2019 Site Solutions Summit Faculty

Gail Adinamis
CEO and Founder
GlobalCare Clinical Trials

Gail Adinamis is the CEO and Founder of GlobalCare Clinical Trials. She has over 35 years of comprehensive phase I-IV clinical trials experience including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. She founded the business model for centrally managed homecare services for clinical trials in 1992.

 
Roberto Aguirre, MD, CPI, CCRP
VP/Global Research Director
AGA Clinical Trials

Roberto is a foreign physician with 13 years of experience in clinical research. He is the VP and owner of AGA Clinical Trials (operating in the USA and Ecuador), which has conducted more than 150 trials since 2004.

 
Whitley Albright, MSN, RN
Site Partnership Manager
Sanofi

Whitley Albright is a Site Partnership Manager at Sanofi who is passionate about improving the site experience across all Sanofi interactions. In this role, she strives to ensure sites are engaged in all stages of clinical trial development. Having previously worked as a clinical research coordinator (CRC), she has a great appreciation for the value of insights and experiences of site partners. When not working with sites, she is somewhat fanatical in her work as a Risk Based Monitoring Subject Matter Expert and also contributes to improvements in Study File Maintenance. Whitley has her MSN, with a focus on Clinical Trial Management, from Kansas University with experience as a CRA, Clinical Trials Assistant and Pediatric CRC. Whitley will take any opportunity to enjoy the beautiful Midwest weather, whether it be gardening, hiking, reading a book, or chasing a toddler which, in all honesty, is the best part of all activities.

 
CAPT Richardae Araojo, PharmD, MS
Associate Commissioner for Minority Health/ Director, Office of Minority Health and Health Equity
U.S. Food and Drug Administration

CAPT Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA). In this role,she provides leadership, oversight, and direction on minority health and health disparity matters for the Agency. CAPT Araojo previously served as the Director of the Office of Medical Policy Initiatives in FDA’s Center for Drug Evaluation and Research (CDER), where she led a variety of broad-based medical and clinical policy initiatives to improve the science and efficiency of clinical trials and enhance professional and patient labeling. CAPT Araojo joined FDA in 2003, where she held several positions in CDER’s Office of New Drugs. CAPT Araojo received her Doctor of Pharmacy Degree from Virginia Commonwealth University, completed a Pharmacy Practice Residency at University of Maryland, and earned a Master’s degree in Pharmacy Regulation and Policy from the University of Florida.

 
Rick Arlow, MS
Founder & CEO
Complion

Complion founder Rick Arlow was immersed in clinical research during a NIH-funded MD/PhD medical scientist training program at Case Western Reserve University, which resulted in publications with several leading journals including Neuroscience. Although he loved the work, he was shocked at how cumbersome operations and regulatory compliance were for the research sites and how much time was wasted on manual tasks and paper binders. Inspired by his experience and drawing on his engineering background, Rick put together a world-class team experienced in clinical research and enterprise content management to build Complion, the first and only eRegulatory platform built specifically around the needs of clinical research sites. Rick is a frequent lecturer for several professional research organizations including ACRP, MAGI and SCRS. He was involved with a biotech business resulting in several patents and was recognized in Business Week’s “Top 25 Under 25 Entrepreneurs."


 


Samir Arora, MD
President & Medical Director
Aventiv Research

Dr. Arora is the President and Medical Director of Aventiv Research, Inc. His company has conducted over 450 clinical trials since its start 2007 with 55+ pharmaceutical sponsors. Over 20,000 patients have passed through the doors of Aventiv’s multiple offices in Ohio, Arizona and Pennsylvania, allowing sites to become a top enroller in multiple therapeutic areas and a priority site with CROs and Sponsors. Dr. Arora has been a Principal and Sub Investigator involved in Phase I-IV clinical research on over 200 studies. Dr. Arora serves as an advisor on various pharmaceutical drug development panels and is a frequent speaker across the country.

 
Ari Axelrod, MBA, CFA
Managing Director
Boston Clinical Trials

Ari is Managing Director and CFO of Boston Clinical Trials (BCT), an independent, multi-specialty clinical research center. In this role he is responsible for the strategic direction of the company, its finances, and administration. Since 2003, he has negotiated well over a hundred agreements with Sponsors and CROs and has been instrumental in accelerating the company’s growth and improving its profitability. Ari’s expertise is in corporate finance and included senior roles with Banyan Advisors, Credit Swisse, Lehman Brothers, and Boston Consulting Group. He holds an MBA degree from Harvard University and is certified as Charted Financial Analyst (CFA). In his spare time Ari is an avid tennis player and a backroads biking enthusiast.

 
Wayne Baker
Chief Commercial Officer
Greenphire

As Greenphire’s Chief Commercial Officer, Wayne is responsible for the global commercial strategy of the rapidly growing organization, including the execution of sales and marketing programs. Wayne is a proven strategic sales executive with more than 25 years of commercial experience in technology and life science industries. Prior to joining Greenphire in 2016, Wayne served in numerous senior leadership roles at Advanced Health Media (AHM), a leading global provider of SaaS-based solutions designed to manage compliant interactions with healthcare professionals and organizations. During his tenure, Wayne helped establish AHM as the market leader, playing an integral role in the organization’s 1500 percent revenue growth during a four-year period. Earlier in his career, Wayne gained sales leadership and industry experience at Parametric Technology Corporation (PTC) and Brent International. He earned his bachelor’s degree in Chemical Engineering from Drexel University. Wayne resides in the Philadelphia area with his wife and four children.

 

Brian Barnes, MA
Director, Risk Based Monitoring
PPD

Brian is a Director of Risk Based Monitoring (RBM) and has been with PPD for 14 years. He has been engaged with RBM for over 7 years and specializes in RBM operationalization for small to large pharma, biopharma, and biotech companies. Brian has presented and published on the topic of RBM within a number of industry meetings, conferences, and journals and is the co-liaison for the ACRO RBM Working Group.

 
Silvina Baudino, MS
Director, Strategic Site Networks
IQVIA

Silvina Baudino has over 20 years of experience working in clinical trials industry; including health, pharma and CRO sectors in the Americas. As Director of Site Strategic Networks she supports CRO-Site alliances and thought leader engagement. Focus on building and implementing innovative site-centric delivery models as well as creating strategies to improve quality and accessibility to clinical trials for patients across therapeutic areas globally. Previously she held a variety of roles in CRO and pharma including trial monitoring, project management, feasibility, quality and site & investigator relations.

 
Anne-Marie Baughn
Director, Business Development
Rx Trials, Inc.

Anne-Marie Baughn has been with Rx Trials for over 21 years. Anne-Marie has been Director of Business Development for Rx Trials for the past 19 years. She is primarily responsible for developing and identifying clinical research opportunities and marketing RxTrial's clinical research sites to pharmaceutical and biotech companies, and clinical research organizations. Previously, Anne-Marie was the Director of The Congestive Heart Failure Clinic at Georgetown University Medical Center for seven years where she was responsible for all administrative, clinical, and research related activities related to the department. Anne-Marie is a former cardiac critical care nurse. She holds both a Bachelors of Nursing degree and a Masters of Nursing in Administration degree from Georgetown University. She is also a member of the Association of Clinical Research Professionals. Anne-Marie is a frequent speaker at several industry conferences including ACRP, DIA, and MAGI.

