2019 Site Solutions Summit Faculty

Mr. Anthony Abey, Chief Executive Officer, is a founding executive of Alliance Clinical Network. Under his leadership, the company has seen significant revenue growth while expanding the businesses into multi-specialty research facilities across multiple states. Mr. Abey has a Bachelor of Science Degree specializing in Finance from California State University Northridge.

Laku is an experienced leader of software engineering teams and executive. He loves technology when used as an enabler to help solve real world problems. Laku focuses on defining a strategy and helping teams execute to it. He also communicates this strategy to customers, other executives and board members.

Experienced Compliance/Quality Professional with a demonstrated history of working with Clinical Research, Regulatory Affairs, Medical Affairs, and Pharmacovigilence teams in the pharmaceutical industry. Skilled in leading global/regional cross-functional teams, change management and training management.

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.

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.

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.

Anna currently leads Veeva's site solutions strategy to deliver innovative technology solutions to clinical research sites. Prior to joining Veeva, Anna spent 10 years in clinical research operations leadership working at Mayo Clinic, Georgetown University, Houston Methodist, and UCSF. For the past 5 years Anna has focused on clinical research technology with CTMS integrations, EHR clinical research implementations, eTMF, and billing compliance business process design. Anna's research expertise includes study feasibility and logistics planning, research operations finance and forecasting, research program development, Epic Research Applications, CTMS, EHR billing compliance and system design, coverage analysis, eTMF, eRegulatory/ISF implementation and clinical research business process design.

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."

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.

Sameer Ather is a cardiologist and data scientist based in Birmingham, Alabama. As a physician-scientist, Dr. Ather faced the problem of poor patient recruitment in his clinical trials. To solve the problem of poor patient access, he cofounded XpertDox with a mission of improving patient access to healthcare and clinical trials by leveraging big data analytics. One of the products, XpertTrial, is a white labeled, clinical trial search engine and patient recruitment platform for in-network clinical trials that is custom built for individual trial sites.

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.

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 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 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 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 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 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 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.

Lisa Bjornestad has over 20 years of clinical research experience. She has extensive experience in site operations, having directed both early and late phase research centers for the better part of her career. She has also worked in Project Management and Business Development. Currently, she is the Director for the PAREXEL Site Alliance program in the Americas.

Dr. Nicole Brainard is a trained behavioral scientist whose career centers around the application of behavior change techniques to foster sustainable health behavior change, and improved health outcomes. With ten years of behavioral science experience, Dr. Brainard has collaborated with large health care payers, cancer centers, community-based organizations, and academia. During that time her work largely focused on improved access to care, cancer survivorship, and healthcare payment and delivery reform.
Currently, Dr. Brainard manages the development and implementation of digital behavior change interventions for internal and external partners. Some of her projects include the 7 Minute Workout®, My Care Activator on cancer.com, and thought leadership in patient – provider wellbeing. Dr. Brainard also contributes her expertise in intervention mapping – a protocol for developing, implementing, and sustaining evidence-based health promotion programs.

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 Irish America Healthcare and Life Sciences 50, which recognizes the work of Irish-American and Irish-born medical professionals. Dr. Brennan earned her medical degree from Windsor University in the West Indies, her MBA with distinction from Hofstra University and her bachelor of science from St. John’s University.

Julia Brenner, MHA is the current Finance and Regulatory Manager at Coastal Pediatric Research, a research site embedded in a large group practice dedicated to pediatric research and sub-specialty pediatric research. She currently manages all budget and contract negotiations, regulatory start-up and maintenance, policies and implementation of the site’s QA program, and non-licensed clinical research coordinators. She is the super-user for the site’s CTMS, Clinical Conductor, and eRegulatory system, Complion. Julia has been working in pediatric research for almost four years.

Carolyn demonstrates passionate and effective collaboration, knowledge and content professional with expertise in project management, communications and information management. She is proficient at designing and managing collaboration and content solutions, recognized for developing and fostering business partnerships, and acknowledged for combining analytical and problem solving expertise to deliver business solutions.

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 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 develops marketing strategies for clinical research studies, new site development, and company brand. As the Director of Marketing, he identifies the current and future needs of the company and align the marketing strategy to aid in accomplishing those goals. His job functions include, but are not limited to developing marketing plans, overseeing daily study advertising, measuring success and correcting issues, managing budgets, designing graphic collateral, identifying ways to target new sites, managing online presence, and planning for a cohesive corporate culture.

