Speakers

Bishoy Anastasi

Director, Clinical Research Finance, UCLA Dean’s Office of Clinical Research / CTSI
Research Academy

The training is led by Bishoy Anastasi, Director of Clinical Research Finance at UCLA’s Dean’s Office of Clinical Research and CTSI. Bishoy is regarded as a national clinical research subject matter expert, particularly related to research operations, coverage analysis, research pricing & financials, as well as clinical research billing compliance. In addition to co-authoring UCLA’s coverage analysis and research pricing policies, Bishoy brings over 20 years of clinical research operations and management experience.

Sessions

• Coverage Analysis Certification™

Candida Barlow, MSN, CTN, RN

Clinical Research Strategist
Advarra

Candi Barlow is the Clinical Research Strategist at Advarra, supporting clinical research sites nationally and globally while implementing best practices for utilizing electronic systems to their fullest extent. Throughout her career, Candi’s created an established a clinical research institute, served as an NCI administrator, and recently, served as an IRB consultant. Prior to Advarra, Candi has more than 25 years in the nursing field in both the academic medical and hospital health system settings, Candi has served as a research nurse, clinical research coordinator, principal investigator, clinical research associate, and director of clinical research.

Sessions

• Key Performance Indicators: Are You Marketing the Study or Your Site?
• Electronic Systems in Clinical Research - How to Implement Validation in the New Virtual World

Cheryl Byers, MHA, CIP, CHRC

Principal, Advarra Consulting Institutional Research CoE
Advarra

With over 20 years’ research compliance experience, Cheryl Byers is an expert in human subject research. She has provided oversight to programs such as pre-clinical, conflict of interest, HIPAA Privacy, research misconduct, institutional biosafety, radiation safety, export control, and facility security. Byers is a former AAHRPP site visitor and step 1 reviewer; is certified in healthcare research compliance; and is a certified IRB professional.

Sessions

• Panel Discussion: Improving Site Feasibility & Selection through Collaboration

Robann Cunningham

Chief Commercial Officer
Advarra

Robann Cunningham earned her bachelor’s of science degree in biology from the University of Kentucky and started her career in environmental science. Robann brings over 20 years of experience in sales, management, marketing and client relations to her role as Chief Commercial Officer at Advarra. In this role, she oversees all sales activities for the Reviews and Consulting Services and her teams are actively engaged with pharmaceutical sponsors, biotechs, medical device companies, CROs, research sites and institutions. In her role, Robann also helps guide Advarra’s strategic planning and provides ongoing analysis of market opportunities, including the competitive landscape, pricing and development of new services. Before Advarra, she was vice president of sales and marketing at Schulman IRB, where she was a key member of the executive management team, and provided leadership and expertise on the IRB market during successful private equity transactions in 2014, 2017, and 2019. When she’s not working Robann enjoys travel; she’s visited over 30 countries across 5 continents. Robann is also an active member of the Healthcare Businesswomen’s Association and she has served as a volunteer and board member for the last 10 years. She lives in Northern Kentucky with her husband, Donny, and her three children Charlie (7), Caty (6), and Clark (5) and works out of the Advarra Blue Ash office.

Sessions

• Panel Discussion: Creative Approaches to Accelerate Study Startup

Nick Fisher, MBA

Executive Director of Research & Business Administration
Siteman Cancer CenterWashington University & Barnes Jewish Hospital

Nick Fisher is the Executive Director of Research & Business Administration at the Siteman Cancer Center. Mr. Fisher has nearly 20 years of experience managing Siteman’s administrative operations and oncology clinical trials program. He was named Director of Clinical Research in 2013 where he was responsible for all clinical research operations across the center. In 2015, Fisher became the Director of Operations, taking on responsibility for all of the center’s research administration operations. Finally, he accepted the Executive Director role in 2017, assuming oversight of all research and business operations for Siteman and representing the center’s research interests throughout the university. Fisher received his Masters of Business Administration from Washington University in St. Louis in 2011.

Sessions

• Tracking and Reporting Minority Clinical Trial Accruals

Aidan Gannon

Director, Client Services
Advarra

Aidan has over 20 years’ experience in clinical research, having managed global studies from both the sponsor and CRO perspective. Aidan’s particular passion is to make conducting and participating in clinical trials a less burdensome experience for site staff, and patients, their families and caregivers. As Director of Client Services at Advarra, Aidan guides development and adoption of the Longboat Platform, providing study portals, tools, and apps to support and empower trial participants, site staff, study monitors, and the extended study team.

Sessions

• How Sites and Sponsors Can Work Together to Improve Site Experience

Clare Grace, PhD

Chief Patient Officer
Parexel

As Chief Patient Officer for Parexel, Dr. Grace leads Parexel’s global patient advocacy and site efforts, including patient engagement strategies and efforts to enhance clinical trial diversity as well as new, innovative approaches to help teams and customers work more effectively with investigative sites. With more than 20 years of experience in the CRO and biopharmaceutical industries, Dr. Grace was recognized in 2018 by PharmaVOICE as one of the top 100 most inspirational leaders in the pharmaceutical industry. She earned a doctorate in Molecular Oncology from the University of Manchester Institute of Science and Technology and a bachelor's degree in applied biochemistry from Liverpool John Moores University, both in England.

