From Phase 1 Screening to Commercial Strategy
As increasingly complex, poorly water-soluble molecules enter development, choosing an amorphous solid dispersion (ASD) technology based only on near-term needs can create costly challenges later. This overview examines why leading approaches, including spray drying, hot-melt extrusion, co-precipitation, and KinetiSol™, should be evaluated early and on a drug-specific basis. Through comprehensive screening, optimization, biopharmaceutical analysis, and…
Read MoreAustinPx Capabilities Overview
Join Dave Miller, Chief Scientific Officer at AustinPx, for an overview of the company’s integrated formulation development, analytical, and clinical manufacturing capabilities for complex oral drug programs. The webinar explores AustinPx’s data-driven approach to preformulation, bioavailability enhancement, dosage form development, and speed-to-clinic manufacturing, including its broad ASD technology toolkit and proprietary KinetiSol™ Technology. Real client…
Read MoreAmorphous Solid Dispersions: Development Trends, Challenges and the Future
The pharmaceutical industry is pushing the boundaries of the chemical drug space in search of new and more effective compounds. However, many of these new molecules have properties that make them difficult to develop, including challenging physiochemical characteristics. As a result, the number of poorly soluble drugs in the pipeline is increasing, and there is…
Read MoreDe-Risking Development: Guiding Formulation Strategy with MacroFlux to Predict Human Outcomes of KinetiSol-Processed Etravirine
KinetiSol™ Technology enables formulation of poorly soluble compounds, but predicting human performance remains a key challenge in early development. In this session, Daniel Davis, Ph.D. (Director of Business Development, AustinPx), presents a case study on developing a generic equivalent for Intelence (Etravirine) using MacroFlux™ to establish in-vitro/in-vivo correlation and optimize formulation strategy. By linking dissolution…
Read MoreAustinPx Live Episode 2: Navigating Complexity: Tailored Analytical & Preclinical Services
Originally aired on August 19th, 2025 In the second session of AustinPx Live, Chief Scientific Officer, Dave Miller, Ph.D., will share how AustinPx designs data-driven, early-phase strategies to solve complex drug development challenges. He’ll highlight our tailored analytical services, preclinical expertise, and how they connect with our broader CDMO model. This 30-minute session includes a…
Read MoreAustinPx Live Episode 3: From Molecule to Milestone: Fast-Track Formulation
Originally aired on September 25th, 2025 Watch the third session in our AustinPx Live series! Chief Scientific Officer, Dave Miller, Ph.D., will share how AustinPx approaches conventional formulation to accelerate First-in-Human studies without sacrificing scientific rigor. He’ll highlight how our expertise in powder-in-capsule dosing, phase-appropriate analytical support, and early manufacturability considerations helps sponsors navigate tight…
Read MoreAustinPx Live Episode 4: From Brick Dust to Breakthrough: The Power of Enabled Formulation
Originally aired on October 22nd, 2025 Join us for our fourth episode of AustinPx Live where Chief Scientific Officer, Dave Miller, Ph.D., will share how AustinPx uses enabling formulation strategies to advance molecules once considered too complex to develop. He’ll highlight how our expertise with KinetiSol™, polymer and excipient screening, and biopharm-guided design-of-experiments creates formulations…
Read MoreAustinPx Live Episode 5: Re-thinking ASD Development: When Your Molecule Breaks the Rules
Originally aired on January 22nd, 2026 Chief Scientific Officer, Dave Miller, Ph.D., will explore how KinetiSol™ is reshaping the design space for amorphous solid dispersions (ASDs). He’ll break down how our solvent-free platform enables rapid screening, broader excipient use, and higher-performing formulations compared to conventional technologies like spray drying or HME. The session will also…
Read MoreAustinPx Live Episode 6: Re-thinking ASD Development: Designing for Scale from Day One
Originally aired on March 18th, 2026 Chief Technology Officer, Chris Brough, Ph.D., will lead a discussion on what it takes to successfully scale amorphous solid dispersions from early development into manufacturing. He will explore common scale-up challenges across ASD technologies, the data and decisions that matter most as programs move toward GMP, and how early…
Read MorePushing the Boundaries of Drug Development: Is Lipinski’s Rule of Five Still Relevant?
