MAGI

Other

Registration

Break

Breakfast

Workshop · Clinical Operations

Good Clinical Practice (GCP) Training

Janet Holwell, Holwell Clinical Research Consulting · Patricia Mendoza, Medpace · Linda Coleman, Yale University

Workshop · Billing Compliance

Billing Compliance Workshop: Part 1

Jennifer Syburg, University of Wisconsin Madison Clinical Trials Institute · Joe Fugitt, Corewell Health · Sandra Smith, WCG Clinical · Nicole Bruecker, Optum

Talk · Clinical Operations

Choose Your Path: Making Strategic Career Moves in LIFE

Sakshi Bubna, Northeastern Univeristy · Quincy Byrdsong, Ballad Health · Lovie Negrin, Randomize Now · Lauren Stockwell, SCRS · Jami Walker, Mead Johnson Nutrition

Talk · Budgets

Site Study Budget Prep: Tactical/Strategic Do's & Dont's

Wesley Warren, City of Hope · Candida Barlow, Oklahoma State University Center for Health Sciences · Jaidyn Nguyen, WeGo Solutions · David Rodin, UpSite Clinical

Talk · Contracts

Soft Skills & Etiquette in CTA Redlines & Negotiations

Phil Boyce, Boyce Life Sciences, LLC · Robert King, HonorHealth · Casi Morales, The GOG Foundation · Monica Tiffee, Honor Health

Talk · Clinical Operations

The Queen of Hearts’ Council: Harmonizing Sites, Sponsors, and Providers for Success

Darian Trojacek, HBA · Jimmy Bechtel, SCRS · Catherine Gregor, Florence Healthcare · Liza Micioni, Tris Pharma, Inc. · Rui Rui Zhang, MEDSIR

Break

Networking Break

Workshop · Billing Compliance

Billing Compliance Workshop: Part 2

Sandra Smith, WCG Clinical · Bryant Shields, Boston Medical Center · Kelly Willenberg, Kelly Willenberg & Associates · Tina Bowdish, AdventHealth

Talk · Contracts

Clinical Trial Agreements (CTA): Part 1

Katherine Leibowitz, Leibowitz Law · Megan Albaugh, ICE Global Consulting · Phil Boyce, Boyce Life Sciences, LLC · Don Mankoff, PTC Therapeutics · Matt Collins, Merck Sharp and Dohme

Talk · Clinical Operations

Collect the Right Cards: Strategies for Career Wins in LIFE

Anne Aly, Black Women in Clinical Research/BIDMC · Sydnee Bradford, AbbVie/ Black Women in Clinical Research · LaTrenda Jamison, PPD/Thermo Fisher · Bryce Nichols · Elizabeth Tabor, Clinical Research Referral Club

Talk · Quality / Regulatory

FDA Inspections: Always Be Ready and What to Do When They Actually Come Knocking on Your Door!

Kaitlin Gillette, Syneos Health · Paul Papagni, Baptist Health South Florida

Talk · Budgets

The Art, Philosophy and Science of Negotiation for Clinical Site Budgets & Contracts

Tara Krieg, UNC · Jaidyn Nguyen, WeGo Solutions · Kelly Smith, V2 Clinical Inc.

Talk · Clinical Operations

We’re All a Little Mad: The Mad Hatter’s Guide to Feasibility & Start-Up

Raid Faddah, Henry Ford Health System · Mitchell Hilbe, DiversiTrials / Clinical Research Pro · Tina Karunaratne, Karuna Integrated Clinical Services (KICS) · Amanda Martin · Jess Thompson, Association of Clinical Research Project Managers (ACRPM)

Talk · Budgets

Budgeting for Diversity: Funding Inclusion Initiatives in Clinical Trials

Alyssa Gateman, Yale Cancer Center · Jaidyn Nguyen, WeGo Solutions · LaTisha Weaver, LDM Clinical Research Source

Break

Boxed Lunch

Talk · Budgets

Balancing Ethics and Performance: Strategies for Responsible Financial Management and Effective Communication in Clinical Trials

Kaye Mottola, Boston Medical Center · Alan Abraham, Preferred Primary Care Physicians, Inc. · Daniel Fox, CRPN · Ashely Mitchell, Arizona Neuroscience Research

Talk · Contracts

Clinical Trial Agreements (CTA): Part 2

Collin Gruener, WCG · Megan Albaugh, ICE Global Consulting · Phil Boyce, Boyce Life Sciences, LLC · Matt Collins, Merck Sharp and Dohme · Don Mankoff, PTC Therapeutics

Talk · Clinical Operations

Don’t Skip a Turn: Opportunities for Growth in the Game of LIFE

Jason Long, Clinical Research Pro · Danielle Mitchell, Black Women In Clinical Research (BWICR) · Desiree Powell, Unlimited Potential Education LLC · Leanne Woehlke, SOGLIA

Talk · Quality / Regulatory

FDA Inspections: Always Be Ready and What to Do When They Actually Come Knocking on Your Door!

