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.
A 60-second executive briefing on the consortium's CGT sub-advisory proposal for the Abu Dhabi HELM Cluster — covering the strategic opportunity, the WS2 + WS3 mandate, and the operational expertise we bring to Day 1.
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.
EY × MADE Scientific delivers across two HELM workstreams — building Abu Dhabi's CGT manufacturing ecosystem (WS2) and amplifying it through global partnerships and showcase positioning (WS3).
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
Identify and prioritize strategic partnerships with global life sciences leaders — anchored in CGT, with adjacencies into clinical trials and digital twin priorities
Structure collaboration models aligned with clinical trials, cell and gene therapy, and digital twin priorities — IP, governance, and commercial frameworks
Formalize minimum 3 high-impact partnership agreements (MoUs, collaborations) — SOW target by December 2026
Support international outreach activities and cross-border collaboration — leveraging EY's global network and MADE's CGT ecosystem relationships
Develop unified communication and marketing strategy across HELM achievements — clinical trials, cell & gene therapy, and digital twin initiatives
Select and prepare flagship initiative outcomes for the ADGHW 2026 showcase — evidence-led, partner-attributed, narrative-ready
Coordinate unified HELM presence during Abu Dhabi Global Health Week 2026 — booth, panels, partner activations, media program
Execute communication plans across pre-event, event, and post-event windows — measured against awareness, partner attraction, and DOH narrative-control KPIs
GMP process development, scale-up, and manufacturing across CAR-T, MSC, NK, iPSC, TIL, and HSC platforms — autologous and allogeneic — under FDA 21 CFR 1271 / 210/211, EU GMP Annex I, and ICH Q7/Q9/Q10 frameworks.
Process development and GMP manufacturing of lentiviral, AAV, and retroviral vectors — supporting CAR-T construct supply, in-vivo gene therapy programs, and CDMO partner integration for vector-dependent ATMPs.
ATMP IND/BLA regulatory strategy, GMP compliance, and emerging-market quality system design — paired with operator training, scientist secondments to MADE's Princeton facility, and capability-building curricula tuned to DOH/MOHAP frameworks.
End-to-end facility readiness — cleanroom design, process & equipment engineering, SOP authoring, MES/eQMS digital systems integration, and IQ/OQ/PQ validation support — delivered as a packaged build-operate-transfer offering for greenfield ATMP sites.
MADE Scientific is the named technical and GMP sub-advisor on a sovereign Gulf-region ATMP manufacturing program — a first-of-its-kind initiative in the MENA region. This engagement establishes our active in-region credibility and demonstrates our capacity to navigate sovereign regulatory environments, ATMP facility design and CGT operating-model development at scale.
MADE Scientific is a U.S.-based, FDA-registered cell therapy CDMO (FEI: 3039488058), headquartered in Princeton, NJ. Our manufacturing infrastructure is aligned with FDA 21 CFR 1271, 21 CFR 210/211, EU GMP Annex I, and ICH Q7, Q9, Q10 — the international standards governing modern cell and gene therapy manufacture.
Current cleanroom suites support clinical-to-commercial supply today. Expanded ballroom suites online June 2027 — purpose-built to scale with Abu Dhabi demand.
Active in-region delivery on a sovereign Gulf ATMP manufacturing program — a first-of-its-kind initiative for the MENA region. Deep familiarity navigating DOH, SFDA, and emerging ATMP frameworks.
End-to-end technology transfer program design — process characterization, SOPs, staff training, and local capability building aligned to Abu Dhabi's cluster goals.
Comprehensive operator training programs, scientist secondments to MADE's Princeton GMP facility, and a phased build-operate-transfer (BOT) model — MADE runs operations during ramp-up, transferring full ownership to local Abu Dhabi teams once readiness milestones are met.
Interested in learning more about the EY × MADE Scientific partnership for the Abu Dhabi HELM Cluster? Reach out to our team leads.
Partner — MENA Healthcare & Life Sciences Sector Leader
EY
Fadi.Smeirat@sa.ey.com LinkedIn
