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 [...]

Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies

By |2022-06-30T16:04:53-04:0006/30/2022|

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 [...]

Benefits of Using Foreign Trade Zones for Emerging Biotech Companies

By |2024-04-11T11:37:12-04:0012/07/2021|

Benefits of Using Foreign Trade Zones for Emerging Biotech Companies We often see clients incurring high duties on importing key starting materials into the US. For emerging companies conducting R&D, paying duty on each import can significantly impact cashflow, sometimes measuring in the hundreds of thousands of dollars. This impact is amplified [...]

Scaling Clinical while Preparing for Commercial Supply

By |2024-02-06T10:31:40-05:0009/17/2019|

Scaling Clinical while Preparing for Commercial Supply Introducing Demand & Operations Planning PDF Version 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 [...]

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