Craig Donnelly Takes the Helm as COO at Achieve Life Sciences

Craig Donnelly Promoted to Chief Operations Officer

SEATTLE and VANCOUVER, British Columbia — Achieve Life Sciences, Inc. (NASDAQ: ACHV), a specialized pharmaceutical company focused on developing innovative solutions for nicotine dependence, announces the exciting promotion of Craig Donnelly to the position of Chief Operations Officer. This strategic move is seen as a vital step toward enhancing operational efficiency and gearing up for the anticipated product launch.

Craig Donnelly's Vision for Operations

Having been a valued member of the Achieve Life Sciences team since 2022, Donnelly initially served as the Executive Vice President overseeing Chemistry, Manufacturing, and Controls (CMC) along with Regulatory CMC. His promotion places him at the forefront of integrating supply chain and manufacturing operations with the company’s commercial strategies. As Achieve prepares for a product launch in the near future, Donnelly’s leadership will be crucial in ensuring a seamless transition and efficient operational execution.

Preparing for Product Launch

In his new role, Donnelly will focus on optimizing manufacturing processes, enhancing supply chain logistics, and maintaining the highest standards of quality and regulatory compliance. These responsibilities are essential as the company navigates its shift from late-stage development to commercial viability of cytisinicline, an innovative treatment aiming to support smoking cessation.

Leadership Praise for Donnelly

Rick Stewart, Chief Executive Officer of Achieve Life Sciences, expressed his enthusiasm regarding Donnelly's new position, stating, "Craig’s extensive experience and exceptional leadership qualities have proven vital in advancing our clinical and regulatory objectives. His adeptness in managing the complexities of regulatory processes will be indispensable as we approach the potential FDA approval for our groundbreaking smoking cessation treatment.”

Craig Donnelly's Background

With over 25 years of experience in the biopharmaceutical field, Craig brings a wealth of knowledge in both technical development and regulatory processes. Prior to joining Achieve, he held significant roles at various companies, including NuCana and F. Hoffman-La Roche. His career began at Pfizer, where he honed his skills as an analytical chemist before progressing to leadership positions. Donnelly's academic credentials include a Bachelor’s degree with honors in Chemical and Pharmaceutical Sciences from the University of Sunderland.

About Achieve Life Sciences, Inc.

Achieve Life Sciences is dedicated to tackling the challenges posed by nicotine dependence on a global scale. The company is advancing the development and commercialization of cytisinicline, an oral treatment option designed to assist individuals seeking to quit smoking. The FDA has recently accepted Achieve's New Drug Application (NDA) for cytisinicline, setting an important date for potential approval in the foreseeable future.

The Need for Effective Solutions

Currently, millions of adults in the United States are grappling with nicotine dependence, which leads to significant health issues and fatalities each year. Cytisinicline offers a novel approach, at a time when existing aids for smoking cessation are limited. As vaping becomes increasingly popular, cytisinicline is being explored as a potential treatment for e-cigarette cessation as well.

Looking Ahead: Achieve's Future Direction

Craig Donnelly's expanded role marks a pivotal moment for Achieve Life Sciences as it prepares for the next phases of development and market introduction of cytisinicline. The goal is to deliver effective solutions to those in need while navigating the complexities of pharmaceutical development and regulatory approval. This forward-thinking strategy positions Achieve for success in a competitive market, where the need for effective smoking cessation solutions is more critical than ever.

Frequently Asked Questions

What is the role of Craig Donnelly as COO?

Craig Donnelly will oversee the integration of operational efficiency in supply chain and manufacturing, ensuring readiness for the launch of cytisinicline.

What is cytisinicline?

Cytisinicline is an investigational treatment designed to assist individuals in quitting smoking and has potential applications in helping e-cigarette users as well.

When is the anticipated release of cytisinicline?

The company is preparing for potential FDA approval, with key milestones in the upcoming years as it moves towards product launch.

How does Achieve Life Sciences support smoking cessation?

Achieve Life Sciences focuses on developing innovative therapeutic options to address nicotine dependence and improve public health outcomes.

What experience does Craig Donnelly bring to his new position?

Mr. Donnelly has over 25 years of experience in the biopharmaceutical industry, with a strong background in regulatory CMC and operational oversight.

About The Author

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