Lost in translation? – How you can smoothly progress to clinical development and beyond
by Diane Seimetz
The transition from R&D to clinical stage is an important phase in biopharmaceutical product development. The conventional clinical development paradigm consisting of phase 1, phase 2 and phase 3 clinical studies may no longer apply to all programs. The enhanced use of biomarker and adaptive clinical trial designs have led to a more streamlined development with combined clinical phases, such as phase 1/2 or phase 2/3 study designs. For some product categories, such as ATMPs or orphan products, the first study could already lead into a pivotal study, depending on the effect size and safety profile. The acceleration of clinical development – though highly desirable – has substantial implications on the manufacturing and quality control strategy (CMC) and the overall development approach.
For a smooth transition to clinical development stage, careful and intertwined upfront planning across important drug development disciplines is essential. This includes for example smart selection of the lead candidate, a tailored nonclinical program, a well thought out manufacturing and control strategy, and a diligent plan towards the first in human study including risk mitigation strategy. Involvement of regulatory agencies at defined milestones should be considered as well to increase the success rate. The set-up of an integrated development and regulatory plan is a valuable approach towards structured drug development. The discussion in a multidisciplinary team ensures that no essential element is missed.
An overview of the key steps for transition from research to development is shown in Figure 1.
Figure 2: Addressing translational challenges
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Parrish MC, Tan YJ, Grimes KV, Mochly-Rosen D: Surviving in the Valley of Death: Opportunities and Challenges in Translating Academic Drug Discoveries. Annu Rev Pharmacol Toxicol. 2018 Sep 12.