Sessions

• Panel Discussion: Creative Approaches to Accelerate Study Startup

Anuja Gutal

Research Information Systems Administrator
Intermountain Healthcare

Anuja Gutal is a Research Information Systems Administrator at Intermountain Healthcare. She has a Master’s of Science in Information Systems from the University of Utah and Bachelors of Engineering in Information Technology from the Mumbai University, India. She is one of the CTMS administrator who manages all the CTMS specific responsibilities for Intermountain Healthcare’s Office of Research. In addition to CTMS, she also manages other research applications like REDCap, Progeny (Laboratory Information Management System) and Publication Library. She also holds interest in SQL, R programming, business intelligence report creation, and data related topics.

Sessions

• Implementing CRPC Billing Grid Integration with Clinical Conductor

Yasmeen Hafeez

Clinical Research Informatics Specialist
Henry Ford Health System

Yasmeen takes immense pride in being part of Henry Ford Health System and is interested in creating innovative approaches to the management of healthcare information. She works on various research studies, focusing on improving efficiency of workflows to optimize standards and outcomes.Yasmeen started her career as a certified Oracle Database Administrator and has over 15 years of experience in Clinical data management systems. She leverages her knowledge of multiple electronic data capture systems to create novel solutions for researchers in their projects. She enjoys cooking, gardening, and spending time with her husband and two children.

Sessions

• Demystifying Change Control for Validated Systems

Helen He

Product Manager
Advarra

Helen He joined the EVAL team in 2021 as the EVAL Product Manager. She is passionate about product and user experience. Before Advarra, she worked at Epic, focusing on quality assurance and user research for several billing products. She is a graduate of the University of Michigan-Ann Arbor, where she studied political science and sociology and discovered her love of squirrel-feeding.

Sessions

• Leveraging Advarra Technology to Support CCSG Reporting

Dave Henderson

Business Analyst
Karmanos Cancer Institute

Dave has an MBA from Baker Graduate School and is a Six Sigma Black Belt. He joined Karmanos Cancer Institute in 2018, focusing on Clinical Trials / Financial process improvement.

Sessions

• Our Experience in Re-modeling our Approach to the Financial Builds in OnCore

Leah Henley

Clinical Systems Manager
AES: Accelerated Enrollment Solutions

Leah is the Clinical Systems Manager at AES within a team of five members from the US and Europe. She has spent 5 years in the pharmaceutical research industry and has a comprehensive background with Budgets and Contracts and the Study Build processes within CTMS. Leah understands the effort and work put in by clinical staff users and wants to ensure the system runs at full efficiency and is effective for site use. Leah primary goal is for her team to be of value to the organization by providing technical solutions within the CTMS to operational challenges.

Sessions

• Optimize Your Technology to Maximize ROI

Neal Herman

Director, Site Start-Up & Regulatory
Syneos Health, NA Country SSU

Neal has 14 years experience in a clinical research organization (CRO) all being in the Site Start Up group which includes overseeing a group of 20+ Functional site Contract negotiators and currently serving as the Sub-Regional Head of the NA Country SSU team for Syneos Health. The NA Country SSU team is a dedicated group that works directly with sites to collect regulatory documents, negotiate ICFs and assist with IRB submissions.

Sessions

• Panel Discussion: Creative Approaches to Accelerate Study Startup

Laura Hilty

VP, Strategy
Advarra

As Vice President of Strategy, Laura leads efforts to create efficiencies for all stakeholders in the clinical research landscape through Advarra solutions and external partnerships. In her eleven years with Advarra, Laura has worked with customers and community members to grow the company’s range of services that address inefficiencies within the clinical research industry, as well as launching several products. Given the many years working with research sites in depth and seeing the challenges they face on industry studies in particular, she is passionate about bringing together multiple stakeholders to collaborate in industry-wide efficiencies across sites, sponsors, CROs, the IRB and participants.

Sessions

• Leveraging the Advarra–Huron Formal Partnership at Your Organization
• General Session: Welcome & CEO Keynote

Jessica Houlihan

ClinicalTrials.gov Manager
Duke Office of Clinical Research (DOCR)

Jessica Houlihan is a QA and Regulatory Associate in the Duke Office of Clinical Research (DOCR) within the Duke University School of Medicine. In her 10+ years working for Duke she has gained experience in study and regulatory coordination, calendar building, and study start-up. She currently helps support the Duke research community with their use of ClincialTrials.gov and Advarra’s OnCore and eReg systems.

Sessions

• Managing Remote Monitoring

Rachel Jarrard

Manager, Pre-Award Contracting
Karmanos Cancer Institute

Rachel Jarrard, PhD has been with KCI since 2014.  She is responsible for managing the Pre-Award budget and contract negotiations and the research billing compliance for clinical trials supported by industry sponsors, grants, and foundations. Rachel received her Doctorate in Medicinal Chemistry/Molecular Pharmacology from Purdue University and her Bachelor of Science in Biology-Chemistry from Saint Joseph’s College in Rensselaer, Indiana.

