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Chief Medical Officer Summit -CMO 360°
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
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At Veristat, we pride ourselves on transforming challenges into triumphs, particularly in the complex pharmaceutical and biotech development world. Our recent collaboration with a small-sized biotech company targeting cancers of the reproductive system stands as a testament to our commitment and expertise in guiding companies through the intricate journey of Investigational New Drug (IND) submissions and beyond.
Understanding the Challenge
When this ambitious biotech firm approached us, they were determined to expedite their journey to clinical trials. However, they soon encountered the daunting complexities of the regulatory landscape. Navigating this terrain, especially for small to medium-sized companies in the pharmaceutical and biotech industries, can be overwhelming. Tight budgets and strict timelines add to the pressure, making expert guidance beneficial and essential.
Our Role and Strategy
Veristat stepped in to steer this project back on track as a full-service clinical trial and regulatory partner. We conducted a thorough pre-IND meeting and prepared for the IND submission. Our strategy was twofold: provide comprehensive support and foster an educational environment for the sponsor.
1. Strategic Consulting and Project Management
We offered strategic consulting, which included educating the sponsor about the critical elements of a successful IND submission. Our project management support ensured that every step, from medical affairs services to regulatory publishing, was meticulously planned and executed.
2. Direct FDA Interaction and Protocol Updates
Understanding the value of direct interaction with the FDA, we prepared for and facilitated these crucial meetings. This saved months of time and garnered valuable feedback, significantly enhancing the clinical trial's design and approach.
3. Adapting to Challenges
The road to FDA approval is rarely smooth. The sponsor faced several Chemistry, Manufacturing, and Controls (CMC) issues, but our team’s agility and expertise allowed us to incorporate late-breaking data into the submission swiftly. This adaptability was key in filing the IND ahead of the revised schedule.
4. Efficient Regulatory Expertise During Review
During the FDA's 30-day review period, our regulatory experts excelled in facilitating and addressing agency requests. Their efficiency was instrumental in updating the protocol and achieving a favorable outcome without any clinical hold.
The Impact
Our collaborative efforts culminated in the FDA's approval of the IND, enabling the sponsor to progress to the Phase I clinical trial, which Veristat’s global operations team has spearheaded.
This case study is a goldmine of insights and strategies for regulatory strategists, directors of operations, and VP-level professionals in the pharmaceutical and biotech industries. It underscores the significance of early and effective regulatory interactions, the importance of flexibility in project management, and the value of strategic planning in navigating the regulatory maze.
Two key lessons emerged from this successful endeavor:
Early and Effective Regulatory Interactions: Engaging with regulatory authorities early can significantly reduce costs and time to approval while mitigating potential clinical holds.
Team Flexibility and Streamlined Projects: Engaging Veristat's ability to dynamically incorporate team members from various functions streamlined the project, reducing timelines and enhancing efficiency.
As your full-service clinical trial and regulatory partner, Veristat is dedicated to guiding you through every drug development and submission stage. Our experience with this small-sized biotech firm illustrates our ability to turn regulatory challenges into successful milestones. We invite you to download our case study and explore how Veristat can be your compass in the complex journey of drug development and regulatory success.