2022 Faculty

Stephanie Abbott, PharmD
Clinical Operations
Innovo Research

15 years of experience building and leading innovative clinical research practices in an inpatient, cancer partnership and outpatient multispecialty clinics; serving as both the liaison between the clinical research site and the trial sponsor, as well as a clinical investigator bringing the care directly to the patients. Responsibilities include designing the SOPs and infrastructure for not only the clinical and regulatory processes but also for leading the build out and integration of the clinical trials and clinical practice technology platforms.

Blake Adams
SVP Marketing
Florence Healthcare

Blake joined Florence in 2017 to help research teams advance cures by introducing them to innovative software solutions. He is a passionate storyteller and growth leader who also loves to travel – he’s been to over 30 countries! Extensive Marketing and Growth Background in SaaS, Healthcare, and Athletics. BS from the Georgia Institute of Technology.

 

Tolu Adewuya, PhD, M.MedSci
Director, Clinical Operations
Javara 

As Director of Clinical Operations, Tolu Adewuya, PhD currently leads strategic planning, administration, and operation efforts for all clinical research activities conducted within Javara healthcare partner organizations. Prior to joining Javara, she managed Oncology Cellular Therapy Clinical Trials with the Winship Cancer Institute at Emory University and served on the Oncology Cellular Therapy and Multiple Myeloma Work Groups. Tolu joined Javara in 2021.

Rick Arlow
CEO & Founder
Complion

Complion Founder Rick Arlow began his career in clinical research while participating in a NIH-funded MD/PhD medical scientist training program at Case Western Reserve University (Cleveland, Ohio). 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.

Rick embarked on putting together a world-class team experienced in clinical research and enterprise content management to develop the initial version of Complion software — the first eRegulatory document management and workflow platform for research sites.

Since the company’s founding in 2012, Complion Inc. has grown to be the industry-leading solution used by physicians, hospitals, academic medical centers, health systems and cancer centers around the country.

Rick is a frequent speaker for several professional research organizations including ACRP, MAGI and SCRS. He takes great pride in Complion’s contributions to the research community and its mission to improve patient outcomes and expand medical knowledge.

Katy Armstrong
Therapeutic Area Head, Oncology
Genentech

Katy has over 19 years of drug development experience and is currently a Therapeutic Area Head in Genentech Research and Early Development (gRED) Clinical Operations responsible for Oncology portfolio leadership of vaccines, cell therapy and molecular oncology. She’s spent the last 16 years at Genentech and is passionate about transforming and accelerating drug development, addressing barriers to clinical trial participation and advancing inclusive research globally. She’s currently the lead of gREDs Inclusive Research and Health Equity Pillar spearheading efforts across the drug development lifecycle to increase diversity in our clinical trials, patient samples and research cell lines. gRED aims to be a key leader in Inclusive Research to advance health equity for underrepresented communities and improve health outcomes for all patients.  She is also active across Genentech/Roche D&I priorities. Katy received a BA in Biology from University of California Berkeley.

 

Andrea Bastek, PhD
Senior Director of Innovation
Florence Healthcare

Andrea Bastek is Senior Director of Innovation at Florence Healthcare. Her team’s mission is to identify the biggest challenges in clinical trial operations and harness technology to solve them. Prior to Florence, Andrea worked in clinical trial operations in the cardiac medical device industry, at Abbott and St. Jude Medical. She holds a PhD in Bioengineering from Georgia Tech, as well as MS and BS degrees in Biomedical Engineering from Tulane University.

Jimmy Bechtel, MBA
Vice President, Site Engagement
SCRS

Jimmy Bechtel is the Society for Clinical Research Sites’ (SCRS) Vice President, Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Mr. Bechtel provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter and operations manager. On the pharma side where he worked in innovation project management, Mr. Bechtel utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Mr. Bechtel to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Mr. Bechtel is in charge of developing and executing the company’s site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. He also manages some of SCRS’s large industry initiatives that are based on innovative concepts and helps oversee the organizations membership.

Jane Bentley, PhD
Vice President, Clinical Strategy-Oncology
Syneos Health

Jane has over 30 years of experience in Clinical Research, including Executive Leadership, project and portfolio management, and clinical monitoring, with most of this focused on oncology research.  Jane has experience with assets from first dose through marketing approval that drives unique insight into the impact of innovations in Novel and Emerging Therapies (including Adoptive Cell Therapies) in Oncology Patient Care. 

Deena Bernstein, MHS
Vice President, Customer Success
Datacubed Health

Entrepreneurial fearless spirit with grit that is unstoppable. During her historical career trajectory, Deena has been instrumental in designing and building the infrastructure of research site management organizations from inception and have led them to achieve tremendous success in the clinical research industry. Areas of expertise are creating value for organizations and employees, customer success, patient journeys, customer-obsessed, building high-performing teams, influencing adoption of new technology, developing strategy, patient engagement, recruitment and enrollment, conscious leadership, employee empowerment, strategic partnerships, integration, on-boarding, and achieving KPI’s.

 

Lisa Bjornestad
VP of Clinical Operations & Growth
DM Clinical 

Lisa has been involved with Clinical Research for over twenty five years. Well-grounded in both early and late phase operations and project management, she can provide a unique perspective to clients in the pharma, biotech, and CRO industry as they proceed with development plans.

Specialties: Clinical Operations, Project Management, CRO services, Research Sites, Subject Recruitment.

 

Stacey Bledsoe, RN, MSN
Senior Director-Diversity in Clinical Trials
Lilly

Stacey Bledsoe RN, MSN has over 19 years’ experience in the pharmaceutical industry across multiple disciplines including Research & Development, Global Health Outcomes, Medical and Six Sigma. She has demonstrated success in Six Sigma methodology, Health Outcomes research, medical information, and the hospital and payer environment. Stacey currently leads the initiatives around increasing diverse representation through partnerships and collaboration for Lilly which allows her to use her passion to move this very important topic forward. Prior to beginning her career at Eli Lilly and company she held a Registered Nurse role on the Level III Newborn Intensive Care Unit at Riley Hospital for Children. Stacey earned her Bachelor and Master of Science in Nursing from Indiana University. Stacey’s goal is to help influence and ensure that all patients have access to clinical research and life changing medications that will ultimately improve their lives.

