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Move from Molecule-to-Market Seamlessly with Data-Driven Strategy
May 29, 2023
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A well-designed molecule-to-market plan starts in discovery and continues into lifecycle management. As you begin to navigate the wide and ever-evolving world of clinical development and drug regulation, you may find your team in need of guidance to help you identify the right indication to prioritize and build around. IQVIA’s Regulatory Affairs and Drug Development Solutions (RADDS) group provides multi-phase support to mitigate common roadblocks. Throughout your drug’s development cycle and beyond, RADDS provides a wide range of services, including: |
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- Recommending an indication to prioritize based on scientific, commercial, and operational data.
- Developing a target product profile and clinical development plan.
- Engaging with the Food & Drug Administration (FDA) during pre-investigational new drug (IND) meetings and subsequent IND submission.
- Conducting gap analysis to identify potential pitfalls.
- Leading dossier development and submission.
- Integrating technology to increase collaboration and transparency.
Use Proven Techniques to Design Effective Strategy
No two drugs follow identical pathways to the patients who need them. However, RADDS has established tried and true metrics that can help you assemble a path to market that aligns with your goals. RADDS helps customers move through the phases of product development, constructing action plans to answer the following questions (and more):
- What assets and indications should we prioritize?
- How do we build our target clinical and product profiles?
- What gaps exist in our clinical and nonclinical plans that need to be addressed prior to our first in-human studies (FIH)?
- How do we map out our clinical trials and what will be the associated time, cost, and risks to take us through registration?
- When should we file our IND?
- What special designations might our product be qualified for?
And the support doesn’t end once marketing authorization is achieved. To ensure continued safety and access for patients, RADDS provides customers with regulatory advice, market application expansion opportunities, and variation documentation.
Where Can I Learn More?
In a recent webinar hosted by RADDS team members, Michel Denarié, Senior Principal, and Michelle Gyzen, Senior Director, they illuminate how the RADDS team aids customers, breaking down the crucial steps needed at each phase of development. To learn more about the possibilities of partnering with RADDS on your drug’s journey to market, watch the on-demand webinar. To read a full summary and case study about a long-term RADDS partnership that led to cost savings and an expedited timeline, download the comprehensive whitepaper.
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