This workshop is the first in a planned series of workshops designed to share valuable insights from industry and academic experts to accelerate development and delivery of cell and gene therapies for patients in need. This workshop will build connections between California academic and industry CGT developers while highlighting unique expert perspectives on collaborative approaches to clinical development, manufacturing innovation and patient access strategies.
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Workshop Goals:
- Knowledge Sharing: Equip participants with practical knowledge and tools for accelerating their CGT projects.
- Networking: Foster collaboration among professionals in the CGT industry to share experiences and insights.
- Actionable Insights: Provide actionable strategies that participants can implement early in the development lifecycle.
Who Should Attend:
- CGT Developers: Scientists and executives involved in the all stages of CGT development.
- Regulatory Affairs Professionals: Individuals responsible for compliance and regulatory interactions.
- Investors and Financial Advisors: Those looking to invest in or support CGT initiatives.
This interactive workshop will feature:
- Presentations from leading industry and academic experts.
- Panel discussions on key challenges and solutions in CGT development.
- Breakout sessions for in-depth exploration of specific topics.
- Networking opportunities to connect with peers and experts.
Agenda
8:00-8:30 AM | Registration & Breakfast
8:30-8:45 AM | Welcome Remarks by California Life Sciences (CLS) and California Institute for Regenerative Medicine (CIRM)
8:45-9:30 AM | Keynote Address: Opportunities and Challenges for Curative Therapies
- Deepak Srivastava, MD, President and Senior Investigator, Gladstone Institutes
9:30-10:30 AM | Industry Panel: Navigating Evolving Regulatory and Capital Market Landscape
- Moderator: Karen Tkach Tuzman, PhD, Director of Biopharma Intelligence, BioCentury
- Jie Li, MD, Head, Physician Scientist, Astellas Gene Therapies
- Ram Mandalam, PhD, Founder & Chief Executive Officer, Citra BioConsulting
- Katharine Miller, PhD, Vice President, Global Head of Biologics Development Analytical and Quality, Bayer
- Brad Ringeisen, PhD, Executive Director, Innovative Genomics Institute, UC Berkeley
- Ming Wang, Director of Consulting Services, Azzur San Francisco
10:30-11:00 AM | Coffee Break
11:00-12:30 AM | CMC Presentation
Learning and adopting best practices from the successful maturation of other technology platforms.
- Presenter: Paolo Gargini, PhD
- Q&A Facilitators: Taby Ahsan, PhD, Vice President, Cell and Gene Therapy Operations, City of Hope and Shyam Patel, PhD, Senior Director of Business Development & Alliance Management, California Institute for Regenerative Medicine (CIRM)
12:30-1:30 PM | Networking Lunch
1:30-3:00 PM | Patient & Market Access Presentations
Best practices for successfully incorporating evidence generation for commercialization and reimbursement early on in a clinical development strategy.
- Philip Cyr, Senior Vice President, Precision AQ
- Geoff Lomax, Associate Director Medical Affairs & Policy, California Institute for Regenerative Medicine (CIRM)
- David Miklos, MD, PhD, Chief of BMT & Cell Therapy Program, Stanford University
- Eric Schuur, PhD, Chief Executive Officer & Co-Founder, HepaTx
3:00-4:00 PM | Closing Remarks, Networking Coffee Break
Thank you to our sponsors:
Registration Fees
The registration fee includes breakfast, lunch, and coffee breaks throughout the day.
- CLS Member Attendee – $50
- Non-member Life Sciences Company Attendee – $100
- Non-member Service Provider Company Attendee – $250
Interested in becoming a member of CLS? Contact [email protected] to learn about applying your ticket cost towards yearly membership!
For the purposes of registration for any CLS event, classification of a registrant as a research and development company, an industry service provider, an academic or a qualifying investor is subject to review by CLS. In its sole discretion, CLS reserves the right to make the determination of the proper classification of a registrant. Depending on this classification, an additional fee maybe required. CLS reserves the right to publish materials and restrict event access consistent with these determinations.
