Agenda: 2022 West MAGI

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Time	Name	Speakers	Track	This Module is Eligible for	Location Name
7:00 AM - 8:00 AM	Breakfast				Celebrity Foyer
7:00 AM - 5:00 PM	Registration				Mezzanine
8:00 AM - 10:30 AM	Good Clinical Practice (GCP): Part 1	Linda Coleman - Director, Human Research Protection Program - Yale University Janet Holwell - Clinical Research Consultant/Trainer - Holwell Clinical Research Consulting Patricia Mendoza - Senior Quality Assurance Auditor - Medpace	Workshop	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 1
8:00 AM - 10:30 AM	Drug Development 101	Jennifer Peterson - Director, Head of Clinical Quality - M3 Wake Research	Workshop	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
8:00 AM - 10:30 AM	Dissecting a Clinical Trial Agreement (CTA) Part 1	Collin Gruener - Operations Manager, WCG Site Network - WCG Ethan Denny - Associate Counsel - Research Foundation for SUNY Erick Lee - Senior Counsel - Research, IP, and Life Sciences - Sutter Health Monalee Shah - Legal Reviewer - Astellas Pharma	Workshop	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
10:45 AM - 1:15 PM	Good Clinical Practice (GCP): Part 2	Linda Coleman - Director, Human Research Protection Program - Yale University Janet Holwell - Clinical Research Consultant/Trainer - Holwell Clinical Research Consulting Patricia Mendoza - Senior Quality Assurance Auditor - Medpace	Workshop	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 1
10:45 AM - 1:15 PM	Clinical Trial Designs and Concepts 101	Kaitlin Gillette - Associate Director, Clinical Operations - Syneos Health	Workshop	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
10:45 AM - 1:15 PM	Foundation Course: Billing Compliance	Nancy Umbeck - Manager- Clinical Research - Mercy Research Xonia Cerro - Director, Sponsored Programs - University of Miami - Sylvester Comprehensive Cancer Center Amanda Miller - Manager, Quality and Development - WCG Jennifer Syburg - Clinical Trials Associate Director of Finance - University of Wisconsin Clinical Trials Institute (UW CTI)	Workshop	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 3
10:45 AM - 1:15 PM	Dissecting a Clinical Trial Agreement (CTA) Part 2	Collin Gruener - Operations Manager, WCG Site Network - WCG Khan Lau - Fmr. Director Clinical Research - Glaukos Sarah Shelgren - Sr. Manager, Site Engagement - Amgen	Workshop	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
1:15 PM - 2:30 PM	Boxed Lunch				Celebrity 4
2:30 PM - 4:00 PM	Good Clinical Practice (GCP): Part 3	Linda Coleman - Director, Human Research Protection Program - Yale University Janet Holwell - Clinical Research Consultant/Trainer - Holwell Clinical Research Consulting Patricia Mendoza - Senior Quality Assurance Auditor - Medpace	Workshop	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 1
2:30 PM - 4:00 PM	Professional Skills 101	Barry Sagotsky - Owner - Magnolia Lane Consulting	Workshop	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
2:30 PM - 4:00 PM	Master Course: Billing Compliance	Denise Goode - Manager- Clinical Research - Mercy Geoffrey Schick - Director, Strategic Site Partnerships - WCG Kelly Willenberg - President - Willenberg	Workshop	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 3
2:30 PM - 4:00 PM	Participant Recruitment: Innovations and Best Practices	Kai Bode - Director, Digital Innovation & Patient Strategy - Merck & Co	Workshop	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
4:00 PM - 6:00 PM	Opening Reception				Mezzanine

Time	Name	Speakers	Track	This Module is Eligible for	Location Name
7:00 AM - 8:00 AM	Breakfast				Mezzanine
7:00 AM - 5:00 PM	Registration				Mezzanine
8:00 AM - 8:15 AM	Opening Remarks		Plenary		Celebrity 5-8
8:15 AM - 9:30 AM	Keynote: The Importance of Clinical Research - A Patient’s Perspective	Mary Elizabeth Williams - Author, consultant, and doctoral student - self	Plenary	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 5-8
9:30 AM - 10:00 AM	Networking Break				Mezzanine
9:30 AM - 6:30 PM	WCG MAGI Headshot Studio			CCB Credits, CLE Credits, CME Credits, CNE Credits	Mezzanine
9:35 AM - 9:55 AM	AI is Everywhere Understand How Modern Language Models Work, Where They Work Best, and How to Identify Pitfalls and Risks. (Sponsored Session: Aspen Insights)	Walter Storm - CEO - Aspen Insights	Sponsored Session		Innovation Theater
10:00 AM - 10:45 AM	Contract Breakout: Creating and Using a Clinical Trial Agreement (CTA) Playbook	Micheal Mott - Director - WCRN-COGI Virginia Gilbert - Director, Global Site Agreements - Merck Sharp & Dohme LLC Carla Otterson - Assistant General Counsel, Research and Intellectual Property - Sutter Health	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 1
10:00 AM - 10:45 AM	Clinical Trial Success: It’s All About Relationships - How to Start on the Right Foot	Kimberly Guedes - Principal - Glial consulting Sharon Medendorp - President and EVP - Premier Consulting	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
10:00 AM - 10:45 AM	Research Ethics and IRBs Breakout: Proper Payment - Best Practices in Participant Payment	John Baumann - Associate Vice President Research Compliance - Indiana University Kelly Fitzgerald - Executive IRB Chair & VP, IBC Affairs: ISO Top Mgmt - WCG Michelle Stickler - Associate Vice President for Research - The University of Texas at Austin	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 3
