Accelerating Time to Market for New Chemical Entities Through Strategic CDMO Collaboration

Bubendorf, Switzerland – Bachem has published a new thought leadership article examining why time to market is a critical success factor in New Chemical Entity (NCE) development and how strategic CDMO partnerships can help streamline this process without compromising quality or regulatory compliance.

Bringing an NCE to market is a complex, time-intensive process. Preclinical studies typically require one to two years, followed by Phase I–III clinical trials that can extend for six to eight years. Regulatory review may add a further two years. For peptide- and oligonucleotide-based therapies in particular, challenges related to stability, bioavailability, and manufacturing complexity can further increase development risk and attrition rates.

Strategic CDMO Collaboration as a Time-to-Market Lever

Against this backdrop, reducing time to market requires more than simply accelerating individual milestones. Instead, integrated development strategies and early collaboration with experienced partners can significantly improve efficiency across the entire lifecycle—from research and clinical development to commercial-scale manufacturing.

According to Bachem’s analysis, strategic partnerships with specialized Contract Development and Manufacturing Organizations (CDMOs) help ensure continuity between development stages, minimize technology transfer risks, and align manufacturing processes with regulatory expectations from the outset. Early process optimization, robust documentation practices, and proactive regulatory engagement can reduce delays during clinical transitions and submission reviews.

From Discovery to Commercialization: Rethinking NCE Development Timelines

Emerging approaches such as adaptive clinical trial design, patient-centric development strategies, and digital data platforms are also contributing to more efficient development pathways. For sponsors working with complex modalities such as peptides and oligonucleotides, access to deep technical expertise and scalable manufacturing capabilities is increasingly important.

With more than 50 years of experience in peptide and oligonucleotide development and production, Bachem supports NCE programs from early research through GMP-compliant commercial supply. By combining technical expertise, quality-focused manufacturing, and collaborative project management, the company aims to help sponsors accelerate development timelines while maintaining regulatory alignment.

As the pharmaceutical landscape grows more competitive, the ability to shorten development cycles without compromising safety or compliance remains a decisive advantage. For NCE developers, strategic collaboration is emerging as a key lever in bringing innovative therapies to patients more efficiently.

About Bachem

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With more than 50 years of experience, the company provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.

Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.

For further information, see www.bachem.com

Resources

Go to The Importance of Time to Market for New Chemical Entities to read full article.
See Risk Management in Clinical Trials: A Case Study in API Production to learn more.
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