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 [...]
Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies The CMC landscape is complex, uncertain, and dynamic, driving the CMC team to constantly adjust their plans and timelines. It can be challenging for Finance to assess the upstream and downstream impacts of such changes. Similarly, strategic business changes [...]
Webinar on May 26 @ 11a-12p ET What CMC and Finance Leaders Need to Know about Aligning CMC Programs with Finance CMC and Finance leaders often find themselves at odds with one another at many emerging companies. The CMC landscape is dynamic, often changing substantially. It can be difficult [...]
CMC Project Plans: A Critical Tool for Early-Stage Biopharma The Challenge for CMC Teams CMC activities are critical to early-stage biopharma companies preparing for commercialization. Growth of the company depends on the CMC team achieving milestones, which are technical and cross-functional. They also typically require capital investments. CMC teams operate in [...]
A gene therapy company spent over a decade developing their first-generation product, partnering for many early development capabilities. Then when the product was moving into the final stage clinical development, they bought out the rights and now owned 100% of the molecule. However, with a lean organization who had limited CMC and analytical [...]
Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a question of how much, and how soon? We see some companies 'build for success' who [...]
PDF Available > Development of advanced therapies requires innovative manufacturing and process engineering. CMC (Chemistry, Manufacturing, and Controls) activities expand, evolve, and refocus over time. Companies move from toxicology studies through IND-enabling activities, and from preclinical and clinical testing through commercialization. Tasks and objectives change, but the need for speed, precision, flexible thinking, and [...]
CMC QA/The Quality System Webinar on 9/30/2020 Essential Characteristics of a Stage-Appropriate Quality System Read the Event Recap Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place. By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The challenge is in establishing an appropriate [...]
Introducing Demand & Operations Planning Assumptions and decisions built into clinical trial design have a major impact on emerging companies’ capacity planning and supply strategy. Protocol changes affect enrollment rates, production volumes, regulatory activities, logistics and managing data. It makes planning particularly challenging for both clinical and commercial production. Our client was [...]