Latest news with #NabihaSaklayen
Yahoo
12-06-2025
- Business
- Yahoo
EY US Announces Nabiha Saklayen of Cellino as an Entrepreneur Of The Year® 2025 New England Award Winner
Entrepreneur Of The Year celebrates ambitious entrepreneurs who are shaping the future BOSTON, June 12, 2025--(BUSINESS WIRE)--Ernst & Young LLP (EY US) has named Nabiha Saklayen, Ph.D., CEO and Co-Founder of Cellino, a winner of the Entrepreneur Of The Year® 2025 New England Award. Now celebrating its 40th year, Entrepreneur Of The Year is one of the most prestigious business awards programs in the world, recognizing visionary leaders who are redefining how business is done and making a lasting impact on their industries and communities. Dr. Saklayen was selected by an independent panel of judges for her bold vision, scientific ingenuity, and unwavering commitment to transforming the future of cell therapy manufacturing. Under her leadership, Cellino is pioneering a new era of regenerative medicine by building the first autonomous facility for induced pluripotent stem cell manufacturing, leveraging AI and laser-based technologies to make personalized stem cell therapies scalable, accessible, and affordable. "This award is a reflection of the groundbreaking work our team at Cellino is doing to shape the future of medicine," said Dr. Saklayen. "I'm honored to be recognized alongside so many inspiring entrepreneurs who are driving real change." Entrepreneur Of The Year celebrates founders, CEOs, and multigenerational leaders who embody innovation, resilience, and purpose. As a regional winner, Dr. Saklayen joins an esteemed community of past recipients and will now be considered for the National Entrepreneur Of The Year Awards, taking place this November at the Strategic Growth Forum®, one of the most influential gatherings of high-growth companies in the U.S. Regional award winners were announced on Wednesday, June 11th during a special celebration in Boston, MA and will become lifetime members of an esteemed community of Entrepreneur Of The Year alumni from around the world. The regional award winners will then be considered by the National judges for the Entrepreneur Of The Year National Awards, which will be presented in November at the annual Strategic Growth Forum®, one of the nation's most prestigious gatherings of high-growth, market-leading companies. Sponsors Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards include presenting sponsors PNC Bank, Cresa, LLC, Marsh USA, and SAP. In New England, sponsors also include Platinum sponsor, DLA Piper, Gold sponsor, Selective Insight, and Silver sponsor, ADP. About Entrepreneur Of The Year Founded in 1986, Entrepreneur Of The Year has celebrated more than 11,000 ambitious visionaries who are leading successful, dynamic businesses in the US, and it has since expanded to nearly 60 countries globally. The US program consists of 17 regional programs whose panels of independent judges select the regional award winners every June. Those winners compete for national recognition at the Strategic Growth Forum® in November where National finalists and award winners are announced. The overall National winner represents the US at the EY World Entrepreneur Of The Year™ competition. Visit About EY EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. All in to shape the future with confidence. EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. Information about how EY collects and uses personal data and a description of the rights individuals have under data protection legislation are available via EY member firms do not practice law where prohibited by local laws. For more information about our organization, please visit About Cellino Cellino is a leader in advanced biomanufacturing technology, committed to making personalized cell, tissue, and organ replacements a reality for patients around the world. Learn more at and follow us on LinkedIn and X. View source version on Contacts Media Kimberly HaKKH
Business Wire
12-06-2025
- Business
- Business Wire
EY US Announces Nabiha Saklayen of Cellino as an Entrepreneur Of The Year ® 2025 New England Award Winner
BOSTON--(BUSINESS WIRE)--Ernst & Young LLP (EY US) has named Nabiha Saklayen, Ph.D., CEO and Co-Founder of Cellino, a winner of the Entrepreneur Of The Year® 2025 New England Award. Now celebrating its 40th year, Entrepreneur Of The Year is one of the most prestigious business awards programs in the world, recognizing visionary leaders who are redefining how business is done and making a lasting impact on their industries and communities. Dr. Saklayen was selected by an independent panel of judges for her bold vision, scientific ingenuity, and unwavering commitment to transforming the future of cell therapy manufacturing. Under her leadership, Cellino is pioneering a new era of regenerative medicine by building the first autonomous facility for induced pluripotent stem cell manufacturing, leveraging AI and laser-based technologies to make personalized stem cell therapies scalable, accessible, and affordable. 