2017 Site Solutions Summit Faculty

Todd Albin, CCRP
Senior Director of Site Enrollment Optimization
Acurian
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, PharmD, PMP
Senior Clinical Project Manager
Merck
Adrelia has worked in clinical research at Merck for 18 years in varying roles as a Clinical Research Associate, Country Clinical Project Manager, and Clinical Research Manager. She is responsible for managing the clinical trial operations for therapeutically assigned trials in the U.S. Therapeutic areas of clinical research experience include Insomnia, Neurology, Respiratory & Allergy, Rheumatology, Osteoporosis, and Vaccine. Adrelia is a certified Project Management Professional and received a Doctor of Pharmacy Degree from the Florida A&M University College of Pharmacy.
 
Richard Arlow
Chief Executive Officer
Complion
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.
 
Claire Asogwa, MSc
Site Account Manager
Merck
 
Wayne Baker
Chief Commercial Officer
Greenphire
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.
 
Sheila Bello-Irizarry, PhD, RAC
Integrated Product Development Associate
Rho
Sheila works primarily in regulatory submissions and consulting, medical writing and feasibility efforts for clinical studies. She has more than 12 years of experience in the biomedical sciences, particularly in clinical and basic research. Before her tenure at Rho, Sheila was part of the Global Community Advisory Board (GCAB) for the NIH-funded HIV Vaccine Trials Network (HVTN), AIDS Clinical Trials Group (ACTG), and the Pediatric HIV Program. At the local Community Advisory Board (CAB) in Rochester, NY, she was also part of the Rochester Victory Alliance Outreach Committee with aims of educating and encouraging minorities to participate in clinical trials. Dr. Bello‑Irizarry received her Ph.D. in Microbiology and Immunology at the University of Rochester, School of Medicine and Dentistry.
 
Deena Bernstein, MHS
Vice President, Site Services
Qcare
Deena is directly responsible for the site operations of the Qcare affiliated sites. Qcare, a QuintilesIMS company, is a site services provider that partners with sites to deliver operational efficiencies in the clinical trial process and provides full-service site support. Qcare sites are multi-therapeutic and conduct pharmaceutical sponsored studies Phase II-IV. Her prior role was the Director of Clinical Research at Sheridan Clinical Research, Inc. Deena has served on the Leadership Council of SCRS since its inception. Through her activity with SCRS she is on the Site Advisory Group (SAG) for TransCelerate’s Investigator Global Platform. Deena received a Certificate in Clinical Research Administration and a Master in Health Sciences in Clinical Research Administration from George Washington University.
 
Tim Bidgood
Head of US/Canada Research and Development Solutions Operations
QuintilesIMS
Tim is the leader of a multi-function team of more than 2200 talented clinical research professionals. He is focused on the US/Canada contributions and commitments across the entire QuintilesIMS clinical trial portfolio including site participation, patient recruitment, and the quality and timely delivery of data to our customers. Team functions include site identification, start up, clinical monitoring, therapeutically aligned patient enrollment support, and site partnerships.
 
Lisa Bjornestad, CCRC
Director, Site Alliances the Americas
PAREXEL
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.
 
Michael Bonavilla
Senior Sales Executive
Bio-Optronics
 
Brandi Bonner, MS
Manager, Clinical Operations
Covance
Brandi Bonner received her master's degree in Clinical Research Organization and Management from Drexel University in 2015. Brandi began her career in clinical research in 2004 working in a phase1 research center. Brandi spent the first half of her clinical research career managing study participant recruitment. In 2011 Brandi joined the start-up team at Covance. Brandi is currently a clinical operation manager in Covance’s start up department where she focuses mainly on the role of Start-Up Country Manager. In this role, Brandi is responsible for ensuring site activation timelines are met. Brandi oversees the start-up process for various Sponsors and sites located in North America, including US, Canada and Puerto Rico. Brandi was the 2015 recipient of the Covance Way Award for leading advancement in people, process, and Clients
 
Lisa Bozza-Archer
Senior Account Manager
Complion
As a former Clinical Research Associate with one of the largest CROs, Lisa obtained a strong foundation in clinical research and a diversified therapeutic experience ranging from Neurology, Rheumatology, Endocrinology and Oncology. She also gained additional exposure to site operations while working in the Compliance Office of an Academic Medical Center, where she helped support investigators with a variety of regulatory and research tasks. These experiences provide her keen insight, both to the needs and the daily experiences of Complion’s clients. As an Account Manager of Complion’s Customer Success Team, Lisa regularly engages with clients to promote successful adoption and utilization of the Complion System. She actively educates and promotes awareness of Complion’s solution to clients and the research industry.
 
Bonnie Brescia
Founding Principal
BBK Worldwide
Bonnie has been a leader in patient recruitment and engagement for more than 30 years. Widely recognized for helping to shape the recruitment discipline and a preeminent voice for patient centricity, her insights regarding the global clinical research community inform the industry and help fuel BBK's leadership, innovation and global expansion. She leads the company's involvement in its efforts dedicated to global excellence in clinical research, and was recently honored by the Boston Globe Magazine with a Top 100 Women-led Business award.
 
