PepGen brings in gene therapy veteran to accelerate breakthrough neuromuscular treatments

In a strategic leadership move aimed at bolstering its clinical and regulatory execution, PepGen Inc. (Nasdaq: PEPG) has appointed Dr. Kasra Kasraian as Chief Technology Officer. The decision reflects the biotechnology company’s expanding focus on mid-stage clinical advancement, manufacturing scalability, and regulatory precision for its next-generation oligonucleotide therapies targeting severe neuromuscular and neurological conditions.

Dr. Kasraian’s appointment comes as PepGen navigates a critical inflection point in its development trajectory, having already demonstrated early-stage clinical promise through its Enhanced Delivery Oligonucleotide (EDO) platform. With over 25 years of experience in product and process development, chemistry, manufacturing and controls (CMC), and regulatory compliance across gene, cell, and small-molecule therapies, Dr. Kasraian brings deep operational and translational experience to the biotech firm.

What Is Dr. Kasraian’s Track Record in Advanced Therapeutics?

Before joining PepGen, Dr. Kasraian held senior executive roles at bluebird bio, where he led end-to-end technical operations during the commercialization of three major gene therapies: SKYSONA™ (elivaldogene autotemcel), ZYNTEGLO™ (betibeglogene autotemcel), and LYFGENIA™ (lovotibeglogene autotemcel). These therapies, designed for rare and debilitating genetic disorders such as cerebral adrenoleukodystrophy and transfusion-dependent β-thalassemia, underscored his proven ability to align cutting-edge science with commercial and regulatory requirements.

At bluebird bio, his roles included Senior Vice President of Quality, Regulatory Affairs, and CMC Sciences, and earlier, SVP of Technical Development and Operations. His responsibilities spanned CMC development strategy, manufacturing process scale-up, and global health authority submissions—competencies that are immediately applicable to PepGen’s maturing pipeline.

Dr. Kasraian also held critical leadership roles at Zafgen, Biogen, Pfizer Inc., Wyeth Biotech, and Genetics Institute, making significant contributions to formulation development and CMC management for both biologics and small molecules. At Biogen, he led CMC submissions that resulted in the approval of three Biologics License Applications (BLAs) or Marketing Authorisation Applications (MAAs), reinforcing his reputation as a technically adept executive capable of translating science into approved therapies.

How Will This Appointment Influence PepGen’s Development Strategy?

According to James McArthur, PhD, President and CEO of PepGen, the company views Dr. Kasraian’s appointment as a pivotal enhancement to its executive leadership team. The CEO stated that his rare combination of product development insight and regulatory leadership will be essential in scaling PepGen’s clinical programs from early-phase trials through late-stage development and potential commercialization.

Dr. McArthur noted that Kasraian’s particular background in advancing therapies for rare genetic diseases aligns with PepGen’s mission to address the root causes of neuromuscular disorders. Given PepGen’s ongoing pipeline initiatives—including clinical-stage programs targeting Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1)—Kasraian’s experience in orphan drug development is expected to be directly additive to current clinical execution.

What Makes PepGen’s EDO Platform Distinctive in the Neuromuscular Space?

Founded on over a decade of scientific research, PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is designed to overcome the historic challenge of poor cellular uptake in oligonucleotide therapeutics. EDO peptides facilitate deeper tissue penetration and improved delivery to target cells, particularly muscle cells—an essential requirement in the treatment of neuromuscular diseases.

By leveraging cell-penetrating peptides conjugated to oligonucleotides, PepGen is developing candidates that can reach disease-relevant tissues at pharmacologically meaningful concentrations. This platform innovation supports PepGen’s vision of tackling the underlying genetic mutations that cause DMD, DM1, and potentially other systemic disorders that have historically been difficult to treat with conventional gene therapy or antisense technologies.

The company’s lead clinical candidate, PGN-EDO51, is currently undergoing clinical testing in patients with DMD. PGN-EDO51 is designed to increase dystrophin protein production in patients with mutations amenable to exon 51 skipping—addressing a segment that represents roughly 13% of the total DMD population.

What Broader Industry Trends Does This Move Reflect?

PepGen’s decision to strengthen its CMC and regulatory leadership echoes a broader trend in the biotech sector, where small- and mid-cap companies advancing complex therapies are increasingly prioritizing early operational readiness for commercial scale-up. In particular, the neuromuscular and gene-modified oligonucleotide space has seen rapid innovation but also considerable regulatory scrutiny, especially around delivery technologies, long-term safety, and manufacturing reproducibility.

The appointment also reflects a growing emphasis among biotech companies to derisk development by bringing in senior talent capable of bridging R&D innovation with real-world regulatory expectations. This is particularly important as the FDA, EMA, and other global regulatory bodies continue to raise the bar for manufacturing consistency, comparability, and CMC transparency for advanced therapeutics.

What Is Known About Dr. Kasraian’s Academic Background and Technical Roots?

Dr. Kasraian earned both his PhD in Pharmaceutical Sciences and BS in Chemical Engineering from the University of Kentucky, equipping him with an interdisciplinary foundation that has guided his career at the interface of science, engineering, and regulatory strategy. This unique academic blend has supported his ability to navigate diverse modalities across biologics, small molecules, and cell/gene therapies—making him an ideal candidate to lead technical and process innovation at PepGen.

What Are the Near-Term Implications for PepGen’s Clinical Pipeline and Investors?

The addition of Dr. Kasraian signals PepGen’s readiness to transition from a research-focused organisation into a late-clinical and pre-commercial enterprise, with increasing focus on regulatory submissions, scalable manufacturing infrastructure, and global market readiness. For investors, this strategic hire is likely to be interpreted as a move to fortify execution risks and accelerate time-to-market for key assets.

Given his past experience overseeing three gene therapy launches, investors may see this appointment as a credible step toward PepGen’s longer-term goal of securing BLA approvals and possibly building a commercial platform around its EDO technology. Moreover, his tenure at companies that navigated both FDA and EMA pathways adds an additional layer of global market fluency that could support PepGen’s international ambitions.

How Does This Position PepGen for the Next Phase of Its Evolution?

As PepGen continues advancing multiple oligonucleotide candidates in clinical trials, the need for proven leadership in CMC, technical operations, and regulatory navigation becomes increasingly pressing. Dr. Kasraian’s multi-modal background, covering biologics, small molecules, and gene therapies, positions him well to optimize PepGen’s platform across therapeutic classes and geographies.

In a field that is rapidly shifting from laboratory validation to real-world application, biotech firms like PepGen are placing a premium on cross-functional leaders capable of executing at pace, with quality, and within the boundaries of complex global regulatory frameworks. With this appointment, PepGen signals its intention not only to develop transformative therapies—but also to deliver them at scale, with precision and patient impact at the forefront.