcare business operations, having worked in-house for Stanford Medical Center, Abbott Vascular, Genentech and Roche. Moe is currently an Editorial Advisory Board Member at Applied Clinical Trials, and Clinical Operations and Funding Advisor at Mount Sinai Hospital.


Arti Bajpai
President, COMPLIANCE AND QUALITY INTEGRATION (CQI) CONSULTING

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Arti Bajpai is a strategic leader with over 30 years of experience in the pharmaceutical industry. Ms. Bajpai’s diverse experience provides the foundation from which she leads innovative change to establish proactive compliance and quality management leading to a culture of compliance within organizations.

Currently CQI consulting provides strategic management consulting services to pharmaceutical, CROs and clinical investigator sites on Process development, building Quality Management Systems, Risk Assessments and Gap Analysis, Clinical Research Site Quality Improvement, GCP QA Audits, Regulatory Inspection Readiness and Compliance Program Design and Implementation.

Arti is also leading a global initiative for ACRES to develop global Clinical Research Investigator Site Accreditation Standards. These standards will be developed using global alliances and will lead to accreditation of clinical research sites.

Before launching CQI Consulting in 2013, Ms. Bajpai held positions at Adria Labs, Pfizer and Shire in disciplines of Quality Assurance, Compliance, Clinical Operations, and Medical Affairs. Ms. Bajpai led teams who helped establish a compliant infrastructure for robust clinical research programs in non-ICH countries and regions such as India, Africa, and Latin America. Most recently as the head of Compliance and Quality Improvement Ms. Bajpai provided strategic and tactical support for R&D, establishing quality metrics and processes which enabled the organization to achieve quality and compliance objectives.

Ms. Bajpai is a visionary team builder and motivator who thrives on continuous improvement and driving change to “make a positive difference.”


Nora Belcher
Executive Director, TEXAS E-HEALTH ALLIANCE

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Nora Belcher is the Executive Director of the Texas e-Health Alliance, a nonprofit advocacy group that she started in 2009 to give health information technology stakeholders a voice in public policy. The Texas e-Health Alliance serves as the state’s leading advocate, from local communities to the national level, for the use of information technology to improve the healthcare system for patients. Prior to starting the Alliance, Ms. Belcher worked in the private sector as a consultant advising health information technology companies on how to do business with government. She also served in Governor Perry’s office for five years as deputy director in the Governor’s Office of Budget, Planning and Policy, where she was responsible for managing the policy and budget issues for the Texas health and human services system. Ms. Belcher holds a bachelor’s degree in government from the University of Texas at Austin and owns a hardcover first edition of Game of Thrones.


Deirdre BeVard
Vice President, Development Operations, NEKTAR THERAPEUTICS

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Deirdre BeVard is Vice President of Development Operations at Nektar Therapeutics. She is responsible for the operational execution of Nektar’s clinical development programs and has the pleasure of working with a creative team responsible for clinical trial leadership, data management, contracting and outsourcing, and clinical documentation for pipeline programs. Deirdre strives to create an environment with a focus on enhancing the clinical trial process and team performance/dynamics through thoughtful analysis and fostering of productive relationships among key stakeholders. Her focus is on creating an environment where the sponsor and external partners perform as an integrated team with a shared mission of optimizing the clinical study experience for sites and patients.


Sarah Bilali
Associate Director, Clinical QA, UCB PHARMA

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Sarah Bilali has been working in the clinical research space for the past 15 years. She is currently Associate Director of Medical Devices in the Clinical Quality Assurance group at UCB Biosciences Inc, located in Raleigh, NC. Sarah began her career as a study coordinator at a clinical trial academic site and worked in data management, statistics and clinical operations. Sarah then expanded her career development into the device clinical trial industry at a CRO where she began working in quality assurance. In 2010, Sarah joined UCB Pharma in Clinical Quality Assurance as a Manager. Since 2015, she has been spearheading an effort at UCB to integrate device and combination product clinical trial activities.

Sarah holds a Bachelor of Science in Psychology from Muskingum University and Master of Arts in Psychology Experimental Research from Cleveland State University. Sarah currently holds the RQAP GCP audit certification from SQA.


