CEO and Founder
CEO and Founder
Andrew Schorr of Carlsbad, California near San Diego is a medical journalist who, working in partnership with his wife, Esther, has devoted his life to educating and empowering families affected by serious illnesses since 1984. First as the producer of brief educational videos and, more recently hosting worldwide broadcasts on the Internet, Andrew and his team have touched the lives of several million patients. They have won numerous national awards for the quality and impact of their work.
In 1996, Andrew became a patient himself. After an abnormal routine blood test, he was diagnosed with chronic lymphocytic leukemia, “CLL,” the most common leukemia in adults. By participating in a Phase II clinical trial he enjoyed a deep, 17-year remission which enabled him to lead a full life and accelerate the Schorrs’ work in patient education and medical journalism. In 2011, after the discovery of abnormal clots in the veins of his legs and being followed in a Phase III clinical trial for an investigational blood thinner he was diagnosed with a second blood-related cancer, myelofibrosis or scarring in the bone marrow. This was possibly an after-effect of chemotherapy he had received years earlier. Andrew was fortunate that an oral genetic inhibiting medicine was approved for myelofibrosis that same year and that medicine continues to be effective care for him. In 2017 Andrew’s CLL remission ended, and he received 6 months of monoclonal antibody infusions which have led to a second deep remission. Andrew continues to receive monthly immune system boosting medicine (immunoglobulin) as well as taking pills to prevent viral and bacterial infections. Fortunately, his health status is good and he remains very active as an executive producer and host of Patient Power’s global programs, as a prolific writer and columnist, and as a national speaker.
For more about Andrew Schorr, please click here.
Debra Patt, MD, PhD, MPH, MBA, FASCO
Executive Vice President
Texas Oncology/US Oncology Network
Dr. Debra Patt is a practicing oncologist and breast cancer specialist in Austin, Texas, and an executive vice president of Texas Oncology with responsibilities in healthcare policy and strategic initiatives. She is an active leader in breast cancer research, serves on the US Oncology Research breast cancer committee, and chairs the breast cancer subsection of the pathways task force for The US Oncology Network as well as the leader locally for breast cancer research. She has expertise in healthcare policy and has testified before Congress to protect access to care for Medicare beneficiaries. She is a leader in clinical cancer informatics, and is involved in system innovations to enhance care delivery across a national network of oncology practices. She is the Editor In Chief of the Journal of Clinical Oncology- Clinical Cancer Informatics. Her clinical informatics research focuses in imaging informatics for breast cancer, clinical decision support systems, predictive analytics to reduce risk in patients with advanced cancer, and quality improvement.
For more about Dr. Patt, please click here.
David M. Waterhouse, MD, MPH
Medical oncologist and hematologist
David M. Waterhouse, MD, MPH, is a medical oncologist and hematologist with OHC, Cincinnati. His specialties are lung cancer and urologic cancer, and his passion is for cancer clinical research. Dr. Waterhouse is the founder and Co-Director of OHC’s nationally-recognized Clinical Research Program. Dr. Waterhouse received his medical degree from the University of Massachusetts in Worcester, where he also completed an internship and residency. He completed a fellowship in medical oncology and hematology at the University of Michigan in Ann Arbor, where he later also earned a Master of Public Health.
In 1992, Dr. Waterhouse received a Young Investigator Award from the Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO) to support his transition from the fellowship program to a faculty appointment. Since then, he has devoted his career to advancing cancer research and improving patient access to the best possible treatments. His accomplishments have largely been achieved as a community-based oncologist, helping to change the face of cancer research from that of a strictly academic-only pursuit.
For more about Dr. Waterhouse, please click here.
Archana Sah, MSc (Pharm), PMP
Vice President, Head of Clinical Operations, Tizona Therapeutics
Chair, SCRS Oncology Program
She has led highly matrixed, cross-functional teams to create value and deliver strategy and execution with several molecules in Phase I-III development through approvals. Archana is recognized as a strategic expert on emerging topics ranging from therapeutic landscape/treatment trends expertise to thought leader relationship management. Her passion is to develop high-performing teams and create inclusive, empowering and diverse cultures focused on accountability and customer-centric mindset.
Ms. Sah also chairs the Society for Clinical Research Sites Oncology Board with a vision to cure cancer through efficiency in process and strength in the relationships between clinical research sites, pharmaceutical companies, oncology vendors and patients. She provides direction and guidance for the vision, mission and three strategic workstreams for the Board. Ms. Sah also serves as a member of American Cancer Society Cancer Action Network workstreams on Barriers to Clinical Trial Enrollment Implementation and Clinical Trial Matching.
She holds patents, publications, performance awards, and is often an invited speaker at several industry conferences. Ms. Sah received her Master’s in Pharmaceutical Sciences from University of Cincinnati, College of Pharmacy and a Bachelors in Pharmacy from M. S. University in India.
CEO & Founder
GlobalCare Clinical Trials, LLC
Gail Adinamis is the CEO and Founder of GlobalCare Clinical Trials. She has over 35 years of comprehensive phase I-IV clinical trials experience including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. She founded the business model for centrally managed homecare services for clinical trials in 1992.