 
Sarah Beeby
EVP, GM Lifesciences
Clinithink

Sarah has over two decades of experience in the global life sciences industry, and has a wide range of operational, therapeutic and regulatory expertise, with a focus on collaborative working opportunities to enhance delivery and patient experience. Her diverse background in life sciences, in roles ranging from CRA, Global Program Manager, VP to COO in Pharmaceutical, CRO, Medical Device and Investigator Site companies, has made her a globally recognised leader in the industry. Sarah joined Clinithink in 2017 to bring technology, in particular AI, to life science projects. Sarah has a particular interest in the opportunities and business changes that accompany disruptive technology, as well as the potential outcomes of delivering clinical trials and novel treatments to wider patient populations.

 


Deena Bernstein, MHS
Senior Strategic Advisor
Circuit Clinical

Deena Bernstein graduated from Seton Hall University with a BA degree in English. She received a Certificate in Clinical ResearchAdministration in 2005 from George Washington University, and a Masters in Health Sciences in Clinic Research Administration from George Washington University in 2006. Deena began her career in the clinical research industry in 2000, as the Director of Clinical Research for Sheridan Clinical Research where she created and developed their research program from its inception that supported over 6500 physicians Nationwide. She also, was created their investigator initiated research program in 2015, Sheridan Scientific Intelligence. Ms. Bernstein held a position at IQVIA where she was recruited to develop and operate their first SMO from the ground floor. She on-boarded Qcare’s first 8 sites and built the infrastructure of the business unit, which included policies and procedures, site metrics, hired and led high preforming team that met their goals and objectives during their first three years in operation. Currently Deena serves as Senior Strategic Advisor at Circuit Clinical and also providing consulting services for a Clinical Research Technology organization, and Kelly Willenberg & Associates.

 
Dex Bilkic, MBA, HBSc
Manager, Study Startup, Patient Recruitment, Outsourced Studies
Bayer

Dex Bilkic is a Manager, Study Start-Up, Patient Recruitment and Outsourced Studies at Bayer Inc. He began his career at the Centre of Forensic Sciences as a Technologist. Previous to his current position he worked as Leader of Business Support Group at Boehringer Ingelheim, as well as Associate Project Manager at AstraZeneca and a Scientist at GlaxoSmithKline. Dex has more than 25 years of experience in the pharmaceutical industry where he has held various positions from working in research on the lab bench to managing clinical trials. Dex holds an Honors BSc and an MBA degrees. He is an accomplished leader in the pharmaceutical industry with a progressive and extensive experience including trial planning, contractual negotiations and vendor management. Dex has also served under TransCelerate Biopharma Inc., working to enhance clinical research efficiency.

 
Reg Blynn
Global Head of Business Development, Qcare
IQVIA

Reg Blynn started his medical career selling EHR’s and Billing systems back in 2001. Since then, Reg has played several key roles at various medical companies in the business development and sales arenas. After selling EHR’s and developing Clinically Integrated Networks for research at the eCast Corporation for 5 years, Reg joined PrimaryRx as their VP of Sales in 2006. This company provided family practice, urgent care centers and self-insured company doctors the ability to dispense medications directly to their patients at the point of service. In 2011, Reg decided to go back into clinical research and went on to form Medical Research Alliance, a 34-site network that spans across the US. MRA is still in existence today as one of the preeminent performing networks with partnerships across all the major Sponsors and CROs. While there, Reg created and developed a revolutionary software for business development in Clinical Research called Devana Solutions. Devana is also still running today with great success. In 2016, Reg decided to go over to the CRO side of the business and went to IQVIA (then Quintiles) as their Vice President of Client Services. His job there was to build and create a SMO under the business line called Qcare. In the first 3 years there, they have had tremendous success with a current active network of over 1,000 physicians at 8 large multi-specialty sites across the US. The expansion of Qcare will continue at IQVIA under Reg’s direction. In addition, Reg also runs the sales division of the Qcare CRC Network of Excellence, a division which places Clinical Research Coordinators across the globe to help with various protocols that need additional resources.

 
Christina Brennan, MD, MBA, CCRC
VP ,Clinical Research
Northwell Health

Christina Brennan, MD, MBA has devoted her career to clinical research and currently serves as Northwell Health's vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 19 years of extensive clinical research experience, including over 14 years in clinical research management roles. She is the immediate past president of the NY Metropolitan Chapter of the Association of Clinical Research Professionals. She also is on the advisory board of the Weschester Biotech project. She is an active member of the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA, where she actively sits on some of their committees. She also sits on the oncology advisory board and technology site advocacy group with the Society for Clinical Research Sites (SCRS)She is also an active member of the Drug Information Agency, the Regulatory Affairs Professional Society and the American College of Healthcare Executives. Dr. Brennan also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings. She was a 2015 and 2016 honoree of the trish America Healthcare and Life Sciences 50, which recognizes the work of Irish-American and Irish-born medical professionals.

 
Christian Burns
President
ClinEdge

Christian’s passion for clinical research began when he first participated in a clinical trial at a young age. Since then, his fascination with the industry and entrepreneurial spirit has continually pushed him to find ways to transform and improve upon existing processes, from site operations and management to digital marketing and technology. Through his leadership of three companies, GuideStar Research, BTC Network and ClinEdge, Christian continues to expand much needed services and offer more innovative solutions within the clinical research space.

 
Jennifer Bush
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.  Jennifer has worked in large pharma, large CRO and IT, working in both business and IT departments managing data transformation and loading, eClinical implementations including implementation of EDC, clinical trial management and other clinical 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..

 
Gina Calderon, MS
Director Clinical Site Manager
Pfizer

Gina joined Pfizer in 1997 and has held various positions in clinical research including, Study Manager, Regional Study Lead and Clinical Research Associate and has covered multiple therapeutic areas and most recently supported Oncology. She lives in Coconut Creek, Florida. In this current role Gina ensures appropriate resources to deliver on key clinical-site management milestones. Manages site-facing oversight roles to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practice and Pfizer standards. Leads initiatives that support the clinical development environment within region/cluster to facilitate Pfizer’s clinical development goals and scientific leadership. Responsible for reviewing metrics, delivering analyses, offering an escalation pathway and options for mitigation (both at the study and site level) for driving the business in her region/cluster. Prior to joining Pfizer, she worked as a nurse in critical care, cardiovascular intensive care, and trauma.

 
Chris Caldron
Director of Patient Qualification
StudyKIK
 
Miaesha Campbell, BA
Director, Patient Recruitment and Retention
Medpace

Miaesha oversees the global patient recruitment department at Medpace, a Clinical Research Organization based in Cincinnati,OH. She joined Medpace in October 2016 to develop the patient recruitment department at the company. Since joining Medpace, the department has successfully grown under her leadership. Miaesha leads her team, consisting of senior managers and coordinators, to drive patient recruitment processes and provide alternative solutions and guidance to clinical trial teams especially for those clinical studies that are more difficult to enroll.
Miaesha graduated from California State University at Dominquez Hills in May 2002, earning a Bachelor of Arts degree in English and minor in Communications. Her early career was spent in Public Relations, developing campaigns focused on community relations, consumer and travel products. She was recruited to support the marketing of clinical trial programs in 2007 geared toward educating patients and caregivers about the opportunities to join clinical research studies. This includes execution of large scale project strategies for the recruitment and retention of subjects in clinical trials through paid media, community, and site relations for global clinical trial recruitment and retention campaigns. Miaesha is a proud member of Delta Sigma Theta sorority and enjoys spending her spare time with her three children, Levon, Javon and Hannah.