Drew Bustos
Director, Strategy and Research, ERT

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Drew Bustos is the Director of Strategy and Research at ERT, where he is responsible for obtaining and evaluating information about industry and market trends, competitive threats, and possible business opportunities.

Before joining ERT in 2016, Drew spent 12 years holding executive roles in strategic marketing, product marketing and global communications at IMS Health. Prior to IMS Health, Drew spent 13 years in the telecommunication industry holding general management, brand strategy, channel marketing strategy, project management, operations and product management roles.

Drew holds a Bachelor in Business Administration from Fairleigh Dickinson University and attended executive development programs at the Wharton School of Business and SMU’s Cox School of Business.


Alfred L. Chester
Director, Clinical Quality and Compliance, MEDIMMUNE

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Al is the Director of Clinical Quality and Compliance at MedImmune in Gaithersburg, Maryland and is involved in the management of the clinical biologics quality management system to ensure that the system is effective and meets the needs of the organization. Al has more than 27 years of experience in regulated industry and has worked in government, academia, and the medical device and pharmaceutical industries. His career has included serving as a Consumer Safety Officer with the Food & Drug Administration and working in industry in research and development, clinical research, and manufacturing. He has experience in GCP, GLP and GMP. Al holds a Bachelor of Science degree in biological sciences from the University of South Carolina. He maintains a Regulatory Affairs Certification (US) with The Regulatory Affairs Professionals Society.


Craig Coffman
Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS

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Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, NEKTAR THERAPEUTICS

Craig Coffman is currently Executive Director, Clinical Business Operations & Outsourcing at Nektar Therapeutics. He is focused on providing strategic direction, oversight and expertise to the organization in order to bring operational excellence to the business planning and financial management of clinical trials, and to the identification, selection and management of external service providers. Prior to his career in outsourcing, Craig held senior management and leadership positions with CROs in a variety of functions including business development, corporate marketing and clinical operations across pre-clinical, clinical and contract manufacturing service providers.


Grace Crawford
Vice President, Clinical Quality and Compliance, MEDIMMUNE

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Grace Crawford, VP Clinical Quality & Compliance, MEDIMMUNE

Grace joined MedImmune in April 2015 as head of the Clinical Quality and Compliance function responsible for the Quality Management Framework that supports Clinical Biologics. Prior to joining MedImmune, Grace spent more than 21 years at ICON where her main focus was leading the Clinical Quality Assurance Department. She is active in the industry, participating in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium and the Linking Leaders Clinical “Quality” Roundtable. Before joining ICON, Grace was a medical technologist in the Clinical Laboratory (Special Chemistry and Immunology) at Bryn Mawr Hospital in Pennsylvania. She earned a Master of Science in clinical microbiology at The Medical College of Pennsylvania.


Sina Djali
Head of Risk Management – Central Monitoring Integrated Data Analytics and Reporting Global Clinical Development Operations, JANSSEN R&D

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Sina Djali has more than 25 years of experience in drug and clinical development in various companies and academia. Currently he is the Senior Director of Risk Management-Central Monitoring at Janssen Pharmaceuticals. In this role Sina is responsible for incorporating risk management principals in the day-to-day R&D clinical operations. Prior to this role, Sina was the Quality Representative for Cardiovascular and Metabolism Therapeutic Area at Janssen. Previously he was responsible for the Clinical Process and System Department at Tibotec Pharmaceuticals, where he developed a data-driven QRMS. Prior joining Tibotec he held several positions in regulatory affairs and clinical QA departments at Wyeth and Aventis Pharmaceuticals.


Andrea Falkoff, MBA
Vice President Operations, WORLDCARE CLINICAL

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Andrea Falkoff oversees the Operations group and all clinical programs at WCC. She has more than 10 years of experience in the clinical research industry managing imaging trials for pharmaceutical, biotechnology and medical device companies. Andrea has a proven track record of ensuring high-quality, on time service delivery to clients. Before joining WCC, Andrea was Vice President of Imaging Operations at Intrinsic Imaging. Andrea also earned her Master in Business Administration from Boston University, with a concentration in leadership and organizational transformation.