Sessions

• Our Experience in Re-modeling our Approach to the Financial Builds in OnCore

Mark J. King, MA, ACRP-CP

VP Research & Innovation
Novant Health

Responsible for strategy and execution of all clinical research operations across a 15-hospital, 3,254-bed, 2,300 physician, $6BN system, including 750 care locations to improve patient access to clinical trials, expand the health system's clinical research portfolio and partner with investigators, pharmaceutical companies, device manufacturers, research consortia and academic medical centers to deliver innovative care options to those we serve. Provide leadership for the healthcare system’s research operations across eleven Institutes and all acute care facilities conducting oncology, cardiology/HVI, neurosciences, orthopedics, women’s and children’s, infectious diseases, surgery/hospital-based medicine, and other centers of excellence. Provide administrative oversight to three hospital-based Institutional Review Boards, ensuring appropriate review and protections of human subjects research across the healthcare system. Provide oversight of research-related M&A activity, technology investments, integration and external partnerships. Designed and constructed two oncology Phase I infusion units. Built on a foundation of ethics, patient safety, quality, compliance and stewardship, apply emerging technologies such as artificial intelligence to drive clinical research efforts, advancing remarkable care to the patients we serve through clinical research, including innovative treatment options and clinical data analytics. Serve on corporate Information Governance Steering Committee, Privacy Oversight Committee, chair Research Advisory Council. Lead corporate clinical research department consisting of research finance, study coordinators, data management, regulatory, IRB, quality assurance/education and research informatics teams.

Sessions

• Panel Discussion: Improving Site Feasibility & Selection through Collaboration

Miranda Kolb, PhD

Manager, Technology Training
Advarra

Miranda Kolb, PhD is a Manager of Technology Training at Advarra. She has worked in training and higher education for over 10 years, including 6 years of teaching and research at the University of Wisconsin – Madison where she earned her doctorate in Organizational Communication. Her current focus is on utilizing technology to create effective and engaging content for both instructor-led and self-guided courses. She believes in finding unique solutions so that distance learning does not mean diminished learning. When not leading or creating training, she enjoys spending time with her partner and their dog, going hiking, and trying new recipes.

Sessions

• A Deep Dive into OnCore Calendars
• OnCore Training Transformation in the Face of a Pandemic

Ann Kreeger

Program Manager
Advarra

Ann has over twenty years project management experience with information technology and software implementation. She has been with the Advarra Implementation Project Management Office for over 11 years, working with dozens of customers and many of our potential customers. Her “forte” focuses on implementation planning, as well as integrations and research financials. If you haven’t heard it yet, just ask her about the “ends of the roast” or any of her other stories.

Sessions

• Leveraging the Advarra–Huron Formal Partnership at Your Organization

Alison Lakin, RN, LLB, LLM, PhD

Associate Vice Chancellor for Regulatory Compliance
University of Colorado Denver I Anschutz Medical Campus

I have been at the University of Colorado Denver I Anschutz Medical Campus since 2001, and, in my current role, I have responsibility for the day to day functioning of the Human Research Protection Program in collaboration with its four affiliated hospitals. Our research award funding totals around $650 million and we manage about 6000 human subject protocols across a broad range of biomedical and social behavioral specialties as well as manage translational science projects in our various research laboratories. My academic background is in oncology / palliative care nursing and law and I obtained my doctorate from King’s College, London in international law, health policy and human rights.

Sessions

• Panel Discussion: Creative Approaches to Accelerate Study Startup

Rudy Latta

Manager, Product Support
Advarra

Rudy has been working in the Clinical Research world since 2011. His career started working at a Clinical Trial Global Lab for 7 years running 4 support teams globally. He later transitioned to work with Clinical Trial Management Systems and eSource systems, where he worked closely with customers to train and deploy Clinical Conductor and eSource throughout their organizations.

Sessions

• Comprehensive Study Builds in Clinical Conductor CTMS

Kristen Matta

Lead Business Systems Analyst
University of Michigan

Kristen Matta is a business systems analyst with the University of Michigan’s Calendar Review & Analysis Office, where she collaborates across a variety of teams to help support OnCore workflows and operations at U of M. She is passionate about leveraging the power of creativity to turn challenges into opportunities and brings over a decade of experience in research financials, administration and coverage analysis to her current role, which focuses on engineering process efficiencies and providing direct support to OnCore end-users.

Sessions

• Operationalizing Knowledge to Optimize Calendaring Workflows

Jill McKinley

Staff Augmentation
Advarra

Jill has been working in the technology support and training for 25 years and has been with Advarra for 13 year. Her roles include Product Support, Training, Implementation Support and Optimization. Her current role is with the Staff Augmentation team to help customers directly with their goals and projects. She prides herself in providing adoptable solutions and helps customers with ​OnCore coordination, project planning, workflow discussions, documentation, training, and adoption sessions. In her free time, she enjoys reading, camping, and podcasting.

Sessions

• Hidden Gems Within the OnCore Enterprise Research System

Jen Mead

Director, Customer Success
Advarra

Crystal Mendenhall

Sr. Application Specialist
Advarra

Crystal has been working in the Clinical Research world since 2012. Her career started in Business Development, but she later transitioned to work with Clinical Trial Management Systems, where she worked closely with customers to train and deploy Clinical Conductor throughout their organization.

