2017 Site Solutions Summit Faculty

Todd Albin, CCRP
Senior Director of Site Enrollment Optimization
Todd Albin, MBA, CCRP is an experienced clinical research professional who has worked in the late phase site environment for 18 years. He has worked as a study coordinator, site manager/director and regional manager for research sites and site management organizations in Florida, California and Arizona. Todd was also an adjunct faculty instructor for Pima Community College’s Clinical Research Coordinator program where he developed curriculum and taught classes on clinical research site coordination and management, ethics and diversity in clinical research. In 2014, he joined the Global Patient Recruitment and Retention company, Acurian, where he is the Senior Director of Site Enrollment Optimization. Todd is a Certified Clinical Research Professional and received his bachelor’s degree in business from the University of Miami and his Master’s in Business Administration from Florida International University.
Adrelia Allen
Senior Clinical Project Manager
Richard Arlow
Chief Executive Officer
While embarking on a dual MD/PhD training program, Rick witnessed the pain of regulatory processes at clinical trial sites. He subsequently leveraged his background in clinical research, engineering, software development, and entrepreneurship to launch Complion. Rick holds several patents, is recognized in Business Week Top 25 Under 25 Entrepreneurs, and has published in leading journals.
Wayne Baker
Chief Commercial Officer
Wayne has worked at Greenphire since 2016, and is responsible for leading the global commercial strategy, including the execution of sales and marketing programs. He has more than 25 years of global commercial experience in technology and life science industries. Before joining Greenphire, he served as the Chief Sales Officer and Senior Vice President of Advanced Health Media, LLC and served as its Senior Vice President of Business Development and Vice President. Wayne holds a B.S. in Chemical Engineering from Drexel University.
Lisa Bjornestad
Director, Site Alliances the Americas
Lisa has been involved with Clinical Research for over a decade. She is well-grounded in both Operations and Management and can provide a unique perspective to clients in the pharma, biotech, and CRO industry as they proceed with development plans.
Jennifer Bush
Director, Life Sciences Product Strategy
Jennifer is a life sciences professional with over 19 years of industry experience in both business and IT environments. She has worked in large pharma, large CRO and IT, working in both business and IT departments managing data transformation and loading, EDC implementation and managing development of clinical trial management systems. Jennifer now works as a Life Sciences Product Strategist at Oracle focusing on clinical trial planning, management and monitoring offerings and risk based monitoring.
Don Butler
Senior Vice President R&D, Clinical Research Solutions
Outcome Health
Andy Chung
Senior Manager Information Systems
Jae Chung
President and Founding Visionary
Jae is committed to bringing innovation to the way life science companies start clinical trials by improving operational efficiencies, compliance, and collaboration - ultimately speeding the delivery of life-saving therapies. Jae previously worked with Rock Health to mentor healthcare technology startups and co-founded Celltrion, a leading biopharmaceutical manufacturing company.
Ivor Clarke
Chief Executive Officer
Ivor has over 12 years of C-suite experience in online marketing and specializes in the creation and operation of enterprise-class SaaS solutions. As the first risk-free clinical trials marketplace for patient recruitment, SubjectWell engages the 96% of Americans who have never participated in a clinical trial and only charges for patients who randomize. Before SubjectWell, Ivor served as President of Brightfire, an internet marketing and call center operation that helps more than one million people a month find better jobs by providing job matching and career support. Ivor has also held positions at Datran Media, where he delivered a 150% increase in revenue while improving customer satisfaction, and Microsoft, where he oversaw the user interface for Mac Office.
Cathy Collins
President and Chief Executive Officer
Clinical Consulting Solutions
Cathy is currently providing full service clinical trials consulting firm. She has worked in the clinical research industry since 1991. She is the past CEO of Meridien Research (co- founded in 2000) and of Insearch (co-founded in 2008) and sold both companies to private equity in December 2012. Cathy’s operational experience in the clinical trials industry puts her in a unique minority of individuals in the industry. Cathy has both a bachelor’s and master’s degree in nursing and is a February 2015 graduate of the Harvard Business School Owners Presidents Managers (OPM) program.
Ashley Davidson
Director, Vault Study Startup
Veeva Systems Inc.