Fred Feldstein
Vice President, Global Head of BioResearch Quality and Compliance, JOHNSON & JOHNSON

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Fred Feldstein is the Vice President and Head of Janssen BioResearch Quality & Compliance (BRQC) for Johnson & Johnson. Fred is a member of the J&J Quality Leadership Team, Janssen Quality Leadership Team, and R&D Leadership Team.

Fred is responsible for driving the strategic direction and design of Bioresearch Quality & Compliance across R&D to deliver oversight of and drive adherence to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Pharmacovigilance (GVP). Fred is also a board member of the Latino Resource Group and actively engaged with the development and implementation of strategies for increasing diversity in clinical trials.

Fred joined JNJ from Pfizer where he served as Vice President, Regulatory Compliance. In that role, he was responsible for the process development and oversight of the R&D Quality Management System, and QMS standards including CAPA, and issue management and escalation standards.

Fred holds a Bachelor of Science degree in zoology and a Juris Doctor.


Kristy Galante, M.S.
Director/External Alliances, Global Clinical Development Operations, JANSSEN RESEARCH & DEVELOPMENT, LLC

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Kristy Galante has over 17 years of experience in the clinical research industry in both the pharmaceutical and CRO arenas. At present, Kristy is a Director of External Alliance at Janssen R&D. In this role, Kristy’s primary focus is in CRO collaboration with a focus on establishing and managing process and infrastructure and driving innovation within various outsourced models. Prior to her current role, Kristy played in integral part in clinical trial leadership in several global clinical trials within Janssen R&D. Kristy holds a B.S. in Biochemistry from Mount Saint Mary’s College and a M.S. in Quality Assurance / Regulatory Affairs from Temple University School of Pharmacy.


Martin Giblin
Vice President, Data Science, Safety and Regulatory Operations, QUINTILESIMS

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Martin is global leader of Quintiles’ RBM Initiative, Data Driven Trial Execution (DTE ) and also leads the Centralized Monitoring team. Martin has worked at Quintiles for more than 10 years and has spent time working in data management, technology delivery and clinical operations. Martin has a degree in Engineering Science and Mathematics from Trinity College Dublin and an MBA from University College Dublin.


Frances Grote
Director and Practice Lead, Clinical Sourcing Advisory Services, ISG

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Frances Grote, Senior Director, Clinical Operations Vendor Oversight, BIOGEN IDEC

Frances Grote has been in the biopharma industry for more than 20 years. She has worked extensively in both clinical operations and clinical vendor management, including an “ex-pat” in strategic sourcing. Fran is well known as an innovator in drug development outsourcing, focusing on leading-edge approaches to maximizing the value of outsourced relationships for both the customer and the provider. She has created unique provider partnerships for companies such as Bristol-Myers Squibb, Takeda and Biogen. She currently leads the Clinical Sourcing Advisory Services practice at ISG, focusing on helping both sponsors and providers design and implement collaborations that create best-in-class outsourcing vision, strategy and implementation.


Beth Harper
President, CLINICAL PERFORMANCE PARTNERS, INC.

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Beth is the President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance management. She has passionately pursued solutions for optimizing protocols, enhancing patient recruitment and retention and improving sponsor and site relationships for more than 30 years. Beth is an Adjunct Assistant Professor at the George Washington University who has published and presented extensively in the areas of study feasibility, site selection, patient recruitment and protocol optimization. Beth is currently serving on the CISCRP advisory board and is a member of the CTTI Recruitment Team.

Beth received her B.S. in occupational therapy from the University of Wisconsin and an MBA from the University of Texas.


Wen-Yaw (Alex) Hsieh
Director, Quality Predictive Analytics, PFIZER

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Alex Hsieh is a Director of Clinical Development Quality Analytics in Quality Performance and Risk Management in Pfizer Clinical Development Quality. Alex joined Pfizer in March 1999. During the past 18 years, Alex held progressively responsible roles, moving from positions of Statistician to Master Black Belt, Project Manager, Risk Management facilitator, and most recently, to the director role in Quality Performance and Risk Management responsible for using quality analytics, including utilization of multivariate statistics and machine learning techniques, to drive quality excellence of clinical trials.

