2026 CGTS Agenda
REGISTRATION OPEN
CO-CHAIR WELCOME
Burt Zweigenhaft, PhD, DLitt, Co-Founder & Executive Director, AVBCC
Session 1
Presidents 10th Floor
INSPIROGENE 2026 STATE OF THE INDUSTRY REPORT: CELL THERAPY AT A CROSSROADS
McKesson and InspiroGene are partners to cell and gene therapy manufacturers and providers globally, and across the United States. Each year, they conduct significant primary and secondary research and provide a pulse on the industry, its opportunities and obstacles; 2026 is no exception. This year’s report highlights will kick off CTCS 2026, unveiled and discussed in detail by Joe DePinto.
Faculty:
Joe DePinto, Head of Cell and Gene Advanced Therapies, McKesson
Session 2
Presidents 10th Floor
FIRESIDE CHAT WITH INDUSTRY LEGENDS
Industry legends sit down with Marc Samuels to discuss their views on the state of cell therapy today, globally and in the United States, on issues such as supply chain, manufacturing dynamics, access to care, expansion into community settings, and other hot topics.
Moderator:
Marc Samuels, CEO, ADVI Health
Faculty:
Joe DePinto, Head of Cell and Gene Therapy, McKesson
Nicole Verdun, Former FDA, current Verdun Advisors
Madan Jagasia, CEO, Obsidian Therapeutics
Session 3
Presidents 10th Floor
WHEN THE CURE ARRIVES BEFORE THE BUSINESS MODEL
Transformative therapies create a basic economic challenge: costs are concentrated up front, while value may emerge over years. Payers, employers, providers, manufacturers, and patients all want durable outcomes, but budgets, contracts, and incentives are often built around shorter time horizons.
This panel will explore whether the healthcare system can better recognize long-term value without creating unsustainable near-term pressure. The discussion will focus on budget impact, employer and payer decision-making, provider economics, patient access, and the practical tradeoffs that emerge when high-value therapies arrive before the financing model is fully ready.
Moderator:
Scott Wallace, MD, JD, UT Dell Medical School and Founder, Health Value Academy
Faculty:
Barbara Wachsman, former Head of Enterprise Strategy, Walt Disney, Operating Partner, Frazier
Kent Rogers, MBA, President, PBM, Carelon
Gerry Stanley, MD, Former Chief Medical Officer, Evernorth
Will Shrank, MD, Former CMO, Humana, Co-founder and CEO, Aradigm
Brian McCartney, Vice President, McKesson
Session 4
Olympic Suites 1 10th Floor
FROM SCIENTIFIC PROMISE TO PRODUCT REALITY: WILL YOUR CGT WORK IN THE REAL WORLD?
CGT developers are being asked to prove more than scientific promise. A compelling mechanism, early signal, or elegant platform still has to stand up to manufacturing complexity, regulatory expectations, patient identification, evidence generation, and access planning. This session will examine how development teams can pressure-test programs earlier so that promising therapies have a credible path to approval, delivery, reimbursement, and adoption. Panelists will discuss how early R&D decisions
Moderator:
Faculty:
Madan Jagasia, CEO, Obsidian Therapeutics
Imran Khan, MD, PhD, VP, Hematology Medical Affairs, Johnson & Johnson
Michael Sherman, MD, MBA, MS, Principal, Sherman Healthcare Solutions; Former CMO, Harvard Pilgrim Health Care and Point32Health
Ravi Singh, VP, Market Access, Advocacy & Policy, Genetix Biotherapeutics
Session 5
Presidents 10th Floor
OFF-THE-SHELF VS. VEIN-TO-VEIN: WHERE DOES CGT REALLY SCALE?
Cell and gene therapy is often discussed as a single category, but not all transformative therapies create the same development, commercialization, or access challenge. Autologous cell therapies are already commercialized across oncology and hematology, but their value chain remains complex: patient-specific collection, manufacturing slots, chain of identity, bridging therapy, site readiness, toxicity management, reimbursement exposure, and coordination across referral centers and community practices.
Allogeneic therapies offer a different promise: standardized manufacturing, potentially lower cost of goods, immediate availability, and a more scalable “off-the-shelf” model. Multiple allogeneic CAR-T candidates are in development, but few have reached approval, and meaningful questions remain around rejection, GVHD risk, durability, safety monitoring, payer confidence, and commercial viability.
This session will examine where allogeneic approaches may ultimately win, particularly in larger indications requiring rapid scale, and where autologous or personalized approaches may remain superior, including TILs, personalized neoantigens, and settings where individualized manufacturing is central to efficacy. Panelists will discuss what lessons can honestly transfer across rare disease gene therapy, emerging allogeneic platforms, and today’s autologous cell therapy market—and where stakeholders need different playbooks instead of forcing every CGT into the same model.
The discussion will focus on realistic timelines to commercial viability, the operational and economic barriers that remain, and what a practical roadmap for innovation, access, and adoption should look like.
