Many pharma companies are seeking new ways of making drug development more efficient and cost-effective through innovation, new technologies and process evolution. This has led to an increase in the outsourcing of development activities to contract research partners who focus solely on disciplines such as discovery chemistry, clinical testing, and formulation development and manufacturing. This in turn has created a siloed approach to drug development where there is a distinct lack of communication and interaction between the multiple vendors working on a particular drug molecule. For example, the Contract Development & Manufacturing Organization (CDMO) who is making the drug product, will seldom talk to the Clinical Research Organization (CRO) who is actually designing and performing the clinical trial.
This webinar explains the benefits of Translational Pharmaceutics, a unique approach which integrates formulation development, real-time adaptive GMP manufacturing and clinical research. The webinar will illustrate how, by breaking down the siloes and integrating horizontally, we can operate with more flexibility in the early phases of drug development, reducing costs and shortening timelines.
In addition, it will describe a different approach to drug product manufacturing, called “real-time adaptive manufacturing” and how it can help adapt to clinical trial requirements quickly and manufacture on demand the precise drug product required. The webinar will describe ways of maximizing flexibility around batch size, scale and product stability, whilst being truly responsive or “on demand” to the clinical trial requirements and the timing of product supply to any selected site, in response to emerging clinical data, or patient recruitment.
Key Learning Objectives
- Discover how an integrated approach enables a quick transition of molecules from first-in-human to POC;
- Understand how drug product formulations and doses can be adjusted and manufactured "real-time", often in response to emerging human data;
- Learn how to save valuable API, through significant reductions in the amount of drug product manufactured;
- Discover how to adapt to clinical trial requirements quickly and manufacture only the product your patients need;
- Hear how this integrated approach can accelerate your drug development timeline.
Listen to case studies which cover
- Re-engineering the first-in-human program for improved efficiency and flexibility;
- Screening of formulation systems using clinical data with a focus on poorly soluble molecules;
- The use of pharmaceutical design spaces and bracketing strategies to optimize formulations with increased precision and potential for success;
- Real-time adaptive manufacturing to make product on-demand, and only the product required to meet the needs of the clinical trial.