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.

Greg brings to Clincierge a bachelor’s degree in business administration and marketing from Robert Morris University, extensive and diverse experience as a sales leader, and a 15 year successful track record as Director of Sales for companies such as OraSure Technologies, Roche (Boehringer Mannheim Corporation), and American Medical Depot (AMD)”. He has effectively led organizational change management initiatives and specializes in sales team growth and development.

Daniela is a highly skilled data scientist with over ten years of experience in leveraging data insights to influence positive change. Passionate about promoting inclusion for all.

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.

Kevin has 3 years at PRA and over 20 years in the industry. Having had a distinguished private sector career, Kevin chose to come to PRA as a “second career.” This extended his experience in health care law and brought a new point of view to PRA for research. Kevin is a member of the Bar in the Commonwealth of Virginia. He graduated of the University of Virginia where he was member of the Virginia Law Review and Order of the Coif. He serves as Senior Advisor to PRA CTA negotiators and liaison to Legal Counsel of our Top Pharma and Biotech clients.

Christian has been serving in the capacity of Director of Clinical Site Management since December 2016. Christian joined Pfizer in 2010 as a Clinical Operations Lead and has served in various roles of increasing responsibility including Investigator Site Development Lead and Director of Compliance & Oversight. Prior to these experiences, Christian served as Clinical Trials Manager at MassBiologics, Boston. Christian has a BS in Biology from the University of Massachusetts and a Masters Science degree in Clinical Investigation from Boston Massachusetts General Hospital Institute of Health Professions.

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.).

Yvonne is an experienced Owner with a demonstrated history of working in the research industry. She is skilled in Electronic Data Capture (EDC), Oncology, Good Clinical Practice (GCP), Clinical Research, and CRO Management. Yvonne is a strong business development professional and is a graduate of Arkansas State University.

Stephanie is a 52-year-old Cystic Fibrosis patient, diagnosed at the late age of 13. At that time the life expectancy was living to 18-years-old. She also has CF-related Diabetes and has been insulin-dependent for 16 years. Stephanie entered her first clinical trial 17 years ago and has sought participation in several others. In October 2018, Stephanie entered a new clinical trial with 3-4 hour-long appointments every 2 weeks. Today she remains on the drug, with visits every 3-4 months. Stephanie has a career in corporate America, has been married for 20 years and has an adopted daughter in her first year of college.

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.

Dr. Asha S. Collins is the US Country Head for Country Clinical Operations at Genentech, a member of the Roche Group. Previously she led the US Clinical Trial Sourcing business at McKesson Corporation, one of the largest healthcare organizations in North America. Prior to McKesson, Asha focused on creating new operating models for leading biopharmaceutical companies as a management consultant working at Quintiles Consulting, then at Deloitte, where she led the global process redesign of a clinical development process for the largest pharmaceutical company in the world. In addition to her passion for transforming biopharmaceutical companies, Asha is equally passionate about using her skills and experience to build communities. She is a mentor for Backstage Capital, helps lead community activities with Healthcare Businesswomen’s Association, an angel investor and has ongoing work focused on improving healthcare access in East Africa. Asha Collins earned a Ph.D. in Cancer Biology from the University of Wisconsin-Madison and a B.S. in Biology from the University of Pittsburgh. When not working on business plans for startups or Fortune 500 companies, you can find Asha out in nature, on a yoga mat or simply out adventuring.

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.

Dr. Cruz currently leads the Medical Affairs team for the Shared Investigator Platform at Cognizant. His role has been vital to Sponsor and Site adoption. He currently leads the efforts to onboard + 120 top Academic Medical Center and Organizations around the world. Dr. Cruz also leads the Cognizant SIP Global Adoption. He received his M.D. degree from UAG School of Medicine and currently working on his MBA from the University of Nebraska Omaha. He is actively involved at conferences around the world and helps drive SIP requirements and road map. Dr. Cruz has worked at CHI Health, Nebraska Medicine, and the University of Nebraska Medical Center. He has experience in multiple therapeutic areas service as researcher, scientific writer, study manager, and regulatory expert. Prior to that role, he worked at Blue Cross Blue Shield Health, where he acquire a better understanding of how the payer side works.

