In an increasingly competitive environment, each step of the drug development process must be strategically planned to ensure an asset’s success. Our Value & Development Consulting team helps life science organizations navigate the industry’s most pressing challenges including how to combat competitive pressure and threats, overcome access hurdles, and develop complex therapies. By providing insights across the development spectrum, our industry-leading experts can help you reduce risk and maximize the value of your product.
Our Latest Insights
Early Engagement Strategies to Set Cell & Gene Therapies Up for Success
Cell and gene therapy product development is complex and ever-evolving. Bringing a product from the research bench to the bedside can be a very challenging journey. A group of our experts sat down to discuss what key elements drug developers need to focus on in the early stages of their cell and gene therapy program that will set them up for future success.Learn More
Oncology Developer Utilizes Integrated Scientific Advice to Optimize Phase III Trial, Aligning Regulator and HTA Needs
Gain insight into how Evidera’s Value & Development Consulting team leveraged our Integrated Scientific Advice (ISA) offering to provide feedback to drug developers to optimize their evidence generation plans and satisfy stakeholder requirements.
Incorporating Innovation into the 505(b)2 Development Pathway
Utilizing innovative approaches to the 505(b)2 pathway can save companies time, money, and resources in developing their new product. This webinar will examine the benefits and challenges associated with the 505(b)2 pathway and how innovative solutions and planning in the early stages of development can help support a more streamlined and faster pathway towards approval.View On-Demand
Navigating US FDA Initiatives to Expedite Development, Approval, and Emergency Access to COVID-19 Treatments
The availability of these multiple FDA pathways makes it difficult to identify which pathway is appropriate for specific assets, and the timing of FDA interactions to seek approval/concurrence for the selected pathway. This webinar will provide a concise overview of these FDA initiatives and strategic regulatory guidance for selecting the optimal regulatory pathway for COVID-19 treatment development programs in the US.View On-Demand
Four Considerations to Shape Your Orphan Drug Designation Application StrategyRead Now
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Learn more about the consulting solutions we provide across the drug development lifecycle.
Regulatory Consulting & Product Development