Event Recap: Supply Chain Planning for Today’s Uncertain World

By |2023-06-28T16:44:42-04:0004/06/2023|

Event Recap: Supply Chain Planning for Today’s Uncertain World Contributors: Supply Chain Director Jeremy Friedler, Supply Chain Consultant Sean Carroll & Intern Ryan Chapados Uncertainty and risk have been consistent themes inherent to biopharmaceutical supply chains. The recent pandemic has only amplified this notion. Since the pandemic started, many emerging companies [...]

DSCSA Implementation & Readiness Efforts for 2023

By |2023-03-21T11:13:11-04:0003/20/2023|

DSCSA Implementation & Readiness Efforts for 2023 2023 is a crucial year for pharmaceutical trading partners as the Drug Supply Chain Security Act (DSCSA) deadline for full traceability approaches in November. To allow supply chain stakeholders an opportunity to share their perspectives, the FDA held a 2-day virtual public meeting. DSCSA Implementation [...]

Event Recap: What CMC & Finance Leaders Need to Know about Maintaining Alignment on CMC Programs

By |2023-07-07T11:38:00-04:0002/28/2023|

Event Recap: What CMC & Finance Leaders Need to Know about Maintaining Alignment on CMC Programs CMC and Finance in emerging biotech companies are important partners, but they often find themselves at odds with one another. Complex CMC programs are dynamic, often changing substantially, and require large investments. Similarly, the financing environment in [...]

Traps to Avoid When Preparing for Commercial Launch

By |2023-04-17T10:39:49-04:0002/23/2023|

April 6 @ 6-8p Eastern | Boston Marriott Cambridge Traps to Avoid When Preparing for Commercial Launch Preparing for commercial launch is a big deal for most companies. It requires strong leadership and coordination across many functional areas. There are also technical and regulatory hurdles. The company is investing significant efforts and [...]

Minimizing COI & COC Risk

By |2023-02-07T13:24:28-05:0002/07/2023|

Minimizing COI & COC Risk 3 Essential Components for Autologous Cell Therapy Facilities Originally Published as a MassBio Guest Blog Autologous cell therapies involve collecting and processing a patient’s own cells, and later administering the processed cells back into the body to treat the same patient. The personalized nature of these [...]

What Commercial Companies Need to Know about S&OP

By |2024-02-06T14:12:14-05:0011/09/2022|

What Commercial Companies Need to Know about S&OP Sales and Operations Planning (S&OP) is an iterative planning process. It ensures cross-functional alignment on sales forecast and performance, as well as manufacturing forecast and performance. It also provides visibility into forecasted demand and an accurate view of volumes for inventory and production. With this [...]

Event Recap: 2022 & Beyond – Serialization Requirements for Manufacturers

By |2022-11-14T11:53:27-05:0010/25/2022|

Event Recap: 2022 & Beyond - Serialization Requirements for Manufacturers To ensure product safety, the Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks product movement and traceability through the supply chain. The sharing of data is dependent on the Electronic Product Code Information System (EPCIS). Although [...]

Supply Chain Planning for Today’s Uncertain World

By |2023-04-13T14:30:15-04:0009/05/2022|

Webinar on October 19 @ 11a-12p Eastern Supply Chain Planning for Today's Uncertain World Read the Event Recap Supply chain leaders in life sciences companies operate in a highly uncertain environment. Commercial and regulatory uncertainty is now compounded by the risk of supply disruptions and geopolitical barriers. For companies [...]

Info Sheet: Extending Your Quality Capabilities

By |2024-02-06T15:00:21-05:0008/18/2022|

Extending Your Quality Capabilities Info Sheet Download PDF Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance from early in the lifecycle. A well-designed and stage-appropriate Quality Management System (QMS) is essential to facilitate the development and commercialization of these advanced [...]

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