MAGI@home 2026

Talk · Billing Compliance

Introduction to Clinical Trial Billing: How It All Fits Together

Allison Mongan, WCG · Scott Streibich, The Johns Hopkins University School of Medicine · Wendy Landow, Empower Growth Strategies

Talk · Contracts

Subject Injury Trapdoors

Collin Gruener, WCG · Merry Johnson, WCG · Erik Martin, Polsinelli

Talk · Artificial Intelligence

AI Prompting 101: Communicating With Your New Teammate

Vanessa Diaz, Illinois Bone & Joint Institute · Samir Hooker, Intake · Will Cohen, WCG Clinical

Break

Break

Talk · Contracts

Blindsided: Legal, Operational and Insurance Mistakes That’ll Leave a Mark

Collin Gruener, WCG · Phil Boyce, Boyce Life Sciences, LLC · Nina Cantafio, Triligent International, Inc. · Peter Sullivan, Sullivan Group

Talk · Billing Compliance

Reading a Protocol for Billing: What to Look For and Why It Matters

Jason Spivey, Unifora · Brenda Steinert, The Medical College of Wisconsin · Ina Kansariwala, Huron Consulting

Talk · Artificial Intelligence

Introducing AI to the Legal Department

Jim Wagner, WCG Clinical · Michael Nichols, H. Lee Moffitt Cancer Center and Research Institute, Inc. · Theresa Latham, H. Lee Moffitt Cancer Center and Research Institute, Inc.

Break

Break

Talk · Budgets

Introduction to Clinical Trial Budgets: Key Components and Terminology

LaTisha Weaver, LDM Clinical Research Source · Eboney Ware, EJIW InsightWorks LLC · MaryAnn Bowman, ClinGRO | Coffee To GRO

Talk · Clinical Operations

Leadership Under Pressure: Sustaining Clinical Operations Teams Through Change, Burnout, and Complexity

Sandy Smith, WCG Clinical · Nathaniel L. Harris, University of Cincinnati College of Medicine Office of Clinical Research · Melody Keel, The Research Associate Group, Inc · Susan Night, Translational Drug Development (TD2)

Talk · Quality/Regulatory

What FDA Warning Letters on Informed Consent Are Telling Us

Kelsey Bratton, Flourish Research · Margaret Bussineau, Academic Health System In Philadelphia

Talk · Artificial Intelligence

AI & Change Management: Bringing Your Team Along

Maya Pochiraju, WCG · Eleana Rodriguez, University Health Network

Break

Break

Talk · Budgets

Understanding Study Costs: What Drives Site Expenses

Sandy Smith, WCG Clinical · Eve Sakran, Holy Cross Hospital · Deborah Suarez, Baptist Health South Florida

Talk · Clinical Operations

The Future of Community-Based Clinical Trials: Building Sustainable, Scalable, and Equitable Research Models

Crystal Foushee, BlueRock Therapeutics, LP · LaToya Hinton-Howery, Next Innovative Clinical Research · Lovie Negrin, Randomize Now

Talk · Quality/Regulatory

Transforming Compliance Culture: A “Wellness Visit” Approach to Advancing Research Quality

Kelsey Bratton, Flourish Research · Angela Brinkley, Tampa General Hospital

Talk · Artificial Intelligence

AI for End-to-End Study Startup

Jim Wagner, WCG Clinical · Andrea Kukla, Mayo Clinic · Maya Pochiraju, WCG

Talk · Billing Compliance

Words Matter: When Financial Promises Become Compliance Obligations

Cynthie Lawson, Cynthie Lawson Consulting · WENDY PORTIER, Portier & Associates, LLC · Darshan Kulkarni, Kulkarni Law Firm

Talk · Contracts

From “No AI” to “Know AI” in Clinical Trial Agreements

Collin Gruener, WCG · Katherine Leibowitz, Leibowitz Law · Michael Swartz, Merck Sharp & Dohme LLC

Break

Break

Talk · Billing Compliance

Reimbursement and Coverage Analysis

Sarah Duffy-Clinton, Hay Hill Advisors · Shanna Ford, Attain Partners · Chris Conway, Meade, Roach & Annulis, LLP

Talk · Contracts

Challenging Our Assumptions on Risk Management.