Ashley is an industry veteran with 16 years of experience encompassing global study start-up, business process optimization, and eClinical technology solutions. At Veeva, Davidson leads a cross-functional strategy team that includes market owners, product management, marketing, services, and sales engineering with a primary focus on helping large-scale global organizations and mid-sized companies meet their business needs in the study start-up space.
Dairine Dempsey
Vice President, Strategic Regulatory Affairs
ICON plc
Theresa Devins
Senior Associate Director
Boehringer Ingelheim
Theresa has 15+ years clinical research experience including publications in prestigious peer-reviewed journal. She has extensive expertise in international and national clinical study leadership and international/national regulatory requirements, including experience in international matrix management, cultural sensitivity, and direct line management. As the key author of two white papers on increasing minority patients in clinical trials and retention strategies in long term outcome trials, Theresa is a specialist in diversity in clinical trials including change mechanisms to ensure sustainability.
Glen de Vries
Medidata Solutions
Glen is the president and co-founder of Medidata Solutions, the leading cloud platform for life sciences research. Glen has been driving Medidata's mission since the company’s inception in 1999: Powering smarter treatments and healthier people. His publications have appeared in Applied Clinical Trials, Cancer, The Journal of Urology, Molecular Diagnostics, STAT, Urologic Clinics of North America and TechCrunch. He is a member of the Carnegie Mellon University President’s Global Advisory Council, a Columbia HITLAB Fellow, and serves on the board of the Young Scientist Foundation.
Robin Douglas
Site Solutions Director, Site and Patient Networks
Molly Downhour
Director of Strategic Solutions- Clinical Research
Molly has over 20 years of healthcare experience with specialization in oncology, research, and health care administration. She earned her bachelor's of nursing and master of health administration as well as achieved and maintained her nurse executive advanced, oncology nurse, and clinical research coordination certifications. As a former director of a leading phase I clinical trial site, she has proven ability to streamline processes resulting in improved clinical operational efficiencies, financial gain, and employee and patient satisfaction.
Lisa Dyment
Director, Strategic Site Collaborations
Lisa is a clinical research professional with over 19 years of experience in clinical management, project management, and proposal development in the CRO environment. She possesses a broad skill set including technical and creative writing, vendor relations, adapting to rapidly evolving business needs, innovative problem solving, strong communication, and negotiating skills.
Melissa Easy
Founder and President
As founder of DrugDev and current President of SiteStart, Melissa (Liss) Easy is responsible for leading DrugDev’s site activation activities. Originally from Sydney, Australia, Liss worked for small and large contract research organizations (CROs), where she identified inefficiencies in the process for matching investigators to new drug protocols by CROs and pharmaceutical companies, and developed the concept of DrugDev. The company grew quickly through referrals and acquisitions to become a leading provider of technologies to conduct clinical trials from startup through closeout. Liss has been honored as PharmaVOICE 100 most inspiring people in life sciences, PBJ's “40 Under 40” honoree and Partnerships in Clinical Trials Woman of the Year.
Max Elbaz
Vice President, Sales and Marketing
Max joined Bio-Optronics in March of 2016, bringing more than 20 years of senior management experience in the geospatial, high tech, software/service and environmental sectors. He is a multilingual executive with strong multinational experience in emerging and developed countries. His areas of expertise include international business development, operations, sales and marketing, strategic planning, and the development of strategic partnership alliances with Fortune 500 companies and government agencies. Previously, Max was the President of Teledyne Optech, Inc., and held executive positions at Geospatial Systems and Earthdata International.
Debbie Elliott
Executive Director, Clinical Operations
Marie Emms
Head, Global Clinical Trial Engagement
InVentiv Health
Kathleen Fusco
Senior Director of Marketing
Tracey Gashi
Executive Director, Site and Patient Access
INC Research
Martin Gibson, MD, PhD, MB ChB, FRCP
Chief Executive Officer
Northwest EHealth
Martin Gibson serves as Clinical Director at the NIHR Clinical Research Network for Greater Manchester, Associate Director for Industry (Clinical Research Networks), Chief Executive Officer at Northwest EHealth, and as a Consultant Physician (Diabetes and Endocrinology) for the Salford Royal NHS Foundation Trust.

His areas of interest include:
• The processes by which insulin resistance and glucose intolerance predispose individuals to vascular disease focusing on the role of the insulin-like growth factor (IGF) system.
