GBI’s Amita Quadros, Ph.D., Vice President of Commercial Operations participated in this Pharma Almanac’s roundtable discussion.
The topic of discussion was “The biopharmaceutical industry faces increasing pressure to reduce time-to-market. What strategies are being employed to accelerate product development and commercialization without compromising quality?”:
Amita Quadros, Ph.D., Vice President of Commercial Operations, GBI
The biopharmaceutical industry has been actively exploring various strategies to accelerate product development and commercialization while maintaining high-quality standards. Some of the key strategies include:
1. Advanced technologies:
• Using artificial intelligence (AI) and machine learning (ML) for drug discovery, target identification, and predictive analytics to streamline the research and development process.
• Developing platform technologies that can be applied to multiple products or therapeutic areas, allowing for more efficient development processes and economies of scale.
• Analyzing large data sets to gain insights into disease mechanisms, patient populations, and clinical trial outcomes, enabling more informed decision-making.
• Employing adaptive trial designs that allow for real-time adjustments based on interim data analysis. This helps optimize the trial process and reduce timelines.
2. Continuous manufacturing:
• Transitioning from traditional batch manufacturing to continuous manufacturing processes, which can lead to increased efficiency, reduced costs, and a more agile response to market demands.
3. Collaborative Partnerships and Regulatory Pathways:
• Forming strategic collaborations and partnerships with academic institutions and other pharmaceutical companies to leverage complementary expertise, resources, and infrastructure.
• Taking advantage of expedited regulatory pathways, such as the FDA’s Fast Track, Breakthrough Therapy, and Accelerated Approval programs.
By combining these strategies, the biopharmaceutical industry can combat challenges associated with time-to-market pressures, accelerate innovation, and bring safe and effective therapies to patients more rapidly.