Fernando Bravo
Clinical Trial Manager
Mary Crowley Cancer Research Centers

 

A graduate of Southwestern University in Georgetown TX, Fernando joined the Mary Crowley team in summer of 2015 and since then has served multiple roles within this research site. From Data coordinator to Patient coordinator/Enrollment specialist, to now a Clinical Trial Manager and member of the regulatory department, he has worked in and learned from different departments, always striving to improve communication between them as well as providing the very best service possible for our patients.

 

 

Kent Buhler, MS, MBA
Executive Director, Operations Strategy Lead, Clinical Research Group
PPD, part of Thermo Fisher Scientific 

 Mr. Buhler has been with PPD since 2005; starting within the Project Delivery group providing program and project oversight to a broad portfolio of oncology and hematology trials.  In his current position, Mr. Buhler works as leader of Hematology/Oncology operational strategy leads.  The operational strategy leads are responsible for proposing clinical trial strategies that meet our clients’ scientific, operational, and budgetary objectives.  Prior to PPD, Mr. Buhler did Research Operations for Cell Therapeutics, Inc., a biotech company focused on the oncology space.  Mr. Buhler started his career at the Genitourinary Cancer Research Laboratory at the University of Washington where his research activities focused on preclinical models of prostate cancer/bone biology and the development of hormonal and radioimmuno-therapies.  

 

Jennifer Clauson, MHA
Director for Strategic Research Partnerships
Tempus Labs

Jennifer Clauson is the Head of Strategic Research Partnerships for Tempus’s TIME Trial site network. She joined Tempus to develop and start the precision oncology TIME Trial network in 2019 which now has over 60 participating sites and has set a new standard for Just-In-Time study activations. Prior to Tempus Jennifer was the System Director for Clinical Trials Operations at AMITA, the largest health system in Illinois with 19 acute care hospitals, and as the Director for Rush Cancer Center Clinical Trials Office. She has an MHA from University of Illinois at Chicago.

April Coburn, MA
Associate Director of Scientific Affairs, Site Activation Liaison
ICON

 

Trevor Cole, BHS, MBA-HCM-PM, CCRC
Senior Manager, Client Delivery
WCG Avoca

Trevor is currently a Sr. Manager at WCG Avoca- a life science consulting firm dedicated to improving quality and compliance in the clinical trial execution process. Trevor has a bachelor’s degree in health science, an MBA in healthcare management and project management, is a certified research coordinator and certified project management professional. Trevor’s passion for site focused improvements comes from his experience as a research coordinator in several disciplines, a pediatric oncology CRA, and leading development and expansion of a research quality program at an academic institution. Trevor has first-hand experience constructing and leading quality management system construct within a research organization and currently helps CROs, Sponsors, and Sites identify gaps and implement sustainable solutions to ultimately get high quality treatments to patients faster and more efficiently.

Patrick Conley, MS, CBSP, NREMT
Director, IBC Operations
Clinical Biosafety Services

Patrick Conley is dedicated biosafety professional and industrial hygienist focused on developing value driven safety programs and services supporting basic research, translational medicine, patient care, and community education. Patrick has a bachelor’s in Microbiology and a master’s degree in Industrial Hygiene, as well as is a certified Biosafety Professional, a licensed Emergency Medical Technician, and a certified Mold Consultant.

Prior to coming to Clinical Biosafety Services, Patrick spent 7 years working on sexually transmitted diseases, invasive diseases, biotoxins, and select agents and toxins and 13 years as a Director within the University of Texas Southwestern Medical Center’s Office of Safety and Business Continuity. Through his director’s role, Patrick oversaw UT Southwestern’s institutional biosafety committee, chemical safety committee, select agent and toxin program, biosafety program, chemical safety program, industrial hygiene program, hazardous waste program, and environmental compliance program. Additionally, through his role as the hazmat section chief of the UT Southwestern Environment Care Committee, Patrick managed all hazardous materials and waste programs within the UT Southwestern ambulatory clinics and hospital facilities.

Patrick is a passionate safety educator, training developer, and community speaker who has worked with the S.T.A.R.S Program, UT Southwestern, and the Dallas Independent School District to encourage high school students to enter the fields of science and medicine. He and his family enjoy traveling, hiking, and the outdoor life, especially when it involves mountains, snow, and wildlife.

Rachel Corrigan, MS
Associate Director, Clinical Project Development
EQRx

Rachel is a Clinical Operations leader with more than 15 years of biotech, pharmaceutical and CRO experience developing oncology assets with a current focus on clinical study strategy and execution.             

Mary Costello
Head of Site and Investigator Network
Medable, Inc.

Mary has 30+ years of healthcare and clinical research experience, including leadership roles at Covance, ThermoFisher Scientific, eClinical Solutions LLC and Elligo Health Research. She is a founder and board member of BioAustin.

Sean Cunningham, MBA
Strategic Account Lead Director
Janssen

Sean Cunningham is a Strategic Account Lead Director with Janssen Global Clinical Operations. As a Strategic Account Lead Director, he heads up a team that 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.             

Dan DeBonis
Principal
Signant Health

A founder of one of the first eCOA companies (Concordant Rater Systems, 2002), focused primary in Neuroscience. Held leadership roles within organizations that are now part of Signant Health for the past 10 years, and now sit as a technology and product strategy advisor in the Science and Medicine team. Active in leadership roles within industry groups, including the Decentralized Trials Research Alliance (DTRA_

Dana Deighton
Assoc. Director of Outreach and Strategic Partnerships, Esophageal Cancer Survivor
Scripps Research, Patient Advocate

Dana Deighton, an esophageal cancer survivor, shares her diagnostic odyssey of false starts and life-threatening detours.

Deighton had always been healthy—she didn’t smoke, didn’t drink and exercised every day. Then came a joint pain that wouldn’t go away, visits to numerous doctors, a series of misdiagnoses, invasive tests, and growing symptoms. The correct diagnosis of stage 4 esophageal cancer “was not the diagnosis anyone wants.” But she refused to accept physicians’ recommendations for palliative care as a solution.

She describes her persistent advocacy to convince doctors to consider her as an individual different from expectations and generalizations. She asked the hard questions and had the hard discussions, resulting in an outcome better than expected.

She recommends physicians and patients do the homework, energetically collaborate and consider the individual patient in the quest for a solution. “Don’t be a passive patient.”

