Wheeler Bio, a clinical contract development and manufacturing organization (CDMO), announced Marc Helouin is appointed Chief Quality and Regulatory Officer (CQRO). Marc will be leading the quality assurance and regulatory compliance activities across Wheeler Bio’s development and manufacturing activities in support of Wheeler's proven tech platform – Portable CMC™ – which rapidly advances biologics programs from discovery to clinical trials.
With over 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, Marc 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 AstraZeneca’s 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, Marc 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 a leading 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 Marc Helouin, SVP and CQRO at Wheeler Bio. "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.”
In addition to holding degrees in chemistry (B.A., University of Colorado, Boulder) and law (J.D., Capital University), Marc is also a graduate of the US Navy’s Nuclear Power School, starting his post university career as a nuclear power officer in the US Navy, eventually rising to the rank of Lieutenant Commander. Marc is a member of the bar for the state and federal courts of Ohio, as well as being a member of the bar of the Supreme Court of the United States. Additionally, Marc is a Certified Supply Chain Professional (CSCP) and is certified as a Lead Auditor against the Pharmaceutical Quality Management System of the International Register of Certificated Auditors.
"I'm delighted to be joining the co-founders Jesse McCool, Christian Kanady (Echo Investment Capital), and Errik Anderson (Alloy Therapeutics, Inc.) along with the very talented team at Wheeler Bio to help accelerate the discovery of the next generation of medicines for patients worldwide,” said Marc.
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