Biograph Capabilities to Fast-Track Innovation
Capabilities
Biograph serves pharmaceutical, consumer healthcare, and medical device companies with strategies and solutions that expand access to treatment. Biograph offers innovative approaches to personalize treatment journeys and extend product lifecycles.
Biograph applies a unique set of capabilities and digital care connectivity to activate portfolio strategies for business growth. Our team helps companies navigate access frameworks, regulatory guidelines, and commercial implications as they consider investments in consumer engagement, novel distribution models, and portfolio expansion.
Strategic Business Planning
Landscape Assessments
Rx-to-OTC Switch / NPD
Investment Rationale
Access Planning
Care Interventions
Move from Idea to Implementation with Optimal Speed and Certainty
Embrace FDA Policy Evolution
Biograph helps internal, cross-functional teams to understand the intent and intricacies of new regulations, including the ACNU and PMI rules.
Together, we facilitate a team exercise to break down complexities in the rule, highlight key requirements, explore eligibility criteria, and summarize potential benefits and drawbacks for the company's specific products, categories, and future investment decisions.
Assess Investment Options to Inform Business Decisions
Biograph works with client teams to assesses the suitability of product candidates for company investment. In this exercise, called the Biograph BD Thesis, candidates may include products that likely will need an ACNU and may include some that can be pursued via conventional regulatory pathways. The BD Thesis renders a fully auditable business conclusion informed by both qualitative and quantitative inputs.
Engineer New Products and CX for Enduring Value
Once a drug product is identified, Biograph works with the sponsor company to develop a Pre-IND that reflects the chosen regulatory pathway. In the case of ACNU programs, Biograph works with sponsors to design and specify an engaging Consumer Experience (CX) of Additional Labeling and Additional Conditions for safe nonprescription use of the product.