 
Daniela Cardeal, BSN, MSc
Compliance Process Training and Systems Advisor (CPTS)
Roche
 
Michael Casey
Executive Director
hyperCORE

Michael is the Executive Director of hyperCORE International, an Integrated Research Organization (IRO), bringing his 19 years of clinical research and industry experience to this innovative network. Formerly of IQVIA’s innovative Strategic Drug Development (SDD) unit, Michael has designed a multitude of clinical programs and streamlined operations to further optimize clinical trial execution. Using data analytics and creative consulting he brings a unique approach to clinical optimization, site identification, and feasibility for the industry by deconstructing traditional pathways and collaborating partners to develop new approaches.

 
Lauren Chazel, MBA
Vice President of Global Strategic Alliances
Headlands Research

Lauren Chazal has a strong command of the clinical trials industry from a site operations, business development and financial management perspective. She began her career in clinical trial operations with a privately-held multi-site clinical research organization. Since 2012, she has held a pivotal role in business development and relationship management for large national and global site networks. Lauren has in-depth knowledge of the complex interactions between clinical research centers, CROs and sponsors combined with a keen understanding of the importance of access to high quality trial sites and unique patient recruitment solutions. She currently holds the role of Vice President of Global Strategic Alliances with Headlands Research, a large private equity backed San Francisco based site company. Lauren graduated from Lehigh University with a bachelor's degree in Finance and Marketing and subsequently University of Florida with a Master's in Business Administration (M.B.A.).


 
Danielle Ciara, MBiotech, PMP
Therapy Area Leader (TAL), US Oncology
Roche
 
Steve Clemons, MSN, FNP-BC, NP-C
Founder, CCO
VitaLink Research

Founding Principal of VitaLink Research – a wholly owned and fully integrated private equity-backed site management organization. He currently serves as Vice President of Operations and board member. Steve has 19 years of clinical research experience in all phases and types of clinical trials. VitaLink Research has 11 locations in NC, SC and GA and is currently reviewing acquisitions to grow 4x in the next 4 years.


 
Larissa Comis, MJ
Lead, Shared Investigator Platform
Cognizant

Larissa Comis is Cognizant’s Product Leader for the Shared Investigator Platform. She works closely with sponsors, investigators, CROs, and technology partners to drive adoption across the clinical ecosystem. Larissa has extensive experience in clinical trial informatics and technology, with a concentration in oncology. She has led strategy and clinical products for Medidata, Thompson Reuters, and Eviti (now NantHealth). During her nine years at the Coalition of Cancer Cooperative Groups, she grew its nascent programs to become a national leader in cancer clinical trials matching services and patient advocacy. Larissa earned her Masters in Journalism from Temple University.


 
MarieElena Cordisco, MA, APRN, NP-C, CCRC
Director of Clinical Trials
Western Connecticut Health Network 
MarieElena Cordisco, MA, APRN, NP-C, CCRC is an experienced family nurse practitioner with a specialty in endocrinology and research since 2006. She earned a Master of Arts in Professorial Nursing, Post Masters Certificate Family Nurse Practitioner and Certificate of Graduate Study in Public Health. In 2015, Ms. Cordisco became Director of the Office of Clinical Trials at Western Connecticut Health Network. She leads a team of professionals managing clinical trials for three hospitals and 70 outpatient offices in more than a dozen therapeutic areas. As a research leader, Ms. Cordisco has special interest in increasing nurse practitioner-led clinical trials. In 2018, she was invited to join the leadership council for the Society for Clinical Research Sites. She sits on the steering committee for the Joseph L. Belsky Research Day and the inaugural Spark Tank Employee Idea Challenge for her organization.
 
Anthony Costello
Vice President, Mobile Health
Medidata Solutions

Anthony Costello is Vice President of Mobile Health at Medidata. After beginning his clinical research career at Genentech 20 years ago, Anthony Costello has gone on to co-found several clinical trials technology start-up companies including Nextrials (acquired by PRA Health Sciences) and Mytrus (acquired by Medidata). Over his career, he has focused on disruptive and innovative technology that can simplify clinical trials for patients, sites and sponsors. He has been selected as one of the PharmaVoice Top 100 Most Inspiring People in Clinical Research, has served as Chairman of the Board for the Society for Clinical Data Management and is currently a member of the editorial advisory board for Applied Clinical Trials magazine. He is a frequent author and presenter on topics related to the efficient use of technology in clinical research and has a degree in Sociology from UC Berkeley.

 
Darren Cowan, RPN
Area Head, America’s Global Site & Study Operations
Pfizer

Darren joined Pfizer in 2000 and has held various Clinical Operations roles in both Canada and United States and currently works out of the New York Headquarters Office in the role of Area Head for the America’s. In this current remit Darren has overall responsibility for and accountability to deliver strategic and operational direction to the area management teams, & to ensure deep understanding of and execution to departmental strategies, culture, and goals. Additionally, Darren sponsors workstreams in technology, flexible trial locations, diversity, and investigator training. Prior to joining Pfizer, Darren worked in a variety of nursing specialties including emergency, psychiatry, corrections, community, education, and remote telemedicine.

 
Sean Cunningham, MBA
Director, Strategic Account Lead
Janssen R&D

Sean Cunningham is a Strategic Account Lead with Janssen Global Clinical Operations. As a Strategic Account Lead, he is responsible for strategic partnerships and collaborations with Strategic Accounts in the US, which consist of academic/research institutions or large health systems across multiple therapeutic areas. In this role, Sean identifies mutually beneficial opportunities and develops and drives solutions to enhance relationships, processes, and communications between Janssen and research institutions. Sean earned his BA from the University of Colorado - Boulder and his MBA from the Olin School of Business at Washington University in St. Louis. Sean has over 20 years of industry experience and joined Janssen in 2007.

 
Prof. Edward Czerwinski
Director
Krakow Medical Centre
Professor Edward Czerwinski, founder and head of Krakow Medical Centre since 1996 and Professor of Jagiellonian University being the Head of the Department of Bone and Joint Diseases. He has been a practicing medical doctor in orthopaedics for 46 years as well as an active university lecturer, scientist and community benefactor. In Krakow Medical Centre he supervised 124 trials that have been completed in the fields of: cardiology, bone and joint diseases, endocrinology, dermatology, gastroenterology, hematology, kidney, rheumatology, osteoporosis, neurology, nephrology, pain management. Prof. E.Czerwinski is a member of the international Scientific Advisory Boards of: International Foundation of Osteoporosis, EULAR and EFFORT, 10 boards of scientific international magazines, member of 20 societies, organizer of 21 medical congresses in Poland including World Congress on Osteoporosis in 2018. Author of 502 publications, Impact Factor of 191 and Hirsh index 16. 
 
Glen de Vries
President & Co-Founder
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 trustee of Carnegie Mellon University, a Columbia HITLAB Fellow, and a member of the Healthcare Businesswomen’s Association European Advisory Board. Glen received his undergraduate degree in molecular biology and genetics from Carnegie Mellon University, worked as a research scientist at the Columbia Presbyterian Medical Center and studied computer science at New York University's Courant Institute of Mathematics.