AC Corbin has had a long career in global law, contracts, and regulations. AC has served as General Counsel and as a consultant for boutique CROs and technology companies, addressing international contracts and establishing infrastructure to internalize regulatory compliance in these organizations. AC lead the establishment of a Fortune 500 company’s Phase IV global contracting, budget, and regulatory teams, establishing a body of Phase IV regulatory knowledge and infrastructure and the teams to negotiate these considerations. Most recently, AC joined the IQVIA Virtual Trials team and is facilitating the establishment and assimilation of global regulations addressing the operations of Virtual Trials in Phase II, III, and IV research, as well as leading the global contracting and budget teams in Virtual Trials.

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 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 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.

Kathy Cox is a business owner and entrepreneur who lives on the leading edge. Kathy received her B.S. Ed. degree in 1984 and her master's degree in Exercise Physiology in 1989. While writing her thesis,Kathy developed her passion for research. Kathy started in the clinical research industry in 1989 working as a coordinator at the VA Hospital in Madison, WI. From there she moved to the UW Hospital and Clinics working as a research coordinator on NIH funded asthma research studies. Kathy saw an opportunity to provide centralized business development activities for clinical research sites and was off and running having established one of the industry’s first TMO's in 1996. She continues to work that business model today and enjoys the reputation of being a trusted, connected, leader. Kathy has two children who are both graduates of the University of Wisconsin. She enjoys spending time with family, traveling, speaking at conferences, fishing and officiating high school basketball games.

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.

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 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 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 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 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.

Kristi Etchberger founded Clinical Research Billing in October 2015 to help independent research sites manage their CTMS and generate cash flow through invoicing and collections. After nearly four years, she and her partners have built Clinical Research Billing into a successful, growing small business.

Rick has over 25 years of healthcare and clinical research experience. Currently Rick is the Head of Site Activation Operations at IQVIA, leading all aspects of Site Identification and Start Up in North America. Rick has spent the past 12 years in leadership roles at IQVIA where he was hired to help pioneer the IQVIA Prime and Partner program in North America. Rick led the IQVIA Global Feasibility team where he gained insights and expertise that support his role today. Rick has prior research experience in the medical device industry and has managed an academic research program at Duke University. Rick is committed to bringing a site and patient centric experience to the Clinical Research Industry.

Greg Folz is a 20+ year veteran of the life sciences industry where he has overseen the conduct of more than 800 clinical trials. He was recently recognized as 2018 Top 20 Innovators in the clinical research industry; the recipient of the 2016 SCRS Site Tank Award for Innovation; and a finalist for the Society for Clinical Research Site’s 2015 Innovation Award for patient recruitment. He serves as a national consultant and speaker on the development of clinical research operations and business structures, and has assisted more than a dozen US hospital systems, networks, and physician groups on the strategic growth of their clinical research initiatives. Greg is the founder for Kits4Life [www.kits4life.com], a nonprofit platform for the Life Sciences industry to repurpose unused clinical trial labs kits for humanitarian aid. He is also the co-founder of the Cardiovascular Research Consortium [www.cardiorc.com], a nationwide network of community-based cardiology practices. Prior to his career in the life sciences industry, Greg excelled in healthcare administration, where his strategic marketing efforts were featured in US News & World Report, Fortune, Advertising Age, Hospital Magazine, Modern Healthcare, numerous other trade journals, and in four college textbooks.

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 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.

Laura has a unique role which blends internal and external components. Laura is Merck & Co., Inc.’s assigned leadership to the Oversight Committee of TransCelerate BioPharma Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck’s objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.

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 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.

Kerry Gorman is a professional who has developed an understanding of clinical research and customer service through her past industry roles and current role as Head of IQVIA Strategic Site Solutions for the US and Canada.

Kerry’s prior position with a large research network has allowed for the right skills and knowledge to further develop and foster relationships via the IQVIA Prime and Partner site program. Kerry’s earlier career included work with pharmaceutical companies and innovative medical education communication ventures, which both have added to the depth of experience and insight needed for our current clinical research environment.

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.

Dr. Grach, President & CEO, has more than 30 years of experience in clinical research and has been influential in guiding her company’s growth and development.