Christian Burns
President & CEO
ClinEdge
Christian, a dedicated entrepreneur and research advocate, is the President & co-founder of ClinEdge & BTC. He is passionate about serving patients and sites by identifying innovative solutions that will transform the traditional clinical trial model. ClinEdge & BTC work directly with research institutions, sponsors, and CROs in over 130 countries to support their operations, sales, marketing, and technology needs.
 
Jennifer Bush, MS
Director, Life Sciences Product Strategy
Oracle
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.
 
Rodney Butt, MSc, MBA
Vice President, Programs
Nutrasource Diagnostics
Rod has 25 years of experience in clinical operations, quality assurance and project management in both pharmaceutical and contract research organizations. His experience includes developing product infrastructure for clinical trials. In addition to providing logistical support for international trials, Rod has managed up to 15 operating clinical trials site simultaneously. In his current role, he is spearheading the design and implementation of process and infrastructure for the global development and approval of natural health products as prescription pharmaceuticals.
 
Teresa Byrne, MS
Senior Director, Clinical Operations
InClinica
 
Nina Cannon, JD, CPCM, CFCM
Manager, Clinical Trials Solutions Architecture
Axiom Global Solutions
Nina works at Axiom Global and is an attorney specializing in clinical research contracts, providing valuable advice to clients to mitigate business risks and compliance concerns. She has managed the contracts function at the Duke Clinical Research Institute and UNC-CH. She is a National Contract Management Association (NCMA) Certified Professional Contract Manager and NCMA Certified Federal Contracts Manager. Nina is a member of the New York State bar, holds a B.S. in Business Administration from American University, and a J.D. from Western New England University.
 
Mike Capone, MBA
Chief Operating Officer
Medidata
Mike brings a unique blend of client-facing operational experience and strong technical knowledge to his role at Medidata. Mike oversees delivery of all of the company’s products and services, including product management, software development, data science, professional services, as well as sales and marketing. Prior to joining Medidata, Mike spent 25 years at ADP, where he was most recently the CIO and CVP of product development. One of the world’s largest B2B software providers, ADP earned a number of accolades for its technology leadership and innovations during Mike’s tenure.
 
Hugo Cervantes
VP, Vault EDC
Veeva Systems
As vice president, Veeva Vault EDC, Hugo Cervantes is responsible for Vault EDC strategy, market adoption, and customer engagement. Hugo has spent the last 15 years in management consulting and professional services. At Deloitte and Accenture, Hugo worked with seven of the top 10 pharma to help increase their returns on R&D investment and deliver innovative new operating models and technologies, often including eClinical and EDC.
 
Janet Christoff, BA, RN, CCRA
Regional Clinical Research Associate Manager
Seattle Genetics
Janet has been in the clinical research industry for over 20 years. She is currently a CRA Manager with Seattle Genetics, a global oncology biotechnology company, which focuses on antibody-based therapies for patients with cancer. Janet works closely with clinical sites to build relationships between site staff and sponsor. She would like to see protocols becoming more patient-centric, and most recently has participated in an assessment of available technologies to improve the informed consent process.
 
Jae Chung, MBA
President and Founding Visionary
goBalto
Jae Chung is the founding visionary of goBalto. A startup evangelist, Jae works with Rock Health to mentor healthcare technology startups. Jae previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical manufacturing company and was a strategy consultant with McKinsey & Company. In 2013 he was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. Jae has an MBA from New York University and holds a CPA.
 
Luther Clark
Global Director, Scientific Medical and Patient Perspective, Office of the Chief Patient Officer
Merck
 
Ivor Clarke
Chief Executive Officer
SubjectWell
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.
 
Steve Clemons
Founder / Vice President - Clinical Operations
VitaLink Research
 
Nicole Berkebile Cohen, MA
Senior Director, Head of Site Partnerships
Covance
Nicole has extensive experience working cross-departmentally and leading global teams, including 11 years within clinical roles at QuintilesIMS, and another 4+ within various research site settings (private practice, university, and research-only centers). Her responsibilities have included overseeing a global team, partner site relationship management, study document management, clinical monitoring, patient recruitment and retention, study drug management, and safety surveillance & reporting. She has been involved in all aspects of a study from start-up to close-out and has managed a global team including colleagues in North America, Europe, and Asia.
 
Cathy Collins, MSN
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.
 
Philip Coran, JD, CIPP/US, CISA
Principal, Global Compliance & Strategy
Medidata Solutions
Philip has over 12 years of experience in the pharmaceutical industry including successful tenures at an innovative Software as a Service (SaaS) Provider and Big 4 audit firms. He recently earned a JD and was admitted to the bar, which builds on MBA, CISA (Certified Information Systems Auditor) and CIPP (Certified Information Privacy Professional) credentials. His international experience includes compliance investigations/audits, internal and external training, and consulting.
 
Nicole Cureton, MA, CCRC
Lead Site Coordinator
Quality Clinical Research
 
Ben Daniel
Director of Regional Sales
goBalto
Ben has over 15 years of industry experience in accelerating and improving clinical trial start-up through the utilization of innovative technology and process solutions. At goBalto, Ben leads the go-to-market efforts in helping sponsors, CROs and investigative site networks decrease overall cycle times associated with site identification, selection and activation.
 