• The development novel interventions across primary and secondary care to measure and optimise vascular risk reduction utilizing district-wide electronic patient information systems to target and monitor intervention programmes. This includes the ongoing development of a proactive contact-centre based diabetes management and prevention systems.
•Use of electronic clinical information systems to support improved healthcare and clinical research including the development of large scale 'real world' studies.

Dr. Gibson's specialties include Diabetes, Lipid Disorders, Clinical Trials, Clinical Data Systems, and Patient Self-Management.
Clare Grace
Vice President, Site and Patient Access
INC Research
Clare brings nearly two decades of strategic global leadership expertise to her role, including a unique blend of academic, pharmaceutical, biotech and CRO industry experience. She joined INC Research from PPD where she held several senior leadership roles, including most recently Senior Direct and Head of Global Site Intelligence. Clare holds a PhD in Molecular Oncology from the University of Manchester Institute of Science and Technology and a bachelor’s degree in applied biochemistry from Liverpool John Moores University.
Pablo Graiver
Founder and Chief Executive Officer
Under Pablo’s leadership, Antidote (formerly known as TrialReach) has raised almost $20m in venture capital and grown to become a leading player within the digital health sector, empowering thousands of patients worldwide to discover and access potential new treatment options. Pablo is a seasoned entrepreneur and manager of internet companies. He has been building high-scale businesses in online retail, travel, mobile, media, and now health sectors since the late 90s, including firms such as NetJuice, DondeComprar.com, Kelkoo.com (acquired by Yahoo!), Kayak.com (acquired by Priceline), and ValueClick (acquired by Conversant). Pablo has spoken about technology, healthcare, and innovation at Harvard Medical School, DIA, Disruptive Innovations, Health 2.0, Digital Health Forum, and many others. He was recently included in the “100 Club” by SVC2UK and the “Ones to Watch” list by The Sunday Times’ Tech Track 100. He’s also been featured in the Financial Times, Forbes, TechCrunch, Re/code, and more.
Scott Gray
Chief Executive Officer
Scott is the co-founder and CEO of Gray Consulting International (GCI), an events management and travel company focused on serving the pharmaceutical industry, which since 2007 has been named 6 times to the “Top 25 Full-Service Event Management Companies in North America.” In 2013, he co-founded Clincierge®, which builds on GCI’s organizational and logistical expertise and precise communications proficiency to offer a much-needed innovation that improves patient-centricity in both clinical trials and general medical treatments. In its first year of operations, Clincierge achieved over 700% growth and was the recipient of a 2016 Clinical Informatics News “Best Practices” Award for clinical trials innovation. In building his businesses, Scott has a long track record of providing a mentoring environment whereby those working for him have learned and honed skills that enabled them to create career paths of their own, becoming leaders at other companies and, in some cases, entrepreneurs themselves.
Rick Greenfield
Chief Executive Officer
RealTime Software Solutions
With over 12 years of experience owning and operating a large multi-specialty clinical research site and with an education in Business Information Systems, Rick Greenfield has led the formation of and is Chief Executive Officer of RealTime Software Solutions, LLC. RealTime Software Solutions is an industry innovator of Clinical Trial Management Software (CTMS) for clinical research sites. With an emphasis on work-flow management, RealTime-CTMS provides a powerful, yet intuitive interface for research sites to manage everything from subject recruitment, visit tracking, study financials, integrated stipend payment solutions, text messaging and more. RealTime is currently working on many new innovations to bring to research sites within the very near future.
Traci Griffin
Vice President, Monitoring and Site Management
Gerrit Hamre
Clinical Project Manager
Clinical Trials Transformation Initiative (CTTI), Duke Clinical Research Institute
Gerrit has over ten years of regulatory, legislative, and business management experience in the pharmaceutical and healthcare industry. His professional endeavors have occurred in corporate, Federal Government and Non-Government Organization (NGO) sectors, both domestically and internationally. CTTI engages patients, industry, academia, and regulatory agencies as equal partners to analyze existing research impediments and recommend consensus-driven, actionable solutions that will lead to a more sustainable and effective clinical trial system.
David Hansen
Regional Head for North & South America, Global Study Operations
Chris Heironimus
Director of Business Development
Chris has served as the Director of Business Development at Insearch since its inception in 2008. She has been instrumental in developing the vision of Insearch which fulfills both the long-term pipeline needs of its client sites as well as the quality requirements of participating Pharma and CROs. Chris’s varied background has contributed to Insearch’s success. Prior to Insearch, her position as Clinical Site Director of a busy multi-therapeutic research facility gives her a unique understanding of the study acquisition process from both the site and the Sponsor/CRO perspective. Chris has over 30 years of management experience in the customer relations, sales, and finance industries.
