BioPharm International: Using Risk-Based Quality Frameworks to Fast-Track Biopharma Development: A Q&A with Abzena’s Dr. Jeffrey C. Mocny

In this article in BioPharm International, Abzena’s Dr. Jeffrey C. Mocny discusses how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data to improve patient outcomes and safety.

Click Here to Listen to the Interview

In a recent Q&A with BioPharm International, our VP of Regulatory Strategy, Dr. Jeffrey C. Mocny, explores how embedding quality risk frameworks early, coupled with leveraging prior knowledge that CDMOs possess, is helping sponsors move faster, make better decisions, and ultimately get products to patients more efficiently.

The discussion highlights how FDA guidance changes, adaptive clinical trial designs, and data integrity are transforming the drug development lifecycle. They note how, by embedding quality risk management into initial process designs and leveraging prior knowledge from contract development and manufacturing organizations (CDMOs), the industry can achieve greater manufacturing efficiency, faster innovation, and improved patient outcomes.

BioPharm: How are evolving global regulations shaping biopharma quality standards?

Dr. Mocny (Abzena): There is a shift toward risk-based thinking and leveraging prior knowledge as often as possible. As drug developers, we need to understand the products we manufacture and maintain control over the manufacturing process, materials, and analytical aspects to demonstrate the molecule meets requirements. As regulators adopt this risk-based thinking, leveraging the prior knowledge held by CDMOs offers opportunities to use existing tools in new ways to allow for faster innovation. This reduces development time and allows developers, sponsors, and CDMOs to focus on better patient outcomes and faster-to-market strategies.

How do recent vaccine and immunization guidance changes affect compliance?

Dr. Mocny (Abzena): Recent FDA guidance and changes in thinking will change the landscape. Placebo-controlled mandates are beneficial for understanding drug performance, and returning to these clinical trial basics is helpful. Reduced animal testing and the incorporation of real-world evidence offer better chances for novel strategies to reach the market and affect positive health outcomes. From a CDMO perspective, this introduces aspects of supply chain and strategic compliance, such as the BIOSECURE Act.1 This has caused intensified oversight of local US-based manufacturing operations, which benefits the market by driving the development of high-quality, patient-centric medicines. It also offers CDMOs an opportunity to modernize approaches, be more competitive on the global market, and offer higher-quality materials at lower prices.

Click Here to Read the Full Interview