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 [...]

CMC Project Plans: A Critical Tool for Early-Stage Biopharma

By |2022-01-25T10:42:30-05:0001/25/2022|

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 [...]

Ensuring the Path to Compliant Analytical Methods

By |2024-02-06T10:27:14-05:0011/06/2020|

Ensuring the Path to Compliant Analytical Methods PDF Version 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, [...]

Event Recap: Stage-Appropriate Quality Systems

By |2023-06-28T11:34:04-04:0010/22/2020|

Event Recap: Stage-Appropriate Quality Systems Ashutosh Pandit, Consultant & Todd Applebaum, Managing Director 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 [...]

Info Sheet: CMC Expertise

By |2024-02-06T15:11:57-05:0009/18/2020|

CMC Expertise Info Sheet Download PDF 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 [...]

Essential Characteristics of a Stage-Appropriate Quality System

By |2023-01-03T16:18:28-05:0008/18/2020|

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 [...]

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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