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.
 
Theresa Devins, DrPh, MS, BA
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.
 
Megan DiGregorio-Fecteau
Director, Central Monitoring North America/Adaptive Monitoring Leadership
PRA Health Sciences
Megan has over 15 years of experience working in the CRO industry. She has extensive background in clinical operations and in the last 3 years has been focusing on Risk Based Monitoring. Megan joined the CRO industry in 2002 as a clinical research associate. Since then, she has served as associate director of clinical team management, principal clinical team manager, clinical project manager, and senior clinical research associate. In her current role at PRA, Megan is responsible for the centralized monitoring for North America and is part of the global RBM leadership team.
 
Robin Douglas, MA, CCRC
Site Solutions Director, Site and Patient Networks
QuintilesIMS
Robin has 23 years of clinical research experience, including 16 years as a site manager. Currently Robin's core responsibility is to ensure an enhanced site experience when working with QuintilesIMS which includes enhanced site strategies in CNS. Previously, she served as Site Solutions Director, focused on enhancing communication and engagement with investigator sites outside or a project. Prior to that, she served, as Director of Site Management and was responsible for the performance of the Prime and Partner Program for multiple regions of North America.
 
Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC
Director of Strategic Solutions- Clinical Research
Medix
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
PPD
Lisa is a clinical research professional with over 21 years of experience in clinical management, project management, proposal development, feasibility, and site network management 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
DrugDev
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.
 
Sylvia Eberhardt
Shared Investigator Platform and Investigator Registry Business Lead
Roche
Sylvia has long-term pharmaceutical industry experience and expertise. She focuses on conducting clinical studies in various positions with proven team management and project management skills in an international working environment. She is a business leader in a project developing a new process setup and infrastructure for data review after data entry as the interface between business requirements and technical/process implementation.
 
Rhonda ​Ehmann, RN, BSN, MSN, PMP
US Feasibility & Recruitment Partner, Site Management & Monitoring, Clinical Operations
AstraZeneca
 
Max Elbaz, MS, MBA
Vice President, Sales and Marketing
Bio-Optronics
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, PhD
Executive Director, Clinical Operations
Medpace
Debbie has 20 years of clinical research experience, including over 4 years in Phase 1 research and over 16 years in Phase 2/3 clinical trials. She holds a PhD in Biological Psychology with a minor in Neurobiology. Debbie has directly managed over 50 studies ranging from small first in human studies to a large Phase 3 cardiac/stroke prevention trial conducted in 40 countries with over 1200 sites and 18,000 patients enrolled. She has provided senior level oversight for many other studies to ensure that high-quality deliverables are consistently provided. Most recently, Debbie directed the global Study Start-Up team within Medpace and currently oversees the Proposal and Feasibilities team.
 
Mary Elmer, MS
Associate Director
Merck
 
Marie Emms
Head, Global Clinical Trial Engagement
InVentiv Health
 
Mary Fleres
Sr Manager, Quality Management Services
Allergan
Mary is responsible for inspection readiness and management activities as well as managing procedural documents and training for Global R&D Quality. Prior to joining Allergan, she held positions of increasing responsibility for the design, deployment and management of clinical development procedural documents at multiple companies, including Pfizer, Bristol-Myers Squibb, and J&J Pharmaceutical Research and Development.
 
Diana Foster, PhD
Vice President, Strategy and Development
Society for Clinical Research Sites
Diana Foster, PhD, is the Vice President of Strategy and Development for the Society for Clinical Research Sites and is responsible for building relationships with industry that help amplify the voice of the clinical research site. She is a recognized expert in the intricacies of site management and an innovator in the use of strategic marketing tactics. Diana has designed and facilitated site management and patient recruitment trainings across the globe.
 
Bill Fugate
Manager, Sites & Patient Access
INC Research/InVentiv Health
Bill Fugate has a total of 18 years of experience in the pharmaceutical industry, 6 of those in sales and 12 in clinical research/ CRO. His CRO experience includes 10 years as a CRA where Bill established strong relationships with the sites he monitored and it was therefore a natural progression two years ago for him to transition into the Manager role within the Site and Patient Access group at INC Research/ InVentiv Health. In this role, Bill is responsible for developing and maintaining relationships with an elite network of therapeutically aligned sites and for helping to develop and initiate processes within the Catalyst Site Network Program. 
 
Rocco Fusco
Director, Operations Support Services
Greenphire
 
Tracey Gashi, PhD
Executive Director, Site and Patient Access
INC Research
Tracey joined INC Research in 2015 and is responsible for developing and implementing the Catalyst site relationship strategy. She brings a unique blend of clinical and commercial expertise to her role. With over 20 years of industry experience, she started her career as a Clinical Research Associate with PPD in 1996. Since then, she has held a number of positions ranging from Study Leader to Program Leader roles, predominantly in the Cardiovascular and Oncology therapy areas at both GlaxoSmithKline and AstraZeneca.
 