Andrea Skafel, MSc, CCRP
Clinical Research Support, Office Director, University of California, San Francisco
Helen Diller Family Comprehensive Cancer Center
Andrea Skafel has been working in the field of clinical research for 15 years. Originally from Canada, she is now the Clinical Research Support Office Director at the Helen Diller Family Comprehensive Cancer Center at the University of California San Francisco, overseeing the implementation and execution of over 450 active clinical trials. In addition to Oncology, Andrea has worked in the fields of cardiology and nephrology. Andrea has a Bachelor’s degree in Kinesiology and a Masters in Health Research.
Mark Fleury, PhD
Principal, Policy Development, Emerging Sciences
American Cancer Society Cancer Action Network (ACS CAN)
Mark Fleury is a policy principal for the American Cancer Society Cancer Action Network (ACS CAN). He specializes in research, drug development, and regulatory policies along with other science and technology-related projects. He led a coalition in 2016 that authored a landscape report on drug development challenges in pediatric cancer, and led another coalition in 2017 that created a report and recommendations focused on overcoming cancer clinical trial enrollment barriers. In addition to his ACS CAN experience, Mark’s policy work includes time as a Capitol Hill legislative advisor focusing on healthcare reform, and work at the American Association for Cancer Research (AACR). He holds a PhD in bioengineering from the Ecole Polytechnique Federale de Lausanne in Switzerland.
Jane Fang, M.D., M.S/strong>
Head, R&D Information for Clinical Biologics
Jane is the head of AstraZeneca R&D Information for Clinical Biologics. She is a physician scientist with training in nephrology, healthcare management and informatics. She has 25 years of broad experiences across from medical practice, clinical, immunology research to clinical innovation strategy and advanced analytics in healthcare and biopharmaceutical industries. Jane has provided leadership roles in building clinical innovations, evidence-driven trial feasibility and patient recruitment, EHR trials, RWE/RWD practice for clinical trials and digital capabilities to enable better clinical research and trial delivery.
Susan Night, JD, LLM
Director Research Optimization
McKesson Specialty Health, US Oncology Research
Susan Night is Director of Research Optimization with US Oncology Research, a clinical trial site management organization representing 160 research sites across the United States. She has over 20 years of experience in healthcare and research ranging from policy, law, ethics, finance and strategy. Her most recent passion has been in the area of data integrity and development of optimal processes that support parties to clinical research to meet regulatory requirements and ensure participant safety.
Dawn East, RN, BSN
Oncology Board Member
Over 30 years of oncology research experience. Experience includes working at a NCI designated Cancer Center enrolling patients into clinical trials, Clinical Project Management at a Pharmaceutical company as well as several CROs, and worked at a company that brought research to research naïve sites and quickly changed them to successful research sites. Recently founded East Oncology and Associates and reviews oncology trials for IntegReview IRB.
Executive Director at inVentiv for 11 years and over saw the oncology department for the America’s. Part of the transition team during several mergers. Was the first oncology employee hired at INC Research and grew the oncology business very quickly and became the highest award wins for the department of oncology. Became the first home-based oncology employee for the newly created oncology department at Quintiles. Was successful in growing new business (oncology was awarded the most successful in bringing in full service business). Successfully submitted NDA for Oncology/HIV investigational drug with a small team and oncology specific CRO at IVAX (now TEVA). Manager, Clinical Research Services at University of Miami School of Medicine’s Sylvester Comprehensive Cancer Center.
Sandy Smith, RN, MSN, AOCN
US Oncology Research, McKesson
Sandy Smith leads US Oncology Research, a clinical trials site management organization representing approximately 160 locations across the United States. US Oncology Research has enrolled over 75,000 subjects onto clinical trials since its inception and is managing over 350 clinical trials. With corporate offices located in The Woodlands, Texas, US Oncology sites are located in 26 states across the county.
Vice President, Head Oncology Clinical Project Management
Jenine Cauklins has 28 years of pharmaceutical industry knowledge specializing in clinical development research trials ranging from phase I-IV studies. Her primary focus in the last 19 years has been in the Oncology therapeutic area. Her pharma knowledge includes 15 years of working at Pfizer in Clinical Development and Development Operations focusing on Central Nervous System, Cardiovascular and Oncology. For the past 12 years at Bayer, she has been working in Oncology, Cardiovascular, and NOHI (Neurology, Ophthalmology, Hematology and Immunology) in Clinical Development and Clinical Project Management.
Vice President of Partnership Development
Amanda Wright began her career in clinical research in 1998, working as a Clinical Research Coordinator at PMG Research. She has served in various roles across the site enterprise, including leadership roles in operations, patient engagement, business development and marketing. A great deal of her career has been centered on forging shared value strategic partnerships and collaborations that serve to innovate business process, patient engagement, and predictive modeling. In addition, Amanda has served as a leader with Greater Gift (501c3) since its inception in 2010, a non-profit designed to celebrate clinical trial participation and global health and well-being. She assumed the role of Board Member and Executive Director for Greater Gift in 2013, and since that time has led strategic program development and expansion.
Amanda serves on numerous boards and committees throughout the industry, many of which are centered on patient engagement and enhancement of the clinical trial process to address current industry trends. Amanda is a graduate of UNC-Chapel Hill as well as various leadership programs.
