What's In Store For You? 

Advanced Therapies Europe 2025 provides a vital platform for regulators to engage directly with the global cell and gene therapy ecosystem. Join discussions that influence policy, align on scientific standards, and ensure safe, scalable innovation.

Whether you're navigating evolving regulatory frameworks, contributing to guidance development, or exploring scientific advancements, this is the forum to stay informed and connected.

  • Collaborate with Industry and Academia: Connect with biotech, pharma, and academic researchers to exchange insights and align on next-generation regulatory science.

  • Shape the Future of ATMP Oversight: Participate in forward-looking conversations on regulatory harmonisation, risk-based approaches, and innovative trial design.

  • Stay Ahead of Scientific and Clinical Advances: Learn about emerging technologies and clinical strategies that will define the future regulatory landscape.

Apply to attend

Key themes

  • Stay Ahead of Regulatory Change - Stay updated on evolving ATMP frameworks, including expedited pathways and decentralised trial oversight to improve alignment and clarity in your policy work.
  • Understand Real-World Challenges - Hear industry pain points and jointly explore pragmatic solutions and build mutual understanding, and inform more effective guidance.
  • Shape the Future of CGT Policy - Shape the future of CGT regulation in direct dialogue with developers and payers, fostering policies that support innovation without compromising safety.

Your Personalised Itinerary

09:55
  1. Plenary

    Deep dive into the regulatory framework that governs CGT across major rejoins, focusing on recent updates, new legislation and how companies can navigate the changing landscape.

10:25
  1. Plenary
    A conversation with key patient advocates and organisations to highlight the importance of patient engagement, access, and ensuring therapies meet real-world needs in CGT.
12:50
    • R&D, clinical innovation & translation
    Theatre 1
    • Scientific advances and key breakthroughs.
    • Safety, efficacy, and regulatory challenges.
    • Investment trends and commercialisation potential.
14:30
    • Manufacturing, scale up & commercial strategy
    Theatre 2
    • Transitioning from academic proof of concept to market-ready product 

    • Why biotech teams must integrate CMC, regulatory and pharmacology early 

    • Avoiding pitfalls of overselling and overpromising 

15:05
    • Manufacturing, scale up & commercial strategy
    Theatre 2
    Discuss the key challenges in patient-centric manufacturing, focusing on ensuring timely delivery of therapies, managing logistics, and addressing issues related to personalised treatments, from patient selection to product delivery. 
16:00
    • R&D, clinical innovation & translation
    Theatre 1
    • Manufacturing, scale up & commercial strategy
    Theatre 2
12:15
    • R&D, clinical innovation & translation
    Theatre 1
    • Best practices for early interactions with EMA, FDA, MHRA etc. 

    • How proactive regulatory engagement reduces delays and de-risk trials 

    • Lessons learned from companies that successfully navigated approval 

     

    • Manufacturing, scale up & commercial strategy
    Theatre 2
    • Explore strategies for securing reimbursement and market access for cell and gene therapies, focusing on pricing, HTAs, and policy advocacy to ensure patient access. 

14:00
    • Manufacturing, scale up & commercial strategy
    Theatre 2
15:15
  1. Plenary

    AI is everywhere, but in CGT, real deployment remains limited. This session goes beyond the buzz to explore the tangible opportunities, early wins, and critical barriers to broader adoption. 

    We’ll look at where AI is beginning to make a difference and what’s still needed to move from isolated pilots to real impact. What kind of data, infrastructure, and cross-functional collaboration will unlock AI’s full potential in CGT? 

16:00
  1. Plenary
    As we wrap up two days of deep discussions on the current state of the European CGT landscape, this final panel will chart the path ahead. Which steps must Europe take to remain competitive and lead the way in the next 5–10 years? Each panellist will share their key takeaways from the last two days, reflecting on the insights, challenges, and opportunities discussed. 

Discover Advanced Therapies Week as a regulator

Explore how Advanced Therapies Europe supports regulators in staying at the forefront of innovation. From engaging with global experts on the latest scientific and regulatory developments to fostering dialogue with biotechs, pharma, and policymakers, every moment is designed to enable informed decision-making. Dive into the agenda, collaborate with peers, and help shape the frameworks advancing safe and effective cell and gene therapies.

Content Packed Agenda

Gain insights, meet investors, and accelerate your path to commercialization.

State of the Art Networking

Discover promising companies, network with peers, and explore new opportunities.

Unlock Funding Opportunities

Meet funders and explore translational grants designed to move your research from lab to clinic.

Shape the Future of CGT

Join discussions on the critical role of academia in driving early-stage innovation and equitable access.

Who Might You Find On the Show Floor?

Sample Attendee List Current Exhibitor List

500+
Attendees
40+
Companies
150+
Speakers
170+
Therapeutic Developers

 

  • "What an incredible few days at the ATE conference by Phacilitate! Grateful for the power of my network and the opportunity to meet so many familiar faces while growing it further.”
    Head of Business Development: Cell Therapy and Laboratory Services | Cell and Gene Therapy
  • “Impactful moments and connections.”
    Director Global Cell and Gene Therapies Portfolio Management | EMBA | Deep Tech
  • “Already having fantastic conversations here at ATE24 in Lisbon.”
    Experienced Leader in Cell and Gene Therapy Business and Commercial Strategy