'This award is a reflection of the groundbreaking work our team at Cellino is doing to shape the future of medicine,' said Dr. Saklayen. 'I'm honored to be recognized alongside so many inspiring entrepreneurs who are driving real change.' Entrepreneur Of The Year celebrates founders, CEOs, and multigenerational leaders who embody innovation, resilience, and purpose. As a regional winner, Dr. Saklayen joins an esteemed community of past recipients and will now be considered for the National Entrepreneur Of The Year Awards, taking place this November at the Strategic Growth Forum®, one of the most influential gatherings of high-growth companies in the U.S. Regional award winners were announced on Wednesday, June 11 th during a special celebration in Boston, MA and will become lifetime members of an esteemed community of Entrepreneur Of The Year alumni from around the world. The regional award winners will then be considered by the National judges for the Entrepreneur Of The Year National Awards, which will be presented in November at the annual Strategic Growth Forum ®, one of the nation's most prestigious gatherings of high-growth, market-leading companies. Sponsors Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards include presenting sponsors PNC Bank, Cresa, LLC, Marsh USA, and SAP. In New England, sponsors also include Platinum sponsor, DLA Piper, Gold sponsor, Selective Insight, and Silver sponsor, ADP. About Entrepreneur Of The Year Founded in 1986, Entrepreneur Of The Year has celebrated more than 11,000 ambitious visionaries who are leading successful, dynamic businesses in the US, and it has since expanded to nearly 60 countries globally. The US program consists of 17 regional programs whose panels of independent judges select the regional award winners every June. Those winners compete for national recognition at the Strategic Growth Forum ® in November where National finalists and award winners are announced. The overall National winner represents the US at the EY World Entrepreneur Of The Year™ competition. Visit About EY EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. All in to shape the future with confidence. EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. Information about how EY collects and uses personal data and a description of the rights individuals have under data protection legislation are available via EY member firms do not practice law where prohibited by local laws. For more information about our organization, please visit About Cellino Cellino is a leader in advanced biomanufacturing technology, committed to making personalized cell, tissue, and organ replacements a reality for patients around the world. Learn more at and follow us on LinkedIn and X.
Yahoo
19-05-2025
- Business
- Yahoo
Cellino's iPSC Manufacturing Technology Receives FDA Advanced Manufacturing Technology (AMT) Designation
AMT Designation Positions Cellino to Accelerate the Development of Scalable, Personalized Regenerative Medicines CAMBRIDGE, Mass., May 19, 2025--(BUSINESS WIRE)--Cellino, a leader in advanced biomanufacturing, today announced that its optical biomanufacturing technology for generating induced pluripotent stem cells (iPSCs) has received the FDA's Advanced Manufacturing Technology (AMT) designation from the Center for Biologics Evaluation and Research (CBER). This prestigious designation highlights the transformative potential of Cellino's automated technology for scaling up high-quality iPSCs to industrialize next-generation regenerative therapies. The FDA encourages the adoption of advanced manufacturing technologies (AMTs) that improve manufacturing reliability, product quality, and production scale. The AMT designation accelerates timelines for therapies manufactured using Cellino's optical biomanufacturing technology, offering higher priority within the FDA, along with earlier and more frequent interactions during Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) processes for a faster path to market. "We are honored to receive the AMT designation for our proprietary technology stack," said Nabiha Saklayen, Ph.D., CEO and Co-Founder of Cellino. "This recognition affirms our commitment to revolutionizing the production of patient-specific iPSCs, enabling faster and more consistent clinical and commercial-scale manufacturing. It's a pivotal moment in our mission to deliver personalized regenerative therapies that can scale globally, transforming healthcare for millions." Autologous iPSC manufacturing has long been one of the most complex challenges in biomanufacturing, involving labor-intensive processes like manual passaging and colony picking that only a limited number of experts worldwide can perform. These hurdles have slowed progress, preventing many therapeutic programs from advancing past early-phase clinical trials. Cellino's proprietary optical bioprocessing