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® helps accelerate timelines and reduce costs in drug development. This innovative approach helps drug developers reach milestones quickly and efficiently for first-in-human studies, drug product optimization, and integrated ADME programs.
Limitations of traditional outsourcing models
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.
Applying an innovative approach to drug development
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 allows 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.
Our CDMO and CRO integration helps drug developers:
- reach proof-of-concept (PoC) milestones as quickly and efficiently as possible
- accelerate the development of optimized and scalable drug products
How pharmaceutical companies can apply Translational Pharmaceutics®
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 Translational Pharmaceutics® enables development decisions to be made based on 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.
Large CDMOs typically insist on larger than required minimum batch sizes for drug product manufacturing; however, a 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 numerous activities.
Outsourcing these functions to a single partner that offers integrated capabilities as a single program of work, managed by a dedicated project manager, can significantly ease a sponsor’s management burden and contracting responsibilities.
Read case studies providing examples of how Translational Pharmaceutics® integrated programs have helped both small biotechs and large pharma clients alike overcome development challenges.