Sharon Hanlon is Head of Engagement & Enrollment at Bristol-Myers Squibb (BMS). Throughout her 19 years at BMS, Sharon has held clinical development positions of increasing responsibility from Line Management to Project Management across multiple therapeutic areas including cardiovascular, metabolics, immunology and oncology. Sharon’s team builds relationships with site and patient groups to gather insights about their disease/clinical trial experience and explore potential tactics to recruit more patient and site friendly clinical trials. Sharon received her Master of Sciences in Nursing from Thomas Jefferson University in Philadelphia, PA and prior to her career in pharma, had a career as a critical care nurse, nurse educator and research nurse coordinator at hospitals in the Philadelphia area.

Ramy has been in clinical research for 19 years and currently works at Pfizer as a Site Relationship Partner. He graduated from the University of Michigan with a B.S. in Biochemistry and lives in San Diego, CA.

Dr. Hoeck is responsible for the overall management of Trialcare Research. Dr. Hoeck has extensive senior clinical experience both as a clinician, scientist and as a PI on numerous studies from Phase I-IV. He has worked as a senior executive in the biopharmaceutical industry for over 15 yearsDr. Hoeck founded Trialcare Research with the purpose to bridge critical gaps between science and patient care. This includes a vision to share accumulated knowledge from the biopharmaceutical industry with highly specialized colleagues within different therapeutic indications with the overall objective for their patients to have access to the newest and best therapies. Dr. Hoeck holds MD degree from the University of Southern Denmark. He is a board certified specialist in Internal Medicine, Endocrinology & Diabetes and holds a PhD in Medicine from the University of Copenhagen.

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.

Jeannie Inge is Executive Director of Site Commercial Solutions, PRA's business unit dedicated to the commercial relationship with sites.    For more than 18 years she had lead the implementation of key strategic projects in IT, Quality and Process Management, and Compliance.  This includes the creation of PRA's global, to Fair Market Value Budget development, Clinical Trial Agreement negotiation, Grant Payments, Reporting for project management, financial and regulatory compliance,and system design and delivery.   In addition to leading the SCS Business Unit, she also Chairs PRA's Enterprise Data Governance Committee which supported the implementation of EUGDPR compliance and Data Integrity.   Prior to working at PRA, she was at the University of Virginia where she worked on systems management and compliance with the University of Virginia Medical Center,  Procurement, and QA.  She received her BS, MS and MS in Information Systems from the University of Virginia.

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.

Felicia Irvin joined the IACT Health team in 2009 and currently serves as the Director of Sales and Marketing, where she oversees business development, patient recruitment, and marketing for the IACT network of sites. The IACT network consists of 16 sites across 8 cities and more than 30 therapeutic specialties. In addition, she serves as the IACT representative for hyperCORE International, a super-network of highly experienced research sites. Felicia holds a Masters degree in Business Administration and a Bachelor of Arts degree in Biology with a minor in Equestrian Science. In her free time, you can find her at Creekside Farm pursing her passion with horses.

Summer is a Director, Process and Standards Lead in Global Site and Study Operations at Pfizer. She has over 20 years of clinical research experience in monitoring, study management and related processes including roles as a CRA, Study Manager and process lead. Summer has led and contributed to many process and technology initiatives at Pfizer related to monitoring and investigator sites. She also represents Pfizer on TransCelerate initiatives such as Site Qualification and Training (SQT) and the Shared Investigator Platform (SIP), and has served as a speaker and module lead for SIP. Summer holds a Masters of Sciences in Health Sciences- Clinical Research Administration from George Washington University.

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.

Ryan is CEO of Florence Healthcare. Florence advances clinical research through software. The Florence eBinder Suite replaces paper investigator site files, trial master files and source binders with a shared platform between trial sites and sponsors. Before joining Florence, Ryan was president of Pubget (acquired by the Copyright Clearance Center), a research platform serving clinicians at over 600 hospitals and research institutions worldwide. Ryan joined Pubget from Microsoft’s enterprise search group, where he helped the web’s largest sites make information understandable and accessible with search technology. Before Microsoft, Ryan analyzed enterprise software investments at Commonwealth Capital Ventures and built technology market strategies at the Yankee Group. A frequent speaker, he has been quoted by the New York Times, Wall Street Journal, and the Harvard Business School Press. Ryan has an AB from Dartmouth College and an MBA from UC Berkeley, where he was a Price Fellow. He is an avid cyclist, pilot and a terrible golfer.

