Sessions

Overcoming Challenges and Setting Up for Success on the Path to Commercialisation
Overcoming Challenges and Setting Up for Success on the Path to Commercialisation
Workforce of the Future: Talent, Change Management and Enabling Future Development
Delivering Projects and Managing Timelines in the Variable, Continuously Changing Environment Of Cell and Gene Therapy
How to Market my Biotech to Investors: Lessons Learned from Successful Investment and Funding Rounds
Patient and Payer Challenges: Enabling Access to Patients through Market Access, Pricing and Patient-Led Discussion
Moving the Industry Towards Automated Systems for Scale-up Success
Tech Review: New Platforms and Closed-Systems to Enable Commercial Success
Working With a CDMO is not Just an Outsourcing Contract but a Partnership: Learnings from Successful Biotech/CDMO Partnerships

Overcoming Challenges and Setting Up for Success on the Path to Commercialisation

26 Jan 2022
11:00
SPONSORED BY
Lonza Ltd

11:00  Chairperson’s Opening
Katy Spink, Chief Operating Officer & Managing Partner, Dark Horse Consulting

11:05 Building and Leveraging an FDA Regulatory Plan

  • Understanding the FDA regulatory requirements for your product
  • Avoiding common regulatory pitfalls
  • Developing your FDA regulatory plan

Barbara A. Binzak Blumenfeld, Shareholder – FDA & Biotechnology, Buchanan Ingersoll & Rooney PC

11:20 Planning for Success – The Path to Commercialisation

  • Conquering the challenges in a controlled & strategic manner
  • Incorporation of Quality by Design in early development
  • Sharing experience of integrating automated modules into manufacturing processes from early stage
  • Considerations for digital automation

Donna Rill, Chief Technical Officer, Triumvira

11:35 Derisking the Path to Commercial Manufacturing

  • What does it really take to manufacture cell and gene therapies at a commercial scale?
  • Understanding the logistics of providing therapies to large patient populations.

Joseph Garrity, Director, Commercial Development (CGT), Autologous Cell Therapy, Lonza

11:50 Panel Discussion & Speaker Q&A

Speakers

Katy Spink
Chief Operating Officer & Managing Partner
Dark Horse Consulting
Barbara A. Binzak Blumenfeld
Shareholder, FDA & Biotechnology
Buchanan Ingersoll Rooney
Donna Rill
Chief Technology Officer
Triumvira Immunologics
Joseph Garrity
Director, Commercial Development (CGT), Autologous Cell Therapy
Lonza Ltd