 

Jade Dennis
Sr. Director, Design Hub Data Insights
Lilly

Jade is a global clinical development leader with 20 years experience across Phase I-IV trials within Pharma/Biotech with a current focus on applying data analytics and AI/ML technology to optimize clinical study designs, investigator and country selection.
Jade enjoys pioneering innovative approaches and is known for designing clinical research with a patient centric and data-informed focus.

Jennifer Doraski
US Site Partnership Manager, Oncology
Sanofi

Clinical Research Professional since 2002 within Site, CRO and Sponsor Settings. Broad range of experience, including Site Operations, Monitoring, Clinical and Quality Operations, Training, Mentoring and Regulatory. Prior to first entering the industry as a Research Dietitian and Study Coordinator, worked as a Clinical Dietitian in Hospital, Community and Cancer Center settings. Currently, as a Site Partnership Manager at Sanofi, utilizes previous experience to build site relationships by promoting collaboration, transparent and proactive communication, and operational excellence.

Tonya Edison
Senior Director, Trial Capabilities, North America
Lilly

Tonya Edison joined Eli Lilly and Company in 2003 and has since held a variety of positions in support of patient safety, quality, and the delivery of clinical programs.  Tonya currently leads the Trial Capabilities organization responsible for defining and executing strategies for site activation, maintenance, execution of clinical trial agreements and site closeout activities.  Her team collaborates with clinical trial sites across the United States and Canada to deliver and improve site activation operations that enhance clinical trial experiences for sites and study participants. 

Sara Edwards, MSc, CCRC
Associate Director, Trial Capabilities
Lilly

Sara Edwards joined Eli Lilly and Company in 2020 as Associate Director in Trial Capabilities where she leads site activation for oncology assets. Prior to joining Lilly, Sara supported oncology clinical trial operations at academic institutions and community practices where she held positions as a Study Coordinator, Regulatory Coordinator as well as leadership positions for Quality Assurance and training, multicenter IITs and CTMS oversight. In her current role, Sara leads SIP adoption and site activation metrics for US and Canadian sites and is an advocate for process improvement efforts that will enhance the site and patient experience.

 

Dave Espenshade
Vice President, CRO Partnerships
Greenphire

Dave brings more than two decades of experience in the software and life science industries and a demonstrated expertise in establishing successful partnerships between software providers and CRO businesses.

Dave has a proven ability to successfully establish strategic collaborations between industry leading global CROs and software providers. Earlier in his career, Dave held several senior leadership sales positions at IntraLinks, YPrime, and ePharmaSolutions.

Melanie Flores
VP of IRB Operations
Advarra

Melanie Flores is the Vice President of IRB Operations at Advarra. She is responsible for the Early Phase Center of Excellence which is dedicated to assisting researchers perform Safer, Smarter and Faster research which is Advarra’s mission. She has over 20 years of IRB experience and is passionate about protecting subjects in clinical research.          

Diana Foster, PhD
VP, Strategy and Special Projects, SCRS Diversity Awareness Lead
SCRS

Dr. Foster serves as a consultant to the Society for Clinical Research Sites as the Vice President of Strategy and Special Projects. In her role she is responsible for building relationships with industry that help amplify the voice of the clinical research site.

Diana is a recognized expert in the intricacies of site management and an innovator in the use of strategic marketing and positioning tactics. Diana has designed and facilitated site management and patient recruitment trainings across the globe. While serving as president at DAC Patient Recruitment Services (formerly D. Anderson & Company), Diana led the organization through its evolution as a niche site management organization. Her early tenure as head of an SMO, Rheumatology Research International, also gave her a unique understanding of how sites operate and what they need to reach enrollment goals within targeted timelines.

Over the past two decades, Diana has addressed audiences across five continents, published multiple papers and articles, and written five authoritative industry books including “Global Issues in Patient Recruitment and Retention,” a sequel to “International Patient Recruitment: Regulatory Guidelines, Customs and Practices.” The books have served as teaching tools for colleges and universities, along with her earlier works: “A Guide to Patient Recruitment,” “A Guide to Patient Recruitment and Retention” and “50 Ways to Cope with Arthritis.” In addition, she has been a sought after speaker and given copious of presentations across the world.

Her personal honors include recognition by the Global EXEC Women’s International Council as an International Woman of Influence, being named a finalist for Ernst & Young’s Entrepreneur of the Year Awards, and an induction into the PharmaVOICE “100 Most Inspiring People in the Life-Sciences Industry.” She is among accomplished women around the globe who are changing the way international clinical trials are conducted.

Peter Fredette
Strategic Site Networks Director, Oncology, Regional EPON Director
IQVIA

Peter Fredette has almost 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 many therapeutic areas. Peter’s current responsibilities include supporting CRO-Site alliances and thought leader engagement; 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 site & investigator relations.

Angela Fritsche, MPA
Operations Administrator
Mayo Clinic Cancer Center

Angela Fritsche is the Operations Administrator for the Mayo Clinic Cancer Center Clinical Research Office. Ms. Fritsche received a Bachelor of Science in Business Administration – Human Resources Management and a Master of Public Administration with a specialization in Healthcare Administration from West Virginia University, Morgantown, WV.  Previously, she was the operations manager for the Mayo Clinic Cancer Center CRO where she managed the protocol development and study conduct units and navigated clinical trials through the onset of the COVID-19 pandemic which included developing the staffing plan, lead the research shield CRC workgroup and co-authored the SBAR that led to permanent remote monitoring.  Prior to joining the Cancer Center, she was a senior program coordinator for the Nursing Research Division where she supervised the study coordination team and streamlined nursing research operations and processes for the enterprise-wide Division.  In addition, she was the Epic Super User for Nursing Research and developed the social media strategy for nursing research including receiving Bronze Fellow status for her strategy from the Mayo Clinic Social Media Network.

Her past experience includes managing a National Institutes of Health (NIH) program project (P20) grant and multiple R01 grants for 12 research laboratories at West Virginia University Sensory Neuroscience Research Center. She has also led the grant management operations at the University of Alaska, Institute of Arctic Biology.  Ms. Fritsche was a program administrator for the University of Minnesota, School of Nursing in Minneapolis, MN, and office manager at the Rochester campus. Ms. Fritsche served as a Certified Approver for grants at the University of Minnesota, Rochester campus and was a member of the Grant Manager User Network Advisory Committee for the University of Minnesota. 