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.

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.

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.

Dr. Jeff Kingsley: Medical Degree from Philadelphia College of Osteopathic Medicine in 2001. He is founder and CEO of IACT Health, a research management organization, and 15 wholly owned and integrated clinical research offices throughout the Southeastern United States. The family of companies conduct phase Ib through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. He has dedicated his career to clinical research since 2006. He enjoys each day with his wife Christine and four beautiful children.

Kristin Kinlaw is responsible for the patient recruitment, engagement, and corporate communications teams at PMG Research, an integrated network of 14 clinical research sites. Kristin has over 10 years of experience in patient engagement and clinical research communications, creating effective recruitment strategies at both the central study and site levels. She has developed innovative programs including The Patient Voice, a feedback platform offering patient insights for clinical trial protocol development, feasibility, recruitment, and more. Kristin believes that building patient relationships within our communities is crucial to helping sites connect patients with the right trials, and supporting industry partners in bringing life-saving treatments to patients more quickly. 

Serving as Exostar’s Director of Health IT & Life Sciences, Kenny Kong leads Exostar’s Healthcare practice. He has consulted and advised some of the world’s largest Healthcare and Biopharmaceutical companies in enabling on-demand access to eClinical technologies using digital identities to securely extend trust across traditional enterprise boundaries. His thought leadership supports the development of Federal Health IT Standards and in his tenure, has worked in all areas of Healthcare from launching Electronic Prescribing of Controlled Substances (EPCS) nationwide to combat the Opioid epidemic, to co-founding federal programs that bring Health IT to medically underserved areas across the United States.

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.

James Lewis is a senior recruitment Professional with over 12 years experience working with Contract Professionals.

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.

Jennifer Logue Nielsen is a Competency Development Specialist in Data Management at Novo Nordisk in Denmark, and she has been part of the Transcelerate eSource workstream since 2016, where she has been particularly active in the Site Advocacy Group and People and Process sub-teams, as well as a member of the core team.

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.

Robin Marcus is Chief Strategy Officer with GlobalCare Clinical Trials. Over the past 25 years Robin has become known as an innovative healthcare executive focused on operationalizing new products and services. Her talents have been leveraged with companies of all sizes including Caremark, Mediware, Home Healthcare Laboratory of America, and Integrity Health Care. She began her professional career as a an Oncology and Bone Marrow Transplant Nurse in San Francisco after receiving her BA from University of California San Diego and her BSN from The University of San Francisco.

Dr. Miller was drawn to medicine as a calling, deeprooted in concern for people and helping them live better lives. Dr. Miller attended Columbia University and then Cornell Medical School in New York City. He continued his education at the Mayo Clinic in Rochester, Minnesota. At Mayo Clinic, Dr. Miller participated in groundbreaking clinical and scientific research in osteoporosis, calcium metabolism, and how hormones work. He is board certified in both internal medicine and endocrinology. Dr. Miller returned to his native San Antonio in 1977 to the University of Texas Health Science Center San Antonio Faculty where he practiced and taught students and residents endocrinology and directed the clinical research center at Audie Murphy VA Hospital.

Since 1978, Dr. Miller has been in private practice in San Antonio. He actively diagnoses and treats patients with diabetes and other hormone disorders, and he directs clinical research studies to help patients with these problems.

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.

Nicole Mills, MS-CRM recently joined Medix as a Clinical Research Field Specialist, bringing with her a decade of understanding of problems facing sites today. She has her Masters Degree in Clinical Research Management and previously was the Research Director at a large hospital system in Phoenix, AZ. She has held positions as operations manager, clinical research coordinator, and business development manager for several dedicated research sites. Nicole is a past-president of the Phoenix Chapter of ACRP, has been an active board member for over 6 years, and is a certified trainer for the ACRP CRC Boot Camps.

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.

With over 20 years of experience in marketing across a variety of industries, Paul leverages his expertise to lead patient recruitment and retention efforts. Presently, he oversees the global product development and business strategy at iPatientAxis, a new technology company driving patient quality and qualification through real world evidence. Prior to this Paul was the Senior Director of New Markets and Innovation at Acurian, developing its global capability and implementing new approaches to patient recruitment. Extensive experience engaging consumers in large sectors including FMCG, energy, automotive and retail has positioned Paul to apply his leadership and marketing skills to clinical trials.

