Industry Member Newsletter

ISCT INDUSTRY Community  NEWSLETTER
DECEMBER 2025
2025 Year End Reflections: Celebrating the Impact of the ISCT Global Industry Community
Phil Vanek, PhD
Phil Vanek, PhD ISCT Chief Commercial Officer

As I approach my first anniversary as ISCT’s CCO, I’d like to reflect on 2025 and what has been a tumultuous and news-filled year for the field. 

We are in a period of transition, our industry has shifted focus on measuring progress though therapeutic advances -- INDs, therapeutic approvals, and companies created along the way -- to focusing on delivery, clinical adoption, patient access, and transformative healthcare.  We have an unprecedented opportunity to help shape the future, and I’m inspired by how our community is addressing these challenges head-on.

What encourages me most is the clarity and impact of ISCT’s voice. Working with the Alliance for Regenerative Medicine (ARM) and the American Society for Cell and Gene Therapy (ASGCT), we have taken important positions, including putting a 10 year moratorium on Heritable Human Genome Editing (HHGE), and advocating for global regulatory reforms to accelerate development of novel therapies. Our joint efforts, I believe, have been instrumental in informing the US FDA leadership’s recent New England Journal of Medicine editorial promoting a “plausible pathway” approach which accelerates the regulatory review of rare genetic diseases where clinical trials are impractical if not impossible.

In 2025, the Industry Committee and its subcommittees, continued to lead meaningful discussions and deliver tangible projects aligned with our members’ top priorities.  With 75 members companies across North America, Europe, and Asia Pacific, we are a truly international voice shaping the commercial vision for our industry.  This year alone, ISCT Industry Committees have collectively curated over 33 resources; crafted Cytotherapy manuscripts on Pluripotent Stem Cell Therapies and Artificial Intelligence applications, created thought-leadership webinars across several disciplines, and helped educate investors to the importance of maintaining momentum in the field.  In Spring 2025, ISCT expanded its Committee portfolio to welcome the Europe Industry Committee which  provides a unique forum addressing the particular challenges (and opportunities) of conducting business in the EU.  We couldn’t do this without the tireless leadership of our subcommittee co-chairs, and the active participation of all 450-industry community members, so a hearty thanks you to you all!

As we look forward to 2026, I’m heartened by a revitalized sense of optimism for the year ahead.  The ISCT Industry Pillar will continue driving its strategic priorities, exploring AI applications and strategies for patient access and adoption, while continuing to create resources for early-stage companies and expanding region-specific education initiatives. Together, our shared commitment to educating patients, providers, payers and investors will help ensure that the technological breakthroughs of today become the accessible, life-changing medicines of tomorrow—no matter where patients live.  I’m confident that in 2026 ISCT will continue to be the global rallying voice for advanced therapy progress, for patients (especially those enrolled in clinical trials!) and their families, that give us the inspiration to carry on this important work.  So, once again, a big thank you to all of our ISCT industry community, and I look forward to continuing this journey with you in 2026!

Signature of Phil Vanek

Guiding CGT Forward in 2025: Four Impactful ISCT Industry Initiatives

Through curated expert education and critical cross-functional dialogue, the Industry Community drove clarity, alignment, and forward momentum across the CGT field.

ISCT CGT Investor Behavior Survey

Amid shifting regulatory and geopolitical conditions, the ISCT BDF Committee monitored investor sentiment to benchmark CGT market progress and provide timely insights on capital flows and dynamics.

Learn More
ISCT APAC Regulatory Roadmap Series

Addressing the region’s regulatory complexity, the ISCT APAC Industry Committee developed essential guidance to help stakeholders navigate approval pathways, beginning with three key Asia CGT markets: Singapore, South Korea, and Japan.

Learn More
ISCT Commercialization Signature Series

The ISCT Industry Community gathered for a half-day executive workshop to examine the operational, regulatory, and technological levers essential to CGT industrialization and to outline a shared direction for moving the sector forward

 Learn More
ISCT Europe Industry Committee

ISCT strengthened its presence and influence in Europe, by launching a dedicated European Industry Committee to address region-specific commercialization challenges, and by being formally accepted into the EMA Industry Standing Group, securing a direct channel for regulatory dialogue with the EU.