Christy Godwin
Site Relationship Specialist
Acurian
Relationship development is a key component to Christy's everyday activities. as the Site Relations Specialist for Acurian. She is an accomplished professional with extensive experience in the pharmaceutical, clinical research and healthcare industry. Christy is skilled in many disciplines and disease states with proven ability to cultivate relationships, manage project teams and enroll clinical studies. She is tenacious in approach with the ability to develop strong relationships, as well as prepare targeted recruitment presentations and convey complex concepts to audiences of varying backgrounds and understanding. Christy has a passion for clinical research patient recruitment and it shows!
 
Bridget Gonzales, CCRC
Clinical Research, Workforce Engineer
Medix
Bridget has over 10 years of Clinical Research experience in positions as a CRC, QA Manager, Site Director, Project Manager and Business Operations Manager. Her experience has been within multi-therapeutic late phase dedicated research facilities as well as a Phase 1 Oncology Research Institute. She has a passion for research and an eye for seeing the big picture and process improvement. Recently she has taken on a new role to be a resource to research sites, Sponsors, and CROs in staffing and consulting.
 
Clare Grace, PhD
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
Antidote
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
Clincierge
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, MA
Vice President, Global Clinical Trial Services
Bayer
With over 25 years of pharma experience in the areas of clinical operations and clinical trial optimization, Traci most recently led a large global monitoring organization, conducting Phase I-III International clinical trials across various therapeutic areas for Bayer. She has currently taken the position of Head of Global Clinical Trial Services overseeing various expert functions and developing business strategies in clinical trial planning, conduct, and analytics. Traci also retains a specialized focus on approaches to enhance the site and patient experience, and to cultivate strategic partnerships.
 
Gerrit Hamre, MBA
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
Director, Global Study Operations
Amgen
David has been in the Bio-Pharmaceutical industry for 20+ years working at various companies such as Merck, Pfizer, and currently at Amgen. David’s roles have spanned across Information Services, Clinical Development Management, Process Improvement, and Clinical Site Management. Currently he is the Director & Regional Head Site Management at Amgen Inc. overseeing North and South America clinical operations and monitoring.
 
Beth Harper, MBA
President
Clinical Performance Partners, Inc.
Beth specializes in enrollment and site performance management. She also serves as the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Beth is an Adjunct Assistant Professor at the George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment and sponsor-site relationship management.
 
Chris Heironimus
Director of Business Development
Insearch
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.
 
Bryan Hill
Chief Technology Officer
Cognizant
Bryan has a proven track record in delivering enterprise-level digital solutions in web, mobile, and social that drive business value, maximizing global operational efficiency and transforming young technology organizations into industry leading technology-enabled solutions providers. He is a creative thinker and strong communicator known for fostering R&D and entrepreneurial culture leading to highly motivated teams and innovative market-ready solutions.
 
Carmela Houston-Henry, CCRA
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.
 
Katarina Hugeneck
Global Study Training Manager
Katarina has over 20 years of experience in clinical research in a variety of roles such as monitoring, study coordination, project management, training, and people management. She joined Lilly in 1996 as a Clinical Research Associate where she managed Neuroscience core registration trials in Eastern Europe and the Middle East. Katarina is currently managing a team that focuses on implementation of improved site training solutions. Katarina has acted as the leader of the Site Qualification and Training work stream at TransCelerate BioPharma since it started in 2012 and is still involved in the maintenance and realization efforts of the initiative’s deliverables.
 
Jeannie Inge, MS
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, PhD
Head, United States Clinical Operations
GlaxoSmithKline
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.
 
Deb Jendrasek
VP, Strategic Development Partner
Chiltern
Deb Jendrasek currently holds a dual role overseeing Risk Based Monitoring within Chiltern as well as being a Service Partner for several Chiltern clients. Deb is a champion of technology enhancements and is responsible for leading the services teams to leverage data technologies and processes to improve clinical trial quality, efficiency, and outcomes. She is an experienced Biometrics Manager with more than 20 years in the clinical trial industry and has spearheaded many process improvement projects including paper to EDC transitions. Deb holds a degree in Computer Information Systems from Bentley College, Waltham, MA.
 
Vaughan Jenkins
Senior Manager, Site Commercial Solutions
PRA Health Sciences
 
Jill Johnston
President
WCG Clinical Service Organization
Jill is responsible for developing the strategy, driving the vision, and delivering outcomes as WCG continues to drive ingenuity in the clinical research space. With over 20+ years in clinical research, Jill is an expert in operational strategy, delivering transformational initiatives, sparking innovational ideas, and driving clinical trial efficiency. Prior to joining WCG, Jill was the VP, Vault Clinical at Veeva where she was responsible for providing thought leadership and driving development of product and market strategy for the Vault eTMF and Vault SSU products as well as designing Vault CTMS. Prior to Veeva, Jill spent a majority of her career at Covance, where she held a wide variety of strategic and operational roles in clinical operations and project management.
 
Leonard A. Jokubaitis, MD
Clinical Operations Head, Americas CTC, Global Clinical Operations
Janssen
Leonard (Len) is a physician with over 28 years’ experience within the pharmaceutical industry. In his current position, he oversees the deployment and execution of all research programs sponsored by Johnson & Johnson’s Pharma Medical Affairs organizations throughout North and South America. The group manages a portfolio of trials including both interventional and non-interventional studies, along with support of Investigator initiated studies and Expanded Access/Compassionate use programs. Before joining the industry in 1989, he was on medical staff at Newark Beth Israel Medical Center and at Newark Community Health Centers as a member of the National Health Service Corps. He also taught resident physicians from UMDNJ-New Jersey Medical School and the Mountainside Hospital in Montclair, N.J.
 
