Jacques Galipeau, MD, MD FRCP(C)
President, ISCT
Associate Dean for Therapeutics Development
University of Wisconsin School of Medicine and Public Health
A few weeks ago, I gave the opening keynote address at the 2nd edition of the Dubai Stem Cell Conference (DSCC) chaired by Dr Fatma Alhashimi which brought to the stage an impressive array of global and regional Cell and Gene Therapy (CGT) scientific and thought leaders, including ISCT’s very own Katarina Le Blanc. The conference also showcased the homegrown MENA (Middle East and North Africa) talent and scholar engagement in advancing evidence-based living therapeutics development within the region. Gulf State members of the conference are now deploying commercial CAR-T at scale and have established state-of-the art GMP cell manufacturing capacity to leverage regional CGT deployment commercial and investigational. Congress members enthusiastically communicated their clear vision for regulatorily managed development of this ecosystem so as to be part of the CGT global scholarly and commercial community and to provide safe and effective investigational and approved CGTs to their populace. The UAE (United Arab Emirates) has a vision for it to become a beacon medical destination for regional and global care seekers. A quick primer on UAE, it is a young national entity politically structured as an elective monarchy formed from a federation of seven emirates, consisting of Abu Dhabi, Ajman, Dubai, Fujairah, Ras Al Khaimah, Sharjah and Umm Al Quwain. Amongst these emirates, Abu Dhabi is the country's capital, while Dubai, the most populous city, is an international hub. These two centers concentrate on the political, educational, and business assets of the federation. From a drug regulatory perspective, each emirate has substantial autonomy, and the Abu Dhabi Department of Health (DOH) has taken a national lead in establishing an FDA-like regulatory framework to further leverage its growing CGT activities. Shahrukh Hashmi - a Mayo Clinic expat with close mentee ties with Peter Marks from FDA – recently took on the role of standing up the Abu Dhabi regulatory initiative as a means to encourage CGT innovation. In conversations with him, he emphasized the following salient facts and goals:
- The DOH's Research Committee encourages all types of research pertaining to Regenerative Medicine, whether it be pre-clinical or clinical.
- We strongly encourage Investigator initiated trials, but we are very open to industry clinical trials.
- We would allow cell therapy research to be translated into first-in-human trials, if the research is done on international standards.
- The timelines for first response of the Research Proposals from the DOH are shorter than average timeframe of the EU or US FDA.
- We have some GMPs in the UAE, and now they are gearing up for international accreditation, which will tremendously help in the overall ecosystem of clinical research for CGT.
- We encourage bringing in the whole manufacturing facility for products within UAE for which, we have incentives for external companies as the goal is to Make in the Emirates.
- CAR-T cell and Gene Therapy clinical trials are highly encouraged given the immense need for the patients, as rare diseases are quite prevalent in the UAE including monogenic disorders.
It is evident that the UAE with its well-resourced efforts in CGT science and commercialization centred in the Abu-Dhabi and Dubai emirates will provide important groundbreaking achievements reflective of the MENA region. To this engine of innovation, a grassroots regional community of scholars is formalizing a new MENA Stem Cell and Regenerative Medicine Society (SCRMS) led by the efforts of Fatima Jamali and Shaikha Almazrouei. I had the opportunity to meet in my capacity as ISCT President with an expanded group of eighteen scholars with representatives from UAE, Qatar, Jordan and other MENA countries which included the above-named as well as Asawari (Asa) Bapat and Essam Abdelalim both involved in the organization of DSCC.
Their collective vision is to establish a collaborative NGO platform for stem cell and regenerative medicine researchers, clinical practitioners, and stakeholders in the MENA region. Their goals are:
- Develop a membership based and government supported collaborative platform for stem cell and regenerative medicine researchers, and clinical practitioners in the MENA region.
- Harmonize regulations of stem cell and regenerative medicine in the region concerning research and clinical applications of CGT.
- Promote training and education on Good Clinical Practices (GCP) and clinical Good Manufacturing Products (cGMP) in the MENA region and collaborate with international organizations for accreditation.
- Promote innovative research and academic collaboration between universities in the MENA region.
- Support the ecosystem and infrastructure building for commercially viable CGT products.
- Attract multi-site clinical trials related to CGT in the different fields of stem cells and regenerative medicine as well as international pharmaceutical and biotechnology to the region.
- Increase the visibility of the MENA region in established international platforms by organizing an annual regional meeting in addition to the active participation and hosting of international meetings.
The professed mission of MENA SCRMS is well aligned with that of ISCT, and I believe we – and the global CGT community - can provide our enthusiastic support to the fledgling MENA SCRMS in their efforts to innovate, develop and deploy safe, effective and impactful evidence-based living therapeutics to their community.
Jacques Galipeau, MD
President, ISCT
Associate Dean for Therapeutics Development
University of Wisconsin School of Medicine and Public Health
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