Chris is the clinical financial manager at BTC Network. Previously, he worked in credit and collections where his customer service skills were used to manage a large AR and protect company assets through contract review and negotiation. He utilizes his current and previous skills to maximize profitability for his clients and establish new relationships within the field of clinical research. In his spare time, he enjoys spending time with his two daughters, working on his house and watching the New England sports teams in action.

Born and raised in San Juan, Puerto Rico, Ms. Navarro is the CEO and Head of Operations of Caribbean Medical Research Center. Prior to leading CMRC, Carmen was a strategy consultant at The Bridgespan Group (Bain & Company) and worked as a Project Director at the World Economic Forum where she focused on health and education across Latin America. She obtained her Bachelors Degree in Economics and International Relations at the University of Pennsylvania and her Masters Degree at the Harvard Kennedy School of Government.

Virginia Nido is Head of Product Development Industry Collaborations for Genentech and Roche. Virginia serves on leadership teams for TransCelerate BioPharma, the Clinical Trials Transformation Initiative, the Association for Clinical Research Professionals, and the Society for Clinical Research Sites. Virginia is passionate about the power of industry collaborations to improve the efficiency and quality of clinical research.

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 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.

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 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.

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 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 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, 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.

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 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 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 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 has over 20 years of experience leading private and academic programs in the healthcare, human subject protections, and lab animal care and use fields. He skillfully manages large operations and technology teams to keep research moving forward. James was previously the vice president of operations and director of technology at another major accredited central IRB and Assistant Director in the Institutional Review Office of the Fred Hutch Cancer Research Center. He has served on the board of the Northwest Association for Biomedical Research (NWABR) and the steering committee of the Clinical Trials Transformation Initiative (CTTI). He has also served as an AAHRPP site visitor. In addition to being on the editorial board of the journal IRB Advisor and the leadership team for the Alliance for Clinical Research Excellence and Safety (ACRES) Committee on Accreditation, he is a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R) and other industry conferences and a terrible golfer.

Dr. MaryAnne Rizk has 20+ years of experience transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Dr. Rizk has globally lead Oracle’s and Medidata’s CRO partner market strategy and building eClinical outsourcing alliances for over 90+ organizations from global pharma to emerging biotech/medtech firms. Prior to joining software SaaS firms, MaryAnne found her patient-driven mission working at Merck for nearly a decade, where she led both clinical and commercial outsourced global technology initiatives. Effective in building enterprise clinical outsourcing collaborations, MaryAnne enables organizations to leverage innovative SaaS cloud-based platform technologies to accelerate drug/device development among lifescience stakeholders: Pharma, Emerging Bio, MedTech, CROs.

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

Jason Roth leads Platinum Research Network, which consists of seven well-establish Clinical Research Companies including 83 investigators operating in 15 specialties, at over 40 site locations in the United States and Mexico. Jason has over 15 years’ experience in the clinical research industry, supporting business development, feasibility, clinical operations, and patient recruitment activities for academic institutions, hospital systems, private research centers, and CROs. He’s also been a participant!

Clinical Research Professional with over 17 years of combined experience in Site Monitoring, Quality Assurance/Inspections, Project & CRA Management and Site/Investigator Intelligence developing in-depth and productive relationships with key professionals in academic, clinical, and big research organizations to optimize business opportunities. Currently working for Covance as a Senior Manager in Site Partnerships helping to develop new partners for Covance. Love the outdoors, exercise and healthy cooking.

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 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 began her career as a registered nurse (RN) and after many years of working in various roles within a hospital setting and conducting nursing research, she began her first position as a clinical research coordinator. In 2001 Kay's life as a business owner and entrepreneur began when she 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. They are recognized for their high quality, meeting enrollment goals and breadth of capabilities- Phase 1-4 in multiple therapeutic areas. Their paradigm at CTT is partnering with sponsors/CROs to bring new treatments to their community and our world as efficiently as possible. Kay feels honored to be in an industry that works to improve lives.

Pharmaceutical industry experience from site, sponsor and CRO perspective – 7 years at a German investigational and Key Opinion Leader (KOL) site as Study Coordinator and Research Manager, 4 years as a Global Project Manager and Clinical Trial Manager at a biotech company, 5 years as Clinical Feasibility Leader at PAREXEL in Site Selection and currently engaging with global SMOs to achieve the most efficient study set-up.