10:00 AM - 10:45 AM	Study Billing Breakout: Intro to Medicare Coverage Analysis	Melissa Orbegoso - Manager , Sponsored Programs - University of Miami Derek Johnson - Coverage Analysis Quality Manager - WCG Alyssa Robberstad - Supervisor, Research Coverage Analyst - Moffitt Cancer Center	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 3
10:00 AM - 10:45 AM	Quality Breakout: How do YOU Define "Quality"?	Linda Sullivan - Senior Advisor, Metrics & Performance Management - WCG	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 4
10:00 AM - 10:45 AM	Medical Devices 101 Breakout: Differences Between Medical Device and Drug Regulations	Kimberly A. Dorsch - Sr. Director, Clinical Affairs - Hemanext Bryant Gordon - Compliance Program Manager - University Of Utah Emily Ostrander - Director of the Conflict of Interest Office - University of Utah Judith Skroback - Affiliated IRB Member - Advarra	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
10:45 AM - 11:30 AM	Contract Breakout: Indemnification Clauses: Taming the Beast!	Micheal Mott - Director - WCRN-COGI Phil Boyce - CEO - Boyce Life Sciences Peter Sullivan - Principal - Sullivan Group	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 1
10:45 AM - 11:30 AM	Clinical Trial Success: It’s All About Relationships - How to Achieve a Win-Win Relationship	Kimberly Guedes - Principal - Glial consulting Vishnu Nitta - President - Arrow Clinical Trials Orlan Romm - CEO - Tandem Clinical Research	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
10:45 AM - 11:30 AM	Research Ethics Breakout: DSMBs and You - The Role of Data Safety Monitoring Boards	Sujatha Sridhar - Executive Director, Research Compliance - University of Texas Health Science Center at Houston John Baumann - Associate Vice President Research Compliance - Indiana University	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 3
10:45 AM - 11:30 AM	Study Billing Breakout: Billing Compliance and Reimbursement for Device Trials	Melissa Orbegoso - Manager , Sponsored Programs - University of Miami Lisa Butler - Associate Director, Reimbursement Clinical Trials - MCRA, LLC Geoffrey Schick - Director, Strategic Site Partnerships - WCG	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CME Credits, CNE Credits	Melrose 3
10:45 AM - 11:30 AM	Quality Breakout: The Top 10 Site KRIs Sponsors are Measuring and How They Use the Results	Linda Sullivan - Senior Advisor, Metrics & Performance Management - WCG Duncan Hall - CEO - Triumph Research Intelligence Adam Larrabee - President - Rochester Clinical Research, Inc. Stephanie Love - Director, Clinical Monitoring - United Therapeutics	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 4
10:45 AM - 11:30 AM	Medical Devices 101 Breakout: Categorizing Medical Devices - IDE, Assessing Risk Level, and What the IRB Will Want To Know	Kimberly A. Dorsch - Sr. Director, Clinical Affairs - Hemanext Andrea Itskovich - IRB Chair/Vice Chair (Medical) - WCG IRB Rachel Lally - Executive Director, Human Research Protection Program - Penn State University	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
11:30 AM - 12:15 PM	Contract Breakout: Insurance	Micheal Mott - Director - WCRN-COGI Phil Boyce - CEO - Boyce Life Sciences Peter Sullivan - Principal - Sullivan Group	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 1
11:30 AM - 12:15 PM	Clinical Trial Success: It’s All About Relationships - Can We Just Talk About it?	Kimberly Guedes - Principal - Glial consulting Vishnu Nitta - President - Arrow Clinical Trials Orlan Romm - CEO - Tandem Clinical Research	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
11:30 AM - 12:15 PM	Research Ethics and IRBs Breakout: Complicated Inclusion - When Employees Are Study Participants	Rhonda Oilepo - Assistant Vice President for Human Research Administration - UT Southwestern Medical Center Ann Johnson - Director, IRB & Human Research Protection Program - University of Utah John Baumann - Associate Vice President Research Compliance - Indiana University	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 3
11:30 AM - 12:15 PM	Study Billing Breakout: Medicare Coverage Analysis Out of the Ordinary	Kelly Willenberg - President - Willenberg Marie Jackson - Director - ATSU	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 3
11:30 AM - 12:15 PM	Quality Breakout: Creating a Quality Culture In Your Organization	Linda Sullivan - Senior Advisor, Metrics & Performance Management - WCG Stephen Loosli - Executive Director - Boeson Research Tarin McTague - Dir, R&D Quality Continuous Improvement - Seagen Patricia Mendoza - Senior Quality Assurance Auditor - Medpace	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 4
11:30 AM - 12:15 PM	Medical Devices 101 Breakout: Site Operations for Medical Device Studies	Kimberly A. Dorsch - Sr. Director, Clinical Affairs - Hemanext Angela Rose - VP Clinical Trial Operations - Verici Dx	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
12:15 PM - 1:00 PM	Lunch in the MAGI Cafe: Birds of a Feather				Celebrity 4
1:00 PM - 2:00 PM	Dessert in the MAGI Lounge				Mezzanine