Carmela Houston-Henry
Director, Corporate Development and Operations Support
Biomedical Research Alliance of New York (BRANY)
Carmela is an innovative professional with expertise in project management and business development. She is a Certified Clinical Research Associate (CCRA) with proven effectiveness in management and leadership roles.
Jeannie Inge
Chair, Data Governance Committee
PRA Health Sciences
Jeannie is a passionate and pragmatic leader who focuses on strategic innovation and project management. With these skills, she achieves optimized operational management and service delivery through the use of technology, quality management systems, process improvement, change management, and financial stewardship. She is experienced in data collection, analysis, and governance.
Anne Marie Inglis
Head, United States Clinical Operations
Anne Marie began her career over 20 years ago at GSK as a Clinical Research Scientist, designing protocols and preparing Clinical Trial Reports for Phase I and Phase II Proof of Concept Studies. She moved into GSK Vaccines in 2006, where she became more involved in in-country clinical operations, managing teams of local study managers, local clinical trial supplies specialists, site selection specialists, and clinical monitors. She moved into her current position in 2015, and is accountable for execution of all GSK US studies. As part of her current role she is interested in developing strong working relationships with clinical trial sites to improve delivery of recruitment to plan. She is an active member of the GSK Clinical Trial Diversity initiative and believes that enabling clinical trial sites to better recruit and retain underrepresented populations is critically important in delivering medicines of value to the people who need them.
Sheila Bello Irizarry, PhD, RAC
Integrated Product Development Associate
Sheila is a research scientist with more than 10 years of experience in the biomedical sciences. She has participated in clinical protocol reviews in federal-funded vaccine and drug clinical trials, and she has written, reviewed, and edited scientific manuscripts, technical reports, study protocols, SOPs, fellowship proposals, performing research literature search and data analyses, preparing abstracts and presentations for scientific conferences. Sheila excels in improving and optimizing experiment design, analytical endpoints and protocols.
Len Jokubaitis
Clinical Operations Head, Americas CTC, Global Clinical Operations
Jeff Kasher
Patients Can't Wait
Jeff has a passion for improving outcomes, bringing patients and research sites into the development process, and dramatically decreasing time to market. His experience includes novel product development from bench through market launch, research and clinical trial leadership, innovation center start up, and new industry paradigm creation.
Lauren M. Kelley
Associate Director, GCP Compliance
Polaris Compliance Consultants, Inc.
Lauren has worked for over 35 years in the pharmaceutical industry and specializes in Good Clinical Practice auditing. She has worked with sponsors, CROs, IRBs and clinical sites to assure compliance with the GCP regulations and has trained many regulatory and clinical research professionals in GCP compliance. She has worked with both large and small companies including Burroughs Wellcome, Boehringer Mannheim, and Ostuka Pharmaceuticals. Ms. Kelley has a B.A. degree from the University of North Carolina at Chapel Hill, a legal assistant certification in civil litigation from Meredith College in Raleigh, NC and she is a Certified Clinical Research Professional.
Jacalyn Kent
Sr Director, Product Delivery Supply Planning and Systems
Jackie joined Eli Lilly and Company in 1990, within the IT organization. Jackie has held a variety of positions within IT both technical and leadership before moving into Lilly Research Labs, supporting global clinical development in 2001. Presently, Jackie is responsible for the organization that is responsible for all of the clinical trial supply planning and IT systems. This group provides all of the clinical trial materials to the sites across the globe across the Lilly portfolio. Jackie is also the sponsor of the Shared Investigator Platform Program at TransCelerate.
Barry Lake
Chief Executive Officer
Devana Solutions®, LLC
Devana Solutions® is a SaaS provider driven by the core belief that selection of the top-performing research sites to align with drug sponsors and CROs are the key to reducing drug costs and curing disease. As CEO of Devana Solutions®, Mr. Lake is responsible for the overall strategic vision and execution of the leading cloud-based clinical research technology company delivering centralized real-time business intelligence to clinical research sites, sponsors and CRO’s (www.devanasolutions.com). Sites on the Devana Solutions® IGNITE FOR SITES platform can set their site apart from competition through the delivery of real-time, timing and performance metrics reports, extremely high-value data for sponsors and CRO’s. Devana Solutions® MATCH PERFORMANCE companion technology is extremely coveted by major sponsors and CROs in an age where identifying the top research sites is the key to reducing cycle time and clinical trial costs and, ultimately, lowering the cost of prescription drugs.
