The race to first-in-human clinical trials has become more critical than ever for drug developers. The FDA has even developed 4 major tracks to speed up the process and make drugs available to patients as fast as possible:
- Fast Track: Facilitates drug development and expedites the review of drugs designed to treat serious conditions and/or fill an unmet medical need
- Breakthrough Therapy: Expedites the development and review of drugs that may demonstrate substantial improvement over the currently available therapy
- Accelerated Approval: Allows drugs for serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint
- Priority Review: This designation means the FDA’s goal is to take action on an application within 6 months
But as with any race, several factors – redundancy, communication, technology, continuity, etc. – can slow down the process. The increasing complexity of drug substances and the specialization of the manufacturing process haven’t changed the demand for more productive and cost-effective drug products. So, a strategy focused on quality and efficiency is key to winning the marathon to market for new drugs.
To combat these challenges and shorten timelines, biopharmaceutical companies are increasingly outsourcing projects to Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) for everything from drug discovery and development to scale-up and manufacturing. Working with a research organization that can offer an integrated approach from the earliest stages of discovery chemistry to commercial manufacturing helps companies shorten overall development timelines, reduce costs, and navigate complex regulatory hurdles.
Accelerating Timelines with Efficiency
Every company in the life science industry knows that time literally equals money when it comes to developing and commercializing new therapies. Therefore, finding efficiencies and ways to shorten timelines leads to significant cost savings.
Shortened timelines are a priority for both sponsors and the CROs and CDMOs that partner with them. Shortened timelines are especially important for small biotechs and virtual companies as they are continually innovating and are the ones bringing most small molecule drugs into development, but these small organizations often lack the infrastructure and expertise to do one-stop R&D as well as manufacture their compounds. Additionally, they are sometimes limited with funding.
CROs and CDMOs play a critical role in the process, as outsourcing to a reputable organization means that the sponsor can reduce their overall research costs by eliminating any need to invest in expensive equipment or specialized personnel. Single-cell cloning with the Beacon® platform for antibody discovery is an excellent example of this. The cost investment in this technology for a sponsor would be millions of dollars as well as hundreds of hours in staff training as it can be incredibly nuanced work requiring highly specialized work to get it right. However, partnering with an experienced CRO in this technology can save months of time over traditional hybridoma studies while delivering even better results. Those months saved mean a faster track to the market, equating to both potential cost savings for development and increased product revenue. In fact, one study from Tufts found that one-stop sourcing increased revenue by $24.1 million per each approved new drug.
Specialized Expertise and High Caliber QA
CROs and CDMOs are niche specialists in their craft. They hire experts in each stage of development and manufacturing that many biopharmaceutical companies wouldn’t have access to otherwise. This specialized expertise can enhance the quality of the research and the overall success. Additionally, by outsourcing to a qualified CRO, sponsors can focus on their core competencies and reduce the time and resources they would otherwise have to devote to non-core activities.
As the complexity of drug compounds increases, compounds often require specialized processing or enabling technologies. The bioavailability enhancement process is time and cost-intensive because of the expertise needed to improve the pharmacokinetic properties of these compounds. Because of this, many sponsors turn to CROs and outsource these activities to ensure that everything is worked out before Phase I clinical trials. In the recent bioavailability enhancement technologies report by Roots Analysis, they note the shift of focus for drug developers toward the development of lipophilic drug compounds and that this will drive even more outsourced commercial demand for bioavailability enhancement, a CAGR of approximately 10% over the next 13 years.
Additionally, finding a CRO/CDMO who can integrate drug discovery, preclinical development, and manufacturing significantly reduces the timeline to an IND submission as the sponsor reduces their procurement and supplier management requirements, and projects can be seamlessly transferred between CRO/CDMO departments as the drug advances through the pipeline.
Overcoming Manufacturing Hurdles
For biopharmaceutical sponsors looking to streamline, or those with aggressive development timelines, working with a CDMO during the development process is essential. This integrated approach ensures schedules and timelines align, quality control and quality assurance are solid, and it simplifies data sharing, internal technology transfer, and validations. Additionally, by involving the CDMO early in the process, or working with a CRO/CDMO hybrid company, the logistics, administration, communication between facilities, and production scale-up processes are streamlined.
Overall, identifying and circumnavigating challenges in discovery and development with a experienced contract research partner allows biopharmaceutical companies to shorten timelines and recognize potential issues early to mitigate and prevent them from becoming bigger problems in later phases of development. Working with an integrated CRO/CDMO that invests in front-end strategy, optimizes for efficient problem solving, and supports data transparency can save months or years during manufacturing, thus saving potentially millions of dollars.