 
William Dirkes, Jr. MD, MBA
President, Chief Research Officer
Sentral Clinical Research Services & SentralBinders

Dr. Dirkes has owned and operated Sentral Clinical Research Services for eight years. During that time, Dr. Dirkes has implemented innovative solutions that allowed the research site to function paper-free. He developed SentralBinders as a user-friendly, validated, regulatory-compliant means of becoming paper-free at the site. The research site has been using SentralBinders now for three years. Dr. Dirkes achieved front-line experience managing the transition process, staff acceptance, regulatory issues, and resolving sponsor/CRO concerns. His site has experienced significant efficiencies by becoming paper-free, and site staff report greater work satisfaction related to less paper filing. Dr. Dirkes received his MD degree from the University of Cincinnati and his MBA degree from the Kellogg School of Management at Northwestern University. He is a board certified Anesthesiologist and practiced anesthesia for 15 years before moving into the clinical research arena. Prior to starting his site, he was the COO of Goodwyn IRB.

 
Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC
Executive Clinical Research Strategy
Medix
Molly has over 20 years of healthcare experience with specialization in oncology, research, and health care administration. Molly earned her bachelors 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 her ability to streamline processes resulting in improved clinical operation efficiencies, financial gain, and employee and patient satisfaction. Now Molly shares her passion, experience, and expertise with sites as the strategy executive for Medix Clinical Research.
 
Lisa Dyment BA
Director, Strategic Site Collaborations and Patient Centricity
PPD, Inc.
Lisa is a clinical research professional with over 22 years of experience in project management, proposal strategy, feasibility and site network relationship management in the CRO environment. Her strengths are in collaborative strategy development across multiple departments and regions, ability to assess client needs and develop a ‘big picture’ strategy to deliver, ability to interpret data and make recommendations to clients based on this data to meet the ultimate goals of their development plan.
 
Debbie Elliott PhD
Executive Director, Feasibility and Proposals,Clinical Operations
Medpace
Debbie Elliott has over 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’s therapeutic experience includes neuroscience, cardiovascular, endocrine, respiratory, digestive disease, and immunology. 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.
 
Marie Emms
Head of Patient Engagement
Syneos
Marie Emms has 20 years of experience in healthcare communications, spanning PR, medical education and patient engagement. She has spent the past 15 years focused solely in patient engagement, supporting pharma, biotech and CRO clients. She specializes in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness, consent through to compliance and adherence. Marie has worked on a wide variety of therapeutic areas across neonatal, pediatric, adult and geriatric studies.
 

Diana Foster, PhD
Vice President, Strategy & Development
SCRS

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.

 
Nancy Fuller
Director Customer Engagement – Shared Investigator Platform
Cognizant
Nancy has more than 20 years experience in consulting, process reengineering, and technology implementation related to clinical trials. Her pharma experience includes roles in Clinical Development, Clinical Training, as an IT Business Partner, and as an Organization Development Consultant for a Clinical Organization. She also has served as a consultant, advising CROs and Pharma companies in the adoption new technologies and how to gain benefits from technology investments. As the Director of Customer Engagement for the Shared Investigator Platform, she is responsible for partnering with customers and users to establish product priorities, develop the product roadmap, and define requirements. She also oversees product training and communications.
 
Melynda Geurts, MS
Senior Vice President, Site & Patient Engagement
Total Clinical Trial Management
Melynda Geurts' career has focused on advancing education within the healthcare industry for the past 23 years. Since 1998, Melynda has shifted her focus on educating the public about participating in clinical trials through global programs. She currently serves as the Senior Vice President of Site & Patient Engagement for Total Clinical Trial Management (TCTM). Melynda will focus on TCTM’s commitment to strengthening relationships with research sites and Investigators as well as maintaining the company’s track record of meeting 100 percent of enrollment targets on all completed studies. Melynda is invited often to present and train worldwide at industry conferences and has contributed to the industry's overall body of literature through her writing contributions. Melynda holds a M.S. in Healthcare Administration and a B.B.A. in Marketing.
 
Angela Gill Nelms
COO
Florence Healthcare
Angela has 10+ years experience driving clinical research efficiency and compliance. Her diverse sponsor/site experience includes improving inspection preparedness, activation/enrollment timelines, and implementing successful monitoring techniques. At Florence she drives the team to create easy-to-use resources that are complaint, reduce redundancy and errors, and ultimately lead to faster trial completion times. In her free time she is a mother, 6 time IRONMAN finisher, and student pilot.
 
Gretchen E. Goller, MSW
Global Head, Patient Recruitment and Retention Solutions
ICON
Gretchen has amassed over 20 years of clinical research experience, including work at the site, sponsor and CRO level. Gretchen leads the Patient Recruitment and Retention Solutions group at ICON working with a team of strategists to implement recruitment and retention programs on all pertinent ICON studies. Gretchen has a BA from the University of Massachusetts and an MSW from the University of Pennsylvania.
 
Clare Grace, PhD
Vice President Site and Patient Access
Syneos Health
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.
 
Scott Gray
CEO
Clincierge
Scott Gray is an innovative leader in the world of corporate meetings and clinical trial performance improvement. Founded in 1994 as a full-service meeting planning company (Gray Consulting, Inc.), Scott changed the direction of the company after a 2013 client meeting to discuss patients’ challenges with logistics for participation in global clinical trials. The Clincierge® concept was born as a means to improve recruitment & retention and contain timelines & budgets in clinical trials through customized patient-centric support services. In addition to his role as CEO of Clincierge, Scott has been Chairman of the World Orphan Drug Congress, sits on the Board of Governors at Valley Youth House in Philadelphia, and represents Clincierge as a Global Impact Partner with SCRS.
 
Rick Greenfield, BBA-IS
CEO
Realtime Software Solutions
Rick Greenfield is the CEO of RealTime Software Solutions, a leading Clinical Trial Management Systems provider. Rick also co-owned and managed one of the largest multi-specialty research sites in the US for nearly thirteen years where RealTime-CTMS was first created and implemented to streamline site operations for all staff and processes. Today, RealTime is the only CTMS vendor that can offer the industry-leading site SOMS (Site Operations Management System) that fully integrates CTMS, TEXT, PAY, eDOCS and eSOURCE into a single platform.
 
Karin Gulbrandsen
Sr. Director, U.S. Head, Global Clinical Operations
Janssen, The Pharmaceutical Companies of J&J
Karin has worked at Janssen Pharmaceuticals since March 2015 as the U.S. Head for Global Clinical Operations with focus on quality delivery of Late Development and Medical Affairs studies. She has 22 years of experience in the pharmaceutical business which includes experience in training, building capabilities, and leading global initiatives. She oversees the U.S. operational country teams managing programs across multiple therapeutic areas such as Neuroscience, Oncology, Immunology, CV, Metabolism, Infectious Disease and Vaccines. 
 