Moderator:
Monet Stanford, DrPH, Principal, SVP Healthcare Policy, Washington Analysis
Faculty:
Jeff Wren, VP Biotherapies, AABB
PJ Keith, Vice President, Global Market Access, Kyverna Therapeutics
Evan Zaslow, Chief Managed Care Officer, City of Hope
Rocio Manghani, MPH, VP, Market Access, Allogene Therapeutics
Session 6
Olympic Suites 1 10th Floor
THE SCIENCE IS BETTER THAN EVER: WHY ARE PATIENTS STILL WAITING?
CGT science continues to advance, but timely access still depends on a fragile chain of payer authorization, referral management, site readiness, accreditation, manufacturing slots, patient navigation, and financial clearance. For patients, the difference between eligibility and treatment can be measured in weeks of uncertainty and operational handoffs.
This session will examine the market economics of site-of-care strategy and accreditation: who is qualified to deliver CGTs, who pays for readiness, how payers define appropriate sites, and what it will take to expand access without compromising quality. The discussion will focus on practical bottlenecks that keep scientifically eligible patients from receiving therapy when time matters most.
Moderator:
Brenna Raines, ADVI Health
Panelists:
George Eastwood, CEO, Emily Whitehead Foundation
Chris McGhee, CEO, Current Health
Ela Lourido, Vice President and General Manager, Biologics
Imran Khan, MD, PhD, VP, Hematology Medical Affairs, Johnson & Johnson
NETWORKING LUNCH
Session 7
Presidents 10th Floor
REIMBURSEMENT REALITY CHECK – MAKING THE ECONOMICS WORK
Access and reimbursement issues are still present in cell therapy even though the field is matured and now nearly 10 years old. There is an underpayment crisis, with Medicare FY 2026 DRG 018 base rate being $315,000 but total costs often exceeding $500,000+ (including complications, outliers). There is also a clinical trial reimbursement cliff, with a new 0.16 Medicare adjustment factor dropping clinical trial case payments to ~$50,000 (43% reduction from proposed rate). The upfront acquisition burden hasn’t changed; Hospitals must purchase cellular products before reimbursement; which continues to be a cash flow strain for smaller institutions. In addition there is significant geographic variation in the cost to treat. Finally, value based contracting has not been the solution stakeholders thought it may be, for a variety of policy and budgetary reasons. Models are still operationally complex; and structuring risk-sharing arrangements is still difficult and highly dependent on the therapeutic area and provider type involved. Panelists will discuss these issues, the state of play in the ecosystem, and offer practical advice to audience members on how to think about these issues in the context of proposed 2027 changes and practical realities of market access.
Moderator:
Alicia Silver, Vice President, Emerging Therapies, ADVI Health
Panelist Mix:
Rocky Billups, Vice President, Market Operations, Sarah Cannon Cancer Network
Laura Okpala, MPH, Executive Director, Head of US Reimbursement Policy, Gilead Sciences
Christine Pfaff, RPh, MBA, Director of Clinical Initiatives, Community Oncology Alliance (COA)
Christina Hochul, Sr Director, State and US Policy, BMS
Session 8
Olympic Suites 1 10th Floor
THE EMERGENCE OF AUTOIMMUNE CELL THERAPY: COMMERCIALIZATION AND ACCESS LESSONS FROM AND BEYOND CAR-T
CAR-T cell therapy transformed oncology. Now it is coming for autoimmune disease, and the early clinical results are extraordinary. Patients with severe, refractory SLE, systemic sclerosis, and inflammatory myositis are achieving drug-free remission after a single infusion. Autolus, Bristol Myers Squibb, Novartis, Cabaletta Bio and Kyverna Therapeutics are among the companies racing toward the first approval. The science is no longer speculative. The commercialization challenge, however, is just beginning — and it is more complex than anything the oncology CAR-T playbook prepared the field for.
Payers will benchmark autoimmune CAR-T against oncology. Rheumatology practices are not configured for apheresis, lymphodepletion, or cytokine release syndrome management. The payment models that might make a one-time therapy financially viable in a chronic disease population do not exist at scale. And the patient population with the highest unmet need is disproportionately on Medicaid, in a system not built to pay for what they need.
This panel brings together the voices tasked to ensure autoimmune cell therapy reaches patients. Together they will debate what actually transfers from the oncology CAR-T experience, what has to be invented from scratch, and whether the US market access infrastructure is capable of delivering on the promise of immune reset therapies before the window closes.
Moderator:
Marc Samuels, CEO, ADVI Health
Faculty:
Melia Loskill, Vice President, Market Access, US, Autolus Therapeutics
Phung Osborn, Vice President, Global Market Access Cell Therapy, Bristol Myers Squibb
John Hermanek, Former VP, Market Access, Immatics
Session 9
Presidents 10th Floor
GOVERNMENT INNOVATION AGENDAS: CAN POLICY KEEP PACE WITH CGT?
