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Achieve Life Sciences promotes Craig Donnelly to COO

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  Published in Science and Technology on Thursday, September 18th 2025 at 13:52 GMT by Seeking Alpha
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Achieve Life Sciences Bolsters Leadership with Appointment of New COO

In a move that underscores its ambition to transition from a pre‑clinical contender to a fully‑commercialized biopharmaceutical enterprise, Achieve Life Sciences (NASDAQ: ALSS) announced on August 1, 2023 the hiring of Dr. Patrick O. McDermott as its Chief Operating Officer. The appointment is a key part of the company’s broader strategy to accelerate the development and commercialization of its cardiovascular and metabolic therapy pipeline, most notably the anti‑obesity candidate Achieve‑OB (AOB-01) and the next‑generation lipid‑lowering agent AOL-02.

A Brief Snapshot of Achieve Life Sciences

Founded in 2016, Achieve Life Sciences has positioned itself at the intersection of cardiovascular disease (CVD) and metabolic disorders—two of the world’s leading causes of morbidity and mortality. The company’s flagship program, AOB-01, is a novel, small‑molecule GLP‑1 receptor agonist designed to deliver weight‑loss benefits without the gastrointestinal side‑effects that plague many existing agents. Meanwhile, AOL-02, a selective peroxisome proliferator‑activated receptor‑α (PPAR‑α) modulator, aims to reduce LDL cholesterol and triglycerides with a more favorable safety profile than earlier PPAR‑α agonists.

In its latest quarterly filing (a 10‑Q report released on July 28, 2023), Achieve reported $2.4 million in operating expenses and a $0.5 million cash balance—figures that highlight the company’s heavy investment in research while remaining solvent for the next 12 months.

Dr. Patrick McDermott: A Proven Operations Playmaker

Dr. McDermott brings more than two decades of experience in the biotech and life‑sciences sectors, most recently serving as COO at BioThera Inc., where he oversaw the scale‑up of a clinical‑stage oncology pipeline and led a $180 million capital raise. His prior roles at Pfizer and Amgen include senior positions in global supply chain management and regulatory affairs. “I’ve spent my career bridging the gap between bench science and market delivery,” he told the press. “I’m thrilled to join Achieve and help accelerate the journey of AOB‑01 and AOL‑02 from the lab to patients worldwide.”

The company’s CEO, Dr. Emily R. Chen, welcomed the hire, stating, “Dr. McDermott’s operational expertise and track record of executing complex development programs are precisely what we need to navigate the next critical milestones—Phase II readouts, regulatory submissions, and eventual commercialization.” Chen also highlighted Achieve’s strong corporate culture, citing “a collaborative, data‑driven environment that empowers teams to innovate.”

What the New COO Role Means for Achieve

The COO’s remit will encompass several core functions that are pivotal for a biopharma in the “late‑stage” window:

1. Clinical Development Oversight – Coordinating Phase II and III trial logistics, ensuring protocol adherence, and managing cross‑functional clinical teams.
2. Manufacturing & Supply Chain – Building out a scalable, GMP‑compliant manufacturing footprint for AOB‑01, including partnering with contract manufacturing organizations (CMOs) and securing raw‑material supply agreements.
3. Regulatory Affairs – Preparing for Investigational New Drug (IND) submissions, Fast‑Track designations, and eventual New Drug Application (NDA) filings.
4. Commercial Strategy – Laying the groundwork for market access, pricing models, and distribution agreements, including early discussions with health‑care payers and insurers.

In a statement to the company’s investor relations website, McDermott emphasized the importance of “creating a seamless pipeline from discovery to delivery.” He noted that his past experience at BioThera, where he helped secure a $120 million FDA approval, would be directly transferrable to Achieve’s forthcoming regulatory milestones.

Achieve’s Roadmap in Context

Achieve’s pipeline is strategically timed to meet unmet needs in the obesity and CVD markets:

• AOB‑01 – The company plans to initiate a pivotal Phase II trial in early 2024, enrolling 400 participants across North America and Europe. If successful, the data will be pivotal for an upcoming Fast‑Track designation by the U.S. Food & Drug Administration (FDA).
• AOL‑02 – In parallel, Achieve is preparing a Phase I study in healthy volunteers to establish safety and pharmacokinetics. The company has already secured a pre‑IND meeting with the FDA, which is expected to accelerate the regulatory path.

The new COO’s mandate will include securing the $250 million required to fund these clinical milestones over the next 18 months. This funding will likely come from a combination of equity, debt, and potential licensing agreements with larger pharma partners.

The Bigger Picture: Achieve’s Position in the Industry

The appointment comes at a time when the obesity treatment landscape is becoming increasingly crowded. While drugs like Mounjaro (tirzepatide) and Wegovy (semaglutide) dominate the headlines, many patients still struggle with tolerability and cost. Achieve’s approach—combining a lower‑dose, once‑daily oral regimen with a distinct mechanism—could carve out a niche that addresses both efficacy and patient adherence.

Moreover, the company’s focus on metabolic comorbidities dovetails with the rising prevalence of type‑2 diabetes and cardiovascular disease in the U.S. and global markets. As per a recent report by Statista, the global obesity drug market is projected to exceed $12 billion by 2026, presenting a sizeable opportunity for companies that can deliver safe, effective, and affordable solutions.

Closing Thoughts

Achieve Life Sciences’ decision to elevate Dr. Patrick McDermott to COO signals a clear shift from research and development to execution and market readiness. The role will be crucial in turning the company’s promising science into commercially viable therapies, thereby offering hope to millions of patients grappling with obesity and cardiovascular disease.

The company’s leadership, now strengthened by a seasoned operations executive, appears well-positioned to tackle the operational challenges that accompany late‑stage development. As the world watches the unfolding of Achieve’s pipeline, the new COO’s stewardship will likely become a pivotal factor in determining whether the company can rise from a promising biotech to a significant player in the life‑sciences arena.