T.J. Sharpe is a Stage IV melanoma patient sharing his journey through cancer in his Patient #1 Blog. Diagnosed in 2012 with tumors in multiple organs, he has undergone six surgeries and four immunotherapies across two clinical trials. The initial failures, and subsequent response, have been chronicled in his posts. He is a keynote speaker and consultant to the biopharma and clinical research industries, working with major pharmaceutical corporations and as a patient advisor to TransCelerate to bring an educated patient voice as a true stakeholder in challenging healthcare's status quo. A South Jersey native, T.J. lives in Fort Lauderdale, FL, with his wife Jennifer and two young children, Josie and Tommy, and can be found on Twitter at @TeamTJSharpe.

Cassandra Smith currently serves as the diversity & inclusion in clinical trials initiative lead at Janssen. In this role, she leads efforts to increase access to and representation in Janssen clinical trials and expansion of the clinical trial diversity strategy. Prior to this role, Cassandra was associate director, patient engagement strategies within Janssen. In this position Cassandra led efforts to optimize the informed consent experience for clinical study participants, including co-creating the ICF with patients and scaling eConsent for broader use within Janssen. Cassandra holds a BS in General Science from Pennsylvania State University and an MBA in Healthcare and Pharmaceutical Marketing from Saint Joseph’s University.

Lead the US Oncology Research site management organization (SMO) for McKesson Specialty Health. The oncology research network consists of approximately 165 locations across the United States and includes early and late phase clinical trials in all therapeutic areas. Since its inception, the research network has enrolled almost 75,000 subjects on clinical trials. Previous role within McKesson have included leading the integration of new practices into the US Oncology Network, Clinical Services Director, and Director of Clinical Education Services. Prior roles have included managing oncology private practices and oncology service lines within hospital-based cancer programs.

Lisa Sorrells is Head of Study Management for the Site Performance and Excellence in Delivery (SPEED) team at GlaxoSmithKline. During her 16½ years with GSK, Lisa has had increasing levels of responsibility, including authoring and implementing the Business Continuity and Crisis Management Plans for the US Local Operating Company. In her current position, Lisa leads a team of professionals whose primary responsibilities are to gather quality country- and site-level feasibility data that is used to determine the appropriateness of US participation in a given study, the probability of meeting global timelines, making site and study participant projections and identifying study risks developing mitigation strategies which assist central study teams in making country-level decisions regarding US participation in upcoming studies. Following country selection, Lisa’s team facilitates the site selection process to ensure the best sites are selected to ensure both site and study success.

Kate arrived at Langland in 1998, founding and championing clinical trial recruitment (CTR) to increase awareness of and promote participation in clinical trials. Having overseen this as the fastest growing area of Langland in recent years, Kate went on to set up the US CTR offering in 2016. She now focuses exclusively on nurturing the growth and success of this part of the business.

Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University with a Masters of Information Systems and an MBA. At Medidate, Alicia works to infuse the patient perspective throughout the product development lifecycle and help engage patients in novel ways.
Alicia is also a three-time cancer survivor, first diagnosed with Hodgkin's disease as a sophomore during college. Over the past 10 years, she's applied her engineering background to improve the patient experience for those dealing with cancer. With an extensive network of patient advocates and non-profit organizations, she collaborates with a wide range of stakeholders to help improve processes and policies that impacts cancer care.An early adopter of social media, she co-founded #BCSM, which attracts over 1,000 global participants each week to its scheduled online discussions. Since its launch, #BCSM has been showcased at SXSW in 2013, 2014, 2015, and 2017 and is recognized as the gold standard for disease-specific social media networks. She's co-led numerous research studies on how patients share information in online forums. As a champion of patient advocacy and engagement, she understands the critical issues facing patients seeking to engage in clinical research. With a keen focus on improving access to clinical trials, Alicia is passionate about making a difference for patients seeking clinical trials.