Sessions

• Hidden Gems Within the Clinical Conductor CTMS

Orla Mester

SVP, Professional Services
Advarra

Sessions

• General Session: Product & Service Deep Dive

Jake Meyer

Senior Manager, Business Operations Services
Advarra

Jake Meyer is the senior manager at Advarra and oversees the coverage analysis, budget negotiation, and CTMS study build services. He has assisted research sites across the nation in their CTMS, billing, and budgeting efforts associated with clinical trials. Prior to joining Advarra, Jake worked on behalf of a service provider and academic medical center. With 5+ years of experience supporting research operations, Jake takes price in his work and helping the industry grow.

Sessions

• This Year’s Most Common Pitfalls in Coverage Analysis

Marcus Miers

Director of Client Training
Advarra

Marcus Miers serves as the Director of Client Training for Advarra’s Technology Solutions division. Since 2012, he has worked in training and eLearning in both public and private sector organizations. Marcus has expertise in consulting on learning approaches, eLearning content development, and scaling learning programs. His passion is in finding the most impactful solution for training, whether it’s through optimizing training delivery methods or creating new learning services.

Sessions

• Models to Scale Training During and After the Pandemic

Chris Mulhern

Solutions Consultant
Advarra

As a Solutions Consultant Chris works with current and prospective Advarra customers to understand their organizational needs and identify pain points in their current workflows that could be alleviated by Advarra’s technology solutions. He specializes in providing in depth demonstrations of Advarra OnCore, EDC and eReg solutions.

Sami Naber

Program Manager, Clinical Trial Billing
Cedars-Sinai Medical Center

Sami has been part of the Post Award team in Office of Research Administration at Cedars-Sinai for seven years, and is the primary OnCore Biller at the hospital. He was a key stakeholder in the organization’s Accounts Receivable integration of OnCore with Peoplesoft.  Prior to joining the central office, Sami began his career as a research administrator in the Kidney Transplant department at Cedars-Sinai. In his free time, he chases around his surprisingly fast 2 year old son.  He has been at Cedars-Sinai for 11 years.

Sessions

• Integration of Financial Systems with OnCore: Lessons Learned About Maximizing Efficiency

Erin Nelson, MPH, CCRP

Regulatory Manager
The Ohio State University

Erin Nelson is the Regulatory Manager for The Ohio State University Comprehensive Cancer Center – Clinical Trials Office. She has been working in regulatory compliance for over 3 years and clinical research for 5.5 years. She currently supports her institution by providing regulatory guidance to investigators and clinical staff as well as external sponsors. She trains her team of 25 staff members on how to promote regulatory compliance in clinical research through the use of tools like Advarra OnCore and eReg.

Sessions

• Managing Remote Monitoring

Carrie Nemke

SVP, Customer Relationships
Advarra

Carrie Nemke brings nearly 20 years of experience in healthcare, clinical research, and sales to her role as Senior Vice President of Customer Relationships at Advarra. In this role, she oversees the sales and customer success activities for Advarra Technology Solutions. With a background in healthcare and clinical research, Nemke brings an understanding of research operations to the sales and relationship development process. The customer relationship team focuses on a consultative approach to understand customer priorities, working across our internal teams to ensure customers’ commitments are fulfilled. Prior to Advarra, Nemke worked in clinical research at a small medical device company and was a physical therapist specializing in neurological rehabilitation in the Madison, WI area. Nemke holds her MPT of Physical Therapy and BS in Kinesiology from the University of Wisconsin-Madison.

Sessions

• General Session: Welcome & CEO Keynote

Kim Nothnagel

Research Contract & Budget Specialist
Karmanos Cancer Institute

Kim Nothnagel joined KCI in 2017 as a Research Informatics Specialist and moved to KCI’s Pre-Award team in March 2020 to learn clinical trial budget negotiation and help train team members to build calendars and budgets in OnCore.  Before joining KCI, Kim worked in the legal field for 22 years, and in higher education administration for 7 years.  She received her B.A. Degree in Liberal Studies from the University of Michigan-Dearborn, and M.A. Degree in Human Resource Management from Marygrove College. 

Sessions

• Our Experience in Re-modeling our Approach to the Financial Builds in OnCore

Casey O'Hara

Application System Technical Analyst – Consultant
Intermountain Healthcare

Casey O’Hara is an Application System Technical Analyst with Intermountain Healthcare. She has worked as a software QA engineer, change manager, event manager, and system analyst in both the financial and healthcare industries. She is a 15-year cancer survivor and joined Intermountain Healthcare 9.5 years ago, eager to give back to the healthcare community that enabled her survival. She was heavily involved in the Cerner EHR implementation starting in 2014 and recently moved to the Research Informatics/Precision Medicine team. She is excited to learn and make a difference with the research team.