Diane Lazzeri
Director Monitoring Excellence- Americas
Andrew Lee
SVP, Head of Global Clinical Trial Operations
Andrew (Andy) leads all operations related to the conduct of Merck clinical trials, focusing on global, in-patient clinical trials. He is also responsible for the design and data management of clinical protocols in all regions and countries. Andy joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO) and Head of the CSO Clinical Operations Cluster. Earlier in his career, he spent more than 16 years at Pfizer. Andy holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc., a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies.
Kayla Leverton
Director of Sales & Marketing for Community Sites
Forte Research Systems
Kayla drives the strategy for promoting Forte’s ecosystem of products to the community site market. She works directly with research sites to understand their operational challenges and to offer education and software solutions to resolve those challenges.
Craig Lipset
Head of Clinical Innovation
Craig brings over 15 years of leadership and innovation in the field of drug development. His Global Product Development at Pfizer is impacting clinical research through digital tools, innovative research approaches, and game-changing collaborations. Craig previously served as Venture Partner in Pfizer Venture Investments (Pfizer’s VC arm), where he focused on diversifying the company’s $50M annual budget for private investments in the areas of diagnostics and health technology. He was also Senior Director in Molecular Medicine, where he spearheaded initiatives driving innovation in clinical research and personalized medicine by drawing upon tools from health information technology, telemedicine, and eHealth. Craig has been listed among the PharmaVOICE most inspiring people in the life sciences, Pharmaceutical Executive’s Emerging Leaders, and AlleyWatch Who's Who in eHealth.
Lindsay McCarthy
Vice President
Lindsay has over nine years of clinical research experience including the management of strategic partnerships with industry sponsors and CROs. She is skilled in driving down expenses and increasing profit. She has a strong background in operations, leadership, and strategic direction, and has been successful in diversifying services and products.
Ken McFarlane
Managing Principal Engagement Consultant
Medidata Solutions
Ken has over 16 years of experience in clinical research. He spent most of his clinical career as a clinical operations monitor, project manager, and director across PPD, MDS Pharma, RPS and working directly with large and mid-sized pharma customers. In strategic consulting, Ken specializes in study planning and study oversight solutions, helping customers in organizational design, enhancing business processes, and implementing efficiency models.
Edwin McLindon
Vice President, SMO Affairs
Lynn Meyer
President and Managing Partner
IntegReview IRB
Lynn provides guidance and support to IntegReview IRB as well as business development and client relations. Under her leadership, the IRB has grown to include six boards that now serve clients in the United States, Canada, and Latin America as well as a wide breadth of high-profile industry research sites and sponsors. In 2007, IntegReview achieved full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which continues to be sustained. As a woman-owned business, IntegReview is certified by the Women’s Business Enterprise (WBE) and is an accredited business by the Better Business Bureau. Her industry career began in 1986 at one of the country's premier CROs, where she advanced from various administrative positions to an 11-year term as manager of its affiliated Institutional Review Board. Lynn has been active in the Consortium of Independent Review Boards (CIRB) since its 1993 inception and currently serves as the Treasurer. In 2007, Lynn satisfactory completed all the stated requirements to earn her Certification of Clinical Research Professionals (CCRP).
Matt Miller
Vice President of Global Patient Recruitment & Feasibility
Ramon Mohanlal
Chief Medical Officer
BeyondSpring Pharmaceuticals
Ramon has more than 20 years of global experience in strategic drug development at big pharma and biotech start-ups, including GlaxoWellcome (GSK), Pharmacia (Pfizer), Vertex, Interleukin Genetics, Syntium, Novartis, and AstraZeneca. His expertise includes drug development in all Phases (preclinical and 1, 2, 3, 4 clinical, post-marketing), regulatory filings, and maintaining drugs on the market. He played a crucial role in bringing five drugs to market and was deeply involved in the development of 15 marketed drugs, including Wellferon, Atovaquone, Lamuvidine, Zomig, Advexin, Abilify IM Depot, Zometa, Femara, Aredia, Proleukin, Cardioxane and Exjade. Most recently, he was the Clinical Head of Established Oncology Products for Novartis, where he managed all clinical and regulatory maintenance work for the division, which represented total annual revenue of approximately $2 billion. He also developed immuno-oncology development programs based on checkpoint inhibitor combination therapy at AstraZeneca.