Freda C. Lewis-Hall, MD, DFAPA
Chief Patient Officer and Executive Vice President
Pfizer

During her 35-year career in medicine, Dr. Freda Lewis-Hall has been on the frontlines of healthcare as a clinician, researcher, and leader in the biopharmaceuticals and life sciences industries, passionately advocating for health equity and improved outcomes for all patients.
As Pfizer’s first Chief Patient Officer, Dr. Lewis-Hall leads Pfizer’s work to advance patient-focused programs and platforms – from drug discovery and development through patient access. Her commitment to patient-centricity serves patients globally by seeking their input, and understanding and responding to their needs, to help people live longer, healthier lives. From 2009-2019, Dr. Lewis-Hall served as Pfizer’s Chief Medical Officer.
Before joining Pfizer, Dr. Lewis-Hall held senior leadership positions with Vertex, Bristol-Myers Squibb, Pharmacia and Lilly. Prior to joining industry, she served as Vice Chairperson and Associate Professor in the Department of Psychiatry at Howard University College of Medicine and was an advisor to the National Institute of Mental Health. Dr. Lewis-Hall graduated from Johns Hopkins University and earned her medical doctorate at Howard University College of Medicine.
Dr. Lewis-Hall appears regularly on health-related television programs in major global markets, including CBS-syndicated shows such as The Doctors and Dr. Phil. She also shares health and medical information through GetHealthyStayHealthy.com. She currently serves on numerous boards including SpringWorks Therapeutics, Dell Medical School, Harvard Medical School, FasterCures, the Foundation for the NIH, and the Patient-Centered Outcomes Research Institute. >/p

 
Larissa Harrison
Regional Director
Qcare
Larissa Harrison is an experienced clinical research professional with over 10 years of industry experience. Larissa currently serves as the Regional Director of Qcare, an IQVIA company, where she provides operational oversite of Qcare’s Midwest sites as well as support in the growth and development of Qcare’s site network. Prior to joining IQVIA, Larissa served as the Director of Site Development for the largest, global Site Management Organization where she managed all aspects of establishing new research sites, training and mentoring new staff and establishing strategic partnerships and initiatives. Early in her career, she has also held roles as a Clinical Research Coordinator and Site Manager focusing on multiple therapeutic areas including endocrinology, immunology/vaccine, cardiology, and pain management. In her free time, Larissa is an avid world traveler and outdoor enthusiast enjoying activities such as hiking, sailing and snowboarding. Larissa holds a Bachelor’s Degree in Psychology from Arizona State University.
 
 
Chris Hoyle, MBA
Executive Director
Elite Research Network LLC
Mr. Hoyle entered clinical research in 2001 after obtaining his MBA. While working at a dedicated research site, he was involved in all aspects of investigator site management, including patient recruitment, budgets and contracts, and business development. In 2004, he founded Elite Research Network where he manages business development, feasibility, and strategy. He earned his BS in Zoology from NC State University and his MBA from UNC – Wilmington.
 
Anne Marie L. Inglis, PhD
Head of US Clinical Operations
GSK
Anne Marie Inglis began her career over 20 years ago at GSK (formally SmithKline Beecham) 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, Head of US Clinical Operations for GSK Pharmaceuticals 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 study start up and delivery of recruitment to plan. She received her PhD in Pharmacology at the University of Pennsylvania.

 
Denise Johnson Sura
Senior Engagement, Site Engagement
Eli Lilly and Company

Denise Johnson Sura joined Eli Lilly and Company in 2004 as a Clinical Research Associate and has since held a variety of positions across the organization supporting the global development of medicines. Presently, Denise leads the global organization responsible for the identification, qualification, support and collaboration with clinical trial sites participating in Lilly studies. Denise and her team recognize the value of site and patient feedback in the design of efficient and effective studies, ultimately leading to improved clinical trial experiences.

 
Janusz Kabata, MD, PhD, MBA
CEO
GP4research
Janusz Kabata MD, PhD, MBA is a successful entrepreneurial healthcare professional with 40 years of academic and executive experience in public and private healthcare sectors in Europe, and 30 years of experience in various aspects of clinical trial management, including managing central laboratory services and home-care services for global clinical trials. He is co-founder of GP4research that develops European GP Practice-Based Research Network. Prior to GP4research, he co-founded GlobalCare Clinical Trials Ltd, and developed the network of home care service providers in Europe and Asia. He established Synevo Central Lab. He is a specialist in public health and laboratory medicine. He was Associate Professor at Gdansk Medical University, Poland and Visiting Professor at Hematology Department at Basel University, Switzerland. He has been an invited speaker at several clinical research industry conferences and scientific meetings in laboratory medicine and hematology. With his wife, he manages GP practice in Gdańsk, Poland.
 
Victoria Kenny
Business Development Executive
Splash Clinical
Victoria Kenny is a Business Development Executive for Splash Clinical, an innovative patient recruitment firm that has pioneered the use of digital & social media to recruit patients for clinical trials. Ms. Kenny helps develop and foster partnerships with Sponsors, CROs and Research Sites.   Ms. Kenny has been with Splash for more than three years and is involved in encouraging the company’s focus on patient recruitment. Ms. Kenny has a broad range of experience in various therapeutic areas and has the knowledge to assist with any patient recruitment needs.
 
Jackie Kent
SVP Head of Product
Medidata

Jackie serves as SVP, head of product at Medidata. She has over 30 years of organizational development experience, including clinical development process, complex IT strategies, and system solutions. Prior to joining Medidata, Jackie spent 28 years at Eli Lilly, starting with technical IT and moving into leadership roles. She developed a comprehensive knowledge of information technology, clinical trial design & execution, as well as CT supply planning. Jackie also had accountability for the IT systems that supported these teams, including the Clinical Trial MRP system (SAP) and the Lilly IRT system. Jackie is a member of the Society for Clinical Research Sites (SCRS) Leadership Council, where she previously represented pharma companies, and now continues representing Medidata. Jackie received her B.S. in Computer Science from Butler University.

 
Jessica W, King, CCRA
Senior Manager, Site Partnerships
Covance, Inc.
Jessica King is a Senior Manager in the Site Partnerships Division at Covance. Her 22 years of experience in the clinical research industry has provided her with a strong expertise in study execution, leadership, effective communication and a comprehensive understanding of what it takes to remain innovative and successful in the face of a constantly changing research environment. Prior to joining the Site Partnerships team at Covance, she has worked in several roles over the years, including study monitoring, global project management and trial site and sponsor relations. Although she has worked across multiple therapeutic areas, Jessica’s passion lies in the field of oncology which has been her focus for the last 13 years.
 
Irfan Khan, MD, FACC, FHRS
CEO
Circuit Clinical
Dr. Irfan Khan is a board-certified cardiologist, principal investigator and CEO of Circuit Clinical, an Integrated Research Organization (IRO). He has led the successful development of multiple eClinical products. His passion for the intersection of patient engagement and technology has led to numerous national speaking engagements, including TEDx. 

 
Kim Kundert, RN, BSN
VP Operations
VirTrial

Kim Kundert is an experienced research executive and currently VP of Clinical Operations for VirTrial. Prior to VirTrial, she served as the SVP of Operations for Radiant Research/Synexus, the largest site network in the world. Kundert was responsible for overseeing operations and performance of 84 research sites across the US. In her 19 years at Radiant, Kundert helped develop a platform of standardization across the network sites and had some hand in approximately 10,000 trials. Kundert has served on pharmaceutical advisory boards and CRO planning committees to provide input on protocol development and enrollment strategies from a site’s perspective. Kundert is a winner of two Stevie Awards for women in Business- Best Executive in Service Businesses in 2011, Silver Stevie for Female Executive of the Year in 2012. Kundert graduated Summa Cum Laude from Arizona State University with a bachelor’s degree in Nursing.