1:05 PM - 1:25 PM	Unlock the Key to Fast and Accurate Patient Recruitment (Sponsored Session: VigiLanz)	DeAnn Cary - Director, The Sharp Center for Research - Sharp Health Care	Sponsored Session		Innovation Theater
1:35 PM - 1:55 PM	Precision Patient Care: Pathology, Explainable AI & Trial Matching Solutions (Sponsored Session: Inspirata)	Chakra Chennubhotla - Associate Professor, Department of Computational and Systems Biology - University of Pittsburgh Mark Lloyd - EVP & Founder - Inspirata	Sponsored Session		Innovation Theater
2:00 PM - 2:45 PM	Contract Breakout: Deal Breaker Terms in Clinical Trial Agreements (CTA)	Lisa Switzer - CEO/Executive Director - Western States Cancer Research NCORP Leanne Tran - Principal - JD MD Solutions Jessica Weidman - Associate Director, Global Site Agreements, GCTO - Merck Sharp & Dohme LLC	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 1
2:00 PM - 2:45 PM	Data Privacy and GDPR Breakout: Watch out for HIPAA! Data Sharing and the Mischaracterization of Data Sets	Phil Boyce - CEO - Boyce Life Sciences	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 2
2:00 PM - 2:45 PM	Research Ethics Breakout: Ethics and Compliance - Where’s the Overlap?	John Baumann - Associate Vice President Research Compliance - Indiana University Quincy Byrdsong - Vice Provost for Health Affairs - Lipscomb University	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 3
2:00 PM - 2:45 PM	Study Billing Breakout: Billing Audits and Monitoring	Kelly Willenberg - President - Willenberg Dawn Pittinger - Research Financial Compliance Officer - Moffitt Cancer Center Tracy Popp - Educator/Advisor/Contractor - A Clover Group	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 3
2:00 PM - 2:45 PM	Special Considerations in Pediatric Research Breakout: Providing Gender-Affirming Care in Pediatric Research	Michelle Adams - Director - Cincinnati Children's Hospital	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 4
2:00 PM - 2:45 PM	Investigator Initiated Trials (IIT) Breakout: I'm Doing What?! Regulatory Responsibilities When the Investigator is Also the Sponsor	Sarah Wicks - Associate - Goodwin Procter Sierra Clark - Industry Contracts Manager - University of California San Francisco Lin Feng - Clinical Research Coordinator - UBMD Orthopaedics & Sports Medicine Matthew Porteus - Professor - Stanford University Julie Tibbets - FDA Practice Chair - Goodwin Procter LLP	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
2:45 PM - 3:30 PM	Contract Breakout: Subject Injury: Contracting and Billing Considerations	Lisa Switzer - CEO/Executive Director - Western States Cancer Research NCORP Cara Jacobs - Senior Director, Contracts & Legal - Biorasi Janice Crow - Director, Cell Therapy and Clinical Research Network Contracting - City of Hope	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 1
2:45 PM - 3:30 PM	Data Privacy and GDPR Breakout: Understanding GDPR - Where are the Lines?	Phil Boyce - CEO - Boyce Life Sciences	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 2
2:45 PM - 3:30 PM	Research Ethics Breakout: Dealing with Data: Future Use and Data Sharing	John Baumann - Associate Vice President Research Compliance - Indiana University Joshua Fedewa - Director, IRBMed - University of Michigan David Forster - Chief Compliance Officer - WCG	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 3
2:45 PM - 3:30 PM	Study Billing Breakout: Panel Discussion: Operationalizing Your Research Billing Compliance Plan	Kelly Willenberg - President - Willenberg Marie Jackson - Director - ATSU Carly Tucker - Corporate Compliance Manager - Tufts Medicine Nancy Umbeck - Manager- Clinical Research - Mercy Research	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 3
2:45 PM - 3:30 PM	Special Considerations in Pediatric Research Breakout: Assent, Permission, One or Two Parents - Getting Consent in Pediatric Research is Different!	Carrie Croson - Regulatory Affairs Manager - Cincinnati Children's Hospital	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Melrose 4
2:45 PM - 3:30 PM	Investigator-Initiated Trials (IIT) Breakout: Pros and Cons of IIT Program Structures - Which One Is Right for Your Organization?	Sarah Wicks - Associate - Goodwin Procter Sierra Clark - Industry Contracts Manager - University of California San Francisco Lin Feng - Clinical Research Coordinator - UBMD Orthopaedics & Sports Medicine Matthew Porteus - Professor - Stanford University Julie Tibbets - FDA Practice Chair - Goodwin Procter LLP	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
3:30 PM - 4:00 PM	Networking Break				Mezzanine
3:35 PM - 3:55 PM	Wrong Technology for the Right Job: Applying Technology Where it Isn’t Needed. (Sponsored Session: Clinical.ly)	Henry Kravchenko - CEO - Clinical.ly Adam Larrabee - President - Rochester Clinical Research, Inc.	Sponsored Session		Innovation Theater
4:00 PM - 5:15 PM	Solving the Challenges of Decentralized Clinical Trials (DCTs)	Sandra Smith - Senior Vice President - WCG Chad Adams - AVP \| COO - HonorHealth Research Institute Anthony Brogno - Director of Clinical Operations - Lindus Health Catherine Catherine - Florence Healthcare - Gregor Lovie Negrin - Director of Research - Randomize Now Luke Snedaker - Senior Director, Site Development Operations - SiteBridge Research	Plenary	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 5-8
