Table of Contents
- Five Predictions for the Future of Exploratory INDs in Biologics
- 1. Exploratory development will come to biologics.
- 2. "SmartScale" manufacturing will become a competitive advantage Looking Ahead
- 3. Rare disease will reshape commercial manufacturing.
- 3. Rare disease will reshape commercial manufacturing.
- 4. Technology transfer will become the exception, not the rule.
- 5. Lifecycle CDMOs will emerge as a distinct category.
- Attending BIO International 2026?
The GBI team is excited to be attending BIO International Convention 2026 and connecting with innovators who are shaping the future of biologic medicines. BIO is where groundbreaking science meets the partnerships that bring new therapies to patients. It’s an opportunity to meet emerging biotech companies, established pharmaceutical leaders, investors, and industry experts – all working toward the same goal of advancing human health. It’s also an opportunity to learn, get feedback on new ideas, and understand new trends and anticipated disruptions.
Five Predictions for the Future of Exploratory INDs in Biologics
As we head into BIO on the 20th Anniversary of the publication of the FDA Guidance on “Exploratory IND Studies”, we’ve been thinking about whether the industry is on the verge of reimagining early biologics development. While the FDA’s Exploratory IND Guidance has existed for more than two decades, it has seen limited adoption for biologics. We are starting to see movements.
Here are our predictions:
1. Exploratory development will come to biologics.
Not necessarily through formal Exploratory INDs, but through smaller, risk-based early clinical studies designed to answer critical questions before large CMC investments are made.
2. “SmartScale” manufacturing will become a competitive advantage Looking Ahead
Advances in high-titer cell lines, platform purification, single-use technologies, and rapid analytics mean sponsors no longer need to manufacture every molecule as if it will become a blockbuster.
3. Rare disease will reshape commercial manufacturing.
An increasing number of biologics will reach commercialization serving hundreds—not hundreds of thousands—of patients. Commercial manufacturing will be defined by lifecycle reliability rather than production volume.
3. Rare disease will reshape commercial manufacturing.
An increasing number of biologics will reach commercialization serving hundreds—not hundreds of thousands—of patients. Commercial manufacturing will be defined by lifecycle reliability rather than production volume.
4. Technology transfer will become the exception, not the rule.
The traditional progression from clinical manufacturing to a large commercial facility introduces cost, time, and regulatory risk. Many future biologics will remain on a right-sized manufacturing platform from first GMP material through commercial supply.
5. Lifecycle CDMOs will emerge as a distinct category.
The next generation of CDMOs won’t simply offer development or commercial manufacturing—they’ll provide an integrated path from exploratory development through market launch, reducing transitions, accelerating timelines, and enabling sustainable supply for specialized therapies.
The biologics industry has spent decades optimizing for blockbuster medicines. we believe the next decade will be about optimizing precision medicines, rare diseases, and right-sized manufacturing.
We’d be interested to hear whether others see the same shift—and what conversations you’re expecting at BIO this year.
Attending BIO International 2026?
Click here or visit GBI Biomanufacturing at the Florida Pavilion Booth #1319 to meet our team and discuss emerging industry trends, SmartScale™ GMP Solutions, rapid small-scale production platforms, and how we can help accelerate your path from development to IND and beyond.
Jesse D. McCool, Ph.D., is an operations executive, advisor, and board-level leader with 20+ years of experience scaling regulated manufacturing and mission-critical operations across biotech, CDMOs, and healthcare. He has held senior leadership roles at Lonza Group, Cytovance Biologics, Wheeler Bio, Bionova Scientific, and Our Blood Institute leading greenfield and brownfield facility start-ups and scale-ups and driving operational transformation. His background spans plasmid DNA manufacturing, monoclonal antibody development and production, and viral vector–enabled advanced therapy supply chains, with strengths in quality systems, tech transfer, and process validation. Jesse is known for disciplined operating rhythms, KPI-driven management, and culture-building that improves performance and customer experience. He earned his Ph.D. from the University of Massachusetts Amherst and completed postdoctoral studies at Dartmouth and TU Delft.
