A strategic partnership between EY and MADE Scientific to operationalize Abu Dhabi's advanced therapy manufacturing ecosystem and establish the emirate as the MENA hub for CGT innovation.
The UAE is at a strategic inflection point. With DOH-backed GMP manufacturing initiatives, Masdar City's life sciences infrastructure, and ADIO's commitment to biotech investment, Abu Dhabi is positioned to become the first truly scalable ATMP hub in the MENA region.
No large-scale commercial ATMP manufacturing facility exists in MENA today. Hospital-based, small-scale labs handle limited demand — far below what a regional CGT hub requires.
Multiple DOH-backed initiatives in 2025–2026 are actively planning or building GMP manufacturing facilities, gene therapy production centers, and regional CDMO capabilities.
The HELM Cluster's Cell & Gene Therapy workstream targets 12 partnerships by 2026, scaling to 26 by 2028. Operationalizing these requires expert advisory from day one.
Abu Dhabi Investment Office is actively facilitating biotech investment with targeted incentive frameworks aligned to Abu Dhabi Vision 2030's economic diversification mandate.
The Health & Life Science Hub (HELM) Cluster positions Abu Dhabi as a globally competitive center for innovation, research, and commercialization across three priority initiatives.
Clinical trials infrastructure development and international sponsor attraction
Advanced therapy development, manufacturing capabilities, and regulatory framework
Population-scale digital health modeling initiative
Prime Contractor
Named CGT Sub-Advisor
The EY + MADE Scientific partnership uniquely combines EY's regional reach and government advisory credibility with MADE's hands-on CGT manufacturing expertise and MENA market precedent — creating the only team capable of delivering both the strategic advisory and operational implementation that Abu Dhabi's HELM Cluster requires.
Define Abu Dhabi's CGT positioning framework — target modalities, manufacturing models, competitive differentiation within MENA
Design the manufacturing and development operational model — CDMO vs. in-house vs. hybrid, GMP infrastructure requirements
Identify and engage leading global CGT companies; structure MoUs and agreements aligned with DOH's KPI targets
Develop quality and regulatory framework for ATMPs — aligned with DOH, MOHAP, and international standards (EMA/FDA)
Systematic identification and prioritization of global CGT leaders — academic, commercial CDMO, and technology platform partners
Conduct ATMP regulatory gap analysis — benchmark UAE against EMA, FDA, MHRA; identify gaps and develop roadmap to close
Establish minimum 2 strategic CGT partnerships (SOW target); structure collaboration models aligned with HELM priorities
Design training and capability building programs — GMP operations, ATMP quality, clinical translation for advanced therapies
GMP manufacturing process development and scale-up for autologous and allogeneic CAR-T constructs
Mesenchymal stem cell manufacturing with established GMP protocols and multi-indication experience
Natural killer cell manufacturing for oncology applications — both donor-derived and iPSC-derived NK platforms
Induced pluripotent stem cell manufacturing and differentiation for off-the-shelf allogeneic cell therapy products
ATMP IND/BLA regulatory strategy, GMP compliance, quality system design for emerging market regulatory bodies
End-to-end technology transfer program design — process characterization, training, and local capability building
MADE Scientific provided the ATMP PMO advisory strategy for KFSHRC's CAR-T manufacturing program — the first of its kind in Saudi Arabia. This engagement established our MENA market credibility and demonstrated our capacity to navigate regional regulatory environments and healthcare system dynamics.
Interested in learning more about the EY × MADE Scientific partnership for the Abu Dhabi HELM Cluster? Reach out to our team leads.