Learn More
ISCT Industry Committees Addressing Emerging Sector Challenges

Bringing together global experts across functions and regions, ISCT’s Industry Committees identify emerging challenges, drive strategic conversations, and deliver practical guidance to advance the field. Their work strengthens cross-field alignment, elevates member expertise, and supports a more connected, commercially viable CGT ecosystem.

See below the complete list of ISCT Industry Committee initiative's published in 2025

CO-CHAIR
Sven Kili, MBChB, MRCS (Eng)
CO-CHAIR
Patrick Rivers, MBA
Business Development & Finance (BDF) Committee
38 Members representing Senior Executives, CGT Investors & Analysts

The BDF Committee work to bring visibility to investment trends and market dynamics supporting ISCT Members to align development plans with investor and partner expectations — improving funding success and commercial viability.

Webinars:

Roundtables at ISCT 2025 New Orleans:

  • Bridging the “Valley of Death”
  • Navigating Capital Markets
  • Aligning with Pharma Licensing Priorities

Additional Outputs:

  • Third iteration of the ISCT CGT Investor Behavior Survey - completed by over 100 CGT-focused investors
  • Telegraft Article delivering market insights & investment commentary
Headshot of Dominic Clarke
CO-CHAIR
Dominic Clarke, PhD
Headshot of Sam Molina
CO-CHAIR
Sam Molina, PhD
Process Development & Manufacturing (PDM) Committee & Working Groups 
 108 Members representing Manufacturing & Lab Directors, Heads of Process Development, Senior Scientists & Engineers 

The PDM Committee tackles complex manufacturing challenges and shares best practices, empowering ISCT members with key knowledge on product quality, risk reduction, production efficiency, and scalability.

Roundtables at ISCT 2025 New Orleans:

  • Can cellular starting material predict outcomes? 
  • Safety vs. Scalability: The Allogeneic iPSC Problem
  • What Value Does Your QC Process Add?
  • Uncommon Starting Materials – Navigating Uncertainty to  Evaluate Benefits
  • Decentralized Manufacturing – New Technologies and Strategies
  • Investing In Your Manufacturing – Implementation Hurdles for PATs in CGTs
  • How to Freeze in the Cold Chain?
  • Protecting Donors, Saving Patients - Conceptualizing a National Registry

White Paper Publications:

Telegraft:

Webinars:

Headshot of William Hwang
CO-CHAIR
William Hwang, MBBS, FRCP, FAMS, MBA
Headshot of Antonio S. J. Lee
CO-CHAIR
Antonio S. J. Lee, BSc.(Hons), MSc., PhD
APAC Industry Committee
 26 Members representing Senior Executives, CDMOs, CROs, and enablers based in the region. 

The APAC Industry Committee addresses regional challenges and bottlenecks impacting CGT development unique to Asia Pacific market , while promoting communication and alignment between Eastern and Western perspectives.

Roundtables at ISCT 2025 New Orleans:

  • Harmonizing cGMP standards in APAC to Lower Costs
  • Regulating Clinical Access to Unapproved and Unproven Cell Therapies - Lessons From APAC
  • Cheaper CAR Ts - Are They as Good?

Whitepaper:

Webinars:

Additional Outputs:

  • Doing Business In Asia Symposium at ISCT 2025 New Orleans  

Headshot of Lindsay Davies
CHAIR
Lindsay Davies, PhD, FHEA
Europe Industry Committee
17  Members representing Senior Executives, CDMOs, CROs, and enablers based in the region. 

The Europe Industry Committee addresses its region's complex CGT market and regulatory landscape, unpacking innovation and commercialization strategies through enhanced collaboration and knowledge sharing.

In Progress Output:

  • From Concept to Commercialization of ATMPs in Europe  - Infographic for publish Q1 2026
The ISCT Global Industry Community at a Glance
450 Senior Industry Professionals
75 Innovation-Driven Companies
20 CGT Leading Countries
All Major CGT Markets
Membership Type Chart Regional Distribution Chart
Be Part of the Community Driving CGT Forward
Become an ISCT Industry Member 

Engage with the community driving global initiatives on hot topics such as Organoids, AI & Automation, Starting Material Characterization, and enhanced Cold Chain Procedures, while gaining exclusive insights into regulatory updates, market trends, and innovative partnership strategies shaping the future of CGT.
 
Connect with leaders, influence initiatives, and ensure your organization is part of the conversations defining the cell and gene therapy sector.  Contact Lydia@ISCTglobal.org for more information. 
ISCT 2025 Industry Member Companies