Camber Gadberry, MBA, BSN
Alliance and Partnerships Director- Site Alliance
Genentech

Camber Gadberry, BSN, MBA has over 25+ years of experience in clinical research and a prior career in nursing. Camber is the Alliance and Partnership Director for Site Alliances at Genentech where she oversees the strategic development of site relationships across the early development portfolio.  Prior to this role Camber has held several positions at Roche/Genentech which have all been site facing, with the goal for finding better ways of working with sites and external partners.

Camber is proud of the deep relationships Roche/Genentech has built over the years and is especially excited about the communities of practice that have developed as a result of the imCORE network.

In Cambers free time you will likely find her tending to their family flower farm or riding her Harley Davidson aptly named Petunia. 

Melynda Geurts, MS
Senior Vice President, CRO Services
Total Diversity

A clinical research veteran with more than 20 years of leadership experience in the support of clinical trials, Melynda Geurts, M.S. joined Total Diversity Clinical Trial Management (Total Diversity) in 2018 from DAC Patient Recruitment Services, an Imperial Clinical Research Services division, where she served as the vice president of clinical operations.

Kerry Gorman
Director, Strategic Site Solutions
IQVIA

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 Director 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.

Catherine Gregor, MBA, CCRP, CCRC
Chief Clinical Trial Officer
Florence Healthcare

Catherine Gregor, MBA, CCRP, CCRC is the Chief Clinical Trial Officer at Florence. She has more than 15 years of experience analyzing and implementing change across back-office research operations for finance, clinical operations, regulatory, and health information systems. She has worked in a myriad of community and academic environments. Most recently, she served as the Director of Clinical Research Administration at the Vanderbilt-Ingram Cancer Center.

Joe Grosso, MBA
Associate Director- Site Engagement-Oncology
Lilly

Over 20 years’ experience in Clinical Trial Operations in site facing roles in the biotech and pharmaceutical industry. Skilled in all aspects clinical trial management primarily focused in oncology research but also in vaccines and COVID Therapeutics..

Nadege T. Gunn, MD, CPI
Medical Director
Impact Research Institute

Dr. Nadege Gunn is a Gastroenterologist and Hepatologist who focuses mainly on finding therapies for liver related illnesses. She is also a Certified Principal Investigator by the Association of Clinical Research Professionals (ACRP). Her work concentrates on linking cutting edge clinical trials in non-alcoholic fatty liver disease and gastrointestinal illnesses to the populations who need them desperately. She is a fellowship-trained Gastroenterologist and Board Certified in both Internal Medicine and Gastroenterology. She has a broad clinical research and community practice background.

Erin Lynch Hall
Associate Director- Oncology Site Engagement
Lilly

Over 20 years experience in the pharmaceutical industry with experience in sales, training and leadership, with the recent 10 years specializing in site relationship management for Lilly Oncology Clinical Trials Operations.

Betsy Henk
Director, US Oncology Research Quality Assurance
McKesson 

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.

Angela Hirst, RN
Director, Site and Patient Services
Syneos Health

Angela is currently a Director, Site and Patients Services, with senior oversight for the Catalyst sites, Oncology and CNS in the EU and USA. During her time at Syneos Health, Angela has grown and developed the Oncology Network in the EU, whilst continuing to maintain our carefully selected sites within the US. Angela has been with Syneos for 3 years.

Prior to joining Syneos Health, Angela was a Director of Feasibility, Proposals and Budgets at a Site Management Organisation. A post she held for 3 years.

She gained her nursing qualification from the University of Sheffield UK in 1995 and took up a post as an oncology nurse, at Christie hospital in Manchester. She finished her nursing career in 2005 as the lead Breast Cancer Research Nurse at the Royal Preston Hospital where she quickly identified potential recruitment opportunities across 2 other hospital sites, which resulted in an increase in patient recruitment and future research opportunities for the trust. Upon leaving the NHS, Angela was a Site Lead within IQVIA’s Access to Patients programme. This involved identifying and developing a network of GP surgeries and Oncology hospitals within the UK, in order to widen the inclusion of participating sites in research Studies.

 

Faith Holmes, MD
Senior Vice President of Medical Affairs, Medical Director
Elligo Clinical Research Center

My background is over 30 years in clinical practice. Board certified in Family Medicine as well as Hospice and Palliative Medicine. In the latter role have worked extensively with oncology patients. I started in clinical research a little over 3 years ago and have served as Central Coordinating PI as well as local site PI for decentralized clinical trials.

Jolee Holt, MSN, RN, CCRC
Director, Oncology Site Community, Optimal Research
PPD

 

Jolee Holt is an avid patient and site advocate within the clinical research space. After 20 years’ experience working at sites, she joined PPD’s Optimal JIT striving to change the landscape of oncology research to that of a patient-centric approach, while remaining cognizant of the challenges sites and patients face.  The knowledge gained in Clinical Research Regulations, Oncology, Clinical Trials, and Community Sites, throughout her career, enables the 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. 

Esther Howard, MBA
Head of Oncology Solutions
THREAD Research

Esther Howard oversees THREAD’s oncology strategy and collaborates directly with clients to help them build the best oncology solution in a DCT design that integrates with THREAD’s platform.

Ms. Howard is committed to the mission of improving the lives of cancer patients, globally. She has twenty years of experience in the healthcare and clinical research industry, primarily in oncology drug development at PRA Health Sciences (now ICON) and Labcorp Oncology. For the past 5 years Ms. Howard has been working hard to find a path to bring clinical research as a care option to cancer patients and is now working with THREAD and THREAD’s customers to design and innovate to achieve this mission.

 

Jennifer Hunter, CCRP
Director of Research Operations
Mary Crowley Cancer Research

Jenn Hunter joined Mary Crowley Cancer Research in 2013 and currently serves as the Director of Research Operations, overseeing study development, regulatory affairs, trial management, clinical coordination, medical records, quality assurance, and data management. Believing that people are any organization’s greatest asset, her core focus is empowering the team and developing new leaders. She values innovation, boldness, and solution-focused brainstorming. Jenn and the MCCR team have conquered various system implementations, process improvements, and an organizational restructure; these opportunities have created a culture of continuous improvement, complete with team synergy and pioneer thinkers.