Sessions

• Implementing CRPC Billing Grid Integration with Clinical Conductor

Mary Jo O'Loughlin

Director Pre-Award Contracting
Karmanos Cancer Institute

Mary Jo O’Loughlin is the Director Pre-Award Contracting at the Karmanos Cancer Institute.  She has more than 20 years of experience in research.  Mary Jo and the Pre-Award team manage the negotiation and execution of the CDAs, MTAs, and budget and contracts for the clinical trials.  She facilitates the review of budgets for investigator-initiated studies funded by grants, foundations or pharmaceutical or device companies.  The Pre-Award team is responsible for the Coverage Analysis and billing compliance processes for the clinical trials. 

Sessions

• Our Experience in Re-modeling our Approach to the Financial Builds in OnCore

Jeff Parks

Director, Product Management
Advarra

As the Director of Product Management, Jeff is responsible for Clinical Research Operations products at Advarra. This includes leading product management activities for OnCore and Clinical Conductors CTMS solutions. Jeff has been part of the product management team at Advarra for the last 4 years.

Sessions

• Leveraging Advarra Technology to Support CCSG Reporting

Makenzie Pick

Manager, Solutions Consultants
Advarra

Makenzie Pick is the manager of the Solutions Consultant team at Advarra who specializes in providing demonstrations of Advarra’s portfolio of software. She previously worked on healthcare software implementations for three years where she focused on project management for major academic institutions across the country. Makenzie is passionate about helping organizations understand how software can be used to create efficiencies for staff throughout the healthcare and research realms.

Tiffany Danielle Pineda

Research Navigator and Chair, DC3 (Diversity and Cultural Competence Council)
UF Clinical and Translational Science Institute

Tiffany Danielle Chisholm Pineda was born in Philadelphia, Pennsylvania. She is a poet, comedian, author, orator, radio personality, educator, and writer. She is the mother of three amazing children Gregory II, Courtney, and Noah. Tiffany Danielle graduated from the University of Florida in Gainesville where she still resides with her family. She holds certifications in Minority Mentorship from the University of Florida; Cultural Competence from Albany State; and Diversity, Equity, and Inclusivity in the Workplace from University of South Florida. Tiffany Danielle has created a certification for Obtaining Consent for Research Participation with an emphasis on cultural competence and many other trainings related to diversity, equity, and inclusivity. She is the Chair and co-founder of the University of Florida’s Clinical and Translational Science Institute’s Diversity and Cultural Competence Council known as DC3. Tiffany Danielle is a Regulatory Specialist at the University of Florida where she has been blessed to work in various positions for over 24 years including having been an Institutional Board Member for almost a decade. She has been a Board Member of Kids n Capes a non-profit dedicated to protecting children for over three years.

Sessions

• Bright IDEA: Improving Inclusion, Diversity, Equity and Access in Clinical Research

Dawn N. Pittinger, MBA, CHRC, CRCP

Corporate Compliance – Research Billing Compliance Manager
Moffitt Cancer Center

Dawn Pittinger is currently the Corporate Compliance Research Billing Compliance Manager at Moffitt Cancer Center. She is responsible for developing, implementing, and overseeing an auditing program for clinical research billing and grants management activities across Moffitt. Dawn has 13+ years of experience in clinical research operations, specializing in research billing, finance, compliance, regulatory, and electronic systems for research. She has experience implementing and overseeing a centralized research billing office and multiple electronic system deployments. Dawn has an MBA in Healthcare Administration, are CHRC and CRCP certified, and is currently working on her DBA.

Sessions

• Leveraging GCP and Billing Compliance Efforts to Decrease Non-Compliance

Michael Rauwerdink

Product Manager, Interfaces
Advarra

With a passion for connecting workflows across enterprise systems, Michael guides development of interfaces that empower collaboration across research, clinical, and finance teams.  Michael brings a strong technical background from nearly 20 years in software engineering and a strong industry background in enterprise integration focused on healthcare interoperability standards to inform his work setting the interface product roadmap for Advarra’s OnCore Enterprise CTMS.

Sessions

• SAE Integration between Epic and OnCore

Tiffany Reinson

Training Specialist
Advarra

Tiffany's training career began in 2004 working with the American Red Cross teaching infant, child and adult CPR across various Florida State Parks. From 2009 to 2019, she contract trained Veeva CRM and Veeva Vault MedComms to major pharmaceutical companies across the industry. She transitioned to the research side training Clinical Conductor's CTMS and eConsent products with new and existing customers. Over her career she has presented to more than 2000 participants using mirrored instruction, demo and train the trainer techniques in her field of work.

Sessions

• Comprehensive Study Builds in Clinical Conductor CTMS

Kacey Richards, MPH, CCRP, PMP

Senior Business Systems Analyst
Yale Center for Clinical Investigation (YCCI)

With a Masters degree in Public Health from Yale University, I started working at the Yale Cancer Center in 2013. In 2015, I transitioned to YCCI as a Clinical Research Coordinator. Ahead of the pandemic in early 2020, I took on the role of Project Manager, focusing primarily on our OnCore system. Most recently, I have expanded my focus at YCCI to include our EDC and eReg systems in my current role as Senior Business Systems Analyst. With a combined 6 years working at YCCI in several diverse roles, I have been able to harness that unique experience to better serve our research community.  

