In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.
The newly developed G1-3 fermentation process makes use of short, straightforward fermentation regimes for optimized space time yield.
This webinar will review regulatory expectations in assessing the comparability of biosimilars through protein chemistry techniques and cell based bioassays. Key considerations for developing robust bioassays for biosimilar comparison will be presented.
A recent survey conducted by the Economist Intelligence Unit highlights the new products that the biopharma industry identifies as most disruptive to their growth strategies in the next five years. The findings raise a challenge to biopharma to go beyond barriers to bringing new products to market by presenting ways to overcome these hurdles and make novel therapies a reality.