Paul Papagni, Baptist Health South Florida · Kaitlin Gillette, Syneos Health

Talk · Billing Compliance

Navigating Coverage Analysis Development: Choosing between In-House and Outsourced Solutions

Casey Charlton, Medical University of South Carolina · Tara Krieg, UNC · Geoffrey Schick, Huron Consulting

Talk · Clinical Operations

The Cheshire Cat’s Guide to Streamlined Clinical Operations: Tools, Templates & Processes

Jess Thompson, Association of Clinical Research Project Managers (ACRPM) · Maliha Arshad, Research Ready · Mylea Charvat · Jennifer Kirkwood, Hightower Clinical · Samantha Register, Komodo Health

Networking

Opening Reception

Other

Yoga

Leanne Woehlke, SOGLIA

Break

Breakfast

Other

Registration

Other

Welcome Remarks

Carmin Gade, WCG

Talk

Innovation Challenge

JILL JOHNSTON, WCG Clinical · David Almeida, Erie Retina Research · Ellen Brearley, Tufts Medical Center · T. Patrick Frazier, University of Alabama at Birmingham · Jane Vines, University of Alabama at Birmingham (UAB)

Break

Networking Break

Demo · Sponsored Session

Innovation Theater: Faster Contracts = Faster Cures: Streamlining Research Agreements with Safe AI

Maya Pochiraju, The Contract Network

Talk · Quality / Regulatory

From Exclusion to Inclusion: IRBs to Address Language Barriers in Research Leading FDA’s Diversity Inclusion Guidance

Jennifer Peterson, EmVenio · Viviana Coppo, WCG

Talk · Contracts

Investigator Initiated Trial (IIT) Clinical Trial Agreements

Collin Gruener, WCG · Istvan Fekete, Attain Partners · Gary Grabow, Law Office of Gary Grabow

Talk · Billing Compliance

Maximizing Clinical Research Billing Compliance: One Site's Journey to Success

Jennifer Syburg, University of Wisconsin Madison Clinical Trials Institute · Suzanne Rose, Stamford Health

Talk · Budgets

Re-Evaluating Your Participant Payment Strategy: How to Compliantly Enable Wider Participation

Geoffrey Schick, Huron Consulting · Donna Libretti Cooke, ImpactSphere Clinical, LLC · Mo Punjwani, Mural Health

Talk · Clinical Operations

Who Decides? Navigating ICH-GCP E6 (R3) Strategic Implications for Advanced Practiced Providers and PI Oversight in Clinical Research

Lilith Mist, Merck · Ellen Neylon, Palm Research Center · Jean Kelly, Rochester Clinical Research

Break

Lunch

Break

Dessert

Talk · Clinical Operations

Beyond the Buzzword: Putting Diversity Strategies to Work

Giovannie Jean-Louis, PROBr- Join Studies Easier · Sylvia Baedorf Kassis, MRCT Center · Michael Caldwell, Meharry Medical College · LaToya Hinton-Howery, Next Innovative Clinical Research · Jonathan Low, Centro Health Solutions

Talk · Quality / Regulatory

Building Blocks to the Informed Consent

Jennifer Peterson, EmVenio · Kelsey Bratton, Flourish Research

Talk · Billing Compliance

Navigating DRG & ICD-10 Coding Challenges

Geoffrey Schick, Huron Consulting · Denise Quint, Denise Quint, LLC

Talk · Sponsored Session

Putting You In Control of Your Clinical Research Technology Presented by Clinical.ly

Henry Kravchenko, Clinical.ly

Panel · Budgets

Sponsor Panel: Cracking the (Budget) Code

Crystal Foushee, BlueRock Therapeutics, LP · Ryan Benson, Medtronic · Sahar Naureen, Hoffman La-Roche · Teresa Ramaglino

Talk · Contracts

The Emerging Art of AI Whispering: A Guide to Effective Prompting in Clinical Trial Agreements

Collin Gruener, WCG · Jim Wagner, WCG Clinical

Workshop · Sponsored Session

Get Hands-On with the Clinical.ly Research Suite: Live Demos & Q&A

Henry Kravchenko, Clinical.ly

Break

Networking Break

Demo · Sponsored Session

Innovation Theater: Discover Useful Patient Recruiting Solutions That Will Increase Effectiveness and Results

Lance Nickens, The Patient Recruiting Agency

Talk

State of the Industry

Kenneth Getz, Tufts Center for the Study of Drug Development, Tufts University School of Medicine · Wenora Johnson, Facing Our Risk of Cancer Empowered · Amrit Ray, Arsenal · Michael Seiden, N Power Medicine

Networking

Social Hour

Other

Yoga

Arianna Tornatore, SUNY Upstate Medical University

Break

Breakfast

Break

Breakfast Roundtables: Navigating the Future of Clinical Research: Overcoming Funding Challenges

Other

Registration

Talk

Navigating the Changing Regulatory Landscape: Clinical Research in 2025

David Peloquin, Ropes & Gray · Ella Balasa, Balasa Consulting · Lisa Ballance, Virginia Commonwealth University · Kelly Ann Keenan, Henry Ford Health

Break

Networking Break

Demo · Sponsored Session

Innovation Theater: Unlocking Cost & Time Savings for Sites and Sponsors: The Impact of Workflow Technology on Site Orchestration