Marie E. Lamont
Marie has more than 25 years as a global biotech leader. She has held senior leadership positions in many areas focusing on patient services, corporate strategic planning, data and analytics, commercial operations, finance and accounting, and payer contracting and reimbursement. Prior to Inteliquet, Marie headed up an executive consulting and advisory firm for the life science and technology industries that advised companies on commercialization and integration planning, data and analytics, M&A support, operational performance excellence and global market expansion. Marie was also President of the Patient Services Business at Dohmen Life Science Services (DLSS), now part of EVERSANA (a provider of global services to the life science industry). She directed all aspects of the unit and was responsible for improving the client and patient focus, as well as improving patient support and employee engagement. She also was heavily involved in the success of DLSS’s brand positioning, strategic road mapping, sales business development, and patient journey adoption, along with targeting analytics for key initiatives.
Marie holds a bachelor’s degree in Business from Saint Michael’s College, and attended Harvard Business School and Kellogg Executive Education programs. She lives in the St. Louis area.
Jolee Holt, MSN, RN (multi-state), CCRC
Director of Oncology Network
Jolee Holt is an experienced executive with a demonstrated history of over 20 years working in clinical research. Skilled in Clinical Research Regulations, Oncology, Clinical Trials, and Healthcare. Ability to differentiate logistics of a clinical trial and decipher the ability of their implementation into clinical practice. Strong professional with a Master’s Degree focused in Nursing Administration and Leadership.
Cheryl-Ann Hawkins, RN, MHA
Clinical Research Manager of Oncology
Cheryl-Ann Hawkins is currently the Clinical Research Manager of Oncology at Alfred Health. She is the Australian Ambassador for the Society for Clinical Research Sites (SCRS) and Chair of SCRS AsiaPac Summit 2019. She has worked in various leadership Oncology nursing roles in a career spanning 25 years. Over the past 15 years she has focused her career on early phase/first in human drug trials, recently moving into her research manager role to broaden her management experience. Cheryl-Ann completed a post graduate diploma in Oncology/Palliative care nursing in 1996, a Master Degree in Health Administration in 2004 and a post graduate certificate in Oncology Research in 2012. Cheryl-Ann holds an affiliate position with Monash University as an educator in Good Clinical Practice (GCP).
Leslie Powell was diagnosed with Chronic Lymphocytic Leukemia (CLL) in the summer of 2013 during a routine physical and bloodwork. The doctor commented that her white count was high, but it was probably just from getting over an infection. She told him that wasn’t the first time I’d heard that. Upon further testing, it was confirmed that she had CLL. In December 2013, Leslie was introduced to Andrew Schorr as he was reporting from the ASH conference about a new drug in trial (which became Ibrutinib). Hear her story.
Today, Leslie works part-time for an event management company. She has adult kids and grandkids, enjoys traveling, and is thankful that the drugs in trial have afforded her health to continue living her best life.
Associate Director, BioPharmaceuticals R&D
Barbara is an Associate Director, BioPharmaceuticals R&D at AstraZeneca with 20+ years of pharmaceutical industry experience. She is experienced in various therapeutic areas with a passion for oncology research. Currently, Barbara is an oncology therapeutic area lead in US Site Management & Monitoring overseeing delivery of oncology trials across all phases and stages to get treatments to the patients who need them.
Christina Brennan, MD, MBA, CCRC
Vice President, Clinical Research
Christina Brennan, MD has devoted her career to clinical research and currently serves as Northwell Health’s vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 20 years of extensive clinical research experience, including over 15 years in clinical research management roles. She is on the board of trustees for the Association of Clinical Research Professionals. She is the immediate past president of the NY Metropolitan Chapter of the Association of Clinical Research Professionals. 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, Women in Bio 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.
Candida Barlow, MSN, CTN, RN
Assistant Professor of Nursing, College of Nursing, Oklahoma University & Clinical Research Consultant
Ms. Barlow’s career began in healthcare as a Certified Nurse’s Aide 25 years ago. She then went on to complete a BSN in Nursing in 2005 at Langston University and an MSN in Nursing with an advanced specialty practice in Clinical Trials at Drexel University in 2011. Currently, Ms. Barlow is pursuing her Ph.D. in Nursing, with a specialty focus in Interdisciplinary Health Systems through Walden University, expected graduation Fall 2020. Ms. Barlow has served as a research nurse, clinical research coordinator, clinical research monitor, principal investigator, clinical research associate, and as the director of clinical research serving six-hospital health systems. She has served in the academic medical center and in community-based hospital health systems conducting clinical trials.
Throughout her career, Ms. Barlow created and established a clinical research institute across Northeastern Oklahoma, implemented clinical research compliance, e-regulatory, electronic medical record source documentation, and automated billing compliance programs. Ms. Barlow specializes in clinical trial electronic systems, and she is a clinical research nurse specialist. She has served as an IRB consultant for the last eight years, developing policy and procedure and overseeing clinical trial reviews. Ms. Barlow has also served in academia, teaching research, and critical care to nursing students.
Ms. Barlow is currently serving as a Clinical Research Consultant for Bio-Optronics, focusing on real-world applications of the world-leading Clinical Conductor clinical trial management system. In her current role, she provides best practices to clinical trial sites improving workflows and efficiencies in clinical trial conduct utilizing the Clinical Conductor software suite for clinical trial management.
|Selin Kurnaz, PhD
Co-Founder & CEO
Dr. Selin Kurnaz, CEO and cofounder of Massive Bio. After emigrating from Turkey and completing a PhD at the University of Michigan, receiving multiple engineering degrees, Selin spent more than a decade specializing in delivering revenue enhancement, margin optimization and capital efficiency improvements for Healthcare and Life Science companies. Her startup, Massive Bio, brings the latest knowledge in cancer care to patients treated at community practices in the US and worldwide. Selin has written and spoken extensively about life sciences in tech and how to deliver information in creative ways. Massive Bio is an alumni of eLab and PhilipsHealthworks Precision Cancer Care start-up acceleration programs.
