Forum AGENDA
SIIA members consistently cite Cell & Gene Therapy (CGT) as one of the hottest topics affecting the self-insurance industry today, with the likelihood that it will be even more impactful in the years ahead. Join leading experts in the field, as well as thought leaders within the self-insurance industry, who will cover this topic from multiple angles.
Wednesday, May 20
3:00 p.m. – 6:30 p.m.
Registration Open
5:00 p.m. – 6:30 p.m.
Welcome Reception
Thursday, May 21
7:00 a.m. – 8:00 a.m.
Continental Breakfast
8:00 a.m. – 8:15 am.
Welcome & Forum Overview
SPEAKER:
Ashley Hume
President, Emerging Therapy Solutions
Chairperson, SIIA Cell & Gene Task Force
8:15 a.m. – 9:00 a.m.
Regulatory Pathways: Critical Policy Updates
The pharmaceutical and gene therapy landscape is undergoing major shifts in 2026 and beyond. This session will highlight the most significant federal policies and regulatory directives shaping the industry—from evolving FDA approval pathways and initiatives to bolster domestic pharmaceutical manufacturing, to the impact of tariffs and other cost‑related measures. We will also explore emerging global collaboration models for gene therapy review, along with policy efforts designed to support innovation and accelerate the development of safe, effective treatments.
SPEAKER:
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Chris Condeluci, Esq.
Legal and Policy Counsel
Self-Insurance Institute of America, Inc.
9:00 a.m. – 9:15 a.m.
Networking Break
9:15 a.m. – 10:15 a.m.
Approval to Launch: Navigating the Path from FDA Decision to Commercial Readiness
Bringing a cell and gene therapy or specialty pharmaceutical product to market requires more than scientific breakthrough. Success hinges on navigating a complex path from FDA approval to commercial execution. This session will unpack the critical steps a Manufacturer must take once a therapy receives regulatory approval, including operational scale up, manufacturing readiness, distribution strategy, patient services design, and payer engagement. Attendees will gain valuable insight into how launch activities influence timing, access, and utilization of newly approved therapies.
SPEAKER:
Angie Ballard
Sr Director Market Access Enterprise
Bristol Myers Squibb
10:15 a.m. – 10:30 a.m.
Networking Break
10:30 a.m. – 11:30 a.m.
Emerging Gene Therapies and Specialty Drug Trends:
What’s Next for FDA Approvals through 2027
Explore a forward-looking overview of the evolving gene therapy and specialty pharmaceutical landscape expected to shape the market over the next 18 months. Specific highlights will include the FDA regulatory and accelerated approval pathways, pipeline products approaching key FDA decision points, innovations in RNA-based gene therapy, and more. Together, these topics aim to equip stakeholders with a clear understanding of where the market is heading and how upcoming regulatory decisions may shape access, adoption, and payer impact.
SPEAKER:
Erin O’Mara, PharmD
Lead Pharmacist, Pharmacy Operations
HM Insurance Group
11:30 a.m. – 1:00 p.m.
Hosted Lunch
1:00 p.m. – 2:00 p.m.
Experience Trends and Market Developments Driving Gene and Cell Therapy Impact
Dive into historical experience and recent developments that inform whether we are approaching the long-awaited cell and gene therapy tsunami. Discussion will include insights from actual cell and gene therapy claims experience and continually evolving regulatory and market developments that signal changes to indicators used in forecasting.
SPEAKER:
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Brenda Cordell, MBA
Senior Healthcare Consultant
Milliman
2:00 p.m. – 2:15 p.m.
Networking Break
2:15 p.m. – 3:15 p.m.
Blueprint for Success: Strategies that Drive Results
This session will provide insights from subject matter experts on the strategic options for Cell and Gene Therapy solutions, as well as explore the lifecycle of a Cell and Gene Therapy case with a focus on employer education and engagement, benefit plan documentation, and vendor capabilities.
MODERATOR:
Laura Carabello
Principal
CPR Strategic Marketing Communications, Inc.
SPEAKERS:
Shealynn Buck, MD
Chief Medical Officer
Lockton
Meredith Hunter
Senior Vice President, Specialty Division
Amwins Group Benefits
3:15 p.m. – 3:30 p.m.
Networking Break
3:30 p.m. – 4:45 p.m.
The Oncology Cost Surge: Why Cell Therapies are Reshaping Catastrophic Risk
As oncology care continues to evolve, cancer-related costs have risen steadily over the past three years, driven less by rare gene therapies and more by the expanding clinical use of cell therapies—particularly CAR-T—alongside broader shifts in cancer treatment. Drawing on clinical insight and global market data, this session will examine how advances in cell therapy, later-stage diagnoses, growing use of immunotherapies, longer patient survival, combination treatment strategies, and pricing dynamics are collectively reshaping the cost and complexity of catastrophic cancer claims. Panelists will explore what these trends mean for the future of oncology care, medical spend, and risk exposure across the health benefits ecosystem, with a particular emphasis on the growing role of cell therapies in shaping outcomes and costs.
This session will cover:
- Clinical evolution and expanding indications for cell therapies within modern oncology care
- Macro trends in cancer incidence, treatment patterns, and survival influencing total cost of care
- Implications of accelerating cell therapy adoption for catastrophic risk and future cost trajectories
MODERATOR:
Jeremy Freestone
Senior Vice President
Symetra
SPEAKERS:
Michael Keinrock
Lead Research Director
The IQVIA Institute
4:45 p.m. – 5:00 p.m.
Wrap Up
Join us for the wrap-up conference session, where we will reflect on the key takeaways from the presentations and discussions. Don't miss this final session to recap and consolidate your learning from the conference.
SPEAKER:
Ashley Hume
President, Emerging Therapy Solutions
Chairperson, SIIA Cell & Gene Task Force
