The global pharmaceutical supply chain is a complex network vital for patient health, and its components are undergoing a period of significant transformation. In this webinar, Marken’s regulatory experts will share a comprehensive overview of the current state of these intricate systems, examining the confluence of evolving regulatory landscapes and the disruptive impact of recent US policy shifts. Speakers will delve into the intricacies of international sourcing, manufacturing, and distribution, highlighting the vulnerabilities and emerging opportunities that define today’s supply chain environment. 

A key focus will be on the profound influence on recent changes in U.S. policy, particularly the implementation of tariffs and their effects, such as the push for onshoring or nearshoring of pharmaceutical production. We will analyze how these measures are reshaping global trade flows, impacting drug costs, and potentially altering the structure of international logistics networks. The discussion will also address the ongoing challenges of maintaining stringent regulatory compliance across diverse jurisdictions - examining the implications of these policy changes for Good Manufacturing Practices, quality control, and the overall integrity of the pharmaceutical supply chain in a dynamic global environment. 

Join Mike O'Mara, COO of Cellipont Bioservices, and Marcia Blackmoore, VP of Customer Operations at L7 Informatics, for a candid conversation on what it really takes to digitalize cell therapy manufacturing. Moderated by Contract Pharma, this session will explore how a data-first approach drives scalability, ensures traceability, and accelerates time-to-market—without compromising on quality.

Bringing a sterile injectable product from development to commercialization requires a seamless scale-up process—one that minimizes risk, optimizes efficiency, and ensures regulatory success. In this exclusive webinar, experts from August Bioservices will discuss the critical factors that make or break a successful scale-up, sharing insights from a CDMO’s unique perspective.

Our discussion will focus on three key perspectives:

• • Talent & Expertise: Scaling a business requires specialized expertise across multiple disciplines—from formulation development and process optimization to analytical testing and regulatory compliance. We will explore how the right talent at each phase of building a sterile injectable CDMO ensures that the right people are in the right roles at the right time, mitigating bottlenecks before they arise.
• • Equipment & Facility Readiness: Having the right infrastructure in place is crucial to scaling a CDMO. We’ll discuss how state-of-the-art manufacturing lines, flexible capacity, and facilities designed to meet global regulatory requirements play a role in accelerating scale-up while maintaining product quality and regulatory compliance.
• • Customer-Centric Approach: A CDMO is more than just a service provider, it’s a strategic partner. We’ll highlight why close collaboration with clients throughout the development and scale-up process is essential, ensuring alignment on goals, timelines, and quality expectations. From early-stage development through commercial launch, our team works as an extension of our clients’ teams, and that collaborative approach ultimately serves to de-risk the process and enable long-term program success.