CEO & Co-Founder
As CEO of Devana Solutions since inception in 2016, Mr. Lake is responsible for the overall strategic vision and execution of the most innovative cloud-based software company in the clinical trial industry. Mr. Lake and Devana Solutions are driven by a core belief that performance data transparency through technology is critical to selection of the top-performing research sites to align with pharmaceutical Sponsors and CROs to reduce clinical trial cycle time and costs and speed the delivery of therapeutic advances to patients.
Katherine E. Cameron
Director – Site Engagement
Katherine (Katy) Cameron has over 23 years of Ph I-IV global drug development experience focused in portfolio project management, clinical trials operations and quality management, across a variety of therapeutic areas including neuroscience, pain, diabetes and oncology. Katy spent 5 years at a CRO before joining Eli Lilly and Company in 2002 as a Clinical Project Manager, and has since held a variety of leadership positions across the organization supporting the global development of a portfolio of medicines. Presently, Katy is the Director of US Site Engagement, the organization responsible for the identification, qualification, support and collaboration with clinical trial sites participating in Lilly studies. Katy 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 for both. Katy received her undergraduate degree from Indiana University, and her Masters at Tufts University in Boston.
Donna Katz, MSN, APRN, FNP-BC, OCN
Research Operations Director
Donna has spent nearly 24 of her 26 years of nursing in the field of Oncology. She has spent the last 19 years with UCLA focusing on clinical trials in the Oncology outpatient setting. She has served as coordinator and/or sub-investigator in more than 80 clinical trials with the majority of those trials in breast, lung, and colorectal cancer. She took on the role of Research Operations Director for the UCLA/TRIO-US Network in 2018 and now oversees all clinical research activities involving TRIO-US trials in 16 sites across the US.
She has spoken in various clinical settings on subjects ranging from oncology drug administration and nursing issues to side effect management and clinical trial success. Additionally, she holds active membership in both Oncology and Nurse Practitioner national groups and serves on numerous Pharmaceutical Advisory boards and committees.
Founder and Board Chair
Lazarex Cancer Foundation
Dana Dornsife is Chairman of Lazarex Cancer Foundation, a nationwide non-profit organization she founded in 2006 in response to a family experience with cancer. The unique mission of Lazarex is to improve the outcome of cancer care, giving hope, dignity and life to advanced stage cancer patients and the medically underserved by providing assistance with costs for FDA clinical trial participation, identification of clinical trial options, community outreach and engagement.
In 2016, Dana expanded the mission at Lazarex to bring sustainable and transformational change to the bench to bedside process of clinical trial enrollment, retention, minority participation and equitable access with IMPACT (Improving Patient Access to Cancer Clinical Trials). Most recently, Lazarex created collaboration around a public health initiative in Philadelphia, PA – Community IMPACT. This bold initiative is aimed at creating a replicable model to improve cancer health outcomes and associated co-morbidities for the residents of medically underserved and socioeconomically challenged minority neighborhoods throughout major metropolitan cities and beyond.
Dana is a graduate of Drexel University in Philadelphia. She is a board member of the USC Brain and Creativity Institute at University of Southern California, serves on the UCSF Cancer Leadership Council, and the MGH Presidents Council. She is on the governing board of the Yosemite Conservancy, in addition to being a council member. Dana and her husband, Dave Dornsife, a USC Trustee, support a WASH initiative – Water, Sanitation and Hygiene, in 24 African countries through World Vision, an international humanitarian agency.
Jim Murphy, MS
Chief Executive Officer
As Greenphire’s CEO, Jim leads the strategy for the company, including client satisfaction, business operations, commercial execution and financial performance. He is committed to fostering a culture of growth, innovation, excellence and employee satisfaction. Jim has focused his career on building innovative eClinical software companies to address challenges and unmet needs within the global clinical research ecosystem. Prior to joining Greenphire, Jim most recently served as the president and managing director of Almac Clinical Technologies, where he was responsible for strategic, financial and operational leadership. While at Almac, Jim also served as the president and managing director of Almac Pharmaceutical Services – Asia, where he established and managed the Almac Group’s Asia Pacific organizations and business operations across all solution areas.
Jim earned a Bachelor of Science in Biochemistry and a Master of Science in Molecular Biology from the University of California at Santa Barbara.
Janet Christoff, RN, CCRA
Manager, Regional Field CRAs
Janet Christoff is a registered nurse who has been in the field of clinical research for over 20 years. She has worked for both CRO and sponsor companies in various therapeutic areas, beginning her career as a study coordinator, moving to the role of CRA and then into clinical trial management. She is currently a manager of regional CRAs with Seattle Genetics, a bio-tech company focused on the development of innovative treatments for patients with cancer. Throughout her career she has worked closely to improve communication with site staff, collecting feedback on protocol design and operational aspects of clinical trials. She recently took a leadership role in developing the Quality Control program for CRA staff, to ensure quality oversight at each clinical site.
