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Global Trial Accelerators™
Global Trial Accelerators™
Accelerate Your Path from First-in-Human to Exit Hosted by Jesús E. Moreno (Business Development Director, bioaccess®), Global Trial Accelerators™ is the only podcast for healthcare startup founders and innovators navigating first-in-human (FIH) clinical trials. The show is produced by bioaccess® and was founded by Co-Founder & CEO Julio G. Martinez-Clark. bioaccess® is a CRO purpose-built for first-in-human (FIH) trials — serving MedTech, Biopharma, and Radiopharma startups. This podcast delivers strategies, regulatory insights, and founder stories to get your technology into humans faster and affordably, with data designed to support FDA and EMA submissions. Each episode features candid conversations with clinical trial pioneers, regulatory strategists, and founders who've compressed timelines, reduced costs, and generated the clinical evidence investors demand — by leveraging Latin America's clinical research infrastructure. What You'll Learn: - Regulatory pathways across 10+ Latin American countries (Colombia, Mexico, Brazil, Chile, Argentina, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay) - Why ethics approval in 4-8 weeks (vs. 6-12 months in US/EU) changes the game for startups - Strategies to generate FIH data that unlocks your next funding round or acquisition - The Innovation Runway: from prototype to clinical milestones before capital runs out - Case studies from 58+ companies — seed-stage startups to Fortune 500 MedTech - Decentralized trials, AI-driven recruitment, and post-trial commercialization "bioaccess® compressed our timeline by 9 months vs. our US plan. This podcast is why we partnered with them." – Digital Health Startup CEO New episodes weekly. Subscribe to unlock your shortcut from first-in-human to exit. Brought to you by bioaccess® — an FIH-dedicated CRO for healthcare startups. Faster timelines, lower costs. Since 2010.
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Aug. 7, 2025

Sarfaraz Niazi Professor, Pharmaceutical Sciences

Today’s guest is Dr. Sarfaraz K. Niazi, a globally recognized biopharmaceutical scientist, regulatory advisor, prolific author, and inventor. Dr. Niazi works closely with regulatory authorities to streamline guidelines and help companies comply in bringing biotherapeutic products to market—including biosimilars, gene therapies, mRNA vaccines, and advanced protein delivery systems. He has published hundreds of books and scientific papers, sharing both the science and the a...

Today’s guest is Dr. Sarfaraz K. Niazi, a globally recognized biopharmaceutical scientist, regulatory advisor, prolific author, and inventor. Dr. Niazi works closely with regulatory authorities to streamline guidelines and help companies comply in bringing biotherapeutic products to market—including biosimilars, gene therapies, mRNA vaccines, and advanced protein delivery systems.

He has published hundreds of books and scientific papers, sharing both the science and the art of making life-saving treatments accessible to patients. With over 100 U.S. biotechnology patents—all offered royalty-free—Dr. Niazi is a true advocate for innovation and global health equity.

Sarfaraz K. Niazi Profile Photo

Author/Professor/CEO

# Sarfaraz K. Niazi: A Trailblazer in Biosimilars and Biopharmaceuticals

## **Biography**

Dr. Sarfaraz K. Niazi is a distinguished pharmaceutical scientist, entrepreneur, and inventor who has revolutionized the biosimilar industry and established himself as one of the most influential figures in biopharmaceutical development. Born on July 10, 1949, in Lucknow, India, Niazi's journey from a pharmacy student to a globally recognized expert demonstrates his exceptional commitment to making life-saving medications accessible worldwide.

## **Educational Foundation**

Niazi's academic journey began at the University of Karachi, where he earned his Bachelor of Science degree in pharmacy in 1969. Following his family's migration to the United States in 1970, he pursued advanced studies at Washington State University, obtaining his Master of Science degree in pharmaceutical sciences in 1971. He completed his doctorate in pharmaceutical sciences at the University of Illinois at Chicago in 1974, establishing the foundation for his groundbreaking career.

## **Career Highlights**

### **Academic Excellence**
From 1972 to 1988, Niazi served as faculty at the University of Illinois at Chicago College of Pharmacy, progressing from instructor to tenured associate professor. He currently holds adjunct professor positions at both the University of Illinois and the University of Houston, continuing to share his expertise with the next generation of pharmaceutical scientists.

### **Industry Leadership**
Niazi's … Read More

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Understanding Biosimilars: A Guide with Dr. Sarfaraz Niazi

Welcome to an in-depth exploration of biosimilars, a crucial area within modern medicine. In this blog post, we delve into the world of these biotherapeutic products, exploring their science, regulation, and profound impact on making life-saving tre…