DCAT Week debuted a new education program on Tuesday, “The Best Practices Platform: Industry Case Studies.” Tapping into the expertise and experience of DCAT Member Companies, this program provided concrete, specific examples of innovative approaches to optimize the bio/pharma customer–supplier relationship to make supply more robust, cost- and time-efficient, and secure.

Case Study from Biogen’s Development Pipeline on Using a Sustainability Efficiency Scorecard

First, Suzanne Opalka, associate director, chemical process development, biogen, and Ken Shultis, managing partner, Rondaxe Pharma, gave a presentation on how Biogen has adopted a sustainability efficiency scorecard to evaluate its manufacturing process using green chemistry metrics—thereby achieving milestones in achieving a more safe, efficient, practical and sustainable process.
 
Rondaxe’s SimpliDATA platform helped Biogen to understand what the weaknesses of its processes were by analyzing data and scoring categories including safety, operations, carbon dioxide, environmental impact, efficiency and complete E-factor. It then helped to accelerate continuous improvement by targeting these weak points.

De-Risking Raw Materials Supply Through a Joint Audit Model

Jennifer Goodman, senior director of quality, Avantor, and Priya Patel, senior quality manager–auditing, PTC Therapeutics, discussed how a joint audit program approach can help suppliers de-risk supply chains.
 
They are called “joint” audit programs because the sponsors “join” together to have a single collaborative audit conducted, while confidentiality is maintained for the sponsors. This allows for the cost of the audit to be shared among the sponsors, reducing cost burden for them, as well as overhead and time burden for the auditee.
 
These audits, intended to help establish and share best practices for supply-chain security, are designed to be more thorough than those conducted by individual pharmaceutical manufacturers because they focus on the entire supply chain from the origin of raw materials to shipment of product.

Utilizing a Customized Risk-Based Governance Model

Lastly, Max Brescia, senior global director, contract manufacturing, oral solid dose, API and fermentation, AbbVie, talked about the benefits of establishing a customized risk-based governance model—a framework that outlines the organization’s general leadership accountabilities and sets the interaction rules.
 
This model allows bio/pharma companies to operate with greater confidence and agility in a highly regulated and risk-sensitive environment.
 
Benefits of adopting a customized risk-based governance model include:
 

• Improved decision-making: By focusing on the most critical risks, resources are allocated more effectively.
• Enhanced compliance: The model helps ensure the company adheres to industry regulations and ethical standards.
• Reduced errors and incidents: Proactive risk mitigation leads to fewer problems and improved patient safety.
• Increased efficiency: Streamlined processes and controls save time and money.