PDF Available > DSCSA serialization regulations in the U.S. and EUFMD directives in Europe are now being enforced for manufacturers. Other standards around the globe are also advancing. The focus of Life Sciences manufacturers is shifting from serialization planning and preparation to execution, management, and business value. With manufacturer requirements in place, serialization is [...]
Life Sciences Supply Chain Working Group Webinar on 11/16 @ 12-1p ET REQUEST THE PRESENTATION REQUEST FOR RECORDING This event will provide insights on emerging methods and practices for designing supply chains focused on building and maintaining close relationships with physicians and patients. Supply Chain Working [...]
The COVID-19 pandemic exposed the risks and fragility inherent in global pharmaceutical and biotechnology supply chains. This isn’t really news though. For some time, these supply chains have lagged other industries in speed, flexibility, agility, redundancy, and diversification. With risk considerations at the forefront resulting from shortages during the pandemic, the US government is [...]
Today’s biopharmaceutical supply chains often stretch around the world. Key starting materials (KSM) and API originate more frequently from Asia. Manufacturing is commonly conducted in Europe and North America. And commercial distribution is spread across the globe. This globalization has resulted in increased logistics and global trade compliance (GTC) complexity along with ever-changing import/export [...]
Clinical supply professionals are responsible for ensuring that patients on clinical trials receive the right drug at the right time for their treatment protocols. The environment is dynamic and challenging, so companies embrace innovation to enable educated and responsible supply decision making. More than ever, biopharmaceutical sponsors are moving towards a digital clinical supply [...]
Emerging pharmaceutical companies frequently place responsibility for clinical supply chain management on their clinical operations team and CROs. This approach can work initially for small, resource-constrained organizations. However, it does not help companies build the internal capabilities, knowledge, and resources to successfully run their clinical supply chain over time as they grow. One [...]
Converge develops commercial supply chain business processes, commercial systems architecture & last mile strategies. Our client was an emerging pharmaceutical company focused on rare diseases, in clinical trials with an ultra-orphan drug. There were two competitive therapies also in development, so they began preparations for commercial launch on a compressed timeline to [...]
Many of our clients are innovator companies developing novel treatments that are often complex and extremely high value. As a result, they face similar supply chain challenges in preparing for commercialization. Often, these specialty products are also orphan and rare disease treatments, as well as extremely low volume. The supply chains for these emerging [...]
Building Supply Chain Resilience The Biden Administration’s 100-Day Supply Chain Review Findings on Pharmaceuticals and APIs On February 24, 2021, President Biden signed an Executive Order on America’s Supply Chains (EO) as a step toward building more secure, robust and resilient supply chains. The EO initiated a 100-Day Supply Chain Review, which detailed an assessment of the strengths and [...]
Jeremy Friedler, senior consultant, and Rashi Gupta, consultant, focus on biotechnology and pharmaceutical operations at Converge Consulting. The COVID-19 pandemic and resulting economic crisis exposed the vulnerabilities of both domestic and global supply chains across multiple industries. Given the complexity and far-reaching global nature of their supply chains, pharmaceutical and biotechnology companies were [...]