On-Demand Conference Video: Gene Therapy Immunogenicity
Assays that measure neutralizing antibodies (NAb) have become an essential part of the development process for many gene therapeutics. When these NAb assays are used to determine eligibility for treatment, there are heightened regulatory concerns.
On-Demand Webinar: Pricing Strategies for Advanced Therapies
There is no doubt that the advanced therapies sector is growing at an exponential rate. According to a recently published 2021 Report by ARM (Alliance for Regenerative Medicine), the sector has raised $14.1B in financing in the first half of 2021 which is already 71% of what was raised in all of 2020. In addition, there are over 2,600 advance therapy clinical trials being conducted with 264 of those trails being Phase 3 trials and another 1,500 being Phase 2 trials.
AMCP & Precision ADVANCE Corporate Training Program
Cell and gene therapies present tremendous clinical and humanistic opportunity to change the course of disease but also present several unique aspects that differ from more traditional therapies. These differences will impact how innovators develop evidence and manufacture and distribute products. Payers also need to adapt how they assess value, make coverage decisions, and manage reimbursement.
Focus on Drug Prices Continues Amid Uncertainty Over Potential Changes
High prescription drug prices continue to be of concern at the federal level. Despite proposed changes to drug pricing policy by the administration and HHS, industry experts question whether any significant changes will occur in the near future. Precision’s Ryan Cox and Erin Lopata weigh in on the factors contributing to the uncertainty about drug policy pricing changes.