5:15 PM - 6:30 PM	Networking Reception and Book Signing				Mezzanine

Time	Name	Speakers	Track	This Module is Eligible for	Location Name
7:00 AM - 8:00 AM	Breakfast				Mezzanine
7:00 AM - 5:00 PM	Registration				Mezzanine
8:00 AM - 8:15 AM	Welcome Remarks		Plenary		Celebrity 5-8
8:15 AM - 9:30 AM	Ensuring Appropriate Representation in Clinical Trials to Advance Medicine and Reduce Health Disparities	Quincy Byrdsong - Vice Provost for Health Affairs - Lipscomb University Richardae Araojo - Associate Commissioner for Minority Health - U.S. Food and Drug Administration Katherine Cornish - Associate Director of Patient Advocacy and Clinical Research Diversity - WCG Clinical Rueben C. Warren - Executive Director, National Center for Bioethics for Research and Healthcare - Tuskegee University Kendal Whitlock - Head of Digital Optimization - Walgreens Health	Plenary	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 5-8
9:30 AM - 10:00 AM	Networking Break				Mezzanine
9:30 AM - 5:30 PM	WCG MAGI Headshot Studio				Mezzanine
9:35 AM - 9:55 AM	Communication Barriers: Facilitating Diverse Enrollments (Sponsored Session: Care Access)	Amy Pace - Senior Director, Global Study Operations - Care Access	Sponsored Session		Innovation Theater
10:00 AM - 10:45 AM	Site Management Breakout: Employee Retention and Motivation	Stephen Loosli - Executive Director - Boeson Research Chad Adams - AVP \| COO - HonorHealth Research Institute Marty Jacobson - Sr. Director, Hospital Solutions - Boeson Research	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
10:00 AM - 10:45 AM	Study Budgets Breakout: Budget Development and Negotiations for Sites	Geoffrey Schick - Director, Strategic Site Partnerships - WCG Michael O'Gorman - Chief Executive Officer and Founder - LifeScience Marketplace, LLC Brandy Haslam - CEO - ImageBloom	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 3
10:00 AM - 10:45 AM	Gene Therapy Breakout: Gene Therapy 101	Daniel Kavanagh - Senior Scientific Advisor - WCG	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 3
10:00 AM - 10:45 AM	Special Issues in Oncology Clinical Trials Breakout: The Side Effects of Narrowing Eligibility Criteria in Oncology Studies	Cheryl Sampson - Director, Clinical Research Office - University of New Mexico Comprehensive Cancer Center Donna Katz - Director, TRIO-US Network - UCLA/TRIO-US Susan Night - Vice President, Site Engagement and Network Strategy - Translational Drug Development (TD2)	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 4
10:00 AM - 10:45 AM	Recruiting and Retaining Study Participants Breakout: Clinical Research Paid Marketing Strategies in an Ever-Changing World	Laura Halloran - President & CEO - Halloran Consulting Group Jane Howie - Research Marketing Consultant - Cincinnati Children's Hospital Medical Center	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
10:45 AM - 11:30 AM	Site Management Breakout: Right-sizing your SOPs	Trevor Cole - Associate Director - WCG Victor Capetillo - Site Manager - Injury Care Research/Family Care Research	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
10:45 AM - 11:30 AM	Study Budgets Breakout: Hidden Costs for Sites and Sponsors	Geoffrey Schick - Director, Strategic Site Partnerships - WCG Neal Herman - Director, SSU & Regulatory - Syneos Health Brad Hightower - CEO - Hightower Clinical	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 3
10:45 AM - 11:30 AM	Gene Therapy: Unique Operational Aspects of Gene Therapy Research	Daniel Kavanagh - Senior Scientific Advisor - WCG Karen McCulloch - Chair, IBC Services - WCG IBC Services Steven Schmid - Senior Director, Laboratory Strategic Planning and Development - Flourish Research	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 3
10:45 AM - 11:30 AM	Special Issues in Oncology Clinical Trials Breakout: Best Practices for Sites Interested in Conducting Phase 1 Oncology Studies	Cheryl Sampson - Director, Clinical Research Office - University of New Mexico Comprehensive Cancer Center Ann Lovelace - Director, Research Operations - Comprehensive Cancer Centers of Nevada AnaArlene Ramirez - Manager, Phase I Research Operation - Comprehensive Cancer Centers of Nevada Renee Smith - Head, ED Oncology Capabilities and Alliances - Janssen	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 4
10:45 AM - 11:30 AM	Recruiting and Retaining Study Participants Breakout: Democratizing Clinical Trials – Bringing the Trial to the Patient	Laura Halloran - President & CEO - Halloran Consulting Group Owen Garrick - Chief Medical Officer, Clinical Trial Services - CVS Health R'Kes Starling - Chief Executive Officer - Reveles Clinical Services	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
11:30 AM - 12:15 PM	Site Management Breakout: How Research Operations and Compliance Can Work Together	Meghan Colozzo - Director, Compliance & Privacy Officer - Beth Israel Deaconess Medical Center Douglas Reichgott - Executive Director, Clinical Research - Beth Israel Deaconess Medical Center Carly Tucker - Corporate Compliance Manager - Tufts Medicine	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