Brigid Jordan
Senior Operations and Finance Manager
PRA Health Sciences
 
Les Jordan
Vice President and Chief Product Evangelist
Target Health
Les is responsible for the software side of the business, providing overall product vision and technical direction to software development teams, while overseeing sales and marketing. Prior to Target Health, he spent almost 10 years as the CTO for Microsoft’s Life Sciences Industry Unit, where he was responsible for providing Life Science industry guidance while serving on industry standards groups including CDISC, IHE and HL7. Les is a noted expert and speaker on the topic of using technology to change the Health and Life Sciences industry, particularly around using patient engagement technologies to streamline how clinical trials are run and how drugs are brought to market.
 
Sandra Jovanovic
Senior Manager of Talent Innovation
Medix
Sandra leads the division within Medix responsible for developing, delivering and driving innovative strategies. She uses her previous experience from higher education and international marketing to develop programs and workforce solutions such as Medix Match® and Medix Intelligence℠ to better align the network of talent and clients Medix partners with.
 
Jeff Kasher, PhD
President
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, CCRP
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
Lilly
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.
 
Karol Knoop, RN, BS, CCRA
Senior Clinical Trial Manager
Adare Pharmaceutical
Karol has a dynamic career in Pharma and CRO organizations managing top-producing clinical operations as well as competitive high-growth businesses. Karol is skilled at merging cross-functional teams and achieving objectives, and she embodies a genuine commitment to promote and support the mission and values of the organization.
 
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, RN, BSN, MHA
Director Monitoring Excellence- Americas
Merck
Diane started her career as a CCU nurse and became interested in clinical research after meeting a nurse researcher there. After graduate school, Diane worked for the Veterans Administration with the Cooperative Studies Program where she learned a great deal about clinical trial operations and eventually joined Pharma as regional CRA at Pfizer. While at Pfizer she held various roles as regional CRA, CRA trainer, regional manager and regional director. Diane also worked for 2 years as a regional manager at Allergan prior to joining Merck as Director of Monitoring Excellence for the Americas. Diane is a member of Women in Bio Baltimore Chapter and the DIA RBM workgroup.
 
Andrew Lee, MD
SVP, Head of Global Clinical Trial Operations
Merck
Andrew (Andy) leads and manages all operations related to the conduct of Merck clinical trials, with a particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed, and quality standards. He is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems, and processes used in clinical trial executions. Andy joined Merck in September 2014 from Sanofi. Earlier in his career, he spent more than 16 years in a range of positions of increasing responsibility at Pfizer.
 
Craig Lipset, MBA
Head of Clinical Innovation
Pfizer
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.
 
Elizabeth (Beth) Mahon, JD
Director, Strategic Account Lead
Janssen
 
Effie Manos
Functional Manager-Neuroscience, Global Clinical Operations
Janssen
 
Chris Matheus, MBA
Executive Director, Business Development
Lexitas Pharma Services
Chris is a clinical research industry business development professional with a focus on technology and specialty services. He excels in establishing strong working relationships with internal and external customers and has a significant network of contacts.
 
Lindsay McCarthy, MBA
Vice President
Pharmaseek
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.
 
Lorie McClain, MS
VP, Product Management, Product Development & Technology
Bioclinica
Lorie is a senior life sciences industry professional with more than 20 years of experience spanning technology, operational, and financial aspects of the life sciences and healthcare industries. Lorie's in-depth knowledge of clinical trial project financial activities, including accounting, operational finance, clinical trial budget development, and technology management for both complex ERP system implementations and clinical trial financial solutions, is an asset to sponsors and CROs. Lorie earned a master's degree in Computer Science and Information Systems as well as bachelor's degrees in both Computer Science and Accounting from the University of North Carolina Wilmington. Lorie is a licensed CPA in the state of North Carolina.
 
Sheila McCorkindale, MBChB, FRCGP
Clinical Research Specialty Lead, General Practitioner
National Institute for Health Research (NIHR) Clinical Research Network
Sheila is the primary care clinical research specialty lead for NIHR CRN Greater Manchester. Passionate about primary care clinical research, with a special interest in real world research, Sheila was PI on numerous studies in her practice and has been part of the Salford Lung study team from the outset.
 
Rosie McKellar, MPH
Executive Director, Central Monitoring
INC Research/inVentiv Health
Rosie has over 28 years of experience in clinical operations and has held a variety of regional/global leadership roles. For the last 6 years she has led clinical Central Monitoring at INC Research/inVentiv Health. Rosie holds post-graduate qualifications in pharmacology and public health.
 
Patrick McLaughlin
CEO
Anaheim Clinical Trials
 
E.B. McLindon II
Vice President, SMO Affairs
ICON
 
Lynn Meyer, CCRP
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
StudyKIK
Matt has been a leader in the use of digital and social media campaigns for patient recruitment on a single site and multi-site level with experience at a major CRO. He has developed cutting edge techniques to patient recruitment using social media for various therapeutic areas and disease states.
 