Alex has a breadth of experience in Pharmaceutical Sciences and Clinical Development and supported several new product developments as well as other developing compounds. Alex holds a B.S. in Physics from Fu Jen Catholic University, a Master’s Degree in Statistics from Columbia University, and another Master’s Degree in Pharmaceutical Engineering from the University of Michigan. He also is an American Statistical Association (ASA) – Accredited Professional Statistician (PStatÆ), American Society for Quality (ASQ) – Certified Master Black Belt (CMBB), Certified Six Sigma Black Belt (CSSBB), Certified Quality Engineer (CQE), and PMI’s Project Management Professional (PMP) and Risk Management Professional (RMP).


Mitchell Katz, Ph.D.
Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA

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Dr. Mitchell Katz is Head of Clinical Research and Drug Safety 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 over 25 years’ 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 seven 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.


Caryn Laermer
Associate Director, AVOCA QUALITY CONSORTIUM

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Caryn Laermer is Associate Director of The Avoca Quality Consortium. In this key role, Ms. Laermer manages and oversees all Consortium strategies and initiatives, member engagement and recruitment, Industry communications, and Summit/other Consortium meetings.

Prior to joining Avoca, Ms. Laermer had several years of executive and management experience. She was Vice President, Institutional Derivatives at Donaldson, Lufkin & Jenrette (now Credit Suisse), specializing in the sales and trading of stock options, foreign currency derivatives and futures.

Ms. Laermer holds an MBA in Finance from New York University. She graduated from Tufts University with a B.A. in Economics, and is a member of Omicron Delta Epsilon, International Economics Honor Society.


Jon Lightman
Partner and Practice Lead, Life Sciences, ISG

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Jon Lightman, Partner and Practice Lead, Life Sciences, ISG

Mr. Lightman heads ISG’s Life Sciences practice. He advises clients on all aspects of the services life cycle from initial strategy through design and build of governance organizations. As a qualified English attorney he initially focused on  transactional activities and still maintains deep SME knowledge relating to the structuring and negotiation of contracts as well as M&A. His experience includes more than 50 ISG engagements whose scope comprised ITO, BPO, FSO and KPO elements, and he has also assisted clients in developing enterprise vendor management functions. He has supported clients in more than 10 countries and is based in New York City.


Doreen McGirl
Director, Quality Assurance, CARDIOVASCULAR RESEARCH FOUNDATION

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Doreen McGirl, Associate Director, Clinical Quality Management, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

Doreen is the Director of Quality Assurance at the Cardiovascular Research Foundation in NYC. She is responsible for the management, maintenance, and oversight of the GCP and GLP quality programs for CRF, leading its quality initiatives, and ensuring compliance with applicable GCP/GLP federal regulations. She manages the audit and CAPA management programs, the CRF Controlled Document program, and provides the processes to ensure that required trainings for regulated areas are current and adequately documented. She is also the primary contact for regulatory and quality assurance issues, and hosts sponsor audits and regulatory inspections.


Adrian McKemey
Senior Vice President and Managing Director, QUINTILESIMS

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Dr. McKemey focuses on business transformation, portfolio management, risk partnering, scenario planning and outsourcing strategies. Some recent relevant case work includes the streamlining of end-to-end development process and organization in a top five pharma company; the development of a biomarker strategy for a top five biotech company; assessment and gap analysis of a portfolio of early stage assets for a top five pharma company discovery/ED spin out, including due diligence preparedness; and the creation of new a cross-functional business unit within clinical development for a top 10 pharma company. Prior to assuming leadership at Quintiles Advisory Services, Adrian was a Principal with the Boston Consulting Group (BCG) working in the life sciences practice in New York helping pharma clients with business process reengineering and organizational change, along with new product R&D/commercialization strategies. Prior to BCG, Adrian was an independent strategy consultant in London and Menlo Park for pharmaceutical and diagnostic companies. He was also a tenured faculty member at Brunel University in London and visiting professor at Stanford. Adrian has a BSc (First Class) from London University, Westfield College and a Ph.D. from London University, Royal Holloway College and CERN Geneva in high energy particle physics.


