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Leveraging Advanced Drug Delivery Systems to Improve Clinical Viability
An Interview with:
- Jerry Williamson, Chief Executive Officer
Advanced therapeutics are expanding faster than the industry's ability to deliver them reliably in vivo. Whether the payload is mRNA, siRNA, plasmid DNA, protein, or a still-emerging next-generation drug product, the same truth applies: the biology may be compelling, but clinical viability depends on delivery.
Phosphorex operates at the intersection of formulation science, process design, and analytical rigor, helping biotech and pharma teams translate promising payloads into delivery systems that perform in animal models, withstand the realities of development, and ultimately move into the clinic. In a recent interview, Phosphorex CEO Jerry Williamson shares his thoughts on the current drug-delivery landscape, why so many programs stall before clinical translation, and where Phosphorex is investing to help change the equation.
Drug delivery has become a defining challenge across modern modalities. Why is it so central to clinical viability?
Jerry Williamson (JW):We're in an era of unprecedented therapeutic innovation, and that's exactly why delivery matters more than ever. Understandably, research and development teams typically primarily focus on the drug molecule itself: the payload, the target, the mechanism. But in practice, a drug isn't a drug until you can administer it in a way that's stable, controlled, effective, and safe.
You can't deliver many of these new modalities “naked.” Nucleic acids are a great example. If you dose a patient with an unprotected mRNA or other oligo-based payload, it's going to be cleared rapidly. Even proteins and other biologics can be fragile, immunogenic, or quickly degraded in vivo. So, drug delivery approaches are the enabling factors that determine whether a therapeutic concept becomes a clinical reality.
In many ways, COVID-19 mRNA vaccines opened the world's eyes to what's possible, but therapeutics introduce a new set of evaluation criteria given the realities of repeat dosing, diverse patient populations, different safety expectations, and often the need to reach tissues beyond the liver. That's why I'm extremely bullish on drug delivery as a dynamic area of the pharmaceutical industry. There is much to learn and innovate, but the upside is enormous, and demand for more effective drug delivery systems is only growing.
How would you describe where Phosphorex fits in the drug delivery ecosystem?
JW:Our expertise is in engineering delivery systems for therapeutic payloads such as mRNA, DNA, siRNA, proteins, peptides, and other therapeutics, using lipid nanoparticles, polymeric nanoparticles, or polymeric microspheres, depending on the application. We're drug-agnostic, meaning we're here to help encapsulate a range of therapeutic payloads, protect them, and deliver them effectively in vivo.
In practical terms, we're strongest in early-to-mid development, building proof-of-concept delivery systems, optimizing particle design, understanding how those systems behave, and preparing them for scale-up and transfer for GMP production. We're fully dedicated to designing clinically relevant delivery processes and working with partners to bridge to GMP production when the program is ready.
Why is it risky to view early-phase formulation and development as “check-the-box” steps just to move into animal studies as quickly as possible?
JW:Imprudent acceleration creates a false sense of progress. If you rush formulation to generate a batch for animal studies, you might achieve the desired response to the therapeutic molecule, but you may also lock in a drug delivery system that isn't feasible for clinical, much less commercial, production.
Clinical viability is not only about promising data from early-phase animal studies, but also about delivering a well-understood, reproducible, scalable drug product to the right tissue with acceptable tolerability.
Many early-phase development teams underestimate how long drug delivery development can take without a well-structured, disciplined approach. Historically, developing micro and nanoparticle delivery systems can take six to twelve months because traditional iteration cycles of build, test in vitro, test in vivo, interpret, adjust, and then repeat can be slow.
The risk is twofold when early-phase programs are poorly designed. First, you waste time generating data that cannot be translated into a clinically viable drug product. Second, you delay the start of creating an effective, scalable drug delivery system that can withstand regulatory scrutiny. To ensure more advanced therapy programs reach the clinic, we must begin designing the delivery system earlier.
What do you see as the most significant technical barriers preventing advanced delivery systems, especially LNPs, from progressing beyond early development?
JW: Two themes are consistently front and center: precision therapeutic targeting and accelerating the development process.
The first is targeted biodistribution. Most systems have a default behavior, and for LNPs, in particular, tend to be routed to clearance organs such as the liver. If your therapeutic target is in the liver, that's helpful. If your target is elsewhere, it becomes a major constraint. The challenge is engineering a delivery vehicle with targeted biodistribution that avoids immediate clearance and instead reaches the tissue of interest.
There are established strategies for this targeting, such as surface modifications, ligand or antibody attachment, tuning chemistry and architecture, and altering particle properties. However, it takes significant expertise to reproducibly design these molecules.
The second theme is speed. Traditional drug delivery development can be slow because each experiment is expensive and sequential. We're investing in approaches that compress timelines, aiming to move from months to weeks by improving how we select and test lipid combinations and by using more sophisticated screening methods to identify formulations and processes most likely to work earlier.
You mentioned the importance of speed and targeted delivery. What is Phosphorex doing to help partners reach those goals faster and more reliably?
JW:We're building the next horizon of best practices for delivery development, especially for teams that don't have the internal infrastructure or time to develop drug delivery strategies through trial and error.
One of our focus areas is improving how micro and nanoparticle delivery systems are screened and selected. In traditional workflows, you might test a handful of lipid combinations and iterate gradually. But the space of possible combinations is enormous, including factors such as lipid selection, ratios, buffer conditions, mixing parameters, and more. We're developing advanced technology-enabled methods to predict and prioritize what's worth testing, and to validate it rapidly.
There's also a broader shift in that fewer development teams want to rely solely on extensive, time-consuming animal testing. It's slow and expensive, and there's also regulatory pressure to be smarter about the use of in vivo studies. So, if we generate more intelligence in silico and well-constructed high-throughput early-phase screening, we can reduce timelines, decrease costs, and improve decision quality.
What clients value most in their relationships with Phosphorex is a combination of technical depth, rigorous analytics, and development experience, along with the assurance that we continually work to improve effectiveness and efficiency.
What are your thoughts about Phosphorex providing GMP manufacturing services in the future?
JW:Because there is presently excess GMP manufacturing capacity that was built to support the tremendous volume needed for COVID-19 vaccine production, we've decided that our opportunity to provide the greatest value to clients is to focus on drug delivery system design, formulation optimization, analytical expertise, process engineering, and CMC.
We are happy to work with a GMP manufacturer of our client's choice, or we have several close relationships with manufacturing partners. Our tested tech transfer playbook allows us to transfer the process seamlessly. Because our team developed the processes and knows them best, we can also support process optimization as the program scales and process troubleshooting.
Closing Thoughts
If there's one message we're working hard to reinforce, it's that drug delivery cannot be an afterthought. The companies that succeed will be those that integrate formulation, process design, and analytical strategy early, so that biodistribution intent and product performance are preserved as programs scale and mature.
Phosphorex is helping many developers leverage LNP, polymeric nanoparticle, and polymeric microspheres to achieve these objectives. We're excited when innovators contact us with exciting programs, no matter how significant the challenge.