Andrew (AJ) Mills
Executive Director, Sales Strategy
ICON
Andrew (AJ) is a dynamic, strategic sales & marketing professional. He has a track record of building sales and marketing departments from scratch to exceed results, for example, sales of $24.5M within 5 years of starting up operations. He is a strategic, analytical thinker with the ability to assess both business and customer needs while motivating and developing others by communicating a clear vision.
 
Ramon Mohanlal, MD, PhD, MBA
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.
 
April Mulroney
Managing Director, Payments
Medidata
April holds Chartered Accountancy designations in Canada, the US, and the UK, bringing her finance, international tax, and client-facing operational experience. Prior to Medidata, April was a CFO and operational lead for clinical finance industry. She is a Deloitte alumna, having worked in International Corporate Tax. April holds a BComm from University of Toronto.
 
Jim Murphy
CEO
Greenphire
 
Amy Musolino, MBA
Program Director, New Services Development
Fisher Clinical Services
 
Carrye Nibbelink, MBA
Associate Director, Central Monitoring
PRA Health Sciences
 
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
Roche
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.
 
Raymond Nomizu
Co-Founder
Clinical Research IO
 
Casey Orvin
Executive VP of Business Development
Synexus USA
Casey serves as Executive Vice President of Business Development for Synexus, the world’s largest site network with nearly 200 sites located in 11 countries, a database of 4.6 million, and 15,000 studies successfully conducted in the past 25 years. With over 17 years in the clinical research industry at the site and network level, he oversees the US BD/Commercial team, and has been crucial in the development of strategic partnerships with the majority of the major pharmaceutical sponsors and CROs. As an experienced site leader, Casey’s focus on developing and creating key partnerships with sponsors and CROs has made Synexus the largest and most sought after site network in the pharmaceutical research industry.
 
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.
 
Bryce Palchick, MD
Physician
Preferred Primary Care Physicians
Bryce is board-certified in family medicine and internal medicine with an additional certification in geriatrics. A graduate of the University of Michigan Medical School in Ann Arbor, he completed residencies in family medicine and internal medicine at the University of Missouri in Columbia, Missouri. On staff at Jefferson Regional Medical Center since 1993, he is a member of the hospital's clinical resource management committee, a consultant to Highmark's Clinical QI Committee, and a member of the Gateway Health Plan Pharmacy and Therapeutics Committee. Dr. Palchick has been conducting clinical trials since 2003.
 
Scott Palmese, MS
Vice President of Site Network
BTC Network
 
Brittany Parker
Senior Manager, Marketing and Communications
Total Clinical Trial Management
Brittany is the Senior Manager, Marketing and Communications for Total Clinical Trial Management. She oversees branding efforts, media relations, advertising, and website development, and has extensive knowledge of digital marketing methods. She graduated from The University of Texas at Dallas with a B.S. in Marketing.
 
Mitchell Parrish, JD, RAC, CIP
Vice President & General Counsel
Kinetiq
 
Doug Peddicord, PhD
Executive Director
Association of Clinical Research Organizations (ACRO)
Doug oversees ACRO staff, directs ACRO policy, and represents the Association before Congress, regulators, industry groups, and the media. He has policy expertise in the conduct and regulatory oversight of clinical trials. Following a career as a clinical psychologist, Doug came to Capitol Hill as an American Association for the Advancement of Science (AAAS) Congressional Fellow in 1994. He worked on Medicare and a range of other health care issues. Doug is a current member of the Clinical Trials Transformation Initiative (CTTI) Steering Committee.
 
Christine Pierre
President
Society for Clinical Research Sites
Christine is the President of the Society for Clinical Research Sites (SCRS). She is internationally known for her expertise in clinical research site management and patient recruitment and retention for the clinical trials industry. In addition, she also addresses audiences around the world on issues pertaining to human subject protection, site operations and subject recruitment and retention. Her global reach has included presentations in Australia, Canada, Africa, Israel, and the United States.
 
Melissa Poindexter
President
Advances in Health
 
Nina Pruitt
Sr. Director, Global Product Marketing
Medidata Solutions
 
Suzanne Pryor-Tillotson, MS
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
QuintilesIMS
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, MCSE, CIP, CPIA
Vice President of Client Services
Kinetiq
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.
 
David Rodin
CEO
Amici Clinical Research
 
Debra Rogge, BSN, MSA
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.
 
Janelle Sabo, PhD, MBA
Global Head, Product Delivery
Lilly
Janelle is an International drug development expert and experienced senior executive. She specializes in integrated drug development and portfolio management, early and late phase drug development, global logistics & distribution, supply & demand management, and outsourcing. Janelle manages critical chain, alliances, and partners, and she has expertise in mergers and acquisitions.
 
Maryanne Santilli, Macc
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.
 
Steve Satek, MBA
Vice Chair, Global Site Solutions Summit Planning Committee
President and Founder
Great Lakes Clinical Trials
Steve brings more than 25 years of research experience to Great Lakes Clinical Trials. He began his career as a bench researcher at the Northwestern University Robert H. Lurie Cancer Center and since that time has held senior management positions at the Chicago Center for Clinical Research, Radiant Research, Cognitive Drug Research, Theivon-Wright Consulting Group and Forenap Pharma. Steve has project managed and/or coordinated over 100 trials.
 