Ed Miseta
Chief Editor, CLINICAL LEADER

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As an editor of Clinical Leader and Life Science Leader, Ed produces original articles on topics and issues related to clinical research, clinical operations and sponsor/CRO relationships. He also edits contributed articles and is instrumental in producing two weekly newsletters for Clinical Leader. In addition to his writing responsibilities, Ed also attends industry trade shows and takes part in moderating panel discussions and focus groups.

Prior to joining the Life Science Connect team at Jameson Publishing, he spent nine years covering the mass storage industry as editor for Business Solutions magazine and the newsletter Mass Storage News.

Ed also spent 10 years in the banking and financial service industries as an auditor, mortgage loan operations manager and investment consultant, in addition to spending eight years as a lecturer in economics for his Alma Mata Penn State, where he taught courses in microeconomics, macroeconomics, labor economics, and money and banking.

Ed has a B.S. degree in business economics and a master’s degree in business administration, both from The Pennsylvania State University.


Tanya Momtahen
Vice President, Global Scientific and Clinical Procurement, SANOFI

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Tanya Momtahen is Vice President, Global Scientific and Clinical Procurement in Sanofi since September 2014. Tanya is responsible for all clinical and scientific outsourcing and those markets for Sanofi Group – worldwide. She ensures internal knowledge and awareness of markets, suppliers and technologies for all relevant categories within that perimeter and manages an international team that develops sourcing strategies balancing risks and opportunities that are aligned with the business needs. Her team leads key supplier relationships and drives the development of new market opportunities.

Tanya previously worked in research and development for more than 25 years. Most recently she was the Vice President, Anti IL-6R Global Project Head in the Immunology and Inflammation area in Sanofi, where she transitioned the project from phase 2 through to the first phase 3 results. She led the project, which is co-developed with Regeneron, for 3.5 years. Over the past 15 years within Sanofi she has held several R&D leadership positions, including Head of Development and Realization for the previous Fibrosis and Wound Repair Unit and the Vice President of Metabolism Project Direction.

Prior to Sanofi, Tanya was a project leader at Glaxo Welcome in the late ‘90s. She started her career in medicinal chemistry in research at Rhone Poulenc Rorer in 1989. She holds a M.S. in organic chemistry from Villanova University and a B.A. from Immaculate University.


Paulo Moreira
Vice President, Global Clinical Operations – External Innovation, EMD SERONO

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Paulo Moreira is a clinical development executive with 25 years of experience in clinical R&D. He has been with EMD Serono for the last 15 years in diverse positions within clinical development. He presently serves as the Head of Global Clinical Operations External Innovation. In this capacity, Paulo is responsible for clinical innovation as well for patient centricity in clinical development and operations, where he has had a preponderant role in establishing EMD Serono as an industry leader in patient centricity around clinical trials.

Paulo is also a Visiting Scholar at Boston College, where he teaches at the Essentials of Clinical Research and Project Management Program. Paulo is very active in several industry-wide organizations. He dedicates some of his time to the Steering Committee of the Clinical Trial Transformation Initiative (CTTI). He represents EMD Serono on TransCelerate’s Operations Committee, PhRMA’s Clinical Trial Advocacy Group and fulfills the role as the Global Impact Partner of the Society for Clinical Research Sites (SCRS). Paulo also serves on the Advisory Board of a couple of companies that provide services to the pharma/biotech industries. Lastly, Paulo was named this past August to PharmaVoice’s 100 Most Inspirational Leaders of 2015 in recognition of his industry leadership around patient centricity.


Judith K. Murphy, Ph.D.
Senior Director, Head of External Partners, Clinical Development Operations, SHIRE

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Judith K. Murphy, Ph.D., is currently the Head of External Partners, Clinical Development Operations, Shire. This group actively manages the Strategic Partners and works closely with the cross-functional clinical trial study teams to facilitate the associated clinical trial-related outsourcing needs. Judith has extensive experience in the biopharma, medical device and CRO sectors in the areas of strategic outsourcing and alliance management across a wide variety of therapeutic areas. She was previously the Global Head of External Partnerships at Baxalta. She holds a Ph.D. in experimental pathobiology from the University of Southern California.


