Issue link: https://www.e-digitaleditions.com/i/1481708
4 Pharmaceutical Technology ® Trends in Formulation 2022 eBook PharmTech.com K ALYAK AN - STOCK.ADOBE.COM T ime-to-market remains a significant fac- tor in drug development today, as delays in timelines can often have costly and damaging effects, not only to the drug de- veloper but to the patient. Challenges in the drug development cycle arise early in the drug candidate screening process, but how are industry players us- ing technology to enhance workflows and shorten time-to-market? Overcoming early-stage obstacles The biggest challenges in early-stage dr ug candi- date screening are always the same when referring to small molecules—that is, new chemical entities (NCEs), says Ciriaco Maraschiello, PhD, executive vice-president and global head of drug development at Evotec, a Germany-based life science company. These challenges include safety, bioavailability (in the case of oral dosages), and the translation of both efficacy and safety from pre-clinic to clinic. Regarding large molecules, in particular mono- clonal antibodies (mAbs), translation is still an issue, Maraschiello notes. He further explains that the for- mulation aspects of large-molecule drug candidates are even more important than with NCEs because of the "commercial decision." The formulation must be developed in parallel to the lead optimization efforts in the discovery phase for large molecules, with the selected formulation being already established as the definitive formulation at the early stages of develop- ment, Maraschiello adds. "The formulation is indeed an inherent part of the efficacy of a mAb. In the case of [NCEs], it is import- ant to develop formulations that ensure the highest Using a Drug Candidate Screening Strategy to Mitigate Late-Stage Risk Feliza Mirasol, science editor An early drug candidate screening strategy should incorporate clear targets to lessen late-stage failure.