Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
I’m a Senior Consultant within the Product Lifecycle Management team, acting as a Subject Matter Expert and Project Manager for drug development projects. I create and implement key strategic plans for a variety of life-science clients and manage complex manufacturing and transfer projects for products under development or already licensed. Within my role, I aim to get products to market efficiently while maintaining and adhering to regulatory and safety requirements, ensuring only high-quality drugs are in the hands of patients.
One of the most impactful concepts I learned and applied early in my career was the use of Quality by Design (QbD) in the development of drug therapies. QbD is a systematic, proactive approach to embedding quality considerations across the entire product lifecycle, from conception through production. The core principle of QbD is to identify and understand the relationships between a product's Critical Quality Attributes and the Critical Process Parameters that influence them. Applying QbD principles to drug development and manufacturing enhances safety, efficacy, and overall quality, while also reducing timelines.
The pharmaceutical industry is highly regulated to ensure drug safety and efficacy, but navigating its complex and evolving regulatory framework can be difficult. ProPharma has a large team of experienced and knowledgeable professionals who can support and guide clients through this regulatory landscape.
Pharmaceutical companies are increasingly outsourcing drug development and manufacturing to optimize costs, enhance flexibility, and access specialized expertise that benefits both clients and patients. However, outsourcing multiple activities demands greater oversight and coordination to ensure a smooth workflow and maintain timelines—something my colleagues and I at ProPharma have extensive experience with.
Clients benefit by gaining access to experienced and knowledgeable professionals who have managed products from conception through end-of-life. The PLM team ensures that products are efficiently developed, avoiding budget overruns, delays, and design failures. By leveraging their expertise, ProPharma's PLM specialists guide clients in defining processes that optimize efficiencies, selecting technology tools that improve data transparency and reporting, and collaborating with the right partners. This comprehensive approach ensures high-quality, cost-effective products reach stakeholders smoothly and on schedule.