Catherine Gregor, Florence Healthcare

Talk · Quality / Regulatory

Are You Ready? Study Site Sponsor GCP Audits and Regulatory Inspections

Kaitlin Gillette, Syneos Health · Shanley Curran, Boston Scientific · Ivanka Whalen, Boston Scientific

Talk · Clinical Operations

Artificial Intelligence Decoded (Part 1): Your Roadmap to Clinical Research Innovation

Lilith Mist, Merck · Beau Balthazar Bruneau, Florence Healthcare · Jim Wagner, WCG Clinical

Talk · Billing Compliance

Best Practices for Billing DCT

Geoffrey Schick, Huron Consulting · Wendy Portier, Kelly Willenberg & Associates · Denise Quint, Denise Quint, LLC

Talk · Contracts

Impact of Recent Developments in Electronic Technologies on CTAs

Collin Gruener, WCG · Wesley Warren, City of Hope · Katherine Leibowitz, Leibowitz Law

Talk · Budgets

Real World Evidence (RWE) Research

Kim Collison Farr, Mercy Research · Tiffany Hadzi, OM1 · Nicole Ansani, UPMC Enterprises

Break

Lunch

Break

Dessert

Demo · Sponsored Session

Innovation Theater: Budgets, Benchmarks, and Breakthroughs: How AI and FMV Are Reshaping Negotiations

David Rodin, UpSite Clinical · Greg Lubin, UpSite Clinical

Talk · Clinical Operations

Artificial Intelligence Decoded (Part 2): Clinical Research Reimagined: AI Success Stories from the Front Lines

Maree Beare, Clinials · Tara Rabe, Mayo Clinic · David Almeida, Erie Retina Research · Khizar Jaffry, Revival Research Institute

Talk · Quality / Regulatory

I Wish I Had a Crystal Ball: Approaches to IND Submissions for IITs

Amy Hummel, Yale Center for Clinical Investigation · Kaitlin Gillette, Syneos Health

Talk · Budgets

Oncology Trials and (lack of) Patient Stipends

Sandra Smith, WCG Clinical · Chad Adams, HonorHealth Research Institute · Olga Balderas, WCG IRB · Gunnar Esiason, RA Ventures · Peter Fredette, Site Centered Research

Talk · Contracts

Proven Strategies for Improving Workflow in High-Volume Research Contract Negotiation

Collin Gruener, WCG · Phil Boyce, Boyce Life Sciences, LLC · Dino Mazzarelli, Mass General Brigham

Talk · Billing Compliance

Where Rubber Meets the Road: The Co-evolution of Policy and Process Improvement

Geoffrey Schick, Huron Consulting · Tanisha LaVeck, Holy Cross Hospital · Kaye Mottola, Boston Medical Center · Eve Sakran, Holy Cross Hospital

Break

Networking Break

Talk · Billing Compliance

Moving the Needle: Billing Compliance

Geoffrey Schick, Huron Consulting

Talk · Budgets

Moving the Needle: Budgets

Sandra Smith, WCG Clinical

Talk · Clinical Operations

Moving the Needle: Clinical Operations

Lilith Mist, Merck · Jess Thompson, Association of Clinical Research Project Managers (ACRPM) · Dan Schell, Clinical Leader

Talk · Contracts

Moving the Needle: Contracts

Collin Gruener, WCG

Talk · Quality / Regulatory

Moving the Needle: Quality / Regulatory

Kaitlin Gillette, Syneos Health · Carolina Hewell, Merck

Talk

Moving the Needle Readouts and Voting

Other

Registration

Break

Light Breakfast

Talk · Professional Development

Artificial Intelligence and Machine Learning in Clinical Research

Silvio Galea, WCG · Matthew Wood, WCG Clinical · Kyle Miller, WCG Clinical

Talk · Professional Development

ICH E6(R3) Updates: Operationalizing Risk Management in Clinical Operations

Carolina Hewell, Merck · Brian Barnes, BioNTech

Talk · Professional Development

Retention Strategies that Work: Insights from Different Career Stages in Clinical Research

Jackie Stanwood, Alexion Pharmaceuticals · Haden Franken, N/A · Ryan Handy, Alexion Pharmaceuticals, Inc. · Stephen Loosli, Boeson Research · Elizabeth Spy, Alnylam Pharmaceuticals

Break

Networking Break

Talk · Professional Development

Artificial Intelligence and Machine Learning in Clinical Research

Silvio Galea, WCG · Matthew Wood, WCG Clinical · Kyle Miller, WCG Clinical

Talk · Professional Development

Change Management: Navigating Mergers & Acquisitions in the Clinical Research Industry

Carolina Hewell, Merck · Penny Berger, Corewell Health · Wesley Warren, City of Hope

Talk · Professional Development

People First: Practical Strategies to Recruit, Retain, and Reignite Your Clinical Research Team

MaryAnn Bowman, ClinGRO | Coffee To GRO · Minessa Konecky · Stephen Loosli, Boeson Research · Christele Strowder, PPD/A Company of Thermo Fisher Scientific