How Personalized Formulation Is Redefining Precision Medicine
For most of the pharmaceutical industry’s modern history, drugs were developed with large populations in mind. The objective was simple: create treatments that worked well enough for most people, most of the time. While that model produced tremendous public health advances, it often failed to meet the specific needs of smaller, more complex patient groups. Today, that’s changing.
Precision medicine, tailoring therapies to defined subgroups based on genetics, physiology, or lifestyle, is ushering in a new era of drug development. The goal is no longer “good enough for the average patient,” but “just right for this patient.” With this philosophical shift comes a new set of scientific and manufacturing challenges, especially as small molecule developers work with molecules that defy traditional assumptions around solubility, bioavailability, and manufacturability.
This is where formulation becomes mission-critical, and a new kind of outsourcing partnership between biotech and contract development and manufacturing organization (CDMO) is emerging to meet the moment.
Formulation Must Catch Up to Discovery
Precision medicine is no longer a fringe trend; it’s becoming the standard. Over the past nine years, precision medicines have accounted for at least a quarter of all new drug approvals, and experts predict this tailored approach will drive the next generation of healthcare by 2030. However, while discovery has rapidly advanced by identifying new targets and designing therapies for narrower patient populations, formulation science has struggled to keep up.
According to pharmaceutical industry screening programs, approximately 40% of new chemical entities (NCEs) face challenges during formulation and development. It’s one thing to engineer a drug that binds to a specific protein – it’s another to convert that compound into a product that can be reliably delivered, absorbed, and manufactured at scale.
Today’s molecules have become more chemically and structurally complex, often falling outside the traditional parameters of conventional formulation. Nearly 40% of approved drugs and 90% of pipeline drugs are poorly water-soluble, have low permeability, or possess challenging pharmacokinetics. These compounds are not “undruggable” where their biological potential is clear, but they’re often classified as “undevelopable” due to limitations in standard manufacturing processes like spray drying or melt extrusion.
Precision medicine requires more than targeted science. It needs formulation strategies as individualized as the therapies themselves – custom-built to support a molecule’s performance, route of administration, and the patient’s real-world needs.
From Vendor to Strategic Partner
Precision medicine starts with precision partnerships. Drug sponsors navigating the complexity of personalized development need more than transactional CDMOs. They need proactive partners who can think strategically, solve problems collaboratively, and tailor formulations to match the molecules’ and the market’s demands.
Smaller CDMOs are often best equipped to meet this need. Their flatter organizational structures and cross-functional teams make them more agile, responsive, and better able to integrate strategic expertise relating to the scalability and manufacturability of the molecule. This early-stage integration helps prevent common missteps that can delay timelines or escalate costs, especially in accelerated development programs.
Smaller CDMOs also uniquely combine scientific specialization and operational agility, enabling more flexible, targeted approaches. With personalized strategies built in from the start, they help developers reach clinically viable formulations earlier in the process. This includes making informed, targeted recommendations; evaluating risks across time, cost, and scalability; and proactively addressing potential setbacks before they become bottlenecks.
Partners that can offer value-added dosage forms — those that improve clinical potency, reduce development hurdles, and enhance marketability — are essential in bringing precision therapies to life. Beyond formulation, advanced in-house technologies such as next-generation ASD platforms, omics-based tools, and biomarker integration give developers a broader design space and more meaningful levers for customization.
Personalization Isn’t Just About the Drug — It’s About the Experience
Personalized medicine doesn’t stop at targeting biology. It must also address how patients interact with the treatment. Patient experience is essential for long-term adherence, tolerability, and therapeutic success.
This means the format and delivery of the drug matters. For example, orodispersible tablets can help patients with dysphagia, controlled-release dosage forms support better compliance for chronic conditions, and pediatric and geriatric populations may require mini-tablets or liquids to accommodate swallowing difficulties or dosing flexibility.
Formulation is the bridge between molecule and patient. When CDMOs integrate human-centric design into the technical development process, the result is not just a pharmacologically active drug; it’s one that patients can and will take.
Technology as a Competitive Advantage
Traditional binary amorphous solid dispersions were once considered advanced, but today’s molecules often demand more. Sophisticated, multi-component formulations that incorporate wetting agents, stabilizers, and a broader excipient library can unlock solubility and stability profiles once thought impossible.
Some of the most advanced platforms allow scientists to move beyond the rigid limitations of solvent-based or melt-extrudable systems. Instead of forcing molecules into existing boxes, these technologies open a wide formulation design space, enabling true customization. The difference is like painting with a 12-color palette vs. a four-color palette. A broader selection leads to a more detailed and specific result.
This customization also creates a strategic benefit: exclusivity. Highly tailored delivery systems produce formulations almost impossible for generics to reverse-engineer, even after patent expiration. When traditional IP protections weaken, formulation extends product defensibility and market differentiation long beyond the molecule’s patent life.
What’s Next: Expanding Access to Precision Platforms
One exciting development is the emergence of leasing models that allow larger pharmaceutical companies to bring advanced formulation tools in-house. Rather than outsourcing all development, these organizations can license specialized equipment and platforms to support precision formulation internally. This hybrid model balances control and capability, allowing for faster, more customized development without the scale limitations of traditional methods.
As personalized medicine matures, the drug development process must evolve alongside it. That means rethinking the capabilities of CDMOs, elevating the role of outsourcing, and prioritizing technologies that enable tailored formulations.
The future of pharma will not be shaped by the biggest players with the largest facilities. It will be defined by those with the agility to respond fastest to the molecule and to the patient. Precision medicine demands precision formulation, and precision formulation requires partnerships built not on volume but on vision and collaboration.
Elizabeth Hickman
Elizabeth Hickman serves as Chief Executive Officer at AustinPx, a leading contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement of orally delivered small molecule drug candidates. Elizabeth brings over two decades of expertise in the biotech and pharmaceutical sectors, formerly serving in leadership positions for West Pharmaceutical Services, Catalent, and Pii. Elizabeth holds a BA in Microbiology from The University of Texas at Austin and an MBA in Marketing from San Diego State University.
Dr. Dave Miller
Dr. Dave Miller currently serves as the Chief Scientific Officer at AustinPx, where he leads their pharmaceutics and analytical development teams and oversees the application of the KinetiSol™ Technology, which he co-invented. Dr. Miller specializes in formulation and processing technologies for improving the oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through all stages of development, from early discovery to line extensions, and he has published over 40 research articles in peer-reviewed journals, authored 8 book chapters, and is co-editor of the First, Second, and Third Editions of the textbook, “Formulating Poorly Water-Soluble Drugs.” Dr. Miller holds a B.S. in Chemical Engineering and a Ph.D. in Pharmaceutics from the University of Texas at Austin.