 
Barry Lake
CEO
Devana Solutions
As CEO of Devana Solutions®, Mr. Lake is responsible for overall strategic vision and execution (www.devanasolutions.com). Devana Solutions® IGNITE FOR SITES is the leading cloud-based operations and data analytics platform for clinical research sites, site networks, Academic Medical Centers and Health Systems. By having all functional teams on a common platform from trial lead through completion means better accountability and process efficiency allowing site leadership to leverage data analytics to drive operational improvements. IGNITE FOR SITES technology automatically captures key site timing and performance metrics data which can then be displayed and reported to Sponsor and CRO clients validating a site’s performance reliability and leading to more trial awards. Devana Solutions® transformative MATCH PERFORMANCE technology works in tandem with IGNITE FOR SITES. The companion technologies allow Sponsors and CROs and their research site, site network, Academic Research Center or Health System partners to achieve an unprecedented level of operational alignment through performance data transparency. Specifically, the technology allows these research stakeholders to synchronize and share not just historical site metrics data but, also, real-time performance metrics on currently running trials laying the foundation for a true collaboration between investigative sites and industry Sponsors and their CROs and a drastic reduction in clinical trial cycle time and costs. As a result, new therapies to benefit patients can be delivered faster and more cost effectively.
 
Matt Lowery, ACRP-CP, CCRC
Director
CRBD+

Matt holds the ACRP-CP and CCRC certifications through ACRP, is a member of SCRS, ACRP, MAGI, and SoCRA. He has over 12 years of experience in clinical research on both the site and sponsor level. On the site side, Matt has worked as a study coordinator, site manager, director of clinical research, and assists other sites with general consulting, business development, and budget/contract negotiation. On the sponsor side, he’s gained knowledge and experience in monitoring, clinical operations, finance and accounting, and has drafted and revised several protocols for Parkinson’s disease and provided insight for protocols for Alzheimer’s disease, autism, hallucinations, multiple system atrophy, and schizophrenia.

 
J. Daniel Mallory IV, Esq.
Head, Regulatory and Contracts
Qcare Site Services, Inc.
A native of South Carolina, Daniel studied Psychology at The Citadel, and participated in research, presenting twice at annual conventions of the South Eastern Psychological Association. Upon graduation, Daniel attended the University of South Carolina School of Law where he earned his J.D., and became a practicing attorney in 2011. In 2014 Daniel moved to North Carolina’s Research Triangle to work for Quintiles where he specialized in Start Up with major Academic Institutions. In this position, Daniel learned many of the concerns of Sites in the budgeting and Start Up processes, and worked closely with Sites to educate Sponsors on their particular circumstances and needs. In March of 2018, Daniel joined Qcare to lead the Regulatory and Contract group, to take on the next step in addressing the challenges Sites face as they navigate towards Initiation into studies.
 
Ana Marquez, MSF
Founder and CEO
Marquez ClinicalSite Partners, LLC
Ana T. Marquez, is the founder and CEO of Marquez Clinical Site Partners, LLC, a network of rapidly growing investigative sites in the USA. Prior to entering the research world, she worked as a Practice Administrator, and Accountant for several years. Ana then worked as the Chief Operating Officer and CFO for a highly successful clinical research site in Florida, until she opened up her own Company and began building new research teams in various therapeutic indications. Because she’s been exposed to the coordinating, the financial, and administrative aspects of conducting a clinical trial, she has an overall understanding of the challenges facing sites today. Ana has consulted for sites across the country, helping them improve their financial operations, negotiating clinical trial budgets, establishing sound accounts receivables processes, preparing for FDA inspections, and implementing quality control programs. Additionally, she’s very passionate about helping sites understand the importance of having a solid grasp on financial operations, and the impact that negotiating sound budgets has on their bottom line.
Ana earned a Masters of Science degree in Finance from Florida International University. Currently, she serves as Chairman for DIA’s SIAC’s Committee for Investigative Sites globally, and works closely with SCRS as Chairman of the Membership Committee. With a strong background in finance and accounting, she has spent a number of years negotiating clinical trial agreements and budgets in various therapeutic indications for a number of sites. Throughout the years, she’s served as a Clinical Research Coordinator, Research Director, Chief Operating Officer, CFO, Site Owner, as well as an industry speaker and moderator at clinical research conferences.
 
Effie Manos
Associate Director - Neuroscience, Global Clinical Operations
Janssen Research & Development
Effie Manos has been in clinical research for almost 20 years. She has held various positions in data management, study coordination, quality assurance, site management, training, operations management and leadership. Since 2001, Effie has been at Janssen- the pharmaceutical division of Johnson & Johnson. She is an Associate Director in Global Clinical Operations for Neuroscience. She currently leads a successful team in optimizing operations to bring new therapies to market. Effie is also the Diversity in Clinical Trials Lead for Janssen where she and her team work on developing partnerships and raising awareness in disparities associated with Clinical research. She is an avid yogi and resides in Portland Oregon with her 2 children and cinematographer husband where they fully enjoy all the Northwest has to offer including hiking, biking, and exploring.
 
Jason Methia, MS
VP, Sit SiteVault & Clinical Network
Veeva Systems

Jason is accountable for Veeva’s overall site technology strategy. Prior to joining Veeva in 2013, Jason held a variety of roles within clinical development at the Dana Farber Cancer Institute, Wyeth Research and Vertex Pharmaceuticals. Jason received his M.S. in drug development and regulatory affairs from Northeastern University and his B.A. in psychology from the University of Vermont.

 
Dan Milam
Vice President Global Engagement
SCRS

With over twenty years of experience working in the pharmaceutical, CRO, and site sectors, Dan has gained a wide perspective and understanding of the needs of the industry as a whole that aid to facilitate and build strong alliances. His focus is on expanding SCRS’ global footprint and the inclusion of all industry stakeholders in SCRS initiatives with the goal to foster sustainability for clinical research sites.

 
Mohammad Ali Millwala, MBA, CPA
CEO
DM Clinical Research
Founder and CEO of DM Clinical Research, Mohammad has been a natural entrepreneur in the healthcare sector since 2002. DM Clinical Research is an industry leading, multi-therapetic site network that has successfully conducted over 845 trials. DM Clinical Research comprises of 13 sites in Chicago, Houston, San Antonio and Alexandria.
 
Raymond Nomizu
Co-Founder
Clinical Research IO
Raymond Nomizu is co-founder of Clinical Research IO (CRIO), the industry leading eSource system for research sites. CRIO enables sites to streamline workflows and improve compliance, and is based on Raymond’s experience as the owner and manager of a dedicated research site. Raymond spent the bulk of his career as a management consultant, first with The Boston Consulting Group and then as an independent. He has a JD from Harvard University. 
 
Lance Nickens
President
The Patient Recruitment Agency
Lance Nickens is the President and founder of The Patient Recruiting Agency™ (TPRA), a full service global patient recruiting and retention organization supporting Investigators, CROs and Sponsors since 1999. Mr. Nickens holds a B.A. degree in marketing from the University of Texas-Austin and has over 20 years of advertising and marketing experience with 19 years specifically in patient outreach campaigns for clinical trials. Since 1999, Mr. Nickens 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. TPRA’s strategic focus is derived from Mr. Nickens’ creative energy, client orientation, drive for accountability and passion for creating and developing unique technological solutions. Mr. Nickens’ 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. 
 
Carlos E. Orantes , BS, MBA
CEO
Accel Clinical Research Sites
As CEO, Mr. Orantes provides strategic direction and leadership to Accel Clinical Research Sites and its affiliates. Bringing 24 years of experience of CRO and life sciences, his background includes executive/operational management, process re-engineering, compliance and business development. Prior to joining Accel, he was COO of Frontage Laboratories, where he led efforts to expand the company’s capacity of services and managed the business that led to a successful recapitalization. Mr. Orantes was previously CEO of AVANZA Laboratories. He developed the company’s strategy and led the business to a successful asset purchase by the Smithers Group. Prior to AVANZA, he was GM/VP for Bridge Laboratories, a toxicology and immunology testing laboratory where he managed the US operations. Earlier positions included 10 years of operational, quality assurance, process improvement and management roles of increasing responsibility at Covance. Mr. Orantes earned an MBA from Old Dominion University, and a BS in biology from George Washington University. He is Six Sigma Black Belt certified from the Six Sigma Academy.
 