Sessions

• SAE Integration between Epic and OnCore

Lauren Rogers

Director of Clinical Research
Prism Health North Texas

Lauren Rogers is the Director of Clinical Research at Prism Health North Texas (PHNTX) in Dallas Texas. She has worked at PHNTX since 2007 and assisted in the creation and development of its Clinical Research Department. The Clinical Research Department has participated in over 40 clinical trials (both NIH and industry sponsored), enrolled over 500 study participants, and its work has contributed to FDA approval of 16 medications for the treatment and prevention of HIV. Lauren manages the day-to-day operations of two clinical research sites and supervises the team of clinical research coordinators, data mangers, and laboratory technicians. She also oversees the administrative and financial management of the clinical research program and department.

Sessions

• Improving Financial Management and Reporting Using a Clinical Trial Management Software

Shannon Roznoski

Director, Product Management
Advarra

As Director of Product Management, Shannon guides the strategic planning and management of Clinical Data Management solutions at Advarra. She is an advocate for 21 CFR Part 11 awareness and the adoption of industry standards to ensure Advarra solutions meet the needs of its customer community. Shannon has over 20 years of clinical data management and IT experience, and is a CCDM through SCDM.

Sessions

• Demystifying Change Control for Validated Systems

Gadi Saarony, MBA

Chief Executive Officer
Advarra

Gadi Saarony, Chief Executive Officer at Advarra, has over 25 years of leadership experience, including strategic, commercial, and operational clinical research roles. Prior to joining Advarra, Saarony served as Executive Vice President and Chief Clinical Research Services Officer at Parexel and was a member the company’s executive leadership team. Saarony was responsible for the operational delivery of Parexel’s global clinical research services, including site strategy and selection, patient recruitment, data management, biostatistics and programming, clinical operations, project management, resourcing, clinical trial supplies and logistics, and Phase I units. Prior to that, Saarony held several other senior-level positions at Parexel and was instrumental in achieving rapid growth in Parexel’s regulatory consulting and medical communications businesses. Saarony initially joined Parexel in 2003 in the area of strategy development.Saarony also previously served as Director of Consulting Services for Habama, Inc., and as Associate Director, Strategy, with Ernst & Young, LLP, Inc. He graduated from Rider University with a bachelor’s degree in economics and holds a master’s degree in international business from The American Graduate School of International Business (now Thunderbird School of Global Management).

Sessions

• General Session: Welcome & CEO Keynote

Brian Sevier, PhD

COO, Clinical & Translational Science Institute
University of Florida

Brian Sevier, Ph.D., is the Chief Operating Officer of the UF Clinical & Translational Science Institute (CTSI) and the Director of the Office of Clinical Research (OCR). As the COO of the CTSI, Brian oversees the operational implementation of the UF-FSU CTSA Hub strategic initiatives, establishing new collaborations, and partnering with health system administrators to execute on the mission of the CTSI within the academic medical center. Additionally, this role oversees the administration of multiple research cores and auxiliary service centers, managing revenue recovery portfolios. As the Director of the OCR, Brian leads a multidisciplinary team of research administrators delivering high levels of customer service to internal stakeholders and extramural sponsors. The OCR is responsible for managing all UF|Research workflows related to clinical study protocol activation, contracting, pre- and post-award financial management, award setup and management, CTMS operations, and coverage analysis.

Sessions

• Bright IDEA: Improving Inclusion, Diversity, Equity and Access in Clinical Research

Stephen Shapiro

Senior Training Advisor
Advarra

Stephen is a Senior Training Advisor at Advarra. He works mostly with OnCore and Advarra EDC. He has a vested interest in just-in-time training materials, how to make classroom training more engaging, and general public speaking. Outside of work, he enjoys cooking, taking long walks, making music, and playing with his cat Carlos and dog Bandit.

Sessions

• It's an Art, Not a Science: EDC Form Design Principles
• Embrace the Rainbow: Why Your Training Program Must be Unique

Bhanu Sharma, PhD

Regulatory Compliance Leader
Stanford University

Dr. Bhanu Sharma is a Regulatory Compliance Leader for the Stanford Center for Clinical Research. He has more than 15 years of experience working on drug and device trials in both industry and academia. He recently contributed to a significant project relating to Software as a Medical Device (SaMD). Over the years, he was instrumental in bringing out many clinical systems such as electronic data capture system, ePRO and medical devices. Dr. Sharma is a key opinion leader on 21 CFR Part 11 and has lectured around the globe. He holds a PhD in Biochemistry and bachelor’s in Information Technology.

Sessions

• 21 CFR Part 11 Perspectives in SaMD and Software Systems

Jonathan E. Shough

President Technology Solutions
Advarra

Jonathan E. Shough is President, Technology Solutions, at Advarra. In this position, he drives technology product strategy and offerings, commercialization, and customer relationships. Jonathan has over 30 years of experience in information technology, including more than 20 years in the clinical research industry. He has deep expertise in both the development and commercialization of innovative, award-winning technology solutions. Before joining Advarra, Shough was Senior Vice President and CIO, LabCorp Drug Development and GM Software Platforms, where he managed a large data and technology team and worked on several successful mergers and acquisitions. Prior to that, he held the position of Senior Vice President and Chief Data Officer at Syneos Health where he was responsible for developing and executing the data and commercialization strategy. At IQVIA, Shough served as Executive Director, IT, where he developed the technology go-to-market strategy. Earlier in his career, he held numerous information technology leadership positions in the financial and telecommunications industries. Shough attended Guilford College and is a US Marine Corps veteran.