Paulo Moreira
Vice President, Global Clinical Operations - External Innovation
EMD Serono, Inc.
Paulo is a Clinical Development executive with 25+ years of experience in Clinical R&D. He has been with EMD Serono for the last 17 years in diverse positions within Clinical Development, and 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 leads TransCelerate’s Clinical Research Awareness & Access workstream and represents EMD Serono on TransCelerate’s Operations Committee 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 twice to PharmaVoice’s 100 Most Inspirational Leaders of 2015 and 2017 recognizing his industry leadership around patient centricity.
Lance Nickens
President and Founder
The Patient Recruiting Agency
The Patient Recruiting Agency™ (TPRA) is a full-service global patient recruiting and retention organization supporting Investigators, CROs, and Sponsors since 1999. Lance has over 20 years of advertising and marketing experience with over 15 years of experience specifically in patient outreach campaigns for clinical trials. Since 1999, he and TPRA have completed over 3,500 recruiting and retention campaigns seeking patient populations for more than 150 different healthy, disease specific, rare and hard-to-reach indications seeking males and female patients of all ages and races in multiple languages and countries. Lance’s commitment and hands-on approach to developing unique and efficient solutions to patient recruitment and retention challenges has strategically aligned TPRA as an integral benchmark provider of global recruitment and retention services.
Virginia Nido
Global Head, Industry Collaborations
Virginia is an experienced leader with strong competencies in drug development team systems and business processes. She leads successful multi-functional projects across groups and therapeutic areas with a wide breadth of experience in Phase II-IV clinical trials in multiple indications. She is seasoned in cross-cultural projects and multinational firms.
Andrew Onikepe
Al Pacino
President and Co-Founder
BlueCloud® by Health Care Point
Al is a United States Army veteran and cancer survivor with over 32 years of experience in healthcare and clinical research. BlueCloud® is a leading global network of over 1 Million healthcare professionals and industry stakeholders focused on connecting and sharing “real-time” information to ensure quality, compliance and standards processes. Al is also the Vice President of Collaborative Network Development for the Alliance for Clinical Research Excellence and Safety (ACRES), and he is actively involved with NIH based standardization programs and other global healthcare and clinical research initiatives.
Nina Pruitt
Sr. Director, Global Product Marketing
Medidata Solutions
Suzanne Pryor-Tillotson
Vice President, Clinical Development Execution
Vertex Pharmaceuticals
Suzanne is a pharmaceutical professional with over three decades of diverse and extensive experience in Clinical Research and Clinical Operations. She received her B.A. in Microbiology from Rutgers University, her M.S. in Microbiology from Seton Hall University and she is certified in Lean Six Sigma and Change Management. Suzanne joined Vertex Pharmaceuticals in 2015 as Vice President and Head of Clinical Development Execution within Global Medicines and Development Affairs. Her group is responsible for multiple aspects of clinical development including program and study planning and execution, data management, vendor strategy and management, trial optimization and study and site metrics for all Phase I through IV studies at Vertex. Prior to joining Vertex, Suzanne spent almost 30 years at Merck & Co. Inc. in a variety of roles in Clinical Research and Operations. Her latest role was head of the Clinical Development Execution Organization with key responsibilities including global study execution, regulatory document authoring, recruitment and retention strategies and medical monitoring. She is passionate about developing high performing teams and lean processes. Her current focus is on bringing the voice of patients and research sites into the design of clinical trials.
Kimberly Ray
Vice President, Site and Patient Networks
Kimberly has had a 30-year career in the healthcare industry, primarily within Quintiles, spanning a variety of roles across the drug development continuum. Over the past six years, Kimberly 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. She currently serves in a leadership role in Quintiles’ Site and Patient Networks division, 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.
James Riddle
Vice President of Client Services
At Kinetiq, a consulting and technology division of Quorum Review IRB, James employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Kinetiq worldwide. James is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R). Prior to joining Kinetiq, Mr. Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers. His expertise includes re-engineering operational processes, systems evaluations, development and implementation of technology solutions, integration of technology solutions with operations, and management of large IRB and IACUC systems.