 

Lloryn Hubbard
Associate Director, Patient Diversity 
PPD

With more than 10 years of clinical operations experience, Lloryn has made ensuring diverse populations are represented in clinical trial research a priority throughout her career. As a project lead for Health Equity and Population Science, she has led several efforts at Genentech to address disparities in medicine, including spearheading the development of a portfolio of solutions to embed inclusive research across the drug development lifecycle. Before moving into clinical operations, Lloryn worked at the global health organization PATH where she focused on creating low-cost diagnostics for developing countries. Lloryn received BA in Biology with a minor in Cultural Anthropology from Seattle University.

Kathleen R. Hurtado, R.Ph.
AVP, Office of Research Administration, Medicine & Science
Cancer Treatment Centers of America

Drug development expert and long-time healthcare senior executive across various healthcare channels including Fortune 500 pharmaceutical companies, national academic and clinical research institutions, biopharma startups, and national and regional hospital systems.

Sahar Hussain
Site Partnership Manager, Oncology Team Lead
Sanofi

Sahar Hussain serves as a Site Partnership Manager at Sanofi mainly focused in Oncology.  She has over 17 years of clinical operations industry experience in various roles within pharma, biotech, and CRO companies. When she lost her close cousin to cancer, clinical research shifted from being her career to being her passion.  Being part of research was rewarding knowing that the treatment will save so many other family members, caregivers and patients from losing their battle to cancer.   As a Site Partnership Manager she is dedicated to building trustworthy and sustainable collaborations with key institutions to become partners in patient care.  When she is not working you can find her spending time with her daughters, biking, traveling, hiking and trying her hand at painting. 

Felicia Irvin, MBA, ACRP-CP
Executive Director of Business Development
IACT Health

Clinical research professional experienced with transitioning strategy into execution. A strong leader adept in managing top business accounts, driving company sales, cross functional teams, and project management initiatives. Ability to create and maintain a high-performance environment characterized by positive leadership and strong team orientation. Demonstrated track record providing success and results with ability to continue to grow within multiple departments of an organization. Experienced leader of high-performance teams and skilled mentor of individuals. Capable of rapidly assessing a business environment, defining a vision and implementing a plan.

Sheila Johnson
Patient Advocate
Medidata Solutions

A powerful and passionate speaker with a compelling story, Sheila Johnson is a pioneering breast cancer advocate with a particular focus on the black community.  She has overcome personal adversity to help support and educate her community about the risks of breast cancer and how to advocate for yourself once diagnosed. “Breast cancer affects black women differently as we are proportionally dying at a faster rate due to many socioeconomic factors that affect the black community.  All women should
be given the same standard of care and the same treatment options once diagnosed with breast cancer.”  

Sheila uses her voice to raise awareness about the racial disparities faced by black women throughout their breast cancer journey. Receiving a breast cancer diagnosis is devastating for anyone, and Sheila passionately believes that racial disparities should not have an impact on the standard of treatment that black women receive.   Sheila has also taken part in a clinical trial, something that she feels is vitally important because African American women are under-represented in clinical trials.

A metastatic breast cancer (MBC) survivor for 10 years, Sheila seeks to empower and support breast cancer patients and survivors, using her voice to educate and provide hope to other MBC patients.  

Sheila is a decorated United States Air Force military veteran who served for 25 years active duty.  She views every day as a chance to impact lives positively. “Every day is a new challenge for me.  Every day, I get up and I ask myself how I can make the breast cancer community a better space not only for newly diagnosed women and men but also for survivors.”  

Denise Johnson Sura
Senior Director, Site Engagement
Lilly

 

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.

Carmen Kallstrom
Senior Site Manager, MAO Aligned Trials
Janssen

Carmen is a Clinical Research Professional with over 14 years of experience in the industry. After completing her bachelor’s degree from The University of North Texas, Carmen began her research career as a Clinical Research Assistant. Later she pursued opportunities as a Clinical Research Coordinator, Clinical Research Associate and currently holds a Site Manager position with Janssen.

Daniel Kavanagh, PhD, RAC
Senior Scientific Advisor, Gene Therapy
WCG Clinical

Hillary A. King
Director, Clinical Site Operations
Pfizer

Kim Kundert, RN, BSN
SVP of Site Development Services
Total Diversity

Experienced Senior Vice President Of Operations with a 20 year history of success in the research industry. Knowledgeable in clinical site development and expansion. Proficient in clinical site operations having managed 84 sites within a US site network. Strong healthcare background with a Bachelor of Science (B.S.) in Nursing from Arizona State University.

Malia Lewin, JD
Global Head of Strategy
Teckro

Malia Lewin is global head of strategy, ensuring both clinical and market fit for Teckro products. An attorney by training, Malia Lewin has over 20 years of experience in the life sciences industry. Passionate about getting life-changing healthcare innovations to patients, Malia has worked on behalf of non-profit organizations, pharmaceutical and biotechnology companies, hospital systems, and technology companies to expedite the path of scientific discoveries from bench to clinic.

Most recently, Malia served as chief business officer of CherryCircle Software, where she led the global go-to-market strategy for QbDVision, a SaaS platform to optimize the development and manufacturing of drug products. Prior to that, she served as director of global oncology strategy at Veeva Systems, where she worked closely with clients in the oncology space to harness the power of technology to develop and commercialize oncology innovations. During her seven-year tenure as VP of client services and head of strategic operations at Rivermark, LLC (an IQVIA company), Malia led strategic consulting teams advising on the development, launch, and adoption of diagnostics and treatments, across therapeutic areas. This included the development of novel digital products for stakeholder mapping and engagement, network visualization and activation, and reporting and analytics. Earlier in her career, Malia had the opportunity to serve non-profit organizations as the founding CEO and executive director of the International Psoriasis Council and as lead partner of Networking and Affiliations at Ascension Health.

Malia holds Bachelor of Arts Degrees in English and in Women’s Studies from the University of Richmond and a Juris Doctor from The George Washington University Law School.

