In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week.
Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.
How can leveraging AI/ML reduce risk in drug development?
Artificial intelligence (AI) and machine learning (ML) tools offer an ultra-material-sparing approach to accelerate early-stage drug development, significantly reducing time, cost, and risk for poorly soluble new chemical entities. These in-silico tools aid in selecting the best technologies and formulations for complex molecules, such as protacs.
How do molecular dynamics and quantum calculations inform decision making?
Implementing an in-silico framework using quantum mechanical calculations and molecular dynamics simulations accelerates decision-making by predicting favorable excipients and optimal drug loading. These methods provide molecular-level insight into drug-polymer interactions, narrowing the formulation design space and avoiding extensive experimentation.
Why is shifting toward rational design driving efficiency?
The industry is moving away from extensive trial-and-error toward rational design, which uses conceptual and mechanistic models to form focused hypotheses for targeted experimentation. This efficiency-first approach leads to faster timelines, reduced expenditure of resources, and ultimately more optimized product outcomes in formulation development.
What does the excipient landscape look like in the digital era?
Excipient innovation is critical for meeting current drug development demands, especially for optimizing oral solid dosage bioavailability and enabling advanced forms like 3D-printed tablets. Digitalization and AI/ML are transforming excipient selection by using in-silico modeling to accelerate specialized strategies, such as amorphous solid dispersion development.
How are therapeutic and analytical advancements helping drug substance testing evolve?
Newer therapeutic modalities, including cell/gene therapies, peptides, and oligonucleotides, necessitate a greater emphasis on sophisticated biological assays for assessing potency, efficacy, and safety. Furthermore, data integrity, impurity characterization, and evolving stability requirements remain key regulatory focus areas, prompting the adoption of advanced analytical technologies like mass spectrometry.
Is biopharma ready for the CNPV’s rapid review?
Ultra-accelerated regulatory programs, such as the FDA Commissioner’s National Priority Voucher (CNPV) pilot (1–2 month review), mandate a shift from sequential launch activities to a parallel execution model, requiring quality, regulatory, and commercial teams to operate in lockstep. Manufacturing and quality systems must achieve near-perfection pre-submission, as the compressed review window leaves no time to resolve compliance gaps.
How should CDMOs handle audits and inspections?
Sponsor companies hold ultimate responsibility for ensuring that any contract development and manufacturing organizations (CDMOs) follow good manufacturing practices. CDMOs should proactively prepare for both regulatory authority inspections (covering the six systems) and client audits by maintaining a robust quality system encompassing corrective and preventative actions, investigations, and deviations.