Adrian Otte
Vice President, Global Development Operations, AMGEN

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Dr. Otte has more than 30 years of industry experience and joined Amgen in 2007 as Vice President, Global Development Operations, where he is responsible for clinical operations activities associated with Phase 2-4 clinical studies.

Dr. Otte joined Amgen from Pfizer, where he served as Senior Vice President, Worldwide Development Operations for six years. At Pfizer, he was responsible for phase 1-4 clinical trial operations worldwide. Prior to joining Pfizer, Dr. Otte was Chief Operating Officer, Clinical Studies and Healthcare Research, at Innovative Clinical Solutions, Ltd., one of the largest clinical site management organizations in the U.S. Previously, he was Vice President, Medical Research for Zeneca Pharmaceuticals, and also held several positions of increasing responsibility at PAREXEL International Corporation, both in Europe and in the U.S.

Dr. Otte began his career as Medical Advisor for Solvay Duphar in the United Kingdom, where he spent 10 years, eventually overseeing the company’s European Clinical Research organization.

Dr. Otte received his medical degree from the Welsh National School of Medicine in Cardiff, United Kingdom.


Christine Pierre
President, SOCIETY FOR CLINICAL RESEARCH SITES (SCRS)

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Christine Pierre is the President of the Society for Clinical Research Sites (SCRS). She is internationally known for her experience and expertise in clinical research site management and patient recruitment and retention for the clinical trials industry. In addition to being a frequent guest speaker at industry conferences, she has also addressed audiences around the world on issues pertaining to human subject protection, site operations, and subject recruitment and retention. Her global reach has included presentations and consulting in Australia, Canada, Africa, Israel and the United States. Christine is also the Founder of RxTrials, a network of investigator sites. Christine has served as Chairman of the Board of the Association of Clinical Research Professionals (ACRP) and has served on numerous editorial boards of industry publications. She is currently a member of the Steering Committee of the Clinical Trials Transformation Initiative (CTTI) and is on the Board of Advisors for both the Center for Information & Study on Clinical Research (CISCRP) and Hands Across the Americas. In 2016 PharmaVOICE honored Christine with the Red Jacket Award and she has been nominated as one of the top female business professionals in Maryland. In 2011, the National Association of Professional Women (NAPW) named her “Professional Woman of the Year.” Christine co-authored the book Responsible Research: A Coordinators Guide, and has contributed to several recognized publications related to patient recruitment. She holds a degree in nursing and is an avid philanthropist for many organizations. She has developed her expertise in human subject protection and clinical site operations for more than 25 years and is a sought-after advisor to clinical research organizations around the world.


Richard Polgar
Director, Global Procurement, R&D, BRISTOL-MYERS SQUIBB

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Rich Polgar is the Director of R&D Global Procurement at Bristol-Myers Squibb. He joined the organization in 2009 and has held positions of increasing responsibility as a category strategist for the CRO and Clinical Lab areas. Rich recently developed and implemented a strategy that has integrated central labs, biomarker labs and bioanalytical labs with internal operations at BMS. This effort reduced costs by more than 25% while bringing new technology and innovation into the organization. Rich’s efforts in logistics have achieved more than 35% savings through demand management, cost control and innovation. His efforts in the lab space have expanded beyond pricing and focused on study design optimization, reduced blood draws, integration of new technology, strategic technology transfers of assays as well as reduced cycle time through better program and enterprise-level planning of assays. This effort has saved more than 42 million dollars in three years.

Prior to BMS, Rich worked at Schering-Plough in the Vendor Strategy & Management group and at two CROs. Rich earned his B.S. in Biology and his Masters in Neuroscience from Syracuse University.


Stephen Potter
Director, Clinical Development Quality, PFIZER

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Stephen Potter is a Director of Clinical Development Quality at Pfizer. Stephen has 23 years of experience in pharmaceutical development across a broad array of disciplines, including risk assessment and mitigation, quality assurance, clinical operations, and global feasibility. Currently, as Director of Clinical Development Quality his responsibilities include managing the operational activities for quality risk management as well as supporting clinical trial quality planning and oversight. Stephen holds an M.A. in biology as well as B.S. degrees in business administration and biology.