Karri Venn, RD, CDE, CCRC
LMC Manna Research
Karri Venn brings over 20 years of clinical research experience working at LMC Manna Research. Ms.Venn has brought experience, knowledge and drive to many of the positions held at LMC Healthcare. In 2006, Ms. Venn was promoted to Director, Research of LMC Clinical Research and subsequently in 2015 to President, Research of LMC Manna Research with a key responsibility of integration of Manna with LMC clinical sites to create the largest clinical community research site network in Canada. Additional responsibilities include the successful openings of 12 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 therapeutic expertise in all phases of research. Ms. Venn has led the project management teams for > 1500 clinical trials and led the response to > 50 Sponsor & Regulatory audits. LMC Manna has become a reputable program and has received the distinct award as a Centre of Excellence in Diabetes clinical research, PRIME status with IQVIA, awarded in the Top 50 Great Places to Work for Canada and SPRIA winners at the 2017 SCRS conference. A founding member of hyperCORE International a leading Super Network of clinical sites which comprises of 80 sites, 5 countries and 10 site networks.
Ms. Venn has been certified in project management through the Project Management Institute, as well as longstanding certification as a Clinical Research Coordinator and Diabetes Educator. Today, she is a founding Board member of the Canadian Association of Independent Clinical Research Sites (CAICR) and great supporter of both Society for Clinical Research Sites (SCRS) & Association of Clinical Research Professionals (ACRP).
Senior Principal in the Oncology Real World Data and Technology Practice
Joseph Wagner is a Senior Principal in the Oncology Real World Data and Technology practice at IQVIA. In his role, Joseph facilitates the identification and usage of oncology Real World data sources and partnerships to address evidence needs for IQVIA’s customers. This includes the development of innovative solutions such as external comparators, HEOR studies, prospective studies and clinical trial design. Joseph is also supporting IQVIA’s partnership with Friends of Cancer Research, an initiative consisting of a series of projects that began with the completion of the first pilot which proposed a framework for evaluating real world endpoints in oncology. Joseph has 15 years of experience within the healthcare industry with 12 years of experience using real world patient data from claims, electronic medical records, labs and consumer sources. During this time, he has supported clients from drug development through commercialization as well as facilitating research by institutions and third parties.
Joe received a BA in Pharmaceutical Marketing from Saint Joseph’s University.
Gena Rangel, BSN, RN, OCN
Manager of Research Navigation
Mary Crowley Cancer Research
Gena Rangel, BSN, RN, OCN has over 16 years of experience working in the field of Oncology. She has worked both inpatient and outpatient, with both Solid Tumors and Hematologic Malignancies, pre and post Bone Marrow and Stem Cell Transplant, Infusion, Radiation Oncology and end of life care. In addition, for the past 3 years she has been working in Oncology Clinical Research and currently holds the position of Manager of Research Navigation at Mary Crowley Cancer Research (MCCR). Her duties include managing incoming patients through referral, consultation, and screening procedures, up through enrollment. She is also spends a great deal of her time managing slot allocation and sponsor correspondence for the center. Her team, in conjunction with the Principal Investigators, are responsible for reviewing all open enrolling trials and aligning the trials that best fit each patient that comes through the center. This involves more than looking at the patients’ diagnosis but also identifying and helping patients overcome any barriers to participation, including financial, social, and clinical issues. Her team sees roughly 50 new patients a month, in addition to reviewing established patients for other trial options once they have completed participation in previous trials. She is also a member of the Protocol Review Committee, Scientific Review Committee, and Clinical Outreach Team at MCCR.
Gena received her Bachelor’s Degree of Nursing from Baylor University in 2003.
Janie Hofacker, MS, BSN
Director of Programs
Association of American Cancer Institute
Janie Hofacker oversees the implementation and strategic expansion of the Association of American Cancer Institute’s (AACI) Programs, Clinical Research, Physician Clinical Leadership Initiative, Network Care Initiative and CAR T Initiative. She is also responsible for developing and implementing new initiatives providing value to AACI’s membership.
Ms. Hofacker joined AACI after two years as administrative director of the Clinical Trials Office at The Ohio State University Comprehensive Cancer Center. She began her clinical research experience as a clinical research coordinator (1992-1998), regulatory manager (1998-2003) and clinical research manager (2003-2008) at the University of Pittsburgh Cancer Institute. She is a registered nurse with current licensure in the state of Pennsylvania and received a bachelor science degree in nursing and graduate degree in leadership from Carlow University.
Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC
Strategy Executive-Clinical Research
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.
Senior Director, Head of Site Activation Operations
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. He 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. He 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.
Associate Director, Research Quality
Betsy Henk has been actively involved in Oncology Research for more than 30 years. She began her career as a data manager (Clinical Research Coordinator) for cooperative group studies. She started performing quality audits approximately 20 years ago.
Study Development Manager
Mary Crowley Research
Alisha Myers reviews more than 200 protocols each year for logistic feasibility, determining which will be a match for Mary Crowley Cancer Research (MCCR) sites. She uses technology to ensure efficiency for everything from answering emails to coordinating pharma visits. All of this is done with one goal in mind: getting the newest cancer products to patients as fast as possible.
Margaret Scott, MS, CCRC
Director of Research Operations
Cancer Care of Western New York/New York Urology
As the Director of Research Operations, Margaret is responsible for the development of the clinical trials departments of a large multi-specialty group. Prior to joining Cancer Care, Margaret has worked as a Data Manager, Clinical Research Associate, and a CRO Project Manager. Having experience from the perspective of multiple stakeholders has encouraged her to work with site, sponsor, and CRO teams to find opportunities for collaboration and efficiency.