Collin Gruener, WCG · Gary Grabow, Law Office of Gary Grabow · Eli Judge, WCG

Break

Break

Talk · Clinical Operations

What the One Big Beautiful Bill Act (OBBBA) Means for Clinical Trial Operations

Nathaniel L. Harris, University of Cincinnati College of Medicine Office of Clinical Research · Quincy Byrdsong, Ballad Health · Akilah Adams, Black Women In Clinical Research

Talk · Budgets

Budgeting for Start-Up, Closeout, and Administrative Work

Candida Barlow, Oklahoma State University Center for Health Sciences

Talk · Quality/Regulatory

Responsible AI: Governance, Oversight & “Who Reviewed the Robot?”

Miles Wingfield, Intake AI · Edye Edens, EEDEE Law · Huzaifa Hussain, Emerge Research Institute LLC

Break

Break

Talk · Budgets

When the Site Says No: How Participant Payment Advocacy Changed a Sponsor’s Mind

Ashely Mitchell, Arizona Neuroscience Research · Donna Libretti Cooke, ImpactSphere Clinical, LLC · Martha Falcon, Wellness Research Center

Talk · Clinical Operations

Winning Playbook: Launching a World Class Research Site

Jeanie Magdalena Gatewood, Advanced Research Institute (ARI) · Katherin Mendez, UNLV

Talk · Quality/Regulatory

Applying ISO 9001 Principles to Clinical Research

David Borasky, WCG

Talk · Sponsored Sessions

From Protocol to Defensible Budget: AI-Assisted Coverage Analysis and Budget Development

Talk · Sponsored Sessions

Navigating Coverage Analysis in Cell Therapy Trials

Brad Gruener, Elevate CRS · Shelby Waldmann, Elevate Clinical Research Solutions

Talk · Billing Compliance

From Complexity To Clarity: The Clinical Research Billing Compliance Audit Process

Jyothi Inampudi, Queens City Research Center · Raquel Amaya, UCLA Health · Polina Eshkol, UCLA Health · Laura Fong, UCLA Health

Talk · Contracts

Expanded Access & Compassionate Use Agreements

Ana Causo, University of Michigan · Lark Haunert, University of Michigan · Misty Gravelin, University of Michigan

Break

Break

Talk · Billing Compliance

CTMS, EMR, and Humans: Building Research Billing Compliance Without Losing the Plot

Pamela Gonzalez, Huron Consulting · Miguel Desormaux, RealTime eClinical Solutions

Talk · Contracts

Negotiating AI-Related Clauses in Contracts

Jim Wagner, WCG Clinical · James Mantia, Icahn School of Medicine at Mount Sinai · Eli Judge, WCG

Break

Break

Talk · Budgets

From Amendment Whiplash to Activation Velocity

Gyongyi Diosomito, AdventHealth Research Institute · Melissa Quintero, AdventHealth Research Institute · Maree Beare, Clinials

Panel · Clinical Operations

Panel Discussion: AI at the Front Door - Faster Screening, Better Enrollment

Mitchell Hilbe, DiversiTrials / Clinical Research Pro · Kaye Doiron, Research Works INC · Miles Wingfield, Intake AI · Jeanie Magdalena Gatewood, Advanced Research Institute (ARI)

Panel · Quality/Regulatory

Panel Discussion: R3 Transition Office Hours: Small-Group SOP Troubleshooting

Maryleen Lovell- Petronilia, EmVenio Clinical Research · Angela Wilmer, WCG · Jennifer Peterson, EmVenio

Break

Break

Talk · Budgets

The CRO Role in Budget Negotiations: Balancing Sponsor and Site Needs

Marco Macente, Worldwide Clinical Trials · LaTisha Weaver, LDM Clinical Research Source

Talk · Clinical Operations

Building a Lifecycle Approach to Clinical Operations

Jess Thompson, Clinical Research Pro · Kate Trigg, N/A · Shay Webb, Breakthrough T1D

Talk · Quality/Regulatory

Managing FDA Inspections

Megan Vaz, ClinGRO Solutions | Coffee To GRO · Heather Kim, WCG

Talk · Sponsored Sessions

The New Carbon Copy: AI-Native EDC for Real-Time Clinical Research

Albert Cai, Harbor

Talk · Billing Compliance

Egad! A Device Trial?! What Makes Device Research Billing Different"

Denise Quint, Denise Quint, LLC · Diva Milians · Tina Bowdish, AdventHealth

Talk · Contracts

Indemnification: What's Fair for Each Party?

