Newsletter | July 28, 2025

07.28.25 -- FDA Trials And Tribulations With Connect Biopharma's Barry Quart

SPONSOR

 

Mark your calendar for BioFuture™ 2025!

BioFuture returns to New York City this October, bringing together pioneers, investors, and decision-makers who are redefining the future of medicine. This year’s summit will focus on the convergence of biopharma, digital medicine, big data, and TechBio. With 600+ attendees, 100+ speakers, and 80+ presenting companies. Learn more and register.

FEATURED PODCAST

FDA Trials And Tribulations With Connect Biopharma's Barry Quart

On this week's episode of the Business of Biotech, Barry Quart, CEO of Connect Biopharma, weighs in on the current state of engagement between drug developers and the FDA, and how that key relationship continues to evolve under new leadership. Barry also discusses moving the company from China to San Diego, why a U.S. financial reporting structure helps attract investors, and how Connect is finding the white spaces in respiratory disease -- the company's lead candidate is a biologic drug targeting acute asthma and COPD exacerbations.

 

INDUSTRY INSIGHTS

 

HTA In Japan: The Glass Remains Half Full (For Now)

While Japan's current HTA system is seen as pro-innovation, potential reforms in 2026 could expand its scope, creating uncertainty for manufacturers in one of the world's largest markets.

 

Harnessing Predictive Modeling To Overcome Trial Enrollment Challenges

By shifting from reactive problem-solving to proactive planning, predictive intelligence ensures clinical trials meet their enrollment goals more efficiently.

 

Scope 3 Emissions: A Shared Challenge, A Collective Responsibility

Despite growing sustainability efforts, our industry lags in climate goals, especially Scope 3 emissions. Discover why bold action and deep collaboration across the value chain are essential for real progress.

 

De-Risking Development With Analytical Characterization Capabilities

Review the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver medicines in a safe, compliant, and efficient manner.

 

Creating Inclusive Clinical Trials

Increasing clinical trial diversity requires community engagement, simplified trial information, and collaboration to build trust and create accessible pathways for patient participation.

 

What Is Direct-To-Patient Clinical Trial Recruitment?

What is the direct-to-patient (DtP) recruitment, and how can sponsors and organizers leverage this approach to boost patient recruitment and achieve clinical trial goals?