Product Selection and the Importance of Early Strategic Design for Success

Why do some new drug products gain approval, but launch with lower-than-anticipated drug sales? Why then can some drug products gain approval and launch and perform well commercially? Is it possible to align a new drug product candidate for success at launch?

At Premier Consulting, we believe it is possible to position a drug candidate for success from the beginning. We believe early strategy applied to a drug candidate and its development program will have a direct positive effect when it launches. We call this early strategic alignment and design Product Selection.

What Is Product Selection?

Product Selection is based on four quadrants each drug development program needs to be successful. The four quadrants include:

• Regulatory
• Scientific
• Medical
• Commercial

Each aspect is carefully developed and analyzed early to ensure each of the four areas for the drug development candidate are aligned with the target from the beginning.

The Four Quadrants

Regulatory

From the inception of a drug development program, it is possible to take the various regulatory requirements and consider the necessary elements for 505(b)(2) approval. One important guide for development is a Target Product Profile.

Additional considerations include:

• Can we influence what program is necessary and required?
• Is the clinical design protocol optimal and creative?

Scientific

Recent statistics prove many Refuse to File letters from the FDA result from underdeveloped or insufficient Chemistry, Manufacturing, and Controls (CMC). One important factor in developing optimal CMC is to rely on in-house experts in every stage of development. That way, CMC is built in to every aspect of the development, and prevents later uncorrectable errors.

Additional considerations include:

• Can the CMC be done?
• Will the manufacturing be reliable and consistent?

Medical

Relying on the above-mentioned Target Product Profile, Medical considerations ensure alignment with a recognized patient need. The future target audience is determined, as well as how they think about the therapeutic space. These determinations identify the customer and patient journey, as well as current available treatments.

Additional considerations include:

• Does the product satisfy an unmet need?
• Do we understand the practice of medicine related to the unmet need?

Commercial

The patient journey helps a drug developer to understand the decisions and choices a patient makes to select the drug they buy. A qualitative Strategic Assessment is needed to understand the behaviors and needs of future customers, including the dynamics with health care providers, caregivers, patients, payers (insurance, commercial and government), distributers, policy developers, and advocacy organizations.

Additional considerations include:

• Is the product commercially viable?
• How will it be reimbursed?

Premier Consulting utilizes and assesses the four quadrants throughout product development in order to ensure alignment for success.

Learn More

The Premier Consulting team develops each of our clients’ drug candidates in cross-functional teams. Contact us to learn more about partnering with a multi-disciplinary team ready to bring unparalleled experience and expertise to your drug development strategy.