Sessions

• General Session: Product & Service Deep Dive

Kelly Smith

Senior Solutions Consultant
Advarra

Kelly Smith,CCRP began in research in 2007. Kelly joined Advarra via legacy Bio-Optronics in October 2016. She brought with her a site perspective and an understanding of the problems facing the industry today as well as an extensive knowledge of Clinical Conductor CTMS and eClinical products. She currently supports the Account Executives with demonstrations, proposed configurations, and solutions. Before that Kelly worked as the CTMS Administrator for an Investigative Site Network. She started as a Regulatory Document Specialist and evolved into a Quality Assurance Coordinator for a dedicated research site. Kelly lives in San Diego and enjoys spending time with her family, hiking, traveling, cooking, and practicing Pilates.

Denise C. Snyder, MS, RD, LDN

Associate Dean of Clinical Research
Duke School of Medicine

After spending time in public health and clinical nutrition, Denise started work at Duke 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 and launch REDCap for the School of Medicine. For nearly 10 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.

Sessions

• Clinical Research Unit Scorecards: Metrics that Drive Performance

Samantha Spell

Clinical Systems Application and Learning Specialist
AES: Accelerated Enrollment Solutions

Samantha is a CTMS Application and Learning Specialist with AES. Samantha has spent almost 8 years in pharmaceutical research, with approximately 4 years of site experience. In this unique role, Samantha facilitates administrative duties within the application as well as leading CTMS training for users, using data reporting to isolate key training needs. Samantha fully supports cohesive workflows through training. A believer of teamwork, she thrives on training system users to understand the CTMS as well as comprehend the need for accurate and efficient data.

Sessions

• Optimize Your Technology to Maximize ROI

Erick Sperloen

Senior Training Specialist
Advarra

Erick Sperloen is a Senior Training Specialist at Advarra with focuses on OnCore and EVAL. He has worked as a software trainer, educator, and coach across various fields for over 12 years. Erick has always been passionate about education having received his Bachelor’s in English at the University of Wisconsin – Madison and his Secondary Education Licensure from the University of Wisconsin – Whitewater. Focusing on developing efficient training strategies and workflows, Erick also works to prep and support customer trainers as well. When he isn’t training, he enjoys playing and coaching competitive baseball as well as taking long walks with his dog, Zeus.

Sessions

• Models to Scale Training During and After the Pandemic
• A Deep Dive into OnCore Calendars

Tim Spinler

eLearning and LMS Manager
Advarra

Tim Spinler is the eLearning and LMS Manager at Advarra.  He has worked within adult education and training for almost 20 years, including work within the telecommunications, health care, and insurance industries.  He has focused on eLearning development for the last 10 years, including earning a Masters in eLearning Education from the University of Illinois. Tim strives to create online learning that is effective, efficient and fun.  When he’s not creating new training, he enjoys spending time with his wife and two kids and playing drums in multiple punk rock bands.

Sessions

• Advarra University: Training as Good as Gold!

Chelsey Stephens

Senior Customer Success Manager
Advarra

Lauren Talley

Manager, Clinical Research Informatics
St. Jude Children’s Research Hospital

Lauren Colvin-Talley is a Manager of Clinical Research Informatics Services Program (CRiSP) at St. Jude Children’s Research Hospital. Lauren has twelve years’ experience in clinical research system development, implementation, and management. Lauren believes it is critical for research to be supported by the appropriate eco-system. Over the past two years, CRiSP has implemented four new systems into their Clinical Research eco-system providing ample opportunity to improve training strategies with each go-live. Lauren has been with St. Jude for four years primarily focusing on collaborating with clinical research stakeholders and information services to ensure seamless communication and collaboration during each phase of a clinical research system. Prior to joining St. Jude, Lauren started her career in research at the Social Science Research Center at Mississippi State University and the Preventive Medicine Department at the University of Tennessee Health Science Center. She holds a Bachelor’s Degree and Master’s Degree in Social Experimental Psychology from Mississippi State University.

Sessions

• OnCore Training Transformation in the Face of a Pandemic

Tim Van Dijk

Business Systems Analyst
University of Michigan

Tim van Dijk is a business systems analyst for the Calendar Review and Analysis Office in the University of Michigan Medical School Office of Research. He has been with CRAO since the adoption of OnCore at U of M, and has been building, maintaining, and optimizing calendars over the course of multiple migrations and procedural changes. In addition to calendaring, he is also involved in Medicare coverage analysis, supporting end-users both within CRAO and throughout the Office of Research, and collaborating with the Clinical Trials Support Unit (CTSU) to implement workflow efficiencies that meet the ever-changing needs of the research community. He holds a Bachelor’s degree in English from the University of Michigan.

