STREAMLINE YOUR DRUG DEVELOPMENT JOURNEY

Expert guidance from discovery to market

Streamline your drug development process and reduce time-to-market with an integrated asset development framework. From early-stage research to late-stage commercialization, we leverage AI technologies to enhance the strategic guidance and support needed to clear regulatory hurdles, design robust clinical trials and develop effective market entry strategies.

NAVIGATING ASSET DEVELOPMENT

A synchronized approach

By combining regulatory, clinical, and commercial strategies with advanced AI/ML analytics and methodologies, we improve the efficiency and effectiveness of your drug development. Leverage Healthcare Grade AI® throughout your strategic planning — from prioritizing the best indications for your asset through operational feasibility assessments. Manage changing market conditions and stakeholder needs effectively with Integrated Asset Development solutions.

Explore our suite of Integrated Asset Development solutions

INDICATION PRIORITIZATION AND SELECTION

Unlocking therapeutic potential

Choosing the right indication for a new therapeutic is a crucial decision that can involve numerous possibilities. Our experts help you prioritize indications not just based on scientific rationale, but also by considering the complexities of clinical development, regulatory strategy and commercial potential. Guide your drug development journey with a comprehensive view of disease landscapes, competitive environments and market opportunities.

TARGET PRODUCT PROFILE DEVELOPMENT

Charting the course

Your Target Product Profile is a strategic planning tool that outlines your product’s critical attributes, from efficacy and safety to manufacturing and pricing. Defining these attributes early on fosters stakeholder alignment, facilitates efficient resource allocation, and increases the likelihood of developing a successful product. Our experts will delve into the intricacies of your product — understanding its unique strengths and potential applications — and align these insights with market needs, regulatory requirements and competitive landscapes, resulting in a clear, compelling profile.

PRE-CLINICAL CONSULTING

Optimize for safety and efficacy

Assure your product safety and effectiveness before it enters clinical trials. Work with a dedicated team who understands the complexities of non-clinical development activities, including safety assessments, toxicology and pharmacokinetics / pharmacodynamics (PK/PD) aspects. Get the critical insights you need to inform the design and execution of your clinical development program.

OPTIMIZED CLINICAL DEVELOPMENT PLANNING

Steering the course

Ensure your product's unique attributes and market objectives are met with a tailored clinical development plan. Strategic guidance on study design, patient population selection, endpoints determination and regulatory strategy allow you to make evidence-based decisions for your clinical development program. By outlining a clear strategy, setting realistic goals and preparing for potential risks, you can increase the likelihood of your product’s success.

PLANNING FOR REPRESENTATION AND ACCESS

Ensuring access for all patient populations

Representative practices in clinical trials is essential for ensuring products are safe and effective for all populations. Address gaps in care by reaching the minority subgroups most impacted by the disease state within your clinical trial. Targeted recruitment and retention strategies that extend from action plans through study design and site selection ensure your therapy meets the needs of the patients who need it most.

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