11:30 AM - 12:15 PM	Study Budgets Breakout: Methodology for Measuring, Negotiating, and Managing Staff Workload	Geoffrey Schick - Director, Strategic Site Partnerships - WCG Suzan Bruce - Research Finance Supervisor - UC Davis Jimmy Thai - Senior Clinical Research Coordinator and CRC Team Lead - Clinical and Translational Science Center, UC Davis	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 3
11:30 AM - 12:15 PM	Gene Therapy Breakout: Unique Ethical and Operational Issues in Gene Therapy Research	Daniel Kavanagh - Senior Scientific Advisor - WCG Rafael Escandon - Principal - DGBI Consulting, LLC Emma James - VP Medical & Patient Affairs - Encoded Therapeutics	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Melrose 3
11:30 AM - 12:15 PM	Special Issues in Oncology Clinical Trials Breakout: Managing and Retaining Health Care Providers Who Support Research	Cheryl Sampson - Director, Clinical Research Office - University of New Mexico Comprehensive Cancer Center	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Melrose 4
11:30 AM - 12:15 PM	Recruiting and Retaining Study Participants Breakout: Keeping Patients Engaged Once You Find Them	Laura Halloran - President & CEO - Halloran Consulting Group Erica Rivas - Director of Patient Engagement - Accel Research Sites Network Kyle Hogan - President - Datacubed Health	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Wilshire AB
12:15 PM - 1:00 PM	Lunch in the MAGI Cafe: Regions				Celebrity 4
1:00 PM - 2:00 PM	Dessert in the MAGI Lounge				Mezzanine
1:05 PM - 1:25 PM	Direct Transfer of Data From EHR and eCOA to eCRF Eliminates the Double Data Entry and Time Spent with Monitors on SDV (Sponsored Session: Triomics)	Sarim Khan - Co-Founder & CEO - Triomics	Sponsored Session		Innovation Theater
1:35 PM - 1:55 PM	How Sites Can Identify and Recruit Patients in their Own Health Systems and Community (Sponsored Session: BEKHealth)	Halley Loosekamp - Vice President Corporate Strategy - BEKHealth	Sponsored Session		Innovation Theater
2:00 PM - 3:30 PM	Best Practices for Incorporating Patient Feedback Into Drug Development Programs	T.J. Sharpe - Patient Engagement Program Manager - Medidata Solutions Emma James - VP Medical & Patient Affairs - Encoded Therapeutics Jennifer McNary - Principal - J McNary Consulting Jaye Bea Smalley - Head, Patient Advocacy - Immunovant Jamie Tyrone - Patient Advocate - Self	Breakout	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 1
2:00 PM - 3:30 PM	A Pro/Con Debate: Should We Refer to Clinical Trials “as a Care Option”	David Forster - Chief Compliance Officer - WCG Karla Childers - Head, Bioethics-based Science & Technology Policy - Johnson & Johnson Maximiliano Elizari - Clinical Research Director - Merck	Breakout	ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits	Celebrity 5-8
3:30 PM - 4:00 PM	Networking Break				Mezzanine
3:35 PM - 3:55 PM	Leveraging AI to Improve the Financial, Operational and Scientific ROI of Clinical Research (Sponsored Session: Deep6AI)	Rachel Heiss - VP of Operations - Deep 6 AI Mary Veazie - Principal - Clinical Research Consulting & Education Services, LLC	Sponsored Session		Innovation Theater
4:00 PM - 5:30 PM	Technology in Clinical Trials	Suzanne Caruso - SVP, Clinical Solutions – Insights and Analytics - WCG Patrick Floody - Executive Director - Regeneron Pharmaceuticals, Inc Lisa Hoebelheinrich - Associate Vice Chancellor for Research Administration - University of Kansas Medical Center Ryan Jones - CEO - Florence Healthcare Dinesh Mudaranthakam - Director of Research Information Technology - Kansas University Medical Center	Plenary	ACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 5-8

Time	Name	Speakers	Track	This Module is Eligible for	Location Name
7:30 AM - 8:30 AM	Breakfast				Celebrity Foyer
7:30 AM - 10:00 AM	Registration				Mezzanine
8:30 AM - 10:00 AM	WCG Innovation Challenge	Jill Johnston - Chief Innovation Officer - WCG Brandi Bratrude - Program Administration Manager - Boston Children's Hospital Paul Cox - Health Value Translation Lead - Sanofi Hannah Reimer - Clinical Research Nurse - Temple University Donna Libretti Cooke - Clin Ops Consultant - Consultant Kylie Sands - Clinical Research Associate - St. Lawrence Health	Plenary	CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 5-8
10:00 AM - 10:30 AM	Networking Break				Mezzanine
10:30 AM - 12:30 PM	Networking Session for Biopharma Executives	Barry Sagotsky - Owner - Magnolia Lane Consulting Jennifer Peterson - Director, Head of Clinical Quality - M3 Wake Research Jill Johnston - Chief Innovation Officer - WCG	Breakout	CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 1
10:30 AM - 12:30 PM	Hot Topics - Join the Discussion!	George Gasparis - President - PEER Consulting	Breakout	CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 2
10:30 AM - 12:30 PM	Avoca Quality Consortium Roundtable	Trevor Cole - Associate Director - WCG Linda Sullivan - Senior Advisor, Metrics & Performance Management - WCG	Breakout	CCB Credits, CLE Credits, CME Credits, CNE Credits	Celebrity 3

Chad Adams - AVP | COO - HonorHealth Research Institute
Michelle Adams - Director - Cincinnati Children's Hospital
Richardae Araojo - Associate Commissioner for Minority Healt...