Doug Schantz
Executive Director, Clinical Operations
AstraZeneca
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.
 
Neil Schmitz
Co-Founder
Research Hive
Neil co-founded Research Hive in 2015 to develop software for research professionals. He is an experienced clinical trial coordinator who is passionate about the drug development process. Neil is driven to provide tools to sites that increase data quality and enhance patient experience, while at the same time eliminating delays caused by outdated methodologies and inefficiencies. By bringing a fresh approach and embracing the latest available technologies, the Research Hive team shares a calling to find innovative solutions that will bring healing and hope to as many as possible.
 
Regina Schwind
Director of Research Operations
Forte Research Systems
 
Meri Kay Scott, RPh, PhD
Senior Director, Clinical Project Management
Lilly
 
Kay Scroggins
President/CEO
Clinical Trials of Texas
 
Lisbeth Seerup
Senior Director
Novo Nordisk
Lisbeth is the Senior Director GCP Support. She has worked in clinical development for the past 27 years including 10 years in Denmark, 10 years in Japan and the last six years in the USA. One of her main responsibilities is managing authority inspections including support to external authority inspections at clinical sites.
 
Earl Seltzer, MBA, CCRC
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.
 
Jessica Shepherd, MBA
Site and Patients Network Director
QuintilesIMS
Jessica is a health enthusiast who considers clinical research a team sport. She is in the game, tirelessly using her strong scientific background and solution-oriented approach to advance medicine. She approaches all problems and issues as opportunities, and she understands that change is an unavoidable element of progress. Jessica enjoys matching needs with solutions in a variety of functional areas within the biopharmaceutical research industry.
 
Roger D. Smith
Senior Vice President and General Manager, Accelerated Enrollment Solutions
Acurian
Roger heads PPD’s Accelerated Enrollment Solutions business unit; he is responsible for PPD’s strategic direction and financial growth in all areas that encompass trial acceleration via innovative site and patient-centric approaches. This includes PatientAdvantage that fully incorporates all site, patient enrollment and PPD services in a cost-per-patient budget construct.
 
Kenneth Somberg, MD, MBA
Founder and CMO
Somberg Consulting
Ken formed Somberg Consulting LLC in 2017 to leverage his senior leadership experience in global pharma and contract research organizations with demonstrated expertise in corporate strategy, clinical research design, clinical trial operations, regulatory affairs, business development, due diligence and global team management. Known for bringing medical/scientific perspective to corporate strategy development, he most recently served as Chief Medical Officer of Covance Inc., a leading global contract research organization. While at Covance he oversaw drug development planning and execution across the therapeutic spectrum. Prior experience at Novartis Pharmaceuticals included serving as a global therapeutic area head in both Clinical Research and Regulatory Affairs. Prior to joining industry Ken served on the faculty at the University of California, San Francisco as Associate Medical Director of the Liver Transplantation Program.
 
Charlie Speno, MAT
Vice President of Business Development
CSSi
Charlie specializes in life-cycle management experience with a focus on patients. He entered the bio-pharmaceutical industry through sales and marketing. He crossed into clinical and market development by working on large global phase II-IV development programs. Charlie brings a unique perspective that covers the development through commercialization of patient therapies to pharmaceutical and device clients.
 
Nicole Stansbury
Executive Director, Adaptive and Intelligent Monitoring
PPD
Nicole develops PPDs strategy and approach to risk-based monitoring. She is leading the implementation of PPDs risk-based monitoring approach globally and cross-functionally. She excels in adapting PPD’s roles, process, and tools to accommodate a risk-based approach to monitoring while assessing and developing new metrics to measure the success of PPD’s RBM approach.
 
Sean Stanton
Sr. VP Global Operations
Bioclinica Research Network
 
Jeff Stein, MBA
President
Stamford Therapeutics Consortium and New England Research Associates
Jeff came to Stamford Therapeutics Consortium in 2007, bringing his varied business and healthcare industry experiences to STC with the objective of taking the clinical trials company to a new level of success. Jeff began his career on Wall Street working for Salomon Brothers from 1980 to 1989. He left Wall Street in 1995 and acquired a controlling interest in Healthcare Properties, a nursing home chain with four skilled nursing facilities (SNF). Under Jeff Stein’s management, the company became one of the founding members of the first network in the country of independent SNF’s focused on sub-acute care. In 2007, Jeff Stein brought his Wall Street and healthcare experience together as he searched for an opportunity to lead a profitable and successful company in the medical field. He was introduced to STC through his role as a private investor in Comprehensive Neuroscience Inc., a company that conducts phase I-IV clinical trials.
 
Neal H. Surasky, CCRC
Director of Compliance
Chesapeake Research Group
Neal obtained his certification as a Licensed Practical Nurse in 1995. He worked in a variety of settings as an LPN for 9 years, then decided to make a change to clinical research. He started doing predominantly bioequivalence studies, but the research bug had bitten. Neal moved to Chesapeake Research Group in 2005. As he continued to learn and develop, he became the Data Manager for the company, responsible for all data entry and quality assurance. He was recently awarded the title of Director of Compliance, overseeing both internal and regulatory compliance. In 2014, Neal earned his credentials as a Certified Clinical Research Coordinator.
 
