Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion, without, for the most part, shorter development timelines. The advancement from drug discovery to personalized medicine has increased the development process' overall complexity. New technology has given us adaptive trial designs; novel drug delivery mechanisms; better understanding and integration of biomarkers, surrogate markers, imaging; and more, all of which are constantly evolving the landscape. Sponsors and CROs have been challenged to change and adapt—forward-thinking CRO/CDMO partners, like Altasciences, have risen to the challenge, and implemented strategies that simplify and accelerate the important work that sponsors do of bringing new drugs to market.
Here are five ways an integrated drug development solution can simplify and accelerate your programs:
1. Fewer Handoffs Shorten Development Timelines
A CRO that can support various phases of drug development means that more of your program can occur in-house. This reduces the number of different service providers involved, which also reduces complexities, mitigates risk, and condensces timelines. Starting at formulation, through to preclinical testing, clinical manufacture, early phase clinical trials, and bioanalysis up to Phase IV, Altasciences' Proactive Drug Development Solution offers an innovative and seamlessly integrated drug development journey, with mulitple points of entry. With early phase drug development centralized and synchronized, Altasciences can reduce research and development timelines by up to 40%. Engaging with an integrated CRO/CDMO saves you time, trouble, and money, as your molecule advances efficiently through the critical preclinical and safety phase to first-in-human trials, and beyond.
2. Adaptive Clinical Trial Designs Improve Speed and Flexibility
Adaptive clinical trial designs allow a sponsor to examine the data as it becomes available, and adjust upcoming activities based on real-time results. In a standard dose escalation study, if early results showed that the dose needed adjustment, or if additional cohorts of participants were required, the design could only be changed with an amendment, as well as regulatory and IRB approval. Adaptive designs, and specifically adaptive language in protocols, allow for these types of changes based on data collected, leading to significant time and cost savings.
3. Integrated Clinical Sites Accelerate Timelines
Well-suited and qualified clinical pharmacology units (CPUs) for early phase trials are getting more expensive to run due to the growing complexity of required clinical procedures, and the precision around participants to be recruited. Altasciences has U.S. and Canadian CPUs with compounding pharmacies, that are integrated with our bioanalytical labs and manufacturing and analytical campus. In fact, one of our bioanalytical laboratories is located within a few minutes' drive of our Montréal CPU, contributing to speedy data acquisition. And integration with our CDMO ensures the clinical trial drug product is available on time.
4. Accurate, Real-Time Data Allows for Rapid Decision-Making
The effective management of all the complex data that goes into a clinical trial has a significant impact on costs and timelines. Many providers of clinical trial services are using advanced technologies, such as electronic sourcedata capture, to provide comprehensive, accurate, real-time data to sponsors, expediting results and allowing for quick and informed decisions. Altasciences leverages a single and easily accessible, CDISC-compliant data source that greatly reduces study start-up costs, and delivers final CSRs in a time- and cost-effective manner.
5. Synchronized Bioanalytical Laboratory Capabilities Facilitate Project Progression
CROs with laboratories and bioanalytical capabilities have the flexibility to adjust their workflows, as well as reserve both instrument and analyst time to meet the needs of their clients. With state-of-the-art instrumentation, method development expertise, and regulatory bioanalysis project oversight, quality assurance personnel, and a highly effective management structure, Altasciences' laboratories facilitate project progression and manage overhead costs. Diversified experience with a wide variety of development programs for both small and large molecules, including cell and gene therapy and vaccines, allows for operational efficiencies to deliver expedited assay validation, sample analysis, and reporting processes.
Having a single partner for all your early phase drug development work, that can streamline the processes, optimize your drug development roadmap, and improve your chances of success, is a major benefit. Altasciences is that partner—contact us today to get started.