Sessions

Delivering Projects and Managing Timelines in the Variable, Continuously Changing Environment Of Cell and Gene Therapy
Workforce of the Future: Talent, Change Management and Enabling Future Development
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
Overcoming Challenges and Setting Up for Success on the Path to Commercialisation

Delivering Projects and Managing Timelines in the Variable, Continuously Changing Environment Of Cell and Gene Therapy

26 Jan 2022
15:30
SPONSORED BY
American Red Cross
CRB

15:30 Chairperson’s Opening
Kim Raineri, Chief Manufacturing and Technology Officer, AVROBIO

15:35 Partnering With Key Raw Materials Providers To Ensure Timely Scale-Up In Support of Your Commercial Cellular Therapy Launch

  • Cellular Therapy products are inherently complex to manufacture, whether they are based on autologous or allogeneic cells
  • Laying out a timeline for the transition from clinical to commercial is challenging, given uncertainty regarding receipt and timing of regulatory approval
  • Working closely with your key raw material providers to plan for supporting your therapy in a commercial launch, and to prepare for scaling up to meet increasing demand, can help ensure that supply of such materials does not limit the commercial success of your therapy
  • In this session, the American Red Cross will share how they have supported commercial launch of cellular therapies, and discuss the benefit of close collaboration to ensure timelines and expectations are met
  • In addition, the advantages of maintaining vendor continuity through clinical into commercial will be discussed

Melissa Sebok, Executive Director – Product, Client & Business Development, Direct Patient Care & Emerging Offerings, American Red Cross

15:55 The Value of A Commercial Mindset Years Before Launch

  • The potential commercial success of a new medicine is decided long before launch
  • Operating a company with an early commercialization mindset means making strategic decisions based on deep customer insights at key development milestones to ensure the product fulfills an unmet patient need, is differentiated from standard of care (if one exists), and demonstrates economic value to the health care system
  • In this presentation, Holly May will outline the different considerations and steps companies need to take to ensure they have an early commercialization mindset and that they ultimately meet the needs of their entire stakeholder ecosystem when they bring a product to market

Holly May, Chief Commercial Officer, AVROBIO

16:15 Planning of Long Term Commercial Success: The Second Wave of Cell and Gene Therapy Manufacturing

  • In this presentation, expert Peter Walters looks at what cell and gene therapy developers can do to plan for long-term commercial success while so much change is underway at the lab bench
  • In a recent report produced by CRB, drawing on survey data from over 500 industry experts, Walters will discuss how technologies like single-point, process-in-a-box systems will transform the future of drug manufacturing
  • Diving into the survey data, he will give a high-level overview on what’s happening right now, trends towards what’s next and what is no longer happening in the cell and gene therapy industry

Peter Walters, Director, Advanced Therapies, CRB Group

16:35 Speaker Q&A and Panel Discussion

Speakers

Kim Raineri
Chief Manufacturing and Technology Officer
AVROBIO
Melissa Sebok
Executive Director – Product, Client & Business Development, Direct Patient Care & Emerging Offerings
American Red Cross
Holly May
Chief Commercial Officer
AVROBIO