Kelly Willenberg, DBA, MBA, BSN
MAGI East 2015 Outstanding Speaker
A Top Speaker Award at ACRP 2015
Featured in Women of Distinction Magazine
Kelly Willenberg, LLC
Kelly Willenberg, DBA, MBA, BSN, CHRC, CHC, CCRP, 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).
Senior Realization Project Manager (On Rotation)
Product Development Industry Collaborations
PD Clinical Operations (PDG)
Jenny Hahn is a Clinical Operations Leader with over 20 years of experience in clinical development across all Phases. Although the majority of her work the last 10 years has been focused on oncology research, she has broad therapeutic area experience including rheumatology, endocrinology, ophthalmology, gastroenterology, and hematology. She started her career as a research assistant at a university hospital ordering records which came in bound volumes, data entering 4 part NCR CRFs and blinding imaging films with a sharpie for submission to the sponsors. In the intervening years, she has been a CRA, a Project Manager at a CRO, a Global Study Lead and an Operations Program Leader. She is currently on a rotation as a Senior Realization Project Manager at Genentech within Product Development Industry Collaborations.
Marietta Kashmer, JD
Associate Director, Global Clinical Operations
Marietta Kashmer is currently an Associate Director of Global Clinical Operations in Oncology for Janssen R&D. She has previous experience as manager of Oncology site contracting at Janssen, as well as contracts counsel at the Eastern Cooperative Oncology Group. She received her Juris Doctor degree in 2009 from Villanova University, and currently resides in Saint Augustine, Florida.
Kirsten Barbee Orand
Sr. Clinical Research Manager
Knight Clinical Trials
Kirsten has a broad background in clinical trial operations, with expertise in oncology research and hospital operations. As part of her various roles in clinical trial management, she has participated in multiple projects that required implementation of processes across various departments. This has included development of a study feasibility workflow for evaluating new oncology trials for a community hospital system, and the design and implementation of standardized research processes to integrate with oncology patient flow in new hospital. In addition, she successfully oversees the operations of five hematologic malignant research teams, which is comprised of data managers, coordinators, regulatory project managers, and Investigator Initiated Trials (IIT) project management.
Jeff Kingsley, DO, MBA, CPI, FACRP
Chief Executive Officer
Dr. Jeff Kingsley, DO, MBA, CPI, FACRP, received his Bachelor of Science degree from the University of Scranton in 1995 with concentrations in biology, chemistry, history, and cultural anthropology, and his Master of Science degree in 1997 in biochemistry. His medical degree was received from the Philadelphia College of Osteopathic Medicine in 2001 and his MBA was received from Emory University’s Goizueta Business School in 2011. Dr. Kingsley has been faculty with the Columbus Regional Health Family Medicine Residency as well as Director of Family Medicine and Urgent Care. He currently holds faculty appointments with the Mercer School of Medicine and the Philadelphia College of Osteopathic Medicine Georgia. Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and 15 wholly owned and integrated clinical research offices in multiple cities in two 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.
Dr. Kingsley is the current COO and Chair for hyperCORE International, LLC Centers of Research Excellence. He is also the past Chair of the Board of Trustees for the Association for Clinical Research Professionals which represents more than 13,000 clinical research professionals internationally. He is the former Treasurer for ACRP and APCR, Past President of ABSAME, sits on three additional Boards, and participates on numerous other local, national, and international committees. Dr. Kingsley obtained his CPI in 2009 and his FACRP in 2017.
He enjoys each day with his wife Christine and four beautiful children.
Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. Prior to ACRP, Jim consulted for a variety of clients such as investigator sites, academic institutions, sponsors, and suppliers. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, Jim spent 24 years with Eli Lilly and Company. From 1999 to 2008, he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. Jim is on the advisory board of CISCRP (a non-profit organization focused on enhancing patient participation in clinical trials) and is a volunteer for the Clinical Trial Transformation Initiative (CTTI). He is a frequent presenter at industry conferences and has written articles and papers that have been published in a wide variety of trade journals.
CAPT Richardae Araojo, PharmD, MS
Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE)
Office of the Commissioner at the U.S. Food and Drug Administration (FDA)
CAPT Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. Food and Drug Administration (FDA). In this role, CAPT Araojo provides leadership, oversight, and direction on minority health and health disparity matters for the Agency. The Office of Minority Health and Health Equity aims to promote and protect the health of diverse populations through research and communication of regulatory science that addresses health disparities.
CAPT Araojo previously served as the Director of the Office of Medical Policy Initiatives (OMPI) in FDA’s Center for Drug Evaluation and Research (CDER), where she managed the OMPI immediate office and three divisions. 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 worked collaboratively with other FDA disciplines, program areas, and FDA centers to foster an interdisciplinary approach to policy development and to enhance the integration of the continuingly evolving science and policy into FDA’s drug development and regulatory review processes. She provided oversight and direction for cross-cutting center and Agency working groups, as well as collaborations with external constituents, to advance medical policy development.