Collin Gruener, WCG · Don Mankoff, PTC Therapeutics · Istvan Fekete, Attain Partners

Break

Break

Panel · Billing Compliance

Panel Discussion: AI That Talks to Everything: MCP, Governance, and the Future of Trial Tech

Phil Richards, WCG · Gokhul Srinivasan, AWS · Andres Garcia, Florence Healthcare

Talk · Contracts

Fast-Tracking Negotiations to "Yes": The Soft Skills for Faster Contracting

Collin Gruener, WCG · Casi Morales, The GOG Foundation · Kaela Spruill, WCG Clinical

Break

Break

Talk · Quality/Regulatory

Beyond Compliance: Preparing Investigator Sites for ICH E6(R3)

Karen Harvey, AQC · Michelle Webb, WCG

Talk · Clinical Operations

From Vision to Execution: Turning Big Ideas into Reality

Katherin Mendez, UNLV · Kayla Arroyo, Ballad Health Research Institute · Raid Faddah, Henry Ford Health System · Danish Siddiqui, ICON

Talk · Budgets

Holdback is Not a Quality System and Other Hidden Costs

Melissa Quintero, AdventHealth Research Institute · Ryan Helber, Research Minded

Break

Break

Talk · Budgets

Portfolio-Level Budget Planning for Research Leadership

Suzanne Rose, Stamford Health · Candice Vance, MedStar Health Research Institute · Aneesha Raghunathan, Rightview

Talk · Clinical Operations

Investigator Engagement & Clinical Affairs: Driving Stronger Trial Execution

Susan Hernandez, M3 Wake Research

Talk · Quality/Regulatory

What the IRB Sees: Noncompliance Patterns from the Other Side of the Submission

David Borasky, WCG · Heather Kim, WCG

Talk · Contracts

Key Contract Considerations for Industry-Supported Investigator-Initiated Clinical Trial (IIT) Agreements

Collin Gruener, WCG · Avril Liu, University of Illinois Chicago · Kate Duffy Mazan, Clinical Technology Transfer Group · S. Asra Husain, University of Wisconsin-Madison, Office of Research and Sponsored Programs

Talk · Billing Compliance

Clinical Trial Budgeting, CAR-T coverage Analysis, General Coverage Analysis

Preeti Dave, Davai Clinical Research · Alicia DeFrancesco, Huron · Tina Karunaratne, Karuna Integrated Clinical Services · Nishat Premani, Huron Consulting Group · Deborah Suarez, Baptist Health South Florida

Break

Break

Talk · Billing Compliance

How to Explain Study Costs & Billing to Patients

Geoffrey Schick, Huron Consulting · Tina Bowdish, AdventHealth

Panel · Contracts

Panel Discussion: Contracts - Stump the Experts

Collin Gruener, WCG · Katherine Leibowitz, Leibowitz Law · James Mantia, Icahn School of Medicine at Mount Sinai · Phil Boyce, Boyce Life Sciences, LLC

Break

Break

Talk · Budgets

Using Historical Data to Improve Budget Accuracy

Ryan Benson, Medtronic · Joe Fugitt, Corewell Health · Tina Karunaratne, Karuna Integrated Clinical Services

Panel · Clinical Operations

Panel Discussion: Bringing Clinical Research to Rural Patients: Overcoming Barriers, Shifting Perceptions, and Lessons from a Research Navigation Program

Kim Vigal, Florida Cancer Specialists & Research Insititute · Sandy Smith, WCG Clinical · Lora Black, Sanford Research · Kylie Sands, St. Lawrence Health · Jess Thompson, Clinical Research Pro

Talk · Quality/Regulatory

CAPA-Beyond the Fix: Understanding Root Cause, Corrective Action & Prevention

Jennifer Peterson, EmVenio · Kelsey Bratton, Flourish Research

Break

Break

Talk · Budgets

Using AI and Automation to Accelerate Study Budget Development

Jim Wagner, WCG Clinical · Tyler Larson, WCG · Seth Halvorson, WCG

Talk · Clinical Operations

Embedding Compliance into Clinical Research Operations

Quincy Byrdsong, Ballad Health · Stephanie Nwegbo, Aurora Pharmaceutical Consulting · Andrea Arruda, pharmaDev Consulting · Katherin Mendez, UNLV

Panel · Quality/Regulatory

Panel Discussion: The TMF Is the Trial - What eTMF Audits Actually Find

Sandy Smith, WCG Clinical · Marilyn Stasinopoulos, WCG · Carol Federline, Ocular Therapeutix, Inc. · Suzanne Turner, ICE Consulting