Sessions

• Operationalizing Knowledge to Optimize Calendaring Workflows

Jennifer Warneke

Vice President Clinical Operations
G1 Therapeutics

Jennifer Warneke joined G1 Therapeutics in June as the VP of Clinical Operations and is responsible for the Operationalization of G1’s book of work. Previously she was the Global Operations Lead for the Oncology BU at Syneos Health where she led a team of 1300 and was responsible for project delivery of the Oncology portfolio. A big believer in getting it right the first time, Jennifer views site identification and the associated feasibility process as one of the most critical elements in successful trial delivery. With the availability of data on site performance available in the market right now, understanding how to synthesize and leverage this data for success is a focus for Jennifer and G1 Therapeutics.

Sessions

• Panel Discussion: Improving Site Feasibility & Selection through Collaboration

Katy Wile

Higher Ed Consulting Director
Huron

Katy is a Director in Huron’s Research Enterprise Solutions group and co-leads the Clinical Trials Management System (CTMS) team. Katy brings over fifteen years of experience in clinical research operations. She specializes in the design, implementation, and optimization of clinical research applications, including OnCore. Her work includes implementation planning, training strategy development, business process redesign, and system integration and optimization. Prior to joining Huron, Katy worked at the Vanderbilt-Ingram Cancer Center where she was a Phase I oncology research coordinator and an OnCore system administrator.

Sessions

• Leveraging the Advarra–Huron Formal Partnership at Your Organization

Mary Elizabeth Williams

Keynote Speaker
Author

Mary Elizabeth Williams is a metastatic melanoma survivor, clinical trial veteran, and the author of "A Series of Catastrophes and Miracles: A True Story of Love, Science, and Cancer." She has written for the LA Times, the Guardian, Health, and other publications. Her New York Times essay was recently adapted for the second season of Amazon Prime's "Modern Love." She has spoken for ASCO, PRIM&R, Bristol Meyers Squibb, and DIA, and is the winner of the 2020 AMWA Walter Alvarez Award. She is currently a doctoral student of Medical Humanities at Drew University.

Sessions

• General Session: Guest Keynote

Michael J. Woods

Chief Executive Officer
Firma Clinical

Michael Woods serves as Chief Executive Officer for Firma Clinical, applying his nearly 35 years of experience in supporting the developmental needs of pharmaceutical, biotech, and device companies. Prior to joining Firma, Mr. Woods served as Chief Executive Officer for Schulman IRB. During this time Mr. Woods led a period of unprecedented growth and success at Schulman, during which Schulman expanded service offerings, customer base and geographic scope to become a global provider of research compliance services. Throughout this expansion, Schulman maintained a pristine regulatory track record and an outstanding reputation for the quality of their services. Before joining Schulman, Mr. Woods held several senior management positions in the medical device and biopharma services industry, including Aradigm Corporation where he led Business Development efforts to secure co-development and strategic partnering deals with pharmaceutical and biotech companies worldwide. Throughout his career in the drug and medical device industries, Mr. Woods has had the opportunity to play a key role in the development of dozens of innovative products and services for a variety of organizations. He is in demand as a member of various commercial and non-profit Boards, industry collaboration efforts, and as a sought-after speaker at numerous conferences, all of which is a testament to his broad understanding of how to maximize the efficiency and effectiveness of development collaborations. Mr. Woods has a MS with Honors in Molecular Biophysics and Biochemistry from Yale University, and a BS, cum laude, in Biology and Chemistry from Walla Walla University.

Sessions

• Panel Discussion: Improving Site Feasibility & Selection through Collaboration

James Wurdeman

Chief Product Officer
Advarra

James joined Advarra in 2005 and has led both the Customer Support and Product Management teams. As Chief Product Officer, James brings a deep understanding of customer needs to the product development roadmap. Collaborating with customers is the cornerstone of Advarra’s product strategy, and James works to ensure that all Advarra products contribute to the company’s over-arching mission of helping our customers succeed.

Sessions

• General Session: Product & Service Deep Dive

Kate Yawman

Director, Product Management
Advarra

Kate Yawman is a Director of Product Management who partners with customers conducting clinical trials to deliver software that streamlines regulatory compliance. Kate believes that technology should play a vital role in facilitating how organizations from sites to sponsors collaborate to run research more efficiently. Kate has been with Advarra (formerly part of Bio-Optronics) for 8 years. Before taking on her current role, she worked on CTMS and eSource products providing a broad view of the clinical research site technology market. Prior to joining Bio-Optronics Kate started her career in pre-clinical research at Johns Hopkins University and University at Buffalo. She holds a Bachelor’s degree in Biological Sciences from the University of Delaware and a MBA in Health Sciences Management and Competitive Strategy from the Simon School of Business at the University of Rochester.

Sessions

• An Introduction to Advarra eConsent

Omid Zia

Grant and Contract Officer
Cedars-Sinai Medical Center

Omid Zia works in the Clinical Trial Administration Office at Cedars-Sinai Medical Center as a Grant and Contract Officer.  Omid assists study teams and Principal Investigators in budget negotiation, Pre-award setup, ICF Financial language, CDAs and Financial language within Clinical Agreements.  Omid was born and raised in Santa Monica, CA.  On Omid’s free time he enjoys going to the beach and hiking.

Sessions

• Integration of Financial Systems with OnCore: Lessons Learned About Maximizing Efficiency