CAPT Araojo joined FDA in 2003, where she held a number of positions in CDER’s Office of New Drugs, first serving in the Division of Psychiatry Drug Products (formerly the Division of Neuropharmacological Drug Products) and then with the Pediatric and Maternal Health Staff (currently the Division of Pediatric and Maternal Health). She then transitioned to the Office of Medical Policy in 2010, where she served as Acting Director of the Division of Medical Policy Programs, Deputy Director of OMPI, and finally Director of OMPI.
CAPT Araojo received her Doctor of Pharmacy Degree from Virginia Commonwealth University, completed a Pharmacy Practice Residency with Emphasis in Community Ambulatory Care at the University of Maryland, and later earned a Master’s degree in Pharmacy Regulation and Policy from the University of Florida.
Jeanne M. Regnante
Senior Vice President of Community Engagement
National Minority Quality Forum’s Center for Sustainable Health Care and Equity and Chair of the Diverse Cancer Communities Working Group (CWG)
Jeanne M. Regnante, is Senior Vice President of Community Engagement for National Minority Quality Forum’s Center for Sustainable Health Care and Equity and Chair of the Diverse Cancer Communities Working Group (CWG) which has 25 active public and private partner organizational members who work together to optimize cancer care, treatment and inclusion to clinical trials for racial and ethnic minorities and medically underserved populations. Jeanne’s experience includes: Founding member of Patient Focused Medicines Development (PFMD), Co-leader for two EU Innovative Medicines Initiative (IMI)focused on standards for patient engagement in medicines development. She has enjoyed her 30+ work experience at Merck & Co. which includes Head of Global Patient Engagement Strategy & Operations, Chief of Staff to Merck’s Chief Medical Officer, Head of Scientific Affairs and Head of an industry leading Global Investigator Studies Program. Jeanne is currently a contributor to the American Cancer Society-Cancer Action Network (CAN) Roundtable on Barriers to Clinical Trials, a member of the American Cancer Society Patient Navigation Roundtable and has served on the advisory board to Patients as Partners and works on several projects in collaboration with the National Health Council and Association of Black Cardiologists. Jeanne has generated several peer reviewed publications based on novel collaborative approaches in the patient engagement and diversity and inclusion in clinical trials area and has submitted an invited Elsevier book chapter on the Patient Voice in Pragmatic Clinical Trials in Industry. Jeanne recently co-founded and launched Patient3i– Patient Insights Inspire Innovation, LLC, Washington, DC which is positioned to transform the global patient engagement framework by focusing on the patient as expert with an innovative business model. Jeanne is a certified Six Sigma Executive Belt and is AED certified by the American Heart Association.
Robin Marcus, RN, MSN
Chief Strategy Officer
GlobalCare Clinical Trials
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.
Jessica Propps, MBA, ACRP-CP
Manager of Research Operations
Jessica Propps is the Manager of Research Operations for Texas Oncology, one of the largest cancer treatment and research providers in the state of Texas. In her current role, Jessica oversees the central research regulatory department. Jessica has over 15 years of clinical research experience including project management, regulatory affairs, and financial operations in the oncology and cardiology arenas. Prior to joining Texas Oncology, Jessica worked in various roles at hospital and academic research sites. Jessica’s wide range of experience has resulted in a passion for improving operations. Jessica holds a bachelor’s degree in biology from Howard University in Washington D.C.
Denise Snyder, MS, RD, LDN
Associate Dean for Clinical Research
Duke University School of Medicine
Duke Office of Clinical Research (DOCR)
After spending time in public health and clinical nutrition, Denise started work as a research coordinator and project manager in 2000 for NIH funded trials in oncology. In 2009, her Research Management Team in the School of Nursing received support from Duke’s CTSA to leverage the group’s services for the School of Medicine. RMT became the home for the REDCap EDC implementation. For the past 7 years, Denise has been the Associate Dean for Clinical Research for Duke University School of Medicine. In this role, she leads the Duke Office of Clinical Research (DOCR) a support office of expertise in coverage analysis, study logistics, data management, regulatory oversight, workforce innovation and guidance for clinical research operations for Duke as a site.
Kandie Dempsey, DBA, MS, RN, OCN
Director, Cancer Research
Helen F. Graham Cancer Center & Research Institute
Christiana Care Health Services
Kandie Dempsey’s career in oncology has spanned over 30 years, having served in a variety of patient caregiver and leadership roles. Since 1998, Kandie has led Christiana Care Health Service’s, Cancer Research Department located at the Helen F. Graham Cancer Center & Research Institute in Newark, Delaware. In this capacity, she provides oversight for the National Cancer Institute Community Oncology Research Program (NCORP), industry based and translational research programs. She led the national Alliance for Clinical Trials in Oncology, Clinical Research Professionals committee for 12 years. In this role, she developed, promoted and implemented training programs to enhance the skills and abilities of clinical research professionals from across the nation. Educational programs included disease-specific and administrative-related presentations that were a key underpinning to the success and quality of NCI sponsored research. Kandie served on a variety of national committees specific to oncology nursing and research including but not limited to; The National Cancer Institute; the Cancer Genome Atlas Project; the National Community Cancer Centers Program; and the Oncology Nursing Society. Dr. Dempsey currently serves on the American Society of Clinical Oncology Community Research Forum, Best Practices Committee and Research Site Qualifications Working Group. She has published in the Journal of Clinical Oncology, Proceedings of the Society of Surgical Oncology, Oncology Issues, Clinical Cancer Research, and the Delaware Medical Journal. She has presented at multiple national and local oncology clinical research conferences, workshops and seminars. She is a certified in Oncology Nursing. Kandie earned a Bachelor of Science in Nursing, Masters of Science in Health Care Administration and a Doctorate in Business Administration all from Wilmington University in Delaware.