Ratan Ratnesh
Director and Head, Clinical Outsourcing, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

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Ratan Ratnesh has over 17 years of global experience in consulting, procurement, clinical development and outsourcing across multiple therapeutic areas. He is Director of Clinical Outsourcing at Otsuka Pharmaceuticals managing clinical contracting and category management of clinical spend. Prior to current role, Ratan served in clinical outsourcing at Novartis and Wyeth Pharmaceutical.

Prior to joining pharmaceutical industry, Ratan worked in supply chain consulting managing several indirect categories for multiple Fortune 500 companies in pharmaceutical, manufacturing, telecom and financial industry. His areas of expertise include design and implementation of procurement process & organization, strategic sourcing and category management and program management.

Ratan has a Bachelor of Science in Mechanical Engineering from National Institute of Technology, India and a Master of Business Administration (MBA) from University of Louisiana.


Kimberly Ray
Vice President, Site and Patient Networks, QUINTILESIMS

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Kim Ray, Vice President, Site and Patient Networks, QUINTILES

Kimberly Ray has a 30-year career in the healthcare industry, primarily within Quintiles, spanning a variety of roles across the drug development continuum.

Over the past four years, Ms. Ray and her team have focused on enhancing the investigator and site experience in clinical trials. As part of these efforts, she led the Site identification and Start-up teams across the Americas and oversaw staff dedicated to site relationships. Currently, she serves in a leadership role in Quintiles’ Site and Patient Networks division, which is focused on strengthening relationships with both sites and patient advocacy groups to enhance their impact on clinical trials. She serves as Quintiles’ representative on the SCRS Global Impact Partner Board and participated in the Institute of Medicine’s Clinical Trial Site Accreditation Collaborative.


Bhargava K. Reddy
Associate Director, Advanced Analytics, UCB BIOSCIENCES, INC.

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Bhargava Reddy currently leads the advanced analytics group within Global Statistical Sciences at UCB Biosciences Inc. He and his group provide the analytics support for RBM and site selection groups. He is also responsible for the advanced analytics support across portfolio of projects within the clinical trials domain.

Prior to this role, he was responsible for the management and oversight of the statistical programming group based in India. Bhargava is an ABD in Business Analytics from Oklahoma State University and has an M.S. in predictive analytics from Northwestern University. He also has an M.S. in electrical engineering from the University of Bridgeport.


Sammie Rivera
Senior Client Services Manager, CMED

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Sammie Rivera has been in the pharmaceutical industry for almost 20 years, working primarily in clinical operations and project management across a range of therapeutic areas and world regions. Ms. Rivera currently serves as a Senior Client Services Manager within Cmed Technology, where she collaborates with clients to best utilize Cmed’s New Generation Clinical Data Suite, encapsia, to improve the capture and management of clinical trials. Ms. Rivera holds a bachelor’s degree in biology and a master’s degree in public health.


Jonathan Rowe, Ph.D., M.S., M.A.
Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

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Jonathan Rowe has 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.


Dennis Salotti, M.S., MBA, CCRA
Vice President, Operations, THE AVOCA GROUP

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Dennis Salotti is the executive lead for Operations of The Avoca Group and is head of Avoca’s Industry Research and Diligent™ Centralized RFI Platform divisions. Dennis leads the strategy and execution of bespoke research projects and Avoca’s broader industry-leading research on quality, risk innovation and clinical trial execution. He is also responsible for the strategy and operations of Diligent, the clinical research industry’s first centralized platform for clinical service provider pre-qualification.

With more than 16 years in the pharmaceutical industry as a Sponsor, Provider and Consultant, Dennis has experience that spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations and strategic management.

Prior to joining The Avoca Group, Dennis was Director of Operations for WriteResult, an eCOA clinical research organization, where he was responsible for client delivery across the portfolio of global clinical trials. He has previously held positions in research and clinical operations for Pfizer and Merck.

Dennis is an Adjunct faculty instructor at Drexel University College of Medicine’s graduate program in Clinical Research Organization Management, and a Member of the Board of Trustees for the Diabetes Foundation. His educational credentials include an MS in Clinical Research Organization Management from Drexel University, an MBA in Technology Management from the New Jersey Institute of Technology, and a BS in Biology from Sacred Heart University.


