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Phase Advance and QNova Capital Forge Alliance to Usher in AI-Driven, Non-Animal Drug Development Era

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Phase Advance

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QNova Capital

Predictive AI modeling startup and biotech-focused venture fund unite to accelerate next-generation therapeutics and reshape the FDA regulatory path.

Together with QNova, we’re using AI to help companies and regulators move beyond animal models toward a faster, smarter, and more human-centered future of drug development.”
— Dr. Tawanda Gumbo

SAN DIEGO, CA, UNITED STATES, October 16, 2025 /EINPresswire.com/ -- Phase Advance, a pioneering AI company capable of predicting drug performance through Phase 3 clinical outcomes for new therapeutics with only their discovery details, has entered a strategic alliance with QNova Capital, the new venture fund of QNova LifeSciences. Together, they aim to transform how therapies are selected, evaluated, and advanced, marking a turning point for an industry seeking to reduce dependence on animal models and dramatically lower regulatory risk.

The FDA is calling for a transition toward New Approach Methodologies (NAMs), innovative, non-animal testing tools that use computational and AI-based modeling to improve how human safety and efficacy are predicted. Phase Advance’s breakthrough predictive modeling platform embodies this vision, offering a validated, AI-driven alternative that can forecast therapeutic outcomes before any human trial begins.

For QNova Capital and QNova LifeSciences, which has experience with more than 500 drugs and biologics over the past three decades, this alliance represents both continuity and transformation. The partnership will leverage Phase Advance’s AI to identify the most promising drug candidates earlier, while reducing cost, uncertainty, and risk throughout the regulatory journey.

“I’ve spent my career navigating some of the most complex regulatory environments in biotech,” said Jim Sergi, President of QNova LifeSciences and partner in QNova Capital. “With Phase Advance, we’re not just improving how companies navigate that process, we’re helping accelerate the FDA’s evolution toward more predictive, AI-driven methodologies that will define the future of drug development itself.”

“This partnership isn’t just about better predictions, it’s about transforming what’s possible,” said Dr. Tawanda Gumbo, CEO and Co-founder of Phase Advance. “Together with QNova, we’re using AI to help companies and regulators move beyond animal models toward a faster, smarter, and more human-centered future of drug development.”

“Our investment process already leverages decades of scientific and regulatory insight to de-risk early-stage opportunities,” said John Stanton, Managing Partner of QNova Capital. “Phase Advance extends that advantage by giving us unprecedented visibility into regulatory outcomes, allowing us to pick winners and invest in the next generation of breakthrough companies.”

Phase Advance’s technology is already demonstrating > 99% accuracy in predicting Phase 3 outcomes based on minimal inputs, a milestone that positions it as one of the most credible and powerful tools in the new field of New Approach Methodologies (NAMs). As the FDA and global regulators move to validate non-animal testing frameworks, this alliance establishes Phase Advance and QNova Capital as frontrunners in defining the AI-driven regulatory future.

The partnership’s goal goes beyond investment returns, it represents a shared mission to modernize the regulatory model for how therapies reach patients, to make drug development faster, safer, and more predictive.

About Phase Advance
Phase Advance is a Dallas, Texas-based company co-founded by physician-scientist Dr. Tawanda Gumbo after several years developing and testing predictive models of lifetime disease progression. The company’s platform predicts patient-level clinical response rates, optimal doses, biomarker performance, and overall therapeutic success — all before the preclinical stage. Clients include pharma companies, CROs, venture investors, and AI-driven drug discovery firms.

About QNova Capital
QNova Capital is a biotechnology-focused venture fund backed by QNova LifeSciences, a leading clinical research and regulatory organization with 30 years’ experience on over 500 drug and biologic development programs. QNova Capital invests in breakthrough life science technologies that reduce regulatory risk, accelerate development timelines, and improve patient outcomes.

Rachael Sparks
Phase Advance
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