UCSF Catalyst Program Presentation

Presenter: Charles Hart

Overview

• Introduction to UCSF Catalyst Program
• Discuss target product profile (TPP) and its role in healthcare product development
• Overview of Catalyst Summer Internship Program
• Detailed breakdown of TPP fields
• Introduction of Ray Manowski for the second half of the workshop

Acknowledgements

• Thank you to participants, Catalyst staff, principal investigators, UCSF Office of Innovation Ventures, case managers, and Catalyst interns

Catalyst Program

• Part of Innovation Ventures at UCSF, the tech transfer office
• Focus on helping UCSF personnel with ideas/inventions in healthcare
• Three programs: Catalyst Awards, Catalyst Launchpad, Summer Internship Program
• Aim: Advance projects along the translational path to commercialization
• Scope: Drugs, tests, devices, digital health
• Advisors: ~100 volunteer industry advisers
• History: Since 2010, almost 300 projects, $12 million awarded

Catalyst Summer Internship Program

• Focus: Create TPPs for Catalyst Award teams
• Goals: Advance projects, help interns gain experience
• Strategy: Fill TPP fields sequentially starting with medical fields
• First task: Meeting between professors, team members, interns, and Catalyst staff

Target Product Profile (TPP)

• Description of the desired product outcome
• Identifies optimal and minimal product attributes
• Used by industry, FDA, WHO, venture capitalists
• Fields vary by product type (drugs, devices, digital health)
• Common fields: Clinical indication, competitive landscape, patents, regulatory path, reimbursement, market opportunity
• Specific fields: Efficacy predictors, performance requirements, etc.

Medical Fields of the TPP

• Indication: Disease or condition targeted
• Current standard of care: Existing treatments
• Unmet needs: Improvements needed
• Ideal patient identification: Biomarkers, diagnostics
• Clinical trials: Design and implementation

Technical Fields of the TPP (To be covered next)

• Vary by product type (e.g., drugs, devices)
• Examples: Toxicity predictors, safety aspects, material requirements

Sources for Information

• Award application and PowerPoint presentation from professors
• Databases on disease incidence, prevalence, treatment, etc.
• Contact Catalyst staff for questions

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Reimbursement Considerations and Pharmacoeconomics

Presenter: Ray Manowski

• Background: MD, PhD from Tufts University, industry experience, consultant
• Focus: Reimbursement strategy, economic value of drugs

Importance of Reimbursement in Drug Development

• Early consideration in development
• Criteria for Formulary Consideration: Need, efficacy, safety, cost
• Payors use various levers to control access: Prior authorization, indication restrictions, etc.
• U.S. vs. Europe: Different approaches and considerations

Market Access and Pricing Strategy

• Real-world evidence: Important for payors
• Steps: Approval, health technology assessment, pricing negotiations
• Payors and restrictions: Examples from the U.S. and Europe
• Importance of early feedback: Adjust development programs accordingly

Live Example of Reimbursement Strategy Development

• Consulting process: Blinded TPP, payor feedback
• Types of questions asked: Study design, Administration, etc.
• Impact on development programs: Real-world evidence studies, pricing considerations

Conclusion

• Importance of early and ongoing reimbursement planning
• Changes in regulations and market landscape
• Investor considerations

Q&A

• Discussed various aspects of payor dynamics, market sequencing, and strategy for different regions

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Next Workshop

• Focus: Technical fields of TPP for diagnostics, digital health, medical devices, gene and cell therapy
• Speakers: Linda Mallister, David Kim, AAA K Kurahara
• Date: Next Wednesday