Competitive Landscape Analysis:

• Identify and analyze existing and potential future competitors in the therapeutic area.

• Assess their market share, product features, and strengths/weaknesses.

• Identify unmet medical needs and opportunities for differentiation.

Medical Value Proposition Development:

• Develop a compelling scientific and clinical rationale for the new drug.

• Translate clinical trial data into clear patient benefits and real-world impact.

• Define the target patient population and their specific needs.

Development of Medical Information Strategies:

• Develop a plan for generating high-quality medical information materials.

• Partner with medical writers to create accurate and concise summaries of clinical data.

• Establish a process for reviewing and updating medical information as needed.

Early Investigator Engagement:

• Identify key opinion leaders (KOLs) and potential investigators in the therapeutic area.

• Initiate early relationship building and information sharing with these stakeholders.

• Gather feedback on the drug's potential impact and clinical trial design.

Development of Public Policy Positions:

• Anticipate potential health policy considerations related to the new drug (e.g., reimbursement).

• Develop preliminary arguments for value and cost-effectiveness for payers.

Product development and formulation:

• Optimize the formulation of drugs or the material composition of medical devices to ensure efficacy, stability, safety, and manufacturability. 

• Selecting appropriate excipients, stabilizers, and ensuring compatibility with packaging materials.

• Collaborate with manufacturing teams to scale up production processes from laboratory-scale to commercial-scale.

Clinical Trial Support:

• Support in clinical design and interpretation.

• Ensure stable and appropriate drug formulations for clinical trials.

• Analyze trial data for pharmacokinetics and pharmacodynamics insights.