Ana Marquez, MSF
CEO
Clinical Site Partners

Conduct Phase I-IV Respiratory, Sleep, Nephrology, Pediatric, CNS, Internal Medicine and Gastroenterology research. Our pulmonary research network has developed long term working relationships with our Sponsors and CRO’s because we have consistently met and exceeded enrollment goals. Often, CRO’s and sponsors recruit us to help them meet their enrollment goals, as well as to train or educate sites who are struggling with Asthma, COPD, bronchiectasis, OSA, or Narcolepsy subject enrollment. We are also proud members of hyperCORE International.

We have helped investigators establish or expand their research facilities, improve their quality control processes, trained sites on negotiating clinical trial agreements/budgets, implemented solid accounts receivables processes, assisted with FDA inspections, and Sponsor/IRB audits.

Professionally, I serve on SCRS’s Planning Committee. Formerly, I also served as Chairman for the Society for Clinical Research Sites’ (SCRS) Membership Committee, and on ACRP’s Committee for Investigative Sites.

Lindsay McIntire, CCRC
Director of Clinical Project Management
Javara

As Director of Clinical Project Management, Lindsay McIntire provides strategic direction and management across Javara to enable the delivery of projects and programs within cost, time, and quality requirements. Passionate about innovations that deliver quality data to industry partners while focusing on patient safety and centricity, Lindsay has held multiple leadership roles throughout her clinical research career. Prior to joining Javara, she served most recently as Director of Clinical Research Operations at Articularis Healthcare Group. A seasoned professional, her previous industry experience includes operationalizing projects in a wide breadth of therapeutic areas, building site network foundations with private practice groups, and developing relationships with key stakeholders to drive collaboration and raise clinical research awareness.

 

Andrew Mackinnon, PMP
VP & GM of eConsent
Medable, Inc.

Experienced drug development professional with a demonstrated history of working across multiple business areas within the research industry. Strong experience in implementing strategic visions through team, client and change management techniques.

Rosemary McQueary, RN
Director of Research
Quality Cancer Care Alliance

Rosemary is Director of Research at QCCA, a network of 14 community based oncology practices, conducting research in malignant hematology and oncology. She has worked in a variety of positions within Pharma, CROs, and at a large clinical site. Prior to joining QCCA, Rosemary worked in site relationship roles at Parexel and Syneos Health.

Dan Milam, EMBA
Director, Clinical Trials Partnerships
EQRx

With over twenty-five 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 aids in facilitating and building strong alliances. His focus with EQRx is to establish and build productive working relationships with healthcare organizations and clinical sites to support EQRx’ goal of bringing innovative medicines to patients at a fraction of the price.

Jessica Moehle, CCRP
Director of Operations, Clinical Trials Office
Huntsman Cancer Institute- University of Utah

Jessica Moehle, CCRP is currently responsible for the Clinical Trials Office operations at the Huntsman Cancer Institute, University of Utah. She has over 16 years of experience in clinical trial operations in adult oncology and oversees 150 clinical research personnel with an active portfolio of 480+ therapeutic oncology trials. She is a member of the Clinical Research Innovation, Association of American Cancer Institutes and serves on a variety of advisory committees, task forces and working groups dedicated to the
improvement of clinical trial conduct and operational site efficiency.

Lindsey Morales
Senior Manager, Site Partnerships
Labcorp Drug Development

Lindsey Morales has been in research for 16 years working at CROs, Sponsors and clinical research sites.  She has had roles in Site Relationship Management, Site Identification, Feasibility, Study Start-Up and Monitoring.  Currently, she works at Labcorp Drug Development as a Senior Manager in their Site Centric Solutions department, where she works with site partners across the industry in multiple therapeutic areas. 

Lindsey lives in Frisco, Texas with her twin 7-year-old boys and enjoys spending time with them at her family’s ranch, cheering them on in Ninja class and trying to keep her golden retriever puppy from eating every sock in the house.

Ellen Morrison
Strategic Account Lead & Alliance Manager-Oncology
Janssen Research & Development

Ellen Morrison is a Strategic Account Lead and Alliance Manager with Janssen Global Clinical Operations within Oncology.  As a Strategic Account Lead and Alliance Manager, she is responsible for strategic partnerships and collaborations with Strategic Accounts in the US. In this role, Ellen helps to establish working norms and mutually shared best practices to increase the quality, efficiency, and effectiveness of clinical research at research institutions through enhanced communication and process improvement. Ellen earned her BS from the University of Saint Louis and her MPH from Tulane University.  Ellen has over 15 years of industry experience and joined Janssen in 2018. 

Tina Nghiem
Associate Director, Clinical Trial Development
Mary Crowley Cancer Research

Tina Nghiem collaborates with sponsors and CROs to ensure that the right trials are brought to Mary Crowley Cancer Research (MCCR) sites.  As a member of MCCR’s Trial Portfolio Review committee, she reviews the accrual of over 100 trials and determines whether the trial continues to service MCCR’s patient population.  The review uncovers unmet needs for continued trial outreach while being mindful of the regulatory, clinic, contract, and budget teams’ workload.

Susan Night, JD, LLM
Vice President, Site Engagement and Network Strategy
TD2

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.

Raymond Nomizu, JD
CEO
CRIO

Prior to co-founding CRIO, Raymond owned and operated a clinical research site. He has over 10 years of management consulting experience, including The Boston Consulting Group. He also started Bench Core, a real estate data analytics company that was acquired by RefineRE. He began his career as an attorney and has JD and BA degrees from Harvard University. When not at work, Raymond likes to attempt yoga poses, and to travel with his wife and 4 children.

Dan Otap, CCRP
Sr. Alliance & Partnerships Lead-gRED
Genentech

Dan Otap is a Senior Alliance & Partnerships Lead within Genentech’s Research and Early Development unit (gRED). Dan’s clinical trial operations and compliance background uniquely position him to provide attuned insight into relational site engagement. Dan serves on various internal Roche/Genentech work streams related to clinical trial execution and innovation. He holds positions with the Association of American Cancer Institute (AACI) as well as the Society of Clinical Research Sites (SCRS). Dan has presented at various clinical research conferences and has authored multiple peer reviewed publications spanning clinical trial topics ranging from Community Oncology Practices, to overall site/sponsor relationships.

