Join like-minded local senior executives in a discussion with Cell and Gene Therapy Catapult’s own senior executives by attending this showcase event. We will be exploring ways in which your organizations can leverage CGT Catapult’s years of manufacturing expertise, facilities, resources and broader capabilities around increasing value of your asset(s) to expedite your access to European and global markets.

We invite you to attend this in-person event at the MassBio Hub in Boston (19th of April at 12pm), to learn how the Cell and Gene Therapy Catapult provides enabling tools and expertise to US-based AT developers to de-risk and accelerate the AT manufacturing pathway and route to clinic.

Attendees will gain knowledge in:

• How you can leverage 10 years of experience of supporting multiple AT companies to licensure to enable you to evolve from a CGT developer to a CGT manufacturer, with expedited timelines and minimal resources
• How your organization can access the biggest CGT cluster outside of the US
• How non-UK companies can access world-class AT clinical research and support in the UK. You will also get exposed to how policies are attracting foreign companies to set-up clinical trials and manufacture in the UK, what resources and expertise are available to allow you to best leverage the UK healthcare system.
• How the CGT Catapult can support you to easily navigate the regulatory pathways for ATs in UK and the European Union (EU).
• Some lessons learned from our CGT Catapult team on navigating requirements relevant to production of clinical material for USA, EU and UK.
• Snippets of wisdom from CGT Catapult’s partners on do’s and don’ts for implementation of in-house manufacturing capabilities.

Agenda

– 12pm: Arrival and lunch

– 12.15pm: Welcome and opening remarks

– 12.20pm: CGT Catapult’s unique model to accelerate AT developers’ pathway to establish mature GMP manufacturing capability – Sharon Brownlow, Chief Business Officer; Mark Fuller, Managing Director Manufacturing:

• Turning therapy developers into experienced therapy manufacturers in partnership
• Successes that provided the hindsight for our new partners

– 1pm: Access Strategy: AT regulatory pathway, clinical trials in UK and routes to successful market access – Jacqueline Barry, Chief Clinical Officer:

• Set up clinical trials in the UK with confidence
• Authorization or authorisation; making best use of acceleration pathways in the UK and EU

– 1.40pm Q&A

– 2pm Close of lunchtime event

– 2pm – 5pm Opportunity for companies to have 121’s with CGT Catapult

On the day there will also be an opportunity for 121’s with the CGT Catapult teams. Please contact John Kelly at john.kelly@ct.catapult.org.uk to arrange. These can be before or after the lunchtime event. We will also be available on Thursday 20th if a more comprehensive discussion is preferred.

Who should attend:

• CGT developers considering establishing GMP manufacture for supply of clinical trial and marketed product globally
• CGT organizations seeking comprehensive assistance for set-up of clinical trials and to ease navigation of regulatory pathways in UK and/or EU for their ATs.

We have limited capacity for this event, so we invite you to register at your earliest convenience.

Venue accessibility can be found here, please contact us for more information.