Matthew Roe
Faculty Director, Global Outcomes Commercial Megatrials
Duke Clinical Research Institute
Dr. Roe received his medical degree and his Masters of Health Sciences in Clinical Research from Duke University School of Medicine. He completed an internal medicine residency at Duke University Medical Center and a cardiovascular fellowship at the Cleveland Clinic Foundation. He is a professor of medicine, with tenure, in the division of cardiovascular medicine. Matthew is the faculty director of the DCRI Global Outcomes Commercial Megatrials group and has participated in the leadership and conduct of numerous clinical trials focused on therapies for acute coronary syndromes and chronic cardiovascular disease, including dal-OUTCOMES-2, TRILOGY-ACS, and ODYSSEY Outcomes. He has a keen interest in the operational conduct of clinical trials, and in the national and global academic collaborations that are critical to the successful execution of clinical trials. He serves as the director of the DCRI’s Research Fellowship Training Program and has contributed to the expansion of the DCRI fellowship program to more than 30 fellows per year. Roe has served as the principal investigator for numerous clinical trials investigating anti-platelet therapies for acute myocardial infarction (MI), as well as myocardial protection agents for patients with acute ST-elevation MI.
Debra Rogge
Clinical Research Manager
Astra Zeneca Pharmaceuticals
Debra is a registered nurse and holds a Master’s Degree in the Management of Health Care Services. Debra‘s clinical research experience has spanned numerous roles in the past 18 years, both in the start-up and maintenance phases of sponsored and investigator-sponsored studies. Debra’s current role at AstraZeneca is managing Support Services to include contract negotiation, budgets, trial master and CTMS systems and quality indicators for the US Site Management and Monitoring organization.
Maryanne Santilli
Associate Director, Clinical Trial Management Finance & Operations
Novo Nordisk
Maryanne is an Innovative and results oriented accountant with strong analytical and financial modeling skills linked with the ability to quickly identify problems and provide cost effective solutions. She has 12 years of clinical research finance operations experience, supporting successful clinical trials by providing leadership in financial analysis, management, accountability, and control.
Doug Schantz
Executive Director, Clinical Operations
Doug is head of US Site Management and Monitoring organization and business sponsor of SCOUT CRO outsourcing program in AstraZeneca's Global Medicines Development Group.
Meri Kay Scott
Senior Director, Clinical Project Management
Earl Seltzer
Director, Global Feasibility
INC Research
Earl has approximately 12 years of industry experience working at both CROs and clinical investigator sites. He started as a study coordinator and eventually moved into site operations management and site business development before moving to a large global CRO. He has worked in global feasibility across many different indications with a special focus on general medicine studies and pediatrics. He understands the site burden of clinical trial participation and explores ways to facilitate better working relationships between sites, sponsors, and CROs.
Susan Taylor
Director of Investigator Engagement Strategy
Johnson & Johnson
Jean-Marc Tellier
Investigator Network Manager, North America
Jean-Marc is responsible for the ongoing development, oversight and management of Sanofi’s global Investigator Network established to accelerate clinical trial recruitment rates, provide a real-life perspective into the development of clinical trial protocols, improve investigator performance metrics, facilitate process improvements through practical input into Sanofi operations and helping in developing cutting edge clinical trial innovation. He has more than 20 years of experience in the management of clinical trials, phase I to IV, in various therapeutic areas and in the different environments of the industry: biotech, pharmaceutical and CRO. Moreover, he expanded his experience to drug development by being part of multidisciplinary teams (CMC, pharmacology, toxicology, regulatory affairs, clinical). Jean-Marc holds a master in biochemistry and has a diploma in Business Administration.
Chris Trizna
CSSi is the only company in the global patient recruitment sector whose focus is on increasing site performance and optimizing patient enrollment. Chris founded CSSi in 2005 with a mission to address the pharmaceutical industry’s need for site-specific patient recruitment and enrollment solutions. In 2010, the company went global and the name was changed to CSSi. Since then, CSSi has supported studies in over 50 countries with a focus on providing country-specific enrollment expertise. Chris is considered an industry thought leader. He has presented at numerous conferences and meetings and been published surrounding the topic of patient enrollment.