Prior to his arrival at Genentech, Dan established his career in oncology clinical trials at various world-leading institutions. His first position was a Research Study Assistant within the Department of Neurology at Memorial Sloan Kettering Cancer Center (MSKCC). In 2011, Dan was recruited to Columbia University Medical Center to become the Clinical Research Manager within the Department of Neurology, Division of Neuro-Oncology. In 2012, he took on a dual appointment between the CUMC Department of Neurology and the Clinical Research Management Office (CRMO) within the Herbert Irving Comprehensive Cancer Center (HICCC). He was instrumental in the creation of an internal QA/Monitoring Division within the Cancer Center.. He subsequently was appointed as the Associate Director, Regulatory Affairs within HICCC, and oversaw all regulatory submission processes, compliance/monitoring/auditing activities, DSMC/PRMC managers, Multi-Site Operations, and IND Office processes, which assisted clinical investigators with correspondence with the FDA. His last site based position was at City of Hope Comprehensive Cancer Center in Pasadena, CA. where he served as the Executive Director of Community & Affiliate Practices, focusing on development of clinical trial infrastructure across 30+ satellite locations across southern California.

Dan holds a Bachelor of Science degree in Psychology with a minor in Religion from Southeastern University in Lakeland, Florida. 

Beverly A. Roy, PhD
Director, Clinical Research 
Mercy

Versatile and highly skilled, I offer expertise in biomedical research and project management gained over 14 years of professional experience and the attainment of a PhD. My academic research, which included 45 hours of statistical coursework, has equipped me with cutting-edge tools and techniques as well as a solid understanding of human action and motivation.

For five years I administered/managed various research projects for the department of Neurosurgery at Oklahoma University Health Sciences Center. This experience involved every aspect of the research process, including study design, data collection, statistical analysis, and publication of results. Additionally, I have experience as a Regulatory Specialist and am presently employed as the Director of Clinical Research for Oncology.

Tyler Prater
Senior Director, Oncology Clinical Development
Lilly

With 13 years of clinical research experience, Tyler has worked in both site and sponsor roles in addition to being a patient in a clinical trial. He began his career at a research center as a Patient Recruitment Coordinator educating the community about clinical research and recruiting for multitherapeutic studies. Later he moved into a Study Coordinator role before ultimately working as the site’s Quality Assurance Coordinator. Tyler joined Lilly in 2015 as a Clinical Trial Manager in oncology with experiences in TMF best practices and strong focus on the investigator and patient experience. He now serves as a Senior Director in clinical development with responsibility for delivering oncology assets.

 

 

Archana Sah, MSc(Pharm), PMP
SVP, Oncology Digital and DCT Solutions
Medable, Inc. 

Clinical operations thought leader with 27 years experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women’s Health. She has held various global positions within Biotech, Big pharma, CRO including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, and two Oncology biotech start up companies.  She is currently the Senior Vice President of Digital and Decentralized Solutions heading up Oncology TA at Medable Inc., a leading technology platform provider across the clinical trials ecosystem.

Aside from her executive role, she is a recognized leader/change agent passionate about bringing innovation and efficiencies within the entire clinical trial ecosystem. She has been the co-founding chair (2019-2021) and now a member of Society for Clinical Research Sites Oncology Board and co-chaired the Annual Oncology Summits. She serves on the Leadership Council for Decentralized Trials and Research Alliance(DTRA)  and has been a member of the Digital Innovation in Oncology Roundtable with DiMe. She also serves as an Advisor to American Cancer Society Cancer Action Network. She has contributed to the clinical trial sites Standardization and Harmonization with the Forum on Drug Discovery and Development, National Academy of Sciences.

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.

Steven M. Schmid, PhD, MA
Sr. Director, Laboratory Strategic Planning & Development
Clinical Trials of Texas, Inc.

Steven M. Schmid, PhD, Clinical Trials of Texas, Inc. (CTT) is Sr. Director, Laboratory Strategic Planning & Development oversees the company’s in-house PBMC and lab operations. Dr. Schmid has spent more than three decades in the pharmaceutical and research industries holding senior-level positions at leading biotech companies.

Dr. Schmid is a highly regarded author and presenter with more than 17 years’ experience in clinical trials, Phases I-IV in oncology, urologic oncology, small molecules, interferons, monoclonal antibodies, and liposomal agents. He has worked for 7 years with human blood products and PBMC isolation and 25 years with pharmacology studies. In addition, Dr. Schmid has completed four capital buildouts that resulted in fully staffed and equipped lab facilities that he led.

Lisa Schultz, BSN, RN, OCN
Associate Director, Site Engagement
Lilly

A Clinical Research Professional with experience partnering with Investigators and research staff to develop relationships and focus on oncology research to execute Lilly Trials. Lisa is an Oncology Certified Nurse with more than 28 years working in Oncology. 

Kay Scroggins
President 
Clinical Trials of Texas, Inc.

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.

Filiz Seimer, MBA, CCRP
Director of Clinical Operations
Deep Lens

Filiz has had a diverse background in the oncology clinical research space for over 14 years.  Prior to joining Deep Lens in 2020, Filiz was a Clinical Site Manager for Parexel, where she managed several Phase 1 oncology clinical trials.

Prior to Parexel, Filiz was a Senior Clinical Research Coordinator for the Breast Oncology Program at The Ohio State University Medical Center, managing over 20 clinical trials.  Prior to working at OSUMC, Filiz worked at Nationwide Children’s Hospital as the Senior Research Coordinator for SWOG, managing their national Biorepository.

Filiz received her Bachelors of Science, Biology from The Ohio State University in 2008 and her MBA in Health Care Management from Columbia Southern University in 2018.  Filiz holds a Certified Clinical Research Professional (CCRP) certificate.

Alexis Shaffer
Sr. Business Development Officer
National Life Sciences,  Medix™

Alexis joined Medix Life Sciences 6 years ago and has served as a talent acquisition consultant for multiple organizations within the life science industry, focusing heavily on the growth of clinical research organizations within the US. Presently, Alexis partners with research companies to identify, attract, and retain top talent in the industry through Medix’s specialized recruitment efforts and unique workforce solutions to match the right talent with employers across the country.

