Conference Day One

7:50 am Registration & Coffee

8:50 am Chair’s Opening Remarks

Strategies to Support Long-Term Market Access Needs

9:00 am Are Reimbursement Systems Ready to Accommodate Outpatient- Administered CGTs?

  • Laura Okpala Executive Director, Head of Reimbursement Policy, Gilead Sciences

Synopsis

  • Understanding the drivers behind the increasing number of CGTs being administered in the outpatient setting, and whether current infrastructure is equipped to manage this growth
  • Sharing strategies to work with states to overcome barriers to access
  • Setting out a roadmap of improvements needed in reimbursement systems to support outpatient administration

9:30 am Pivoting for Sustained Success: Maturing and Emerging Payment Models

  • Mark Trusheim Strategic Director, NEWDIGS, Tufts Medical Center

Synopsis

  • Implications of updated projections of CGT products, treated patients, and resultant product revenues through to 2032
  • Lessons learned that are refining CGT payment models
  • Emerging solutions to remaining challenges in providing patient access

10:00 am Securing Adequate Out-of-State Coverage & Reimbursement

  • Erica Cischke Vice President, U.S. Government Affairs, Alliance for Regenerative Medicine

Synopsis

  • Innovative strategies to overcome the challenge of Medicaid out-of-state coverage, with examples across a variety of states engaged
  • Contracting with out-of-state providers to ensure adequate reimbursement
  • Overcoming cross-border credentialing challenges

10:30 am Morning Refreshments & Speed Networking

Synopsis

Our speed networking is the ideal opportunity to get face-to-face time with many of the brightest minds working in the field and introduce yourself to the attendees that you would like to have more in-depth conversations with. Benchmark against the industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond

Evolving Health Systems to Expand Patient Access

11:30 am Strategies from Academia to Increase Access to Cell & Gene Therapies

  • Robert Richards Corporate Director of Cell Therapy and Transplant, University of Pennsylvania

Synopsis

  • Outlining the Penn Medicine ‘Hub & Spoke’ model and how it is improving community access to CGTs
  • Understanding the types of payment structures being used and important steps to ensure coverage by insurers
  • Distinguishing between starting up a BMT program and CGT program
  • Best practice advice for other community members looking to implement a similar mode

12:00 pm Global Early Access Programs for Cell & Gene Therapies

Synopsis

Speaking Position Reserved for Uniphar

12:30 pm Expanding Access to CAR-Ts Beyond Current Settings: How Can Health Systems Evolve to Meet Growing Cell Therapy Needs?

  • Anik Patel Director, Health Economics & Outcomes Research, Formerly of Kite Pharma

Synopsis

  • Benchmarking the CAR-T expansion journey from its inception, and the current roadblocks to further expansion
  • Discussing studies showing how expansion has improved patient access and outcomes
  • Exploring solutions that have been proposed to improve access to CAR-Ts
  • Outlining areas of research that are needed to address future challenges

1:00 pm Lunch & Networking

Preparing Early for Market Access & Health Technology Assessments

2:00 pm A Case Study of Effective Market Access Involvement in Early Clinical Phase Development

  • Swami Nathan Head of Global Pricing & Contracting, Regeneron Pharmaceuticals

Synopsis

  • Sharing an example of effective clinical trial design to meet future payer and HTA requirements
  • Leveraging real-world evidence and robust evidence generation to supplement trial data
  • Practical advice on payer engagement strategy through clinical development

2:30 pm Talk Details to be Announced Shortly

  • Oswald Bentinck Vice President, Head of Global Value & Access, Rocket Pharmaceuticals

3:00 pm Panel Discussion: Understanding Payer Concerns on CGT Durability, Risks & Benefits

  • Chuka Ndukauba Senior Director, Strategy & Product, Optum
  • Sean Dickson Vice President, America's Health Insurance Plans - AHIP
  • Theresa Galizia Senior Vice President & Chief Underwriting Officer, Berkley Accident & Health

Synopsis

  • Pinpointing key reasons payers have around clinical uncertainty that hinders coverage
  • Assessing the benefits and drawbacks of different strategies to minimise clinical uncertainty
  • Payer perspectives on the current outlook and future direction for outcomes-based agreements
  • Practical advice for manufacturers looking to propose payment contracts that mitigate this risk

3:40 pm Afternoon Refreshment Break & Scientific Poster Session

4:25 pm Outlining the Preparation and Engagement Work Required for an ICER Review

  • Francis Pang Senior Vice President - Global Market Access & International Geographic Expansion, Orchard Therapeutics

4:55 pm Panel Discussion: Designing a Clinical Development Program to Support Future Market Access

  • Laurel Todd Vice President, US Market Access & Policy, IOVANCE Biotherapeutics, Inc.
  • Oswald Bentinck Vice President, Head of Global Value & Access, Rocket Pharmaceuticals
  • Robert Rouse Head of Market Access, CSL

Synopsis

  • What are the critical market access steps when entering the clinic?
  • Bridging the gap between early-phase development and commercial: how can market access push for payer- and patientrelevant endpoints to be included in phase 1 study designs?
  • Practical advice when designing a clinical program for an intended first-in-class therapy
  • Does engagement with Medicare look the same as commercial payers?

5:35 pm Chair’s Closing Remarks

5:40 pm End of Day One