Casey Orvin
President
Society of Clinical Research Sites (SCRS)

Casey Orvin is President of the Society for Clinical Research Sites (SCRS). With nearly 20 years of experience working with the site community, Orvin previously served as Executive Vice President of Business Development for Synexus, and Vice President of Marketing and Sponsor Recruitment for Clinical Research Advantage.

Orvin is a champion for clinical research sites with experience creating outreach programs, developing key partnerships, and generating study opportunities for hundreds of clinical research sites globally. He is an active community member and dedicated volunteer in the Phoenix area where he lives with his wife and three children.

 
Al O. Pacino II
President, Co-Founder
BlueCloud by HealthCarePoint

Mr. Pacino is a USA veteran and a senior executive with over thirty-five years of experience in healthcare and clinical research. Co-Founder and current President of the BlueCloud by HealthCarePoint.com a leading global network of over 1,500,000 healthcare and clinical research professionals from more than 500,000 organizations focused on providing tools and “real-time” networking technologies based on GDPR and CCPA laws which empower members to own, manage and share their information for everyday operational, managerial, compliance and standards processes by connecting healthcare and clinical research stakeholders. Mr. Pacino is a past member of the Association of Clinical Research Professionals (ACRP) Editorial Advisory Board and past chair of the Central Texas Chapter. Mr. Pacino is also actively involved with NIH based global standardization programs among multiple other global healthcare and clinical research initiatives. He is also a 14-year cancer survivor.
Specialties: He has previously introduced the phenomenon and coined the phrase “TrialDrift”, and along with other experts in the field has been able to bring to the forefront the issues, causes, consequences and solutions associated with such clinical research phenomenon. He has extensive experience with standardization, collaborative networks creation and is working alongside industry leaders to eliminate redundancies and minimized costs within healthcare and clinical research.


 
Scott Palmese, MS, BE
VP, Site Operations
BTC Network
Scott Palmese is Vice President of Site Network at BTC Network and has been in the research industry for close to 10 years. As a member of the leadership team at BTC Network, Scott oversees the daily operations of the company and provides guidance for the development of new processes and initiatives. Scott specializes in site operations, including business development, financial management, and patient recruitment and engagement.

 
 
Christopher Petek, MACPR, CCRC
Research Director
Great Lakes Medical Research, LLC
Christopher attended The Ohio State University where he completed both his undergrad in Neuroscience and Masters in Clinical Research Management and Regulatory Affairs. He has over 6 years of clinical research experience both academic and industry with experience in Phase I to VI trials. He is currently the Research Director for Great Lakes Medical Research and Clinical Director for the The Clinical Trials Network (CTNx).
 
Melissa Poindexter, RN BSN
President
Advances in Health
Melissa Poindexter, R.N.,BSN, is president of Advances In Health (AIH), established in 1998. AIH is an independent clinical research site, collaborating on Phase I – IV trials, in Houston, Texas. Melissa is a member of the Consortium for Diversity in Clinical Research (CDCR), SCRS, ACRP, DIA, SOCRA and Diversity in Clinical Trials Workstream.
 
Nazeen Queresh,Bsc (Hons)
Manager, Patient Engagement & Clinical Projects
LMC Manna Research
Nazneen Qureshi is the manager of patient engagement at LMC Manna Research. In this role, she manages study start-up activities, focusing on recruitment and retention strategies. Her objective is to increase the understanding of patient perceptions to improve clinical research processes such as study design, experience, and motivation to participate. Qureshi is the recipient of the SCRS 2017 Site Patient Recruitment Innovation Achievement Award. She holds an HBSc in neuroscience and psychology from the University of Toronto and is completing her MBA at Lazaridis School of Business & Economics.
 
Marisa Rackley, BS, MHA
PMP - Director
Vertex
Marisa Rackley is the Director Clinical Development Execution/Head of Site Engagement at Vertex. In this role, she oversees the country and site allocation process for all studies across the portfolio. She serves as lead of the Regional Site Advocate group for North America. Prior to joining Vertex, Marisa was a Director at Merck & Co., where she worked for over 16 years with increasing areas of responsibility within Global Clinical Trial Operations. She has led cross-functional development teams in bone, endocrine, metabolism, cardiovascular and atherosclerosis in end-to-end development.
 
Amanda Rangel
VP, Business Development
Virtrial

Amanda has spent 15 years in the clinical research industry serving a variety of functions including clinical research coordinator, patient recruitment and engagement specialist, business development, and head of operations for a US based site network. Most recently, Amanda served as Sr. Director, Global Business Development for Synexus, the largest site network in the world. Amanda is now fortunate to help lead VirTrial's integration of telehealth into the clinical research industry.

 
Sean Rice, CPA, MBA
CEO & President
Medical Research South & Medical Research Alliance

Sean is currently responsible for the strategic vision and day-to-day operations for Medical Research South and Medical Research Alliance, which are based in Charleston, SC. Previously, he served as the Vice President of Finance and Operations from 2010 through 2012. Before joining Medical Research South, Sean was the Vice President of Finance at Genscape, Inc. Sean holds a bachelor’s degree in business administration with an emphasis in accounting from Alma College and an MBA with a focus in entrepreneurship from the University of Louisville. He is also a licensed CPA in the state of Kentucky.

 
James Riddle, MCSE, CIP, CPIA, CRQM
Vice President, Institutional Services
Advarra
 
MaryAnne Rizk, PhD
SVP, Digital Strategy Business
IQVIA
 
Debra Rogge, BSN, MSA
Clinical Research Manager
AstraZeneca Pharmaceuticals

Debra Rogge, BSN, MSA Associate Director Astra Zeneca Pharmaceuticals. Debra is a registered nurse and hold a Master’s Degree in the Management of Health Care Services. Debra‘s Clinical Research Experience has spanned numerous roles in the past 21 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 negotiations and budgets, Global Trial Master File, CTMS and Regulatrory submission systems and Quality Indicators for the US Site Management and Monitoring organization

 
Jeffrey Rosen MD
Medical Director
Clinical Research of South Florida
Jeffrey B. Rosen, MD, board certified family physician and also Medical Director and founder of CRSF , has more than 30 years’ experience in clinical research and has conducted over 650 clinical trials in many therapeutic areas. He is a founding member of the Alliance for Multispecialty Research and speaker for several pharmaceutical companies. Dr. Rosen has presented clinical trial results at the European Association for the Study of Diabetes in Vienna, Stockholm, Paris and Berlin and his articles have been published in various medical journals.
Since 2008 Dr. Rosen has been a Medical Director and founder of Community Medical Research, a research site located in Miami, Florida, associated with three community health centers with a large OB/GYN, pediatric and internal medicine patient population.
In addition to engaging in clinical research, Dr. Rosen practices Family Medicine with PrimeCare of Coral Gables, a division of PrimeHealth Physicians, a private group practice adjacent to his research site.
Dr. Rosen is an associate clinical professor of Family Medicine at the University of Miami Miller School of Medicine and at the Florida International University Herbert Wertheim Medical School. He graduated from SUNY Downstate Medical Center in 1979 and is a fellow of the American Academy of Family Physicians and a Diplomat of the American Academy of Family Physicians.
 