John Baumann - Associate Vice President Research Compliance
Kai Bode - Director, Digital Innovation & Patient Strategy -...
Phil Boyce - CEO - Boyce Life Sciences
Brandi Bratrude - Program Administration Manager - Boston Ch...
Anthony Brogno - Director of Clinical Operations - Lindus He...
Suzan Bruce - Research Finance Supervisor - UC Davis
Lisa Butler - Associate Director, Reimbursement Clinical Tri...
Quincy Byrdsong - Vice Provost for Health Affairs - Lipscomb...
Victor Capetillo - Site Manager - Injury Care Research/Famil...
Suzanne Caruso - SVP, Clinical Solutions – Insights and Anal...
DeAnn Cary - Director, The Sharp Center for Research - Sharp...
Catherine Catherine - Florence Healthcare - Gregor
Xonia Cerro - Director, Sponsored Programs - University of M...
Chakra Chennubhotla - Associate Professor, Department of Com...
Karla Childers - Head, Bioethics-based Science & Technology
Sierra Clark - Industry Contracts Manager - University of Ca...
Trevor Cole - Associate Director - WCG
Linda Coleman - Director, Human Research Protection Program
Meghan Colozzo - Director, Compliance & Privacy Officer - Be...
Donna Libretti Cooke - Clin Ops Consultant - Consultant
Katherine Cornish - Associate Director of Patient Advocacy a...
Paul Cox - Health Value Translation Lead - Sanofi
Carrie Croson - Regulatory Affairs Manager - Cincinnati Chil...
Janice Crow - Director, Cell Therapy and Clinical Research N...
Ethan Denny - Associate Counsel - Research Foundation for SU...
Kimberly A. Dorsch - Sr. Director, Clinical Affairs - Hemane...
Maximiliano Elizari - Clinical Research Director - Merck
Rafael Escandon - Principal - DGBI Consulting, LLC
Joshua Fedewa - Director, IRBMed - University of Michigan
Lin Feng - Clinical Research Coordinator - UBMD Orthopaedics...
Kelly Fitzgerald - Executive IRB Chair & VP, IBC Affairs: IS...
Patrick Floody - Executive Director - Regeneron Pharmaceutic...
David Forster - Chief Compliance Officer - WCG
Owen Garrick - Chief Medical Officer, Clinical Trial Service...
George Gasparis - President - PEER Consulting
Virginia Gilbert - Director, Global Site Agreements - Merck
Kaitlin Gillette - Associate Director, Clinical Operations -...
Denise Goode - Manager- Clinical Research - Mercy
Bryant Gordon - Compliance Program Manager - University Of U...
Collin Gruener - Operations Manager, WCG Site Network - WCG
Kimberly Guedes - Principal - Glial consulting
Duncan Hall - CEO - Triumph Research Intelligence
Laura Halloran - President & CEO - Halloran Consulting Group...
Brandy Haslam - CEO - ImageBloom
Rachel Heiss - VP of Operations - Deep 6 AI
Neal Herman - Director, SSU & Regulatory - Syneos Health
Brad Hightower - CEO - Hightower Clinical
Lisa Hoebelheinrich - Associate Vice Chancellor for Research...
Kyle Hogan - President - Datacubed Health
Janet Holwell - Clinical Research Consultant/Trainer - Holwe...
Jane Howie - Research Marketing Consultant - Cincinnati Chil...
Andrea Itskovich - IRB Chair/Vice Chair (Medical) - WCG IRB
Marie Jackson - Director - ATSU
Cara Jacobs - Senior Director, Contracts & Legal - Biorasi
Marty Jacobson - Sr. Director, Hospital Solutions - Boeson R...
Emma James - VP Medical & Patient Affairs - Encoded Therapeu...
Ann Johnson - Director, IRB & Human Research Protection Prog...
Derek Johnson - Coverage Analysis Quality Manager - WCG
Jill Johnston - Chief Innovation Officer - WCG
Ryan Jones - CEO - Florence Healthcare
Donna Katz - Director, TRIO-US Network - UCLA/TRIO-US
Daniel Kavanagh - Senior Scientific Advisor - WCG
Sarim Khan - Co-Founder & CEO - Triomics
Henry Kravchenko - CEO - Clinical.ly
Rachel Lally - Executive Director, Human Research Protection...
Adam Larrabee - President - Rochester Clinical Research, Inc...
Khan Lau - Fmr. Director Clinical Research - Glaukos
Erick Lee - Senior Counsel - Research, IP, and Life Sciences...
Mark Lloyd - EVP & Founder - Inspirata
Halley Loosekamp - Vice President Corporate Strategy - BEKHe...
Stephen Loosli - Executive Director - Boeson Research
Stephanie Love - Director, Clinical Monitoring - United Ther...
Ann Lovelace - Director, Research Operations - Comprehensive...