Doug Stampfli is a professional educator, speaker, skills trainer and coach who specializes in the Art of Alignment and helping people achieve their desires. Doug started his coaching career in 1990 and has displayed a passion for learning and inspiring others to improve performance ever since. In 2003, Doug received his B.S. in Elementary Education and spent the next 14 years teaching HS, MS and Elementary math. In 2007, he started conducting workshops through EduLink, Inc. for educators in WI, MN and CO on the topics of leadership, the power of positive thinking, emotional intelligence, and cooperative learning. In 2011, Doug founded Stampfli Coaching Services, LLC and in 2018, he co-founded Stampfli Cox Creations, LLC to help individuals and businesses realize more of their unlimited creative potential. Doug resides in Madison, WI and loves to travel with his wife, Kari, and their two sons, Samuel and Matthew.

Shawn Tedman is the Director of the Clinical Trials Business at 23andMe, the first and only direct-to-consumer genetic testing company with FDA-authorized health reports. Shawn has deep clinical operations and technology expertise gained in both biopharmaceutical and contract research environments. He has built and scaled global feasibility, site intelligence, and clinical technology teams with a focus on patient centricity and trial optimization. In his current role, Shawn is leveraging this expertise in order to empower 23andMe’s customers to take control of their health and gain access to innovative therapeutic options through clinical trials. Shawn holds an MBA from Duke University.

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.

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.

Katherine (Kathy) Vandebelt believes patients are the most important constituent in clinical development and provide the necessary information to assess the safety and efficacy of new medicines. Kathy is using the power of technology to introduce new experiences and expectations to make the clinical research ecosystem better for patients, healthcare providers, sponsors and regulators. With over thirty years of experience in clinical research working in different geographies and across various TA, Kathy has worked with various organizations to advance their clinical operations and business processes to a better operating model.

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.

David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards, initiatives, publications, presentations and contributions. A native of New Orleans, he has a Masters degree in both Social Work and Business Administration and holds the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC).  He even is a Certified Blockchain Professional.  Among other things he is the a Vice President and Responsible Executive for Clinical Research for HCA Healthcare, providing research-related compliance and strategy consultation to their portfolio of hospitals, physician practices and healthcare technology companies.   He is also the President of the Nashville Angel Capital Group.  David and his wife are empty-nesters living south of Nashville, Tennessee with where they involve themselves in work, family life as well as other charitable and entrepreneurial opportunities.

Gwen is an accomplished clinical, regulatory affairs and preclinical science research professional with experience in pharmaceutical and medical device areas.

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.

Kelly Willenberg is the owner of Kelly Willenberg, LLC. Kelly has extensive knowledge in clinical trials management and research compliance, including all aspects of clinical trial billing compliance. She has nearly 30 years of clinical research experience and billing compliance. She has a Bachelor’s Degree in Nursing, a Masters and a Doctorate in Business Administration. She is an experienced oncology nurse with the majority of her experience in oncology, pediatrics, school nursing and cardiac rehab. Kelly worked for over twelve years at Vanderbilt University Medical Center. She established the enterprise wide billing compliance program at Vanderbilt and served as the first Director of Billing Compliance in 2002. She also served as the Director of the Clinical Trials Office for the Cancer Center managing a Community Oncology Research Program (CCOP and an affiliate network throughout the southeast while at Vanderbilt and was an active member of the nursing committees in the cooperative groups.

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.)

Kristina has lived with Type I Diabetes (T1D) since she was six-years-old, but has never liked being identified by it. She is an advocate for herslef and others by pushing down walls that limit the ability to thrive. Her career and background combines her passion for advancing research and healthcare accessibility and affordability with meeting people and patients where they are, to propose solutions to break down barriers to healthcare access. She has recently co-founded a 501(c)(3) non-profit organizations called Our Odyssey, as an opportunity that uniquely positions young adults impacted by chronic and rare conditions (and our healthcare systems) for greater livelihoods by way of connectivity with our young adults, providers, tools and resources. Beyond participating in and managing some clinical trials, she has also pursued academic research and executive leadership training in Public Health. In her studies, she has observed young adult patient outcomes as it relates to market access and behavioral health, and different prescription patterns in association. She has recently joined the Seeker Health team at Eversana, where she will expand the business, innovate and collaborate across the healthcare industry to bring all stakeholders into the patient recruitment and engagement discussion.

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.

Craig Wozniak is the VP for GCO Americas and Global ED&CP here at Janssen. He is planning to attend and would be happy to be a part of a panel. He was a speaker at an earlier plenary SCRS session when RBM was just rolling out – very active session at that time! He knew Christine well and I know would be honored and also an engaging and energetic addition to a panel at the plenary.

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.