How to save six months from your early clinical development plan
How an integrated approach to development and manufacturing reduces costs and accelerates timelines.
Pharmaceutical R&D continues to grow significantly year-on-year with increasing numbers of pharma companies and therapeutic molecules in development. According to the Pharmaprojects Pharma R&D Annual Review 2018, this expansion has been concentrated in Phases I and II more so than in late-phase development with over 2,000 new therapeutic molecules entering clinical research in 2018. To address this growing need, Translational Pharmaceutics®, an integrated formulation development, real-time adaptive manufacturing, and clinical testing platform, has been proven to accelerate timelines and reduce costs in early drug development. This innovative approach helps drug developers reach proof-of-concept (PoC) milestones as quickly and efficiently as possible and accelerate the development of optimized and scalable drug products.
Limitations of traditional outsourcing
Despite increases in spending, the industry struggles with poor R&D productivity. Outsourcing has become more siloed, with separate vendors focusing solely on discovery chemistry, discovery biology, preclinical toxicology and safety, clinical testing, or formulation development and manufacturing.
In the conventional outsourcing approach, the developer engages with multiple vendors, creating both a management burden and gaps in the development timeline. The contract development & manufacturing organization (CDMO) and the contract research organization (CRO) operate in separate worlds, with limited shared knowledge and no operational synergy between vendors, making it difficult for the pharma company to build efficiencies into the drug development process.
An innovative approach
The early stages of drug development have been proven to be amenable to an integrated platform that ties together formulation development, real-time adaptive manufacturing and clinical testing.
Integration of the “make” and “test” supply chains allow drug products to be manufactured to GMP within days of dosing, rather than weeks or months when using conventional processes. By using 14-day “make-test” cycles, a drug product is manufactured and dosed, clinical data are generated (for example safety, pharmacokinetic, pharmacodynamic or biomarker), and then a decision is made on how to modify the drug product, formulation composition or dosage strength for the next study period.
- reach proof-of-concept (PoC) milestones as quickly and efficiently as possible
- accelerate the development of optimized and scalable drug products
Benefits of an integrated platform
Implementing a Translational Pharmaceutics® approach can trim six months or more from a typical drug development timeline. As well as immediate cost savings in early development, for a drug product forecasted to generate $500 million to $1 billion in annual revenue, such efficiencies can increase future revenue potential by millions of dollars per day.
In addition, given that Translational Pharmaceutics® enables development decisions to be made on the basis of clinical data rather than surrogate in vitro or preclinical data, the program maximizes the potential for success, avoiding the time and cost of potentially repeating multiple rounds of development cycles.
Drug developers also reap direct cost savings from a significant reduction in the amount of drug product that must be manufactured and the amount of drug substance (API) used in a trial. Large CDMOs typically insist on larger than required minimum batch sizes for drug product manufacturing; however, a highly flexible and adaptive manufacturing approach tailored to the clinical trial can reduce API consumption by >85%. That is a significant advantage in early development where API is produced at a small scale and must be carefully rationed to cover a plethora of activities.
When a sponsor outsources all these functions to a single partner that offers these capabilities under a single project manager, an integrated early development program can significantly ease the sponsor’s management burden, as well as the contracting responsibilities. This can have tremendous benefits to small biotech companies with limited resources, but also to large pharma companies that can divert their resources to other molecules in their pipeline.
How pharma and biotech companies are applying Translational Pharmaceutics®
You can read a number of case studies providing examples of how our integrated programs have overcome early drug development challenges, such as the optimization of new formulations and the development of scalable drug products, and have helped pharma companies efficiently reach PoC milestones.