Renee Smith, MBA
Head Early Development Capabilities and Alliances
Janssen

Reneé Smith, MBA has over 25 years of experience in research and healthcare. Reneé is currently the Head, Early Development Oncology Capabilities and Alliances at Janssen Pharmaceuticals. Prior to Janssen, she held the role of Associate Vice President, Global Quality and Education at Sarah Cannon where she greatly expanded Sarah Cannon’s quality infrastructure and training and education resources with oversight of the research and blood cancer network quality program as well as the contract research organization. Reneé currently is a member of the AACI Corporate Roundtable representing Janssen and is a working group member for the Society of Clinical Research Sites (SCRS) focusing on Early Development education for clinical sites. Renee’ previously served as a Council Member on the American Society of Clinical Oncology (ASCO) Research Community Forum and has served on various working groups with the ASCO Research Community Forum. Additionally, she has participated in research-focused working groups with the Clinical Trials Transformation Initiative and the National Academies of Sciences, Engineering and Medicine.

Sandy Smith, RN, MSN, AOCN
Senior Vice President, Clinical Solutions and Strategic Partnerships
WCG Clinical

Sandy works with research sites, sponsors, and patient advocacy groups in support of WCG’s mission to accelerate the development of new medical therapies by improving the conduct and quality of clinical trials. She provides consultation to research sites by strategically aligning clinical solutions to improve and create efficient processes in the areas of ethical review, biosafety, trial initiation, research financial services, staffing augmentation, DSMBs, and statistical consulting. Prior to WCG, Sandy was Vice President of US Oncology Research, an oncology-specific site management organization of independent practices and hospital-based research programs.

Sean Soth
VP, Business Partnerships
SCRS

“Site success impacts everyone in research” is the mission that drives Sean and his team as Vice President of Business Partnerships for SCRS. With more than 15 years experience in clinical business development and a background in association management, Sean works to connect sponsors, CROs and solution providers within the SCRS community.

Nicole Stoffel
Associate Director of Regional Operations Development
PPD

Experienced Clinical Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in Clinical Research, Customer Service, Life Sciences, and CRO Management. Strong professional with a Bachelor of Science focused in Bioenvironmental Studies from Texas A&M University.

Lisa Switzer, MA
CEO, Executive Director
Western States Cancer Research

Lisa is a results-driven professional committed to excellence in relationship management and Appreciative Inquiry as a means to building robust community and stakeholder partnerships. Keys to success involve a strong capacity to function independently, courage to make critical decisions, and the ability to manage program development and lead project management. Additional characteristics include intuitive analytical aptitude, strong conflict resolution abilities, a deep commitment to integrity and ethical decision-making, and excellent people skills at all organizational levels.

Wendy Tate, PhD, MS, GStat
Director, Advanced Analytics and Research Optimization
Advarra

Wendy Tate, PhD, MS, GStat is the Director of Advanced analytics and Research Optimization with Advarra. Wendy’s work is focused on the evaluation of clinical research administration, operations, and workflows. Her passion is to provide helpful and meaningful processes and tools to clinical research professionals that streamline clinical research practices and better the clinical research enterprise as a whole. Prior to Advarra, Wendy spent 15 years at the University of Arizona in various roles within human laboratory, human subjects protection, and clinical research roles, including leadership roles with the IRB and Cancer Center clinical trials office. She holds a Master’s degree in Applied Biosciences and a PhD in Pharmaceutical Economics, Policy, and Outcomes with a minor in Epidemiology.

Michael Tucker
Managing Partner, Patient Cloud
Medidata Solutions

Michael is a Managing Partner of Medidata’s Patient Cloud solution sales team, providing leadership and subject matter expertise in decentralized clinical trials and patient centric technologies.  Over the last decade, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of decentralization technologies for hybrid and virtual clinical trials. He was involved in providing solutions for the first decentralized clinical trial with FDA oversight in 2011 as well as PCORI’s ADAPTABLE study with more than 15,000 patients, and many other fully decentralized and hybrid clinical trials.  His 33 year career in medical research includes nearly a decade with the US government conducting and supporting surgical & preclinical research and more than two decades working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research.  Michael is a decorated veteran of the United States Navy and resides in Brushy Creek, Texas where he is also an elected public official serving his community.

Karri Venn, RD, CCRC
COO, President
Centricity Research

Karri Venn brings over 23 years of clinical research experience working at clinical research sites.  Ms. Venn has brought experience, knowledge and drive to many of the positions held at LMC Healthcare since 1999.  In 2006, Ms. Venn was promoted to Director, Research of LMC Clinical Research, in 2015 to President, Research of LMC Manna Research and 2021 to COO, President of Centricity Research (formerly LMC Manna, True North and IACT Health).  Under her tenure, she has been responsible for the successful openings of 13 LMC Healthcare clinics across Canada, including Canada’s only Diabetes Clinical Research Unit and establishing the largest Canadian non-academic Endocrinology Research program, and the integration of various primary care and specialty clinical research sites to form one of the largest integrated research organizations in North America that include therapeutic expertise in all phases of research inclusive of real world/big data.  Centricity Research has more than 40 site locations across 4 provinces and 2 states.   

Ms. Venn has led the project management teams for > 2000 clinical trials and led the response to > 50 Sponsor & Regulatory audits.  Centricity Research 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 and present CEO of hyperCORE International, a leading Super Network of clinical sites which comprises of 100 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), hyperCORE International, and great supporter of both Society for Clinical Research Sites (SCRS) & Association of Clinical Research Professionals (ACRP).

David Vulcano, LCSW, MBA, CIP, RAC
Honorary President
SCRS

David Vulcano. Vulcano brings nearly 30 years of experience within the clinical research industry and has been a member of the SCRS Leadership Council since 2015, providing guidance and direction for the company’s initiatives as a strong advocate for clinical research sites.

In addition to his new role with SCRS, Vulcano is chair of the SCRS Public Policy Committee and co-chair of SCRS’ Site Payment Initiative. He is a mentor to sites in the SCRS online site member community and frequent speaker at SCRS Site Solutions Summits, webinars, and Sites NOW meetings. Vulcano was selected as the recipient of the inaugural SCRS Christine K. Pierre Site Impact Award in 2019. Currently, Vulcano works with HCA Healthcare, where he has been Vice President of Research Compliance and Integrity for 14 years.

Gwen Welty, MBA
Site Solution Director, Early Phase Site Alliance
Parexel

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

Specialties: Pharmaceuticals, Medical Devices, Clinical Research, Regulatory Affairs, Business Development, Training

Michelle Whyte-Purnell, RN, BSN
Site Partnership Manager
Sanofi

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