Join us on November 17 for our webinar entitled, "Drug selection and candidate development: Getting it right early - Integrated programs to efficiently bridge molecules from discovery to clinic"
Early characterization of new chemical entities (NCE) is critical to selecting the most appropriate drug substance form and formulation(s) to be used in non-clinical and clinical studies. Given the multitude of activities, functions and companies involved in taking a molecule from discovery to clinic, the process is understandably lengthy, costly, and fraught with risk.
As biotech and pharma companies continue to rely more on outsourcing to discovery and development partners, the service sector has concurrently become more fragmented with some contract research partners focusing solely on discovery chemistry, with other companies focusing on solely on product development and others on clinical testing. This in turn has created a siloed approach to drug development where there is a distinct lack of communication and interaction between the groups working on a particular drug molecule.
This webinar explains the benefits of adopting a holistic approach at the candidate selection-development interface. The tight integration of the drug substance, biopharmaceutics and drug product activities, encourages cross-functional workflows enabling chemists to talk to formulators and DMPK scientists to talk to clinicians, for example. With an emphasis on molecular level considerations and feedback mechanisms built in throughout the process, the risk of failure is minimised, and the likelihood of clinical success is maximised.
In this webinar you will learn about:
- Applying key techniques such as salt and polymorph screening to select and fully characterise the drug substance.
- Optimizing drug substance characteristics to influence success criteria such as stability, manufacturability (processing and scale-up) and clinical performance.
- Designing formulations for non-clinical and early clinical studies including the information gained from pre-formulation characterization studies.
- Understanding the importance of the Developability Classification System (DCS) and developing a formulation strategy for poorly soluble molecules.
- Embracing physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) for rational formulation design and mitigating risk during the transition to clinic.
- Assessing non-clinical data against the target product profile and clinical requirements to effectively guide dosage form development and dose selection for the first-in-human study.
- Simplifying the supply chain and outsourcing process to reduce risks, improve scheduling and overall timelines.