The importance of time to market for New Chemical Entities

In the highly competitive pharmaceutical industry, time to market plays a pivotal role in determining the success of a new drug. For new chemical entities (NCEs), rapid development and commercialization can significantly impact patient care and ensure that life-saving therapies reach those in need without unnecessary delays. This blog explores why time to market is crucial in drug development and how strategic partnerships can accelerate this process while maintaining the highest standards of quality and regulatory compliance. Time to market is vital in drug developmentTime to market is a crucial factor in the pharmaceutical industry. The faster a drug can reach the market, the sooner it can provide relief to patients who need it. For NCEs, the importance of reducing time to market becomes even more pronounced, as the need for new treatments is often urgent.Market competition: Getting to market quickly can provide a competitive advantage, especially when addressing unmet medical needs.Patient benefit: For chronic conditions like diabetes, the earlier a treatment is available, the sooner it can improve quality of life and reduce complications. The challenges of bringing NCEs to marketDeveloping NCEs often presents numerous challenges that can delay progress, including complex regulatory requirements, technical hurdles in manufacturing, and the need for extensive clinical trials. However, with the right strategies and partnerships, the following obstacles can be overcome, speeding up the process.Lengthy, multi-phase testing: After 1-2 years of preclinical safety and toxicity studies, clinical trials (Phases I-III) can stretch another 6-8 years, followed by up to 2 years of regulatory review.Rising complexity and attrition: Peptides and oligonucleotides can face stability and bioavailability challenges, which can lead to higher attrition rates during development.Regulatory hurdles: Navigating regulatory approvals can be a time-consuming process. However, efficient documentation and early collaboration with regulatory agencies can help reduce delays.Manufacturing challenges: NCEs often require specialized manufacturing processes that must be developed, tested, and optimized before full-scale production can begin.Currently working on a molecule in clinical trials?Check out our case study on Risk Management in clinical trials!Click hereAccelerating time to market with strategic partnershipsOne of the key factors in reducing time to market for NCEs is forming strong, collaborative partnerships with experienced Contract Development and Manufacturing Organizations (CDMOs) like Bachem. These partnerships ensure that every aspect of drug development, from early-stage research to commercial production, is handled efficiently. Here are some of those benefits:Innovative trial design: Adaptive, precision-medicine and real-world data trials have been shown to increase Phase I-III launch probability by 10-21% compared to traditional designs.AI-driven research: Proactive, cloud-based data management and machine-learning models are fueling growth in candidate molecules entering clinical stages for AI-first biotechs.Expertise and support: CDMOs provide invaluable expertise in optimizing manufacturing processes, streamlining regulatory documentation, and meeting quality standards, all of which contribute to a faster time to market.Collaborative problem-solving: Close collaboration between drug developers and CDMOs enables efficient problem-solving, ensuring that issues are addressed promptly and without compromising on quality. Key benefits of fast time to marketAccelerating the development and approval of NCEs offers several important benefits:Rapid patient access: The sooner a drug is available, the sooner it can help patients, especially in emergency situations or for conditions with limited treatment options.Building trust with regulators: By maintaining a transparent and efficient development process, pharmaceutical companies can build strong relationships with regulatory bodies, facilitating faster approvals.Competitive advantage: A faster time to market enables companies to establish a foothold in the market ahead of competitors, which is critical in a crowded and fast-moving industry. The Bachem advantage in peptide and oligonucleotide manufacturingBachem’s expertise in peptide and oligonucleotide manufacturing and its established track record in bringing complex molecules to market make it an ideal partner for accelerating time to market. With a deep understanding of the peptide and oligonucleotide landscape, demonstrated success across complex development programs and a commitment to maintaining the highest standards, Bachem supports every phase of the development process:End-to-end support: Bachem provides comprehensive support from early research and development through to commercial manufacturing, ensuring efficient progress through every stage.Commitment to quality: Maintaining the highest quality standards throughout the development and manufacturing process is essential to meeting regulatory requirements and ensuring patient safety.For NCEs, time to market is not just about speeding up development – it’s about getting vital therapies into the hands of patients as quickly as possible. By leveraging strategic partnerships, cutting-edge expertise, and a focus on quality, Bachem helps accelerate the path from research to commercialization, ensuring that life-changing treatments are available when they’re needed most. To learn more about how Bachem can support your next program, contact us. The post The importance of time to market for New Chemical Entities appeared first on Bachem.Weiter zum vollständigen Artikel bei Bachem Holding AG Weiter zum vollständigen Artikel bei Bachem Holding AG