technology overcomes these challenges by introducing precision, reproducibility, and scalability, ensuring reliable, high-quality iPSC production for both clinical trials and commercial stages. "This AMT designation underscores the scientific rigor and transformative potential of our technology," said Marinna Madrid, Ph.D., Chief Product Officer and Co-Founder of Cellino. "Automated, optical manufacturing is key to ensuring patient access to regenerative medicines. This milestone brings us closer to scaling therapies from Phase 1 through large-scale commercialization, aiming to address some of the world's most debilitating chronic degenerative diseases." Cellino intends to leverage the AMT designation to expedite the translation of personalized iPSC-derived therapies into clinical practice. With global chronic disease burdens rising and more than 100 million individuals in the U.S. alone who could potentially benefit from iPSC-derived therapies, Cellino's technology is poised to significantly expand patient access to next-generation living medicines. For more information on the FDA's Advanced Manufacturing Technologies Designation Program, visit the FDA AMT Guidance. About Cellino Cellino is a leader in advanced biomanufacturing technology, committed to making personalized cell, tissue, and organ replacements a reality for patients around the world. Learn more at and follow us on LinkedIn and X. View source version on Contacts Media Kimberly HaKKH Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
19-05-2025
- Business
- Business Wire
Cellino's iPSC Manufacturing Technology Receives FDA Advanced Manufacturing Technology (AMT) Designation
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Cellino, a leader in advanced biomanufacturing, today announced that its optical biomanufacturing technology for generating induced pluripotent stem cells (iPSCs) has received the FDA's Advanced Manufacturing Technology (AMT) designation from the Center for Biologics Evaluation and Research (CBER). This prestigious designation highlights the transformative potential of Cellino's automated technology for scaling up high-quality iPSCs to industrialize next-generation regenerative therapies. The FDA encourages the adoption of advanced manufacturing technologies (AMTs) that improve manufacturing reliability, product quality, and production scale. The AMT designation accelerates timelines for therapies manufactured using Cellino's optical biomanufacturing technology, offering higher priority within the FDA, along with earlier and more frequent interactions during Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) processes for a faster path to market. 'We are honored to receive the AMT designation for our proprietary technology stack,' said Nabiha Saklayen, Ph.D., CEO and Co-Founder of Cellino. 'This recognition affirms our commitment to revolutionizing the production of patient-specific iPSCs, enabling faster and more consistent clinical and commercial-scale manufacturing. It's a pivotal moment in our mission to deliver personalized regenerative therapies that can scale globally, transforming healthcare for millions.' Autologous iPSC manufacturing has long been one of the most complex challenges in biomanufacturing, involving labor-intensive processes like manual passaging and colony picking that only a limited number of experts worldwide can perform. These hurdles have slowed progress, preventing many therapeutic programs from advancing past early-phase clinical trials. Cellino's proprietary optical bioprocessing technology overcomes these challenges by introducing precision, reproducibility, and scalability, ensuring reliable, high-quality iPSC production for both clinical trials and commercial stages. 'This AMT designation underscores the scientific rigor and transformative potential of our technology,' said Marinna Madrid, Ph.D., Chief Product Officer and Co-Founder of Cellino. 'Automated, optical manufacturing is key to ensuring patient access to regenerative medicines. This milestone brings us closer to scaling therapies from Phase 1 through large-scale commercialization, aiming to address some of the world's most debilitating chronic degenerative diseases.' Cellino intends to leverage the AMT designation to expedite the translation of personalized iPSC-derived therapies into clinical practice. With global chronic disease burdens rising and more than 100 million individuals in the U.S. alone who could potentially benefit from iPSC-derived therapies, Cellino's technology is poised to significantly expand patient access to next-generation living medicines. For more information on the FDA's Advanced Manufacturing Technologies Designation Program, visit the FDA AMT Guidance. About Cellino Cellino is a leader in advanced biomanufacturing technology, committed to making personalized cell, tissue, and organ replacements a reality for patients around the world. Learn more at and follow us on LinkedIn and X.
