ERP Implementations: How to Ensure a Successful Business Go-Live This series starts with ERP Implementations: Understanding Technical Versus Business Go-Live, which focuses on why it is critical to balance the requirements of both for success. Achieving successful go-lives across both the technical and business dimensions is essential to ensuring a successful Enterprise [...]
Event Recap: Avoiding Common Traps in Commercial Launch The commercial launch of a new drug is a make-or-break moment for a company. It represents the culmination of years of R&D, and the potential for significant benefit to patients, as well as financial gain for the company. Emerging pharmaceutical and biotechnology companies often partner [...]
September 14 @ 11a ET | Webinar Digitization of the Supply Planning Process for Growing Biopharma Companies Digital transformation allows companies to reinvent themselves. Organizations can reimagine how work is done and how to create and deliver value to customers. Your company will need to decide when it’s appropriate to embark on [...]
Navigating Stage-Appropriate Quality System Design Originally Published as a MassBio Guest Blog Our emerging biotech and biopharma clients often request support from our skilled consultants and practitioners to develop a “Stage-Appropriate cGMP Quality System." However, we find that they are often not fully aware of what “stage-appropriate” means or what it looks [...]
ERP Implementations: Understanding Technical Versus Business Go-Live Many life science companies rely on enterprise resource planning (ERP) to help manage and integrate essential parts of the business. Implementing an ERP solution is a major undertaking for any organization. Even when the right ERP option is selected, implementation must consider the needs of [...]
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 [...]
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 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 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 [...]
Webinar on June 20 @ 2-3:30p Eastern Building a Roadmap for the CMC Portion of Your BLA Submission The New England chapter of the PDA is offering this webinar where Todd Applebaum of Converge Consulting and Vijay Chhajlani of ModeX Therapeutics will break down the elements of a strong [...]