JT Tan, MS
Sponsor/CRO Innovation Lead
JT Tan is the Sponsor/CRO Innovation Lead at Complion. With a BS in Biology and an MS in Entrepreneurial Biotechnology, as well as his work as a research assistant in Behavioral Neurobiology, JT is well suited to contribute to Complion’s mission to transform the way clinical trial documentation is created and maintained. Throughout his career, JT has lent his talents to technology product development, analysis and success by finding ways to deliver novel value through entrepreneurship and community building. He has successfully managed development of new markets, and analysis and promotion of strategic data initiatives contributing to road map, business intelligence, marketing and customer success.
Montessa Rodriguez Lizaso, RN, BSN
Associate Director, Site Intelligence Lead
Montessa Rodriguez Lizaso has 25 years of combined healthcare and pharmaceutical experience. She is a Registered Nurse, who started her career in the operating room, and has held various roles as a research nurse, health coach, medical reviewer, and clinical analyst to name a few. Having worked in surgery at the National Institutes of Health in Bethesda, MD, she became a Nurse Specialist in research at the National Cancer Institute, Surgery Branch, coordinating trials, such as isolated hepatic and peritoneal perfusions and was an instrumental contributor to related publications. Her personal journey led her to Las Vegas, NV where Ms. Lizaso worked as a research nurse in Phase I trials at the Nevada Cancer Institute supporting first-in-human trials. Then, she was given the opportunity to return to her surgical roots in the Department of Surgical Oncology of MD Anderson Cancer Center in Houston, TX, contributing to further development of immuno-oncology compounds and perfusion therapy.
As a Clinical Analyst at Covance, Ms. Lizaso was responsible for collecting various sources of scientific, community, and clinical trials intelligence to enable program teams to precisely forecast and course-correct plans during study implementation. Today, Ms. Lizaso is an Associate Director, Site Intelligence Lead with focus in Oncology within the Study Optimization organization at Pfizer. She brings the multidisciplinary skill and clinical insight of her professional evolution into feasibility with the aim to introduce exciting, new clinical trials to the best suited sites and the hope to continue to positively impact patients’ lives.
Renee Rakvica, RN, BSN, OCN
Director Site Services
US Oncology Research
Renee Rakvica started her research career in pre-clinical research while attending Purdue University. Upon graduating, she worked as oncology nurse and then moved to pharma and worked in research in different disease modalities. She then refocused her career to oncology and patient care and had the opportunity to start a research program in Indianapolis, IN.
Renee accepted an opportunity with US Oncology in Texas to work with the practices and implemented an educational program for research nurses across the network. Her current role entails managing a Site Services team, developing new research centers, supporting research programs and acting as the Research Manager focusing on operational efficiencies and strategies for program growth.
Kaelyn Kappeler, CCRC
Clinical Research Manager
Texas Oncology – Austin Region
Kaelyn is a Clinical Research Manager with Texas Oncology – Austin and has over 15 years of oncology clinical research experience. Her main emphasis over the years has been in formulating expanded clinical trial enrollment utilizing physician engagement while maintaining financial stability, data integrity and quality for this very busy Texas Oncology/US Oncology site.
Jacqueline Holz, JD, LLM
Staff Counsel, Pharmaceutical Solutions and Services
Jacqueline Holz is Staff Counsel providing legal counsel and transactional legal support to US Oncology Research to support patient participation in community-based oncology research and clinical trials.
Prior to arriving at US Oncology in January 2017, she served as senior legal advisor and U.S. compliance officer at Chugai Pharma USA. At Chugai she provided for the legal counsel and management associated with both the corporate and the clinical research portions of a global pharmaceutical company.
She received her undergraduate degree from Rutgers University, her Juris Doctor degree from Touro College, Jacob D. Fuchsburg Law Center and Master of Laws in Health Law from Loyola University Chicago School of Law.
Strategic Site Networks Director, Oncology
Strategic Site Solutions, IQVIA
Peter Fredette has 20 years of experience in the drug development industry, including pre-clinical toxicology and all phases of clinical research. He is most experienced in oncology but has worked across a number of other therapeutic areas. Peter’s current responsibilities include site strategies for global and domestic oncology trials and, creating and implementing strategies to improve quality and accessibility of clinical trials for cancer patients around the world. Prior to this, Peter has held a variety of roles at IQVIA over the last 17 years, including trial monitoring, project management, and supporting CRO-Site relations and thought leader engagement.
Elena Jouravleva, MS, PhD
Director, Research Operations, CRO and Regulatory Affairs
US Oncology Research
Dr. Jouravleva has over 20 years of leadership experience in varying aspects of the life sciences industry and clinical research. She has supported clinical trials working with various pharmaceutical and biotech companies and contributed to approvals by various regulatory agencies, numerous pharmaceutical, diagnostic and device products. Dr. Jouravleva currently supports US Oncology Research, a clinical trial site management organization representing approximately 160 locations across the United States, as the Director of Research Operations overseeing Regulatory Affairs, IRB and the Complimentary CRO services groups. She holds Master of Science and Ph.D. degrees in Biology and focused her thesis on genetics of pathogenesis in Vibrio cholerae.