Dave Miller, Ph.D., CSO of AustinPx, challenges the continued relevance of Lipinski’s Rule of Five (Ro5) in today’s pharmaceutical landscape. As technologies like AI and in-silico modeling reshape drug discovery, modern compounds often deviate from Ro5 guidelines yet demonstrate significant therapeutic potential. However, these nonconforming molecules can face hurdles in development due to solubility and…
Read MoreFormulation Strategies for Enabling “Undevelopable” Compounds (Poster)
Many modern drug candidates fall outside traditional guidelines like Lipinski’s Rule of Five, making them difficult to formulate with conventional technologies. This poster, presented by Dave Miller at DDC (2025) and the PECK Symposium (2025), highlights how KinetiSol™ was used to formulate a poorly soluble compound with multiple developability challenges—including high dose, poor solubility, and low…
Read MoreWinning Strategies For Oral Dosage Form Development And Manufacturing
In a recent article, Dave Miller, CSO of AustinPx, highlights KinetiSol Technology as a superior alternative to spray drying for amorphous solid dispersions (ASDs). Failure to identify a compound’s red flags—bioavailability, stability, processability, etc.—early in development often manifests as program delays or failures. These setbacks can be avoided through complete molecular characterization, which can de-risk development and…
Read MoreChoosing the Best Amorphous Dispersion Path Before It Costs You
AustinPx examines why early amorphous solid dispersion (ASD) technology selection can have a major impact on cost, timelines, and long-term product value. As more oral small molecules face poor solubility, low exposure, food effect risk, and dose form challenges, a single technology screen may not provide enough information to choose the strongest development path. The…
Read MorePartnerships To Be Precise
Elizabeth Hickman (CEO, AustinPx) and Dave Miller (CSO, AustinPx) examine how the rise of precision medicine is reshaping the role of CDMOs. As drug developers take on increasingly complex, patient-targeted therapies, formulation strategies must evolve to meet the moment. From multi-component ASDs to lipid-based delivery systems, CDMOs must now deliver tailored solutions that match each…
Read MorePrecision Without a Playbook: How Agile CDMOs Enable Personalised Drug Development
In this article, Elizabeth Hickman (CEO, AustinPx) and Dave Miller (CSO, AustinPx) discuss how as precision medicine becomes the new standard, traditional development models are falling short. This article highlights the challenges of formulating and manufacturing personalised therapies, from poor solubility and stability issues to the growing need for patient-friendly dosage forms. Agile CDMOs are…
Read MoreFrom Disruption to Reinvention: The Story of API-in-Capsule Technology and Its Future
This article traces the evolution of API-in-capsule (AIC) technology, from its early disruption of traditional formulation through the Xcelodose® system, to its reinvention in 3P innovation’s Fill2Weight platform. The authors explore how AIC has shifted from a risky bet to a scalable solution for modern drug development. Looking ahead, they highlight the transformative role AIC…
Read MorePushing the Boundaries: Overcoming Formulation and Manufacturing Challenges (eBook w/ Pharmaceutical Technology)
Winning Strategies For Oral Dosage Form Development and Manufacturing. An eBook in partnership with Pharmaceutical Technology. Oral solid dose (OSD) formulation development must adhere to common considerations, such as project timelines, facilitating CDMO/client transparency and overcoming regulatory challenges. However, development’s difficulty often is compounded by numerous factors such as API supply constraints, challenging physiochemical properties,…
Read MoreCollaborative Innovation in CDMOs: Interview Series with Pharmaceutical Technology (5-part)
This 5-part Pharmaceutical Technology interview series with Dave Miller, Ph.D., CSO of AustinPx, explores how the role of CDMOs is evolving from transactional service providers to true co-developers. Across the series, Dave shares insights on early engagement strategies, protecting and leveraging intellectual property, and applying advanced formulation tools like KinetiSol to solve complex drug delivery challenges. Each…
Read MoreAI Might Find the Molecule, but Delivery Decides Whether it Becomes a Medicine
In this article, AustinPx Chief Scientific Officer Dave Miller examines how the rapid expansion of AI-enabled drug discovery is reshaping the pharmaceutical pipeline. While advanced computational tools can now identify and optimize candidate molecules at unprecedented speed, many of these compounds present significant challenges once they transition from virtual design into experimental development. Issues such…
Read MoreSolving the Problem of Insolubility: The Medicine Maker Interview Series (3-part)
In this three-part interview series with The Medicine Maker, AustinPx CEO Elizabeth Hickman and CSO Dave Miller examine the growing challenge of poorly soluble drug candidates and what it means for modern drug development. As advances in AI-driven discovery, structure-based design, and in silico screening unlock increasingly complex molecules, formulation and manufacturing strategies must evolve to…
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