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Blog & Resources Webinars Which Product to Develop? Product Selection and the Importance of Early Strategic Design for Success

Which Product to Develop? Product Selection and the Importance of Early Strategic Design for Success

Date: October 5th, 2017

Author: Ken Phelps, President & CEO, Camargo Pharmaceutical Services

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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 Camargo, 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 the four quadrants Camargo believes 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 Camargo 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?

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

 

Learn More

At 11 am Eastern today, October 4, 2017, Camargo CEO Ken Phelps will give a free hour-long webinar on Product Selection. Click here to register for and participate in the webinar, as well as receive the valuable questions and answers given and taken during the webinar afterward.

The Camargo team develops each of our client-partner’s 505(b)(2) drug candidates in cross-functional teams with expertise in CMC, Pharmacokinetics, and Toxicology, from our 40+ in-house PhDs. Contact us to learn more about partnering with a multi-disciplinary team ready to bring unparalleled experience and expertise to your drug development strategy.


Get Our Diverse Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our Solutions or Contact Us.


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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