T.J. Sharpe
Cancer Survivor, Blogger and Advocate

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T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog on http://www.philly.com/patient1/. He was diagnosed in August 2012 with melanoma tumors in multiple organs; since then, he has undergone six surgeries and four immunotherapy treatments over two different clinical trials. The initial failures, and subsequent significant positive response, have been chronicled in his blog posts since January 2013. His is a story about life with a serious illness, and the mental and emotional hurdles a patient must clear. He writes how a cancer patient’s challenges mirror those many face, and portrays life through the optimistic prism of a patient who is on the long, winding road toward overcoming melanoma’s long odds and deadly consequences. He also shares the latest melanoma and cancer research breakthroughs, and advocacy events and initiatives to help others avoid, detect and educate themselves on cancer. A South Jersey native, T.J. lives in Fort Lauderdale, FL, with his wife Jennifer and two young children, Josie and Tommy.


Vladimir Shnaydman
President, ORBEE CONSULTING

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Vladimir Shnaydman, Ph.D., is President of ORBee Consulting. Vladimir has B.S. and M.S. degrees in electrical engineering and computer science, an M.S. in applied mathematics and operations research, and a Ph.D. in engineering. He contributed to many industries such as biotechnology, computer networking, data storage, water resources planning and management, telecommunications, transportation, and others. Dr. Shnaydman published more than 50 papers. He is co-author of three books.


Justin Stark
Head/Director, Risk Based Monitoring and Standards, UCB

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Justin joined UCB to lead their implementation of risk-based monitoring (RBM) in September 2016 with the remit to develop, pilot, execute and scale RBM in collaboration with internal stakeholders and UCB’s CRO partners. He has also recently assumed leadership of the team that maintains and oversees UCB’s clinical data standards.

Prior to joining UCB he spent six years with Quintiles where he worked at the intersection of strategy and process, often in direct collaboration with sponsor organizations. He has been actively involved in the RBM space for the last four years. First, he led customer engagement to design, pilot and implement a risk-based, centralized monitoring solution. Later, he led an internal team at Quintiles to design and implement the key cross-functional processes to enable and deliver RBM to its customers.

He joined Quintiles after receiving his MBA from Duke University. Prior to receiving his MBA he worked as a Six Sigma Black Belt after graduating from Harvard University with a B.A. in economics.

Justin and his wife Jenn have three young daughters.


Lakshmi Sundar
Vice President, Strategy and Development, THE AVOCA GROUP

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Lakshmi Sundar is a global business leader who brings together data, technology and storytelling to creatively address business challenges and move strategy forward. In the two decades she has spent in the pharmaceutical industry, Lakshmi has led teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk and lead change with a sense of purpose and fun. At Avoca, Lakshmi will partner with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a “quality culture” within and across organizations to mitigate risk, advance drug development and bring treatments to patients in a more effective manner.


Steve Young
Chief Operating Officer, CLUEPOINTS

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Steve holds a master’s degree in mathematics from Villanova University. He worked for three bio-pharmaceutical companies over a span of 15 years, where he assumed leadership positions in clinical data management and led the successful enterprise roll-out of EDC at both J&J and Centocor. He spent an additional six years with Medidata and then OmniComm, leading the development of analytics and risk-based monitoring (RBM) solution portfolios and providing RBM and clinical operations consulting to many organizations. He also led a pivotal RBM-related analysis in collaboration with TransCelerate, and has co-authored two patents related to RBM methods.


Beth Zaharoff
Director, Patient Focused Clinical Trial Engagement, TESARO

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Beth began work at TESARO in January 2014 when the company had approximately 75 associates. Four years later, TESARO has grown to more than 700 associates. Before that, Beth worked as the Associate Director, Medical Affairs for Spectrum Pharmaceuticals and as an MSL for MedImmune, MGI Pharma, and Allos. She spent four years as the Manager, Oncology Operations and Clinical Trials at New England Medical Center. Early in her career, Beth worked as the IRB Administrator at Boston City Hospital where she found her passion for clinical research.


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