08.15.23
Wheeler Bio, Inc., a boutique CDMO, has appointed Marc Helouin as Chief Quality and Regulatory Officer. Helouin will lead the quality assurance and regulatory compliance activities across Wheeler Bio's development and manufacturing activities in support of Wheeler's tech platform – Portable CMC, which is designed to rapidly advance biologics programs from discovery to clinical trials.
Helouin brings more than 25 years of experience in biopharma across domains ranging from quality assurance, corporate audit, supply chain assurance, clinical and commercial compliance, as well as enterprise risk management. He joins Wheeler Bio from AstraZeneca, where he most recently led a key R&D transformation effort to drive more efficient early discovery programs. Additional experiences at AstraZeneca included roles as corporate head of audit (R&D), focusing on the risk and controls framework for R&D and corporate support functions, as well as leading AstraZeneca's Quality operations functions in France and California through both significant facility upgrades and product launches while maintaining and enhancing those facilities' license-to-operate.
Previously, Helouin held leadership roles in both operations and quality assurance in large multinational pharma companies such as Boehringer-Ingelheim and Pfizer, as well as gaining clinical quality assurance experience through leadership roles at multinational CRO, Syneos.
"I couldn't be more excited to support Wheeler in their mission to speed our partners' journey from discovery to human proof-of-concept," said Helouin, "Wheeler's approach really fills a market need to help identify and develop the next generation of medicines for patients around the world. The philosophy behind Portable CMC really delivers what the market needs—rapidly advancing our clients' products to early phase clinical supply. I look forward to joining the Wheeler Bio team and leveraging my clinical and commercial experience in the quality and regulatory space to do just that."
"I am thrilled to be welcoming Marc to the team," said Jesse McCool, Co-Founder and CEO at Wheeler Bio. "He has an extraordinary breadth of experience across pharma, with a real focus on delivering for both internal and external stakeholders in multiple contexts. His expertise in the quality and regulatory domains will be critical for assuring delivery to Wheeler Bio's clients."
Helouin brings more than 25 years of experience in biopharma across domains ranging from quality assurance, corporate audit, supply chain assurance, clinical and commercial compliance, as well as enterprise risk management. He joins Wheeler Bio from AstraZeneca, where he most recently led a key R&D transformation effort to drive more efficient early discovery programs. Additional experiences at AstraZeneca included roles as corporate head of audit (R&D), focusing on the risk and controls framework for R&D and corporate support functions, as well as leading AstraZeneca's Quality operations functions in France and California through both significant facility upgrades and product launches while maintaining and enhancing those facilities' license-to-operate.
Previously, Helouin held leadership roles in both operations and quality assurance in large multinational pharma companies such as Boehringer-Ingelheim and Pfizer, as well as gaining clinical quality assurance experience through leadership roles at multinational CRO, Syneos.
"I couldn't be more excited to support Wheeler in their mission to speed our partners' journey from discovery to human proof-of-concept," said Helouin, "Wheeler's approach really fills a market need to help identify and develop the next generation of medicines for patients around the world. The philosophy behind Portable CMC really delivers what the market needs—rapidly advancing our clients' products to early phase clinical supply. I look forward to joining the Wheeler Bio team and leveraging my clinical and commercial experience in the quality and regulatory space to do just that."
"I am thrilled to be welcoming Marc to the team," said Jesse McCool, Co-Founder and CEO at Wheeler Bio. "He has an extraordinary breadth of experience across pharma, with a real focus on delivering for both internal and external stakeholders in multiple contexts. His expertise in the quality and regulatory domains will be critical for assuring delivery to Wheeler Bio's clients."