Jean-Marc Tellier, Msc
Head, Global Investigator Network
Sanofi
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.
 
Cindy Tremblay
GM & Director, Training & Development
Devana
 
Chris Trizna
President
CSSi
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.
 
Edward Tumaian
Vice President Clinical Development
TFS
Edward is a dynamic executive with a proven track record of building teams aligned with business strategy. He has created long term business strategies by working with multiple management levels including senior leaders and successfully implemented those strategies for several pharmaceutical companies, along with global management experience across regions and countries. He has extensive knowledge and experience with development strategies and writing of IND, NDA, protocols, CRFs, ICFs, CIBs, ICH, GxP, RFPs, and report preparation.
 
Vivienne van de Walle, MD, PhD, CPI, FAPCR
Director
PT&R
Vivienne studied medicine at the University of Maastricht in the Netherlands and did part of her medical training at the University of Oxford in the UK. She has always combined clinical research with patient care and has been a full-time investigator at independent clinical research sites since 1999. She co-founded the independent research site PT&R in 2006, taking full ownership in 2013. She is a member of the national BROK/GCP exam commission, the ACRON, APCR and the VP of the NVFG (Dutch Federation of Pharmaceutical Physicians) and is a member of Leadership Council of the SCRS (Society of Clinical Research Sites).
 
David Vulcano, LCSW, MBA, CIP, RAC
AVP & Responsible Executive for Clinical Research Clinical Research
HCA Healthcare
 
Robin Whitsell, BA, BPh
President and Founder
Whitsell Innovations, Inc.
Robin has 20 years of industry experience. Prior to founding Whitsell Innovations in 2006, she was the assistant director of preclinical & clinical development at Inspire Pharmaceuticals, a team lead at GlaxoWellcome (now GlaxoSmithKline), and a CRA at Parexel International CRO. She has written many key documents for regulatory authorities, and she has attended and presented at meetings with the FDA. She is a member of the Drug Information Association, the American Medical Writers Association, and the Diversity Alliance for Science.
 
Glenn Watt, CISSP-ISSMP, CISM, NSA-IAM, NSA-IEM
Chief Information Security Officer
Medidata Solutions
Glenn has the ability to develop and implement an organizational vision that integrates key corporate and program goals, priorities, values, and other factors. Inherent to this is his ability to balance change and continuity; to continually strive to improve customer service and program performance within the basic commercial framework; to create a work environment that encourages creative thinking; and to maintain focus, intensity and persistence, even under adversity. He has designed and implemented strategies to enable International Compliance with Data Privacy and Information Security Regulations.
 
Kevin Williams
President
Transcend Trials
Kevin has spent much of his nearly 20 years in clinical trials developing innovative solutions to improve site sustainability, reduce investigator burden, and bring focus to the underserved areas of clinical operations. As President of Transcend Trials, he hopes to continue to spark industry efforts to address and adopt more efficient ways of operating the clinical business.
 
Kelly White, MSN, RN
Global Operations Lead, Oncology
Merck
Kelly is an accomplished clinical research and nursing professional with broad therapeutic area experience. She is seasoned in clinical operations across a variety of operational settings including pharmaceutical, academic/community hospitals, CRO, and vendor organizations. Kelly has achieved positions of increasing responsibility as a result of driving productivity in pursuit of business objectives, identification of opportunities for process improvement, and contributing to team and organizational goals.
 
John J. Whyte, MD, MPH
Director of Professional Affairs and Stakeholder Engagement
US Food and Drug Administration, Center for Drug Evaluation and Research (CDER)
John oversees CDER’s public outreach. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. Previously, he served as the Chief Medical Expert and Vice President, Health and Medical Education at Discovery Channel, developing, designing, and delivering educational programming. John is a board-certified internist. He completed an internal medicine residency at Duke University Medical Center and earned a master’s of public health in health policy and management at Harvard University School of Public Health.
 
Amanda Wright
Executive Director
Greater Gift
 
Gary L. Yingling, MSc, JD
FDA Regulatory Senior Counsel
Morgan, Lewis & Bockius LLP
Gary draws on his experience as a former US Food and Drug Administration (FDA) lawyer to advise individuals, partnerships, and corporations in matters involving new drug applications, food ingredient marketing, product labeling, importation, regulatory marketing strategy, recalls, seizures, and criminal matters. His practice focuses on food and drug industry issues, with a particular interest in clinical research, contract research organization, and sponsor matters. He spent a number of years serving as a trial attorney and later as associate chief counsel for the FDA’s Bureau of Veterinary Medicine and as deputy chief counsel for administration. While at the FDA, he also spent two years as director of the Over-the-Counter (OTC) Drug Review in the Bureau of Drugs where he received the FDA’s highest award, the Award of Merit, for his legal and administrative work.
 
Richard Young
VP of Vault EDC
Veeva Systems
As vice president for Veeva Vault EDC, Richard Young is responsible for establishing Veeva Vault EDC as the best in class solution for all data acquisition, management and reporting purposes. With almost 25 years of experience in life sciences, Richard is known for his executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies.
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