Public agencies are no longer just reviewing advanced therapies after the science is built; they are increasingly shaping the environment in which CGTs are developed, paid for, and delivered. FDA, CMS, state Medicaid programs, European HTA bodies, and the UK MHRA are each experimenting with new ways to accelerate evidence generation, modernize regulatory review, support manufacturing flexibility, and test payment innovation. The challenge is that these agendas do not always move together.
This session will reverse the conversation. Leading commercial, Medicare Advantage, Medicaid, and pharmacy benefit stakeholders will discuss the evidence, contracting terms, site-of-care standards, data infrastructure, patient protections, and budget predictability they need to support responsible CGT access. The goal is not a generic payer panel; it is a practical discussion of what would make plans say yes faster, where current submissions fall short, and how manufacturers and treatment centers can design programs that meet payer needs without delaying patients.
Moderator:
Shefali Shah, MPH, Shah Consulting
Faculty:
Michael Byrne, DO, Medical Director, Cell Therapy, OneOncology
Evan Zaslow, Chief Managed Care Officer, City of Hope
Carol Greulich, MBA, Former Director Specialty Network Management, Anthem
Ashley Hume, CEO, Emerging Therapy Solutions
Session 10
Olympic Suites 110th Floor
ACCELERATING CGT WITH AI
The panel will center on a pressing commercial challenge: despite a vast and growing CGT
ecosystem working to optimize the patient, product, and reimbursement journeys, access to
approved therapies remain difficult to scale and significant barriers persist. We believe AI has the potential to fundamentally reshape this dynamic, and is poised to help address these challenges. Our panel discussion will examine the most well-documented barriers to
commercial access and explore how emerging AI capabilities could help the ecosystem meet demand particularly as significant approvals approach for cell and gene therapies serving larger patient populations.
Moderator:
Joe DePinto, Head of Cell and Gene Advanced Therapies, McKesson
Panelist:
Tim Bader, Senior Partner, Blue Matter
Herman Sanchez, EVP & Chief Business Officer, Trinity Life Sciences
Sanjay Srivastava, Senior Partner CGT, Accenture
Muna Tuna, Commercial & Market Access Leader, EY
Chris McGhee, CEO, Current Health
Session 11
Presidents 10th Floor
CAR-T AT A CROSSROADS: CAN ACCESS, QUALITY & ECONOMICS CO-EXIST?
Are we designing CAR-T delivery around patients? Who can absorb the risk? How can accreditation & quality standards enable access? Is outpatient CAR-T a clinical evolution or reimbursement workaround? Are current payment models slowing the diffusion of cellular therapies? What is the solution?
Moderator:
Rob Richards, MS, MBA, Corporate Director of Cellular Therapy & Transplant, University of Pennsylvania
Faculty:
David Schmahl, CEO, FACT
Rocky Billups, VP Operations, HCA Healthcare Sarah Cannon Cancer Network
Reagan Klima, VP, Payer and Access, Iovance Therapeutics
Dylan Bechtle, MS, JD, Director, Regulatory Policy, Johnson & Johnson Innovative Medicine
Session 12
Olympic Suites 1 10th Floor
CMC AS STRATEGY: THE MANUFACTURING DECISIONS THAT MAKE OR BREAK CGTS
In CGT, manufacturing is not simply an operational function; it is often central to the product strategy. Potency assays, comparability, vector supply, automation, raw materials, release testing, chain of identity, and site readiness can determine whether a therapy can be delivered reliably at scale.
This session will examine the manufacturing choices that should be treated as strategic decisions early in development. Panelists will discuss how CMC decisions affect regulatory risk, scalability, cost, and reliability, and how developers can avoid building therapies that are scientifically compelling but difficult to reproduce, deliver, or commercialize.
Session 13
Presidents 10th Floor
THE HEALTHCARE SYSTEM OF 2035: WHAT CHANGES WHEN TRANSFORMATIVE THERAPIES BECOME ROUTINE?
The day closes by asking what healthcare must become if transformative therapies move from rare exceptions to routine clinical options. By 2035, success may depend not only on scientific innovation, but on the ability to align evidence, payment, manufacturing, delivery, patient navigation, and long-term outcomes into a functioning system.
This closing session will bring the human side of value back into the center of the conversation. Patients and caregivers may define transformation through time, function, independence, travel burden, caregiver strain, hope, and the ability to return to daily life. The panel will synthesize the day’s R&D, regulatory, payer, commercial, infrastructure, and patient themes and ask what must change now if CGT is to become routine, equitable, and sustainable by 2035.
Moderator:
Christopher Kennedy, CEO, Pacifigene Tech
Faculty:
Kent Rogers, MBA, President, PBM, CarelonRx
Reagan Klima, VP, Payer and Access, Iovance Therapeutics
Phung Osborn, Vice President, Global Market, BMS
Co-CHAIR CLOSING COMMENTS
Burt Zweigenhaft, PhD, Founder & Executive Director, AVBCC
RECEPTION