Karen McCulloch - Chair, IBC Services - WCG IBC Services
Jennifer McNary - Principal - J McNary Consulting
Tarin McTague - Dir, R&D Quality Continuous Improvement - Se...
Sharon Medendorp - President and EVP - Premier Consulting
Patricia Mendoza - Senior Quality Assurance Auditor - Medpac...
Amanda Miller - Manager, Quality and Development - WCG
Micheal Mott - Director - WCRN-COGI
Dinesh Mudaranthakam - Director of Research Information Tech...
Lovie Negrin - Director of Research - Randomize Now
Susan Night - Vice President, Site Engagement and Network St...
Vishnu Nitta - President - Arrow Clinical Trials
Michael O'Gorman - Chief Executive Officer and Founder - Lif...
Rhonda Oilepo - Assistant Vice President for Human Research
Melissa Orbegoso - Manager , Sponsored Programs - University...
Emily Ostrander - Director of the Conflict of Interest Offic...
Carla Otterson - Assistant General Counsel, Research and Int...
Amy Pace - Senior Director, Global Study Operations - Care A...
Jennifer Peterson - Director, Head of Clinical Quality - M3
Dawn Pittinger - Research Financial Compliance Officer - Mof...
Tracy Popp - Educator/Advisor/Contractor - A Clover Group
Matthew Porteus - Professor - Stanford University
AnaArlene Ramirez - Manager, Phase I Research Operation - Co...
Douglas Reichgott - Executive Director, Clinical Research -
Hannah Reimer - Clinical Research Nurse - Temple University
Erica Rivas - Director of Patient Engagement - Accel Researc...
Alyssa Robberstad - Supervisor, Research Coverage Analyst -
Orlan Romm - CEO - Tandem Clinical Research
Angela Rose - VP Clinical Trial Operations - Verici Dx
Barry Sagotsky - Owner - Magnolia Lane Consulting
Cheryl Sampson - Director, Clinical Research Office - Univer...
Kylie Sands - Clinical Research Associate - St. Lawrence Hea...
Geoffrey Schick - Director, Strategic Site Partnerships - WC...
Steven Schmid - Senior Director, Laboratory Strategic Planni...
Monalee Shah - Legal Reviewer - Astellas Pharma
T.J. Sharpe - Patient Engagement Program Manager - Medidata
Sarah Shelgren - Sr. Manager, Site Engagement - Amgen
Judith Skroback - Affiliated IRB Member - Advarra
Jaye Bea Smalley - Head, Patient Advocacy - Immunovant
Renee Smith - Head, ED Oncology Capabilities and Alliances -...
Sandra Smith - Senior Vice President - WCG
Luke Snedaker - Senior Director, Site Development Operations...
Sujatha Sridhar - Executive Director, Research Compliance -
R'Kes Starling - Chief Executive Officer - Reveles Clinical
Michelle Stickler - Associate Vice President for Research -
Walter Storm - CEO - Aspen Insights
Linda Sullivan - Senior Advisor, Metrics & Performance Manag...
Peter Sullivan - Principal - Sullivan Group
Lisa Switzer - CEO/Executive Director - Western States Cance...
Jennifer Syburg - Clinical Trials Associate Director of Fina...
Jimmy Thai - Senior Clinical Research Coordinator and CRC Te...
Julie Tibbets - FDA Practice Chair - Goodwin Procter LLP
Leanne Tran - Principal - JD MD Solutions
Carly Tucker - Corporate Compliance Manager - Tufts Medicine...
Jamie Tyrone - Patient Advocate - Self
Nancy Umbeck - Manager- Clinical Research - Mercy Research
Mary Veazie - Principal - Clinical Research Consulting & Edu...
Rueben C. Warren - Executive Director, National Center for B...
Jessica Weidman - Associate Director, Global Site Agreements...
Kendal Whitlock - Head of Digital Optimization - Walgreens H...
Sarah Wicks - Associate - Goodwin Procter
Kelly Willenberg - President - Willenberg
Mary Elizabeth Williams - Author, consultant, and doctoral s...

A Pro/Con Debate: Should We Refer to Clinical Trials “as a Care Option”
AI is Everywhere Understand How Modern Language Models Work, Where They Work Best, and How to Identify Pitfalls and Risks. (Sponsored Session: Aspen Insights)
Avoca Quality Consortium Roundtable
Best Practices for Incorporating Patient Feedback Into Drug Development Programs
Boxed Lunch
Breakfast
Clinical Trial Designs and Concepts 101
Clinical Trial Success: It’s All About Relationships - Can We Just Talk About it?
Clinical Trial Success: It’s All About Relationships - How to Achieve a Win-Win Relationship
Clinical Trial Success: It’s All About Relationships - How to Start on the Right Foot
Communication Barriers: Facilitating Diverse Enrollments (Sponsored Session: Care Access)
Contract Breakout: Creating and Using a Clinical Trial Agreement (CTA) Playbook
Contract Breakout: Deal Breaker Terms in Clinical Trial Agreements (CTA)
Contract Breakout: Indemnification Clauses: Taming the Beast!
Contract Breakout: Insurance
Contract Breakout: Subject Injury: Contracting and Billing Considerations
Data Privacy and GDPR Breakout: Understanding GDPR - Where are the Lines?