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, BA, MICP
Executive Director, Clinical Operations
AstraZeneca

Doug Schantz is an Executive Director in Clinical Operations at AstraZeneca. He’s responsible for US site management and monitoring, risk-based quality management implementation and late-phase CRO outsourcing. Prior to joining Astrazeneca in 2015, Doug worked at Pfizer for 17 years and Eli Lilly previously for 8 years. Doug Started his career as a study coordinator at a group of urgent care centers in central New Jersey. 

 
Kay Scroggins, RN
President & CEO
Clinical Trials of Texas, Inc.

I began my career as a registered nurse (RN) and after many years of working in various roles within a hospital setting and conducting nursing research, I began my first position as a clinical research coordinator. In 2001 my life as a business owner and entrepreneur began when I founded Clinical Trials of Texas, Inc. (CTT). CTT has grown to be one of the largest stand-alone research sites in the U.S. conducting over 100 trials/year. We are recognized for our high quality, meeting enrollment goals and breadth of capabilities- Phase 1-4 in multiple therapeutic areas. Our paradigm at CTT is partnering with sponsors/CROs to bring new treatments to our community and our world as efficiently as possible. It is an honor to be in an industry that works to improve lives.

 
William B. Smith, MD, FACC
President
NOCCR/VRG, An AMR Company, LLC
William B. Smith, M.D. Professor of Medicine, University of Tennessee Medical Center, Knoxville, TN President, New Orleans Center for Clinical Research and Volunteer Research Group Chief Executive Officer, Alliance for Multispecialty Research. Dr. Smith is the Founder of Volunteer Research Group and New Orleans Center for Clinical Research located within the University of Tennessee Medical Center in Knoxville, Tennessee where he is currently a Professor of Medicine. He is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care Medicine. Dr. Smith is Chief Executive Officer of the Alliance for Multispecialty Research, a clinical research company with 22 locations across the country conducting trials in most clinical areas. He has been involved in over 1875 clinical research trials over the past 35 years including cardiac disease, renal/hepatic disease, early development in healthy volunteer and patients, diabetes, women’s health, obesity, neurology including Alzheimer’s, smoking cessation and numerous variations of PK trials including SAD/MAD, patient-based and complex trials. He has extensive vaccine experience in Phases I through IV studies and is a frequent lecturer and author who publishes extensively in clinical and scientific journals.
 
 
Michaela Vancova, Ing., MPH
Clinical Operations Director, Co-founder
Slovak Research Center
Michaela is a chemical engineer with a Masters in Public Health and 12 years of experience in clinical research. She has had a variety of experiences in different positions -  from CRA, LCRA, PM in both CROs and big Pharma companies to founding Slovak Research Center, where she is the Clinical Operations Director. Previous companies: Icon, KCR, Octapharma, Boehringer Ingelheim. 

 
Vivienne van de Walle, MD, PhD. CPI
Director & PI
PT&R

Viviënne van de Walle studied medicine both at the University of Maastricht and at the University of Oxford. In 2004 she successfully defended her thesis for her PhD and in 2011, she passed the CPI exam. She has always combined clinical research with patient care and has been a full time investigator at independent clinical research sites. She co-founded and owns the independent research site PT&R (www.ptr.nu) since 2006. Her entrepreneurship is reflected by her skills as thought leader and in consulting, education, management, and executive functions at CROs, pharma and trade organizations i.e. ACRP, SCRS, TransCelerate and NVFG. With her PT&R-team she was also the proud winner of the inaugural SPRIA EU. She started her research career as a participant in a clinical trial. As a result, Vivienne has a unique perspective of the various sides of the table in clinical research and is eager to share her many years of experience.


 
Karri Venn, RD, CDE, CCRC
President, Research
LMC Manna Research

Karri Venn brings over 20 years of clinical research experience working at LMC Manna Research. Ms. Venn has brought experience, knowledge and drive to many of the positions held at LMC Healthcare. In 2006, Ms. Venn was promoted to Director, Research of LMC Clinical Research and subsequently in 2015 to President, Research of LMC Manna Research with a key responsibility of integration of Manna Research with LMC to create the largest clinical community integrated research organization site network in Canada. Additional responsibilities include the successful openings of 11 LMC Diabetes clinics across Canada which is now the largest Endocrinology group practice in the world and the opening of Canada’s only Diabetes Clinical Pharmacology Research Unit. In total, there are 20 sites that include expertise in all phases of research from Primary Care to Metabolic Focus.

 
Rick Ward
Vice President, Commercial Operations
Trifecta Clinical, USA

Rick Ward is Vice President of Commercial Operations at Trifecta - a leading global clinical technology solutions provider, producing more than 350 live, on-demand and web-based Investigator meetings each year in 87 countries. Prior to joining Trifecta, Rick has driven commercial growth strategies and led business development efforts for various CRO and niche service organizations supporting the Clinical Trial industry. Rick has over 20 years of business development experience, in both direct sales and sales management roles. Rick graduated with a degree in Marketing from the Pennsylvania State University and is a member of the Hammond Society, having served on Penn State’s Smeal College of Business Alumni Society Board of Directors from 1999 through 2013. Rick is also one of the founding members and former President of the Smeal Business Club of Philadelphia.

 
Shaun Williams, PMP
VP, Investigator Management Solutions
Syneos

Shaun Williams, Vice President of Investigator Management Solutions at Syneos Health, has more than 15 years’ experience directing a broad spectrum of operational activities in FDA-regulated industries. As the strategic business unit lead over Syneos Health’s investigator payments, transparency reporting and payments forecasting services, he has been instrumental in tailoring services that lessen site burden while satisfying sponsors’ needs. Mr. Williams holds a Bachelor of Science in Mechanical Engineering from the United States Military Academy at West Point and is a certified Project Management Professional (PMP.)

 
Mark Wolff, PhD
Advisory Industry Consultant , Chief Health Analytics Strategist
SAS Institute

Dr. Wolff has more than 25 years of experience in the health and life sciences industries as a scientist and analyst working in the US and Europe. He joined SAS in 2005 and is an Advisory Industry Consultant and Chief Health Analytics Strategist for the SAS Global IoT Division. Mark is recognized as an accomplished practitioner and thought leader in the development and application of advanced and predictive analytics to complex problems in health and life sciences. Current work focuses on methods and application of Machine Learning to real time sensor/IoT data in support of outcomes and safety research, and the development of intelligent, decision support systems.

 
Amanda Wright
Executive Director
Greater Gift

Amanda Wright has been involved with Greater Gift since its inception in 2010. As of 2013, Amanda assumed the role of Executive Director for Greater Gift, and since that time, she has led program development and expansion to include more than 30 industry partners. Ms. Wright has a passion for patient engagement and believes that the patient needs to be the top priority for those innovating and collaborating. She serves on numerous boards and committees throughout the industry, many of which are centered around the engagement of patients and enhancement of the clinical trial process to address current industry trends. When she is not working, she enjoys cheering on her sons at sporting events and spending time on her farm.


 
Michael Yon
President
Hylant
Mr. Michael Yon has been President of Hylant Nashville Office at Hylant Group, Inc. since May 2016. Mr. Yon is responsible for developing the strategic vision and driving the continued growth and profitability of the Nashville office. Joining Hylant in 2002, Mr. Yon has designed and managed many diverse property and casualty insurance programs, including specialized solutions for pharmaceutical, medical device and clinical research affiliated companies.


 
css.php