Data Privacy and GDPR Breakout: Watch out for HIPAA! Data Sharing and the Mischaracterization of Data Sets
Dessert in the MAGI Lounge
Direct Transfer of Data From EHR and eCOA to eCRF Eliminates the Double Data Entry and Time Spent with Monitors on SDV (Sponsored Session: Triomics)
Dissecting a Clinical Trial Agreement (CTA) Part 1
Dissecting a Clinical Trial Agreement (CTA) Part 2
Drug Development 101
Ensuring Appropriate Representation in Clinical Trials to Advance Medicine and Reduce Health Disparities
Foundation Course: Billing Compliance
Gene Therapy Breakout: Gene Therapy 101
Gene Therapy Breakout: Unique Ethical and Operational Issues in Gene Therapy Research
Gene Therapy: Unique Operational Aspects of Gene Therapy Research
Good Clinical Practice (GCP): Part 1
Good Clinical Practice (GCP): Part 2
Good Clinical Practice (GCP): Part 3
Hot Topics - Join the Discussion!
How Sites Can Identify and Recruit Patients in their Own Health Systems and Community (Sponsored Session: BEKHealth)
Investigator Initiated Trials (IIT) Breakout: I'm Doing What?! Regulatory Responsibilities When the Investigator is Also the Sponsor
Investigator-Initiated Trials (IIT) Breakout: Pros and Cons of IIT Program Structures - Which One Is Right for Your Organization?
Keynote: The Importance of Clinical Research - A Patient’s Perspective
Leveraging AI to Improve the Financial, Operational and Scientific ROI of Clinical Research (Sponsored Session: Deep6AI)
Lunch in the MAGI Cafe: Birds of a Feather
Lunch in the MAGI Cafe: Regions
Master Course: Billing Compliance
Medical Devices 101 Breakout: Categorizing Medical Devices - IDE, Assessing Risk Level, and What the IRB Will Want To Know
Medical Devices 101 Breakout: Differences Between Medical Device and Drug Regulations
Medical Devices 101 Breakout: Site Operations for Medical Device Studies
Networking Break
Networking Reception and Book Signing
Networking Session for Biopharma Executives
Opening Reception
Opening Remarks
Participant Recruitment: Innovations and Best Practices
Precision Patient Care: Pathology, Explainable AI & Trial Matching Solutions (Sponsored Session: Inspirata)
Professional Skills 101
Quality Breakout: Creating a Quality Culture In Your Organization
Quality Breakout: How do YOU Define "Quality"?
Quality Breakout: The Top 10 Site KRIs Sponsors are Measuring and How They Use the Results
Recruiting and Retaining Study Participants Breakout: Clinical Research Paid Marketing Strategies in an Ever-Changing World
Recruiting and Retaining Study Participants Breakout: Democratizing Clinical Trials – Bringing the Trial to the Patient
Recruiting and Retaining Study Participants Breakout: Keeping Patients Engaged Once You Find Them
Registration
Research Ethics Breakout: DSMBs and You - The Role of Data Safety Monitoring Boards
Research Ethics Breakout: Dealing with Data: Future Use and Data Sharing
Research Ethics Breakout: Ethics and Compliance - Where’s the Overlap?
Research Ethics and IRBs Breakout: Complicated Inclusion - When Employees Are Study Participants
Research Ethics and IRBs Breakout: Proper Payment - Best Practices in Participant Payment
Site Management Breakout: Employee Retention and Motivation
Site Management Breakout: How Research Operations and Compliance Can Work Together
Site Management Breakout: Right-sizing your SOPs
Solving the Challenges of Decentralized Clinical Trials (DCTs)
Special Considerations in Pediatric Research Breakout: Assent, Permission, One or Two Parents - Getting Consent in Pediatric Research is Different!
Special Considerations in Pediatric Research Breakout: Providing Gender-Affirming Care in Pediatric Research
Special Issues in Oncology Clinical Trials Breakout: Best Practices for Sites Interested in Conducting Phase 1 Oncology Studies
Special Issues in Oncology Clinical Trials Breakout: Managing and Retaining Health Care Providers Who Support Research
Special Issues in Oncology Clinical Trials Breakout: The Side Effects of Narrowing Eligibility Criteria in Oncology Studies
Study Billing Breakout: Billing Audits and Monitoring
Study Billing Breakout: Billing Compliance and Reimbursement for Device Trials
Study Billing Breakout: Intro to Medicare Coverage Analysis
Study Billing Breakout: Medicare Coverage Analysis Out of the Ordinary
Study Billing Breakout: Panel Discussion: Operationalizing Your Research Billing Compliance Plan
Study Budgets Breakout: Budget Development and Negotiations for Sites
Study Budgets Breakout: Hidden Costs for Sites and Sponsors
Study Budgets Breakout: Methodology for Measuring, Negotiating, and Managing Staff Workload
Technology in Clinical Trials
Unlock the Key to Fast and Accurate Patient Recruitment (Sponsored Session: VigiLanz)
WCG Innovation Challenge
WCG MAGI Headshot Studio
Welcome Remarks
Wrong Technology for the Right Job: Applying Technology Where it Isn’t Needed. (Sponsored Session: Clinical.ly)

Sunday, October 16, 2022
4:00 PM - 6:00 PM
Monday, October 17, 2022
9:00 AM - 6:30 PM
Tuesday, October 18, 2022
9:00 AM - 4:00 PM

Agenda

Exhibit Hall Hours